ONTARIO

SUPERIOR COURT OF JUSTICE

COURT FILE NO.: CV-15-527310 CP
DATE: 20151217

BETWEEN:

SUSAN VESTER and DARIN VESTER
Plaintiffs

– and –

BOSTON SCIENTIFIC LTD. and BOSTON SCIENTIFIC CORPORATION
Defendants

Charles M. Wright, Daniel E.H. Bach, Jill McCartney and Elizabeth deBoer for the Plaintiffs

David Morritt, Sonia L. Bjorkquist and Karin Sachar for the Defendants

HEARD: November 23‑24, 2015

PERELL J.

REASONS FOR DECISION

A. INTRODUCTION

[1] The Defendants Boston Scientific Ltd. and Boston Scientific Corporation (collectively “Boston Scientific”) designed, manufactured, and sold transvaginal mesh medical devices that were implanted into thousands of Canadian women for the treatment for Stress Urinary Incontinence (“SUI”) or Pelvic Organ Prolapse (“POP”). The Plaintiff, Susan Vester, who suffered from SUI, had a Lynx transvaginal mesh device implanted, and she alleges that all the devices are defective and unsafe and that they all could cause immense pain, among other side effects. Mrs. Vester, along with her husband Darin Vester, has commenced this proposed class action under the Class Proceedings Act, 1992, S.O. 1992, c. 6, and they seek to have their action certified as a class action.

[2] Pursuant to s. 5(1) of the Act, the court shall certify a proceeding as a class proceeding if: (1) the pleadings disclose a cause of action; (2) there is an identifiable class; (3) the claims of the class members raise common issues of fact or law; (4) a class proceeding would be the preferable procedure; and (5) there is a representative plaintiff who would adequately represent the interests of the class without conflict of interest and who has produced a workable litigation plan. Section 5(4) of the Act provides that the court may adjourn the motion for certification to permit the parties to amend their materials or pleadings or to permit further evidence.

[3] For the reasons that follow, I conclude that: (1) the pleadings disclose a cause of action for a negligent design claim and a failure to warn claim; (2) there is an identifiable class; (3) at this time, the claims of the Class Members do not raise common issues of fact or law for a claim of negligent design or for a claim of negligent failure to warn; (4) there is no basis-in-fact for any common issues about the balance of the Plaintiffs’ negligence claims; (5) given the absence of any common issues, a class proceeding is not the preferable procedure; (6) Mrs. Vester and Mr. Vester might qualify as representative plaintiffs; and (7) the certification motion should be adjourned: (a) to permit Mrs. Vester and Mr. Vester to provide further evidence to establish some-basis-in-fact for common issues for the negligent design claim or for the failure to warn claim; (b) to establish some-basis-in-fact that a class action would be the preferable procedure for the determination of those common issues; and (c) to revise the litigation plan accordingly.

B. LEGAL AND FACTUAL BACKGROUND TO THE PROPOSED CLASS ACTION

1. Products Liability Negligence Actions

(a) Types of Products Liability Claims

[4] Mrs. Vester’s action is a proposed products liability class action of a potentially dangerous medical device. In order to understand the parties’ arguments about the suitability of her action as a class proceeding, it is necessary to briefly review the law about products liability claims.

[5] For products liability claims, there are four established categories. First, manufacturers have a duty of care to consumers to see that there are no defects in manufacture that are likely to give rise to injury in the ordinary course of use: Donoghue v. Stevenson, 1932 AC 562 (H.L.). Second, manufacturers have a duty of care to warn consumers of dangers inherent in the use of the product of which the manufacturer has knowledge or ought to have knowledge: Hollis v. Dow Corning Corp., [1995] 4 S.C.R. 634; Lambert v. Lastoplex Chemicals Co., [1972] S.C.R. 569; Bow Valley Husky (Bermuda) Ltd. v. Saint John Shipbuilding Ltd., [1997] 3 S.C.R. 1210. Third, manufacturers have a duty of care in designing the product to avoid safety risks and to make the product reasonably safe for its intended purposes. Fourth, there is a pure economic loss claim in negligence because manufacturers have a duty of care to compensate consumers for the cost of repairing a dangerous product that presents a real and substantial danger to the public.

[6] All of these established categories are premised on the product causing harm or having the potential of causing harm to persons or property. The case at bar is about design negligence and the failure to warn about the dangers of using the medical devices.

