Partial Summary Judgment Granted in Baxter Heparin Lawsuit

An Illinois judge has determined that the contaminated heparin imported into the United States by Baxter International, Inc. in late 2007 and early 2008 was “unreasonably dangerous,” granting partial summary judgment in a heparin lawsuit filed over injuries allegedly sustained by two people as a result of the blood thinner. 

In a case pending in Illinois state court in Cook County, Judge Jennifer Duncan-Brice granted the plaintiffs motion against Baxter on Wednesday, determining that it is not necessary for a jury to decide whether the heparin was defective and unreasonably dangerous. However, the plaintiffs must still establish at trial that their injuries were caused by the contaminated heparin.

There are currently about 300 heparin lawsuits consolidated in Cook County Circuit Court against Baxter and an ingredient supplier, Scientific Protein Laboratories, LLC. Additional cases pending in federal court over the Baxter heparin recall have been 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 the blood thinner, which is critical for a number of medical procedures and conditions. Dozens of serious adverse reactions and deaths were reported in connection with the contaminated heparin.

At the time of the recall, Baxter manufactured about half of the injectable heparin sold in the United States and it was discovered that the crude heparin used to make the drug contained a fake ingredient received from a plant in China, which was chemically similar to heparin, yet substantially cheaper. Top FDA officials concluded that the substitution of the fake ingredient that caused the heparin problems was likely done by virtue of economic fraud.

Judge Duncan-Brice’s ruling was based in part on statements by Baxter’s own president and vice president of quality control and president of medication delivery, all of whom described the recalled heparin as defective. The ruling came despite arguments from the drug maker that none of the three executives were scientists qualified to make that determination.

Since the heparin crisis, FDA has ordered the blood thinner to be reformulated in order to more easily detect impurities. However, the new reformulation is 10% weaker than the original heparin formula.