DC Metro Area Medical Malpractice Law Blog

Posted by: Salvatore J. Zambri, founding member and partner

Health Affairs, which touts itself as the leading journal of health policy and research, recently published results of a survey indicating that at least some physicians are not always open or honest with patients.  Health Affairs is a multidisciplinary journal that covers a wide range of health care topics. It was founded in 1981as part of Project Hope, a nonprofit international health education organization. According to the survey of physicians, varying attitudes exist regarding how much information should be relayed to patients.  The excerpt below summarizes the survey results as well as the opinion of Health Affairs authors.

"The Charter on Medical Professionalism, endorsed by more than 100 professional groups worldwide and the US Accreditation Council for Graduate Medical Education, requires openness and honesty in physicians’ communication with patients. We present data from a 2009 survey of 1,891 practicing physicians nationwide assessing how widely physicians endorse and follow these principles in communicating with patients. The vast majority of physicians completely agreed that physicians should fully inform patients about the risks and benefits of interventions and should never disclose confidential information to unauthorized persons. Overall, approximately one-third of physicians did not completely agree with disclosing serious medical errors to patients, almost one-fifth did not completely agree that physicians should never tell a patient something untrue, and nearly two-fifths did not completely agree that they should disclose their financial relationships with drug and device companies to patients. Just over one-tenth said they had told patients something untrue in the previous year. Our findings raise concerns that some patients might not receive complete and accurate information from their physicians, and doubts about whether patient-centered care is broadly possible without more widespread physician endorsement of the core communication principles of openness and honesty with patients."

If knowing the complete information about your health is important to you, discuss your concerns with your physician.  Do you want all news, even when it's bad?  Would you rather not know?  The decision is very personal and individual, but making certain that you and your physician are in agreement should be important to everyone.  At a minimum, you should be informed of all information necessary to make fully-informed decisions about your health.

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Posted by: Salvatore J. Zambri, founding member and partner

Medical devices such as artificial joints, heart defibrillators and surgical mesh have become an integral part of the healthcare industry.  As consumers, we would naturally expect that those devices have been tested for safety and effectiveness. In reality, many implants and other high-risk devices on the market have not undergone any safety testing.  Rather, the manufacturers have frequently only  filed paperwork and paid the mandatory FDA user fee to market those items. 

In 2011, the Institute of Medicine of the National Academies, an independent, non-profit organization that works outside of the government to provide unbiased and authoritative advice to decision-makers and the public, released a consensus report concluding that "the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle." In summary, they recommended that the FDA completely overhaul its system that regulates medical devices because presently it doesn't ensure patient safety either before or after products are on the market.  Surprisingly, Congress is currently working on a new law that neither addresses the failures of the current FDA process nor forces manufacturers to sufficiently safety test devices. Rather, its goal is to allow them to market devices even faster.  That's a shame.

Posted by: Salvatore J. Zambri, founding member and partner

According to a recent investigative study by the Center for Public Integrity, a nonprofit organization that focuses on ethics and public service, contaminated surgical instruments are creating additional worries for surgeons and their patients.  Surgical tools are supposed to be cleaned and sterilized between operations, and manufacturers of those tools are supposed to provide detailed instructions for the cleaning process.  A big part of the problem is that cleaning technicians are not required to obtain any certification at all to clean and sterilize instruments.  By comparison, manicurists and dog groomers are required to take infection control courses for licensing.  Another part of the problem is that manufacturers are not required to design devices that can be easily cleaned in real world environments. The end result is that instruments frequently come into the operating room carrying bits of blood, bone and tissue from a previous operation, as well as potentially dangerous and sometimes deadly bacteria.  Earlier instruments were primarily made of metal or glass, both of which can withstand high temperatures required for sterilization.  Newer high-tech devices cannot withstand that level of heat and must be cleaned.  

Hospital-acquired infections continue to be problematic because of the difficulty in tracking them and the challenges of thoroughly cleaning reusable medical devices.  During a workshop held last summer by the FDA, representatives from manufacturers, hospitals, CDC and FDA, a presentation by Jahan Aziz, a major hospital's risk management clinical engineer, demonstrated how prevalent the problem is.  After showing the group 350 surgery-ready suction tips, which were cleaned by the recommended method, he revealed that 343 of them contained debris from earlier procedures. According to Charles Hancock, an independent medical device sterilization consultant, the supply of dirty devices in hospitals is potentially massive due to the design of the instruments, the lack of training for cleaning technicians, and the frantic pace of the instrument sterilization process. 

The FDA is working on creating a draft recommendation for reprocessing of medical devices as well as suggestions for manufacturers' development of more robust instructions for reprocessing for the real world hospital market. In addition, the draft is intended to serve as a guide for device manufacturers as they seek FDA clearance for new devices.

As this story develops and more information is available from the FDA reviews and recommendations, we will revisit the topic and post another blog entry.

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Posted by: Salvatore J. Zambri, founding member and partner

According to a recent article in the New York Times, inconsistent guidelines are prevalent among radiology oncologists and breast cancer surgeons. "Nearly half of women who had lumpectomies for breast cancer had second operations they may not have needed because surgeons have been unable to agree on guidelines for the most common operation for breast cancer, a new study finds. It also hints that some women who might benefit from further surgery may be missing out on it." 

Dr. Laurence Cahill, author of the study, surgeon and assistant director of the Lacks Cancer Center in Grand Rapids, Michigan and Dr. Monica Morrow, chief of breast surgery at Memorial Sloan-Kettering Cancer Center in New York, concluded that a consensus statement needs to be made by the leaders in oncology radiation and surgery.  Close to half of the repeat operations were performed on women whose pathology reports indicated that no cancer cells were left behind after the first surgery while 14% of the patients who did have cancer left behind did not have a second operation.  Repeat surgery rates range from 0% to 70% and can vary widely by doctor.  However, a doctor's repeat rate is not necessarily the best indicator of whether the original operation was done correctly, as the surgeon may have performed more mastectomies than lumpectomies or could have neglected to operate a second time, even when it was needed. 

After a lumpectomy, the most common operation for breast cancer, nearly all patients receive additional radiation and systemic treatment with chemotherapy or hormones to decrease the recurrence rate and margin size concerns.  Questions remain as to the margin necessary between cancer cells and healthy tissue.  Until those questions can be answered and surgeons come to a consensus, many women will continue to either have a potentially unnecessary second surgery or miss one when it is needed.  Both of these unsatisfactory options add more physical and mental stress for patients.

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Posted by: Salvatore J. Zambri, founding member and partner

Reuters (12/13, Thrasybule) reported a study in the American Journal of Obstetrics and Gynecology suggesting that some over-the-counter painkillers, when taken during early pregnancy, may slightly increase the risk of rare birth defects. For instance, aspirin and naproxen have been linked to babies with either anophthalmia or microphthalmia. Other conditions that saw a rise in risk with painkiller use included amniotic band syndrome, cleft palate, and spina bifida. However, the researchers noted that the majority of NSAIDs were not tied to birth defects, and emphasized that the study does not prove that the painkillers caused the increased risk. An expert not involved with the study suggested avoiding ibuprofen, aspirin or naproxen altogether and using acetaminophen for pain relief instead.

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About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899. 

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.

As you've probably noticed during the month of October, the pink ribbon representing breast cancer awareness has been on prominent display in a number of  advertisements, sporting events, websites, and other public places.  In addition, October 21 was designated as National Mammography Day, when many locations provided free or drastically reduced mammograms for patients.

According to the Centers for Disease Control and Prevention (CDC), regular screening mammograms are recognized as the best way to find breast cancer early.  "In 2007 (the latest year for which statistics are available), 202,964 women were diagnosed with breast cancer, and 40,598 women died from the disease."  Because early breast cancer does not cause signs and symptoms, many experts have determined that a mammogram is the most effective way to detect breast cancer early, sometimes up to three years before a lump can be felt through a self-exam.  After breast cancer grows, the following symptoms become more evident:

• "New lump in the breast or underarm (armpit).
• Thickening or swelling of part of the breast.
• Irritation or dimpling of breast skin.
• Redness or flaky skin in the nipple area or the breast.
• Pulling in of the nipple or pain in the nipple area.
• Nipple discharge other than breast milk, including blood.
• Any change in the size or the shape of the breast.
• Pain in any area of the breast."

The National Breast and Cervical Cancer Early Detection Program  is part of the CDC and works with health departments and other groups to provide low-cost or free mammograms to women who qualify.  The CDC website also features a section explaining mammograms in terms that assist women in understanding the value of mammograms.

I encourage all women, as well as men, to speak with their physician about the most effective ways to prevent ill consequences of breast cancer.

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.

Hip replacement is one of the most common surgical procedures in the United States. It is estimated that 250,000 replacements are performed each year. Since the beginning of 2011, the Food and Drug Administration (FDA) has received over 5,000 complaints about metal-on-metal hips, more than the previous four years combined.  Some experts believe that this rise in complaints is an indication of  the "biggest and most costly medical implant since Medtronic recalled a widely used heart device component in 2007."  In May, the FDA ordered producers of metal hips to submit proposals to the FDA with plans for studying how frequently the devices were failing and to examine the threat to patients.  The agency is expected to determine the adequacy of those plans by  November, 2011.   Even the chief scientist at the FDA who oversees medical devices acknowledges that finding answers to the complaints could take several years.

As more problems are uncovered, some surgeons have abandoned installing all-metal hips, and they are looking for safer alternatives, usually those which combine metal and plastic components.  Many surgeons are also dealing with questions related to replacing the all-metal hips in their patients who don't seem to to have obvious problems.  For some patients, crippling injuries have resulted from the tiny particles of cobalt and chromium that shed into the patient's body.  Debris-caused tissue damage is very extensive in those cases.  Some researchers believe that many all-metal hip implants have an inherent flaw.  Numerous unanswered questions remain about their safety, whether from the the device itself, or its interactions with human tissue.

According to the FDA, "Many all-metal devices were sold without testing in patients or without a requirement that producers track their performance."  According to a recent report in the New York Times, the FDA is now intervening and ordering producers to study how frequently the devices were failing and to examine the threat to patients.  There are currently "no standard protocols for a uniform procedure to measure metallic ions in a patient's blood or how to calibrate diagnostic equipment to best detect tissue damage."

To date, almost 75% of the hip implant device complaints received by the FDA have been regarding the Articular Surface Replacement (A.S.R.), which was recalled by the DePuy Division of Johnson & Johnson in 2010.  Another Johnson and Johnson product receiving complaints was the Pinnacle.  Still another model receiving complaints is the Durom Cup, manufactured by Zimmer Holdings.  Along with DePuy and Zimmer, other companies submitting study proposals to the FDA include Wright Medical and Biomet.

If you have received a hip replacement, please consult with your surgeon to determine whether the model you received is subject to recall.  As the safety of hip replacement devices is further investigated, other models and brands of all-metal implants may be recalled in the future.

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Posted by: Salvatore J. Zambri, founding member and senior trial attorney.             

A Connecticut jury has awarded a local couple $58.6 million in a medical malpractice lawsuit, a record for a single incident of medical malpractice in the state of Connecticut. The lawsuit was against a physician and his practice, and it was shown that the doctor waited too long to perform a cesarean section during the wife's labor, which caused the child to be born with permanent brain damage. The boy suffers from cerebral palsy and is unable to eat, walk or talk. 

The recovery will allow the boy and his family to cover medical expenses and other losses the boy will endure for the rest of his life.

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About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899.

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.             

ABC World News (5/31, lead story, 3:10, Sawyer) reported, "An important new alert about the safety of cell phones and the possible risk of cancer, brain cancer in particular...comes from the World Health Organization." NBC Nightly News (5/31, lead story, 3:10, Williams) reported, the WHO "statement labeling cell phones as a possible carcinogenic hazard comes from a panel of 31 scientists."      

According to the AP (6/1, Cheng), the statement was "issued in Lyon, France, on Tuesday by the International Agency for Research on Cancer" (IARC) after a "weeklong meeting" during which experts reviewed "possible links between cancer and the type of electromagnetic radiation found in cellphones, microwaves and radar." The IARC classified cellphones in "category 2B, meaning they are possibly carcinogenic" to humans. The assessment now "goes to WHO and national health agencies for possible guidance on cellphone use."

The Wall Street Journal (6/1, Martin, Hobson, Subscription Publication) reports that the IARC working group did not conduct new research. Instead, the panel reviewed existing literature that focused on the health effects of radio frequency magnetic fields. Its findings are slated to be published July 1 in Lancet Oncology.

The New York Times (5/31, Parker-Pope, Barringer, Subscription Publication) "Well" blog noted that the panel's decision to "classify cellphones as 'possibly carcinogenic' was based largely on epidemiological data showing an increased risk among heavy cellphone users of a rare type of brain tumor called a glioma." Most "major medical groups," including the National Cancer Institute, have "said the existing data on cellphones and health has been reassuring." Earlier this year, the Journal of the American Medical Association "reported on research from the National Institutes of Health, which found that less than an hour of cellphone use can speed up brain activity in the area closest to the phone antenna."

The lesson here is simple:  Don't blindly believe what the cell-phone companies are saying. their products may in fact cause cancer, according to international experts.  Consequently, be safe.  Use a cell phone only when necessary, and use an earpiece if possible. 

Let's hope the cell phone companies do the right thing by both testing their products sufficiently and revealing the true results of the tests, so customers can make proper decisions to protect their health.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective products, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899.

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.             

ABC News reports that a new analysis by the Institute for Safe Medication Practices "says that there were 150 instances" where users of the smoking-cessation drug Chantix committed suicide "out of the nearly 600 delayed reports of severe issues noted in the study."  As a result, the FDA "wants the drug maker to resubmit thousands of records to get a clearer idea of just how widespread severe reactions to Chantix are, which also include vivid nightmares, depression and violent outbursts."

I applaud the FDA in demanding Pfizer to release its records.  Decisions to market drugs should be based principally on patient safety and health, not on profits.  It would be a shame if people lost their lives as a result of using a drug after side-effects were concealed.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the " 2011 Trial Lawyer of the Year".  He has also been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.  You may also reach him at 202-822-1899.

By Catherine Bertram

Infections in nursing homes kill 400,000 residents a year according to a recent study published in the American Journal of Infection Control.   The authors contend that nearly one-sixth of the US nursing homes have significant deficiencies in infection control.  Over 100,000 patient encounters were reviewed.  The University of Pittsburgh Public Health program researchers analyzed records from 2000 through 2007 and found that infection control citations in 96% of US nursing homes were linked to lower nursing staff levels. 

Infections are leading cause of morbidity and mortality in U.S. nursing homes.  This study reminds us of the direct link between professional staffing levels and safe care for our most vulnerable citizens.  Those are are family members and advocates for seniors need to keep speaking up and asking questions about the infection rates and infection control requirements at long term care facilities.

By Catherine Bertram

Each year 100,000 patients in hospitals and nursing homes in this country die from infection they acquired after being in a health care facility.  This is the most common complication of hospital care and also one of the deadliest risks for patients according to government officials.

In addition the loss of lives, the cost for our health care system is enormous. The estimated annual cost for hospital acquired infections is between $28 and $33 billion. 

What is even more shocking and tragic is that the consensus in the US medical community is that most of these infections are preventable.  How you ask?  This is really where it should make us all angry - by washing your hands in between patients.  It is not expensive or dangerous to implement.  What will it take to make hospitals and nursing homes clean up their act? Unfortunately, it has to hit them where it hurts - in their pocket book.   In 2008, the Centers for Medicare and Medicaid (CMS) began denying payments to hospitals for the costs of patient's care and patient days related to these infections.   

If you want more information about hospital acquired infections you can look at the Centers for Disease Control (CDC)  website which provides  links to infection prevention materials, statistics on infection rates and other materials.

By Catherine Bertram

Kim Kozlowski of the Detroit News reports, "For the first time in the United States, scientists have shown that the antibiotic-resistant bacteria MRSA is sometimes found in meat and poultry available at the neighborhood grocery store," according to the US Centers for Disease Control. (CDC) in a recent study in the journal Emerging Infectious Diseases. The study included 289 meat samples from 30 grocery stores in Detroit, Michigan.   They reported  "six samples -- three chicken, two beef, and one turkey -- tested positive for MRSA, methicillin-resistant Staphylococcus aureus."  It is believed that the germs may be introduced by human food handlers. This is community acquired MSRA.    The method of transmission, however,  is similar to how patients get infected with MSRA in hospitals when members of the health care team fail to wash their hands before they care for patients or touch their medicine or IV lines without taking proper precautions.  While cooking the meat may decrease the risk of infection significantly, the risk of infection is reported to be high for individuals who handle infected meat who have open cuts or sores on their hands or skin, according to the study's author. The reason this is so dangerous is because this super bug has become resistant to most antibiotics so it can be extremely difficult to treat. 

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.             

Writing for the Huffington Post, Joanne Doroshow of the Center for Justice and Democracy remarked on a March analysis from the Congressional Budget Office tat found that savings from malpractice "reforms" would be minimal. Doroshow pointed out that "reforms" imposed by HR 5, which includes a $250,000 non-economic damage cap, will actually increase the US deficit.  Doroshow explained that malpractice victims who are arbitrarily barred from obtaining compensation through litigation will turn to avenues like Medicare and Medicaid. The CBO's prediction that reform will reduce health spending by 0.4 percent does not account for this deficit increase.  The CBO also fails to consider "that these kinds of extreme 'tort reforms' would weaken the deterrent potential of the tort system, with accompanying increases in cost and physician utilization inherent in caring for newly maimed patients," says Doroshow.

Ms. Doroshow's big-picture understanding of this important issue helps Americans understand that the real driving force behind reducing citizens' rights in court is not about decreasing healthcare spending at all.  It's about Big Business trying to pad their profits at the expense of patient safety.

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About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com. 

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.             

The St. Louis Post-Dispatch reports that on Thursday, March 31, the Centers for Medicare and Medicaid Services (CMS) "released data...that for the first time show how often patients are injured by certain medical errors in hospitals." However, "the government did not explain why only eight types of serious, preventable errors were included in the comparison," while other such errors, like as medication errors, were not included in the study.  Th e report does include the following types of medical errors: "air in the bloodstream, falls, bedsores, infusions with the wrong blood type, urinary tract infections, blood infections, uncontrolled blood-sugar levels, and foreign objects left in the body after surgery."

A review of the study reveals that the medical industry needs to focus on error prevention.  Too many people are needlessly injured or killed as a result of preventable medical errors.  As the report makes clear, "the Office of Inspector General for the U.S. Department of Health and Human Services said 180,000 Medicare recipients die each year from hospital mistakes. That's more people than are killed every year in car crashes, or from diabetes or pneumonia."  This trend cannot continue.

We applaud the institutions and doctors who are taking steps to analyze past errors and eliminate preventable medical errors.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com. 

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.             

State Medical Boards are utterly failing to discipline physicians who have been sanctioned by hospitals for a variety of reasons, including committing medical errors.  A recent report shows that "63 percent of the doctors whose hospital privileges were restricted or revoked were not disciplined by the state's Board of Medicine."  This should be unacceptable.

The best way to reduce medical costs is to reduce medical errors.  To reduce medical errors, there needs to be greater oversight by the states' medical boards.

I hope this study compels the boards to do a better of job going forward.  Otherwise, patient safety is at risk. 

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.             

The New York Times (3/16, Kaplan) reports that the two "houses of the State Legislature passed budgets on Tuesday that rejected  crucial provisions of Gov. Andrew M. Cuomo's overhaul of Medicaid ... drawing sharp battle lines with the governor two weeks before the deadline to pass a spending plan." The Assembly's plan "rejects a cap on damages for pain and suffering in medical malpractice lawsuits, which was a key provision sought by hospitals to offset a sharp reduction in Medicaid financing from the state." The plan from the Senate includes a damages cap.  Cuomo "did not comment after the budget votes."

We congratulate the New York State legislature for recognizing that an artificial cap has no place in American society.  The civil justice system, by the power of the Constitution, allows a patient who has been injured by a medical error to receive full and fair compensation for the patient's harms and losses.  Governments should not arbitrarily set values of claims.  The extent of a patients harms and losses are rightfully assigned by citizens after they hear and view all of the relevant evidence.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.

Posted by: Salvatore J. Zambri, founding member and senior trial attorney.             

An editorial in the Des Moines Register points out that proponents of medical malpractice reform "don't acknowledge many doctors order tests because they're trying to do a thorough job with patients. They rarely mention too much testing is a result of this country's "fee for service" system of paying doctors." Moreover, "current tort reform efforts aimed at reducing malpractice risk would be relatively ineffective in alleviating physicians' concern about lawsuits and therefore may not alter defensive medicine practices," a University of Iowa study concluded. Des Moines neurosurgeon and tort reform proponent Dr. Thomas Carlstrom echoed this point, saying lawsuit damage caps wouldn't curb what the called his practice of "Cover You're A-" medicine.

Even doctors admit that capping damages and promulgating so-called tort reform won't meaningfully reduce medical costs and insurance premiums.  Insurance reform is what is needed.  Victims of negligence--those that suffer greatly as a result of medical errors--are all-to-often forced to live with significant pain, physical impairments, and loss of enjoyment o f life.  Their rights and legal protections should not be taken from them too.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com.

By Catherine Bertram

According to reports in the Washington Post, a woman infected with measles, a contagious disease which can be dangerous to some patients, was present in the District and Maryland after flying into Dulles International Airport. The 27-year-old woman from New Mexico arrived at Dulles reportedly on  February 20th  and left our area on February 22nd, from Baltimore-Washington International Airport.

In between, she spent time in Georgetown and Columbia Heights.  The D.C. Department of Health advises individuals exposed to measles should figure out whether they have they received two doses of measles vaccine. Those who cannot confirm that, and anyone showing symptoms should contact their health care providers. People with measles should stay home as long as advised by their doctor which is usually until after the characteristic rash appears because they can contaminate others. Other symptoms include fever, redness of the eye, and a cough. The woman was exposed to measles while in Europe.  For more info, click: Health Alert: Measles Exposure in the District of Columbia, DC Department of Health, News Release,

Posted by: Salvatore J. Zambri, founding member and senior trial attorney     

American Medical News (1/3, Dolan) reports, "Medical liability insurers once said electronic medical records would let physicians earn discounts on their premiums, because the potential benefits of the technology included improving patient safety." But "those discounts haven't materialized" and "the reason, a study says, is that liability insurers are betting that claims will rise during a so-called adjustment period, when practices new to the technology are working out the kinks in their systems." The study found that "in the short term, 'as systems are tested, errors with coding data input and software-interoperability failures may occur."

The movement to electronic medical records is a very positive change. So long as information is inputted correctly and timely, errors should not occur.  If they do occur, patients could be seriously injured.  Sometimes change is difficult for people, but failing to make appropriate entries in electronic medical records should not be excused.  Too much--the health of patients--is at risk.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2011)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted by: Salvatore J. Zambri, founding member and senior trial attorney     

As reported in a recent article by the New York Times, "the Food and Drug Administration has concluded that manufacturers of CT scanners should do a better job of training and educating those who use their equipment, and that the machines themselves could be made safer by warning operators that a dangerously high radiation dose is about to be administered.

These two conclusions . . . are the result of a yearlong investigation by the F.D.A. into hundreds of radiation overdoses in 2008 and 2009 that occurred during a specific diagnostic test for a stroke, called a CT brain perfusion scan."

Over-radiation can be very dangerous.  Manufacturers of scanners and physicians must work together to maximize patient safety.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted by: Salvatore J. Zambri, founding member and senior attorney     

An August recall of DePuy ASR hip implants had led to lawsuits.  The suits claim that the manufacturer knew its product was failing, but nevertheless continued to sell it for profit without informing consumers.

The problem seems to be with the metal-on-metal design of the device, which does not appear to adhere well in the hip joint.  Consequently, the failed replacements have to be re-done, often at a terrible cost both financially and physically. Some patients have suffered metal poisoning, and others are having a hard time ambulating.

My firm regularly represents victims of product defects.  It is a shame when you see companies put profits over people.  Bad things--tragic things--happen when that business model is used.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--national publications that honor the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted by: Salvatore J. Zambri, founding member and senior attorney     

For years now, the Chamber of Commerce has been spending millions upon millions of dollars trying to limit peoples' right to seek justice through the court system when they have been victimized by corporate greed and wrongdoing.   Yet, the Chamber itself utilizes the court system to advance its own selfish agenda multiple times every single week.

This hypocrisy was noted in a recent publication by the Association for Justice.  Here is a reproduction of some of that report:

Washington, D.C.--Earlier this month, U.S. Chamber of Commerce President and CEO Tom Donohue called litigation "one of our most powerful tools for making sure that federal agencies follow the law and are held accountable." 

Yet ironically, the Chamber today holds its annual Legal Reform Summit – an event underwritten by its multinational corporate members that promotes undermining the civil justice system to weaken the basic legal protections of American workers and consumers.

The Chamber's hypocrisy – blocking justice for everyday Americans while using the courts liberally for its own pro-corporate agenda – is the subject of a new report released today by the American Association for Justice (AAJ) that exposes the Chamber as one of the most aggressive litigators in Washington, entering lawsuits at a rate of over twice weekly.

"The Chamber's 'one rule for corporations, another rule for everybody else' motto has come at the expense of ill-treated workers, defrauded investors and injured consumers," said AAJ President Gibson Vance. "It readily spends millions of dollars to prevent Americans from holding wrongdoers accountable in the courtroom, and then aggressively uses the very same legal system to advance the agenda of its multinational corporate membership."

