Bayer Opts to Settle Trasylol® Suits on Case by Case Basis

Bayer’s Settlement Framework Weighs Each Suit on Several Factors

November 2, 2010 — To date, Bayer has settled approximately 200 of the 2,000 cases against it over the drug Trasylol, used to control bleeding during heart surgeries. Rather than settlements based on a universal point system stemming from either bellwether trials or settlement negotiations, Bayer has devised their own framework by which they review the merits of each individual case. In a statement to U.S. District Judge Donald Middlebrooks, Steven Derringer, Bayer’s lead counsel, stated that the company put together a “settlement program aimed at resolving not just one or two cases at a time, but to provide an overall framework for resolving the litigation.”

Marcy Funk, a Bayer spokeswoman, stated, “After a thorough examination of each case, Bayer will, at times, consider the option of settling litigation on a case-by-case basis.” She also said that Bayer would “defend itself vigorously against all claims that are not considered for settlement.” Some of the factors Bayer will be looking at are:

  • Age of patient who took Trasylol
  • If they went on dialysis and for how long
  • When the surgery occurred where Trasylol was used in relation to what Bayer knew about the risk factors of Trasylol at the time

The majority of the Trasylol cases are consolidated in the Southern District of Florida U.S. District Court for pre-trial proceedings. Approximately 1600 of those cases are still pending. Around 200 cases were filed in the mass tort program in the Philadelphia Common Pleas Court in Pennsylvania. Of the Pennsylvania cases, approximately 188 are still pending.

Although it is expected that most of the pending cases will settle, those that Bayer deems as not worthy of compensation may go to trial if the plaintiffs’ attorneys feel they have merit.

The Troubled History of Trasylol

The Food and Drug Administration (FDA) first approved Trasylol (aprotinin) for use in the U.S. to help reduce blood loss in high-risk heart bypass surgery in 1993. Trasylol came under scrutiny after the New England Journal of Medicine published two observational studies in January 2006 reporting that patients who were administered the drug had an increased risk of heart attack, stroke, or kidney dysfunction. The FDA issued a public health advisory and stated that they were “working with the authors of the publications and the manufacturer of Trasylol to carefully evaluate the risks and benefits associated with the use of Trasylol.”

On September 21, 2006, a public advisory committee meeting was held by the FDA to discuss Trasylol’s risk/benefit profile. The committee discussed the two observational studies, the FDA’s review of its post-marketing database, and Bayer’s worldwide safety review. Bayer’s study reported that the use of Trasylol posed an increased risk of death, serious kidney damage, congestive heart failure, and strokes. Although evidence was growing that Trasylol posed a risk to those patients it was administered to, the drug was still not pulled from the market. Instead, the FDA issued a notice to healthcare professionals stating that new labeling for Trasylol had been instituted warning of severe health issues at risk in using the drug. It was not until November 5, 2007, that the FDA announced at a press conference that Bayer had agreed to take Trasylol off the market.