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.

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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. 

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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.

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Posted by: Salvatore J. Zambri, founding partner     

Shriram Harid blogged at the Huffington Post, "President Obama is widely expected to toss Republicans a bone at Thursday's health care summit, by publicly embracing what's known as 'tort reform.'" But as she pointed out, tort reform advocates ignore "how punitive damages [are] essentially the only way that patients have of holding medical professionals and organizations accountable when they kill, maim or injure people through their negligence, ignorance or even malice." Harid remarks, "According to the American Association for Justice . . . legislators ought to be focused primarily on reducing the frequency of malpractice, rather than malpractice litigation, since a mere 2 to 3 percent of all instances of malpractice lead to claims."  And she quotes the President of the Association, Anthony Tarricone, who stated, "The idea of bargaining away the life of injured patients is a very, very bad idea... Opponents of health care have seized on tort reform as a panacea. ... They're bankrupt of any real reforms. The only real solution is eliminating malpractice itself."

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 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     

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. I recommend taking the time to watch this terrific clip by clicking here.

The president of the American Association for Justice recently appeared on CNN’s Anderson Cooper 360 to discuss this issue. That clip is available by clicking here and using the password "justice".

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."

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 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:

By Catherine D. Bertram, Partner                                             

The FDA issued an update about the safety investigation they are conducting regarding CT perfusion scanners and patients' overexposure to radiation. The FDA's initial notice was issued October 8, 2009.

Earlier  there were reports of patients who were accidentally exposed to eight times the normal radiation dose during diagnostic CT scans at Cedars-Sinai Medical Center in Los Angeles are prompting safety warnings to be issued across the country.

According to the FDA, over an 18-month period, 206 patients at the center received 3 to 4 Gy to the head instead of the expected 0.5-Gy dose during perfusion CT imaging.

"Until we get through whether we're dealing with errors that people are making (or) whether these are problems with the CT scanners themselves, we're saying go back to basics," said Jeffrey Shuren, MD, acting director of the FDA's Center for Devices and Radiological Health.

The FDA released a set of recommendations which include:

• Imaging facilities should review their radiation dosing protocols for all CT perfusion studies to ensure that dosing is correct for each study.
• They should implement quality control procedures to ensure that protocols are followed and correct radiation is used.
• For each patient, technologists should check the CT scanner displays to make sure the radiation to be delivered is appropriate.
• If more than one study is performed during one session, practitioners should adjust the radiation dose so it is appropriate for each study.

The FDA also urged imaging facilities to check whether any patients who underwent CT perfusion scans have received excess radiation.

"We're reminding (practitioners) of good practices that they should be employing routinely," said FDA representative Charles Finder, MD.

Tragically, I have specific experience with several cases involving excessive exposure to radiation. Patients can suffer extremely serious and irreversible injuries.   Of course, these are patients who are already fighting challenging medical conditions, including cancer.   We have top notch national experts in radiation oncology who review these cases to determine if the care provided was unsafe and caused the patient harm.  These cases can be a result of an  unsafe medical device or can be caused by the improper conduct of the health care team, or both.

 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:

By Catherine D. Bertram, Esquire                                

The U.S. Food and Drug Administration, FDA, issued an updated warning to health care professionals today regarding excessive radiation exposure for an additional 50 patients during CT brain perfusion scans.  The warning is as follows:

"The FDA, working with state and local health authorities, has identified at least 50 additional patients who were exposed to excess radiation of up to eight times the expected level during their CT perfusion scans. These cases so far involve more than one manufacturer of CT scanners. Some of these patients reported hair loss or skin redness following their scans. High doses of radiation can cause cataracts and increase the risk of some forms of cancer.
On the basis of its investigation to date, the FDA is providing interim recommendations for imaging facilities, radiologists, and radiologic technologists to help prevent additional cases of excess exposure.

These recommendations include:
•    Facilities assess whether patients who underwent CT perfusion scans received excess radiation.
•    Facilities review their radiation dosing protocols for all CT perfusion studies to ensure that the correct dosing is planned for each study.
•    Facilities implement quality control procedures to ensure that dosing protocols are followed every time and the planned amount of radiation is administered.
•    Radiologic technologists check the CT scanner display panel before performing a study to make sure the amount of radiation to be delivered is at the appropriate level for the individual patient.
•    If more than one study is performed on a patient during one imaging session, practitioners should adjust the dose of radiation so it is appropriate for each study."

You can review the MedWatch safety summary, including a link tlo the FDA News Release, by clicking here.

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 can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875. 

By Catherine D. Bertram, Esquire

98,000 Reasons is a website set up to get the word out on how medical errors harm real patients every day and what we can do about it.   According to decade old data published by the National Institute of Medicine, there are  documented preventable medical errors which lead to 98,0000 deaths in U.S. hospitals each year.   That figure does not include patients who are seriously harmed.  Now think about the fact that this number has remained static over 10 years.    Tragically, it is the 6th leading cause of death in our country.  To put that into perspective, 98,000 annual deaths is equivalent to 2 jumbo jets crashing every day all year.  Why doesn't Congress demand answers?  Why are hospitals not held accountable?  How can we allow this to continue?  Those are the questions that we need answers to.   We use our tax dollars to have hearings about baseball and steroid use.

As a former Director of Risk Management at a major teaching hospital in DC, I am saddened that more has not been accomplished on a national level to reduce this number and make hospitals safer for all patients and for our health care providers.  Our goal must be zero.

Please take a minute and click here and follow the link to let Congress know how important an issue this is to your family and our country.

 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 can be reached by email at cbertram@reganfirm.com or by phone 202-822-1875. 

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:

Over the last year, the American Association for Justice (AAJ), has fought to reverse the Bush administration's legacy of complete immunity preemption, pushed to end forced arbitration and advanced the rights of all Americans to hold wrongdoers accountable. This highlights video shows AAJ's accomplishments in promoting the civil justice system as shown in the media.

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.
 

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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. 

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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. 

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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.
 

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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.

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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.

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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.

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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. 

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The Centers for Disease Control and Prevention (CDC) recently issued guidelines for reducing flu among early childhood centers.  Listed below are the basic recommendations provided by the CDC. 

Recommended strategies to use now, for flu conditions with severity similar to spring/summer 2009:

• Get vaccinated against the flu.
• Stay home when sick.
• Conduct daily health checks.
• Separate ill children and staff.
• Encourage hand hygiene and respiratory etiquette of both people who are well and those who have any symptoms of flu.
• Perform routine environmental cleaning.
• Encourage early treatment for children and staff at high risk for flu complications.
• Consider selective early childhood program closures.

Recommended strategies to add in the event of increased influenza severity compared to spring/summer 2009:

• Permit high-risk staff to stay home.
• Increase social distances between children.
• Encourage children with ill household members to stay home.
• Extend the time that ill people stay home.
• Early childhood program closures. 

To read the full document:  CDC Guidance on Helping Child Care and Early Childhood Programs Respond to Influenza during the 2009–2010 Influenza Season:

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.

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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.

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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.

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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.

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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.

Posted by: Salvatore J. Zambri, Esquire 

According to a Reuters article, reported by James Pethkoukis, experts have determined that the FDA's approval process needs to be improved to better protect patients from dangerous risks.

At a congressional hearing, Representative Frank Pallone, who chairs a House Energy and Commerce subcommittee, stated, "There is evidence of an approval system that is broken -- that its standards, its procedures and its rules don't meet modern needs of getting medical devices to those in need with confidence in their safety." The article further comments that "Marcia Crosse, healthcare director for the nonpartisan Government Accountability Office, said various shortcomings 'raise concerns' about the FDA's pre-approval reviews and post-approval monitoring 'that are necessary for ensuring the safety and effectiveness of medical devices.'"

Although Americans benefit greatly from new products, the FDA must do more to protect those who will be using the products in the end--the patients. Without serious oversight, great harm can result.

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 Mr. Zambri at 202-822-1899.

 By Catherine D. Bertram, Esquire

According to an article by Lisa Rein in the Washington Post,  Doctors Community Hospital, in Lanham, Maryland was recently fined by Maryland Department of Health officials for failing to notify them, as required by state law,  that one patient recently died and at least seven others suffered serious injuries last year as a result of mistakes by the hospital's medical staff.

According to Ms. Rein's article, "Doctors Community Hospital paid the $30,000 fine last month for violating a Maryland law that requires hospitals to report serious medical errors. State officials agreed to reduce a proposed penalty of $95,000 as long as the hospital uses the remaining $65,000 to develop a patient safety program."

"We expect errors to occur," said Wendy Kronmiller, director of the state Office of Health Care Quality. "But we expect systems in place to catch them. What we found at Doctors is that the systems essentially didn't exist."

The Hospital Administration acknowledged their failure to comply with the law and promised to "sharpen the hospital's focus on patient safety."

"Our biggest challenge is making sure that someone is stepping back and saying, 'This isn't acceptable. I'm going to focus on dealing with this issue,' " Scott Gregerson, the hospital's vice president for strategy, said Friday. "Everybody in the institution needs a fundamental understanding of what is an error and what are the state's expectations for reporting."

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.

Some of Medtronic's pacemakers have been recalled because wires connecting the electronic circuit to other components could separate — potentially leading to serious injury or death.

The class 1 recall, the agency's most serious type, affects more than 21,000 Kappa (600/700/900 Series) and Sigma (100/200/300 Series) pacemakers. Most were implanted at least 5 years ago.

We have reproduced the FDA Press Release in its entirety:
FDA NEWS RELEASE

For Immediate Release: June 11, 2009

Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Alerts Patients to Medtronic Pacemaker Recall

The U.S. Food and Drug Administration is alerting patients to the Class I recall of certain Medtronic Kappa and Sigma pacemakers. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.

Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. In rare cases, pacemaker-dependent patients may experience serious injury or even death.

There are more than 1.7 million Kappa or Sigma pacemakers implanted in patients throughout the world. Of those, only about 21,000 pacemakers are affected by this recall, most of which have been implanted in patients for five years or longer.

Medtronic Inc. issued a letter to physicians alerting them to this problem on May 18. The company communicated with patients via letter on May 27.

The affected pacemakers are Kappa Series 600/700/900 and Sigma Series 100/200/300. Patients with these models of Kappa and Sigma pacemakers should determine if their pacemaker is part of this recall by contacting Medtronic at 800-505-4636 or going to their Web site at http://www.KappaSigmaSNList.medtronic.com.

Patients who have these recalled pacemakers and those who are unsure if their pacemakers are affected should follow up with their primary care physician or cardiologist.

Through standard medical device reporting requirements, the FDA became aware of possible problems and worked with the company to address them. The FDA classified this voluntary recall as Class I, indicating reasonable probability that the use of the device will cause serious adverse health consequences or death.

For more information:
Consumer article

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. 

Recent budget cuts have caused many hospitals to reduce infection control measures, according to a recent survey by the Association for Professionals in Infection Control and Epidemiology (APIC).  The "2009 APIC Economic Survey" found that over 40% of the 2,000 infection preventionists who responded reported reductions in budgets for infection prevention during the last 18 months. 

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."

By Victor E. Long, Esq.

Research  is changing the way urologists view enlargements of the prostate, known as benign prostate hypertrophy or  BPH. Recent findings suggest that the condition is more complex than originally thought, and these insights are pointing the way to promising new strategies for diagnosis and treatment.  BPH should be distinguished from prostate cancer which has been the subject of a previous blog on this site.
Until recently, BPH was considered to be a single disease responsible for a variety of lower urinary tract symptoms, ranging from discomfort while urinating to the inability to urinate at all. But a new discovery by Johns Hopkins researchers challenges that view. The Hopkins team, lead by Robert Getzenberg, Ph.D.,  suggest that there may be at least two forms of BPH: one type with mild symptoms that are unlikely to cause urinary tract complications and another, more severe form that can lead to irreversible bladder damage. Knowing which form of BPH a man has at diagnosis could help guide treatment choices. The Team also developed a blood test that detects JM-27 protein found in men with severe symptoms. The JM-27 diagnostic test, if eventually approved by the FDA, could be used to identify men with this highly symptomatic form of the disease early, before there is any damage to the bladder or urinary tract.