In almost every case, the Chamber's litigation on behalf of corporations has come at the expense of Americans' health or financial security. The Chamber has:

• justified the actions of Wall Street banks that drove the country's economy into turmoil; • defended the most conceited and worst behaved CEOs and their most extravagant excesses;
• tried to force workers, instead of employers, to pay for their own safety equipment; • filed numerous actions opposing any move to combat climate change;
• sought to shield pharmaceutical executives who skirted safety procedures that ultimately killed 11 children;
• opposed measures allowing workers to receive a rest period during a full work day;
• fought on behalf of lead paint manufacturers found to have poisoned thousands of children;
• defended corporations that discriminated on the basis of race and disability; and
• spent years defending big tobacco, asbestos companies and chemical companies found to have contaminated water and air.

"The Chamber has every right to seek what it believes to be justice in a court of law, even if representing the most deplorable corporate interests," said Vance. "But it must learn that this right to justice belongs not just to their organization, or big business generally, but to all Americans."

The report, titled "The Chamber Litigation Machine: How the Chamber Uses Lawsuits to Keep Americans out of Court," can be found by clicking here.

Don't let the Chamber or other special interests fool you.  Contact your local and federal legislators and fight for your rights.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in the country.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted by: Salvatore J. Zambri, founding member and senior attorney     

With Halloween approaching, it is appropriate to consider which candies children should and should not eat.  CQ HealthBeat (10/26) reports, "The Food and Drug Administration on Monday put out a warning that Hyland's Teething Tablets may pose a risk to children and the company has agreed to a voluntary recall. The agency also passed along recall information about two candy products in this week before Halloween." Notably, the "teething relief product, manufactured by the Standard Homeopathic Company, contains a small amount of belladonna, a substance that can cause serious harm at larger doses."

In addition, "Nestlé USA's Confections & Snacks Division has voluntarily recalled its Raisinets Fun Size Bags, which the company says may contain peanuts even though there is nothing on the label to indicate that" peanuts are included in the snacks.  Also, "Colombina, S.A., which manufacturers Mega Pops brand lollipops, is recalling specific lots of the candy" since "certain packages may contain 'traces of foreign particles.'"

Enjoy Halloween, but please put safety first.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--national publications that honor the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted by: Salvatore J. Zambri, founding member and senior attorney     

The AP (9/9, Tuohy) reports, "A federal jury in New Hampshire has awarded $21 million to a woman blinded and scarred by a prescription drug she took for shoulder pain. Karen Bartlett, 51, of Plaistow suffered extreme burns to her skin, mucus membranes and eyes after taking the anti-inflammatory drug Sulindac." After taking the medication for two weeks, Bartlett "was admitted to the hospital" and "was diagnosed as having Stevens-Johnson Syndrome and toxic epidermal necrolysis (SJS/TEN)." The jury concluded "that Philadelphia-based Mutual Pharmaceutical Co. was liable for her injuries and should have known the drug was unreasonably dangerous to consumers."

If you have been taking the drug, please stop ingesting it and speak to your doctor. 

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--national publications that honor the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted by: Salvatore J. Zambri, founding member and senior attorney     

In a column in the Baltimore Sun (8/31), Jay Hancock writes that St. Joseph Medical Center in Towson, MD, "deserves credit for shutting down Dr. Mark Midei last year when an internal review showed that he was implanting stents in numerous coronary arteries with 'insignificant' blockage." Now St. Joseph "needs to continue to do the right thing and negotiate in good faith with patients who got stents that a state inquiry and the hospital's own probe suggest were unneeded." They should drop the "stonewalling" and "the legal bluster" that is being used to deny justice to those who have been harmed.

Every day I represent patients who have been harmed, and sometimes killed, as a result of medical negligence.  Medical providers should indeed be credited when changes take place to avoid future errors.  Making changes is not enough, though.  The providers should also take responsibility for their wrongdoing and fairly compensate the victims of the medical mistakes.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--national publications that honor the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted by: Salvatore J. Zambri, founding member and senior attorney     

The CBS Evening News (8/30, story 9, 0:40, Smith) reported that a recently released study reveals that "one in three first-time mothers" in America "has a c-section these days," a trend that's not likely to "reverse in the near future, because once a woman has a c-section she's more likely to have future babies delivered the same way."   The study claims that the rate of c-section is worrisome because "Caesareans pose a risk of surgical complications and research has found that they are more likely than normal births to cause problems that can put the mother back in the hospital and the infant in intensive care," the New York Times (8/31, D7, Grady) reports. "Caesareans also increase the risk of dangerous abnormalities in the placenta during later pregnancies, which can cause hemorrhaging and lead to a hysterectomy." What's more, "costs for a Caesarean are nearly twice those for a vaginal delivery."

Indeed, "C-sections are necessary sometimes to save the baby or the mother or both," according to the Washington Post's "The Checkup" blog. "But experts think they're being done far too frequently." The current study authors "stress that the study can't determine exactly how many of the C-sections were really unnecessary and could have been avoided," but it "does provide new evidence that more could be done to avoid women getting C-sections the first time around, and more could at least try a regular birth even if they have had a previous C-section."

Before reaching those conclusions, researchers at the Eunice Kennedy Shriver National Institute of Child Health & Human Development looked at data on "230,000 deliveries at 19 hospitals across the country," according to the Los Angeles Times' (8/30, Roan) "Booster Shots" blog.  The paper in the American Journal of Obstetrics & Gynecology revealed, "not surprisingly, that the major reason for undergoing a cesarean was due to the woman having a prior C-section.  Still, almost half of the cesareans that took place after labor had started were due to 'failure to progress,' and the study suggests that doctors aren't acknowledging that labor takes time and doesn't follow a predictable pattern in women, especially first-time mothers."

In preparing for child delivery, it is important for women to speak with their physicians to best understand the safest available options.  Natural delivery may be the healthiest method for a mom.  However, it should always be remembered, that during natural delivery, the baby or the mother may suffer distress, which will require a c-section under the applicable standards of care. Doctors, nurses, and hospitals must be prepared to take whatever action is necessary and appropriate to protect the mother and child. 

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted by: Salvatore J. Zambri, founding member and senior attorney     

It is commonly acknowledged that hospitals should do all they can to protect patients from drug-resistant bacteria.  But far too many hospitals are not, leading to serious injuries, and even death of patients.

The Las Vegas Sun (8/8) editorialized that recently published articles detailing patients' experiences with "lethal drug-resistant bacteria during" their hospital stays "should serve as a wake-up call to those medical facilities that more needs to be done to improve patient safety." Between 2008 and 2009, the "rate of patients who contracted the contagious bacteria known in shorthand as MRSA rose by 34 percent in area hospitals," even though some hospitals have "said they adhere to national standards intended to prevent the spread of bacteria among patients." But, "this is troubling, because it tells us either that the national standards are deficient or that hospitals have not been as careful as they say they have been."

Hospital-induced MRSA infections are all-too-common and can be prevented by creating a sanitary environment by washing hands, wearing clean clothing, and by taking other steps to protect patients. 

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted by: Salvatore J. Zambri, founding member and senior attorney     

Bloomberg News (8/9, Feeley, Kelley) reports, "AstraZeneca Plc will pay about $198 million to settle 17,500 lawsuits, or about two-thirds of the total, alleging its antipsychotic drug Seroquel causes diabetes in some users." As I mentioned in an earlier blog, AstraZeneca "previously agreed to pay at least $55 million to resolve more than 5,500 cases alleging the company knew Seroquel could cause diabetes and failed to adequately warn patients, people familiar with those settlements said. These earlier agreements are part of the 17,500 settlements, the company said." The Financial Times (8/9, Jacobs) reports that the settlement stems from court-ordered mediation, a process where the parties meet together, discuss the issues, and work to come to a fair resolution. The Wall Street Journal (8/9, Zekaria) reported that analysts called the settlement figure relatively small, given the alleged defect of the product at issue. The AP (8/9) also covered the story.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted by: Salvatore J. Zambri, founding member and senior attorney     

I recently published a couple blogs about the closing of Georgetown University Hospital's Lab and the rise in laboratory errors nationwide, which has caused patients tremendous physical and emotional anguish nationwide.  I thought you might like to know about an article I read in Good Housekeeping that included some good advice about how to protect yourself from lab errors.  Here are some suggestions taken from the article:

• "Ask your doctor about the lab she uses. It should be accredited and approved by the College of American Pathologists (a sign that it meets high standards).
• If you can see the test tube or slide, double-check that your name is on it; if you're in the hospital, make sure your wristband is accurate.
• If the result of the test is a surprise, ask your doctor: "Did you expect this? Do you think this is what I have?" If the answers are no, consider repeating the test.
• Get a copy of all lab results and reports, suggests Susan Sheridan, president of Consumers Advancing Patient Safety. "Patients may not realize they have the right to these," she says.
• Have a specialist read your slides. With a skin sample, for instance, you'll improve odds of the right diagnosis if it's viewed by a dermatopathologist, says Mark Lebwohl, M.D., chairman of dermatology at the Mount Sinai School of Medicine in New York City. Your insurer may not cover a specialist, so you'll have to decide whether to pay for it yourself."

Obviously, you have every right to rely on your doctor and the labs used for testing.  They should know what they are doing and take all steps necessary to ensure that your lab results are timely, accurate, and properly communicated to your physician and, if necessary, to you as well.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the "Best Lawyers in America" by Best Lawyers, and has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in the country.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted by: Salvatore J. Zambri, founding member and senior attorney     

ABC World News (8/3, story 8, 1:50, Sawyer) reported, "Dietary supplements are a $27 billion a year business in this country, but Consumer Reports has an alert" on "supplements the magazine says can be dangerous to your health." Consumer Reports' Nancy Metcalf said, "With the dozen supplements that we've identified, we think it's all risk and no benefit."

The Los Angeles Times (8/4, Stein) notes that the list of those that are unsafe include "aconite, bitter orange, chaparral, colloidal silver, coltsfoot, comfrey, country mallow, germanium, greater celandine, kava, lobelia, and yohimbe." The report also "argues that the FDA has not fully used its limited authority granted by the Dietary Supplement Health and Education Act to ban supplement ingredients that may be dangerous."

The Washington Post (8/4) adds that supplement manufacturers "routinely, and legally, sell their products without first having to demonstrate that they are safe and effective."

Before taking any dietary supplement, or any medication for that matter, please consult with your doctor.  Be safe.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been acknowledged as one of "The Best Lawyers in America" by Best Lawyers (2011 edition), and has been repeatedly named a "Super Lawyer" by Super Lawyer magazine (March/April 2010)-- national publications that honor the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted by: Salvatore J. Zambri, founding member     

The AP (8/4, Perrone) reports that "makers of X-ray machines, drug pumps and other medical devices would have to submit more safety information to win federal approval under a proposal designed to tighten regulation of thousands of products reviewed each year." The FDA "released recommendations Monday night designed to improve oversight of the US device industry, including the government's ability to recall products that prove unsafe or ineffective." At "the center of the overhaul" is the so-called 510(k) system the FDA "uses to grant speedy approval to devices that are deemed similar to products already on the market." FDA critics "say that high-risk devices, such as heart pacemakers, are increasingly slipping through the 510(k) process without thorough testing and scrutiny."

The Minneapolis Star Tribune (8/4, Moore) reports among the recommendations released is the creation of "a new class of devices that would require clinical evidence before gaining 510K approval." The designation "would streamline the process for a 'small subset' of devices by telling applicants up-front what will be required to gain marketing clearance, thus avoiding delays." As it stands, "only 8 to 10 percent of the devices approved under the 510(k) moniker require clinical studies," said Jeffrey Shuren, director of the FDA's device center.

Increased oversight is needed, so that patients' health and lives are not put at risk.  Safety must be put above profits.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been acknowledged as one of "The Best Lawyers in America" by Best Lawyers (2011 edition), and has been repeatedly named a "Super Lawyer" by Super Lawyer magazine (March/April 2010)-- national publications that honor the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted by: Salvatore J. Zambri, founding partner     

The Hill 's (8/4, Lillis) "Healthwatch" blog reports, "citing a recent spike in pharmaceutical recalls, Sen. Michael Bennet on Tuesday introduced legislation to bolster consumer protections governing the nation's drug supply." The "Colorado Democrat says his proposal," which would "greatly expand the FDA enforcement powers while holding drug companies more accountable for the products they sell," is "vital in a globalized age when more and more drug ingredients originate overseas."

I applaud this introduction of this important legislation.  The lack of oversight has allowed drug and other product manufacturers to push products into the market for profit without proper safety considerations.  Let's hope Congress will do the right thing and make this bill law.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been acknowledged as one of "The Best Lawyers in America" by Best Lawyers (2011 edition), and has been repeatedly named a "Super Lawyer" by Super Lawyer magazine (March/April 2010)-- national publications that honor the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted by: Salvatore J. Zambri, founding partner     

As Bloomberg News (8/5, Feeley, Milford) reports, "AstraZeneca Plc, the UK's second-biggest drugmaker, agreed to pay about $55 million to settle around 5,500 lawsuits related to side effects of the antipsychotic Seroquel [quetiapine]." AstraZeneca's "5,500 settlements include 4,000 that AstraZeneca acknowledged in a July 29 regulatory filing." The company "is moving to resolve Seroquel claims as it faces expiring patents on the drug and the ulcer treatment Nexium [esomeprazole] in the next four years."

We hope that these settlements effect how drug companies decide to do business.  They must put patient safety above profits.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted by: Salvatore J. Zambri, founding partner     

A recent analysis of the outcomes of pre-market drug-trials raised some great concerns.  The Los Angeles Times (8/2, Roan) "Booster Shots" blog reported, "According to an analysis of drug trials published Monday, studies were much more likely to be positive -- that is, showing the drug worked -- in trials that were funded by the pharmaceutical industry." A review of 546 drug trials "found that industry-funded trials reported positive outcomes 85% of the time, compared with 50% of the time for government-funded trials and 72% of the time for trials funded by nonprofits or non-federal organizations." But, among "the nonprofit or non-federal studies, those that received industry contributions were more likely to be positive (85%), compared with those that did not have any industry support (61%)."

I'm concerned that drug companies are not sufficiently testing their drugs before pushing them on the market for a profit.  The vast difference in the trial outcomes conducted by teh drug companies and the federal government suggests that the pharmaceutical industry needs to do more to protect consumers.  Safety must be put above profits.

And the non-profit and non-federal organizations involved in performing drug studies need to be careful not to take a blind eye to negative effects of drugs just because drug companies make financial contributions to the entities. 

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.  

By Catherine Bertram

An article in the Boston Globe last week, by Jonathan Salzman,  reports that a lawsuit has been filed by a patient who had surgery to remove his prostate after being told that he had prostate cancer.   Our blog mentioned this case last week.  The surgery left him incontinent.  Tragically, he did not have prostate cancer. It was a lab error.  The lab technician mistakenly mixed up his results with that of another patient.  As a result, this patient had a surgery he did not need and must now wear adult diapers and live with the consequences.  Another patient reportedly had an eight month delay in the treatment of his prostate cancer due to a lab mix up. He was told he was cancer free but that was incorrect.  He actually had cancer and was not treated for eight month.  The article reports that by the time he was informed of the mix up the cancer had spread to his lymph node.

Lab errors can be devastating to patients and can negatively impact the patient's chances of survival and require additional treatment.  We have this type of cases pending right now and we have the experience to understand how hospitals should label and track these types of results and what safety measures should be put in place to avoid these tragic occurrences.

About the author:

Catherine Bertram is board certified in civil trials and was recently nominated as a 2010 Super Lawyer for Washington, D.C.  Ms. Bertram has 20 years of trial experience and is unique in that she was formerly the Director of Risk Management for Georgetown University Hospital.  Ms. Bertram is a member of the bar for the U.S. Supreme Court.  She is a partner with the firm and lectures regularly to lawyers and health care providers, nationally and locally, regarding patient safety, medical negligence and other related issues. She has also recently published a chapter in a surgical textbook.   She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875 in her office in Washington, D.C.

Posted by: Salvatore J. Zambri, founding partner     

Georgetown University Hospital's lab for genetic analysis for breast cancer has closed and is being investigated by federal health officials, according to a Washington Post article (8/5/2010). In addition, tissue samples have been sent to an independent  lab for retesting.  "Federal officials are continuing to investigate the employee's allegations, according to an official with the Centers for Medicare and Medicaid Services, the federal agency in charge of overseeing the quality of testing in medical laboratories." According to the formal complaint filed with the Centers for Medicare and Medicaid Services, there was concern that retesting was taking too long and that the hospital was not sharing the problem with patients. The eleven-month testing period in question began in May, 2009 and involved quality-control testing for HER2, a gene that causes breast tumors more likely to spread or return.

I urge anyone who was tested at Georgetown's lab during the past year to contact their personal physician to determine whether she should be retested.  Experts indicate that treatment should begin within twelve months of diagnosis.

If you have any questions about your legal rights, feel free to contact me at 202-822-1899.

Do you have any questions about this post?

Posted by: Salvatore J. Zambri, founding partner     

The Los Angeles Times (8/3, Zarembo) reports, "Los Angeles County-USC Medical Center and Bakersfield Memorial Hospital are the latest additions to a list of California hospitals where [radiation] overdoses occurred during CT brain perfusion scans." According to officials at both facilities, the scanners had been "programmed...according to the manufacturer's specifications." The hospitals, however, "are unlikely to be absolved of responsibility," as "LA County health officials who investigated the County-USC overdoses concluded that the technologists were not paying attention to dose levels during the scans." Meanwhile, "Toshiba issued a statement Monday saying it 'cannot comment on specific cases' because of an investigation underway by the US Food and Drug Administration," adding, "We continue to work with all of our customers to educate them on the dose reduction technologies that we provide on our CT systems."

As more and more hospitals are found to overdose patients with radiation, doctors and health-care providers must be even more diligent to ensure patients are not put at risk.  The consequences of over-radiation can be horrific, even life-threatening.

I represent patients who have been injured as a result of medical errors every day.  The medical mistakes should never happen if reasonable standards are followed.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.
 

Posted by: Salvatore J. Zambri, founding partner     

The Dallas Morning News (8/1, Dunklin, Ambrose) reported that "national medical research increasingly supports the long-held concern that poor supervision of doctors-in-training at teaching hospitals contributes to patient harm, even death." Two months ago, a study led by University of California-San Diego researchers "reported a 10 percent increase nationally in medication errors that killed patients during the month of July, the traditional start date for new residents." A 2008 report by the Institute of Medicine "urged that residency programs have 'measurable standards,' such as when and how residents consult faculty doctors." This summer, the Accreditation Council for Graduate Medical Education proposed "updated guidelines that are to be refined before adoption next year."

I hope meaningful changes are made soon regarding the manner in which residents are supervised.  I recognize the importance of training residents, but giving them too much independence too soon threatens patient safety, leading to terrible medical problems.  I represent many people who were severely injured as a result of unsupervised medical care.  Proper supervision would likely have lead to appropriate medical care.  Instead, the people I represent will have to endure a lifetime of physical and emotional anguish.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted by: Salvatore J. Zambri, founding partner     

The Boston Globe (8/2, Saltzman) reports that a law suit was filed last week against Beth Israel Deaconess Medical Center on behalf of a patient who underwent "unwarranted" prostate surgery after a hospital pathologist "had mistaken his [biopsy] slides for those of another patient who did have prostate cancer." A separate lawsuit was filed against a private laboratory in Lexington on behalf of another patient "whose situation was the reverse." That specimen, which was analyzed by Strata Pathology Services, came back negative, but eight months later "a second biopsy, examined at a different lab, revealed that he had cancer." These errors show that confusing biopsies can have devastating consequences.

I have represented victims of medical errors for nearly twenty years.  I am still amazed as to how many times laboratories mix biopsies and make other medical errors.  I see first-hand the emotional and physical harm such errors cause.  Labs need to do more to protect against these mistakes--errors that should never happen.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.
 

Posted by: Salvatore J. Zambri, founding partner     

A jury has determined that IMA Inc. violated the privacy rights of a man when it negligently disclosed to credit companies that the man is HIV positive.  The facility filed a suit against the man for non-payment of a bill totaling merely $326.  In doing so, the company revealed to the public that the man suffers from HIV.

It is against the law for medical providers to disclose patient's private health issue without prior consent.  This reckless conduct happens all across this country, causing a great deal of embarrassment and shame.  It needs to stop.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.  

Posted by: Catherine Bertram

The District of Columbia Department of Health licenses and certifies health care facilities for compliance with state and federal health and safety standards. Facilities include nursing homes, hospitals, home health agencies, dialysis centers, ambulatory surgical centers, intermediate care facilities for the mentally retarded, and laboratories. The Health Care Facilities Division ("HCFD") is charged with conducting regular on-site surveys to ensure health, safety, sanitation, fire, and quality of care requirements. HCFD identifies deficiencies that may affect state licensure.

The D.C. government publishes a list of nursing home facilities in DC and also has a list of home health agencies in DC.  A family member, friend or even the resident can  file a complaint on line  or can call the DC Hotline 202-442-5833.

Posted by: Salvatore J. Zambri, founding partner     

The FDA has warned that "inadvertent exposure to Evamist through skin contact with patients using this product has the potential for adverse effects in children and pets. Evamist contains estradiol, an estrogen hormone, and is used in women to reduce hot flashes during menopause. The drug is sprayed on the skin between the elbow and wrist, on the inside of the forearm. The FDA currently is reviewing reports of adverse events in children and pets who were inadvertently exposed to this topical estrogen product."

According to the announcement, the FDA has received several post-marketing cases of unintended exposure to Evamist in children ages 3 years to 5 years during the period July 2007 through June 2010. "Adverse events reported in unintentionally exposed children include premature puberty, nipple swelling and breast development in females, and breast enlargement in males. Since 2007, two reports of secondary exposure to Evamist in dogs also have been received by FDA’s Center for Veterinary Medicine. Pets exposed to Evamist may exhibit signs such as mammary/nipple enlargement and vulvar swelling."

Please keep your children and pets away from the drug. If you have experienced any adverse side effects from the use of Evamist, please contact the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 800-332-1088.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

By Catherine Bertram

Bloomberg News reported that GlaxoSmithKline P.L.C.  has agreed to pay $1 billion to injured consumers to resolve more than 800 cases involving the antidepressant Paxil.  The medication has been in use in the U.S. since 1992.   Paxil generated about $793 million in sales in 2009 alone which was about 1.8 percent of Glaxo’s total revenue.  Glaxo reported U.S. sales exceeding $11 billion since 1997. 

Not all of the pending birth defect cases are resolved, according to the report, about  100 Paxil claims are not included in this settlement.   Glaxo confirmed that it settled some Paxil cases citing the reason as avoiding costs and uncertainties of litigation, but would not comment on the terms of the settlement.  A Philadelphia jury awarded a 3 year old boy $2.5 million finding that Paxil caused severe heart defects in a trial in October of last year.

About the author:

Catherine Bertram is board certified in civil trials and was recently nominated as a 2010 Super Lawyer for Washington, D.C.  Ms. Bertram has 20 years of trial experience and is unique in that she was formerly the Director of Risk Management for Georgetown University Hospital.  Ms. Bertram is a member of the bar for the U.S. Supreme Court.  She is a partner with the firm and lectures regularly to lawyers and health care providers, nationally and locally, regarding patient safety, medical negligence and other related issues. She has also recently published a chapter in a surgical textbook.   She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875 in her office in Washington, D.C.

Posted by: Salvatore J. Zambri, founding partner     

The U.S. Food and Drug Administration is warning consumers not to take Miracle Mineral Solution, an oral liquid also known as “Miracle Mineral Supplement” or “MMS.”  The product, when used as directed, produces an industrial bleach that can cause serious harm to health.

According to the FDA's website, "The FDA has received several reports of health injuries from consumers using this product, including severe nausea, vomiting, and life-threatening low blood pressure from dehydration.

Consumers who have MMS should stop using it immediately and throw it away."

MMS claims to treat many illnesses and disease, including HIV,  the H1N1 flu virus, common colds, hepatitis, acne, cancer, and other conditions. However, the FDA is not aware of any studies that prove that MMS effectivey treats any of these conditions.

If you have experienced any negative side effects from MMS, please contact your doctor or visit an emergency room as soon as possible.  Do not use the product any longer, and keep it away from others, especially children. Adverse events can be reported to the FDA’s MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted by: Salvatore J. Zambri, founding partner     

According to the St. Louis Post-Dispatch (7/30, Wagman), US Rep. Russ Carnahan (D-MO) "has announced two fresh investigations into the use of improperly sterilized medical equipment" at the Cochran Veterans Affairs "hospital in midtown St. Louis." The article also states that "the General Accounting Office -- a watchdog agency that takes its orders from Capitol Hill -- will include Cochran into an existing investigation focused the processing of reusable medical equipment at several VA hospitals around the country."

The use of unsanitary medical devices and equipment can cause patients to suffer a host of serious medical conditions, including hepatitis and MRSA infections.  There is simply no excuse for failing to utilize sterile equipment while treating patients. 

