The first product liability trial over defective batches of the blood thinner heparin, which were used throughout the United States from late 2007 to early 2008 and may have killed 81 people and sickened hundreds more, has been scheduled to begin in November 2010.
At least 50 heparin recall lawsuits are currently consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, in the U.S. District Court for the Northern District of Ohio. All of the cases involve similar allegations that tainted lots of heparin distributed by Baxter Healthcare caused severe and potentially life-threatening allergic-type reactions.
A Baxter heparin recall was issued in January 2008 after a spike in adverse event reports surfaced involving reactions to heparin, an anticoagulant or blood thinner that is critical for a number of medical procedures and conditions.
At that time, Baxter manufactured about half of the injectable heparin sold in the United States and it was discovered that the heparin contained a fake ingredient received from a plant in China that was chemically similar to heparin, yet substantially cheaper.
Investigations by the FDA and a report published in the New England Journal of Medicine in December 2008 found that the heparin reactions were caused by the presence of oversulfated chondroitin sulfate. FDA investigators and researchers believe the fake ingredient was used for fraudulent purposes, to save money.
According to a scheduling order issued last week, U.S. District Judge James Garr ordered that the first individual trial in the Baxter heparin litigation will begin on November 2, 2010. Selection of which case or cases will be tried during the first jury trial is expected to occur by May 1, 2010.