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.

By Catherine D. Bertram, Esquire and Salvatore J. Zambri, Esquire

In recent years, the insurance companies in New York have claimed that there was a crisis in medical malpractice claims which was essentially putting doctors and hospitals out of business.  Were the claims of the insurance companies true?   The answer, according to the federal government claims data, is a resounding "no". 

According to a comprehensive report  based on the federal data,  written by Roberto LoBianco and Bill Mahoney of the N.Y. Public Interest Research Group and Arthur Levin of the Center for Medical Consumers.  When you review the actual data from paid medical malpractice claims it is clear that New York's malpractice system has been remarkable consistent and stable.  In fact, the New York medical malpractice settlement figures since 2006 show that the payouts in these cases have declined since 2006.  Despite claims that doctors were fleeing from New York, the data actually shows that the number of active physicians increased by 20% from 1995 to 2008, even though the state's population grew a mere 6%.

The National Practitioner Data Bank (NPDB) was created by federal law and is managed by the U.S. Department of Health and Human Services.  All medical malpractice insurers are required to report their payments to this data base.   The NPDB public use data file is the only publicly-available comprehensive malpractice database in the country since it includes payments from all insurers across the country.   While the NPDB is prohibited from publically releasing the names of the individual doctors who have paid out on malpractice claims,  it does release aggregated information about those payments.  

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.

Last year on the DC Metro Area Medical Malpractice Law Blog, we reported that there was a 200% increase in the rate of Clostridium difficile (C. Diff.) infections among U.S. hospital patients.

A new study published in this month's American Journal of Infection Control suggests that the problem may be even worse than previously thought.

"The study, which involved a survey conducted by the Association for Professionals in Infection Control and Epidemiology (APIC), concluded that 13 of 1,000 inpatients were either infected or colonized with the C. difficile bug. That rate is 6.5 to 20 times greater than had been previously estimated, APIC reported.

Given this rate, there are at least 7,178 inpatients with C. difficile in American facilities, with an associated cost of $17.7 to $51.5 million, APIC estimates. And the problem is stubborn: 82 percent of APIC respondents said that the rate of C. difficile infections hadn't decreased over the past three years."

For more information:
- read this APIC press release

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)."

As reported in The Lancet, a recently concluded CLOTS (Clots in Legs or Stockings After Stroke) study of patients who were admitted to the hospital following a stroke suggests that guidelines for thigh-length graduated compression stockings may need to be revised.  In general, these stockings have been used to reduce the frequency of DVT (deep venous thrombosis) for patients who have suffered from strokes.  Following is The Lancet summary of the study and its results.

Summary
Background
"Deep vein thrombosis (DVT) and pulmonary embolism are common after stroke. In small trials of patients undergoing surgery, graduated compression stockings (GCS) reduce the risk of DVT. National stroke guidelines extrapolating from these trials recommend their use in patients with stroke despite insufficient evidence. We assessed the effectiveness of thigh-length GCS to reduce DVT after stroke.
Methods
In this outcome-blinded, randomised controlled trial, 2518 patients who were admitted to hospital within 1 week of an acute stroke and who were immobile were enrolled from 64 centres in the UK, Italy, and Australia. Patients were allocated via a central randomisation system to routine care plus thigh-length GCS (n=1256) or to routine care plus avoidance of GCS (n=1262). A technician who was blinded to treatment allocation undertook compression Doppler ultrasound of both legs at about 7—10 days and, when practical, again at 25—30 days after enrolment. The primary outcome was the occurrence of symptomatic or asymptomatic DVT in the popliteal or femoral veins. Analyses were by intention to treat. This study is registered, number ISRCTN28163533.
Findings
All patients were included in the analyses. The primary outcome occurred in 126 (10·0%) patients allocated to thigh-length GCS and in 133 (10·5%) allocated to avoid GCS, resulting in a non-significant absolute reduction in risk of 0·5% (95% CI −1·9% to 2·9%). Skin breaks, ulcers, blisters, and skin necrosis were significantly more common in patients allocated to GCS than in those allocated to avoid their use (64 [5%] vs 16 [1%]; odds ratio 4·18, 95% CI 2·40—7·27).
Interpretation
These data do not lend support to the use of thigh-length GCS in patients admitted to hospital with acute stroke. National guidelines for stroke might need to be revised on the basis of these results."

By Victor E. Long, Esq.

It is estimated that about 15% of colorectal cancers run in families. For that reason, it's important to know the health history of your immediate family and to tell your children.  People with familial adenomatous polyposis (FAP) develop hundreds of polyps in the colon and rectum. Without treatment, FAP usually leads to colorectal cancer by age 40. Less than 1% of all colorectal cancers are due to this rare form of inherited cancer, which is caused by a change in the APC gene.

Surprising data indicates that despite knowing they are at heightened risk for colorectal cancer, some people with or at risk for FAP fail to follow recommendations for endoscopic screening.  Information regarding colonoscopy, woman's screening protocols and  the availability of an alternative, known as virtual colonoscopy, has been provided in this blog.

The major reason respondents gave for not following up with endoscopic screening was that their healthcare provider had not recommended it.

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. 

By Victor E. Long, Esq. 

The Maryland Court of Appeals upheld the dismissal of  a case which sought to  draw a link between the  Thimerosal and Autism.   The high court affirmed a ruling, the first in the nation, subjecting the thimerosal/autism link to a  difficult evidentiary test.  The defendant's moved to disqualify five potential experts on the grounds that the experts were not qualified in epidemiology, the study of the distribution of diseases in populations.  The motion led to a ten day evidentiary hearing.  The CDC has concluded that the evidence favors rejection of a causal relationship.  Many vaccines contain thimerosal.

Blackwell et al v. Wyeth ,CA No. 112 Sept. Term 2008 Filed May 7, 2008.

"Respironics and FDA notified healthcare professionals of a Class I recall of SmartMonitor 2 Infant Apnea Monitor, Models 4002 and 4003, used for the continuous monitoring of respiration and heart rate of infant patients in the home or in the hospital. The monitors may fail to sound an alarm during periods of temporary interruption of breathing or low heart rates. The affected products were manufactured from January 16, 2008 through November 13, 2008 and distributed from January 17, 2008 through December 31, 2008."

Read the complete MedWatch 2009 Safety summary, including a link to the FDA recall notice.

We have reproduced the FDA Recall Notice in its entirety for our readers below:

"Date Recall Initiated: April 23, 2009
Product: Respironics, Inc., SmartMonitor 2 Infant Apnea Monitor (Models 4002 and 4003 with serial numbers 3000033364 through 3000038740)  This product was manufactured from January 16, 2008 through November 13, 2008 and distributed from January 17, 2008 through December 31, 2008.
Use: This device is used for the continuous monitoring of respiration and heart rate of infant patients in the home or in the hospital. The monitor detects and alarms for periods of temporary interruption of breathing (central apnea) or low heart rates.
Recalling Firm: 
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, Pennsylvania 15668-8517
Reason for Recall:  This device may fail to sound an alarm.
Public Contact: Customers may contact the company at 1-888-345-4630.
FDA District:
Philadelphia
FDA Comments: On April 23, 2009, the firm sent a letter to their medical supply companies informing them of the potential problem. The firm requested the companies take the following actions:

• return all units in their inventory
• retrieve and return all units already shipped to patients

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online: www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
• Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• FAX: 1-800-FDA-0178

Updated May 18, 2009"

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."

As reported by the Annals of Family Medicine, cancer screening frequently yields false positives — with resulting invasive procedures.

Researchers studied nearly 68,500 adults, aged 55 to 74, who underwent up to 14 screenings over 3 years in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. Tests included digital rectal examination plus prostate-specific antigen measurement; chest x-ray; flexible sigmoidoscopy; and cancer antigen 125 testing plus transvaginal ultrasound.
Among the findings:

• The risk for having one false positive after four tests was 37% among men and 26% among women; after 14 tests, risks rose to 60% and 49%, respectively.
• The risk for undergoing a false-positive–prompted invasive procedure after four tests was 17% among men and 12% among women; after 14 tests, risks were 28% and 22%, respectively.
• Sigmoidoscopy accounted for the most false positives and related procedures.

The researchers conclude that providers "should educate patients about the likelihood of false positives and resulting diagnostic interventions when counseling about cancer screening."

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.

"The National Institutes of Health has launched an initiative called "Rethinking Drinking" to help patients reduce their risk for alcohol-related problems, reports the New York Times. The program offers an interactive website that includes quizzes to assess drinking behaviors and calculators to measure the alcoholic and caloric content of drinks. A booklet for patients is also provided.
The program draws on information from a previously published guide for clinicians."

 Several comments from participants in the focus groups summarize the benefits of the program:

• "Sometimes we do things out of habit and we don't really stop to think about it. This made me think about my choices."
• "It emphasized that drinking is not bad in and of itself—it's how much you're doing it and how it's affecting your life."
• "I thought the strategies for cutting down were really good. It gives you tools to help yourself."

Click here for a copy of the free patient booklet
 

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.

The Women's Health Initiative began a fifteen-year research program in 1991 with a goal of addressing "the most common causes of death, disability and poor quality of life for postmenopausal women - cardiovascular disease, cancer, and osteoporosis."  Two studies included in the hormone trial were the estrogen-plus-progestin study of women with a uterus and the estrogen-alone study of women without a uterus.  The estrogen-plus-progestin portion of the program was halted in 2002, after results indicated an increase in susceptibility to heart attack, stroke, breast cancer and blood clots.

Advice given to patients after the WHI trial ended was for those who were taking hormone therapy  to protect their hearts to stop immediately. Both patients and their doctors began receiving and giving confusing and often conflicting advice.

According to a recent article in the Washington Post, "Once again scientists are sharply divided over whether, and to what degree, hormone therapy should be rehabilitated. In the seven years since the WHI dropped its bombshell, the study's results have been endlessly analyzed, with detractors wondering how a single randomized, controlled trial, even one as mammoth as this, could have negated dozens of observational and epidemiological studies that showed estrogen reduced women's heart disease risk by as much as 50 percent.

"A misunderstanding of the WHI results has turned off so many women and their physicians from hormone therapy," laments Frederick Naftolin, director of reproductive biology research and co-director of menopause medicine at New York University School of Medicine. "And there may be a price to pay. Women may die prematurely from heart disease and suffer unnecessarily from fractures or diabetes because they or their doctors didn't want to consider estrogen."

The newest HRT studies address the timing for initiation of  HRTwo new studies are underway to determine the effect of Hormone Replacement Therapy (HRT) when it begins closer to the onset of menopause.

• The Early Versus Late Intervention Trial With Estradiol study compares the progression of atherosclerosis (hardening of the arteries) when HRT is prescribed for women who recently entered menopause as opposed to those who have been in menopause for more than 10 years.  Findings are expected to be released in 2010.
• The Kronos Early Estrogen Prevention Study focuses on whether a combination of estrogen and progestin prevents or reduces the progression of atherosclerosis.  Results are expected to be released in 2012.

As charming as therapy dogs in hospitals may seem, a new study reveals that they pose risks to patients by carrying and spreading hospital germs, as reported by the New York Times.

By Catherine D. Bertram, Esquire and Salvatore J. Zambri, Esquire

The Wall Street Journal reports, "Two Delaware patients died last weekend after taking heparin, a widely used blood thinner made by Baxter International Inc., sparking concerns about a repeat of fatal heparin contamination in 2008." Baxter is quoted in the article as stating that "the heparin involved in the cases of the two patients who died is from North American-derived bulk material supplied by Pfizer Inc. In the heparin deaths last year, the bulk material came from China."  According to the press statements, the FDA has "sent medical teams to Delaware, and an FDA agent drove samples of the heparin bags directly to an agency laboratory in Queens, New York."