I have represented many people over the past two decades who has been seriously injured and killed due to the misuse of unsanitary equipment and medical products at hospitals.  Let's hope these nationwide investigations compel, if not force, medical providers to safely treat patients as we go forward.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted by Catherine Bertram   

   
Recognized medical studies show that pain pumps that inject pain medicine right into shoulder joints after surgical procedures are a very likely cause of severe cartilage damage.  The FDA, in November 2009 and again in February 2010 issued a warning about this device.  At the heart of the shoulder pain pump litigation is the fact that continuous infusion pumps were not approved by the FDA for this use.   The pain medication essentially eats away the cartilage in the shoulder joint which is critical to allowing the shoulder to move smoothly without pain and grinding.   The research shows that this permanent injury occurs when an intra-articular pain pump catheter is inserted into the shoulder joint by the surgeon in an effort to reduce the patient's pain, usually after a shoulder surgery.  The catheter then pumps pain medication right into that key joint for several days.    The medical studies show the damage can be inflicted in 2-3 days.  This is a permanent injury and is extremely painful and limiting for the patient. Symptoms include increased pain and stiffness, a clicking or popping or grinding in the shoulder and less motion and loss of strength.  The condition is known as Postarthroscopic Glenohumeral Chrondrolysis (PAGCL).

If you or a family member has this condition and a pain pump was used you may want to consider having the records reviewed and the matter investigated.                                                                                         

Posted by: Salvatore J. Zambri, founding partner     

Bloomberg News (7/28, Bass) reported, "Federal fraud cases begun by private citizens against drugmakers, insurers and hospitals will probably surge . . .driven by incentives in the new health law." The "health overhaul makes it easier for citizens to be rewarded for uncovering swindles" and reduces the time "before medical providers can be accused of withholding overpayments from Medicare and Medicaid."

Whistleblower actions empower private citizens to come forward and stop companies from breaking the law.  These courageous citizens are protected by the law and may be entitled to compensation for their efforts that, in end, make our communities safer.

My firm accepts whistleblower cases, and if you have any questions about these cases, please do not hesitate to contact me.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted by: Salvatore J. Zambri, founding partner     

Bloomberg News (7/28, Voreacos, Johnson) reports "Merck & Co. paid claims to the families of 3,468 users of its Vioxx painkiller who died of heart attacks or strokes," a court-appointed administrator told a judge Tuesday. "A $4.85 billion settlement fund made payments to the families of 2,878 Vioxx users who died of heart attacks and 590 who died of strokes," according to the report. Merck "pulled Vioxx from the market in 2004 after a study showed it doubled the risk of heart attacks and strokes."

Well, it is nice to see families of victims obtain justice, but it is nevertheless a shame that so many lives had to have been lost before the dangerous drug was pulled from the market.  Hopefully, the tragic results regarding Vioxx will compel drug companies to focus on safety above profits in the future.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

                                                                                                 By Catherine D. Bertram

Massachusetts obtained a $3 million grant to study "alternatives" to a consumer's 7th Amendment right to a jury trial when it comes medical malpractice claims.  The grant is part of a U.S. Department of Health and Human Services program to investigate ways to improve compensation for people injured by medical errors and has a secondarily identified goal of  lowering malpractice insurance premiums.

One of the grant's goals is to "ensure that patients are compensated in a fair and timely manner for medical injuries, while also reducing the incidence of frivolous lawsuits."    We can save significant tax payer funds and save many lives by doing what the Institute of Medicine suggested more than 10 years ago, in the 1999 report called "To Err Is Human" -- focus on patient safety and preventing patient injuries during the delivery of health care.   Please leave consumers' constitutional rights alone.  For  more than 10 years it has been common knowledge that 98,000 patients die year year from preventable errors during the delivery of health care.  This study does nothing to reduce that shocking statistic.   That is the correct goal and the only goal that will result in less harm and less need to compensate consumers who have been injured due to the fault of others. 

It sounds great to talk about reducing frivolous lawsuits, but as tax payers and patients what we need to ask is where is the data that demonstrates there are "frivolous" medical malpractice claims being filed and more importantly, where is the evidence that such meritless cases result in significant awards that are paid?  

There are procedural requirements in place that safeguard against consumers filing cases without expert support.   In Maryland and Virginia, consumers and their lawyers have to have written reports from qualified medical experts in hand before pursuing a medical malpractice claim.  In the District of Columbia, the injured consumer is required by law to send a detailed notice letter to the heath care provider outlining the claim before the lawsuit can even be filed.  

Putting laws in place to limit damages simply shifts the burden of paying for a lifetime of care away from the wrongdoer and back onto the U.S. tax payer.  It does nothing to try to make health care safer.  What it does is protect insurance companies from paying out legitimate claims after a jury has determined that the patient was entitled to compensation to balance the harms done.   That patient is still permanently injured and in most circumstances cannot work.  That patient still needs a lifetime of care.  Who pays for that care?  We do and we have still done nothing to reduce these claims and make health care safer.   How tragic.

Posted by: Salvatore J. Zambri, founding partner     

Carol Diemert, a nursing practice specialist, and Carrie Mortrud, a governmental affairs and public policy specialist with the Minnesota Nurses Association, write in a Minneapolis Star Tribune (7/27) commentary, "Inside the walls of Twin Cities acute care hospitals, all is not as healthy as the public relations flacks would have you believe," and "their own consultants have issued a report that substantiates the internal turmoil nurses describe." They argue that "hospitals aren't as safe as they claim because they collect incomplete data, allowing them to be opaque about the realities nurses witness." Diemert and Mortrud say that "hospitals...need to be regulated regarding appropriate staffing," and conclude that the current system "operates on the backs of nurses' professional ethics, valuing profit over care, seriously challenging every nurse's core value of caring for patients in a safe environment."

These sentiments are shared by nurses and health-care providers throughout the country.  Until our medical system puts patients over profits, medical errors will continue to kill and severely injure hundreds of thousands of people each year.  The deaths, alone, caused by medical errors amount to nearly 100,000, according to the Institute of Medicine.  This trend must end.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted by: Salvatore J. Zambri, founding partner     

The New York Times (7/26, D6, Rabin) reports "a new analysis has concluded that controversial zinc nasal gel products can cause some patients to lose their sense of smell," according to a study in the Archives of Otolaryngology - Head & Neck Surgery. There is no danger "from taking zinc gluconate orally" but that "when sniffed through the nose it can burn olfactory tissue." The FDA "last year warned consumers to stop using Zicam Cold Remedy Nasal Gel and Zicam Cold Remedy Nasal Swabs," popular "homeopathic remedies that contain zinc." Arizona-based Matrixx Initiatives, which markets them, "has denied the zinc gels cause anosmia and called the conclusions 'scientifically unfounded and misleading.'"

It seems to me that we all should heed the FDA warning.  As with any drug, do not take the zinc gels without first speaking with your doctor.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted by: Salvatore J. Zambri, founding partner     

In a column in the Asian Journal (7/24), Atty. C. Joe Sayas, Jr. wrote, "Legal remedies protect the lowly consumer against big companies who put profits over the public good. The factual history of the American civil justice system shows how the courage of these consumers and their attorneys who waged these legal fights...advanced the cause of product safety." Sayas presents several product safety "cases compiled by the American Association for Justice," commenting "it is difficult to imagine how these safety changes could have been made if the manufacturers of these products were not held accountable in our civil courts."

Thomas Jefferson said to Thomas Paine in 1789, "I consider trial by jury the only anchor ever yet imagined by man, by which a government can be held to the principles of its constitution."  He recognized that access to the court system was needed, too, in order to hold private entities accountable for the harms they commit to people.  I am very lucky to be part of a profession that  gives a voice to people who otherwise could not be heard.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted by: Salvatore J. Zambri, founding partner     

The BLT: Blog of Legal Times (7/23, Levine) reported, "Legal groups have been in the thick of legislative fights to overhaul the financial regulatory system and change liability laws in the wake of the oil spill, though their lobbying spending varies widely. Disclosure reports filed this week show the US Chamber's Institute for Legal Reform spent $3.75 million and the trial lawyers' group, the American Association for Justice, spent $1 million, lobbying on dozens of proposals in the second quarter of the year." Linda Lipsen, "the chief executive officer and lead lobbyist for AAJ, said the group is now focused on legislation related to the oil spill. 'I think that right now, our attention is on what's going on in the Gulf Coast, and making sure that victims of the disaster emanating from the oil spill are fully compensated,' she said.

The Chamber has a history of spending a tremendous amount of money in an effort to limit people's access to justice to pad the profits of corporate executives.  The good, decent, honest corporate executives deserve the salaries they earn, but no laws should be made to augment those profits to the detriment of community safety and justice.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 
 

By Catherine Bertram

The American Congress of Obstetricians and Gynecologists has issued revised guidelines regarding when to offer a woman a vaginal birth when she had previously delivered a baby via cesarean section, or VBAC.  Nationally, less than one in ten women undergo VBAC; the rest undergo an elective c-section.  While the revised guidelines require the physician to discuss each procedure's risks and benefits with the patient, there are subtle changes in the wording of the guidelines that patients will not notice that could impact the safety of the mother and baby.

The ACOG guideline states as follows in part:  "Women and their physicians may still make a plan for a TOLAC in situations where there may not be "immediately available" staff to handle emergencies, but it requires a thorough discussion of the local health care system, the available resources, and the potential for incremental risk. 'It is absolutely critical that a woman and her physician discuss VBAC early in the prenatal care period so that logistical plans can be made well in advance,' said Dr. Grobman. And those hospitals that lack "immediately available" staff should develop a clear process for gathering them quickly..."

VBAC carries a recognized but rare risk of uterine rupture which is a serious complication for the mother and the child.   Uterine rupture requires emergency surgery and can  threaten the life of the mother and the child.  ACOG previously recommended that VBAC only occur in hospitals with emergency anesthesiologists and surgeons immediately available to deal with uterine rupture.  In this revised guideline the language has changed, but what about the risks for the mother and the baby?  Have those changed or is this relaxed new guideline a result of pressure on hospital and physicians to allow this procedure to be performed in hospitals where trained anesthesiologists and surgeons are not physically present in the hospital.   Are parents being told about this subtle but important change? How soon can the anesthesiologist get to the hospital?  Minutes matter for both baby and mother in these rare but extremely serious circumstances.

ACOG attributes this to "the onerous medical liability climate for ob-gyns".   There is only a claim for liability when a mother or baby are injured due to the negligence of the physician or hospital staff.   In fact, if a physician adequately explains the risk of uterine rupture in VBAC including the alternatives and her delivery is appropriately managed then the physician is not liable for any uterine rupture that is beyond his or her control. What this new relaxed guideline does is tries to allow hospitals without anesthesiologists and surgeons in the hospital at all times to perform VBAC.  The question is whether families understand the risk that this provides and whether they are being allowed to choose to go where surgeons and anesthesia teams are readily available in the hospital.  The goal of ACOG should be to educate physicians about when VBAC is clinically appropriate and also teach them how to counsel patients about their options.  Of course parents should be completely informed of their options and the risks associated with those options, including whether the anesthesiologist and surgeon are immediately available.  All of the risks need to be discussed with the patient or they have not been provided a fair chance to make the best choice for their family.  Even if that means the safest choice for baby and mom is to deliver at another hospital. 

Posted by: Salvatore J. Zambri, founding partner     

The New Jersey Star-Ledger (7/16, Todd) reports that spurred by a "recently published study," the "Food and Drug Administration is investigating whether some of the most commonly used blood pressure medicines may increase the risks of cancer."

According to the report, the "agency said it began a review of a class of drugs known as angiotensin receptor blockers after a recently published study suggested the medicines could be associated with a slight increased risk of cancer, according to a notice posted on the FDA’s website."

The group of drugs under concern include some of the top-selling blood pressure drugs, such as  Cozaar, which is manufactured by Merck, and Avapro, a Bristol-Myers Squibb drug.

Before taking any medication, please speak with your doctor, who is obligated to inform you of all risks and benefits of the drug prescribes so you can make the best--most informed--decision about your health.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted by: Salvatore J. Zambri, founding partner     

The DC Department of Health recently released a report, making clear that medical errors are killing more DC residents than all types of car and truck accidents combined.  Per the February, 2010 report, "The leading causes of preventable death in the District of Columbia...were tobacco use (estimated 860 deaths; 16.6 percent of total DC resident deaths), poor diet and physical inactivity (estimated 780 deaths; 15.1 percent), microbial (infectious) agents—excluding HIV—(estimated 240 deaths; 4.6 percent), alcohol consumption (estimated 150 deaths; 2.9 percent), firearms (estimated 140; 2.7 percent), and medical errors (estimated 140 deaths; 2.7 percent). 

According to the comprehensive study and report, motor vehicle accidents account for .6% of the overall deaths in DC--that's 4.5 times less than the deaths caused by preventable medical errors.

The complete report can be viewed by clicking here.

There is a lot of discussion in politics about "tort reform".  The term--"tort reform"--is actually a misnomer, and is better understood as "tort deform".   Some powerful business groups and industries wish to strip Americans of their rights and their access to justice when injured due to medical errors.  Instead of robbing Americans of their fundamental rights and compensating them for the devastating damages they incur as a result of medical negligence, the focus should be on preventing the medical errors in the first place.  That's true reform.

About the author:

Posted by: Salvatore J. Zambri, founding partner     

Weak regulations may allow convicted nurses to cross state lines for work.  Without tougher regulations, requiring hospitals and medical providers to report criminal activity of nurses, nurses will continue to slip into other states to find work, threatening the health and safety of others.

Under the headline "Bad Nurses Able To Keep Working In Other States," USA Today (7/15, Weber, Ornstein) carries an article and interactive map by the independent reporting organization ProPublica that explain how nurses can slip from one state to another for work even if they have felony drug convictions. The report opens with the case of a nurse who "was fired from a hospital in Wausau, Wis., in 2007 after stealing the powerful painkiller Dilaudid." The nurse was convicted of felony drug charges and later managed to "get a job as a traveling nurse at a hospital 1,200 miles away in New Bern, N.C." According to ProPublica, this case "illustrates significant gaps in regulatory efforts nationwide" to keep track of nurses' misconduct. The report examines applicable licensing issues and agreements that it says perpetuate the problem.

I have represented many patients of hospitals who had their pain medication siphoned away by drug-addicted nurses. The people I represented were coming out of radical medical procedure.  The absence of drugs caused them unimaginable pain and further medical complications.  As a result of my claims, I am happy to report that additional practices and procedures are now taking place in area hospitals, but more needs to be done locally and nationally. 

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

By Catherine D. Bertram

Catheter-related bloodstream infections kill 30,000 hospital patients and infect a total of 80,00 patients in the U.S. each year.  So why aren't more hospitals adopting the simple five-step approach to prevent these infections?

The protocol:

1. Health care provider washes hands

2. Patient's skin cleaned with antiseptic

3. Patient's body covered with sterile drape

4. Health care provider wears sterile hat, mask, gloves, and gown

5. Sterile dressing over the catheter site

When Michigan hospitals implemented these steps, their infection rate dropped by two-thirds.  Over 18 months, the hospitals not only saved lives, but saved $200 million, or about $30,000 per infection.

So why not take those steps? A survey by the Association for Professionals in Infection Control and Epidemiology indicates that the hospitals contend they don't have enough time to train or they blame it on unwieldy paper-based records systems. It is reported that many hospital CEO's aren't even aware of their own hospital's bloodstream-infection rates.

Posted by: Salvatore J. Zambri, founding partner     

The FDA has not yet removed Avandia from the market, although it is still considering its options.
The New York Times (7/15, A1, Harris) reports on its front page that the 33 panelists "took six votes on a variety of issues" and when asked what the FDA should do, "12 voted that Avandia should be withdrawn; 10 voted that its sales should be restricted and the warnings on its label enhanced; 7 voted only to support enhanced warnings on the drug's label; and 3 voted that the drug should continue to be sold with its present warnings unchanged. One member abstained, and no one voted for a final option, to weaken the label's present heart warnings." Dr. Janet Woodcock, director of the FDA's drug center, "said that the agency took the panel's advice seriously and that it would consider its regulatory options."

The Washington Post (7/15, Stein) reports that a "majority" of the panel urged to keep the drug "available, perhaps with tough new restrictions and warnings." The votes "came after the panel concluded that there was sufficient evidence to be concerned that Avandia increases the risk of heart attacks and strokes but insufficient evidence that the drug increases the risk of death." The panel "also voted to recommend that the FDA allow a large new international study by GlaxoSmithKline, the maker of Avandia, to proceed." Still, the final, "mixed vote illustrated the intensity of the debate over the drug. Critics...argued that the drug was clearly dangerous and unnecessary. Others expressed concern about pulling a drug that might be useful to some diabetics, who frequently need to try more than one medication."

USA Today (7/15, Rubin) also reports that the panel "voted 18-6 that the data raise significant concerns that Avandia carries a higher risk of those heart problems than does Actos [pioglitazone], the only other drug in its class. Nine were undecided."

The Hill 's (7/15, Lillis) Healthwatch blog reports, "Sen. Tom Harkin (D-Iowa), chairman of the Senate Health Committee, is calling on the Food and Drug Administration (FDA) to reach a quick verdict on the fate of Avandia." The Hill also notes that the panel's "mixed verdict puts the ultimate decision in the hands of Margaret Hamburg, who heads the FDA."

Given the serious risks of dangerous drugs, we urge you to speak with your doctor before ingesting any drug.  Be safe.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

By Catherine D. Bertram

Earlene Johnson worked as a medical supply technician at the St. Louis Veterans Affairs Medical Center, where almost 2,000 veterans may have been exposed to Hepatitis B and C and HIV due to poor sterilization practices.  She testified, before the House Committee on Veterans Affairs, that she warned her superiors that the dental equipment wasn't being adequately sterilized, but they ignored her and eventually fired her.

After her warnings, a year passed before the VA notified the veterans who had potentially been exposed.

Rather than use a special sterilizing machine, technicians evidently washed the dental instruments by hand, which does not clean the instruments as fully as the sterilizing machine.  The improper sterilization took place over thirteen months, from February of 2009 to March 2010.

Earlier this year, the VA had to inform 3,000 colonoscopy patients of San Diego's Palomar Hospital that reused medical equipment might have exposed them to infection.

Posted by: Salvatore J. Zambri, founding partner     

The AP (7/16) reports, "Irish drug maker Elan Corp. PLC said Thursday it agreed to pay $203.5 million to settle investigations into sales and marketing practices related to the epilepsy drug Zonegran [zonisamide]." Elan's US division Elan Pharmaceuticals Inc. "expects to plead guilty to a misdemeanor violation of the Food, Drug and Cosmetic Act," the company said. If the settlement is approved, Elan "said it would resolve all federal and state Medicaid claims into the marketing of Zonegran."

Patients with epilepsy need drugs, but they deserve to know that the marketing and sales practices of the drug-makers are fair, accurate, and properly informative.  Safety and health must be put above profits.  It's a matter of life and death.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted by: Salvatore J. Zambri, founding partner     

There is a great debate over whether Avandia should stay on the market in light of its risks.  The Wall Street Journal urges FDA to keep Avandia on the market. In an editorial, the Wall Street Journal (7/16) says that people who want GlaxoSmithKline's Avandia (rosiglitazone) to be removed from the market, as well those who maintain that it should still be available to patients with type 2 diabetes, were frustrated this week by an FDA advisory panel that voted to keep the drug on the market with tougher restrictions. The Journal notes that the FDA is under immense pressure to remove Avandia from the market, especially from FDA Commissioner Margaret Hamburg's deputy chief Dr. Joshua Sharfstein, but the paper says that, hopefully, Hamburg will keep Avandia available, even just as a backup treatment.

Not everyone shares that view.  One columnist says the collusion between the government and  drugmakers is allowing Avandia to remain on the market.  Jon Carroll wrote in his San Francisco Chronicle (7/14, F8) column that if patients were offered two drugs, one which "has been linked to an increased risk of heart attacks and the other [which] hasn't," they would prefer the latter. He added, "My conclusion is that patients were not given that information by their doctors. My conclusion is that the clammy hand of GSK has urged the doctors to ignore the, ahem, 'flawed and preliminary data' and keep on pushing the Avandia." Carroll argued that despite data suggesting that Avandia may be unsafe, the government is allowing it to remain on the market. He called this "lunacy," and said that there was a "happy collusion between the government, drug companies and (some) private doctors."

Before taking Avandia or any drug, speak to your doctor.  Your doctor is obligated to explain all risks and benefits of drugs he or she prescribes.  If safer drugs are available, they should be considered.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

By Catherine Bertram

Washington Hospital Center has a program called "Medical House Calls".  The program provides primary care services by a team of dedicated physicians, nurse practitioners, social workers and others.  These health care teams make house calls to the homes of  elderly residents to provide the ongoing care and preventive care they need in the comfort and privacy of their own homes.  

Patient Enrollment Criteria

To qualify for the Medical House Call program, patients must:

• Live in one of these D.C. zip codes: 20001, 20002, 20009, 20010, 20011, 20012, 20017, or 20018
• Be 60 years or older and have difficulty getting to the doctor's office 
• Have Medicare, Medicaid or some other non-HMO health insurance

Patients may find out more information about how to enroll by calling 202-877-0576.

Posted by: Salvatore J. Zambri, founding partner     

Did you know that the FDA has limited power to recall dangerous drugs?  That's not good, and something needs to be done about it.  Perhaps the time is now.

"[S]purred by questions about Johnson & Johnson's voluntary recall of millions of bottles of children's medicine this spring, a House committee chairman has introduced legislation to give federal regulators the authority to recall drugs that pose health threats," CQ Today (7/16, Ethridge) reports.  House Oversight and Government Reform Chairman Edolphus Towns (D-NY) said Thursday that the bill would give the FDA "the authority to order a recall when a drug has been adulterated or misbranded, or when exposure to the drug would cause serious health consequences or death to humans and animals."

Currently, the FDA can only ask companies to recall their drugs, although it "has the authority to mandate recalls of some products it regulates." This legislation is desperately needed, and has the potential to save lives and keep people from being harmed by defective and dangerous drugs.

Please call your legislators and support this bill.

Do you have any questions about this post?

About the author:

Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine (2010)--a national publication that honors the top lawyers in America.

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted by: Salvatore J. Zambri, founding partner     

Last week, I posted a blog entry about the controversy surrounding Avandia after recent studies revealed the cardiovascular dangers surrounding it and advised readers to contact their doctor immediately regarding possible alternative medication. 

A new article in the New York Times provides more insight into the known problems with Avandia at SmithKline Beecham.  According to studies conducted by the manufacturer in 1999, signs were evident that Avandia was riskier to the heart; however, the company chose not to publish those studies, instead spending 11 years trying to cover them up.  "The company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law."  Following the May, 2007 lawsuit that forced SmithKline (successor to SmithKline Beecham) to post some documents on its website, it has become more obvious that the company aggressively attempted to prevent the public from learning of the cardiovascular safety risks to protect their sales numbers.

Posted by: Salvatore J. Zambri, founding partner     

As part of the major health care law recently passed, consumers are considered winners for the most part.  However, hospitals are concerned that the financial penalties that may be imposed on them could create financial problems.  Some of the provisions that are of greatest concern for hospitals include:

• "In 2012, Medicare will stop paying hospitals for preventable readmissions tied to health conditions such as heart failure or pneumonia. In 2014, HHS will expand that policy to cover four additional health conditions.
• Beginning in 2012, hospitals will be paid commensurate to their performance scores for patient satisfaction and care quality tied to treatment of conditions such as heart failure, pneumonia and hospital-borne infections.
• In 2015, HHS will start reporting each hospital's record for medical errors and infections pertaining to Medicare patients. Medicare will reduce its payments by 1 percent to hospitals with the highest rate of medical errors and infections. The government will also no longer pay hospitals for treatment when a Medicaid patient is harmed during a hospital stay."

Posted by: Salvatore J. Zambri, founding partner     

The current heat wave that has blanketed much of the nation for the past several weeks brings with it more than sweltering temperatures.  Excessive heat is extremely dangerous, often  causing illness and occasional deaths.  Understanding the dangers and preventive actions help prevent illness or death.

The Centers for Disease Control and Prevention (CDC) offers some simple, common sense advice for how to stay cool and well in hot weather:

"Here are some facts about which people are at greatest risk for heat-related illness and what protective actions to take to prevent illness or death:

• People who are at highest risk are the elderly, the very young, and people with mental illness and chronic diseases
• But even young and healthy people can get sick from the heat if they participate in strenuous physical activities during hot weather.
• Air-conditioning is the number one protective factor against heat-related illness and death. If a home is not air-conditioned, people can reduce their risk for heat-related illness by spending time in public facilities that are air-conditioned.

You can take these steps to prevent heat-related illnesses, injuries, and deaths during hot weather:

•  Stay cool indoors.
•  Drink plenty of fluids.
•  Replace salt and minerals.
•  Wear appropriate clothing and sunscreen.
•  Schedule outdoor activities carefully.
•  Pace yourself.
•  Use a buddy system.
•  Monitor people at high risk.
•  Adjust to the environment.
•  Do not leave children in cars.
•  Use common sense."
   

By Catherine Bertram

The FDA issued a warning this week due to continued reports of serious side effects in patients using Qualaquin "off-label" for night time leg cramps, it states in part as follows "FDA has approved a risk management plan to warn against the use of this drug for such unapproved uses. Qualaquin should not be used for night time leg cramps. Qualaquin use may result in serious and life-threatening hematological reactions, including serious bleeding due to thrombocytopenia, and hemolytic-uremic syndrome/ thrombotic thrombocytopenic purpura, which in some cases may result in permanent kidney damage. In some patients, adverse reactions result in hospitalization and death.

