Trasylol Kidney Failure Lawsuits Filed in Illinois

Three Trasylol kidney failure lawsuits were filed last month in Illinois state court on behalf of 55 plaintiffs, who accuse Bayer of failing to adequately warn that a recalled heart surgery injection used to control bleeding increased the risk of kidney failure, heart attacks, strokes and death.

The Trasylol lawsuits were filed on September 22 in St. Clair County Circuit Court, according to a report in The Madison Record. The cases come nearly two years after Trasylol sales were halted in November 2007, eventually leading to a complete Trasylol recall in May 2008.

Plaintiffs allege claims against Bayer for defective design, negligence, wrongful death, strict product liability, fraud and other charges, saying the company 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, the complaints allege that they delayed disclosing the data to the FDA or issuing the warnings and recall.

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.

In addition to the new state court lawsuits, Bayer faces nearly 300 lawsuits over Trasylol in federal courts. Those cases 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.