Heparin Class Action Lawsuits
By February of 2008, the FDA reported four deaths and about 350 allergic reactions from Heparin. Most of the reactions were thought to be caused by high doses over a short period of time. Reactions included difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that could lead to life-threatening shock and death.
Adverse reactions increased after the initial recall and included Heparin lots that had not been recalled. By February 28, the FDA reported that the number of deaths had risen to 21. Baxter temporarily halted production of all Heparin products.
The FDA announced on March 21, 2008 that B. Braun Medical Inc., a supplier of Heparin in Canada, began recalling Heparin solutions as a precautionary measure. At the same time, Health Canada announced that the company's heparin products were tainted. Braun has recalled 23 lots (of 25,000 units each) that were distributed to Canada, Australia and the United States.
The FDA has now discovered that the raw ingredient in Heparin from Baxter and B. Braun came from China. It was doctored with chondroitin sulfate, a widely used, over-the-counter dietary supplement made from animal cartilage and used to treat joint pain. When chondroitin sulphate is altered, or "oversulphated," it mimics the blood-thinning action of heparin.
It isn't clear whether chondroitin sulfate was added deliberately or accidentally, but the agency does know that the doctored drug did not occur naturally or as a result of the manufacturing process.
Scientific Protein Laboratories (SPL) of Waunakee, WS has been supplying heparin to the US for 30 years and it supplied both B. Braun and Baxter heparin in its raw form. SPL moved the plant to China three years ago because the country was the biggest pig producer in the world. Ironically, a pig shortage in China due to disease may have been the precursor to the tainted drug. Changzhou SPL purchases crude heparin from brokers who buy from family farmers; allegedly, the doctoring of the drug may have been done by brokers.
The plant in Changzhou was approved by the FDA to provide heparin to the US in 2004, but the agency never inspected it. Now, the FDA is now under fire for approving Baxter's heparin without inspecting the plant. The agency has admitted that it violated its own policies by neglecting to inspect SPL's Chinese plant before approving the drug for sale in the US.
More Information about Heparin Lawsuits
Heparin Injections Law Suit Settlement
Chinese made Blood Thinner Heparin Tied To Several Deaths
FDA Information on Adverse Event Reports and Heparin
Adverse Reactions Spur Recall of Baxter Heparin Vials
Baxter expands heparin product recall
Heparin Recall Expanded Yet Again
Did my Son Die from Heparin?
Tainted Heparin: Just What Is In It?
Tainted Heparin: Counterfeiting is Suspected