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Andersen v. St. Jude Medical Inc.

Andersen v. St. Jude Medical Inc.

This was the first medical device/product liability class action to proceed to trial in Canada.  The trial was conducted by the late Justice Joan Lax as an electronic trial.  The common issues trial lasted 146 days.  There were 40 witnesses called at trial, many of whom were expert witnesses.  The Joint Documents Brief comprised of 17,225 documents and there were 2,293 trial exhibits.

The action was certified as a medical device class action representing class members and provincial health ministries from across Canada excluding British Columbia and Quebec.  It involved Silzone coated mechanical heart valves and annuloplasty rings which were manufactured by St. Jude Medical Inc.  In January 2000, these mechanical heart valves were subject to a worldwide recall after approximately 36,000 valves had been sold and implanted in patients worldwide.

On June 26, 2012, Justice Lax released her decision in the common issues trial and found in favour of the defendants and dismissed the action.  While finding that the defendants were not in breach of the requisite standard of care, the Court found that the Silzone coating applied to the mechanical heart valves did materially increase the risk of a major paravalvular leak for two years post-implant and minor paravalvular leak for six years post implant.

As the first product liability class action common issues trial decision, this case represents the first comprehensive treatment of many of the common issues typically certified in product liability class action cases including common issues relating to the manufacturer’s duty of care and duty to warn, general causation and whether the product creates a material risk of adverse health effects.  The trial decision provides guidance on the role of scientific and medical experts, proof of general causation through the use of epidemiological evidence derived from clinical trials and the role of general causation in proving individual causation.  Numerous novel issues of substantive and procedural law were raised at the common issue trial.