A national class action has been launched against St. Jude Medical Inc. and St. Jude Medical Canada, Inc./Medicale St. Jude Canada, Inc., seeking damages on behalf of all affected Canadians for the manufacture and sale of allegedly defective leads marketed and sold under the brand name Riata. The class action was commenced by the Toronto firms Rochon Genova LLP and Kim Orr P.C.
The Riata Leads are used with implantable cardioverter-defibrillators (ICDs). If a lead becomes dislodged, the ICD may not be able to restore the patient's heart to a normal cardiac rhythm, or it may provide unnecessary shocks. Further, if a lead dislodges, it can perforate the heart or other surrounding tissues, which can lead to life-threatening complications.
A study conducted at the Massachusetts General Hospital - Harvard Medical School and published in April 2007 revealed a high incidence of dislodgment and perforation in patients implanted with certain models of the Riata Leads between January 1, 2005 and December 31, 2005. Similar experiences with the Riata Leads were reported later in September, 2007 at a different hospital in New York and further reports of dislodgement and perforation with the Riata Leads have been published both before and since.
The Riata Leads have not been recalled, and continue to be sold in Canada.
Patricia Pimblott, a 48-year-old resident of Colborne, Ontario is the proposed representative plaintiff in this Canadian class action. Mrs. Pimblott was implanted with an ICD using Riata Leads in March, 2007. Shortly after initial surgery, Mrs. Pimblott experienced extreme chest pain and soon learned that her Riata Lead had dislodged and perforated her heart. She subsequently underwent several further corrective surgeries and was ultimately required to have the Riata Lead removed and replaced with a lead from a different manufacturer.
Mrs. Pimblott is very concerned over her experience and the fact that St. Jude has refused to acknowledge that the leads are defective and that they have not been recalled. She stated: "I don't think that it's right that I had to go through all this pain and suffering when the company has known for years that these leads are dangerous. It just shouldn't be allowed to happen again-these leads should be removed from the market".