Since we follow developments in Canada, and in particular Canadian class action litigation, we thought our readers would like to know about the significant defense win in Andersen v. St. Jude Medical, Inc., 2012 ONSC 3660, slip op. (Ont. Super. June 26, 2012).

However, because of ReedSmith’s involvement in the litigation, we’re limited to telling you what happened.  Then again, since they write opinions differently in Canada − Andersen weighs in at a whopping 215 pages (with a glossary) − maybe that’s not such a bad thing, for you or for us.

Andersen is significant because there are not many instances where a Canadian class action (about 1100 members) has been dismissed outright after a full trial (and we do mean full − 39 witnesses and 140 trial days over the course of nearly 1½ years).  The case involved a medical device, a type of heart valve, and at bottom the class simply alleged negligence.  The plaintiffs sought compensatory and punitive damages, medical monitoring, disgorgement of profits, and provincial insurers’ health care costs, and of course attorneys’ fees for eleven years of litigation.  What was that that Robert Harper said about the XYZ affair?

Proceeding under different, and more liberal, class action standards than in the United States, the Andersen opinion addressed the following “common” issues:

(1) Negligent design/testing/marketing (broken into two parts, pre- and post-marketing)

(2) General causation

(3) Increased risk of medical complications

(4) Medical monitoring

(5) Spoliation

(6) Disgorgement/waiver of tort

(7) Punitive damages (note, our issue numbering is different than the court’s).

Here are the results that the court reached on those issues:

(1a) The evidence did not establish negligence in the device’s pre-market design and testing.  A balance of foreseeable risks and harms favored the defense.  Andersen, slip op. at 20-63.  Plaintiffs’ claim of regulatory fraud was rejected.  Id. at 59-62.

An interesting holding, that lack of testing has no legal significance unless the test results would have made selling the product “unreasonable,” appears on page 42.  This is a Canadian variant of the argument underlying our duty to test cheat sheet − that failure to test by itself is not a separate cause of action.

(1b) The evidence did not establish negligence in the device’s post-market surveillance or failure to recall the device sooner. Andersen, slip op. at 64-76.

(2) Plaintiffs’ evidence of toxicity neither satisfied the Canadian version of Daubert, nor sufficed to establish general causation. Andersen, slip op. at 15-19; 76-107; 110-26.

A case series was insufficient scientific evidence to support a causation opinion.  Id. at 125-26.

(3) The design of the device increased the risk of one condition (paravavular leak within specific post-implant periods), that was not seriously disputed.  Evidence (epidemiology; the court declined to perform a Bradford-Hill analysis) failed to establish any material increased risk of any other condition, those being all the ones in dispute.  Id. at 127-93.

Doubling of risk (relative risk of 2.0) is the legal standard of materiality in toxic tort cases, but as a presumption, not an absolute bar.  Id. at 178-85.

(4) Since general causation was unproven, plaintiffs were not entitled to medical monitoring.  Id. at 193.

(5) There was no intentional spoliation of evidence that could give rise to an adverse inference.  Id. at 107-10.

(6) A theory of “waiver of tort,” basically a cause of action for negligence without proof of causation, was not adopted, because such a change is more proper for the legislature than the courts.  Id. at 193-201.

(7) Without separate discussion, punitive damages are denied.  Id. at 202.

Obviously, we’ve left out a lot of details.   That’s why you have a link to the 215 − page Andersen opinion.