Nolan Law Group: Jury Finds Against Baxter Healthcare Corporation In Nation's First Contaminated Chinese Heparin Case
Published: Jun 10, 2011
CHICAGO, June 9, 2011 /PRNewswire/ -- Today a Cook County jury awarded $625,000 to the estate of a 63 year old Chicago area man, Steven Johansen, who was administered Baxter blood thinner that contained a contaminated ingredient Baxter sourced from China. This was the first of hundreds of pending lawsuits on Baxter contaminated Chinese heparin to go to trial. The lawsuits are pending in the Circuit Court of Cook County in Chicago, Illinois before Judge Jennifer Duncan-Brice and in the U.S. Northern District Court in Toledo, Ohio before Judge James G. Carr. The contaminated heparin crisis and resulting lawsuits received national attention and sparked congressional investigation as they exposed deficiencies in the regulatory oversight of drugs imported from China and other developing countries, and the failure of American drug companies, eager to increase profits by outsourcing, to monitor those foreign suppliers.
The blood thinner was manufactured in part in China and sold by the U.S. drug company, Baxter Healthcare Corporation and its supplier, Scientific Protein Laboratories, L.L.C. (SPL). It was recalled in early 2008 following an alarming and unexpectedly high rate of reported adverse events and deaths that resulted in a national healthcare crisis. The contaminant was determined to be a man-made "fake heparin" called over-sulfated chondroitin sulfate (OSCS), causing among other effects, potentially fatal allergic-like reactions.
The active pharmaceutical ingredient in the contaminated heparin received by Mr. Johansen and other Americans was obtained from Baxter/SPL's Chinese supplier, Changzhou SPL (a joint venture with SPL). This crude heparin was referred to in the companies' own internal records as "the cheap stuff." Baxter and SPL knew that the plant had never been inspected by the U.S. FDA (which the FDA later attributed to clerical error) or Chinese regulatory officials. When the Chinese plant was finally inspected by the FDA after the heparin contamination crisis, multiple violations were found resulting in an import ban. Additional evidence also brought to light during the trial established that Baxter and SPL failed to establish and comport with quality/purity specifications, including an impurity profile, and failed to trace and control their supply chain. At trial, the Court granted partial directed verdict in favor of Mr. Johansen holding that the product sold by Baxter and SPL was defective as a matter of law.
Plaintiffs contended Mr. Johansen received low doses of contaminated heparin during dialysis and a bolus dose during a subsequent hospitalization at Palos Community Hospital on December 12, 2007. According to the form of verdict, the award of compensation was for the pain and suffering over a five day period. The verdict was against both SPL and Baxter.
SOURCE Nolan Law Group