Baxter Loses First Heparin Lawsuit

An Illinois jury has awarded $625,000 to the estate of a man who was given a dosage of the heparin blood thinner that contained a contaminated ingredient,The Chicago Tribune writes. The verdict is the first against Baxter International and its supplier, Scientific Protein Laboratories, among hundreds of such lawsuits. Three years ago, the FDA determined the heparin contained fake ingredients from China.

The heparin scandal, you may recall, focused a harsh light on the pharmaceutical supply chain, notably poorly supervised manufacturing in China and the inability of the FDA to perform sufficient oversight. The episode led to Congressional hearings and significant pressure on the agency to upgrade its supervision (see here, here and here).

Attorneys for the estate of Steven Johansen of Oak Forest, Illinois, said the 63-year-old man received low doses of contaminated heparin in December 2007 during dialysis at a local clinic, and later received a higher dosage at a hospital, where he died that month. In early 2008, Baxter recalled its heparin, which contained an active pharmaceutical ingredient derived from pig intestines (see photo) from hogs in rural China.

"This crude heparin was referred to in the companies' own internal records as 'the cheap stuff.' The contaminant was determined to be a man-made 'fake heparin' called over-sulfated chondroitin sulfate, causing among other effects, potentially fatal allergic-like reactions," Johansen estate attorneys Don Nolan of Chicago and David Zoll told the paper. For its part, Baxter "takes its responsibility for legitimate cases of harm very seriously," the company said in a statement to the Tribune. "Both the Centers for Disease Control and Prevention and FDA identified a well-defined and discrete set of symptoms potentially associated with heparin contamination. Baxter will vigorously defend claims that are not consistent with the definition established by public health authorities."

In 2008, Baxter and Scientific Protein Laboratories maintained a foreign substance was intentionally put in its heparin in the Chinese supply chain. The Chinese government, however, denied the substance was intentionally put into Baxter's heparin. A prior trial case brought against Baxter in an Illinois court was settled earlier this year for an undisclosed amount.

Scientific Protein Laboratories, by the way, has continued to have difficulties. Earlier this year, the FDA issued a warning letter in which SPL was upbraided for failing to move quickly enough to widen an internal investigation into contamination of several lots. That came after the FDA sent an inspection letter last fall because the supplier of active pharmaceutical ingredients received info that lots were contaminated in October 2008, but failed to adequately investigate for a year (back story).