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Wednesday, January 13, 2010

Lawsuits Lingering Over Defective Heparin

In the early months of 2008, the blood thinner Heparin supplied by Baxter International, Inc. was found to be contaminated. At first the situation was puzzling. It was not immediately obvious how a contaminated ingredient had got into the drug. Part of the manufacturing was done in China and eventually investigators traced the problem to over-sulfated chondroitin sulfate made in China.

Successful Research

At the time, Baxter was supplying over half of the heparin used in the U.S. The contaminated supply caused about 80 deaths and injured many other people. Baxter recalled this heparin and researchers at MIT (Massachusetts Institute of Technology) eventually published their discovery of how the tainted heparin had evaded detection at the U.S. border and why the contaminated ingredient made the heparin so deadly.

They had discovered the exact chemical structure of the contamination. They suggested that their discovery methods could be used by federal regulators to prevent any repetition of this error. The FDA had no test that could have discovered the contaminated ingredient. Over-sulfated chondroitin sulfate does not occur naturally, although chondroitin sulfate does, and is used in supplements for arthritis.

The FDA did ask for some new manufacturing standards after the problem was traced to China. The reason Baxter used a manufacturing plant in China is that enzymes from pig intestines are used and China had enough pigs to meet the demand. However, China also had an epidemic of pig disease at the time that reduced their supply and they compensated by making a synthetic ingredient. Twelve Chinese companies were found to be responsible and subsequently, contaminated heparin was found in ten other countries besides the U.S.

Hundreds of Lawsuits

Many lawsuits were filed, including class action suits, some for wrongful death, some for product liability. In Illinois alone, there were about 300 product liability suits. New claims are still being filed. Complaints state that Baxter and its supplier, Scientific Protein Laboratories, LLC, were negligent in allowing the contaminated ingredient to be used. They are demanding monetary damages for those who were injured by the tainted heparin and compensation for the survivors of those who died.

Defective products are constantly in the news. Defective vehicles have been recalled recently by Toyota and this space wrote about that on November 30, 2009. The recall was subsequently expanded. On December 30 this space wrote about the Tylenol recall being expanded.

If you have been hurt by a defective drug or any type of defective product, you may have a basis for a legal claim. Please contact us today if you would like to schedule a free case evaluation.

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posted by Benjamin A. Irwin at 10:18 AM

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