Contaminated Heparin Injury Lawsuits Continue to Mount for Manufacturers

January 19, 2010
By Gabriel Mejia, Esq. on January 19, 2010 10:59 AM | | Comments (0)

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.

The FDA is asking that any heparin-related adverse events be reported using the information available on their website. Adverse reactions associated with contaminated Heparin include anaphylactic-type reactions, acute hypotension, acute gastrointestinal distress, unexplained lack of platelets in the blood, excessive bleeding, and other symptoms explained on their website.

Gabriel Mejia, Esq. is a Coral Springs personal injury attorney handling accident and injury cases in Florida for Law Offices Cytryn and Velazquez, P.A.

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