Trasylol Recall: 2010 Update and Patient Resources

Trasylol Blood Clotting Drug Caused Thousands of Patient Deaths During Heart Surgery

On May 14, 2008, Bayer AG officially pulled remaining supplies of Trasylol, a blood clotting drug used during heart surgery to control bleeding, 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. The study conducted by a Canadian group found that patients given Trasylol had a more than 50 percent higher death rate than patients who were given alternative, cheaper blood clotting drugs.

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.

Under pressure from the Food and Drug Administration (FDA), Bayer AG originally suspended sales of Trasylol in November 2007. The FDA, stated that access to the drug will be limited to investigational use for certain patients who have no acceptable alternatives but supports the removal of Trasylol from regular use.

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.

Earlier in 2007, a major Canadian trial of the drug was terminated because of an increase in deaths for cardiac surgery patients using it. The trial was designed to show that Trasylol was better than other drugs in controlling bleeding. Instead, Patients in the Canadian study receiving Trasylol had a 50 percent increased risk of dying compared with patients receiving the other drugs.

Trasylol has also been associated with renal failure, the failure of the kidneys to function properly, after surgery requiring dialysis.

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.

Submit Your Case

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).

About Lieff Cabraser

Founded in 1972, Lieff Cabraser Heimann & Bernstein, LLP is a sixty-plus attorney law firm with offices in San Francisco, New York and Nashville. For the last seven years, the National Law Journal has recognized Lieff Cabraser as one of the top plaintiffs' law firms in America.

For our personal injury cases, we bring a team of experienced lawyers. Each client is assigned an individual lawyer. In addition, we have on staff multiple nurses, legal assistants, scientific analysts and case clerks to assist the attorneys. Learn more about our firm.