Riata Leads Class Action
Kim Orr P.C., together with Rochon Genova LLP, have launched a national class action against St. Jude Medical, Inc. and St. Jude Medical Canada, Inc. seeking damages for the manufacture and sale of allegedly defective Riata leads.
An implantable defibrillator is a device that monitors the heart for rapid, slow or irregular rhythms. When abnormal rhythms are detected, the defibrillator delivers a shock to the heart to return it to a normal rhythm. The shock is delivered to the heart by way of leads, which are small, insulated wires implanted in the heart and connecting it to the defibrillator.
A study conducted at Harvard Medical School and published in the journal Heart Rhythm in April 2007 indicated that the incidence of dislodgement of ICD leads and perforation was significantly higher in patients implanted with certain models of the Riata Leads. A follow-up letter to Heart Rhythm reported similar experiences at a different hospital in New York. Further reports of dislodgement and perforation have been published since.
When a lead becomes dislodged, it is not able to perform the sensing function and may fail to relay necessary information from the heart to the patient's defibrillator. If this occurs, the defibrillator may not restore the patient's heart to a normal cardiac rhythm if required to do so, or may provide unnecessary shocks. Once a lead becomes dislodged, it becomes an unsecured foreign object capable of movement within the body. It has the potential to perforate the heart or other surrounding tissues, which can lead to life-threatening complications.
The leads have not been recalled, and continue to be sold in Canada. The Riata leads may be repositioned or removed and replaced, if necessary, but this is an invasive and potentially dangerous surgical procedure. St. Jude obtained a licence to sell the leads in Canada in 2005 and 2006.
Patricia Pimblott, a 48-year-old resident of Colborne, Ontario, is the proposed representative plaintiff in the Canadian class action. Ms. Pimblott's Riata lead dislodged and perforated her heart on two separate occasions. Each time, she was forced to undergo surgery to have the lead repositioned, and eventually had a further surgery to remove the defective Riata lead.
For more information, please contact Victoria Paris at vp@kimorr.ca