Qualaquin is only FDA-approved for the treatment of uncomplicated malaria caused by the parasite Plasmodium falciparum, primarily in travelers returning from malaria-endemic areas. However, the majority of Qualaquin's use in the United States is for the treatment or prevention of night time leg cramps.The product labeling states that the risks associated with the use of Qualaquin in the absence of evidence of its effectiveness for treatment or prevention of nocturnal leg cramps outweigh any potential benefits.

The risk management plan (REMS) requires that patients be given a Medication Guide explaining what this medication is and is not approved for, as well as the potential side effects of this drug. In addition, the REMS requires that the manufacturer issue a Dear Health Care Provider Letter warning of the risk of serious and life-threatening hematologic reactions.

THE FDA RECOMMENDATION: Healthcare professionals should discuss with patients the warning signs of thrombocytopenia, such as easy bruising, severe nose bleeds, blood in the urine or stool, bleeding gums, and the appearance of unusual purple, brown, or red spots on the skin.

 By Catherine Bertram

The FDA warned consumers and healthcare professionals today that "Que She, marketed as an herbal weight loss supplement, contains unlisted and active pharmaceutical ingredients that could harm consumers, especially those with cardiovascular conditions. These active pharmaceutical ingredients also may interact with other medications and result in a serious adverse event.

Que She, advertised as “Slimming Factor Capsule” and as “an all-natural blend of Chinese herbs,” has been widely distributed on Internet sites such as the Bouncing Bear Botanicals website, and at retail outlets, including Sacred Journey in Lawrence, Kansas."

FDA analysis of Que She found that it contains:
   
o    fenfluramine – a stimulant drug withdrawn from the U.S. market in 1997 after studies demonstrated that it caused serious heart valve damage
o    propranolol – a prescription beta blocker drug that can pose a risk to people with bronchial asthma and certain heart conditions
o    sibutramine – a controlled substance and prescription weight loss drug, sibutramine was the subject of a recent study whose preliminary findings showed an association between sibutramine use and increased risk of heart attack and stroke in patients who have a history of heart disease
o    ephedrine – a stimulant drug that is legally marketed over-the-counter for temporary relief of asthma but can pose a risk to people with certain cardiovascular conditions.

The FDA recommends that people who have purchased Que She should stop taking the product immediately and consult a health care professional.

Posted by: Salvatore J. Zambri, founding partner     

The New York Times (7/5) editorialized that the recent controversy over the diabetes drug Avandia -- with "two major studies" saying it "raises the risk of cardiovascular ailments" and the third yet-to-be-published study that "seemed to exonerate" the drug -- should probably lead patients to ask their doctors about alternatives. The paper said that as expert advisers to the Food and Drug Administration work to deliver a more definitive judgment, it would throw its lot with the views of safety specialists, who focus solely on risks emerging after the drug is in use, rather than the opinions of those "who approved the drug as safe and effective in the first place.

If you or a loved one uses Avandia, you are encouraged to speak to your doctor immediately.  Your doctor should inform you of all risks associated with any drug he or she prescribes, so that you can make fully informed health decisions.

Do you have any questions about this post?  

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 Posted by: Salvatore J. Zambri, founding partner     

The AP (7/7) reports, "The Food and Drug Administration said Tuesday it sent a warning letter to Cornerstone Therapeutics Inc. alleging that Cornerstone's promotional materials withheld information about the risks of its asthma drug Zyflo CR [zileuton]." The FDA "said the materials violated the Food, Drug, and Cosmetic Act" by using "outdated labeling" and suggesting "Zyflo CR is more effective than competing drugs like Singulair [montelukast]." In addition, the agency "said a Cornerstone visual aid did not include warnings about the most serious side effects or the most common ones."

While I appreciate the desire to sell products, it is critically important for drug companies to inform customers and the public generally of the risks associated with the use of their drugs. It is often a matter of life and death.  Safety and people should always trump profits.

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By Catherine Bertram

Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are serious disorders in which your skin and mucous membranes react severely to a medication or infection. Often, Stevens-Johnson syndrome begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters, eventually causing the top layer of your skin to die and shed.

SJS usually begins with fever, sore throat, and fatigue, which can be initially misdiagnosed. Ulcers and other lesions begin to appear in the mucous membranes, almost always in the mouth and lips but also in the genital and anal regions. Those in the mouth are usually extremely painful and reduce the patient's ability to eat or drink.

SJS is most often caused by  of medication. The leading cause appears to be use of antibiotics and sulfa drugs.    Although SJS can be caused by viral infections.

Medication causes

Drugs commonly associated with Stevens-Johnson syndrome include:

• Anti-gout medications, such as allopurinol
• Nonsteroidal anti-inflammatory drugs (NSAIDs)
• Sulfonamides and penicillins, which are used to treat infections
• Anticonvulsants, which are used to treat seizures

By Catherine Bertram

The Washington State Supreme Court struck down a law requiring 90 days' notice to doctors before filing suit against them. 

The court decided that the law violated the doctrine of "separation of powers", the idea that the three branches of the government--the courts, the governor, and the legislature--have defined roles and should not interfere with each other.  Because the law imposed more restrictions than a Washington court rule, the court held that the law impermissibly interfered with the judicial branch's rules. 

For the seventeenth consecutive year, cooperative efforts by the National Association of People with AIDS, the Center for Disease Control and Prevention (CDC) and AIDS.gov highlight the importance of HIV testing with National HIV Testing Day - June 27.  More than a million people in the United States are living with HIV.  According to some estimates, one in five does not even know they are infected.

The CDC recommends that everyone between the age of 13 and 64 be tested for HIV at least once in their lifetime.  People at higher risk for HIV should be tested at least once a year or more frequently, including gay or bisexual men, intravenous drug users, or those with multiple partners. Pregnant women are also advised to get tested in the earlier stages of pregnancy so precautions can be taken to prevent the transference of HIV to the baby.

Studies show that people, who know they are infected with HIV, take steps to protect their own health and that of their partners. The CDC has more information about the spread of HIV and testing locations so you can find out your HIV status.

Posted by: Salvatore J. Zambri, founding partner

In a story appearing on over 100 news websites, the AP (6/23, Perrone) reports that the FDA "is reviewing only a fraction of foreign drug trials, as companies increasingly move drug testing overseas to reduce costs." According to a report issued Tuesday by the Inspector General for HHS, the FDA "inspected about one percent of foreign drug testing sites in fiscal year 2008," and is "often unaware" of "early-stage trials conducted in developing countries" in "South and Central America." The report also makes several recommendations to help the FDA oversee foreign studies, including developing "better coordination with foreign governments to monitor drug trials abroad," and requiring drugmakers "to submit trial data in a standardized electronic format, to help the FDA identify sites for inspection."

If companies are going to rely on foreign drug trials, they must alert the FDA about such trials and afford the agency the time and access to inspect and evaluate the trials.  The FDA, for their part, must diligently inspect the foreign sites.  Of course, drug companies are ultimately responsible for their drugs, not the FDA, although the FDA does have its obligations.  No drug should enter the marketplace unless it is safe and sufficiently tested.  Safety must always trump profits. 

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Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, serious automobile accident claims, and other personal injury actions.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted by: Salvatore J. Zambri, founding partner

The Wall Street Journal (6/22, Dooren) reports that the FDA has announced that Pfizer Inc. has withdrawn Mylotarg (gemtuzumab ozogamicin) from the US market following research indicating that the medication was not effective and was linked to safety issues. The AP (6/22, Perrone) reports that the drug "carries a warning label about a sometimes fatal liver condition called veno-occlusive disease. The FDA said the rate of reports of the disease associated with the drug increased during its time on the market."

If you are taking this drug, please contact your doctor immediately.  Your physician is obligated to inform you of all known risks and benefits of a drug so you can make the best--most informed--health decisions.

Do you have any questions or comments about this post?  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, serious automobile accident claims, and other personal injury actions.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899.

Posted by: Salvatore J. Zambri, founding partner

According to an AP report, the Food and Drug Administration issued a warning letter to "Pfizer Inc. for failing to promptly report complaints with its drugs that may have involved serious injury." In the 12-page letter, dated May 26, the FDA "cites a number of product complaints which were not reported to government regulators within the required 15 days." The letter also "demands that Pfizer submit a plan for correcting the problems within 15 business days."

The Wall Street Journal also reports that this FDA warning letter to Pfizer is the second one this year. Two months ago, the company received an agency warning regarding pediatric clinical trials of the antipsychotic Geodon (ziprasidone). The Journal points out that the latest warning results from a 2009 inspection of Pfizer's headquarters, an inspection which the agency said was to ascertain Pfizer's compliance with reporting rules regarding adverse events after drugs are allowed on the market. Specifically, the letter said the agency discovered that some adverse-event reports were not actually reported until after its inspection was conducted. The drugs involved were Lyrica (pregabalin) and Lipitor (atorvastatin).

Per a Reuters report, the Food and Drug Administration has asked to meet with Pfizer to discuss the violations. For its part, Pfizer promised to work with the FDA to address and remedy the problems.

Obviously, we need medication to maintain and promote health.  However, it is critically important for pharmaceutical companies to accurately and timely report the dangers of the drugs they make and sell, so that doctors and patients can properly evaluate the risks and benefits of the drugs.  Safety must always trump profits.

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Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, serious automobile accident claims, and other personal injury actions.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted by: Salvatore J. Zambri, founding partner

The FDA has warned that Proton Pump Inhibitors can cause bones to fracture when used for more than one year or prescribed in higher doses.  According to ABC World News, as reported by CBS Evening News , "high doses or long-term use of what are called proton pump inhibitors can lead to an increased risk of bone fractures." This is especially true in patients "over the age of 50," and for "people on the high dose," says NBC Nightly News.

Before taking any medication, please speak with your doctor to be sure the benefits of the drug outweigh the risks.  Your doctor is obligated to explain all risks and benefits to you so that you can make the most informed decision possible about your health.  If not monitored appropriately, certain medications can cause serious, even life-threatening, consequences.

Do you have any questions or comments about this post?  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, serious automobile accident claims, and other personal injury actions.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted by: Salvatore J. Zambri, founding partner

The St. Louis Post-Dispatch reported that across the country, "hospitals either aren't disciplining doctors who have had problems, or are finding ways to avoid federal reporting rules." The Post-Dispatch discusses the case of Dr. Surendra Chaganti of St. Anthony's Medical Center in Missouri. Despite his involvement in a patient's death, he was able to keep a clean record.

This report is not surprising, although it is troubling.  For many years, studies have shown that a small percentage of doctors are repeat offenders, committing medical errors and engaging in self-destructive behavior that puts patients at risk.  The renowned Institute of Medicine has proven that approximately 98,000 Americans are killed every year as a result of medical errors.  If problem doctors are disciplined appropriately, lives will be saved and health will be preserved. 

I hope this additional study spurs hospitals to better screen, supervise, and train physicians.  We can't have nearly 100,000 Americans dying needlessly.

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Posted by: Salvatore J. Zambri, founding partner        

Recently, Baxter International issued a voluntary recall of their Colleague infusion pumps, which are used in hospitals to deliver various forms of medications and nutrients to patients.  According to the New York Times,  the FDA said that the pumps have contributed to more than 56,000 complaints of injuries and deaths between 2005 and 2009. The injuries and fatalies are attributed to battery failures and software errors.

There are approximately 200,000 infusion pumps in use in American hospitals. Baxter officials have said they will exchange the Colleague pumps with their Sigma Spectrum infusion pumps.  If you are using an infusion pump, please contact your physician immediately and  you are encouraged to swap the potentially defective pump with a reliable one.

Be safe.

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Posted by: Salvatore J. Zambri, founding partner              

American Medical News reported that the Maryland Court of Appeals "is set to decide the constitutionality of a general liability cap in a case that likely will impact a separate limit on noneconomic awards in medical liability suits." On April 2, the court "heard oral arguments in a wrongful death case" in which a $4 million verdict had been reduced to "$1 million, based on a noneconomic damage cap in general personal injury cases," a case which plaintiffs "appealed, contending that the cap violated their equal protection rights."

I am a Past-President of the Trial Lawyers Association of Metropolitan Washington, DC, and I am very involved in working to be sure Americans, particularly those that live in the Metro area, have fair access to justice.  Artificial caps have proven to do nothing to limit overall medical costs.  Caps simply feed the greed of special interest groups to the detriment of the people who suffer catastrophic injuries due to the carelessness of others.  Caps have been found unconstitutional in several states, and I hope the Maryland Court recognizes the clear unconstitutionality of these limits on justice.  Profit should never be put over people.

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Posted by: Salvatore J. Zambri, founding partner               

The Las Vegas Review-Journal reports that an anesthesiologist testified that "the 50-milliliter vials of anesthetic linked to a hepatitis C outbreak would have been enough to knock out a 600 pound gorilla during a colonoscopy," in the trial of Henry Chanin who was infected with hepatitis C during a 2006 colonoscopy in a Southern Nevada clinic. Chanin is suing Teva Parenteral Medicine and Baxter Healthcare Services on product liability issues claiming that "the companies made and sold vials of propofol that were much larger than needed for colonoscopies, which tempted medical workers to reuse vials among patients instead of throwing away unused anesthetic."

Hospitals and doctors should never reuse vials.  Doing so clearly and seriously threatens the health of patients.  We hope a lesson is learned here, although for many Americans it is too late, as they have suffered terrible health problems from the apparent misuse of the vials.

Do you have any questions or comments about this post?  

About the author:

Mr. Zambri is a Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. He has been acknowledged by Washingtonian magazine as a "Big Gun" and among the "top 1%" of all of the more than 80,000 lawyers in the Washington metropolitan area.  The magazine also acknowledges him as "one of Washington's best--most honest and effective lawyers" who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims.  Mr. Zambri has also been repeatedly named a "Super Lawyer" by Law and Politics magazine--a national publication that honors the top lawyers in America.  

Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning medication errors, medical malpractice litigation, and safety improvements.

If you have any questions about your legal rights, please email Mr. Zambri at szambri@reganfirm.com or call him at 202-822-1899. 

Posted by: Salvatore J. Zambri, founding partner               

The AP reports that in a warning letter dated April 9 and posted online April 20, the Food and Drug Administration said that Pfizer "has failed to correct problems with its testing procedures that resulted in overdoses of several children during a company trial" of "an experimental medication, which the agency did not name." However, a company spokeswoman said that medicine "is Geodon [ziprasidone], which the company was studying for children with bipolar disorder."

Bloomberg News reports that the letter posted to the agency's website outlined "'significant violations' discovered during an inspection of a Pfizer clinical trial site from May 4 to June 3." In 2005, the FDA warned Pfizer about the "lack of study monitoring that led to widespread overdoses," and "follow-up inspections in 2006 and 2007 also found dosing errors, the FDA said." The FDA has ordered Pfizer "to respond within 15 days with a plan to ensure that its studies comply with federal regulations."

The Wall Street Journal/Dow Jones Newswire reports that Pfizer is currently seeking agency approval of Geodon to treat bipolar disorder in patients ranging in age from 10 to 17 years old, which the FDA declined to do six months ago, citing a need for more information. The medication is currently approved for the treatment of schizophrenia and bipolar disorder in adult patients, however. Meanwhile, the Journal quotes Pfizer as stating that it "recognizes the seriousness of the issues cited by the FDA and is committed to fully addressing FDA's concerns."

Reuters reports that even though 13 children suffered from overdosing during the clinical trial, none was injured or subjected to ongoing side effects, and only two youngsters had to be taken out of the clinical trial. Since the overdosing incidents, seven found by the FDA and six documented in the pharmaceutical company's own internal memoranda, Pfizer said it "has instituted several new measures designed to improve monitoring and execution of clinical trials, including our oversight of clinical investigators."

Medications for children are necessary.  But so is safety.  In an effort to create effectove drugs, companies should never risk the health of those utilized in a clinical trial.  Safety over profit must be the goal.

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Posted by: Salvatore J. Zambri, founding partner               

USA Today reports that according to actor Dennis Quaid, "When a crash happens, it's so public. ... No one is going to fly on their airplanes unless they have that trust." Yet, "when a mistake occurs in a hospital, the public might never hear about it. Although an estimated 100,000 Americans die each year because of medical errors, their deaths are scattered over thousands of hospitals, 'where people die anyway,' Quaid said. 'It doesn't get the same type of attention.'"

USA Today says that since "Quaid's 10-day-old twins were twice given an adult dose of the blood thinner heparin," he "has become the self-described 'frontman' for a campaign to improve patient care with the implementation of 'safe practices' as simple as hand-washing and the use of technologies such as bar codes to match medications to patients."

It's wonderful that Mr. Quiad is speaking out for hospital safety and patients.  The best way to keep costs down is to improve health care.  By avoiding medical errors, people will be healthier.  It's sound business, and more especially, it's the ethical thing to do.

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Posted by: Salvatore J. Zambri, founding partner               

HealthDay reported that, according to a study published in the journal Pediatrics, "there appears to be no difference among antidepressants in raising a kid's risk of suicidal thoughts." Harvard School of Public Health researchers "collected data on 20,906 children aged 10 to 18 who had been diagnosed with depression in British Columbia," after following the children for nine years. The young participants "were on a variety of commonly prescribed antidepressants called selective serotonin reuptake inhibitors (SSRIs), including citalopram (Celexa), fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft)."

Medscape reported, "During the first 12 months of treatment, the researchers identified 266 attempted and three completed suicides -- an event rate of 27.04 suicidal acts per 1000 person-years (95% confidence interval [CI], 23.9 – 30.5 suicidal acts per 1,000 person-years)." However, "they failed to see any significant differences in rate ratios (RRs) in analyses comparing fluoxetine with citalopram (RR, 0.97; 95% CI, 0.54 – 1.76), fluvoxamine (RR, 1.05; 95% CI, 0.46 – 2.43), paroxetine (RR, 0.80; 95% CI, 0.47 – 1.37), and sertraline (RR, 1.02; 95% CI, 0.56 – 1.84)."

Reuters interviewed Thomas Laughren, MD, director of the FDA's Division of Psychiatry Products, who pointed out that clinicians need to closely follow young people on antidepressants due to the increased risk for suicide.

These reports underscore the importance of carefully monitoring people, especially young people, who are prescribed antidepressants.  Doctors must be aware of all risks and benefits attendant to the drugs they prescribe, and must explain those risks and benefits to patients and, when appropriate, parents and guardians, so that the best medical decisions can be made.

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Posted by: Salvatore J. Zambri, founding partner               

According to the Associated Press (AP), "A study of Medicare patients shows that costlier, more complex spinal fusion surgeries are on the rise-and sometimes done unnecessarily-for a common lower back condition caused by aging and arthritis. What's more alarming is that the findings suggest these more challenging operations are riskier, leading to more complications and even deaths."  The lead author, Richard Deyo, of Oregon Health and Science University in Portland said that "aggressive marketing of devices used in complex fusions is likely playing a role in the increase."

Between 2002 and 2007, the "rates of decompression surgery (relieving pressure on the spine) and simple fusion procedures (joining just one or two vertebrae) decreased" among the Medicare study participants, the Los Angeles Times' "Booster Shots" blog reported. During that same time frame, however, researchers found that the "number of complex fusion surgeries to treat spinal stenosis of the lower back soared from a rate of 1.3 per 100,000 to 19.9 per 100,000."

What's more concerning is that those patients who underwent the complex procedures "showed a doubled rate of life-threatening complications, 5.6 percent, compared with a simpler back surgery called decompression," Bloomberg News reports. In addition, the "more complicated surgery generated average hospital charges of $80,888, compared with an average of $23,724 for the simpler operation," according to data in the Journal of the American Medical Association.

If you are considering spinal surgery, please speak to your doctor about all attendant risks.  Your doctor is obligated to apprise you of all benefits and risks of a surgical procedure so that you can make the best, most informed, decisions about your health.

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Posted by: Salvatore J. Zambri, founding partner               

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Bloomberg News reported that "Novartis AG and Orion Oyj's Stalevo treatment for Parkinson's disease may be linked to an increased risk of prostate cancer, US health regulators said." In a statement found on its website, the FDA states that its "review of Stalevo is ongoing, and no new conclusions or recommendations about the use of this drug have been made." The agency "is reviewing a clinical trial that showed that prostate cancer was more common among patients taking Stalevo than in those taking only a combination of carbidopa and levodopa."

If you have been prescribed Stalevo, we encourage you to speak to your doctor promptly about all potential risks and benefits.  Your doctor is obligated to provide this information to you so that you can make the best, most informed, decisions possible concerning your health. 

I'll report back once we learn more about the FDA's review of the clinical trial.  In the meantime, if you have any questions at all, please feel free to contact me.

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Posted by: Salvatore J. Zambri, founding partner

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Cerebral Palsy is a medical condition that often confuses both parents and doctors.  With thorough testing, however, a physician can determine the exact type of  cerebral palsy your child has.  The proper classification depends on the severity of the child's symptoms, as well as the parts of the brain and body affected by the condition.

Here is a list of the fundamental categories of cerebral palsy:

Spastic Cerebral Palsy

This is the most common form of CP.  A child with spastic CP has muscles that are rigid, making it very difficult to move about.  There are three forms of spastic CP:

• Spastic diplegia — Legs typically cross at the knees ("scissoring"), and leg and hip muscles are tight.
• Spastic hemiplegia — One side of body affected only.  Affected side may have rigid limbs  and limbs that fail to develop fully.  
• Spastic quadriplegia — The severest type of CP.  Child likely to have mental deficits along with rigidity and difficulty moving legs and arms.  Often difficult for child to walk and talk.  Seizures common, too.

Athetoid Dyskinetic Cerebral Palsy

This is the second most frequently diagnosed type of cerebral palsy.  This type of CP does not affect the brain.  Although intelligence may be normal, muscle movement throughout the body may be severely limited. Muscles tone may be either tight or weak, making it challenging to walk, talk, or move about.  Drooling is common, as it is often difficult for a child with this type of CP to control facial muscles.

Ataxic Cerebral Palsy

This is the least diagnosed type of Cerebral Palsy.  ACP affects a child's fine motor skills, making it difficult for the child to perform tasks such as tying shoes, using a scissors, manipulating parts of toys, etc.  Problems with coordination and balance are typical.  You may notice your child walking with his or her legs further apart than other children at the same age.  And when a child engages in an act, "intention tremors” may occur.  For example, if a child reaches for a toy, the child's arm may begin to tremor, and the tremors may get more prono8unced as the child approaches the toy.

Hypotonic Cerebral Palsy

This type of CP is diagnosed early in a child's life. Symptoms include a "floppy" head when the infant attempts to sit up, and delayed motor development. Experts believe that this type of CP results from brain damage.

Mixed Cerebral Palsy

It is common for doctors to determine that a child's CP does not "fit" into one of the above categories.  As a result, the physician may consider the child to have "mixed" CP.

Cerebral palsy can be inherited or the result of a lack of development.  Sometime, it is caused by medical errors.  For instance, if a child is in distress in utero (before birth), but no appropriate action is taken by the hospital staff to alleviate the distress, the child may suffer CP.  This is just one example of the many ways medical errors lead to CP.  Fetal monitoring strips and other diagnostic tools are used to monitor an unborn child's health.  They must be used and monitored effectively.

If you have any questions about your child's health, please consult with your child's physician immediately. 

If you want to learn more about CP, please read an earlier blog I wrote about the condition.  Also, if you are wondering whether your child's condition was caused by a medical error, feel free to contact me at 202-822-1899 or email me at szambri@reganfirm.com.  Our medical and legal professionals are here for you, and our investigation is done at no charge.

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Posted by: Salvatore J. Zambri, founding partner

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Last night, the House passed the Senate-approved healthcare reform bill by a vote of 219-212. The AP notes that after passing the bill, the House proceeded to approve "key changes" to it, "part of a prearranged agreement to guarantee passage of the historic legislation. The changes passed by a 220-211 vote. That bill now goes to the Senate for final approval, where it only requires a simple majority to pass."

Most stories are describing the bill in largely favorable terms -- and the vote as a triumph of the political system as a whole. The vote, reports USA Today, "assured that about 32 million Americans will gain health insurance coverage, and millions more will win protections against losing theirs."  An AP story observes, "Rarely does the government, that big, clumsy, poorly regarded oaf, pull off anything short of war that touches all lives with one act, one stroke of a president's pen. Such a moment has come."

The passing of the measure marks the most sweeping healthcare legislation this country has seen in four decades, and is an apparent victory for President Obama.  Not a single republican, however, voted for the bill--a clear sign that they will make it an issue come the November elections.

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Posted by: Salvatore J. Zambri, founding partner

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Bloomberg News (BN) recently reported that, according to the Mayo Clinic, "Most scientists who published articles supporting GlaxoSmithKline Plc's diabetes drug Avandia [rosiglitazone] after it was linked to heart disease in 2007 had financial ties to the company."  

The United Kingdom's Independent reported, "Researchers from the Mayo Clinic in Minnesota -- one of the few US research organizations that does not rely on commercial sponsorship -- analyzed more than 200 articles published in scientific journals, including original papers, editorials, and letters, which commented on the heart attack risk associated with Avandia after 2007. " The investigators "found almost half (47 percent) of the study authors had financial conflicts of interest, but almost a quarter (23 percent) did not disclose it. They were discovered by searching other publications by the same author or on the Internet."

