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CHICAGO - (Mealey's) In what plaintiff attorneys say is the first such case to go to trial, an Illinois state court jury on June 9 awarded $625,000 to the estate of a man who died after allegedly receiving three doses of contaminated heparin (Estate of Steven Johansen v. Baxter International, et al., No. 2009 L 11175, Ill Cir., Cook Co).
Cook County Circuit Court Judge Jennifer Duncan-Brice entered a directed verdict against defendants Baxter International and Scientific Protein Laboratories, finding that their heparin was unreasonably dangerous as a matter of law. The jury awarded $625,000 for Steven Johansen's five days of pain and suffering caused by the contaminated heparin.
No punitive damages were sought.
Johansen, 63, was undergoing kidney dialysis when he received two low doses of heparin to thin his blood and prevent clotting during the mechanical blood-cleansing process. He later received a bolus dose of heparin during hospitalization. He died in December 2007.
At the time, Johansen was being treated for acute renal failure, vasculitis and pneumonia leading to sepsis.
In early 2007, Baxter recalled its heparin after it was discovered that it was contaminated by oversulfated chondroitin sulfate, a low-cost ingredient that mimics the blood-thinning properties of more expensive heparin but that produces adverse reactions, some severe. Subsequent investigation indicated that oversulfated chondroitin sulfate was apparently substituted for heparin active ingredient in China and sold to Scientific Protein, which in turn supplied Baxter.
At trial, counsel for Johansen's estate argued that the "fake heparin" was supplied by Changzhou SPL, a Chinese joint venture with Scientific Protein. Counsel said the defendants' internal records referred to crude heparin from China as "the cheap stuff."
Plaintiffs' counsel also argued that the defendants knew that the Chinese plant was never inspected by the Food and Drug Administration or by Chinese regulatory officials. The plaintiffs also argued that Baxter and Scientific Protein failed to establish quality control specifications, including an impurity profile, and failed to trace and control their supply chain.
Trial began May 11. The 12-member jury deliberated about eight hours over two days.
[Editor's Note: Full coverage will be in the June 16 issue of Mealey's Emerging Drugs & Devices. For all of your legal news needs, please visit www.lexisnexis.com/mealeys.]
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