According to the Chicago Tribune (5/12, Japsen) the hospital where the incidents occurred, the Beebe Medical Center has suspended the use of heparin. "Adverse reactions were reported in five patients who had problems that included internal bleeding in the brain."  It was reported that the new complications involve premixed intravenous bags of heparin. Last year's problems involved bulk supplies, vials of the medicine and drug-coated medical devices.

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

Former patients at several Veterans Administration Hospitals have been tested positive for HIV or hepatitis following exposure to dirty medical equipment.  According to a recent report at Chron.com, "[f]ive patients have tested positive for HIV and 33 have tested positive for hepatitis since February, when the VA started notifying more than 11,000 people treated at three VA medical centers to get follow-up blood checks because they could have been exposed to infectious body fluids." The specific VA hospitals involved are located in Miami, Fla., Murfreesboro, Tenn., and Augusta, Ga.

The VA determined last December that its equipment used for colonoscopies and ear, nose and throat procedures "was either not properly cleaned or set up", states the report.  Despite the medical errors, Dr. Jim Bagian, the VA's chief patient safety officer, boldly proclaimed that patients will never be able to prove that they were infected by the tainted equipment, the report comments. Congress is not satisfied with this statement and wants more information.

Senior partner Salvatore Zambri has handled many cases involving patients becoming infected with HIV as a result of medical errors.  There are clear standards that apply to hospitals governing the sterilization of medical devices and products.  If these procedures are not followed, the consequences can be severe.

If you think you have been injured by a defective or unclean device, 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 Subcommittee on Health will hold a hearing tomorrow regarding The Medical Device Safety Act of 2009.   This is an important piece of legislation that should become law.  We encourage our readers to contact their representatives in Congress and urge them to vote in favor of the bill.

The Medical Device Safety Act of 2009 is important for two principal reasons.  First, it will allow every American patient to hold manufacturers of defective medical devices accountable for injuries and deaths caused by unsafe products.  It will also prevent the manufacturers of defective devices from receiving total immunity from any claims simply because the devices were previously approved by the Food and Drug Administration (FDA). 

On March 19, 2009, the editors of the New England Journal of Medicine endorsed the Medical Device Safety Act. They stated:

"Patients and physicians deserve to be fully informed about the benefits and risks of medical devices, and the companies making the devices should be held accountable if they fail to achieve this standard. We urge Congress to swiftly pass this legislation and to allow lawsuits by injured patients, which have been an important part of the regulatory framework and very effective in keeping medical devices safe, to proceed in the courts."

The New York Times has also endorsed the bill.

Medical devices can be extremely dangerous, and the FDA often does a poor job screening defective products from the public.  If your doctor wants to insert a medical device into your body, ask questions to be sure your physician has sufficiently investigated the device's safety and effectiveness.

If you think you have been injured by a defective device, 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 editorial from yesterday's New York Times challenges the Food and Drug Administration (FDA) , suggesting that the agency has been too lenient in approving medical devices.  The article notes that a “vaginal sling,” used to control urinary leaks, that was previously sold by the Mentor Corporation,  a company that was acquired by Johnson & Johnson, has caused serious medical problems for many women throughout the country. In one instance, a woman's "surgeon inserted a strip of synthetic mesh — Mentor’s ObTape vaginal sling — under her urethra. It stopped the leakage but soon caused pain and bleeding as pieces of the sling worked their way through her vaginal wall. The woman has had five operations to remove bits of the sling, and another is scheduled."

Last year, the FDA received more than 1,000 reports directly from manufacturers about complications with "vaginal-sling"-like devices, according to the report.  About one-fourth of the complaints concerned "ObTape" specifically.  "The injuries may stem from the fact that far too many medical devices are cleared for sale without undergoing rigorous clinical trials for safety and efficacy."

To read the entire article, please click here.

Medical devices can be extremely dangerous, and the FDA often does a poor job screenign defective products from the public.  If your doctor wants to insert a medical device into your body, ask questions to be sure your physician has sufficiently investigated the device's safety and effectiveness.

If you think you have been injured by a defective device, 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.

FDA notified healthcare professionals that it will require two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products’ labels after receiving reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products. We have reproduced the FDA News Release below in its entirety.

A recent story in the Washington Post highlights the anxiety and insecurity often experienced by families who lose loved ones to eating disorders.  Extreme measures for weight control, serious health problems and sometimes even death may result from untreated or under-treated eating disorders.  Many complex reasons can contribute to eating disorders and many factors contribute to misunderstandings about eating disorders. 

Listed below are several helpful resources for individuals or families dealing with eating disorders. 

• The National Eating Disorder Association information and referral help line: 800-931-2237. Web site: http://www.NationalEatingDisorders.org.
• The Eating Disorder Referral and Information Center: http://www.edreferral.com.
• Something Fishy, a Web site offering information and peer support: http://www.somethingfishy.org.
• The eating disorders program at Johns Hopkins Hospital, Baltimore: 410-955-3863 (outpatient and consultation clinic), 410-501-5467 (inpatient or partial hospitalization programs).

In a recent health blog appearing in the New York Times, seven common sense suggestions are provided.  "Every year, there are 36,000 deaths due to flu, mostly among the elderly, very young children and those with compromised immune systems. In the United States, the new swine flu, officially called A(H1N1), does not appear to be more dangerous than the seasonal flu, but experts are uncertain as to its future course."

By Catherine D. Bertram, Esquire and Salvatore J. Zambri, Esquire

The Institute for Safe Medication Practices (ISMP) issued a warning to health care providers that storing insulin vials inside their cardboard cartons after the packages have been opened can be a medical emergency waiting to happen.

The warning explains, that "if the vial is accidentally returned to the wrong carton after being used, that sets the stage for a serious insulin mix-up.   That is because the next person looking for a particular insulin product could read the label on the carton, assume that it accurately reflects what is inside, and end up administering the wrong product."

ISMP recommends that the cartons be thrown out, either in the pharmacy before the medication is dispensed, or when at the nursing station. The bottom line? Do not dispense or store insulin vials in their cartons on patient care units.

Medication errors by health care providers and hospital personnel can be life threatening.  In most instances these tragic errors should have been prevented.  If you have questions about a medication error that caused permanent injury or contributed to the death of a patient you speak with an experienced medical malpractice attorney about the circumstances or call us (202 463-3030. 

By Victor E. Long, Esq.

The FDA has issued guidelines on the disposal of prescription drugs.  The Kaiser Family Foundation states that the average American takes more than 12 prescription drugs annually, with more than 3.8 billion prescriptions purchased each year,

Previously, three federal agencies--the White House Office of National Drug Control Policy, Department of Health and Human Services and Environmental Protection Agency--jointly released new guidelines in February designed to help people safely trash their prescription  drugs.   According to an Enviromental Protection Agency spokesperson  "Flushing medication down the toilet is probably the least desirable of the alternatives," 

In a series of updates, the FDA has now approved updated labeling for antieplietic drugs regarding the suicide risk associated with such drugs. The newest update of May 5, 2009 suggests that all antiepileptic drugs be included in the warning.   We have reproduced the FDA Warnings in their entirety below:

"[UPDATE 05/05/2009] FDA notified healthcare professionals that it approved updated labeling for antiepileptic drugs used to treat epilepsy, psychiatric disorders, and other conditions (e.g., migraine and neuropathic pain syndromes). FDA also required development of a medication guide, to be issued to patients each time the product is dispensed. Since issuing safety alerts on December 16, 2008 and January 31, 2008, FDA has been working with the manufacturers of drugs in this class to better understand the suicidality risk. Eleven antiepileptic drugs were included in a pooled analysis of placebo-controlled clinical studies in which these drugs were used to treat epilepsy as well as psychiatric disorders and other conditions. The increased risk of suicidal thoughts or behavior was generally consistent among the eleven drugs, with varying mechanisms of action and across a range of indications. This observation suggests that the risk applies to all antiepileptic drugs used for any indication.

[UPDATE 12/16/2008] The FDA has completed its analysis of reports of suicidality (suicidal behavior or ideation [thoughts]) from placebo-controlled clinical trials of drugs used to treat epilepsy, psychiatric disorders, and other conditions. Based on the outcome of this review, FDA is requiring that all manufacturers of drugs in this class include a Warning in their labeling and develop a Medication Guide to be provided to patients prescribed these drugs to inform them of the risks of suicidal thoughts or actions.

[Posted 01/31/2008] FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.

Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

The drugs included in the analyses include (some of these drugs are also available in generic form):

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Levetiracetam (marketed as Keppra)
Oxcarbazepine (marketed as Trileptal)
Pregabalin (marketed as Lyrica)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
Zonisamide (marketed as Zonegran)

Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly.

[December 16, 2008; UPDATED May 05, 2009 - Drug Information Page - FDA]
[January 31, 2008 - Healthcare Professional Information Sheet - FDA]"
 

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

The Food and Drug Administration (FDA) has found that more than 70 weight-loss products contain prescription drugs, including four illegal drugs that have not approved by the FDA for sale in the United States, according to Public Citizen, citing its Worst Pills, Best Pills News article released last week on WorstPills.org, the organization’s drug safety website.

The FDA has announced what is obvious--that adding active prescription drug ingredients to otherwise ineffective weight-loss supplements is not only illegal, but can be extremely dangerous.  "For instance, sibutramine (brand name Meridia, an appetite suppressant available by prescription only and a controlled substance) and fluoxetine (brand names Prozac and Serafem, an antidepressant available by prescription only) were among the drugs found in the supplements", states Public Citizen. 

Although the FDA is seeking a voluntary recall of the illegal products, some say the FDA is not acting strong enough.  "The FDA’s response has been inadequate,” said Sidney M. Wolfe, M.D., director of Public Citizen’s Health Research Group and acting Public Citizen president. “Some of the drugs found in these supplements are dangerous and are putting people at an unacceptable risk of injury. To protect citizens, the agency needs to go further and seize these products.”

To read the entire article, please click here.

We encourage our readers to be very careful about what medications they ingest.  All medications should be supervised by a physician.  Don't become a victim of others' greed.

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

Posted by Jacqueline Colclough

Over the years, numerous studies have shown that depression is associated with an increased risk of heart disease, but the nature of this association has never been clear. Researchers at Rush University Medical Center in Chicago have now revealed that depression is linked with the accumulation of visceral fat (fat packed between the waistline and internal organs), which has long been known to increase the risk of cardiovascular disease and diabetes.

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

Both the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have warned the public to be wary of entities selling products through the internet "that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 influenza virus"--the swine flu.  According to the FDA, many of the products are fraudulently advertised, and officials are going after the perpetrators, who face serious consequences if found guilty of fraud.

“The last thing any consumer needs right now is to be conned by someone selling fraudulent flu remedies,” said FTC Chairman Jon Leibowitz.  “The FTC will act swiftly against companies that resort to deceptive advertising.”

To read the FDA press release, please click here.

We encourage our readers to be very careful about what medications they ingest.  All medications should be supervised by a physician.  Don't become a victim of others' greed.

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

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

As we draft this post, there has been one death in the US attributed to swine flu. Yet, almost 100,000 patients die from hospital acquired infections in this country every year. The CDC estimates that there are 4.5 hospital infections for every 100 patient admissions.  Deaths from hospital acquired infections in this country are five times higher than deaths from AIDS. 

"About 2 million Americans get hospital-acquired infections every year, says Lisa McGiffert, Austin, Texas-based manager of Consumers Union’s Stop Hospital Infections campaign. Some patients make a full recovery after a simple course of antibiotics and others battle invasive infections for years.  Nationwide, a standard estimate is that hospital infections cost $5 billion to $6 billion a year, she says."

Almost everyone knows someone who has been significantly affected by a hospital infection. You can compare hospitals on the Department of Health and Human Services website and you can also review these data on the Consumer Union's website.

By Victor E. Long, Esq.

Obesity surgery-related complications in the United States declined 21 percent between 2001 and 2006, and payments to hospitals for obesity surgery decreased by as much as 13 percent, partly because there were fewer patient readmissions due to complications, a new study reports.

