On June 26, 2012, Justice Lax of the Ontario Superior Court of
Justice released her decision in Andersen v St. Jude. It
is the first ever trial decision in a product liability class
action in Canada.1
The Andersen case arose after St. Jude, a medical
device manufacturer, recalled certain heart valves that had a
proprietary "Silzone" coating in early 2000, after a
clinical study revealed a small but statistically significant risk
of medical complications. A proposed class action against St. Jude
was commenced in 2001 with the plaintiffs alleging that St. Jude
had been negligent in the design of the Silzone valve, had rushed
the device to the market and had failed to recall it promptly when
the alleged problems arose. In 2003, the action was certified as a
class proceeding by the Ontario Superior Court. The certified
common issues included issues relating to the defendants'
conduct in the design, manufacture, marketing and recall of the
Silzone valve, the medical