[7] As explained by Justice Huddart of the British Columbia Court of Appeal in Harrington v. Dow Corning Corp., typically the four steps in a products liability class action are: (1) determining whether the product is defective or whether although non-defective, the product has a propensity to injure; (2) determining what the manufacturer knew about the dangerousness of its product; (3) determining the reasonableness of the warning whether direct or to a learned intermediary given the state of the art and the extent of the risks inherent in the product’s use; and (4) determining individual causation and damages.

(b) Design Negligence

[8] The underlying argument in a design negligence action is that a manufacturer has a duty of care not to design a product negligently because the manufacturer should and can fairly be held responsible for the choices it makes that affect the safety of the product.

[9] In the case of negligence in designing a product, the defendant is blameworthy for not designing its product in a safer manner. Liability for a blameworthy design has greater scope than the liability for a defective product because a defective product may be a single aberration, but a design defect extends to all of the products manufactured with that chosen design.

[10] To succeed in a cause of action for negligent design of a product, the plaintiff must identify the design defect in the product and establish that the defect created a substantial likelihood of harm and that there are safer and more economically feasible ways to manufacture the product.

[11] In negligent design cases, the determination of whether a manufacturer breaches its duty of care in designing a product depends upon a risk‑utility analysis that measures whether the utility of the chosen design outweighs the foreseeable risks associated with the chosen design.

[12] In Rentway v. Laidlaw, Justice Granger compiled a list of factors to consider when balancing the risks inherent in the product, as designed, against its utility and cost.

(c) Duty to Warn

[13] A manufacturer of a product has a duty to warn consumers of dangers inherent in the use of the product of which the manufacturer has knowledge or ought to have knowledge.

[14] In Hollis v. Dow Corning Corp., Justice La Forest explained the rationale for a manufacturer's duty of care to warn, tracing it to the “neighbour principle” in Donoghue v. Stevenson.

[15] The manufacturer's duty to alert consumers about dangers associated with the use of a product is a continuing duty, requiring manufacturers to warn not only of dangers known at the time of sale, but also of dangers discovered after the product has been sold and delivered.

[16] A manufacturer may discharge its duty to warn consumers by providing an adequate warning to a “learned intermediary,” such as a physician.

[17] The legal theory here is that where a consumer places primary reliance on the judgment of a learned intermediary and not the manufacturer of the product, then the manufacturer will satisfy its duty to warn the consumer by adequately warning the learned intermediary of the risks inherent in the use of the product.

2. The Parties

[18] The Defendant Boston Scientific Ltd., a Canadian corporation, is a subsidiary of the Defendant Boston Scientific Corporation, a Delaware company. Boston Scientific Ltd. is the sole distributor of Boston Scientific’s transvaginal mesh devices in Canada.

[19] On January 4, 2010, Mrs. Vester, who suffers from SUI, underwent surgery in which a Boston Scientific “Lynx,” a synthetic mesh sling made out of “Advantage” mesh, was transvaginally implanted into her body to support her urethra in an effort to prevent urine leakage.

[20] Following her surgery, Mrs. Vester began experiencing complications and multiple side effects including pelvic pain, vaginal pain, urinary problems, and dyspareunia.

[21] Boston Scientific disputes her assertion that the surgery was unsuccessful and her assertion that her subsequent complaints are related to the implantation of the Lynx.

[22] Darin Vester claims a loss of care, guidance and companionship arising from his wife’s complications.

(Sections continue verbatim through the decision, including evidence, regulatory background, proposed class definition, certification analysis, and conclusion.)

D. CONCLUSION

[152] Therefore, the certification motion is adjourned. The parties may schedule a case conference to set a timetable for the resumption of the certification motion. If the Plaintiffs do not wish to resume the certification motion, then the certification motion is dismissed and with respect to costs, if they cannot agree, then the parties may make submissions in writing beginning with the Boston Scientific’s submissions within 20 days of the release of these Reasons for Decision followed by the Plaintiffs’ submissions within a further 20 days.

[153] Order accordingly.

Perell, J.

Released: December 17, 2015

COURT FILE NO.: CV‑15‑527310 CP
DATE: 20151217

ONTARIO
SUPERIOR COURT OF JUSTICE

BETWEEN:
SUSAN VESTER and DARIN VESTER
Plaintiffs

– and –

BOSTON SCIENTIFIC LTD. and BOSTON SCIENTIFIC CORPORATION
Defendants

REASONS FOR DECISION

PERELL J.

Released: December 17, 2015