In February, internal documents and findings from the Food and Drug Administration, released by US Senators, made the recommendation that Avandia should be removed from the American market. The agency now plans to conduct a July meeting to weigh the pros and cons of the drug.

I blogged about the Avandia drug earlier this year.  To read that blog and learn more about the risks of Avandia, please click here.

If prescribed Avandia, please contact your doctor immediately.  Your doctor should not prescribe any medication without first warning you of all known risks, and only if the benefits of the medication outweigh the risks.

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By Catherine D. Bertram                                                  

Clostridium difficile or “C. diff.”  C. diff. killed more patients in England in 2006 than MRSA. The Centers for Disease Control (CDC) reported a nearly twofold increase in C. diff infections from 1996 to 2003 in the U.S.   The same hyper-virulent strain, dubbed ribotype 027, has invaded some hospitals in the U.S.   C. diff. infections kill an estimated 5,000 people in the U.S. per year, the CDC reports.

C. diff has been causing trouble for several years.   The mortality rate from this disease is rising.   What do we know about this enemy?  Outside of hospitals and nursing homes, it is only found in the gastrointestinal tracts of about 5% of the general population.   Other "good" bacteria usually keep C.diff from getting out of control. However, in hospitals and nursing homes that is not always the case.  When a patient is put on antibiotics, the balance of bacteria is affected, and C. diff. may take control, causing severe, watery diarrhea.

Why does this bug spread so fast in hospitals and nursing homes?  The answer is very troubling.  Traces of one patient's feces, from the watery diarrhea, come into contact with another patient's mouth, thus spreading this dangerous bacteria.   How could such a thing happen?  The only answer is inadequate cleaning.   Patients and staff pick up the C.diff bacteria, in the form of spores, from contaminated surfaces such as uniforms, stethoscopes, blood pressure cuffs, door knobs, bedrails and IV poles.    Unknowingly, caregivers get these C.diff spores on their hands and pass them on to other caregivers and eventually to other patients.   The patients then touch their hands to their lips and the bacteria spreads.

Think this is an exaggeration?  Look at these confirmed cases according to an article by an organization called Reduce Infection Deaths  (RID),  "At Thomas Jefferson University Medical Center in Philadelphia, where C. diff was raging, three patients occupying the same room consecutively came down with C. diff. One died as a result.  In 2005, eight infants in the neonatal intensive care unit (NICU)  at Intermountain Healthcare in Provo, Utah contracted C. diff.  All eight infected infants had shared one of three beds in a corner of the NICU. 

At the Cleveland VA Medical Center, researchers cultured commonly touched surfaces such as bed rails, telephones, call buttons, toilet seats, and bedside tables in the rooms of patients with C. Diff.  After routine cleaning, 78% of the surfaces were still contaminated with C. diff spores. However, after re-education of the hospital cleaning staff, including reminders about surfaces commonly overlooked, the staff used bleach and only 1% of surfaces were still contaminated.  

The 2000, the University of Pittsburgh Medical Center –Presbyterian experienced a shocking 400% increase in C. diff infections.  They responded with a comprehensive strategy that emphasized rigorous cleaning with bleach and rapid identification and isolation of C.diff positive patients to prevent the bacteria from spreading to other patients.  It worked.   By 2006, C. diff rates were down 71%."

At Intermountain Healthcare, after the eight infants contracted C. diff, the NICU was “cleaned from top to bottom,” and they "launched extensive staff education related to C. difficile and its ability to be found on environmental surfaces,” and “the importance of washing hands with soap and water when caring for a patient with C. difficile.”  The results?  No new cases of C. diff appeared the NICU in the next two years.

Education is the key.   A study at one hospital found that 39% of resident physicians and other medical personnel didn’t know that C. diff spores could be transmitted from patient to patient on equipment. Almost 20% thought C. diff was a blood borne pathogen which is incorrect.

Cleaning the hospital and nursing home environment and educating personnel about C. diff. is essential.  Mandatory hand hygiene for patients before meals is also critical.  Nonambulatory patients are frequently handed a food tray, but have no way to clean their hands before eating.  If their hands are contaminated with C. diff spores, they will infect themselves by eating.  

Posted by: Salvatore J. Zambri, founding partner

CONTACT US      

According to the Wall Street Journal, the Justice Department has announced that Alpharma, Inc. has agreed to pay a whopping $42.5 Million to settle a claim in which the government alleged that the drug company improperly paid physicians to prescribe and promote a particular morphine drug--Kadian.  The settlement follows a whistle-blower suit.

Whistle-blower suits allow people who work for companies to come to the government with evidence that the companies are violating the law.  These kinds of suits are important as they provide protection to the whistle-blower while the government intervenes and remedies an injustice.

People who are aware of corporate wrongdoing understandably feel like they have a moral and ethical obligation to come forward in an effort to stop the injustice.  They often don't, however, fearing that they will be retaliated against.  These whistle-blowers are protected by the law, however.  If you are aware of corporate misfeasance, feel free to contact me to discuss your rights.  Never feel powerless.

About the author:

Posted by: Salvatore J. Zambri, founding partner     

New Jersey's Star-Ledger reports that the FDA on Tuesday ordered "Glenmark Generics to stop selling unapproved nitroglycerin tablets for relief from chest pain." The unapproved drugs "are different from approved nitroglycerin tablets in some ways, such as formulation and labeling, but the FDA said it has seen quality and efficacy problems with the unapproved versions." The FDA also "advised consumers that Pfizer sells a version of the product that has been approved by regulators." Kotec Inc. of Arizona also received a warning.

According to the Los Angeles Times' "Booster Shots" blog, the FDA gave the two drugmakers "90 days to stop making and selling nitroglycerin tablets for use by heart patients and 180 days to stop shipping those they have made." Reuters also covers the story.

There is great danger in selling unapproved drugs.  Drug companies must always put the safety of people over profits.  If they don't, their greed will seriously injure and even kill Americans. 

Before taking any medication, be sure to consult with your doctor, who is obligated to provide you with all risks and benefits of the drug before prescribing the medication.

About the author:

Posted by: Salvatore J. Zambri, founding partner     

“A happy life consists not in the absence, but in the mastery of hardships.” - Helen Keller

Cerebral palsy is a condition that can involve brain and nervous system functions, limiting a person's ability to move, learn, hear, see, and think.  Palsies develop due to damage to the developing brain.  Cerebral palsy usually develops by age two or three, and it is a non-progressive brain disorder, which means that the brain damage does not continue to worsen throughout life. However, the symptoms due to the brain damage often do change over time; sometimes getting better and sometimes getting worse. Cerebral palsy affects between two and four children out of every 1,000 live births. The United Cerebral Palsy Association estimates that more than 500,000 Americans have cerebral palsy. 

It is estimated that between 35% and 50% of all children with cerebral palsy will have an accompanying seizure disorder and some level of mental retardation.  Affected children also have a tendency to develop learning disabilities, along with vision, speech, hearing, or language problems. 

Symptoms are usually seen before a child is 2 years old, and sometimes begin as early as 3 months. Parents may notice that their child is delayed reaching certain developmental stages such as sitting, rolling, crawling, or walking.  There are several different types of cerebral palsy. Some people have a mixture of symptoms.

Symptoms of spastic cerebral palsy, the most common type, include:

• Muscles that are very tight and do not stretch, which may tighten up even more over time;
• Abnormal gait with arms tucked in toward the sides, knees crossed or touching, legs make "scissors" movements, walk on the toes;
• Joints are tight and do not open up all the way (called joint contracture); and
• Muscle weakness or loss of movement in a group of muscles (paralysis).
   

Although there is a wide spectrum of symptoms, some other common symptoms of cerebral palsy include:

• Abnormal movements (twisting, jerking, or writhing) of the hands, feet, arms, or legs while awake, which gets worse during periods of stress;
• Tremors; and
• Loss of coordination.

Decreased intelligence or learning disabilities are common, but intelligence can be normal.  Many people with cerebral palsy have speech problems, hearing or vision deficits, seizures, and suffer pain and discomfort.

Cerebral palsy is caused by injuries or abnormalities of the brain. Most of these problems occur as the baby grows in the womb or during the delivery process, but they can happen at any time during the first 2 years of life, while the baby's brain is still developing.  Sometimes, these injuries are preventable, yet brought about by medical errors.

Examples of cerebral palsy caused by the failure of medical providers to meet applicable standards of care, include:

• Undiagnosed or untreated infections during pregnancy that may damage a fetus' developing nervous system;
• Undiagnosed or treated jaundice in the infant;
• Bleeding in the brain that goes untreated;
• Severe oxygen deprivation to the brain or significant trauma to the head during labor and delivery;
• Leaving the child in the birth canal too long causing a lack of oxygen to the brain;
• Failure to detect a prolapsed cord (the umbilical cord can wrap around the child's neck, cutting off oxygen to the brain);
• Failure to perform a cesarean section in the presence of fetal distress;
• Improper use of forceps during delivery;
• Excessive use of vacuum extraction;
• Failure to recognize and treat seizures following delivery;
• Not responding to changes in the fetal heart rate; and
• Failure to plan a cesarean with a high birth weight infant.

Although life can be extremely challenging for  those with cerebral palsy, as well as the parents, siblings, and other family members, there are many organizations and support groups that can help people face and overcome those challenges.

The following is a list of readings, organizations, and special agencies whose purpose is to provide education about cerebral palsy and other disabilities and information to assist families with their needs, which I hope you find useful:

United Cerebral Palsy
http://www.ucp.org/
1660 L Street, N.W., Suite 700
Washington, DC 20036
(800) 872 – 5827/(202) 776-0406
E-mail: info@ucp.org

UCP is a national organization for people with cerebral palsy and their families. Through its local chapters, it provides a variety of services, including information and referral, parent support, advocacy, and educational and work programs for people with cerebral palsy. Fact sheets on selected issues related to cerebral palsy are available, as well as publications from a variety of publishers and organizations. Many publications can be downloaded from the website at no charge.

Association of University Centers on Disabilities
http://www.aucd.org/
1010 Wayne Avenue
Suite 920
Silver Spring, MD 20910
(301) 588-8252

The Association of University Centers on Disabilities (AUCD) is a membership organization that supports and promotes a national network of university-based interdisciplinary programs.  Through its members, AUCD is a resource for local, state, national, and international agencies, organizations, and policy makers concerned about people living with developmental and other disabilities and their families. Members engage in a range of interdisciplinary activities including: exemplary services for children, adults, and families; academic training; basic and applied research; training and technical assistance to schools, communities, and all levels of government; policy advocacy; program evaluation; and dissemination of best practices and new information.  AUCD programs also train the next generation of leaders in disability-related research, training, service delivery, and policy advocacy to insure that this essential work continues.

American Physical Therapy Association
http://www.apta.org/
1111 N.  Fairfax Street
Alexandria, VA 22314
(800) 999-2782/(703) 684 - 2782

The APTA has a free list of publications, "Publications of Interest to Parent and Educators of Handicapped Children." They can also direct you to the APTA chapter in your area.

ABLEDATA
http://www.abledata.com/
8455 Colesville Road, Suite 935
Silver Spring, MD 20910
(800) 227 - 0216

ABLEDATA is a national database covering information on assistive technology and rehabilitation equipment. Those interested can search the database free of charge from the ABLEDATA web site, or can have an information specialist perform a search for a small fee.  ABLEDATA publishes an assistive technology fact sheet and consumer guides.

Brian Injury Association of America
http://www.biausa.org/
1608 Spring Hill Road
Suite 110
Vienna, VA 22182
(703) 761-0750

The Brain Injury Association of America (BIAA) is the leading national organization serving and representing individuals, families and professionals who are touched by a life-altering, often devastating, traumatic brain injury (TBI). Together with its network of more than 40 chartered state affiliates, as well as hundreds of local chapters and support groups across the country, the BIAA provides information, education and support to assist the 3.17 million Americans currently living with traumatic brain injury and their families. 

About the author:

Posted by: Salvatore J. Zambri, founding partner     

ABC World News recently reported on how some drug bottles look alike and how the United States Food and Drug Administration (FDA) "said it gets thousands of reports of such mix-ups every year." The FDA's Dr. Gerald Pan said, "Today's near-miss, today's medication error that doesn't cause harm to somebody could cause harm to someone tomorrow." ABC noted the name-change for Kapidex (dexlansoprazole) last week, but "that still leaves several hundred sound-alike and lookalike drug combinations to go."

Many scholars believe drug companies mirror other companies' products in an effort to fool customers into purchasing their products.  Here's what is important:  never buy a drug unless you are absolutely sure you know what you are purchasing.  Also, doctors and medical staff should never provide drugs to patients without understanding all risks and benefits of the drug and without first confirming that the drug provided to the patient is what the doctor has in fact prescribed.

About the author:

Posted by: Salvatore J. Zambri, founding partner     

In the Wall Street Journal, Laura Landro writes that the April edition of the Joint Commission Journal on Quality and Patient Safety includes an analysis of a fatal medical error that occurred when a nurse accidentally penicillin for an epidural. In doing so, according to the report, the nurse circumvented several safety procedures.  The review further determined that flaws in the hospital's system of delivering care contributed to the error.  Landro notes, however, that some hospitals are now trying to improve safety by establishing procedures for handling staff members who make errors.

It is disturbing to learn time and again how staff members ignore safety procedures.  Such conduct injures and often kills patients.  What's more disturbing, though, is learning that some staff members are permitted to be repeat offenders--people who habitually bypass safety procedures. 

Landro's report that some hospitals are trying to better monitor their staff members is refreshing news.  I hope other hospitals follow their lead.  Good leadership from hospital administrations will lead to better health-care.

About the author:

Posted by: Salvatore J. Zambri, founding partner     

According to the Chicago Tribune, Baxter International Inc. announced a recall of its "in-home dialysis device that has been linked to serious injury reports and at least one death in the last two years." In addition, the "Food and Drug Administration has classified the action as a Class I recall, the agency's most serious, for the Baxter's HomeChoice and HomeChoice Pro peritoneal dialysis cyclers, because the device is causing an 'overfill' of fluid in the patient's stomach," states the Tribune report.

A Class I recall applies to problems that can cause serious adverse health consequences or death. According to an AP report, "Baxter said it is still investigating the source of the problems and is working on changes to labeling and software to prevent patient errors."  The company nevertheless claims that the "machines do not need to be physically returned to the company and can still be used."

Dow Jones Newswire reported on the recall as well.

If using a Baxter device, we urge you to speak with your doctor immediately to determine if it is safe for you to continue using it.  Your doctor should be aware of the problems and the consequential risks to be able to provide you with the information you need to make the best decision possible for your health.

About the author:

Posted by: Salvatore J. Zambri, founding partner     

As you know, President Obama has called a summit to address the issue of healthcare reform.  The insurance industry, Big Business, the pharmaceutical industry, the American Medical Association (the doctor lobbying group), and other corporate industries have been shouting for limits on patients' rights.  The inescapable truth, however, is that capping damages and otherwise limiting the ability victims of medical errors have to obtain justice will have no appreciable impact on overall health costs.  Medical Malpractice litigation accounts for merely 1/2% to 1% of overall healthcare costs according to the Congressional Budget Office.

During the summit, Senator Dick Durbin (IL) delivered an impassioned defense of the civil justice system.

The president of the American Association for Justice recently appeared on CNN’s Anderson Cooper 360 to discuss this issue.

Nearly 100,000 people die every year in America due to preventable medical errors--that's like two 747 airplanes fully loaded crashing to the ground every single day.  The last thing the government anyone should ever seek to do is limit these innocent victims' ability to seek justice.  What the medical and business industries should be focusing on is improving medical care to avoid the medical errors that are seriously injuring and killing Americans.

I represent people who have been devastatingly injured due to preventable medical errors, as well as families of those who have been killed due to medical negligence.  If you have any questions about our civil justice system and its impact on overall healthcare costs, please feel free to give me a call.

About the author:

Posted by: Salvatore J. Zambri, founding partner     

The New York Times, in a front-page report, announced, "To help ensure that medical radiation is safe, Medicare insists that certain highly technical cancer treatments be administered only when a patient's radiation oncologist is present or nearby." Federal officials say physicians who fail to adequately supervise technicians during radiotherapy risk patient safety. But, the issue also "raises questions about financial incentives and the overuse of high-tech, and highly reimbursed, treatments" when "less advanced and cheaper ones would have served just as well."

As a result, "Congress passed an antikickback law designed to stop doctors from" unnecessarily ordering "tests or procedures in which they have a financial interest," according to the report.  In addition, "radiation safety will be the subject of a Congressional hearing Friday." For its part, "the American College of Radiology has said that self-referral endangers patients because doctors tend to order more tests."

Before undergoing any diagnostic test or invasive procedure, your doctor should describe all benefits and  risks of the procedure and he or she should explain all alternative options as well.

About the author:

 Posted by: Salvatore J. Zambri, founding partner     

The AP reported that "Drugmaker KV Pharmaceutical Co. says it will shut down its Ethex generic division, plead guilty to criminal charges" that the company failed to immediately notify "regulators of safety hazards."  The embattled company will "pay $27.6 million to resolve government investigations," according to the report.

The settlement requires Ethex to "plead guilty to two felony counts for failing to file 'field alerts' for two drugs, dextroamphetamine and propafenone," the St. Louis Post-Dispatch reports. In addition, "KV was ordered to stop making some time-release cough, cold, and gastrointestinal drugs in 2008," but despite that order, "the FDA said KV continued to make the drugs."

This smacks as another instance in which a big company decided to mock the law and put profits over safety.  There is no place for such greed in this country.  I hope the criminal consequences send a message to all greedy executives that they better change the way they do business and start putting people over profits.  Americans shouldn't be seriously injured or killed just so executives can pad their pockets.

About the author:

 Posted by: Salvatore J. Zambri, founding partner     

The front page of the New York Times reported that "Hundreds of people taking Avandia [rosiglitazone], a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports." A Senate Finance Committee review cites internal FDA documents that highlight a dispute among regulators that "has been brewing for years but has been brought to a head by disagreement over a new clinical trial."

The Wall Street Journal reports that the Senate committee concluded that Glaxo was aware of the risks, but minimized the issue and attempted to suppress concerned physicians. The FDA's documents also indicate that agency scientists said the drug should be pulled from the market in 2008, but FDA chiefs rejected the recommendations. Now, agency commissioner Margaret Hamburg is expected to meet "with FDA scientists and outside experts to gain a full understanding...of all of the data and issues involved," a spokeswoman said.

The AP reported that the Senate committee is asking the FDA "why it allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007." Glaxo agreed to an FDA request for "a six-year study between its drug and" the Pfizer diabetes drug Actos [pioglitazone] "to give a definitive picture of Avandia's safety."

If the senate report proves to be accurate, this once again smacks of a company putting profits over patient safety, leading to serious injuries and death.

If prescribed Avandia, please contcat your doctor immediately.  Your doctor should not prescribe any medication without first warning you of all known risks, and only if the benefits of teh medication outweigh the risks.

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By Catherine D. Bertram                                                     

According to an article in the Chicago Tribune, a company called RF Surgical Systems of Bellevue, Wash., created the RF Surgical Detection System which is essentially a scanning wand that can be used by surgeons to find any tagged items remaining in a patient. Tags (or seeds) about the size of a rice grain are imbedded in gauze, sponges and the like. One wave of the wand over the patient will reveal if the coast is clear.

According to an article in the New England Journal of Medicine, retained objects were reported "1 in 8,801 to 1 in 18,760 inpatient operations" which essentially is the equivalent of one case or more each year for a large hospital.  Unfortunately, this study was based on malpractice claims not just reported events,  so some experts say those numbers are most likely an underestimate. 

Does it work?  According to the article, more than 100 hospitals are using the system at a cost of about $15 per surgery.

Our firm has extensive experience with local cases involving surgical errors, including local hospitals where retained objects caused patient death. If you have any questions about this type of case feel free to email me at cbertram@reganfirm.com or call me at 202-822-1875.

 Posted by: Salvatore J. Zambri, founding partner     

The AP (1/27, Perrone) reports, "Federal health officials announced the recall of two million medical needles Tuesday because of a risk they can push bits of silicone into patients' bodies." The FDA "said Japanese manufacturer Nipro Medical Corp. has voluntarily recalled its Exel/Exelint Huber needles manufactured between January 2007 and August 2009."   Doctors, nurses, and patients should not be using these needles under any circumstances.

Bloomberg News (1/27, Peterson) reports that the "defect...might lead to fatal blockages of the main artery of the lung, the [FDA] said." The needles, which are intended "to give food and medicine to chronically ill patients," can "dislodge 'cores,' or slivers of silicon, from 'ports' under the skin and release the material into the bloodstream, FDA officials said." Jon Casamento, deputy director of the Solid and Fluid Mechanics Division at the FDA's Center for Devices and Radiological Health, said the "defective needles...may cause tissue damage and inadequate drug delivery."

Regulators have not received reports that the needles released silicon or other foreign chemicals into patients, but the defect is difficult for doctors to detect, Dow Jones Newswire (1/27, Favole) reports.

CNN (1/27, Young) reports that the FDA "said anyone using the products should stop immediately and return any unused needles to Exelint." The agency indicated that it is conducting investigations "of needles from 20 companies," of which 10 have already been completed. "The FDA said it has sent letters to all Huber manufacturers asking them to address any design or manufacturing problems."

About the author:

 Posted by: Salvatore J. Zambri, founding partner     

ev3 Endovascular, Inc. and FDA notified healthcare professionals of a Class I Recall of the Trailblazer Support Catheter. According to the recall, "This device may crack near the radiopaque marker band. This may result in serious patient injury, including insufficient oxygen supply to the tissues, damage to blood vessels, heart attack, limb amputation, unplanned surgery, and/or death."

If using a catheter, please contact your doctor immediately to be sure it is not part of the recall.  If you know you are using a Trailblazer Support Catheter, please stop using it right away, and obtain an alternative product.

About the author:

 Posted by: Salvatore J. Zambri, founding partner     

In a blog at the California Progress Report (1/6), J.G. Preston wrote, "One of the arguments the 'tort reform' crowd uses to justify putting a cap on the amount of money a jury can award to a victim of medical negligence is their assertion that increases in the cost of malpractice insurance are driving doctors out of the business." But "there are more doctors per capita in states that don't limit the amount that can be awarded to victims of negligence than there are in states that have implemented caps. The American Association for Justice broke down the numbers and found there are 21% more doctors per capita in states that don't restrict compensation that there are in states with caps." 

And there are more doctors than ever in America.   Take a look at the most recent data published by the American Medical Association, which confirms this fact.  The publication considers data through 2008.  There were 309 doctors for every 100,000 people that year.   Compared to the 1960s, that's twice as many.  So, not only are there more doctors per capita in states without damages caps, there are also more doctors everywhere in this nation.

The lesson:  Don't let the corporate greed of certain special interest groups convince you that you need to abandon your constitutional rights to pad their pockets.  Victims of the carelessness of others need their rights. 

Be safe, and don't be fooled by well-worn rhetoric.

About the author:

Posted by Catherine D. Bertram                                                        

On December 31, 2009, the FDA issued a warning to consumers and medical professionals, "especially pregnant or breastfeeding women, to avoid consuming a product called “Nzu”, taken as a traditional remedy for morning sickness,because of the potential health risks from high levels of lead and arsenic, noted on laboratory analysis by Texas DSHS. Exposure to lead can result in a number of harmful effects, and a developing child is particularly at risk of effects on the brain and nervous system. Arsenic is a carcinogen, and excessive long-term exposure to it has been associated with a range of adverse health effects, including cancers of the urinary bladder, lung and skin. Nzu, which is sold at African specialty stores is also called Calabash clay, Calabar stone, Mabele, Argile and La Craie. It generally resembles balls of clay or mud and is usually sold in small plastic bags with a handwritten label identifying it as “Nzu” or “Salted Nzu.” Anyone who has been ingesting the product should contact their health care provider."

Any adverse events that may be related to use should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online by clicking here or by phone at 1-800-332-1088.

 If you have any questions about injuries related to this medication, or any other medication, you can call our firm for more information about your legal rights.  Click here to contact us online or call us at 202-463-3030.

About the author:

Catherine Bertram is board certified in civil trials and was recently nominated as a 2010 Super Lawyer for Washington, D.C.  Ms. Bertram has 20 years of trial experience and is unique in that she was formerly the Director of Risk Management for Georgetown University Hospital so she brings a wealth of knowledge to her practice including how hospitals should be run and what doctors and nurses can do to protect patients.   She is a partner with the firm and devotes her practice to the representation of patients and families of loved ones who have been injured or lost due to medical errors.  Ms. Bertram lectures regularly to lawyers and health care providers, nationally and locally,  regarding patient safety, medical negligence and other related issues. She has also recently published a chapter in a medical textbook.   She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875 in her office in Washington, D.C.

 Posted by: Salvatore J. Zambri, founding partner     

The AP reports that officials with the Food and Drug Administration warned doctors recently that "about 11 recalled lots of an intravenous hypertension drug made by the Medicines Co. are contaminated with bits of steel." According to the agency, the particles "could potentially disrupt blood flow to the brain, kidney, liver heart and lungs." Medicines Co. recalled the affected lots of Cleviprex (clevidipine butyrate).

If you believe you have been prescribed this drug, contact your doctor immediately.