The findings from a study by the U.S. Agency for Healthcare Research and Quality are based on an analysis of more than 9,500 patients under age 65 who had obesity surgery, also known as bariatric surgery, at 652 hospitals between 2001 and 2002 and between 2005 and 2006.  The study, "Recent Improvements in Bariatric Surgery Outcomes," to be published in the May 2009 Medical Care, found that the complication rate among patients initially hospitalized for bariatric surgery dropped from approximately 24 percent to roughly 15 percent. Much of this was driven by a reduction in the post-surgical infection rate, which plummeted 58 percent. Abdominal hernias, staple leakage, respiratory failure and pneumonia fell by between 50 percent and 29 percent.

A recent article appearing in the Washington Post highlights the struggles faced when medical providers are unable to communicate with their patients.  According to the report, the Washington area has experienced a sharp rise in immigrant population but the addition of language and cultural services has lagged far behind. 

"Many area hospitals have taken steps such as installing phones to connect patients and staff members to interpreters, hiring interpreters or training employees to do the job, and recruiting bilingual staff. But some large physician practices and small primary and specialty care services have not added language or cultural services.

"All providers in this area should . . . have a mechanism to deal with language barriers," said Isabel van Isschot, director of interpretation services at La Clinica del Pueblo in Washington, which supplies interpreters to health facilities. When patients don't have access to an interpreter, she said, "I think that's a form of discrimination."

Hospitals and doctors, however, are wary of the cost of interpretation services, which can run up to $190 an hour; they say the government, not them, should pay these costs.

"Appropriate funding for these services is needed so that patients don't lose access to care," said Joseph M. Heyman, chair of the board of trustees of the American Medical Association, which has asserted in policy statements that "physicians cannot be expected to provide and fund . . . translation services for their patients."

A 45-year-old federal civil rights law requires hospitals and doctors who accept federal funds to offer language services. Some federal funding for interpretation services is available through Medicaid and the Children's Health Insurance Program, state-run programs that serve the poor and children, respectively. But to obtain the money, states have to pitch in some of their own. The District and Virginia have done so; Maryland has not. "

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

Approximately 1 in 150 children are diagnosed with autism spectrum disorder (ASD). According to Medical News Today, three studies compared all of the DNA of people with ASD with that of people who do not, and small genetic differences were discovered that impact the manner in which brain cells connect to make the circuitry of a child's brain. The largest of the three studies evaluated the DNA of over 10,000 people, states the report.

These finding suggest that "genetic differences in how cells in the brain link together could influence susceptibility to ASD on a large scale," states the report.  Scientists are now "starting to see genetic pathways in ASD that make sense."

According to the report, scientists plan to do a more extensive genome-wide association study to discover more pieces of the complex ASD genetics puzzle.

To read the entire article, please click here.

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

By Victor E. Long, Esq.

Studies show that practices such as meditation or guided imagery and visualization can be calming. Yoga and tai chi also may be helpful. Acupuncture has been shown to provide relief for some kinds of pain. Herbs, such as peppermint and ginger, may help ease the nausea and vomiting associated with chemotherapy. 

 According to a recent study reported in the Journal of Pain and Symptom Management , massage and acupuncture relieved pain and depression in surgery patients more than traditional postoperative care alone.  In the study, both massage and acupuncture were given for 10-30 minutes at the bedsides of 138 people who underwent surgery for intestinal and other cancers. Swedish massage was used along with an acupressure foot massage. Acupuncture was given at points related to the patients' symptoms, which included pain and nausea.

New FTC Staff Report Offers Guidance on Online ‘Negative Option’ Marketing

According to a recent press release by the Federal Trade Commission, two diet supplement marketers violated federal law by offering "free" samples of their products, then debiting consumer credit cards with "negative option" offers.  Below is the FTC report regarding this issue:

"Two dietary supplement marketers that lured consumers on the Internet with allegedly deceptive weight-loss claims and bogus “free” sample offers, and then debited their bank accounts or charged their credit cards for continuing shipments without their consent, have agreed to settle Federal Trade Commission charges that they violated federal law. With the increase in Internet marketing, the FTC staff has issued a report providing guidance for marketers to help them avoid deception in making online “negative option” offers. (With negative option marketing, a company takes a consumer’s silence or failure to cancel as acceptance of the offer and permission to bill them.)

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

For nearly thirty years, in-vitro fertilization (IVF) has been consider relatively safe.  A recent report in the New York Times, however, reports that new epidemiological studies and scientific techniques have revealed findings that suggest that "there may be some abnormal patterns of gene expression associated with IVF and a possible increase in rare but devastating genetic disorders that appear to be directly linked to those unusual gene expression patterns."  The report also states that, with IVF, there "appears to be an increased risk of premature birth and of babies with low birth weight for their gestational age."

To read the entire article, please click here.

If you are considering an IVF procedure, we encourage you to speak with your doctors about all potential risks and benefits, so that you can make fully informed decisions.

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 economy is forcing twenty percent (20%) of Americans to delay or avoid needed medical care, according to a recent Thomson Reuters survey. The survey also reports that more than 20% of Americans believe they will have difficulty paying for health insurance or health services over the next three months.

"We are seeing a positive correlation between Americans losing their access to employer-sponsored health insurance and deferral of healthcare," said Gary Pickens, of Reuters' health-care division, who led the study.  "if this trend continues, it will ultimately have an impact on our collective well-being."

If you are having difficulty affording health coverage, we urge you to contact local and state agencies to see if you qualify for Medicaid or other benefits.  Certain private companies, like Walgreens, provide programs for the unemployed and uninsured, as well.

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

"The U.S. Food and Drug Administration (FDA) has issued a public health advisory recommending that individuals who use transdermal drug patches that contain aluminum or other metal backing remove these patches before undergoing MRI (magnetic resonance imaging) scans. These patches may cause skin burns during the scan.

Transdermal patches, which contain a time-release dose of medication that is absorbed through the skin and into the blood stream, are used for delivery of several types of drugs; these include nicotine for smoking cessation, estrogen for management of menopausal symptoms, nitroglycerin for angina (chest pain), and several forms of pain medication. Some of these patches contain aluminum and other metals, which are used as backing.

Even though this metal backing is not in contact with the skin, it can overheat during an MRI and cause a painful burn on the patient’s skin. In an effort to avoid such injury, the FDA advises that patches containing metal are removed prior to an MRI and individuals who use transdermal patches look for warning labels about risk of burns. And, because not all patches containing metal currently have warning labels, it’s recommended that any patch containing metal is removed before an MRI scan.

In order to avoid a burn during an MRI scan due to metal backing on a transdermal patch, patients are advised to talk to their physician about removing and discarding the patch before undergoing the scan. Physicians will also advise patients about replacing the patch after the scan. As well, when an MRI is scheduled, patients should notify the facility performing the scan that they use a patch. This will help ensure that the correct procedures are followed to remove the patch before the scan and replace it with a new one following the MRI.

The risk of burning associated with transdermal patches during an MRI is avoidable. By consulting with physicians, being aware of this potential complication, and following correct safety procedures, patients can get the most benefit from transdermal medications and MRIs, safely and comfortably."

Reference: Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings [FDA Public Health Advisory]. US Food and Drug Administration Web site.

April 16, 2009.

Recent local outbreaks of measles have prompted health officials to issue immunization and prevention reminders: 

"The virus usually causes a red skin rash, high fever and watery eyes, symptoms that last for about a week. The first symptoms can appear as long as 21 days after exposure. Although most people recover within a week, measles can lead to pneumonia and, in rare cases, can be fatal. Those who suspect that they might have measles are encouraged to call ahead before going to doctors' offices or hospitals to avoid spreading the virus.

Measles cases are uncommon in the United States because vaccinations are required of most schoolchildren and foreign-born individuals who become U.S. citizens. Outbreaks often begin when an unimmunized person visits a country where the disease is still prevalent and then returns with the infection. The virus is usually spread through sneezing and coughing and can remain in the air or on surfaces for two hours. "

Outbreaks continue to occur in high schools (one or two per year) and on college campuses (less than one per year). These educational institutions are potential high-risk areas for measles transmission because of large concentrations of susceptible people.

As the incidence rate of measles declines in the United States, aggressive surveillance becomes increasingly important. Known or suspected measles cases should be reported immediately to local health departments.

Speed in implementing control programs is essential in preventing the spread of measles. Control activities should not be delayed until laboratory results on suspected cases are received. All persons who cannot readily provide 1) a physician-documented history of measles, 2) laboratory evidence of measles immunity or 3) a documented history of vaccination with live measles virus vaccine on or after the first birthday should be vaccinated or excluded from school. Documentation of vaccination should be considered adequate only if the date of vaccination is provided. If a person's measles immunity is in doubt, he/she should be vaccinated."

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

According to MercuryNews.com, technologists monitoring the threat have determined that hundreds of medical devices used at hospitals throughout the country are infected by the computer worm known as "Conficker".  The infected devices include MRI machines and hundreds, if not thousands, of other medical devices.  Manufacturer of the devices told investigators that "none of the machines were supposed to be connected to the Internet — and yet they were. And because the machines were running an unpatched version of Microsoft's operating system used in embedded devices they were vulnerable," states the report.

The report explains that "Conficker spreads by copying itself onto machines running Microsoft's Windows operating system that lack the security patch from October. Conficker installs itself and periodically reaches out for directions from its maker that cause it to rewrite its code, increasing its capabilities for malicious action and decreasing its chance of detection."  Apparently, patients have not yet been harmed, but it is clear that these infected devices place patients at risk.

To read the entire article, please click here.

Many Americans are injured or killed each year due to defective products.  For information about your legal rights, please click here or contact us at Regan Zambri & Long, PLLC at 202-463-3030. 

By Victor E. Long, Esq.

According to Washington Post  the American Cancer Society, finds Virtual Colonoscopy  to be effective at finding large polyps.  Virtual colonoscopy is a procedure used to look for signs of pre-cancerous growths, called polyps; cancer; and other diseases of the large intestine. Images of the large intestine are taken using computerized tomography (CT) or, less often, magnetic resonance imaging (MRI). A computer puts the images together to create an animated, three-dimensional view of the inside of the large intestine.

Invented 16 years ago by a radiologist who got the idea while playing video games on a flight simulator during advanced training at Johns Hopkins, virtual colonoscopy has become an increasingly popular.  However, Medicare has tentatively decided not to pay for virtual colonoscopies.

Posted by Victor E. Long, Esq.

According to a recent study published in the April 2009,  New England Journal of Medicine, although uncontrolled asthma may increase the risk of adverse perinatal outcomes, women with well-controlled asthma in pregnancy generally have good outcomes.  The recommendations in the article are consistent with the guidelines published by the American College of Obstetrics and Gynecology in 2008.

Avoiding allergens and irritants, such as tobacco smoke, that exacerbate asthma can improve maternal well-being and lessen the need for medication. Additional information is available thourh American College.

According to a recent investigation by the Associated Press, "U.S. manufacturers, including major drugmakers, have legally released at least 271 million pounds of pharmaceuticals into waterways that often provide drinking water - contamination the federal government has consistently overlooked."

As recently reported in American Medical News, Washington Hospital Center began a pilot program for residents working in the intensive care unit - an ethics checklist.  The program was implemented after a realization that checklists seemed to have helped in surgery and infection control.  "Hospitals implementing the WHO checklist cut deaths after surgery by 46% and surgical complications by 36%.   Director of WHO Safe Surgery Saves Lives initiative recommends integrating ethics issues."  We have reproduced the ethical checklist in its entirety:

Clinical Ethics Patient Assessment

Add relevant ethical issues to progress notes and report on rounds

• Patient's wishes unclear/refusal of treatment
• Questionable capacity to consent to, or refuse, treatment
• Disagreement involving relatives/surrogates/caregivers
• End-of-life (advance directive/power of attorney, do not resuscitate/allow natural death, withdraw/withhold Rx)
• Confidentiality/disclosure issue
• Resource or fairness issue
• Other (please note)
• No notable ethical issues

"FDA warned consumers to immediately stop using Hydroxycut products by Iovate Health Sciences, Inc. Hydroxycut products are associated with a number of serious liver injuries. Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.

FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.

Read the complete MedWatch Safety summary including links to the FDA news release, Q&A's and a listing of all products included in this alert."

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

Doctors are increasingly practicing medicine in DC, Md, and Va.  This fact flatly rejects the myth that physicians are fleeing because of medical liability concerns.  The new figures from the American Medical Association (AMA) show the number of doctors has risen over the last five years and also outpaced the metropolitan area's population growth.

“The AMA’s own figures show that tort reform is clearly unnecessary, and may actually be detrimental to patient safety," states Salvatore J. Zambri, senior partner at Regan Zambri & Long and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C.  According to a comprehensive study by the American Association for Justice, nationwide, all states saw an increase in doctors; however, the number of physicians per capita (100,000 population) is 13 percent higher in states without caps. In the four states that doctor growth did not outpace population (Georgia, Alaska, Utah and Montana), caps have been passed.  Additionally, a study released in December 2008 from the American College of  Emergency Physicians showed that states with tort reform scored far worse in patient safety.

“Safety improves when patients can hold negligent hospitals or doctors accountable,” said Zambri.  “Tort reform will only help insurance companies that want to hoard more profits while leaving patients less safe.”

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

The U.S. Agency for Healthcare Research and Quality supported a study of 122 closed malpractice claims by Allen Kachalia, M.D., J.D., Tejal K. Gandhi, M.D., M.P.H., Ann Louise Puopolo, B.S.N., R.N., and others, the results were published in the February 2007 Annals of Emergency Medicine 49(2).  That study has been available for more than two years.   Unfortunately, we continue to see these sames types of errors in the cases we have at Regan Zambri & Long.  As set forth below in the AHRQ summary,  a majority of the ER malpractice cases that were reviewed involve  failure to order appropriate test and consults or failure to perform an adequate examination of the patient. 

According to the government study, "65% of the cases involved missed emergency department (ED) diagnoses that harmed patients. Nearly half (48% ) of these missed diagnoses were associated with serious harm, and 39 percent resulted in death. The leading breakdowns in the diagnostic process were failure to order an appropriate diagnostic test (58 percent of errors), failure to perform an adequate medical history or physical examination (42 percent), incorrect interpretation of a diagnostic test (37 percent), and failure to order an appropriate consultation (33 percent).  The cause of malpractice was complex.  A majority of cases involved multiple breakdowns in the diagnostic process, several contributing factors, and more than one provider. The most common contributing factors were mistakes in judgment (87 percent of missed diagnoses), lack of technical competence or knowledge (58 percent), and lapses in vigilance or memory (41 percent).

These cognitive factors operated alone in one-third of missed diagnoses; in two-thirds of cases other factors also contributed to the missed diagnoses. Other leading contributing factors to missed diagnoses included patient-related factors (34 percent), lack of appropriate ED staff supervision (30 percent), inadequate handoffs of patients to new staffers (24 percent), and excessive workload (23 percent)."

Posted by Jacqueline Colclough

On April 27, 2009, the American Urological Association (AUA) issued new guidelines on prostate cancer screening for men. Contrary to recent advice of other groups, AHA recommends that well informed men aged 40 and over who have a life expectancy of at least 10 years should be offered the prostate-specific antigen (PSA) test in order to establish a baseline reading and that PSA testing should be individualized rather than a blanket annual test for any man aged 50 and over. These guidelines have been issued amid growing recent controversy regarding when men should start regular PSA screening, how often, and at what point a biopsy is indicated.

According to a recent editorial in the NY Times, an alarming one-fifth of all Medicare patients discharged from the hospital end up back in the hospital within 30 days, and fully a third return within 90 days. If this yo-yoing could be greatly reduced, Medicare could save billions of dollars. Many patients would certainly benefit from the better care.

High rates of rehospitalization are partly the fault of the hospitals. The more fundamental problem is the fragmented nature of the American medical system: too often, health-care providers fail to communicate with one another, patients fall between the cracks and no one seems clearly in charge of a patient’s welfare.

A new analysis by three researchers, published in The New England Journal of Medicine, estimated that unplanned rehospitalizations among fee-for-service beneficiaries cost Medicare $17.4 billion in fiscal year 2004, which is a big chunk of the $102.6 billion that Medicare paid hospitals that year.

Most patients were readmitted for problems other than those that led to their original hospitalizations. Surgical patients, for example, were typically readmitted for such medical conditions as pneumonia, heart failure or bacterial infections. Some of these readmissions may have been unavoidable in an elderly, sick population. But many could surely have been prevented through better planning and coordination.

The most disturbing finding was that half of the medical (nonsurgical) patients readmitted within 30 days had not seen a physician for follow-up care after they were discharged. They were apparently left on their own, perhaps with poorly understood instructions from the hospital on how to take care of themselves.

There was also wide variation in readmission rates between hospitals and between states: only 13 percent of patients were readmitted within 30 days in Idaho, compared with 22 percent in Maryland. That suggests that there is plenty of room for improvement. The rates were adjusted to compensate for the severity of patients’ illnesses, so hospitals and states with high readmission rates can’t easily blame caring for sicker patients.

Proposed solutions include better discharge planning by hospitals, more effective education of patients and closer cooperation between hospitals and physicians to ensure follow-up care.

The Obama administration, as part of its ambitious health care reform, has proposed that Medicare use incentives and penalties to encourage hospitals and doctors to cooperate in overseeing care from hospitalization through the first 30 days after discharge. The administration estimates the approach could save $26 billion over 10 years. It is a sound idea that should also improve the lives of patients.

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

The Washington Post reported moments ago that Maryland Governor Martin O'Malley has stated that there are now six "probable" cases of the swine flu in the state.  According to the report, of the six cases, three live in Anne Arundel and three reside in Baltimore County.  Each case is linked to individuals who have traveled out of the country to areas where swine flu has been present, including Mexico and the Caribbean, states the report.

"Maryland officials said they expect there will be additional cases in the state,"  according to the report.  "O'Malley (D) said the state will maintain close contact with local health departments and is working to build a stockpile of anti-viral medication."  So far, there are no reported cases of swine flu in either the District of Columbia or Virginia.

To read the entire article, please click here.

Previously on the DC Medical Malpractice Law Blog, we have posted the following articles:

• Swine Flu Raising More Questions Than Answers While the U.S. Sees Its First Fatality;
• World Health Organization Raises Swine Flu Pandemic Alert to Phase 4
• CDC Provides Swine Flu Questions and Answers.

If you have been in contact with anyone who has traveled to parts of the world where swine flu has been detected, we encourage you to seek a medical evaluation.  Obviously, if you suffer any symptoms associated with swine flu, please seek medical attention immediately.

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

Posted by: Amy S. Gurgle, Esq.

While it is not surprising that language barriers can create problems for doctors communicating with patients, a new study published by the Journal of General Internal Medicine found that "doctors' assumptions about communication -- what they deem important in communication -- may also have a role," according to this article from the New York Times. Also, the study found that resident physicians may underutilize interpreters in the interest of saving time, according to the article.

"The medical profession must take steps to "identify, limit, and manage conflicts of interest," the Institute of Medicine advises in a report issued online.

Among the recommendations:

• Medical institutions should create conflict-of-interest policies that mandate "disclosure and management" of personal and institutional financial ties to industry.
• Investigators should not conduct human trials if they have financial interests in the results.
• Academic medical centers and teaching hospitals should ban faculty from accepting gifts or making presentations managed by industry.
• Physicians should provide free drug samples only to patients without the means to pay for them.
• CME programs should be funded without industry support.

The report concludes: "The public needs to be able to trust that physicians' decisions are not inappropriately influenced by their financial relationships with industry."

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

The New York Times reported recently that the Food and Drug Administration (FDA) will conduct a rare meeting to discuss its device division, which is responsible for, among other things, evaluating, monitoring, and regulating medical devices.  According to the report, Dr. Donna-Bea Tillman, the agency's director of device evaluation, called an "all-hands" meeting.  This comes in response to a letter from nine scientists who have written President Obama, charging that some in the agency have acted illegally, exposing the public to harmful, even deadly, products.  

In the letter to President Obama, the scientists claimed that the device center inappropriately approved imaging studies designed to detect breast cancer and also allowed hospitals to wash and reuse device that were designed as single-use products, among other things.  Congress instituted an investigation into the charges. In January, the Government Accountability Office released a report that criticized the device center.

To read the entire Times article, please click here.

We hope that the FDA will seriously evaluate its deficiencies and make the changes that are necessary to protect the public from dangerous devices.

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

Posted by Victor E. Long, Esq.

More than 10,000 veterans who were exposed to the endoscopic equipment--which wasn't sterilized properly--are all being tested. The problem would be unpleasant, enough no matter how the three got infected, but what arguably makes it worse is that each were infected at different hospitals, one at a VA facility in Murfreesboro, TN, one at a facility in Augusta, GA, and a third in Miami. Not only that, there have been six positive hepatitis B tests and 19 positive hepatitis C results at the three facilities.

An orthopaedist  who worked in two different hospitals during 25 years in practice before retiring was confronted with three different spikes in acute infections of Total Joint Reconstruction over a 25 year career. In all three episodes, the hospital's response always was that it was a surgeon problem related to my technique (you must be doing something different that is causing your patients' infections, as the hospital has not changed any of its techniques or personnel).

Based on his experience, there are common problems that need to be addressed.

Posted by Jacqueline Colclough

Although often considered a benign disease, acute gastroenteritis remains a major cause of morbidity and mortality in children around the world, accounting for 1.8 million deaths annually in children younger than 5 years, or roughly 17% of all child deaths. Because the severity of the disease can widely vary depending on hydration status, which is greatly impacted by diarrhea and vomiting, accurately assessing and treating dehydration in children presenting with acute gastroenteritis remain a critical skill for every physician. Fortunately, most cases of dehydration in children can be accurately diagnosed by a careful clinical examination and treated with simple, non-invasive measures.

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

Each year in America there are approximately 16,000 new diagnoses of esphogeal cancer, reports an article in Medical New Today.  Unfortunately, according to the report, only 10% of those diagnosed survive the disease.  The principal reason for this alarming statistic is the lack of early detection.

It is widely recognized that smokers are predisposed to esophageal cancer.  However, as the article points out, there are several other contributing factors, including:

• Excessive alcohol consumption;
• Obesity;
• Lye ingestion; and,
• Gastroesophageal reflux disease (GERD), also known as acid reflux or heartburn.

To read the entire article, please click here.

We encourage our readers to speak with their doctors about their health risks.  Physicians should know to check for illnesses when their patients manifest certain health risks. 

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

 By Catherine D. Bertram, Esquire and Salvatore J. Zambri, Esquire

A recent article in the New England Journal of Medicine, reports that despite “a consensus that the use of health information technology should lead to more efficient, safer, and higher-quality care” , less than 2% of U.S. Hospitals have invested in a comprehensive electronic medical record system. The research was funded by the Department of Health and Human Services and the Robert Wood Johnson Foundation.  This study did not include Veterans Affairs (“VA”) Hospitals, which have been using computerized medical records for more than a decade. 

Posted by Patrick M. Regan

The CBS Evening News (4/22, story 8, 0:20, Couric) reported "an update...on the so-called morning-after birth control pill." On its website, the Food and Drug Administration (FDA) announced on Apr. 22 that "it will obey a judge's order and allow 17-year-olds to buy it without a prescription. The contraceptive, also called Plan B, is taken after unprotected sex and before an egg is fertilized." The FDA's decision, "which overturns one of the most controversial health rulings of the Bush administration, was scorned by abortion opponents and hailed by their abortion rights counterparts."

By Catherine D. Bertram, Esquire and Salvatore J. Zambri, Esquire

The Food and Drug Administration ("FDA ") notified consumers and health care professionals of a recall of 34 dietary supplement products. The FDA lab identified undeclared sibutramine, which is more commonly known as "Meridia",  an FDA-approved drug, used as an appetite suppressant for weight loss. FDA advises that the products listed below pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

Posted by Amy S. Gurgle, Esq.

