Gabriel Mejia, Esq.: January 2010 Archives

January 19, 2010

Contaminated Heparin Injury Lawsuits Continue to Mount for Manufacturers

Heparin manufacturers, including Baxter International, Inc., are facing mounting lawsuits alleging that a known 2008 contamination of the anticoagulant caused severe injuries and deaths. Lawsuits addressing the defective drug are being filed in state and federal courts. The federal court cases are being transferred to multi-district litigation in the Northern District of Ohio.

Heparin is a blood thinner (anticoagulant) used to prevent blood clots in veins, arteries, and lungs, which is often used prior to surgery or as a coating for medical devices. In 2008, the U.S. Food and Drug Administration (FDA) identified an increase in the number of deaths and adverse events, such as anaphylactic-type reactions (allergic reactions) and acute hypotension (extremely low blood pressure), associated with Heparin use. Scientists identified a contaminate in the Heparin described as oversulfated chondroiton sulfate which mimicked heparin activity and eluded routine testing. Because of the contamination, the FDA adopted a new standard for testing Heparin in 2009.

Baxter and other manufacturers began recalling suspected contaminated Heparin in 2008. Investigations have shown that the problem may stem from Chinese producers of crude heparin. A key ingredient in Heparin is made from pig intestines in China because of the large number of available animals. Although the source of the contamination has not yet been determined according to reports, some lawsuits are alleging that the China production facilities did not meet U.S. regulation and were not inspected or approved by the FDA.

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January 12, 2010

Humira, Other TNF Blockers Linked to Cancer in Children

The U.S. Food and Drug Administration (FDA) recently announced that it would require Humira and other tumor necrosis factor (TNF) blocker prescription medications to include its strictest warning on both the packaging and prescribing information for the potentially dangerous drugs. The 'boxed warning' or 'black box warning' is now required after analysis of adverse medical incident reports submitted to the FDA showed an increased risk of lymphoma and other cancers with the use of TNF blockers such as Humira, Enbrel, Remicade and Cimzia in children and young adults. The FDA is requiring that manufacturers warn doctors and patients of the increased risk of leukemia, as well as new-onset psoriasis, on the TNF blocker packaging.



TNF blockers such as Humira, Enbrel, Remicade and Cimzia are used to treat children and young adults with Juvenile Idiopathic Arthritis (also known as Juvenile Rheumatoid Arthritis), Crohn's disease and other diseases. The drugs work by suppressing the immune system to block the tumor necrosis factor which causes inflammation and immune system related diseases.

The black box warning for TNF blockers comes after approximately 30 reports of cancer in children and young adults under the age of 18 taking TNF blockers were reported to the FDA between 1998 and April 2008. The concern included the development of lymphoma (cancer of the cells in the immune system) and other cancers such as leukemia, melanoma and solid organ cancers in children taking TNF blockers such as Humira, Enbrel, Remicade and Cimzia. In August 2009, the FDA announced that it had tracked 48 malignancies from 2001 through 2008 associated with the use of TNF blockers in children after an average of 30 months of treatment. The FDA will continue to investigate and analyze data from long-term studies of the potentially dangerous drugs.

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January 4, 2010

Drunk Drivers Pay More in Florida, Too

A circuit court jury in Missouri recently awarded the family, fiancee, and daughter of a man killed by a drunk driver $89 million dollars in damages.  The man was killed, and his 13-week-pregnant fiancee seriously injured, when the drunk driver crashed head-on with his vehicle.  After police responded and tested the drunk driver's blood alcohol level, they found that the driver was nearly 2.5 times over the legal limit with a blood alcohol content of 0.20.  Making a horrific incident even worse, the drunk driver was driving on a hardship license at the time of the accident issued because of a previous drunk driving arrest.  According to reports, the jury was sending a message with the verdict of their distaste for such blatant disregard for the law and human life.  The drunk driver was sentenced to 10 years in prison in his criminal case for his past drunk driving arrests.

In Florida, juries tend to punish drunk drivers more than drivers who simply cause an accident with no evidence of intoxication or impairment.  Insurance companies tend to offer more money, generally, in drunk driving cases, as well.  If the insurance company refuses to offer a reasonable settlement in an intoxication case, a lawsuit will often bring about the desired result of a larger settlement or large jury verdict.  Florida law allows punitive damages to be sought against drunk drivers in civil cases under certain circumstances.  Even if punitive damages are not awarded, or the defendant driver is "judgment proof", there is a punitive element in most of these verdicts.  Drunk driver accident cases are more persuasive to most jurors and tend to entice insurance adjusters to offer more reasonable settlements.

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