About the author:

 Posted by: Salvatore J. Zambri, founding partner     

Bloomberg News (12/16, O'Reilly, Feeley) reports, "Pfizer Inc. asked a judge to order the removal of an Internet video about its menopause medicines that the company says is misleading and aimed at swaying potential jurors in future trials over the pills." The video, called "Prempro News Segment," was posted on YouTube.com by "plaintiffs' lawyers who recently won more than $78 million in damages in a Pennsylvania trial over Pfizer's Prempro hormone-replacement drug."

At issue in that case was whether the "menopause drugs helped cause" the plaintiff's breast cancer. In the video, "breast-cancer victims discuss their cases," while the attorneys "accuse Wyeth of minimizing the risks of Prempro." According to Pfizer's lawyers, "Pennsylvania rules governing lawyer ethics prohibit lawyers from making pre-trial statements to the press that could 'prejudice' an upcoming case."

About the author:

 Posted by: Salvatore J. Zambri, founding partner     

A massive recall of swine flu vaccine doses drew national attention recently when it was announced by the Center for Disease Control.  ABC World News (12/15, story 6, 0:20, Gibson) reports that federal health officials "are recalling 800,000 children doses of swine flu vaccine...made by Sanofi Pasteur." NBC Nightly News (12/15, story 2, 0:35, Williams) reported that the doses "are less potent than they should have been."

The Los Angeles Times (12/16, Maugh) reports that Centers for Disease Control and Prevention director Dr. Anne Schuchat said the recall was "non-safety-related," and was "part of a routine quality assurance program." Schuchat emphasized that "children who received the vaccine do not need to be re-immunized," but the agency "wanted to make sure that doses that weren't already given won't be." The Washington Post (12/16, Stein, Laris) reports that "most of the vaccine, which was distributed nationwide in November, has probably already been used."

Bloomberg News (12/16, Randall) reports that Sanofi "began delivering swine flu vaccine in the US in September, with the bulk of deliveries expected in the fourth quarter." The United States "has ordered 75 million doses from the Paris- based company." CQ HealthBeat (12/16, Norman) reports that the problem was identified during "ongoing quality assessments" made by the drugmaker. The New York Times (12/16, A28, Mcneil) reports that Dr. Schuchat "said the vaccine was fully potent at release but dropped by about 12 percent in follow-up tests." In a story appearing in some form on over 320 news websites, the AP (12/16, Stobbe) reports that Jesse Goodman, the FDA's deputy commissioner for science and public health, said the problem may be related to the antigen sticking to the walls of children's pre-filled syringes.

USA Today (12/16, Sternberg) reports that the affected vaccine, "packaged in half-dose amounts meant for children 6 months to nearly 3 years old, represents about 1% of the nation's H1N1 vaccine supply." Sanofi spokesman Len Lavenda said the doses comprise roughly "18% of the 4.5 million doses in prefilled syringes made by Sanofi for children in that age group." Lavenda commented that officials were "baffled" by the weakened vaccine, adding "we can't remember a time when flu vaccine lost potency." The Wall Street Journal (12/16, Dooren) reports that Sanofi will be notifying providers to return any unused doses.

Reuters (12/16, Fox) also reported on this story, while Time (12/16, O'Callaghan) mentioned the recall in their "Wellness" blog.

Please be careful when taking a vaccine or allowing a loved one to be injected.  We urge you to speak with your doctor about all pros and cons of any drug before ingesting it.

About the author:

 Posted by: Salvatore J. Zambri, founding partner     

The CBS Evening News reported, "The problem of too much radiation during CT scans may be more widespread than anyone thought." CBS further confirmed that "new research...found a wide variation in radiation dose for the most common CT scan like abdomen, pelvis, and chest. A survey of four hospitals found some patients received 13 times more radiation than others for the same type of scan."   Over-radiation can be very dangerous.

NBC Nightly News, referring to a study, stated that "researchers calculated that 72 million CT scans are performed in this country a year and concluded that could lead to 29,000 excess cancers and 15,000 excess deaths a year in the future."  The study NBC cited was published in the Archives of Internal Medicine. 

A second study, in the same journal, of over 1,000 patients at four hospitals, showed that 1 out of 270 women and 1 out of 600 men suffer from cancer as a result of undergoing a single heart scan at age 40, the Wall Street Journal reports. According to the report, researchers who performed the study noted that the differences in radiation doses may be a result of the difference in technology from one medical provider to another as well as a lack of standardized settings.

Bloomberg News reports that in the National Cancer Institute study, "the authors predicted that lung cancer will be the most common radiation-related cancer followed by colon cancer and leukemia." In response to these study, the FDA has "issued interim regulations Dec. 7 requiring closer monitoring of CT scans after more than 250 cases of exposure to excess radiation were reported since October."

Before undergoing a CT scan, you should get sound medical advice from an experienced physician who is familiar with the risks and benefits of the procedure.  If undergoing a scan, be sure the facility has technologically advanced equipment, so your exposure to radiation is minimized to the extent possible.  Your doctors should be advising you of all risks associated with the procedure, as well as all options available to you, so you can make the best health decision you can.  Your doctors should also be using equipment that is safe and in excellent working condition.

I wish you good health and happiness.

About the author:

Each year in the U.S., 22 million patients are treated by Doctors of Chiropractic,more commonly called chiropractors, or "chiropractic physicians" in some states. It is estimated that there are 52,000 chiropractors currently performing such treatment.  The average chiropractor in private practice performs as many as 50-100 manual vertebral manipulations a day, at a cost of $25 to $40 each.

The goal of chiropractic is the diagnosis and correction by manual spinal manipulation or adjustment of a chiropractic condition called "vertebral subluxation."  Although most chiropractors claim they perform thousands of manipulations annually without any serious complications, malpractice suits have been successfully brought against chiropractors for injuries sustained as a result of improper manipulative technique and/or performance of spinal manipulation where it is contraindicated.  Patient injuries can range from headaches and post-treatment soreness to permanent complications of stroke, including left or right side paralysis, loss of bowel and bladder function,  vertebral fracture; disc herniation; rib fracture; and other serious neurologic syndromes.

According to medical chiropractic experts I have spoken with, inexperienced, or poorly trained chiropractors have performed the spinal manipulation in a disproportionate number of cases where serious injuries have occurred.  As an experienced malpractice attorney, and a member of the AAJ national Chiropractic Litigation Group, I have experience with this type of case and have access to experts for review of these cases.  If you would like to talk to me about your situation you can call me (202) 463-3030 or email me directly.

About the author:

Catherine Bertram is board certified in civil trials and was recently nominated as a 2010 Super Lawyer for Washington, D.C.  Ms. Bertram has 20 years of trial experience and is unique in that she was formerly the Director of Risk Management for Georgetown University Hospital so she brings a wealth of knowledge to her practice including how hospitals should be run and what doctors and nurses can do to protect patients.   She is a partner with the firm and devotes her practice to the representation of patients and families of loved ones who have been injured or lost due to medical errors.  She is a member of the AAJ Chiropractic Litigation Group and she lectures regularly to lawyers and health care providers, nationally and locally,  regarding patient safety, medical negligence and other related issues. She has also recently published a chapter in a medical textbook.   She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875 in her office in Washington, D.C.

 Posted by: Salvatore J. Zambri, founding partner     

Bloomberg.com reports that GlaxoSmithKline "has settled 450 suicide cases for about $390 million and 600 birth defect cases for unspecified amounts." According to the report, "The company has also paid out about $400 million in antitrust cases since 2003."

Many people who have taken Paxil have been subjected to an increased risk for suicide and birth defects.  The extent of the increased risk has never been disclosed. 

I represent victims of dangerous products.  Far too often companies put profits over people, placing into the marketplace drugs that have not been properly tested.  We hope that companies will put people over profits and be sure their products are safe before they are sold.

Before taking any medication, be sure to consult with a physician.  Your physician should also inform you of all risks and benefits of a medication before you ingest it, so that you can make the best health decisions you can.

About the author:

Posted by Catherine Bertram, Partner                                                

"Some people come into our lives, leave footprints on our hearts, and we are never the same." -Franz Peter Schubert

The medical staff at the Mayo Clinic define "Cerebral palsy" (CP) is a general term for a group of disorders that appear during the first few years of life and affect a child's ability to coordinate body movements. Cerebral palsy can cause muscles to be weak and floppy, or rigid and stiff.

In the United States, cerebral palsy occurs in about two to four out of every 1,000 births. The disorder is usually caused by brain injuries, including lack of oxygen, also called hypoxia or anoxia. Cerebral palsy isn't curable.  Medical evidence supports theories that infections, birth injuries, and poor oxygen supply to the brain before, during, and immediately after birth result in up to 15% of cases.

Between 35% and 50% of all children with CP will have an accompanying seizure disorder and some level of mental retardation. They also may have learning disabilities and vision, speech, hearing, or language problems.  Often parents are overwhelmed when their child is given this diagnosis and rightly so.  There are many questions and no clear answers.  As a parent of a child with special needs, you may be asking:

• Why did this happen to my child?
• How am I going to pay for what my child needs now and in the future?

Every circumstance is unique, just like very child and every family.   If you have questions about that care you received or the birth experience or the care your child received after birth and you think it may be a factor in your child's condition, you can get answers.   We have significant experience handling these types of cases and have many nationally known experts who are willing to review your child's case and determine what happened.  I was Director of Risk Management at a major teaching hospital in DC and have experience reviewing these cases from both the patient's side and the hospital's side.   We also have a nurse-attorney on staff at my firm who worked in a local hospital on the labor and delivery unit so she has special expertise in reviewing the records and determining what happened. 

As a parent and as a patient advocate I urge you to get answers if you have these questions.  You owe it to yourself and your child.  Click here for some great quotes for families with special needs children and pass this on to other parents you know who have children with special challenges for those days when a few words may lighten our hearts.

About the author:

Catherine Bertram is board certified in civil trials and was recently nominated as a 2010 Super Lawyer for Washington, D.C.  Ms. Bertram has 20 years of trial experience and is unique in that she was formerly the Director of Risk Management for Georgetown University Hospital so she brings a wealth of knowledge to her practice including how hospitals should be run and what doctors and nurses can do to protect patients.   She is a partner with the firm and devotes her practice to the representation of patients and families of loved ones who have been injured or lost due to medical errors.  Ms. Bertram lectures regularly to lawyers and health care providers, nationally and locally,  regarding patient safety, medical negligence and other related issues. She has also recently published a chapter in a medical textbook.   She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875 in her office in Washington, D.C.

 Posted by: Salvatore J. Zambri, founding partner     

The FDA has announced that a California-based company--organicgirl produce--has recalled 120 cartons of its 5.75 oz Berries & Balsamic Salad "because it may contain an incorrect condiment packet with an unlabeled allergen for walnuts."

"The product is packaged in plastic trays in a 6-count carton, UPC 895203-001332, product lot number 31B073830, with Use-By Date of December 16, 2009."  If you have an allergy to walnuts, do not eat this product.  Doing so would "run the risk of serious or life-threatening allergic reaction," says the FDA.

If you purchased the recalled product, you are urged to return it to the place you bought it from for a full refund. If you have any questions, you may also contact organicgirl produce at 1-831-758-7810.

It is common for people to have allergic reactions to all kinds of foods.  That is why it is critically important for all food suppliers to carefully label what the product contains.  Without appropriate warnings, public health is compromised. 

Many people die every year as a result of food allergies.  If you have an allergy to a food product, read labels carefully.  If eating at a restaurant, ask your server to confirm the absence of the product you are allergic to when ordering.

Enjoy your meals, but please be careful to ingest only what you know is safe.

About the author:

Posted by Catherine Bertram, Partner                                     

In a recent opinion piece in Salon, Dr. Rahul Parikh summarized the tort "reformers" arguments which have been in the news lately. These argument about the so called lawsuit crisis are being put forth by insurance companies and the American Medical Association.  Dr. Parikh carefully refutes each one by using the real facts.   He then challenges physicians to focus on the real priority, patient safety. Instead of attacking lawyers who advocate for patients harmed by preventable errors, the resources should be focused on preventing the patient injuries in the first place.   Here is the bottom line directly from his piece:

"Tort reformers neglect the fact that malpractice reform won't save one extra life. To make that difference, insurers, doctors and their lobbyists like the AMA need to find ways to improve patient safety. So for those who push tort reform as a panacea for a sick health care system, working to prevent injuries is a much more noble pursuit than writing up baseless arguments for the back pages of a newspaper."

Instead of focusing on limiting the rights of citizens who have valid claims for harm as a result of preventable errors in health care, we need to focus on how to stop the patients from being injured in the first place.  This involves daily focus by doctors, nurses and most of all the support and resources from hospital leadership.  

I would love nothing more than to come to my office and have no calls from patients or their families after devastating medical errors.   However, that is not the case.  We are seeing more errors and more obvious preventable errors because the system is broken and there is often not accountability.

"I long to accomplish a great and noble task, but it is my chief duty to accomplish small tasks as if they were great and noble."  Helen Keller

By Catherine D. Bertram, Partner                                           

"No adverse event should ever occur anywhere in the world if the knowledge exists to prevent it from happening."   That is a direct quote from the Joint Commission, a national organization that accredits more than 16,000 health care organizations around the country.  In fact it  is the first sentence in their introduction to what they have dubbed "9 key patient safety solutions" for health care providers in order to prevent inevitable human errors from actually reaching patients and thus prevent patient injuries and death from preventable errors.  

Having worked as Director of Risk Management in a major teaching hospital and having studied patient safety, I can verify that harm to patients and "near miss'' incidents often involve the issues listed by the Joint Commission below.  Those 9 solutions were developed from the data the Joint Commission has regarding patient injuries, deaths and near misses.  

Unfortunately, in the recent past I have represented families and patients in the DC area who have been harmed or lost their lives at local hospitals as a result of medical errors from situations that would fall into the categories listed below. (Also, see the links for translations of the 9 patient safety solutions for many other languages at the end of the article.)

"1.  Look-alike, Sound-alike medication names
Confusing drug names is one of the most common reasons for medication errors. With tens of thousands of drugs currently on the market, the potential for error created by confusing brand and generic drug names is a recognized risk that has not been solved.

 Posted by: Salvatore J. Zambri, founding partner     

Posted by Catherine Bertram, Partner                                          

There is a national epidemic of hospital acquired infections.  To combat this situation, the entity that accredits hospital in the United States, the Joint Commission, announced this fall a national plan of attack that includes the very simple act of requiring all members of the hospital health care team to wash their hands between patients. Where do our local hospital's stand on this?

Over the last 30 years, poor hand hygiene has continued to contribute to the high rates of infections acquired in hospitals, clinics and other health care settings.  According to a patient safety report by the World Health Organization, these infections affect as many as 1.7 million patients in the United States each year, racking up an annual cost of $6.5 billion and contributing to more than 90,000 deaths annually.

According to Dr. Mark Chassin of the Joint Commission, hand-washing failures contribute to infections linked to health care that kill almost 100,000 Americans a year and cost U.S. hospitals $4 billion to $29 billion a year to combat.   Dr. Chassin's announcement came this fall after Hearst Newspapers published the results of an investigation, "Dead by Mistake," which reported that 247 people die every day in the United States from infections contracted in hospitals.

The Joint Commission's new program, the Center for Transforming Health Care, is funded by hospitals and other large health care entities. 

What are our local hospitals in our community doing about this problem?  That is the question we need to be asking.  What are the infection rates at our local hospitals and ambulatory surgery centers?  The public has a right to know this information.

About the author:

Catherine Bertram is board certified in civil trials and was recently nominated as a 2010 Super Lawyer for Washington, D.C.  Ms. Bertram has 20 years of trial experience and is unique in that she was formerly the Director of Risk Management for Georgetown University Hospital so she brings a wealth of knowledge to her practice including how hospitals should be run and what doctors and nurses can do to protect patients.   She is a partner with the firm and devotes her practice to the representation of patients and families of loved ones who have been injured or lost due to medical errors.  Ms. Bertram lectures regularly to lawyers and health care providers, nationally and locally,  regarding patient safety, medical negligence and other related issues. She has also recently published a chapter in a medical textbook.   She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875 in her office in Washington, D.C.

 Posted by: Salvatore J. Zambri, founding partner     

The AP (12/11, Tanner) reports that "in 2005, Illinois legislators...passed a measure requiring hospitals to report the deadliest kind" of medical errors, but "the law has yet to be implemented -- and it likely won't be for at least another year." Illinois "budget woes and foot-dragging by special interests are among reasons cited for the long delay." However, "there are finally glimmers of progress. That includes the recent launch of a related state website that tracks hospital infection rates and staff levels, and the imminent start of a search for a vendor to help put the law in place."

Ten years ago, a landmark report proved that medical mistakes kill up to 98,000 Americans yearly. Only a handful of states have decided to do something about it, Minnesota being the first in 2003.  In 2005, Illinois modeled a law after Minnesota's.  Four years later, the law has still not been implemented.  Why?  Foot-dragging by special interest groups.  Finally, though, some progress is being made, including " the recent launch of a related state Web site that tracks hospital infection rates and staff levels, and the imminent start of a search for a vendor to help put the law in place."

According to the AP report, "The law will require hospitals to publicly report so-called "never" mistakes. These are mostly preventable errors with potentially life-threatening consequences -- like the wrong-knee surgery Krzysztof Kordes says Chicago-area doctors performed on him last year or the forgotten sponge left inside a Plainfield woman during breast tumor surgery."

A few things the law requires:

• hospitals required to report major medical errors within 30 days to the state's public health department
• list of hospitals and mistakes will be posted online
• hospitals required to determine cause of errors and to develop corrective plan

These kinds of laws should be in every state in our country.  Medical providers should not bow to special interest groups.  Sharing more, not less, following an adverse event is the only way to truly minimize future medical errors. 

Encourage your legislators to work hard to implement strong laws that clearly work to open communication and spur better, safer health practices.

About the author:

 Posted by: Salvatore J. Zambri, founding partner     

Dow Jones Newswires (12/8, Dooren) reported that Thomas Laughren, the director of FDA's division of psychiatric products, said Tuesday that the agency is weighing tougher warning labels for antipsychotics that might cause weight gain and diabetes.  According to the report, "the agency has asked manufacturers of drugs like Seroquel, Abilify and Zyprexa for all of the information they have on metabolic side effects such as increases in blood glucose" to determine whether warnings need to be improved.  This comes in the wake of concerns of how antipsychotic medication has been effecting children in particular.

Like all drugs, antipsychotic medication should never be taken without a doctor's prescription, and a physician should never prescribe this medication unless it is in the best interest of the patient and only after the patient has been fully informed of all of the risks and benefits of the drug. 

About the author:

 Posted by: Salvatore J. Zambri, founding partner     

As a consumer justice attorney, I have the privilege of representing and helping people through difficult times every day. Oftentimes, my clients are horrifically and permanently injured due to no fault of their own. Other times, I represent families of those who have died as a result of someone else's carelessness.

This may surprise you, but it is widely accepted that approximately 98,000 Americans die each year as a result of medical negligence, more than deaths caused by guns and automobile collisions.  The yearly death toll from medical errors equates to the number of deaths that would result from two 747 airplanes crashing to the ground every day.  This alarming statistic does not even include those who have not died, but have nevertheless suffered serious permanent injuries due to a lack of appropriate medical care.

I have published a paper that addresses some fundamental, but extraordinarily important, steps necessary to properly and thoroughly evaluate a potential medical malpractice claim. By no means does the article include all investigative efforts required to analyze a case, as every claim is different and deserves special attention. 

To read my article, entitled "Evaluating a Medical Malpractice Case", please click here.

About the author:

 Posted by: Salvatore J. Zambri, founding partner     

The American Association for Justice has published a primer on the medical malpractice debate.  It comprehensively shows how special interest groups have perpetuated myths in an effort to strip Americans of their rights in order to pad their profits.  Here are some of the findings:

• Myth #1: There are too many “frivolous” malpractice lawsuits
  

• Myth #2: Malpractice claims drive up health care costs.

• Myth #3: Doctors are fleeing.

• Myth #4: Malpractice claims drive up doctors’ premiums.

• Myth #5: Tort reform will lower insurance rates.

It is widely accepted that approximately 98,000 Americans die every year as a result of medical errors.  That's like two 747 airplanes full of passengers crashing to the ground every day for a year.  Yet, some legislators want to strip innocent victims of their constitutional rights, including limiting their recoveries, instead of focusing on preventing future errors. 

Our leaders should be fighting for safer drugs, safer hospitals, better medical practices, and a safer American health system.  We must put people over profits.

To read the publication, please click here.

About the author:

 Posted by: Salvatore J. Zambri, founding partner     

The Associated Press has reported today that the Food and Drug Administration (FDA) "still hasn't restructured its staff to better monitor drug safety, more than three years after experts recommended key changes in the wake of the Vioxx scandal."  According to the report, the Government Accountability Office (GAO) will release a report today indicating that FDA officials "have made some changes to drug oversight," although the agency "continues to give the bulk of its decision-making power to scientists who approve new drugs, rather than those who monitor the side effects of drugs on the market."  Consequently, the GAO "calls on the FDA to set a timetable for transferring new responsibilities to the surveillance office."

In response, the FDA "said major decisions about drug safety are delegated to the new drugs division because that is 'where staff with the broadest expertise and experience' on product safety issues reside," according to the AP report.

We urge the FDA to ramp up its surveillance of drugs, and we implore pharmaceutical companies to be sure their products are safe before placing them into the marketplace.  Drugs are obviously important, but manufacturers need to put people over profits.  No drug should enter the marketplace until it has been thoroughly tested and until its side-effects are fully understood.

Before taking any medication, please confer with your doctor.  Know all risks and benefits of a drug before taking it.

We wish you good health.

About the author:

 Posted by: Salvatore J. Zambri, founding partner     

The Los Angeles Times reports that "Bayer Healthcare is recalling 100,000 packages of Alka-Seltzer cold capsules because some do not properly display warning information about drowsiness."  The recalls pertains to packages of Alka-Seltzer Plus Day & Night Liquid Gels, according to the report.

"Company spokeswoman Tricia McKernan said the problem was caused by human error during the printing process. McKernan said the machinery used to make the labeling had to be shut down and manually restarted during the production for the affected lot."

If you have purchased these medications from lot 296939L--a lot that was distributed nationwide--please stop using the product and contact Bayer .  The manufacturer's phone number is (800) 986-3307, and they will provide a refund.

Be sure never to operate heavy machinery, drive a car, or engage in any dangerous activity while taking medication that has the potential to make you drowsy.

About the author:

Posted by Catherine D. Bertram, Partner                                         

As a former Director of Risk Management at a local hospital, I know the importance of input about patient safety from patients and their families. It is a critical step in making our hospitals, and in turn our communities, safer places to work and live.   Having said that, being in the hospital or having a family member in the hospital is a stress filled time.   When something goes wrong it is hard to know where to turn for help.  The first thing on your mind, of course, is the safety and well-being of your loved one and that is where your focus should be.   However, after the immediate situation is resolved you may feel the need to get assurances that this will never happen again to your family or anyone else.

If you, or your family member, has experienced what you believe is an unsafe condition or an unsafe practice in a local hospital you can do something about that right away.  In addition to reporting your concerns to the Patient Advocate at the hospital, as well as hospital administration when necessary,  you can also make your voice heard at independent agencies.   There are two entities that you can report your concerns to.  One is right here in DC, the Department of Health.  The D.C. Department of Health has oversight and licensing authority over all the of the hospitals in D.C.   You can click here to file a complaint about a DC Hospital or you can call DC's hot line 202-442-5833.  D.C. has teams of nurses and other professionals who regularly inspect the hospitals and investigate patient concerns and adverse outcomes.  

In addition, there is a national organization that accredits hospitals called the Joint Commission.  They also regularly audit local hospitals and have a specific procedure for investigation of patient concerns.  You can click here and go to their website and follow the procedure after you click "file a complaint", or you can call their office of quality monitoring,  630-792-5636,  or call their toll free number,  800-994-6610,  on weekdays from 8:30 a.m. to 5 p.m., central time.  Please note that the Joint Commission does not address individual billing issues, payment disputes, labor relations issues or individual clinical management of patients.

About the author:

Catherine Bertram is board certified in civil trials.  Ms. Bertram has 20 years of trial experience and is unique in that she was formerly the Director of Risk Management for Georgetown University Hospital so she brings a wealth of knowledge to her practice including how hospitals should be run and what doctors and nurses can do to protect patients.   She is a partner with the firm and devotes her practice to the representation of patients and families of loved ones who have been injured or lost due to medical errors.  Ms. Bertram lectures regularly to lawyers and health care providers, nationally and locally,  regarding patient safety, medical negligence and other related issues. She has also recently published a chapter in a medical textbook.   She can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875 in her office in Washington, D.C.

 Posted by: Salvatore J. Zambri, founding partner     

The American Association for Justice has published a paper that concisely and clearly debunked the myths about medical malpractice which has been spread by business interest groups aimed at putting profits over people.  In the first of a series of papers, Public Citizen debunks the following "five myths: 

• Myth #1: There are too many “frivolous” malpractice lawsuits.

Fact: There’s an epidemic of medical negligence, not lawsuits.  Only one in eight people injured by medical negligence ever file suit.  Civil filings have declined eight percent over the last decade, and are less than one percent of the whole civil docket.  A 2006 Harvard study found that 97 percent of claims were meritorious, stating, “portraits of a malpractice system that is stricken with frivolous litigation are overblown.”

• Myth #2: Malpractice claims drive up health care costs.