A new study has determined that women whose healthy ovaries are removed during hysterectomy have a higher likelihood of developing a condition leading to death, including lung cancer and heart disease, as reported by the Los Angeles Times.

Posted by Jacqueline Colclough, Esquire, R.N.

Researchers at Duke University Medical Center and Arkansas Children's Hospital have recently reported that a carefully administered daily dose of peanuts has been found to be effective therapy for peanut allergies in children. In fact, the therapy has been so successful that a select group of children involved in the research study is now completely off treatment and eating peanuts daily. The studies were funded by the National Institutes of Health, The Food Allergy and Anaphylaxis Network, Food Allergy Project, Gerber Foundation and the Robins Family Foundation.

Posted by:  Salvatore J. Zambri and Catherine Bertram

Not even the inventors of Botox could have anticipated how widely used the drug has become.  Once thought to be the answer to wrinkles, Botox is now being administered to treat all kinds of  ailments, including,  migraines, speech impediments, skin disorders, muscle and gland problems, and much more, according to a recent publication in the New York Times. 

The Times report quotes Dr. Mitchell F. Brin, a neurologist who is the chief scientific officer for Botox at Allergan, the drug’s maker, who stated, “We see it as a molecule that keeps on giving.  As we understand it more, it gives us new ideas of how to use it." But not everyone agrees.  “It’s trial and error with a nerve poison,” says Dr. Sidney M. Wolfe, the director of the health research group at Public Citizen, a consumer advocacy group. 

To read the entire Times article, please click here.

Botox is a nerve poison produced by the bacteria that cause botulism, a disease that paralyzes muscles and can be fatal. Before taking any medication, please be sure you are evaluated by your physician.  The wrongful administration of medication can cause serious permanent injury or death. 

For information about defective medications and your 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

Thyroid problems can go easily undiagnosed, especially because pregnant women are understandably thinking of lots of others things besides the health of their thyroid.  The thyroid gland produced hormones that regulate many body functions, including metabolism, heart-rate, and body weight.  The development of hyperthyroidism (the production of too many hormones) and hypothyroidism (too little hormones) can lead to premature birth, pre-eclampsia, and diminished intelligence in newborns. 

In a recent New Your Times article, it is reported that 20% (1out of every 5) of women of child-bearing age suffer from hypothyroidism, the more worrisome of the two illnesses. 19% of children born of mothers with hypothyroidism obtain IQ levels of 85 or lower, states the report.

To read the full article, click here.

If you suffer from fatigue, overly-dry skin, anxiety, inability to sleep, or unexplainable weight loss, you may want to get a thyroid test, especially if you are pregnant or desire to become pregnant.

We encourage our readers to be active and follow your doctor's instructions on fitness.  Be safe and healthy.

For information, 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 New York Times, a new study found that pregnant women who took a popular epilepsy drug-- valproate, sold generically and under the brand name Depakote-- to treat migraines, pain and psychiatric disorders had children whose I.Q. scores were significantly lower than similar children who were not exposed to the drug.  Valporate remains the second-most-popular antiseizure medication used for epilepsy, says the report, but users must fully appreciate  its risks.

“My thought is that if I make a mistake and the patient has a breakthrough seizure, I can change the medication and switch the patient to valproate,” said Dr. Kimford J. Meador, professor of neurology at Emory University School of Medicine in Atlanta, and the first author of the new study. “If I put the patient on valproate as a first choice and the baby has cognitive impairment or a malformation, I can’t repair that.”

To read the full Times report, please click here.

Before taking any medication, please be sure you are evaluated by your physician.  The consequences of mixing medications and taking them while pregnant can be devastating. 

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

The American Association for Justice is following a developing story involving FDA approval of uses of the anti-psychotic drug Seroquel.  The FDA has approved the drug for schizophrenia and bipolar disorder, but AstraZeneca has been marketing the drug to patients suffering from depression and anxiety.  AstraZeneca is currently under review by the FDA to have the drug’s use expanded to include patients of depression and anxiety.  However, many believe that sealed documents with the court could shed some light on the side effects of Seroquel.   

Ted Baker, 60, of Bastrop, La., a Vietnam veteran who suffers from post-traumatic stress disorder and major depressive disorder, was prescribed Seroquel in 2001 as an antidepressant and continued to take it until 2006.  Due to his Seroquel use, he was diagnosed with Type II diabetes in March 2004.

Many people fear that the expanded use of this drug could expose others to diabetes.   Please review AAJ's press release for more details concerning this story. 

Public Citizen, a national non-profit public interest organization, has published its annual rankings of state medical boards. Using an analysis of data just released by the Federation of State Medical Boards (FSMB) on all disciplinary actions taken against doctors in 2008, Public Citizen calculated the rate of serious disciplinary actions (revocations, surrenders, suspensions and probation/restrictions) taken by state medical boards in 2008.  

For the first time since Public Citizen has been publishing the rankings, California, the largest state in the country, and Florida, one of the largest, are among the 10 states with the lowest rates of serious disciplinary actions. Minnesota was the worst state when it came to disciplining doctors and, along with Maryland, South Carolina and Wisconsin, has consistently been among the worst 10 states for each of the last six rankings.  Unfortunately, there is considerable evidence that most boards are under-disciplining physicians.    

Posted by Catherine D. Bertram and Salvatore J. Zambri

The Food and Drug Administration (FDA) issued a Class 1 Recall in April 2009 involving defective Defibrillators that may fail.  This is a Class 1 recall, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious injury or death.  According to the FDA's recall notice, Zoll Medical Corporation and FDA notified healthcare professionals of a Class 1 recall of ZOLL AED Plus Defibrillators distributed from May, 2004 through February 9, 2009. The recall was initiated because the device may fail to deliver a defibrillation shock, which could result in failure to resuscitate a patient during treatment of sudden cardiac arrest.”

In the New York Times advertising column, Stephanie Clifford writes that "the Food and Drug Administration sent letters to 14 major pharmaceutical companies late last month, "warning them that their "search advertisements...had to start including risk information about each drug or else be rewritten or removed."

The companies, however, argued that "there was no way to include all the required information" within the "95 characters...allowed for search ads." According to Arnie Friede, counsel at McDermott, Will & Emery, "Until these letters were sent, pharmaceutical and media companies had assumed that there was a one-click rule" under which they would be "in compliance" if they "provided risk information within one click of their search ads." In changing the ads, industry executives now claim they "are even more confusing and misleading" and that "the agency is ignoring the realities of Internet marketing." Furthermore, the drug industry argues that the FDA "is not issuing clear rules about compliance."

By Catherine D. Bertram, Esquire and Salvatore J. Zambri, Esquire

The U.S. Food and Drug Administration announced that it had obtained,  "a permanent injunction barring Neilgen Pharmaceuticals Inc. of Westminster, Md., its parent company, Advent Pharmaceuticals, Inc. (Advent), of East Windsor, N.J., and two of their officers, Bharat Patel and Pragna Patel, from manufacturing and distributing any unapproved, adulterated or misbranded drugs."

Posted by Jacqueline Colclough, Esquire, R.N.

Autism is the most common condition in a group of developmental disorders known as the autism spectrum disorders and is characterized by impaired social interaction, problems with verbal and nonverbal communication, and unusual, repetitive, or severely limited activities and interests. The National Institute of Neurological Disorders and Stroke estimates that three to six children out of every 1,000 will have autism.

April is National Autism Awareness Month in the United States, and it been celebrated by the Autism Society of America (ASA) since the 1970s in order to highlight the growing need for concern and awareness about autism. The month presents a unique opportunity for everyone to educate the public about autism and issues within the autism community, and the ASA suggests eight ways you can celebrate National Autism Awareness Month this year. Continue Reading Posted In Pediatrics , Public Health
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A new study by the advocacy group Donate Life America found that people harbor misconceptions about organ donation preventing them from electing to be an organ donor, as reported by the New York Times.

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

For decades women have been advised to undergo mammograms to screen for breast cancer.  Routine exams, especially after age 50,  are highly recommended.  It was recently reported in a New York Times article, however, that British medical experts came to the conclusion that mammographies may do more harm than good.  The so-called experts suggest that for every life saved by the procedure at least one other person is forced to endure unnecessary and invasive procedures to treat slow-growing cancers that would otherwise cause no harm if left untreated.

Many experts, including the American Cancer Society, dispute the British claim, and urge women with usual risks (ie, family history of cancer, over age 50) to utilize mammograms as part of their routine screening for breast cancer.  On balance, the benefits of earl detection outweigh the risks associated with under-treatment.

To view the Times article, click here.

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

Nearly forty million prescriptions were written in 2008 in an effort to treat Attention Deficit Hyperactivity Disorder (ADHD). A recent study, however, warns that many of these widely prescribed drugs may cause more harm than good, especially if taken for more than two years. According to the study, prolonged use of ADHD medications can lead to significantly stunted growth.

To read the study, which was published in the Washington Post, please click here.

One lesson to take from the study is that it is critically important for parents to communicate well and often with their children's physicians and to question any prolonged prescription plan recommended by a physician. The more informed you are as parents, they better you are able to make decisions in your children's best interest.

For information about your legal rights, please click here or call the law firm of Regan Zambri & Long, PLLC at 202-463-3030.

On April 8, 2009, Genetech and the US Food & Drug Administration (FDA) announced a voluntary phased withdrawal of Raptiva (efalizumab) from the U.S. market.  We have reproduced the FDA  statement for our readers in its entirety.

FDA Statement

 FOR IMMEDIATE RELEASE
Statement
April 8, 2009

Media Inquiries:
Rita Chappelle, 301-796-4672
Consumer Inquiries:
888-INFO-FDA

FDA Statement on the Voluntary Withdrawal of Raptiva From the U.S. Market

Today, Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market. The company is taking this action because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. By June 8, 2009, Raptiva will no longer be available in the United States.

Prescribers are being asked not to initiate Raptiva treatment for any new patients. Prescribers should immediately begin discussing with patients currently using Raptiva on how to transition to alternative therapies. The FDA strongly recommends that patients work with their health care professional to transition to other alternative therapies for psoriasis.

The risk that an individual patient taking Raptiva will develop PML is rare and is generally associated with long-term use. Generally, PML occurs in people whose immune systems have been severely weakened and often leads to an irreversible decline in neurologic function and death. There is no known effective treatment for PML. On Oct. 16, 2008, FDA updated the FDA-approved labeling for Raptiva to warn of the risk of life-threatening infections, including PML. On Feb. 19, 2009, the FDA issued a Public Health Advisory informing patients and prescribers of the risk of PML in patients taking Raptiva, after receiving reports of four patients with PML, three of whom died. On March 13, 2009, the FDA approved a Medication Guide for Raptiva and included additional information in Raptiva's labeling regarding PML.

Raptiva was approved by the FDA in 2003. It is a once-weekly injection for adults with moderate to severe plaque psoriasis.

Prescribers should continue to monitor patients on Raptiva for neurologic symptoms that might represent PML. Prescribers and patients may report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch/report.htm.

More information about the withdrawal of Raptiva is available on the Genentech Web site: www.gene.com/gene/products. Prescribers with questions about Raptiva may contact Genentech Medical Communications at (800) 821-8590.

Additional Information
Efalizumab (marketed as Raptiva) Information

For information about your legal rights, please click here or call
the law firm of Regan Zambri & Long, PLLC at 202-463-3030.

During the past several years, researchers have discovered that Avandia, used to treat Type 2 diabetes, increases patient risks for a variety of problems, including, but not limited to:

• 43% increase for heart attack risk
• 64% increased risk of death from heart disease
• double risk for bone fractures
• increased risk of anemia
• increased risk of vision loss from macular edema

Recent research conclusions published in the America Diabetes Association's (ADA) Diabetes Care advises against use of Avandia because of an increase in life-threatening liver toxicity.  Both the American Diabetes Association and the European Association for the Study of Diabetes released a consensus statement concluding  "given that other [treatment] options are now recommended, the consensus group members unanimously advised against using rosiglitazone (generic name for Avandia)."

