HEPARIN DEATH INVESTIGATION: BAXTER ACCUSED OF OBSTRUCTION BY CHINESE FDA
On May 6, 2008, Reuters reports that the Chinese Food and Drug Administration is accusing Heparin manufacturer Baxter International of “obstructing the investigation into the cause of” the reported fatalities resulting from the drug. As discussed in earlier blogs, Baxter is the U.S. maker of Heparin, a blood thinner used to treat patients undergoing dialysis, surgery and other procedures or with other conditions. After an alarming increase in side effects and deaths were reported from taking Baxter Heparin, the FDA and Baxter discovered a contaminant in the product, reportedly originating from the Chinese factory where the drug was made. Prior to the death increase, the factory had never been inspected by the FDA. Since contamination reports, all Baxter Heparin has been recalled.
The Chinese FDA denies that contamination from their manufacturing plant is to blame, while still unable to explain how contamination occurred in the first place. Additionally, Chinese authorities are stating that Baxter has not provided sufficient cooperation in investigating the Heparin problem including destroying drug samples and records, an accusation that Baxter denies.
Chinese product production continues to cause problem for U.S. regulators. The Chinese Heparin manufacturer allegedly eluded inspection originally since it was registered as a chemical manufacturer, not a pharmaceutical one. According to the Reuters article, the recalled Heparin may have killed 81 people, up nearly twenty victims from previous reports.
If you or a loved one has been killed or had a severe reaction as a result of taking Baxter Heparin in California, you need the help of an experienced and successful personal injury attorney. At the Law Offices of Greenberg & Rudman LLP, we have over 50 years combined experience fighting for your rights. Call us now for your free and confidential consultation at 1-800-ALAWPRO (1-800-252-9776). We are here to help you now.