A class action lawsuit has been launched in Canada, against Bayer Inc. ("Bayer") regarding its drug Trasylol.
Trasylol ("aprotinin") was approved by Health Canada in 1995 for use during heart bypass surgery to help reduce bleeding and the need for blood transfusions. On November 5, 2007, Bayer suspended marketing of Trasylol following results from a clinical trial that suggested an increased risk of death. Use of Trasylol during surgery has been linked to an increased risk of developing cardiovascular or cerebrovascular adverse events, renal dysfunction, or death.
A hearing was scheduled for Wednesday, December 3, 2008, with a panel of experts asked to advise Health Canada on future use of the drug. A review of Trasylol was rushed to print on Tuesday, December 2, 2008 by the Canadian Medical Association Journal in advance of the hearing. The lead author of the review stated that the data did not allow them to identify a subgroup in whom the benefits of Trasylol outweigh the harms.
The Statement of Claim alleges that Bayer failed to adequately warn patients and physicians of the increased risk of serious adverse injury associated with use of Trasylol as compared to safer alternatives.
While it is too early at this stage to quantify the claims of potential class members, it is anticipated that the amount is significant.