Public Citizen, a national non-profit public interest organization requested that FDA ban Avandia in its petition.  Earlier, the FDA included black-box warnings for Avandia, which later were strengthened as more dangers were documented.  The DC Metro Area Medical Malpractice Blog provided summaries and links for earlier FDA notices:  

• FDA to Require Black Box Warning on Avandia, Actos
• FDA Adds [New] Black Box Warning to Actos, Avandia
• Older Diabetes Drugs Rival New, More Advanced Ones: New Study

Although Avandia prescriptions have decreased sharply since the first warnings were revealed, there are still approximately 10,000 prescriptions being filled every day for it.  If you have been prescribed Avandia, consult your physician to determine whether you are a candidate for an alternative medication. 

If you or a family member believe that you have a case involving a medication or medical care please contact us on-line at Regan Zambri & Long or call us at 202-463-3030 for a free consultation.

The FDA has issued a Class 1 Recall for electronic infusion pumps that deliver IV medications and fluids to patients.   Class 1 recalls, the most serious category, are made when there is a reasonable probability that use of the product will cause injury or death.  We have reproduced the FDA Warning Notice in its entirety for our readers. 

Class 1 Recall: Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps

Date Recall Initiated: January 23, 2009
Product:  Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps

Model numbers: Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161and 2M9163

These products were manufactured and distributed from February, 1997 through December, 2008.

Use:  Electronic infusion pumps deliver controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration.

Recalling Firm:
Baxter Healthcare Corp.
Rt. 120 & Wilson Rd.
Round Lake, Illinois 60073

Reason for Recall:

The company identified software and battery usage failures that result in a delay in or interruption of infusion that may cause serious injury and/or death.

Public Contact:
Customers may call Baxter Healthcare Corp. at 1-800-843-7867

FDA District:
Chicago

FDA Comment:

On January 23, 2009, the company sent a correction letter to all of its customers about failures that could lead to:

* interruption of therapy
* damaged battery messages
* smoke and fire hazards
* serious injury and/or death

The letter also:

* advised institutions to have contingency plans to verify that back-up pumps are available
* provided new steps for addressing an interruption of therapy with any failure code
* provided instructions for addressing damaged battery messages
* provided instructions for proper device cleaning

For more information about this recall, please see the company’s press release at: http://www.baxter.com/about_baxter/news_room/ news_releases/2009/03_11_09_colleague.html

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

* Online: www.fda.gov/MedWatch/report.htm
* Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
* FAX: 1-800-FDA-0178

Updated March 11, 2009

The Supreme Court of the United States recently announced its ruling in the Wyeth v. Levine case. The principal question before the Court was whether FDA approval of a drug's label overrides (or preempts) state-law claims of inadequate warning. The argument made by the drug company was that it would be impossible to comply with both state and federal laws if the state's law provides for a stronger warning label than the FDA labeling regulation. The Supreme Court rightly rejected that argument, finding that "Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness." By issuing this ruling, the Court will allow consumers more protection from drug injuries that could have been prevented if the drug label had included proper warnings.

In this case, Diane Levine, a professional musician being treated for migraine headaches was injected with Phenergan, a drug manufactured by Wyeth. Because of the direct IV administration (IV push) of the drug, Ms. Levine's artery in her arm died, ultimately resulting in amputation of that arm. Wyeth was aware of the dangers of the IV push method for administering Phenergan, but never included any warnings to prohibit IV push administration on the label. The FDA had not determined whether the label should have included the warning. However, the FDA's labeling rules require that a prescription drug manufacturer change warning labels as soon as there is reasonable evidence that the drug causes adverse reactions without waiting for FDA approval of the label change.

Government regulations are intended to set minimum safety standards, but cannot guarantee safety. The preamble of regulations was intended to define the agency's interpretation. Beginning in 2005, Federal agencies started adding to the preamble of regulations without Congressional approval. With these additions, the agencies claimed that federal standards overrule any state safety standards and that state tort claims should be discarded. By adding preemption language to the agency preamble, the agencies bypassed Congress in determining if or when state law should be overruled. In 2007, however, Congress passed the Food and Drug Administration Act of 2007 (FDAAA), forcing the FDA to require drug manufacturers to update their labels when the manufacturers become aware of potential hazards.

If you or a family member has been injured as a result of a drug error or other product defect, please contact us on-line at Regan Zambri & Long or call us at 202-463-3030 for a free consultation.

According to recent research by the Mayo Clinic, both risks and benefits may exist for individuals considering aspirin therapy for heart attack and stroke prevention.  Every case must be evaluated individually and discussed with your doctor. 

Issues to consider before daily aspirin therapy include the following risk factors:

• "Smoking tobacco;
• High blood pressure — a systolic pressure of 140 millimeters of mercury (mm Hg) or higher or a diastolic pressure of 90 mm Hg or higher;
• Total cholesterol level of 240 mg/dL (6.22 mmol/L) or higher;
• Low-density lipoprotein ("bad") cholesterol level of 130 mg/dL (3.68 mmol/L) or higher;
• Lack of exercise
• Diabetes
• Stress
• Having more than two alcoholic drinks a day for men, one drink a day for women
• Family history of a stroke or heart attack"

Some conditions may prevent daily aspirin therapy:

• "A bleeding or clotting disorder (bleeding easily)
• Asthma
• Stomach ulcers
• Heart failure
• Other medications or supplements"

Daily aspirin therapy may also have some serious side effects:

• "Hemorrhagic stroke. While daily aspirin can help prevent a clot-related stroke, it may increase your risk of a bleeding stroke (hemorrhagic stroke).
• Gastrointestinal bleeding. Daily aspirin use increases your risk of developing a stomach ulcer. And, if you have a bleeding ulcer, taking aspirin will cause it to bleed more, perhaps to a life-threatening extent.
• Allergic reaction. If you're allergic to aspirin, taking any amount of aspirin can trigger a serious allergic reaction.
• Ringing in the ears (tinnitus) and hearing loss. Too much aspirin (overdosing) can cause tinnitus and eventual hearing loss in some people.
• Excessive bleeding during surgery or dental procedures."

The Food and Drug Administration also warns that regularly taking aspirin means that individuals should limit the amount of alcohol they drink because of its additional blood-thinning effects and potential to upset your stomach. No more than one drink a day if you're a woman or two drinks a day if you're a man. "Aspirin and all other over-the-counter pain relievers and fever reducers for adults will soon carry a warning to people who drink three or more alcoholic beverages a day: Talk with your doctor before using these drugs. Heavy drinkers may have an increased risk of liver damage and stomach bleeding from these medicines, which contain aspirin, other salicylates, acetaminophen, ibuprofen, naproxen sodium, or ketoprofen."

According to the FDA Consumer Magazine, "most health professionals agree that long-term aspirin use to prevent a heart attack or stroke in healthy people is unnecessary. If you are using aspirin to lower the risk of heart attack and stroke and you haven't talked with a health professional about it, you may be putting your health at risk."

New FDA-regulated modifications to over the counter cold and cough medicines should be observed by parents of young children. The following is the FDA statement regarding the new regulations applied to over-the-counter cough and cold medicine. Links have been added to the original statement for the readers' convenience.

  According to a report on medicalnewstoday.com, consumer complaints and Internet searches conducted by members of the Mexico-US-Canada Fraud working group lead the Federal Drug Administration (FDA) to find that 125 products sold online, that are boasting prevention, treatment, and/or cures for cancer, are fraudulent. Government officials are concerned that these products will interfere with legitimate cancer treatment and/or be independently harmful to individuals. Furthermore, it is worrisome that cancer patients may rely on these false claims and not seek appropriate medical care.

 Medicare, the largest insurance provider in the country, announced on October 1, 2008,  that it will no longer be financially responsible for the costs of hospital’s medical errors, nor will these costs be pinned on patients themselves.

Infections of the bacteria Staphylococcus aureus may be an overlooked cause of sudden infant death syndrome (SIDS), according to research published in a recent edition of the medical journal Archives of Disease in Childhood.

Common ultrasound imaging may be able to reveal which patients face a particularly high risk for heart attack or other heart-related illnesses, according to research recently published in the journal Radiology -- official journal of the Radiological Society of North America.

The FDA has issued a warning to consumers regarding expired and suspected counterfeit drugs for two Baltimore pharmacies.   The FDA News Release is reproduced below in its entirety.  

                            FDA News

              FDA Warns Consumers About Potential Problems

                                at Two Baltimore Pharmacies

Expired and suspected counterfeit prescription drugs

found at pharmacies

The U.S. Food and Drug Administration is warning consumers who filled prescriptions at The Medicine Shoppe pharmacies located at 8035A Liberty Road and 5900 Reisterstown Road in Baltimore that they may have received drugs that were either expired or suspected counterfeit. The FDA is particularly concerned because a number of the drugs are for serious diseases and could have an adverse effect on treatment.

The products in question include: 

• Lisinopril (20 milligrams)
• Guaifenesin/Dextromethorphan (600 mg and 1000 mg)
• Gabapentin (100 mg, 300 mg and 400 mg)
• Metoprolol (50 mg)
• Nifedipine (30 mg)
• Diclofenac Sodium (30 mg)
• Glucophage (500 mg Extended Release)
• Glucovance (125 mg and 500 mg)
• Glipizide/Metformin (2.50 mg/250 mg)
• Furosemide (20 mg)
• Tamoxifen Citrate (10 mg)
• Metformin HCl ER (500 mg)
• Calcitrol (0.25 micrograms)

The FDA has no evidence that any other Medicine Shoppe pharmacies outside of the 8035A Liberty Road and 5900 Reisterstown Road facilities are involved.

Because the safety and efficacy of the listed drugs has not been established, the FDA is strongly advising consumers who filled prescriptions for these drugs at these two pharmacies to contact their prescribing physician immediately for new prescriptions. Additionally, consumers in possession of the above listed prescription drugs from these pharmacies should call FDA at 800-521-5783 for further information on how to dispose of the drugs.

Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md 20852-9787, or online at www.fda.gov/medwatch/report.htm.

Whether the drug names are Celexa and Celebrex, Losec and Lasix, or even Prilosec and Prozac, sound-alike drug names pose dangers to patients.  Those dangers are compounded by the multi-ethnic and geographic diversity of the U.S. healthcare system, where strong accents combined with ordinary mispronunciation of complex pharmaceutical terms can lead to catastrophic outcomes if the wrong medication is accidentally dispensed.  Medication errors and sound-alike drug names are the topics of a recent article featured on HealthDay News.

Making certain that young children receive their recommended vaccinations is particularly important for their long-term health ― as well as for the health of their friends and classmates. Vaccines protect children against common seasonal diseases like the flu, but they also help prevent much rarer, more serious diseases.

All parents can determine what vaccines their children need and when the doses should be administered by consulting the nationally recommended Childhood Immunization Schedules, available on the web site of the U.S. Centers for Disease Control and Prevention (CDC).

If a child falls behind schedule on his or her vaccinations, it can sometimes be difficult to determine the best way to catch up. To help, the CDC has developed a Catch-Up Immunization Scheduler -- an online tool that shows parents and healthcare providers the best options for getting children six years of age and younger back on schedule.

The number of fatal medication errors occuring in people's homes has risen dramatically in recent years, particularly in those situations where alcohol or street drugs are also involved.  The finding is the result of research published in a recent edition of the Archives of Internal Medicine.  Authors of the study note that the number of years of potential life lost due to these home-based medication errors is likely greater than the number of years of life lost from all other accidents combined -- including falls and automobile accidents.

A recent FDA report to health care providers, warned of potential "adverse events" due to computerized tomography (CT) scans of patients with electronic devices implanted. Though few incidents have been reported thus far, the FDA is taking all reports seriously. Possible adverse events include medical devices shocking patients, sending inaccurate signals due to the CT scans, malfunctions of insulin infusion pumps, and transient changes in pacemaker output pulse rate.

