Trasylol Lawsuits Continue to be Filed, Nearly Two Years After Sales Stopped

Nearly two years after sales were halted, lawsuits continue to be filed against Bayer over the heart surgery drug Trasylol, which has been linked to an increased risk of kidney failure, heart attacks, strokes and death. However, while reports suggest that there could have been over 20,000 Trasylol deaths caused by the drug, many patients and families of people who died after heart surgery remain unaware that the injection given to control bleeding may have caused their injuries.

Trasylol (aprotonin) was administered to an estimated 4.3 million patients in the hospital prior to heart surgery, but most people were not specifically aware of the name of the drug or that they were given it at all.

Approved by the FDA in 1993, 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 and issued a Trasylol recall in May 2008, after an aborted study found it increased the risk of death by over 54% compared to alternative drugs to control bleeding.

Some experts have estimated that Trasylol may have caused as many as 1,000 deaths a month while it was on the market.

There are nearly 300 Trasylol lawsuits currently pending against Bayer in federal court, which have been consolidated in an MDL, or Multidistrict Litigation, before U.S. District Judge Donald Middlebrooks in the Southern District of Florida.

As the two year anniversary of the sales being discontinued approaches, new lawsuits over Trasylol continue to be brought in state and federal courts, including a case filed this month in St. Clair County Circuit Court in Illinois. According to The St. Clair Record, a man and woman have filed a case alleging that side effects of Trasylol resulted in kidney damage, renal insufficiency and organ failure after the drug was given to control bleeding during coronary artery bypass grafting.

The lawsuits claim that Bayer was negligent in failing to adequately warn consumers and the medical community about the risks associated with the drug. 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.

According to a scheduling order issued in March by Judge Middlebrooks, the first Trasylol lawsuit in the MDL is supposed to go to trial on January 18, 2010. The selection of the first “bellwether” Trasylol trial cases is currently set for November 3, 2009.