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Heparin Lawsuits Sent to Federal Court in Toledo

Jun 11, 2008 | Parker Waichman LLP

Dozens of lawsuits stemming from tainted Baxter Heparin will all be transferred to U.S. District Court in Toledo before Judge James G. Carr.  There are at least 30 lawsuits pending against Baxter International for the tainted heparin that led to scores of deaths and serious reaction across the country, and many more could still be filed as victims and their families are still learning that contaminated heparin made them sick.  

Earlier this year, Baxter International recalled nearly all its heparin injections in the US after some patients experienced extreme - and in some cases fatal - allergic reactions, including difficulty breathing, nausea, vomiting, excessive sweating, and rapidly falling blood pressure that was life threatening after being administered the products. Ultimately, tainted heparin injections have been blamed for more than 80 deaths and more than 700 adverse reactions in the U.S.

There have been similar recalls by other manufacturers of Chinese-sourced heparin in Denmark, Italy, France Germany and Japan. In total, the FDA said tainted heparin has been identified in a 12 countries. In the US, other heparin suppliers have issued precautionary recalls, and some medical devices makers have also recalled heparin-coated products.

In March, the Food & Drug Administration (FDA) confirmed that it had found oversulfated chondroitin sulfate in samples of the active ingredient used in Baxter heparin. The FDA said the chondroitin sulfate was molecularly changed to mimic heparin’s blood-clotting properties. That ingredient was supplied to Baxter by Changzhou SPL, a Chinese plant partially owned by Wisconsin-based Scientific Protein Laboratories. It cost-*s a fraction of the ingredient usually used in heparin, and producers may have used it in an attempt to cut costs.

Last week, the FDA said that medical devices made with heparin had been implicated in 11 additional deaths, and 86 more adverse reactions.  Most of the cases involved heparin used to clean intravenous lines.  The heparin associated with two of the 11 deaths wasn’t contaminated and the FDA is unable to conclusively say how many of the deaths and side effects involved the tainted heparin.  The FDA also did not identify which companies’ products were associated with the adverse reactions and deaths.

The Judicial Panel on Multidistrict Litigation - a seven-member panel of federal judges - ruled that all of the Baxter Heparin lawsuits nationwide would be moved to Toledo.  In the ruling, Judge G. Heyburn II, of the U.S. Western District of Kentucky and chairman of the panel, wrote: "Seven of the 23 known actions are pending in this [Northern District of Ohio], mostly before Judge James G. Carr, who has the time to devote to this docket,"

In addition to Baxter, many of the heparin lawsuits scheduled to be heard in Toledo also name Scientific Protein Laboratories as a defendant.

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