Bayer has reportedly reached an agreement to settle about 150 Trasylol lawsuits filed on behalf of individuals who allege that the heart surgery drug increased the risk of kidney failure, heart attacks, strokes and death.
The Trasylol settlement was announced earlier this month in court, but terms of the agreement were not disclosed. Bloomberg News now reports that Bayer AG will pay at least $60 million to settle the Trasylol lawsuits, averaging about $400,000 per claim.
Bayer faces about 1,600 lawsuits in the Trasylol litigation, involving similar allegations that the drug maker failed to exercise the proper degree of care in designing and testing the drug, and that it did not properly alert healthcare professionals and users to the risks of Trasylol side effects. Although the drug maker was aware of negative study results, some of the complaints allege that they delayed disclosing the data to the FDA and failed to issue adequate warnings or a Trasylol recall.
Most of the cases are federal lawsuits that have been consolidated in an MDL, or Multidistrict Litigation, before U.S. District Judge Donald Middlebrooks in the Southern District of Florida. The first Trasylol trials in the MDL are scheduled to being early next year. It is unclear whether those are among the recently settled lawsuits.
After it was first approved by the FDA in 1993 to control bleeding during heart surgery, Trasylol (aprotonin) was administered to an estimated 4.3 million patients before it was removed from the market.
Concerns about Trasylol problems first gained national attention in early 2006, when preliminary data from a study suggested that the drug increased the risk of serious kidney damage, congestive heart failure, strokes and death. After adding strong warnings to the drug, Bayer ultimately suspended sales in November 2007 after an aborted study suggested that it increases the risk of death by over 54% compared to alternative drugs to control bleeding.