German drugmaker Bayer AG has reportedly pulled $60 million out of its wallet to settle around 150 lawsuits relating to its blood loss agent Trasylol, which was yanked from the market in 2007 on safety concerns.
People close to the case (but not authorised to speak about it) claim that Bayer has agreed pay each patient around $400,000 to settle this particular batch of suits relating to Trasylol (aprotinin), Bloomberg reported yesterday.
However, the company is still facing a stream of lawsuits over its conduct regarding the drug, which was used to reduce bleeding during coronary artery bypass grafting, including allegations that it ignored and failed to disclose research that hinted at safety issues, and hid the potential risks from doctors.
Bayer voluntarily suspended sales of Trasylol in November 2007 after a Canadian study from the Ottawa Health Research Institute, called BART, was stopped after showing that the drug posed a higher risk of death compared to two antifibrinolytic drugs - epsilon-aminocaproic acid and tranexamic acid - used in the trial.
Previously, in October 2006, the company acknowledged that it failed to keep the FDA informed of data that could have had a bearing on the outcome of an advisory panel meeting looking at the safety of the drug, but almost a year later and before data from the Canadian trial emerged, the agency’s Cardiovascular and Renal Drugs and the Drug Safety and Risk Management Advisory Committees voted 15 to one to keep Trasylol on the market, despite the potential health risks.
In 2008, two further studies, published in the New England Journal of Medicine, found that the drug was linked with a higher rate of death and an increased need for dialysis.
A spokeswoman for the company said that on July 6 cases brought by 120 plaintiffs had been settled, but without admission of guilt from the company, according to media reports.