Heparin (also known as heparin sodium) is a blood thinner administered in surgery and other critical care situations to prevent clots. It is crucial in dialysis and heart surgery and other serious procedures. In earlier 2008, Baxter International recalled nearly all its multiple-dose vials in the U.S. after some patients experienced extreme allergic reactions as a result being given heparin. This adverse reaction happens within a few seconds of the injection of the drug and can be fatal.
To date, tainted heparin injections have been blamed for more than 80 deaths and more than 700 adverse reactions in the U.S. Eleven countries have been affected as the FDA continues to investigate the source of the contamination.
In March 2008, the Food & Drug Administration (FDA) confirmed that it found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said a less expensive synthetic compound was used as a substitute to the ingredient usually used in heparin. Raw heparin is usually derived from the intestines of pigs. It is now known that the potentially toxic Baxter heparin was produced in a Chinese factory that was never properly inspected by the FDA.
Baxter has temporarily suspended manufacture of its multiple-dose vials of heparin sodium pending the completion of an extensive ongoing investigation to determine the exact source of the problem. However, based upon available information and litigation to date, it is alleged that Baxter failed to undertake adequate testing that would have shown that its Heparin posed a life-threatening risk to patients. It is also alleged that had Baxter acted responsibly, they could have prevented many of the adverse reactions and deaths.
As Pharmaceutical Drug attorneys we can help
At the Didier Law Firm we have extensive experience in litigating product defect cases involving dangerous pharmaceutical drugs, and stand ready to bring our knowledge and expertise to bear for you. If we can be of assistance to you in evaluating or pursuing a product defect claim relating to the administration or use of Heparin please immediately.