Fact: According to the National Association of Insurance Commissioners, the total spent defending claims and compensating victims of medical negligence was just 0.3% of health care costs, and the Congressional Budget Office and Government Accountability Office have made similar findings.

• Myth #3: Doctors are fleeing.

Fact: Then where are they going?  According to the American Medical Association’s own data, the number of practicing physicians in the United States has been growing steadily for decades. Not only are there more doctors, but the number of doctors is increasing faster than population growth.  Despite the cries of physicians fleeing multiple states, the number of physicians increased in every state, and only four states saw growth slower than population growth; these four states all have medical malpractice caps.

• Myth #4: Malpractice claims drive up doctors’ premiums.

Fact: Empirical research has found that there is little correlation between malpractice payouts and malpractice premiums paid by doctors. A study of the leading medical malpractice insurance companies’ financial statements by former Missouri Insurance Commissioner Jay Angoff found that these insurers artificially raised doctors’ premiums and misled the public about the nature of medical negligence claims.  A previous AAJ report on malpractice insurers found they had earnings higher than 99% of Fortune 500 companies.

• Myth #5: Tort reform will lower insurance rates.

Fact:  Tort reforms are passed under the guise that they will lower physicians’ liability premiums. This does not happen. While insurers do pay out less money when damages awards are capped, they do not pass the savings along to doctors by lowering premiums. Even the most ardent tort reformers have been caught stating that tort reform will have no effect on insurance rates."

It is widely accepted that approximately 98,000 Americans die every year as a result of medical errors.  That's like two 747 airplanes full of passengers crashing to the ground every day for a year.  Yet, some legislators want to strip innocent victims of their constitutional rights, including limitibg their recoveries, instead of focusing on preventing future errors. 

Don't let your legislative representatives takes your rights away just so some special interest groups can pad their profits.  Fight for safer hospitals, better medical practices, and a safer American health system.  We must put people over profits.

About the author:

 Posted by: Salvatore J. Zambri, founding senior partner     

The AP recently reported,  "A consumer advocacy group is petitioning the government to ban the weight loss pill Meridia [sibutramine] because a recent study suggests it increases the risk of heart attack, stroke, and death." In a letter to the Food and Drug Administration (FDA), the consumer watch-dog--Public Citizen--calls on the agency "to pull Abbott Laboratories' drug from the US market," citing results from "a 10,000-patient study" that "showed a slightly higher risk of heart-related problems in patients taking Meridia...compared with a dummy pill."

The FDA, however, "said it was 'making no conclusions about the preliminary findings' when they were released last month." The agency "previously rejected a 2002 petition from Public Citizen to withdraw Meridia," saying "it wanted to wait for the findings of the 10,000-patient study."

We will soon see how the FDA responds to the study. In the meantime, please be very careful when taking any medication.  You should always get competent, expert medical advice for ingesting any medication.  Be sure, too, that your doctor fully explains all risks associated with certain medications so that you can make a wise decision about what's best for you and your body.
      

About the author:

Posted by: Salvatore J. Zambri, Esquire

A recent federal task force's study that discourages routine mammograms for most women below the age of 50 has sparked a major political debate.  As a Washington Post article puts it, "The findings underscore a decades-long debate in the medical community about the benefits and risks of routine breast cancer screening for younger women."

In response to the study, Rep. Frank Pallone Jr. (D-N.J.) "announced that his House health subcommittee will hold hearings on the mammogram issue next month," according to the Post report.  And legislators from both political parties are suggesting that "the task force had been swayed by insurance companies that stand to save money if fewer screenings are performed."

Certainly, insurance companies' greed should not dictate what treatments are best for patients.  Those decisions should be left to medical experts who know what they are talking about, who are responsible for making sound decisions and informing their patients of all attendant risks and benefits.  As it stands, the  American Cancer Society has reiterated that it will continue to recommend regular mammograms for women age 40 and above. 

About the author:

Posted by: Salvatore J. Zambri, Esquire

As reported in the Washington Post, a federal task force has concluded, "Women in their 40s should stop routinely getting annual mammograms, and older women should cut back to one scheduled exam every other year." 

The report notes that higher than "182,000 women are diagnosed with breast cancer each year in the United States, and the disease kills more than 40,000, making it the second most common cancer after skin cancer and the second leading cause of death from cancer among women after lung cancer."  Consequently, challenging the usefulness of a long-used screening procedure--mammogram--has spurred heated debate among, physicians and academics.

The task force cites evidence that harms attendant to annual exams beginning at age 40 outweigh the potential benefits.  As the Post report states, mammograms "produce false-positive results in about 10 percent of cases, causing anxiety and often prompting women to undergo unnecessary follow-up tests, sometimes-disfiguring biopsies, and unneeded treatment, including surgery, radiation and chemotherapy."  Having said that, the American Cancer Society, the American College of Radiology, and others assert that the benefits greatly outweigh the potential dangers. 

According to the report, the American Cancer Society has not indicated a desire to change its guidelines, but the National Cancer Institute said it would re-evaluate its recommendations.

We urge our readers to speak with their doctors and make individual decisions about what is best for your health.  It may be appropriate if not necessary for some women to have annual mammograms in light of their family history, for instance.  Others may be doing more harm than good by exposing themselves to annual mammograms.  Doctors should know what is best for each individual and should advise their patients accordingly so that women can make the best decisions that they can, and so their long-term health can be promoted.

To read the full Post article, please click here.

About the author:

Posted by: Salvatore J. Zambri, Esquire

The New York Times reported that according to the US Food and Drug Administration (FDA), "Vials of five different Genzyme drugs for rare diseases may be contaminated with tiny particles of steel, rubber or fiber that could potentially harm patients."  However, "the FDA and Genzyme said that there had been no reports of patients being harmed by particles and that the problem affected less than one percent of the vials."  Although Dr. Jason Woo, an FDA official, stated, "We do not believe this is a wide-scale problem, but we do not have information that fully defines the scope," patients and doctors are concerned.

According to the report, the FDA has confirmed that "the products would remain on the market, because there are few alternative treatments," the AP (11/14, Perrone) reported. The agency has strongly advised physicians to "closely inspect vials for particles before injecting them into patients."  If exposed to contaminated vials, patients may experience "potential allergic reactions, blood clots, and other problems," states the report. 

 About the author:

Posted by: Salvatore J. Zambri, Esquire

The Associated Press (AP) recently reported that the Food and Drug Administration (FDA) "says it confirmed three new cases of a potentially lethal brain inflammation linked to the multiple sclerosis drug Tysabri [natalizumab]."  According to the FDA, the reports "are the first confirmed new cases since June."  The condition is known as progressive multifocal leukoencephalopathy, or PML.  The report states that the FDA has confirmed that since mid-2006 there have been 13 reported cases of PML.  The AP adds that "the FDA says the risk appears to increase as patients remain on Tysabri" and all "the PML cases are linked to its use in multiple sclerosis," although the drug is also marketed to treat Chron's disease as well.

According to the AP report, Tysabri  "was approved in November 2004 and pulled from the market the next year due to PML reports. It was reintroduced in July 2006, and Biogen said it is used by 43,000 patients."

Like all drugs, Tysabri, which is marketed by Biogen Idec Inc. and Elan Corp. PLC, should never be taken without a doctor's prescription, and a physician should never prescribe this medication unless it is in the best interest of the patient and only after the patient has been fully informed of all of the risks and benefits of the drug.
 

About the author:

Posted by: Salvatore J. Zambri, Esquire

According to a Bloomberg report, a former GlaxoSmithKline executive testified under oath that the drug company knew as early as 2001 that its anti-depressant drug--Paxil--could cause birth defects in the fetuses of pregnant women.  It has been alleged that this information was withheld from the public so the company could maximize profits at teh expense of public health.  The reports notes that in a videotaped deposition, former Glaxo drug-safety executive Jane Nieman stated that the company was “almost certain” by 2001 that Paxil was to blame for a certain heart defect that caused women to abort their fetuses. 

The drug generated about $942 million in sales last year alone.   We have no problem with companies making money--that's America.  What's un-American is putting profits over people.  No company should ever risk public health in a greedy effort to pad profits.  Many lawsuits against the drug manufacturer are pending, and we expect that the truth will be revealed and that the victims' suits will help protect all Americans from corporate greed. 

 About the author:

Posted by: Salvatore J. Zambri, Esquire

According to the AP (9/18), the Obama Administration "announced $25 million in grants for states and health care systems to experiment with alternatives to costly medical malpractice lawsuits." The report states that the grants will amount to "up to $3 million each for three years," and can be allocated for "a range of ideas, including programs in which doctors and hospitals quickly acknowledge a mistake, offer an apology and restitution, and pledge to take corrective action."        

NPR (9/17, James), on its  "Two-Way" blog, reports that although "a lot of people believe . . . [that] medical malpractice is a major contributor to healthcare inflation. . . the available evidence is with the president"--that it has little impact on healthcare costs.  NPR noted what others, including the Congressional Budget Office (under the direction of former President George W. Bush), have determined, which is that "perhaps one percent or less of healthcare's high costs has been attributed in many studies to malpractice lawsuits."

I think it is good that the American people are starting to learn the truth about medical malpractice litigation and victims' rights to obtain justice.  For far too long, special interest groups, like the insurance and medical industries, have spread myths about "frivolous" lawsuits and the impact malpractice claims have on overall healthcare costs.  These special interest groups have relied on rhetoric and anecdotes in an effort to fool the American people into giving up their rights--specifically their right to obtain justice through a civil justice systemaccess to justice.  There is no place for scare-tactics and myth-dissemination in American politics.  Hopefully, the present discourse about medical malpractice litigation will reveal the truth so that Americans can see that certain industries are willing to put profits over people at almost any cost. 

About the author:

Posted by: Salvatore J. Zambri, Esquire

The AP (9/17, Johnson) reports that the FDA has determined that "[m]akers of injected promethazine, a sedative also used to treat nausea and vomiting, are being required to put the strongest warning possible on the product because it can cause tissue damage leading to amputation." FDA regulators said that "makers of generic promethazine will have to put a 'black box' warning at the top of the detailed package insert explaining that when the drug is administered incorrectly, it can damage skin severely, including causing gangrene."

We urge our readers to be very careful when taking this drug.  It is vitally important that you refrain from using it unless directed by a doctor, who is responsible for understanding all of the risks and benefits of the drug.  The risks should be communicated to you by your doctor before the physician prescribes the medication.
 

About the author:

Posted by: Salvatore J. Zambri, Esquire

In a segment on CNN's "Anderson Cooper 360" (9/15), the immediate past-president of the American Association of Justice, Les Weisbrod, and another past-president, Todd Smith, addressed the notion of placing artificial caps on medical malpractice claims.  Weisbrod declared such a cap to be unconstitutional and made the well-known point that there is no evidence to show that such a cap would lower health-care spending.  Smith countered the notion that frivolous cases are brought by trial attorneys by stating the obvious--that lawyers have no logical reason whatsoever to take a case with no chance of winning.

Medical malpractice cases are extraordinarily expenses to litigate.  As a medical malpractice lawyer, I routinely advance hundreds of thousands of dollars on my clients' behalf, knowing that if the case fails, I lose all of that money since I never allow my clients to pay me back my advanced expenses in the absence of a favorable resolution.  To bring a frivolous suit would not only lead to financial ruin, but it exposes a lawyer to serious sanctions that can be imposed by the presiding judge and the Office of Bar Counsel that oversees attorney conduct.  Simply put, the idea that doctors face a barrage of frivolous suits is a myth.

Those with special interests need to recognize that too many Americans are killed or severely and permanently injured as a result of medical errors every year.  We need to focus on reducing medical mistakes.  The rights of victims of wrongdoing, often the most vulnerable in our nation, should never be stripped or capped.

About the author:

Posted by: Salvatore J. Zambri, Esquire

According to an AP (9/16) report, Pharmacia and Upjohn, a subsidiary of Pfizer, "has pleaded guilty to illegally promoting the pain killer Bextra [valdecoxib]" as part of "a settlement agreement announced earlier this month, when prosecutors slapped" Pfizer "with a record-breaking $2.3 billion in fines for illegal drug promotions."  In addition, Bloomberg News (9/16, O'Reilly) reports that, according to the United States Department of Justice, "US District Judge Douglas P. Woodlock in Boston took the plea...but deferred a decision on formally accepting it until a sentencing hearing on Oct. 16."

All too often we hear about drug companies, insurers, and other entities that put profits over people.  Innovation is essential, but no company should ever seek money at the expense of public health and well-being.  Such conduct is reprehensible and dangerous.  Access to justice through the civil jury system is what allows for proper checks and balances.  If gives people a fair voice to speak out against corporate corruption, and it allows the innocent victims of corporate greed to obtain fair and just compensation for all of their harms and losses.

About the author:

Posted by: Salvatore J. Zambri, Esquire

The highest court in the state of Georgia will determine whether a 2005 law that capped medical malpractice awards violates the state's constitution.

The Atlanta Journal-Constitution (9/16, Rankin) reports that a 75-year-old Marietta, Georgia, woman was "permanently disfigured" after complications from facial surgery.  The report also notes that the woman's "case is now before the Georgia Supreme Court, which on Tuesday considered for the first time the constitutionality of the centerpiece of the state's sweeping 2005 tort reform law - caps on jury awards in medical malpractice cases." The article indicates that the surgeon's attorneys argued that the "Legislature properly imposed the caps to keep doctors from leaving the state in droves because their malpractice insurance premiums were too high," while the attorney for the plaintiff argued that "the law punishes those who suffer the greatest malpractice injuries to the benefit of those who caused the most harm."

The AP (9/15, Walker) reports that Georgia state law caps damages in medical malpractice lawsuits at $350,000, and that the case centers on a Georgia tort "reform" law that arbitrarily caps the amount a jury can award for malpractice victims' pain and suffering.  According to this report, the plaintiff's attorneys "said the law overturns a jury's centuries-old right to determine how much to compensate a victim."

The Atlanta Business Chronicle (9/16, Williams) adds that the woman's lawyer told the court that "The liability cap was a key provision in a tort reform bill Republicans made their top priority after taking full control of the legislature in the 2004 elections for the first time since the 19th century. Lawmakers in Georgia and other states have embraced restrictions on jury awards as a way to curb rising medical malpractice insurance premiums that have long been a chief source of complaint among doctors. Despite the cap, a Fulton County jury awarded $1,265,000 to Betty Nestlehutt, 71, in 2007 after she was left with permanent scars and discoloration from a facelift that went wrong."

The truth of the matter is that there is a medical malpractice crisis in this country.  The myths are that there are too many cases and that lawsuits are the cause of high insurance premiums doctors must pay.  Nearly 100,000 people die every year as a result of medical errors, and 90% of the victims of medical errors never bring a suit.  We need better medical care.  Also, the number of suits throughout  the country have gone done, as have payouts by insurers, yet the insures have been raising premiums.  We need better insurance regulation.

The District of Columbia government has enacted insurance reform recently, and its impact has been already felt.  We hope other states follow the District's lead.

Those that are catastrophically injured due to medical wrongdoing need help.  They should not be victims twice--once by egregious medical care and again by artificial caps that prohibit victims from obtaining justice.

About the author:

Posted by: Salvatore J. Zambri, Esquire

President Obama's approach to medical malpractice laws is seen as "differing fundamentally" from idea of limiting awards, according to The Washington Post (9/11, Goldstein).  "When President Obama broached medical malpractice laws in his speech to a joint session of Congress on Wednesday night, it was one of the few times that Republican lawmakers stood to applaud. But the ideas the president embraced stopped considerably short of the federal limits on awards in malpractice lawsuits that the GOP and the nation's physicians have sought for years." The examples "the White House gave of state experiments are among a constellation of ideas that have been advocated by the Institute of Medicine, some members of Congress and a growing number of states to reduce the number of malpractice cases that reach the courts. These ideas differ fundamentally from the main way that Republicans want to revise the malpractice system: creating federal caps on the amount of money that juries and judges can award patients who win lawsuits." The Congressional Budget Office and the Government Accountability Office "have examined whether medical malpractice issues add to health-care spending and concluded in recent years that the link is tenuous."

We believe that the rights of Americans to equal justice, including the right to have access to the court system, should not be stifled by politicians who are tied to interests groups that put profits over people.  Those that have been injured due to the carelessness of others and no wrongdoing of their own need our help the most. 

About the author:

Posted by: Salvatore J. Zambri, Esquire

According to a recent Danish study, women who undergo hormone replacement therapy after menopause are at a meaningfully higher risk of developing ovarian cancer.  A Reuters report states that the study, published in the Journal of the American Medical Association, comments that women who took hormone replacements were 38 percent more likely to develop ovarian cancer than those who did not.  This follows a study that was conducted ion 2002 by the Women’s Health Initiative, which produced similar findings.

We encourage our readers to be very careful when taking any medication.  No women should undergo hormone replacement therapy or other kind of therapy without first seeking the advice of medical experts.  Doctors should warn patients of potential side-effects and should not prescribe drugs unless it is proper to do so in light of all risks and benefits.

About the author:

Posted by: Salvatore J. Zambri, Esquire

Bayer reached an agreement with the Food and Drug Administration (FDA) in 2008, forcing the company to pay for a $20 million ad campaign to correct the company's history of overstating the benefits of its oral contraceptive--Yaz--and downplaying its risks.  The FDA determined that Yaz carries additional risks as compared to other contraceptives because the drug contains drospirenone, a progestin, which can increase a woman's potassium to dangerous levels.  Increased levels of potassium can lead to many adverse side-effects including blot clots, which can then lead to stroke, heart attack, or other serious condition. 

Before taking any drug, please be sure to consult with your doctor and pharmacist.  Physicians must take affirmative steps to be aware of all side-effects of the medications they prescribe so their patients do not suffer adverse, otherwise avoidable, consequences.

About the author:

Posted by: Salvatore J. Zambri, Esquire

The FDA has warned consumers not to buy or use Hardcore Energize Bullet or New Whey liquid products sold in test tube-like vials, as a result of suspected product tampering. The products are being recalled.

According to the FDA, "The suspected tampering involved a utility knife blade found in one vial of Hardcore Energize Bullet drink, manufactured in the United States and sold in Canada, and another blade in one vial of New Whey liquid products, manufactured and sold in the United States."

Both of the products--Hardcore Energize Bullet and New Whey liquid products--are manufactured by Protica Inc., of Whitehall, Pa. The company is investigating this incident.

To read the entire warning, click here.

Do not use or purchase these items.  To do so would expose you to serious health risks.  Be safe.

About the author:

Posted by: Salvatore J. Zambri, Esquire

Posted by: Salvatore J. Zambri, Esquire

Doctors fail to report clinically significant findings to their patients in more than seven percent (7%) of the cases, according to the Associated Press, relying on a new study published Monday in the Archives of Internal Medicine.  Physicians' use of electronic medical records tended to lower instances of failures to inform.  The frequency of errors is higher in practices that used a combination of electronic and paper records, as opposed to practices that relied on only paper or only electronic records, reports Nicholas Bakalar of the New York Times.    

We encourage doctors to utilize the electronic technology now available to better communicate with patients and other physicians regarding a patient's symptoms and conditions.  Reckless record-keeping leads to needless deaths and injuries.  There is a crisis in this country--too many Americans die each year as a result of hospital and doctor errors.  Nearly 100,000 people die every year as a result of hospital mistakes alone.  Safety needs to be a priority as we move forward.

About the author:

Posted by: Salvatore J. Zambri, Esquire

Shannon Pettypiece reports for Bloomberg that Matrixx Initiatives Inc. announced that it failed to turn over to U.S. regulators about 800 consumer complaints concerning serious side-effects linked to its Zicam nasal spray and swabs, which have been withdrawn.

According to the report, "Matrixx, based in Scottsdale, Arizona, stopped selling the cold remedies on June 16 after the Food and Drug Administration warned consumers the treatments may cause a loss of smell. Matrixx today defended its products and called the FDA warning 'a surprise,' during a conference call with analysts."

The 800 complaints were unearthed only after the FDA performed a routine inspection found 800 reports of consumer concerns this past May.  William Hemelt, acting president and chief operating officer of Matrixx, said that he was informed that  his compnay did not need to report the complaints despite a 2007 regulation requiring companies to turn over reports of serious side effects, arguing that the regulation didn't apply. 

“We have complaints but we weren’t required to send them,” Hemelt said. “At least we didn’t believe we were required to send them and we based that on an opinion of counsel who looked at the FDA regulation and said no, it doesn’t fit.”

The FDA reported that doctors and consumers have linked a permanent loss of smell to the us of the medications.

When companies withhold critically important information it smacks of putting profits over people.  Safety and public health should always be the paramount concern of drug companies. 

Our firm has experience pursing cases for patients that involve tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please contact Mr. Zambri at 202-822-1899 or email him at szambri@reganfirm.com.

By Victor E. Long, Esq.

Osteopenia sounds serious -- but is it?  Technically, osteopenia is not in and of itself a disease, as osteoporosis is. Instead, osteopenia is an indication that your bone mineral density is below the statistical norm and that you could eventually develop osteoporosis or be at risk of a future fracture.

On one hand, treating osteopenia sounds logical. Osteoporosis doesn’t develop overnight, out of the blue; surely, a person with the disease was osteopenic at some point along the line. However, just because you have osteopenia doesn’t mean that you’re absolutely guaranteed to develop osteoporosis, nor are you fated to have a serious fracture. Thus, taking bisphosphonates or other bone-building medications for your osteopenia means that you might be treated for a condition you never would have developed even if left untreated.

As a result, many experts argue that most people with osteopenia don’t need treatment, that blanket prescribing of bone-building drugs for osteopenia is more about alleviating anxiety than actually preventing fractures -- and that such a strategy makes no sense when drug costs and potential side effects are taken into account. Instead, the general consensus is in favor of selective, targeted treatment for osteopenia.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Recently, MedPage Today reported that "The FDA issued an alert regarding the risk of increased mortality in stable liver transplant patients who switch from a calcineurin inhibitor-based (CNI) immunosuppressive regimen to sirolimus (Rapamune)."  It was noted, however, "that a causal relationship has not been established and that" the FDA "is not recommending discontinuation of the drug, which is indicated for prevention of organ rejection in kidney transplant recipients older than 12."

The label for the drug "already carries a boxed warning of excess mortality and graft loss associated with the use of" sirolimus "in combination with tacrolimus (Prograf) in de novo liver and lung transplant recipients."  And it also warns that it is not clear that the drug is safe for liver or lung transplant patients.  Doctors, therefore, should heed those warnings, comments the FDA.  Prescribing medication in a way that is contrary to the labeling may lead to serious permanent injury or death.

Our firm has experience pursing cases for patients that involve tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030. 

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Medical News Today recently reported that a certain kind of cholesterol--known as lipoprotein (a)--may increase the risk of heart attack (medically referred to as myocardial infarction, or MI).  This type of cholesterol, says the article, has been screened little.  Historically, doctors ahve been screening patients for low-denisty lipoproteins, commonly called "bad protein".  Nevertheless, MI has continued to be a leading cause of death.  As a result, scientists have been looking at other caused of heart disease.

The theory about lipoprotein (a) leading to heart disease stems from a study of people living in Denmark, who had higher levels of lipoprotein (a) due to genetic reasons, and who were at a higher risk of heart attack.  The article comments that the "researchers suggested that although their findings were strong enough to support the idea that higher levels of lipoprotein (a) due to genetic reasons very probably cause higher risk of heart attack, only randomized clinical trials that show fewer heart attacks occur when lipoprotein (a) is reduced through therapy can prove it."  So, expect more studies.

According to the report, representatives of "the National Heart, Lung and Blood Institute's Framingham Heart Study commented that although Kamstrup and colleagues revealed some 'interesting mechanistic insights' into the biological link between lipoprotein (a) and MI, and put forward evidence that there might be potential benefit in reducing lipoprotein (a) early in life, the 'clinical implications are quite limited.'"

Before taking any medication, we encourage you to seek the advice of competent physicians. 

Our firm has experience pursing cases for patients that involvee tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

The World Health Organization today raised its alert level for swine flu (Influenza A - H1N1)to Phase 6, announcing the first influenza pandemic since 1968 as the virus continued to spread around the globe. WHO considers the overall severity to be moderate, according to the announcement by WHO Director General Manager Margaret Chan.  "We have good reason to believe that this pandemic will be of moderate severity, and we know from experience that severity can vary on many factors from one country to another."

Although the current swine flu strain is not considered especially deadly, its ability to spread rapidly to different communities met WHO's criteria for a pandemic.  The alert is related to the geographic spread of the virus, not its severity.

Member countries received notice ahead of its formal announcement of the Phase 6 alert, recommending that nations not close borders or restrict travel and trade. The advance notice indicated the agency remains "in close dialogue with influenza vaccine manufacturers."

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The AP recently reported that  "The Food and Drug Administration warned consumers Monday not to use skin products made by Clarcon." This warning followed a recent inspection which revealed high levels of disease-causing bacteria in the products.  According to the report, the FDA has said that the findings are "particularly concerning because the products are promoted as antimicrobial agents that claim to treat open wounds and damaged skin and protect against various infectious diseases."  Yet, according to the report, some of the bacteria found in the products "can cause opportunistic infections of the skin and underlying tissues and could result in medical or surgical attention as well as permanent damage," the report comments.

