This class action has settled.
Please see the Developments and Documents sections below for further details.
On December 2, 2008, Siskinds filed a class proceeding against Bayer with respect to their drug Trasylol ("aprotinin"), which was injected into individuals undergoing heart surgery to help reduce bleeding and the need for blood transfusions. Bayer suspended marketing of Trasylol following results from a clinical trial that suggested an increased risk of death. Following a Health Canada review, released in September 2011, the suspension was lifted but additional warnings of the renal risks, the prolongation of measures of clotting time and the risk of under-heparinization with Trasylol, as well as the risk of death with Trasylol when Trasylol is used outside of the authorized indication was requested by Health Canada. Health Canada also requested that Bayer conduct further studies to assess the safety and efficacy of Trasylol in moderate-high risk patients undergoing more complex cardiac surgical procedures.
Use of Trasylol during surgery has been associated with an increased risk of developing cardiovascular or cerebrovascular adverse events, renal dysfunction, or death. The Statement of Claim alleges that Bayer failed to adequately warn patients and physicians of the increased risks of serious adverse injury associated with use of Trasylol as compared to safer alternatives.
Developments
On March 4, 2016, this proceeding was certified as a national class action on consent for the purpose of settlement. On May 26, 2016, the Settlement Agreement and Class Counsel’s fees were approved by the Ontario Superior Court of Justice in the City of London.
Please view the Settlement Approval Order and Fee Approval Order for more details.