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Heparin Baxter Drug Recall and Patient Deaths Emerging Class Action Lawsuit
| Heparin Baxter Drug Recall and Patient Deaths |
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| | 159 | LEAD PLAINTIFF: Case Filed: 2008-03-17 |
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Case Summary: The FDA has reported that up to 21 deaths and 448 allergic reactions may be linked to the blood thinning product. As of February 28, 2008, Baxter has expanded its recall to include single-dose vials and a diluted solution of heparin used to keep blood clots from forming in intravenous lines. The cause of the heparin injuries is currently unknown but the FDA and Baxter have begun examining Baxter manufacturing facilities. Concern has arisen over irregularities in samples of heparin that were processed by Baxter’s supplier in China, Changzhou SPL. According to press reports, despite the fact that Changzhou SPL began shipping heparin to Baxter in 2004, the Changzhou factory was never inspected by the FDA nor by its Chinese regulatory counterpart until late February 2008. Any supplier of active drug ingredients shipped to the U.S. is required to be approved by the FDA by passing physical inspections and evaluations. Authorities are urging doctors to use non-Baxter vials of heparin. Baxter sells roughly half the heparin sold in the U.S. and has agreed to halt making heparin products associated with the reported adverse effects. Case Detail: On February 11, 2008, the Food and Drug Administration ("FDA") announced that the use of heparin in multi-dose vials made by Baxter International Inc., has been tied to an anaphylactic reaction which causes a profound drop in blood pressure, difficulty breathing and sometimes vomiting. This reaction happens within a few seconds of the injection of the drug. This reaction is not the same as Heparin-induced thrombocytopenia. |
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