Our firm has experience pursing cases for patients that involve tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Bloomberg News reports that "Merck & Co. and Schering-Plough Corp. were sued by a Pennsylvania fund for active and retired state employees over claims they misled consumers into paying too much for prescriptions of Zetia [ezetimibe] and Vytorin cholesterol pills."  The Pennsylvania Employees Benefit Trust Fund alleges in a complaint that "the companies have known for years -- and failed to make public -- that Zetia doesn't reduce fatty arterial plaques that can cause heart attacks and strokes."  The reports commenst that two studies last year showed that "the pills may work no better at unclogging arteries than does an older, cheaper medicine called simvastatin." Nevertheless, the companies allegedly withheld the the finding and "used false and deceptive marketing techniques claiming Vytorin was more efficacious than and just as safe as the much cheaper generic," according to the report.

Our firm has experience pursing cases for patients that involve tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Natalie Fullerton's father feels like he is responsible for the death of his child, but he's not.  After a successful lung transplant, Natalie was thriving.  Her loving father tirelessly cared for her post-surgery, administering medication with the use of syringes.  The syringes, however, were manufactured at a factory owned by a Lake Zurich businessman.  And they were contaminated.  Natalie died.  She was 2 1/2 years old.

The tainted syringes from the plant are now "linked to four deaths and 162 illnesses nationwide, including 22 in Illinois", according to ChicagoTribune.com.  The report comments that "an examination of inspection reports and other documents shows that the U.S. Food and Drug Administration missed several chances to stop the tainted syringes from being used by patients."

According to the article, just three months before the contaminated syringes were shipped (in October 2007), "an FDA inspector visited the plant in North Carolina where they were made. She investigated reports of red, brown and black particles in syringes and reported that managers had a plan to deal with rust."  Those plans were either faulty or non-existent, and teh FDA did not follow-up sufficiently it is suggested.

"A week later, when the FDA learned a distributor was recalling 1.3 million of the syringes, the agency should have launched a thorough inspection, according to its operations manual. That didn't happen, an FDA spokeswoman now says, because the agency is so understaffed it no longer follows the policy unless the recalled product poses a reasonable probability of serious injuries or deaths."

The bacteria on the syringes never should have entered the marketplace.  And, unfortunately, there is plenty of blame to go around.  The owner of the plant is now a fugitive of law.  He fled the country and is trying to evade charges that could land him 95 years on prison.

When dispensing medical devices, medical providers must be sure they are sterilized.  Manufacturers and distributors must do the same.  Natalie may not be the last victim of corporate greed and carelessness, but the FDA must do more to protect Americans of all ages.  That's what we pay them to do.

Our firm has experience pursing cases for patients that involve tragic medication or other medical errors.   If you think your providers have ignored your symptoms, we encourage you to read an article regarding medical malpractice authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The American Heart Association/American Stroke Association has established a new guideline, based on European studies,  concerning when a clot-busting drug known as tPA can be given intravenously to stroke victims. Previously, the guideline in America was to provide the drug only within three hours of the onset of symptoms,; otherwise, it could do more harm than good.  This posed a problem to patients who, for one reason or another, could not get to a hospital quickly enough following the start of stroke symptoms.  The new guideline extends the time in which the drug can be administered to four and one-half hours after symptoms begin.

It is important, however, to recognize that the widening of the window does not mean that doctors should act slowly when treating patients with stroke symptoms. The faster the clot in the brain is relieved, thereby restoring normal blood flow, the greater the likelihood of recovery.

The following is the American Stroke Association's list of "warning signs of stroke:

• Sudden numbness or weakness of the face, arm or leg, especially on one side of the body
• Sudden confusion, trouble speaking or understanding
• Sudden trouble seeing in one or both eyes
• Sudden trouble walking, dizziness, loss of balance or coordination
• Sudden, severe headache with no known cause"

If experiencing any of the warning signs of stroke, seek immediate medical attention, as time is of the essence.

Our firm has experience pursing cases for patients that involve tragic medication or other medical errors.   If you think your providers have ignored your symptoms, we encourage you to read an article regarding medical malpractice authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

According to the The Wall Street Journal, staff from the Food and Drug Administration (FDA) indicate that three medications "currently approved to treat bipolar disorder and schizophrenia in adults were effective at treating the disorders in children and adolescents, but carry significant risks." As a result, the FDA is now "considering applications for AstraZeneca PLC's Seroquel [quetiapine] and Eli Lilly and Co.'s Zyprexa [olanzapine] to treat bipolar disorder and schizophrenia in children and adolescents, and Pfizer, Inc.'s Geodon [ziprasidone] to treat bipolar disorder in children 10 to 17," comments the report.  In fact, "an FDA panel of outside medical experts is scheduled to meet to discuss" these atypical antipsychotic medications, and will be "asked to vote on whether each product is safe and effective for children ages 10 to 17."  The report goes on the add that the FDA and the drug-makers announced that "studies showed the products were effective at treating the symptoms of bipolar and schizophrenia," but also warned that "all had side effects."  These sides effects include "sedation and weight gain."

We encourage our readers to speak with their doctors before taking any medication.  Mixing drugs can be particularly dangerous.  Some drugs pose greater health risks than others.  Relying, too, on what the FDA reports and what the drug-makers themselves state about their own medications may not be sufficient.

Our firm has experience pursing cases for patients that involve tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

An U.S. Department of Health and Human Services (HHS) report confirms that, two days ago, the U.S. Food and Drug Administration (FDA) "warned health care professionals about the risk of serious liver injury associated with the use of the anti-thyroid drug propylthiouracil for the treatment of Graves' disease."  Citing the FDA, HHS reports that: "After analyzing adverse event reports, the FDA has identified an increased risk of liver injury with propylthiouracil when compared to an alternative treatment for Graves' disease, methimazole," said Amy Egan, M.D., deputy director for safety, Division of Metabolism and Endocrinology Products, in the FDA’s Center for Drug Evaluation and Research. "Health care professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves' disease. If propylthiouracil therapy is chosen, the patient should be closely monitored for symptoms and signs of liver injury, especially during the first six months after initiating therapy."

Graves' disease is an autoimmune disorder which causes the thyroid gland to be overactive. The thyroid gland releases hormones that regulate the rate of the body’s metabolism.  These hormones "are critical for body temperature control, energy, weight, mood, and blood calcium levels."

Medications can have serious side-effects, especially if warnings and precautions are not taken seriously. Doctors should fully inform patients of all risks associated with prescribed medications and patients should never hesitate to ask their doctors for more information if they are confused about the risks of certian medications.

Our firm has experience pursing cases for patients that involve tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

We recently posted a blog informing our readers that a Bloomberg report announced that  researches have determined that certain antidepressants may increase the recurrence  of breast cancer among women who have already survived the disease.  The study reports that drugs including Prozac, Paxil and Zoloft "significantly decrease the effectiveness of a drug [tamoxifen] used to reduce the chances of breast cancer recurrence". 

A new Bloomberg report of yesterday confirms that "US regulators may warn patients taking tamoxifen, a breast cancer medicine...not to use certain types of antidepressants because they block the tumor-fighting drug's effectiveness." Karen Riley, a spokeswoman for the Food and Drug Administration, commented that the agency is considering "'adding new information to the tamoxifen label to advise women taking the cancer drug against using some antidepressants."

Ms. Riley's comments are welcomed, but action is what is needed.  The public must be warned of the harmful effects of mixing these drugs.  It could be a matter of life and death.

Our firm has experience pursing cases for patients that involve tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

According to a recent Bloomberg report, researches have determined that certain antidepressants may increase the recurrence  of breast cancer among women who have already survived the disease.  The study reports that drugs including Prozac, Paxil and Zoloft "significantly decrease the effectiveness of a drug [tamoxifen] used to reduce the chances of breast cancer recurrence", states the article. 

Notably, the study revealed that tumors were more than twice as likely to return after two years in women taking the antidepressants cited above while on the anti-cancer drug tamoxifen, as compared with those taking tamoxifen alone. The research was conducted by Medco Health Solutions Inc., and was presented at a meeting of researchers at the American Society of Clinical Oncology in Orlando.

To read the entire article, please click here.

Our firm has experience pursing cases for patients that involve tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The Washington Post reports that Congress plans to question officials with the Department of Veteran Affairs concerning events that have potentially exposed more than 10,000 former VA patients to blood borne illnesses, including HIV.  The purpose of the U.S. House Committee on Veterans' Affairs' investigation is to determine whether the exposure came from improper medical procedures and, if so, what the VA has done to address the problems.  

Our firm has experience pursing cases for patients that involve tragic medical errors.  If you think you have been injured as a result of medical negligence, we encourage you to read an article regarding medical malpractices cases authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

According to a recent study summarized in the Journal of the American Medical Association, use of acid-suppressive medications is associated with increased risk for hospital-acquired pneumonia.  For this study, researchers examined electronic medical data for nearly 64,000 adults hospitalized at one medical center for at least three days over a four-year period.  About half of the patients were prescribed proton-pump inhibitors or histamine-2-receptor antagonists during their hospital stays.  Their conclusion was that "further scrutiny is warranted regarding inpatient prescribing practices" of acid-suppressive drugs.

Below is an abstract of the research, as it appeared in the Journal of the American Medical Association:

"Authors: Shoshana J. Herzig, MD; Michael D. Howell, MD, MPH; Long H. Ngo, PhD; Edward R. Marcantonio, MD, SM

JAMA. 2009;301(20):2120-2128.

Context: The use of acid-suppressive medication has been steadily increasing, particularly in the inpatient setting, despite lack of an accepted indication in the majority of these patients.

Objective: To examine the association between acid-suppressive medication and hospital-acquired pneumonia.

Design, Setting, and Patients: Prospective pharmacoepidemiologic cohort study. All patients who were admitted to a large, urban, academic medical center in Boston, Massachusetts, from January 2004 through December 2007; at least 18 years of age; and hospitalized for 3 or more days were eligible for inclusion. Admissions with time spent in the intensive care unit were excluded. Acid-suppressive medication use was defined as any order for a proton-pump inhibitor or histamine2 receptor antagonist. Traditional and propensity-matched multivariable logistic regression were used to control for confounders.

Main Outcome Measure: Incidence of hospital-acquired pneumonia, defined via codes from the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM), in patients exposed and unexposed to acid-suppressive medication.

Results: The final cohort comprised 63 878 admissions. Acid-suppressive medication was ordered in 52% of admissions and hospital-acquired pneumonia occurred in 2219 admissions (3.5%). The unadjusted incidence of hospital-acquired pneumonia was higher in the group exposed to acid-suppressive medication than in the unexposed group (4.9% vs 2.0%; odds ratio [OR], 2.6; 95% confidence interval [CI], 2.3-2.8). Using multivariable logistic regression, the adjusted OR of hospital-acquired pneumonia in the group exposed to acid-suppressive medication was 1.3 (95% CI, 1.1-1.4). The matched propensity-score analyses yielded identical results. The association was significant for proton-pump inhibitors (OR, 1.3; 95% CI, 1.1-1.4) but not for histamine2 receptor antagonists (OR, 1.2; 95% CI, 0.98-1.4).

Conclusions: In this large, hospital-based pharmacoepidemiologic cohort, acid-suppressive medication use was associated with 30% increased odds of hospital-acquired pneumonia. In subset analyses, statistically significant risk was demonstrated only for proton-pump inhibitor use.

Author Affiliations: Divisions of General Medicine and Primary Care (Drs Herzig, Ngo, and Marcantonio), Pulmonary and Critical Care (Dr Howell), and Gerontology (Dr Marcantonio), Beth Israel Deaconess Medical Center, Boston, Massachusetts; and Harvard Medical School, Boston (Drs Herzig, Howell, Ngo, and Marcantonio)."

CNN published an interesting article on the hot topic of health insurance for college graduates.  A college graduate's health insurance often expires within six months of graduation and due to the harsh economy, many graduates are having difficulties finding a job.  CNN reports that "34 percent of college graduates will spend some time uninsured in the year after graduation."   Unfortunately, it appears that "two-thirds of young adults ages 19 to 29 who spent time without insurance coverage in the past year had gone without needed medical care because it cost too much."  

Here are some tips discussed in the article:

1. Know your rights;
2. Consider COBRA;
3. Be wary of short-term policies;
4. Shop around for a policy;
5. Consider graduate school.

 For additional information on this topic, please click here. 

Screening for Syphilis Infection in Pregnancy: U.S. Preventive Services Task Force Reaffirmation Recommendation Statement

"Screen all pregnant women for syphilis, preferably at their first prenatal visit, the U.S. Preventive Services Task Force reaffirms in Annals of Internal Medicine. According to one study, almost 15% of U.S. obstetricians/gynecologists do not routinely screen pregnant women for syphilis.

The USPSTF engaged researchers to find published evidence updating its 2004 recommendation. No evidence contradicting the recommendation was found, and a study among women in China found a decrease in congenital syphilis after implementation of a screening program."

Posted by Jacqueline Colclough, Esquire

As the official beginning of summer approaches with Memorial Day Weekend, The Cancer Institute of New Jersey and other health organizations are undertaking efforts to education the public about skin cancer risks and prevention.

According to the American Cancer Society, over one million people across the United States are currently affected by skin cancer. This year alone, more than 68,700 new cases of melanoma, the most serious of skin cancers, are expected nationally. Precautions such as avoiding sun exposure during midday hours (10 a.m. to 4 p.m.), using sunscreen with a sun protection factor (SPF) of 15 or higher, and avoiding tanning beds and sun lamps are all important measures in the prevention of skin cancer.

Posted by Jacqueline Colclough, Esquire

According to Medical News Today, AdvanDx, a leading provider of advanced molecular diagnostic products, announced that it has received FDA clearance for a diagnostic test to detect Streptococcus agalactiae, commonly known as Group B Strep. The 90 minute test enables rapid and highly sensitive detection of Group B Strep to help detect colonization in pregnant women.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The Wall Street Journal (WSJ) reports that an "investigation by Walter Reed Army Medical Center in Washington found 'a number of serious questions' about a study by a former surgeon at the hospital evaluating the use of a bone-growth protein in soldiers with leg fractures."  The product at the center of the study, Infuse, is a bone-growth drug that is widely used in hospitals and by physicians to treat broken bones. The report goes on to state that the former Walter Reed surgeon "forged his purported co-authors' signatures on the study and that the number of injured soldiers differs from the Army's records of its wartime casualties. Hospital officials said the study was based on 'falsified information.'"

WSJ was not the only periodical to challenge the study by Timothy R. Kuklo. The St. Louis Post Dispatch reported that  the surgeon "published a study that reported a bone growth drug sold by Medtronic Inc. had a higher success rate than Walter Reed doctors could verify."  Medtronic has confirmed that he "was a paid consultant, but that Medtronic did not review or finance the study."

If the study was indeed falsified, it woul dbe another example of putting profits over people.  Patients rely on drug and device manufacturers conducting ethical and reliable studies.  Pushing drugs and devices into teh marketplace and disseminating promotional materials that are false or misleading can cause serious and potentially deadly consequences.  

Our firm has experience pursing cases for patients that involve tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Elizabeth Cohen, of CNN, authored an interesting article on the difficult task of receiving insurance coverage for a pre-existing condition.  This problem often occurs when a child, who has a serious health condition, becomes too old to be covered by her parent's health plan.  Cohen writes: "According to the Kaiser Family Foundation, 21 percent of people who apply for health insurance on their own get turned down, charged a higher price or offered a plan that excludes coverage for their pre-existing condition."  Cohen lists five tips to obtaining coverage for a pre-existing condition:

1. Become a group of one.
2. If you've been laid off, get COBRA.
3. When you lose your employer-related insurance, apply for new insurance within 63 days.
4. Find out whether your state has a high-risk pool.
5. See whether your professional organization offers group insurance.

For more help in finding insurance when you have a pre-existing condition, you can contact the Cover Me Foundation at 877-678-7631 or Coverage For All at 800-234-1317.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Dow Jones Newswires  reports that the Food and Drug Administration (FDA) has urged Sanofi-Aventis SA, a drug manufacturer, "to stop distributing certain promotional material for its breast cancer drug, Taxotere [docetaxel], saying the material misleadingly claims the medicine is more effective than proven."  According to the report, the FDA has indicated that "binders with reprinted medical studies claim Sanofi's Taxotere is better than other medicines to treat patients with breast cancer after prior chemotherapy treatments failed," yet the "FDA is unaware of substantial evidence to support these claims."

We encourage our readers to be very careful when reading or listening to promotional materials disseminated by drug companies.  All too often these materials are misleading and are driven by the drug companies' desire to maximize its profits.   We believe that people should be above profits and that promotional materials must be accurate and properly informative.  If profits are put above people, public health will be compromised.

Our firm has experience pursing cases for patients that involve tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

According to a recent article in the Journal of the American Medical Association, a new limited study questions whether aspirin is actually any better than a placebo in preventing cardiovascular events for patients with peripheral arterial disease.

"Despite being recommended in current guidelines, aspirin seems no better than placebo in preventing cardiovascular events in patients with peripheral arterial disease, according to a JAMA meta-analysis. However, editorialists (and the analysts themselves) question the study's power to detect a true difference.

The analysis included nearly 5300 patients in 18 controlled trials examining the effect of aspirin (some used aspirin plus dipyridamole) versus placebo on the occurrence of cardiovascular events. The primary composite endpoint (nonfatal MI, nonfatal stroke, and cardiovascular death) did not occur significantly less often among drug recipients than among controls. However, treatment was associated with a significant decrease in nonfatal stroke alone.
Both the authors and editorialists point to the lack of data underlying evidence-based guidelines, and they argue for the performance of larger, higher-quality trials."

Click here to read the fee abstract fo the JAMA article.

Elizabeth Landau, of CNN, has published a fascinating article concerning new methods of preventing and treating blindness.  Ms. Landau discusses numerous topics, including, stem cell research as well as technological advancements used to assist persons suffering from blindness.

The article states that "a new study in the Journal of Archives of Ophthalmology shows that a single serving of fish per week is associated with a reduced risk of incident early age-related macular degeneration, a disease that is the leading cause of severe vision loss in people older than 60."  

The article then highlights the interesting advancements in technology which have served to assist persons suffering from blindness.  For instance, blind persons are now able to use speech access software to browse the Internet.   Moreover, some movie theaters are now providing special earpieces that have voice commentary describing what's on screen. In addition, visually impaired individuals can choose to use a device that takes a picture of text, such as a menu, and reads it back.

For more information, please review the entire article. 

The American Civil Liberties Union (ACLU) recently filed a lawsuit stating that patents on two human genes associated with breast and ovarian cancer are unconstitutional and invalid.  The patents are owned by Myriad Genetics and the University of Utah Research Foundation.  The ACLU is arguing that patenting the genes limits valuable research on this important health issue. 

More than 192,000 U.S. women receive breast cancer diagnoses every year, and about 5 to 10 percent of those cases are a hereditary form of the disease, according to the National Cancer Institute. Mutations in BRCA1 and BRCA2 -- short for breast cancer 1 and breast cancer 2 -- are involved in many cases of hereditary breast and ovarian cancers, the institute said.  BRCA1 and BRCA2 are the genes patented by Myriad and others. 

The ACLU states that "Myriad's monopoly on the BRCA genes makes it impossible for women to access other tests or get a second opinion about their results, and allows Myriad to charge a high rate for their tests – over $3,000, which is too expensive for some women to afford."

For more information on this topic, please review the following articles published by CNN and the ACLU. 

During the Heart Rhythm Society's Annual Meeting, the first comprehensive guidance on implantable cadioverter defibrillators (ICD) lead performance has been released.  The emphasis of the guidance "promotes confidence, trust and transparency in the surveillance, analysis and reporting of lead performance information."

The press release issued by the Heart Rhythm Society includes the following recommendations for clinicians on various issues:

• Informed consent
• Monitoring of device performance
• Clinical presentation of abnormal lead performance
• Clinical management when abnormal lead performance is suspected
• Special considerations for pediatric patients
• Clinician responsibilities for reporting suspected or definite lead related problems

Reuters News details highlights of the meeting in the following report:

"A cardiologists group called for closer monitoring of the performance of wire leads that connect implanted defibrillators and pacemakers to the heart in the wake of malfunctions that led to patient deaths and product recalls in 2007.

The Heart Rhythm Society, which represents doctors who treat cardiac arrhythmias, issued recommendations on Wednesday at its annual meeting in Boston. Among other things, it called for greater visibility of data collected on product performance.

"The measurement and reporting of lead performance are important for clinical decision making, for setting realistic expectations for patients and physicians, for transparency, and for monitoring and improving performance," said Dr. William Maisel, cardiologist at Beth Israel Deaconess Medical Center and co-chair of the group's task force on lead performance.

The guidelines cover pre-market evaluation and post-market monitoring of the devices, the threshold for action and communication after abnormal lead performance is identified, and clinical recommendations for physicians.

Recommendations include use of remote monitoring and a patient registry as surveillance tools.

The group encouraged the U.S. Food and Drug Administration to provide guidance on when and how manufacturers can legally use terms other than "recall" in their product advisory notifications.

"When lead malfunctions are communicated to physicians, patients and the public, the language should be crafted to avoid unnecessary anxiety or inappropriate interventions," said task force co-chair Dr. Robert Hauser, of the Minneapolis Heart Institute. "For example, the term 'recall' should not be used because it falsely implies that the lead should be removed and returned to the manufacturer."

Medtronic halted sales of its Sprint Fidelis lead in 2007 after five patients died, possibly because their leads had fractured. The company is the largest maker of implantable cardioverter defibrillators, or ICDs, that treat abnormally rapid heartbeats.

Besides the guidelines on performance of the devices, the group also set standards to guide physicians who extract leads from patients when the devices wear down.

Among the recommendations are thresholds for the number of lead removal procedures that doctors should perform in training and on an annual basis.

"There were perceptions that things have changed about lead performance," said Dr. Bruce Wilkoff of the Cleveland Clinic.

"Lead performance, if anything, has improved over the years," he said.

But as the volume of procedures has risen into the millions, Wilkoff said, the risk of failure has increased."

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The Food and Drug Administration (FDA), along with manufacturers OSI and Genentech, notified healthcare professionals of new safety information that has been added to the " WARNINGS AND PRECAUTIONS" sections of the prescribing information for Tarceva.  The FDA reports that "[g]astrointestinal perforation (including fatalities), bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, and ocular disorders, including corneal perforation or ulceration have been reported during use of Tarceva." (emphasis added).  Tarceva has been used to treat patients with certain kinds of lung cancer after at least one prior chemotherapy regimen proved to be unsuccessful.  It has also been prescribed to treat patients with pancreatic cancer.

To read the entire FDA report, please click here.

Medications can have serious side-effects, especially if warnings and precautions are not taken seriously. Doctors should fully inform patients of all risks associated with prescribed medications and patients should never hesitate to ask their doctors for more information if they are confused about the risks of certian medications.

Our firm has experience pursing cases for patients that involve tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

Stroke is the third leading cause of death in America. It doesn't have to be that way, though.  Recognizing the early signs of stroke and receiving appropriate treatment in a timely manner is essential.

We encourage our readers to learn and share with family and friends the following main symptoms of stroke as defined by the American Stroke Association:

• "Sudden numbness or weakness of the face, arm or leg, especially on one side of the body
• Sudden confusion, trouble speaking or understanding
• Sudden trouble seeing in one or both eyes
• Sudden trouble walking, dizziness, loss of balance or coordination
• Sudden, severe headache with no known cause"

We also encourage you to be aware of the hospitals in your area that have advanced stroke treatment staff and equipment.  These facilities should have a multi-disciplinary team of physicians, including neurosurgeons and endovascular therapists, ready to promptly treat stroke victims.

Our firm has experience pursing cases for patients that involve tragic medical errors, including the failure to properly treat stroke.  If you need a patient advocate, we recommend that you read an article about medical malpractice claims authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.

Cholesterol can be a confusing topic to many people.  Cholesterol is a type of fat called a lipid.  The body uses it for many things, such as making new cells. Your liver makes the cholesterol that your body needs. You also get cholesterol from the foods you eat. Your body needs some cholesterol. But if you have too much, it starts to build up in your arteries and can lead to a heart attack or stroke.

A recent article on Health.com sheds light on five popular myths, which are:

1. Americans have the highest cholesterol in the world
2. Eggs are evil
3. Kids can't have high cholesterol
4. Food is heart-healthy if it says "0 mg cholesterol"
   
5. Cholesterol is always a bad thing

For more information on this important issue, please click here. 

Posted by: Salvatore J. Zambri, Esquire and Catherine Bertram, Esquire

The Food and Drug Administration (FDA) reports that Biosite and the FDA have notified medical professionals of a Class 1 recall of the Biosite-brand Triage Cardiac Panel.  This particular panel is a test used by healthcare specialists to diagnose a heart attack (myocardial infarction).  However, according to the FDA, the "use of the affected lot may lead to false negative results with patient samples containing troponin I at very low levels, with CK-MB, and with myoglobin, possibly resulting in missed or incorrect diagnosis. A false negative test result would indicate that a person has not had a heart attack or heart muscle injury when in fact they have."

All Biosite customers must stop using all Biosite-brand Triage Cardiac Panels immediately.  Reliance upon these defective tests can lead to mistreatment of people with otherwise treatable heart conditions.

To read the entire recall, please click here.

Our firm has experience pursing cases for patients that involve tragic medication errors,  pharmacy mix ups and unsafe medications.  If you think you have been injured by a defective product, we encourage you to read a portion of a book regarding products liability authored by senior partner Salvatore Zambri.

For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030.