Heparin Lawsuit
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The recall of the anticoagulant heparin has generated a number of lawsuits. Heparin is a drug used to avoid clotting during surgery and during many other procedures including kidney dialysis. It has been a basic anticoagulant in widespread use in the U.S. since 1935. In February of 2008 the Baxter Healthcare Corporation recalled most of the heparin products they had put into circulation as a result of the FDA’s report of deaths associated with the use of heparin. Baxter manufacturers half the heparin used in the U.S.
Other firms produce medical devices that are coated with heparin in order to prevent clotting during surgery. One of them, Medtronics, has recalled its products in response to FDA concerns. Another, Covidien, has been sued in a wrongful death action as the result of a fatal reaction to heparin.
This heparin lawsuit was filed in a Boston federal court by a Philadelphia law firm on behalf of the relatives of a Missouri man who had a fatal allergic reaction to the drug. The lawsuit alleges that Covidien failed to recall its tainted heparin products long after other medical device providers had heeded the request of the FDA.
As of April 17th, Baxter was reporting that a dozen heparin lawsuits had been filed and that they were relatively unconcerned about extensive legal action. On April 20th, four more suits were filed in Toledo Ohio alone. The FDA has reports of over 160 deaths probably affiliated with heparin, with the great majority of those occurring in 2008. There have been additional reports of severe allergic reactions to heparin in which the victims have survived.
Heparin lawsuits will continue to materialize as this story continues its twists and turns. While the FDA had granted approval for Baxter’s heparin products, they had failed to inspect the plant in China where the drug is manufactured. Heparin is produced partially from pig intestines, and China is a major producer of the drug globally because of ready access to large amounts of the raw material.
All heparin lawsuits will undoubtedly be filed in federal court. In February of 2008 the Supreme Court ruled that FDA approval of a medical device precludes lawsuits brought by patients against the manufacturer over adverse events in state courts. That presumably applies to medications as well; the FDA is in effect providing a partial shield for pharmaceutical manufacturers.
