Bayer Failed to Warn of Trasylol Side Effects, New Lawsuit Claims

Bayer Pharmaceuticals ignored numerous studies showing its blood-clotting drug Trasylol could be dangerous and failed to warn patients of potentially fatal side effects, according to a new lawsuit.

Don Juan Brown and Jean N. Snyder, two former Trasylol users, have sued Bayer in St. Clair County Circuit Court, according to a report in the Madison Record. The suit was filed on Aug. 20.

As a result of being treated with Trasylol, the plaintiffs say they suffered fear, anxiety, distress, pain and suffering, and depression as well as loss of earnings and incurring costly medical bills. Brown and Snyder accuse Bayer of defective design, strict product liability, intentional infliction of emotional distress, fraud, negligence, and negligent misrepresentation for its marketing of Trasylol.

Their 12-count lawsuit seeks more than $1.2 million in damages, plus costs and other relief the court deems just, according to the Record.

Trasylol Approved, Then Recalled

Trasylol was approved by the Food and Drug Administration in 1993 and used to reduce the risks of fatal bleeding in patients during coronary artery bypass grafting surgery. More than four million people received the drug, which generated about $293 million sales in 2005 alone, according to the lawsuit.

Despite extensive medical research finding a link between use of the drug and renal toxicity in patients, an FDA advisory panel declined to recommend that warnings on Trasylol’s packaging be strengthened to include the risks of deadly kidney damage, heart attack, and stroke.

However, at the time the panel decided against recommending tougher labeling warnings for Trasylol, Bayer knew about a patient study that confirmed Trasylol increased the risk of renal failure, heart attack, and stroke but did not disclose the data to the FDA, according to the lawsuit.

In December 2006, once the additional study came to light, the FDA finally approved revised labeling for Trasylol that includes a warning about increased risks of kidney damage. Trasylol was pulled from the market in the United States in 2007.

According to the lawsuit, millions of patients were subjected to increased risks of side effects during the time Bayer played hide the ball with the Trasylol findings about a link to kidney disease. Also, at least 10,000 people were forced to undergo dialysis treatment to treat complications from the drug.

No related posts.