The Chicago Tribune noted this announcement came as a surprise to physicians, many of whom were aware of these dangers with MRI scans. Dr. Leonard Berlin, chairman of the radiology department at Rush North Shore Medical Center in Skokie says he was not aware of this. "We haven't seen any of these problems and I'm not aware of any of my colleagues having seen them either. But, of course, we'll abide by what the FDA is recommending," Dr. Berlin says.

So what devices are possibly affected?

Rotavirus cases in the current 2007-2008 season showed up much later than usual and have been less severe, overall, than during any previous season on record, according to an interim report issued by the U.S. Centers for Disease Control and Prevention (CDC).

Electronic medical record systems have been touted as the wave of the future in healthcare and research has demonstrated their value in preventing medical errors.  According to new data published in the New England Journal of Medicine, however, only 4% of physicians have extensive, fully-functioning electronic systems, and only 13% have even a basic system.

A six-fold increase in the number of liver cancer patients receiving transplants has been linked to a method of donor organ allocation which was initiated in early 2002.  The research finding was recently published in Gastroenterology, official journal of the American Gastroenterological Association.

Whole milk is as effective as diluted barium when used as an oral contrast agent for patients undergoing a gastrointestinal CT scan.  It's cheaper and safer for patients, according to a new study published in a recent edition of the American Journal of Roentgenology.

The reliability of mammography results varies significantly between medical facilities, according to new research published in a recent edition of the Journal of the National Cancer Institute (JNCI).  Even more importantly, certain organizational characteristics tend to predict which facilities will return a more accurate reading.

The National Center for Complementary and Alternative Medicine (NCCAM) -- a division of the National Institutes of Health (NIH), recently launched an educational campaign to encourage patients (particularly those 50 years of age or older) to speak openly with their primary care providers about complementary and alternative medicines.  The campaign, known as Time to Talk, focuses on medical practices and products that aren't presently considered to be conventional medicine -- items such as herbal supplements, meditation and acupuncture.

The Houston Chronicle reports that more than 700,000 Americans suffer strokes each year and more than one-third will develop depression in the next two years.  Previous research indicates that stroke patients with depression recover more slowly and are more likely to die.  However, new research suggests that doctors may want to give stroke victims antidepressants right away instead of waiting until they develop depression. 

Bacterial infections such as E. coli and Staphylococcus aureus -- sometimes acquired in medical facilities -- may be responsible for many cases of sudden infant death syndrome (SIDS).  The finding is the result of new research published in a recent edition of the British medical journal The Lancet.

The New York Times reported on the Food and Drug Administration's announcement last week of a new system to track already-released drugs' effectiveness. Called the Sentinel Initiative, many bodies such as the Institute of Medicine have recommended such a system for years. Additionally, the Sentinel Initiative is supported by recently-released research showing fast-tracked approval of new drugs leads to problems down the road. However, there are also many criticisms regarding the system's method of collecting data and its accuracy.

Patients who suffer a heart attack often subsequently develop acute kidney injury, a complication significantly increases a patient's risk of death.  The finding is the result of new research published in a recent edition of the Archives of Internal Medicine.

According to statistics reported by the U.S. Centers for Disease Control and Prevention (CDC), almost one in three Americans will develop shingles (herpes zoster) during their lifetime.  The disease is particularly dangerous to people over age 60 and those who are immunocompromised.  Fortunately, there is a way to reduce the risk of developing shingles and the long-term pain that often follows an outbreak of the disease.

Women who quit smoking lower their risk of dying from coronary heart disease by 47% within five years of smoking their last cigarette.  The risks associated with dying from other smoking-related diseases also decreases, but after different lengths of time, depending on the disease.  The findings are the result of new research recently published in the Journal of the American Medical Association (JAMA).

The latest Trasylol study was released Wednesday is slated to appear in print in the May 29 issue of the New England Journal of Medicine.

The 2008 edition of the schedule of recommended immunizations for people 18 years of age and younger has been posted by the Advisory Committee on Immunization Practices (ACIP) -- a division of the U.S. Centers for Disease Control and Prevention (CDC).  The advisory committee releases new recommendations annually to reflect changes in vaccine formulations and current recommendations for the use of licensed vaccines. 

This summer, don't wait until the last few busy weeks before fall school registration begins to make your child's vaccination appointment -- schedule an appointment now, and enjoy a safer summer. 

Changes from the 2007 immunization schedule are as follows:

Elevated levels of allergens in the home are associated with asthma symptoms in allergic individuals, and asthmatics who experience allergies may improve their health by reducing allergen exposures.  The findings are the result of new research published in The Journal of Allergy and Clinical Immunology, and reported in a recent press release by the U.S. National Institutes of Health.

A newly updated annual ranking of state medical boards by the consumer advocacy group Public Citizen has revealed widespread discrepancies in both the numbers of disciplinary actions taken against physicians' licenses, and the rates of those disciplinary actions from state to state.  Though the specific numbers have changed again this year, a pronounced trend of significant discrepancies between individual states has held constant for years.  Unless geography influences a physician's competence, these state-by-state discrepancies point to a dangerously inadequate national system of physician oversight -- one that could conceivably allow dangerous, incompetent physicians to continue to practice medicine by moving from state to state.

Despite the rising costs of fuel this year, millions of Americans will be hitting the nation's roads and airports for a summer vacation -- and for those who suffer from seasonal allergies, summer traveling can pose some unique challenges.  The American Academy of Allergy, Asthma & Immunology (AAAAI), reminds travelers that the climate of your destination, rather than your home, determines the pollens and molds to which you'll be exposed on vacation, and that all seasonal allergy sufferers should take time to plan their clothing and needed medications appropriately. 

The academy offers the following additional allergy management tips for summer vacationers:

New hemoglobin-based artificial blood -- still unapproved for use in the U.S., but heavily studied -- appears to raise a patient's risk of heart attack and death according to an exhaustive review of clinical research data.  This latest research was published in a recent edition of the Journal of the American Medical Association (JAMA).  The findings have spurred critics to allege that the U.S. Food and Drug Administration (FDA) put clinical trial participants in imminent danger by failing to detect or act on research data illustrating significant increases in the rates of heart attack and death reported in trials of these blood substitutes.

Laser eye surgeries such as LASIK (Laser-Assisted In Situ Keratomileusis) are quickly becoming some of the most common and technologically sophisticated procedures available for correcting relatively minor vision problems.  Generally performed on an out-patient basis with the aid of only anesthetic eye drops, LASIK procedures are usually quick and easy, and the results are often remarkable.  Unfortunately, however, the results can be underwhelming, too -- and occasionally even catastrophic. 

To help clear up some misconceptions and misinformation regarding LASIK procedures, and to help consumers better understand the risks of laser eye surgeries, the U.S. Food and Drug Administration (FDA) has established a web page devoted specifically to patient education.  According to the agency, there are a few categories of people who should think twice before they attempt to resolve their vision problems with LASIK surgery.

Melanoma is one of the deadliest skin cancers, but new research demonstrates that melanomas located on the scalp or neck are even twice as deadly as those found on other parts of the body.  The finding is the result of a study published in a recent edition of the medical journal Archives of Dermatology. 

The American Heart Association has issued new pediatric recommendations that call for heart fitness screenings prior to stimulant treatment for all children diagnosed with attention-deficit hyperactivity disorder (ADHD).  The new patient safety guidelines were published in a recent issue of the journal Circulation -- official journal of the American Heart Association -- and they address growing fears that stimulant medications can cause serious heart complications in children with underlying, undiagnosed heart disease.

New figures released by the federal government have revealed a steep and potentially deadly spike of a serious, hospital-based infection that gives patients blood poisoning and sometimes incurable diarrhea.  This latest public health research data, released by the U.S.Agency for Healthcare Research and Quality (AHRQ) shows an increase of 200% in the prevalence of Clostridium difficile (C. Diff.) infections among U.S. hospital patients between the years of 2000 and 2005.

Human Papillomavirus (HPV) -- the sexually-transmitted virus responsible for cervical cancer in thousands of women -- has now been implicated in a rapidly increasing rate of mouth and throat cancers among young men.  Researchers are hoping that a recently-approved HPV vaccine will soon be approved for boys, and tested for its effectiveness in preventing head and neck cancers.  A news article in a recent edition of the Baltimore Sun features Dr. Maura Gillison, an oncologist at Johns Hopkins University's Sidney Kimmel Comprehensive Cancer Center, whose research has been credited with linking the virus and tumors.

The U.S. Food and Drug Administration (FDA) has announced that some flavors of the dietary supplements "Total Body Formula" and "Total Body Mega Formula" have been found to contain dangerously high levels of selenium -- a naturally-occurring mineral that is toxic in high doses.  The sole distributer of the product, Total Body Essential Nutrition, Inc., has issued a voluntary recall. 

A Mumps comeback in the U.S. in 2006 was alarming in its severity, and the disease may now take several years to completely eradicate, according to federal public health experts.  Interestingly, the viral outbreak occurred despite the routine administration of a second dose of a mumps vaccine throughout the early 1990s.  These findings were reported in a recent edition of the New England Journal of Medicine (NEJM).  Among other data presented in the article is the fact that 84% of people between 18 and 24 years of age who contracted Mumps during the outbreak had already been given the second recommended dose of MMR vaccine -- a dose that should have protected them from Mumps.

New U.S. Food and Drug Administration (FDA) guidelines for oversight of "off-label" drug use -- still in draft form and unfinalized -- could allow pharmaceutical companies to market more drugs for unapproved uses.  The proposed guidelines are a step in the wrong direction according to Dr. Randall Stafford, an associate professor of medicine at the Stanford Prevention Research Center.  His concern for patient safety was articulated in a recent edition of the New England Journal of Medicine.

The U.S. Food and Drug Administration (FDA) has announced that it is working with Merck, Inc., the pharmaceutical company, to explore a possible link between the popular asthma and allergy drug Singulair (known generically as montelukast) and behavioral changes, mood changes, and increased rates of suicide among users.  The investigation could take nine months, and although the agency is not yet recommending that anyone stop taking the drug, it is asking health care professionals to monitor Singulair patients for changes in condition that may indicate a suicide risk.

Physicians treating chest pain in patients who are young, or in those who have no obvious risk factors for heart disease, should ask those patients about their potential cocaine use.  The advice is a key recommendation by the American Heart Association (AHA), recently published in the medical journal Circulation. 

If you see someone suffer a heart attack and go unconscious, immediately dial 9-1-1 and begin pushing on his or her chest as hard and as often as you can -- don't stop until someone else can take over, or until paramedics arrive.  Those are the latest instructions from the American Heart Association (AHA), which is now confident that hands-only cardiopulmonary resuscitation (CPR) can be done in an emergency, even by people who have no CPR training.  Throat sweeping and mouth-to-mouth emergency breathing are still recommended, but not for bystanders -- those components are only encouraged for trained medical personnel.  The organization's new position appears in the March 29 issue of the medical journal Circulation.

Adverse drug events affect about 7% of U.S. children in hospitals -- adverse events such as getting the wrong medication, the wrong doses of medication, and dangerous, preventable reactions.  The percentage is much higher than previous estimates, too, underscoring growing concerns about medical errors involving hospitalized children, according to new research published in the journal Pediatrics.

Now that the spring and summer sports season has arrived, the American Association of Endodontists (AAE) is urging all young athletes to "watch their mouths," and to wear a mouth guard for every sport this year, including even those spring sports typically thought of as "non-contact" sports -- like soccer, softball, baseball and gymnastics.

Breathing muscles which go unused during ventilator-assisted respiration weaken more rapidly than previously understood, according to a new study published in a recent edition of the New England Journal of Medicine. 

A complex assortment of pharmaceutical drugs has been found in the drinking water supplies of tens of millions of Americans, according to a recent Associated Press investigation.  The contamination affects the drinking water supplies of at least 24 major metropolitan areas across the U.S., including the DC Metro area.