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Bayer to pay $60m to settle 150 Trasylol lawsuits

Drug used in heart surgery had risk of patient fatalities

By Jef Feeley
Bloomberg News / August 18, 2010

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WILMINGTON, Del. — Bayer has agreed to pay at least $60 million to settle about 150 lawsuits over Trasylol, a drug used to control bleeding during heart surgeries, people familiar with the accords said.

The settlements, which Bayer announced in court earlier this month, provide an average payout of about $400,000 per patient, said three people familiar with the agreements who were not authorized to speak publicly about them.

Bayer pulled Trasylol off the market in 2007 after researchers found it posed a higher risk of death than competing drugs. Studies linked the product to a 50 percent higher risk of death than with rival treatments in patients undergoing heart surgery.

Trasylol was approved in the United States in 1993 to reduce bleeding and to reduce the need for transfusions during open-heart surgery.

“After thorough examination of each case, Bayer will, at times, consider the option of settling litigation on a case-by-case basis,’’ Marcy Funk, a Bayer spokeswoman, said in an e- mailed statement.

She declined to comment on the size of the settlements.

Sales of the injectable drug were $292 million in 2005, before falling 34 percent the next year after researchers raised safety concerns.

Studies in 2006 and 2007 found the drug may cause kidney damage, heart attacks, and strokes, according to documents the company filed in February with the Securities and Exchange Commission.

Bayer faces at least 1,600 suits alleging the company hid Trasylol’s risks from patients and doctors, according to Bayer’s SEC filing. The vast majority of those cases have been consolidated before a federal judge in Florida for pretrial proceedings.

Steven Derringer, one of Bayer’s lawyers, told US District Judge Donald Middlebrooks at a hearing in West Palm Beach, Fla., earlier this year the company had devised 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,’’ according to a court transcript.

Derringer also told Middlebrooks at the April 12 hearing that the drug maker had settled a total of 63 cases at that time. The company brought in a mediator to help resolve the cases, according to the transcript.

“We now have a track record, your honor, that shows these cases are being settled, parties can agree on values, and settlements do not depend on trial dates,’’ Derringer said.

The company had settled with about 120 plaintiffs as of July 6, without making any admission of liability, Funk said in the e-mailed statement.

The first Trasylol trial is set to take place in Pennsylvania state court in Philadelphia in November, said Jim Ronca, one of the lead lawyers representing former users of the drug. He said other cases that had been set for trial had been settled.

“Bayer has launched an active settlement program and is aggressively seeking to settle cases based on an evaluation of their strengths and weaknesses of individual claims,’’ Ronca said.

The lawyer acknowledged he had resolved more than 30 of his cases. He declined to comment on the size of the accords.

Derringer did not return a call for comment.