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Thursday September 2, 2010

Dangerous DrugsBusiness

Another Product Liability Lawsuit Filed Over Trasylol Injuries

People who took the drug Trasylol to control bleeding during heart surgeries have sued the drug’s maker for kidney damage and increased risks of other serious injuries they claim were caused by the drug, which has since been recalled.

Three plaintiffs from Illinois, Pennsylvania, and Wisconsin joined to file the product liability suit on November 3, 2009 against Trasylol’s maker, Bayer Pharmaceuticals, in St. Clair County Circuit Court, according to a report in the Madison-St. Clair Record. The lawsuit claims taking Trasylol resulted in permanent renal damage, renal insufficiency, and multi-system organ failure.

It seeks $1.2 million in damages plus court costs and other compensation the court determines, according to the Record.

Drug Ordered Off Market Due to Injuries

Trasylol was approved in 1993 by the Food and Drug Administration to limit bleeding and reduce the need for blood transfusions during cardiopulmonary bypass surgery. In addition to kidney damage, Trasylol also has been linked to reports of anaphylactic (allergic) reactions in some patients, particularly those who have previously taken aprotinin, the active ingredient in Trasylol, the lawsuit states.

Concerns about injuries linked to the drug prompted officials to pull it from the U.S. market in 2007.

Studies published in the New England Journal of Medicine and other medical journals in 2006 and since have detailed the kidney damage risks in patients given Trasylol. The FDA warned physicians to closely monitor patients given Trasylol for signs of renal toxicity and alerted them about the increased risks of kidney damage.

According to the lawsuit, Bayer knew about the risks of kidney damage, heart attack, and stroke in Trasylol users, but failed to disclose the results of studies establishing the connection to the FDA before the recall.

As many as 4.3 million people have been given Trasylol, according to the lawsuit, putting them at increased risk of serious kidney damage and other life-threatening injuries.

Trasylol Injury Lawsuits Pouring In

Dozens of other plaintiffs have filed suits against Bayer for Trasylol injuries. In September, three lawsuits containing 55 plaintiffs were filed in the same district court. Also over the summer, two other plaintiffs filed a similar lawsuit seeking damages for Trasylol-related injuries.

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