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Baxter Loses First Heparin case

From Chicago Tribune (IL) (June 10, 2011)


June 10--A Cook County Circuit Court jury Thursday awarded $625,000 to the estate of a man who his attorneys say was given a dosage of a blood thinner made by Baxter International Inc. that contained a contaminated ingredient found in the company's supply chain in China.

The verdict is the first from a case against Baxter and its supplier, Wisconsin-based Scientific Protein Laboratories, from hundreds of lawsuits filed against the Deerfield-based medical product giant. A mountain of litigation has been leveled against the companies after U.S. regulators determined in 2008 that Baxter's heparin was contaminated, from fake ingredients sourced in China.

The contamination became an international health imbroglio and intensified regulatory oversight of drug makers that have manufacturing plants and supply chains overseas, particularly in China. The exposed definiciencies in Baxter's supply chain led to Congressional hearings and increased oversight of all U.S. drug makers with plants overseas.

Attorneys for the estate of Steven Johansen, 63, of Oak Forest said the man received low doses of contaminated heparin in December 2007 during dialysis at a center in southwest suburban Crestwood. He later received a higher dosage of Baxter's heparin at Palos Community Hospital in Palos Heights where he died on Dec. 13 of that year.

Baxter's popular blood thinner was used widely in large dosages, often before patients have dialysis or heart surgery. A prior trial case brought against Baxter in Cook County was settled earlier this year for an undisclosed amount.

The incident involving Johansen occurred during a period in late 2007 and early 2008 when the U.S. Food and Drug Administration was investigating scores of reports of deaths and injuries from patients who had received heparin, Tribune reports at the time indicate. Baxter subsequently recalled the heparin in early 2008.

The FDA in early 2008 said Baxter heparin tested positive for an animallike substance known as oversulfated chondroitin sulfate. The heparin had been sourced in China where part of the product's manufacturing took place.

"The active pharmaceutical ingredient in the contaminated heparin received by Mr. Johansen and other Americans was obtained from Baxter (and its supplier Scientific Protein Laboratories') Changzhou SPL," Johansen estate attorneys Don Nolan of Chicago and David Zoll of Toledo, Ohio said in a statement this afternoon. "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."

For its part, Baxter said "it 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 said in its statement. "Baxter will vigorously defend claims that are not consistent with the definition established by public health authorities."

Heparin's active pharmaceutical ingredient was derived from pig intestines from hogs in rural China.

In 2008, Baxter and Scientific Protein Laboratories said they believed 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.

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Copyright (c) 2011, Chicago Tribune

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Posted: June 2011


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