Andersen v. St. Jude Medical: Whither Waiver Of Tort?

Class action litigants have long been awaiting a trial decision that would tackle the controversial doctrine of waiver of tort.

At the certification stage of proposed class proceedings, plaintiffs have been asserting waiver of tort alongside negligence and other tort claims, arguing that the waiver of tort doctrine should allow the court to order defendants to account for and disgorge the profits gained from the impugned conduct if a finding of negligence is made. This would effectively eliminate the traditional need for claimants to prove injury or loss in order to obtain an order for payment of damages. Most judges have punted the tough questions regarding waiver of tort to trial, on the theory that a full factual record was needed to decide them.

On June 26, 2012, Justice Lax of the Ontario Superior Court of Justice issued the decision in Andersen v. St. Jude Medical.1 Having found for the defendants, Justice Lax declined to decide this policy issue and expressly noted that the full factual record in this long common issues trial was not helpful in deciding the issue. It is hoped that this guidance will lead quickly to much-needed clarity in this important area. The case is also noteworthy for the approach taken in several other important aspects of class action product liability cases.

Background

Andersen involved a claim against a global manufacturer of mechanical prosthetic heart valves. At its core, this was a negligence claim, focusing on whether there had been a breach of duty causing injury. Following 138 days of trial evidence and several months of legal arguments, Justice Lax dismissed the plaintiffs' claim in its entirety. The lengthy, thoughtful decision provides guidance on the role of scientific experts, epidemiological studies, and proof of causation through scientific expert evidence, in addition to tackling the doctrine of waiver of tort.

At issue was a prosthetic heart valve with a cuff coated with a proprietary mixture called "Silzone." The Silzone valve was designed to directly reduce the incidence of post-operative infection by inhibiting the growth of bacteria. The plaintiffs alleged that Silzone interfered with tissue healing and impaired the body's ability to incorporate the device into the heart properly, leading to serious medical complications.

In January 2000, St. Jude voluntarily recalled all Silzone-coated products after its own ongoing randomized clinical trial, AVERT, revealed a small but statistically...