Lieff Cabraser Heimann & Bernstein, LLP

Trasylol Blood Clotting Drug and Patient Deaths During Heart Surgery

Trasylol, an expensive drug also known generically as aprotinin, has been in wide use since the 1990s for heart bypass surgery to reduce bleeding. Worldwide, more than four and a half million people had been given the drug. About a third of them were Americans who received it during the 14 years that it was on the U.S. market.

On May 14, 2008, Bayer AG officially pulled Trasylol, from the U.S. market after a major study published in the New England Journal of Medicine found Trasylol significantly raised the risk of death compared to competing products.

Trasylol was recalled because heart bypass, heart valve replacement and other cardiac surgery patients who received Trasylol were more likely to die than patients that received competing blood clotting drugs available on the market. The deaths were due to kidney failure, heart failure, heart attacks and strokes the patients suffered following surgery.

Bayer's Concealment of the Risks of Trasylol

Trasylol was first approved for use in 1993 and became extremely profitable for Bayer. Sales of the drug hit $300 million in 2005, and higher until its recall. In many cases, patients were charged over $1,000 for Trasylol while other equally effective drugs without the same risks cost only $50.

At the time Trasylol was initially withdrawn from the market, Bayer claimed the recall was merely a temporary suspension of sales. "Bayer believes that the totality of the available data continue to support a favorable risk-benefit profile for Trasylol when used according to labeling," the company stated in a press release.

In February 2008, 60 Minutes reported that Bayer was aware for decades of safety concerns with Trasylol and since 2006 of widespread deaths associated with the drug. Yet the FDA allowed the drug to remain on the market and Bayer continued to aggressively market Trasylol. It is estimated Trasylol contributed to the death of one thousand patients a month until its recall.

60 Minutes further reported that Bayer conducted its own internal study to evaluate the risk of patient deaths from Trasylol. Bayer hired a Harvard professor who examined the medical records of nearly 70,000 patients. Patients on Trasylol were found to have an elevated risk of death and acute renal (kidney) failure.

When the FDA conducted a safety review of Trasylol in 2006, Bayer did not reveal the study to the FDA and successfully lobbied the FDA to keep Trasylol on the market. Over a year passed before the FDA again reviewed the adverse effects of Trasylol and it was recalled.

Legal Rights of Patients Injured by Trasylol

The FDA has not imposed any penalty on Bayer. The only way for patients who have experienced heart attacks, kidney failure and other damage caused by Trasylol to obtain compensation for their injuries is to file a personal injury lawsuit against Bayer. Families of loved ones who died may file a wrong death action.

The law in most states provides several personal injury claims for persons who have been seriously injured due to defective prescription drugs and treatments. These claims include strict liability for a defective product, failure to warn, and negligence. Damages sought against drug manufacturers can include compensation for:

• Physical pain and suffering, mental anguish and physical impairment;
• Past and future medical expenses;
• Loss of earnings and/or earning capacity; and
• Punitive damages for extreme wrongful conduct.

Contact Lieff Cabraser

If you have suffered a serious injury following surgery in which you were given Trasylol or are a relative of a patient who died after receiving Trasylol, please click here to contact Lieff Cabraser. Our firm will review your claim without charge or obligation on your part.

Alternatively, you may call Lieff Cabraser personal injury attorney Heather Foster in our San Francisco office at 1-800-541-7358 (the call is toll-free).

Trademark Notice

Trasylol is a Trademark of Bayer AG and is used herein for informational and product identification purposes only. Lieff Cabraser is not affiliated with Bayer AG.