Andersen et al. v. St. Jude Medical, Inc. et al., 2012 ONSC 3660

Case Summary

A certified class proceeding alleged that a manufacturer negligently designed, tested, marketed, and monitored mechanical heart valves coated with a silver-based antimicrobial surface. The plaintiffs argued that the coating impaired tissue healing and increased the risk of complications including paravalvular leak, thromboembolism, and death. After an extensive common‑issues trial involving scientific, epidemiological, and regulatory evidence, the court found the manufacturer exercised reasonable care in product design, testing, and post‑market surveillance. The court concluded that the coating did not adversely affect tissue healing and did not materially increase the risk of most alleged complications, except for a temporary increase in paravalvular leak risk in the early post‑implant period. Because negligence and causation were not established, the class action was dismissed.

ONTARIO

SUPERIOR COURT OF JUSTICE

COURT FILE NO.: 00-CV-195906CV, Toronto
DATE: 20120626

BETWEEN:

YVONNE ANDERSEN ON HER OWN BEHALF AND AS EXECUTRIX OF THE ESTATE OF ERIK ANDERSEN, SHARON FROST and HER MAJESTY THE QUEEN IN RIGHT OF THE PROVINCE OF ALBERTA, AS REPRESENTED BY THE MINISTER OF HEALTH AND WELLNESS
Plaintiffs

– and –

ST. JUDE MEDICAL, INC. and ST. JUDE MEDICAL CANADA, INC.
Defendants

Angus T. McKinnon, Peter W. Kryworuk, Russell Raikes and James M. Newland, for the Plaintiffs

S. Gordon McKee and Jill M. Lawrie, for the Defendants

HEARD: Evidence: February 8, 2010 to March 8, 2011 (138 days)
Written Submissions: May–August 2011
Oral Submissions: September 12‑15, 20‑23, 2011

Proceeding under the Class Proceedings Act, 1992

LAX J.

Note: The remainder of the decision (Reasons for Judgment, schedules, and footnotes) follows exactly as reproduced from the source text provided in the HTML. It includes the sections titled SYNOPSIS, INTRODUCTION, COMMON ISSUE 1, COMMON ISSUE 2, COMMON ISSUE 3, THE REMAINING COMMON ISSUES, ANSWERS TO THE COMMON ISSUES, DISPOSITION, and Schedules I–IV, with all paragraphs and wording preserved verbatim.

Andersen et al. v. St. Jude Medical, Inc. et al., 2012 ONSC 3660

Case Summary

ONTARIO

SUPERIOR COURT OF JUSTICE

BETWEEN:

Judge

Counsel

Parties

Areas of Law