DC Metro Area Medical Malpractice Law Blog

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. 

By Catherine Bertram, Partner -

Former patient Robert Lee claims Dr. Stacy Makhnevich, a dentist and opera singer,  forced him to sign an agreement not to bash her online before she worked on his sore tooth, according to the lawsuit he filed in Manhattan Federal Court last week.  

Mr. Lee claims the dentist and classical singer began billing him $100 a day when he posted his opinions about her on the website YELP, including accusing her of over billing him by $4,000.  “Avoid at all cost!” his Yelp posting read and “Scamming their customers!”   She accused him of breaching the “Mutual Agreement to Maintain Privacy” that he signed.

Lee’s lawyer is Paul Levy of the consumer protection group Public Citizen.  Mr. Levy explained that when big companies and doctors force patients to sign these type of agreements it  violates the patient's constitutional right to free speech and breaches dental ethics.  “This is using these contracts to suppress the other side and deprives the consumer of valuable information,” Levy told the Daily News.

The form the patient was forced to sign apparently came form a company called "Medical Justice" according to some reports. The good news is that according to other reporters,  an official with the company told the tech website Arstechnica.com that in light of the lawsuit, the company is retiring the forms and informing its clients to stop using them.

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.

In 2005, the Food and Drug Administration (FDA) approved a humanitarian exemption for use of tiny brain stents for patients who were at high risk of suffering a second stroke. The wire mesh brain stents were inserted into the brain arteries of high-risk patients in an attempt to remove blockages and prevent strokes.  The original trial involved 45 patients, but did not include a control group for comparing how well the stents worked.  Encouraged by those results, surgeons inserted thousands of wire stents into patients. 

The subsequent trial included 450 patients in a rigorously controlled study.  As recently reported in the New England Journal of Medicine (NEJM), after conducting a multi-center clinical trial, the following statistics became evident:

• "For stent patients:
  
  • 15% had a second stroke or died within 30 days of starting treatment.
  • 20.5% had a stroke or died within a nearly one-year follow-up period.
• For non-stent patients:
  
  • Under 6% had a second stroke or died within 30 days of starting treatment.
  • 11.5% had a stroke or died within a nearly one-year follow up period."

Co-principal investigator Colin P. Deredeyn, MD, of the Washington University School of Medicine in St. Louis, said:

"The complications on the stent side of the trial were higher than we expected.  Further research may identify specific groups of patients who may benefit from these stents, but for now we seem to be able to save more lives by aggressively working to lower blood pressure and cholesterol."

Dr. Derereyn went on to say:

"An earlier study found that high blood pressure and cholesterol levels in this group of patients was strongly associated with increased stroke risk.  We developed 'aggressive medical management' protocols that asked treating physicians to work hard to bring patient blood pressure and cholesterol into safe ranges.  We also regularly monitored patients to see if these goals were being met."

"We only accepted patients whose stenoses blocked 70% or more of an artery, so this was a very high-risk group.  While we were selective in that regard, we did not investigate the nature of the blockages - for example, how much of the blockage was plaque only and how much of it was blot clot on a plaque.  These patients may have different risk of stroke with stenting."

As summarized in an editorial by the New York Times, "This case raises the question of whether the FDA should demand more rigorous trials before a device is granted a humanitarian exemption. It clearly shows the value of conducting rigorous controlled studies with enough patients to provide meaningful results." 

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

According to a recent alert issued by the U.S. Food and Drug Administration (FDA), health care professionals are being cautioned as a result of recent serious eye infections resulting from Avastin injections.  Several recent incidents of patients losing all remaining vision after Avastin injections prompted the FDA alert.  Although Avastin is approved for treatment of some cancers, it has not been approved, but is frequently-prescribed treatment for wet age-related macular degeneration (AMD). Regulators and manufacturers warn against unapproved use of Avastin, citing infection and loss of vision as examples of the risks associated with doing so. It is believed that the tainted injections were from a pharmacy that repackaged the preservative-free vials into smaller single-use syringes.  The investigation continues.

The FDA alert states: "Health care professionals should be aware that repacking sterile drugs without proper aseptic technique can compromise product sterility, potentially putting the patient at risk for microbial infections.  Healthcare professionals should ensure that drug products are obtained from appropriate, reliable sources and properly administered.  Avastin solution for intravenous infusion is approved for the treatment of various types of cancers.  Some physicians also prescribe Avastin off-label for the treatment of wet age-related macular degeneration, although Avastin is not currently approved for this indication."

Genentech, the division of Roche that manufactures Avastin, maintains that caution against unapproved use was always advised.  According to a Genentech spokesman, "Avastin is not manufactured or approved and to date has not been proven safe for use in the eye."  Many ophthalmologists argue that Avastin is a much cheaper alternative treatment of wet AMD and that the infection and vision-loss incidents are due to carelessness instead.  The safety debate regarding off-label use continues.

Please check with your doctor if you have been prescribed any off-label medications.  Although some off-label prescribing of medication has existed for an extended period of time, the fact that serious infections and even blindness can occur when a cancer medication to treat eye disease reveals that it is a risky practice. 

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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.             

I was recently invited to give a presentation to the Connecticut Trial Lawyers Association on the day of their annual gala.  I had a wonderful time meeting members of the Association.  As a past-president of the Trial Lawyers Association of Metropolitan Washington, DC, I always enjoy  meeting leaders of other associations and collaborating about hot-topic issues in the law.

My presentation was about how to maximize the potential to resolve cases favorably for clients through the use of settlement videos.  Settlement videos can be expensive, but they are powerful settlement tools when dealing with significant cases.

I was told by several members that they learned a lot from the presentation, which was very gratifying.  I strongly believe that lawyers should help lawyers become better at what they do.  We are in a fellowship together, working to bring justice to those who need it the most.

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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.             

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.

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.

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.