Executive Summary: Key Legal and Evidentiary Issues

• Paul Pedersen sought certification of a proposed class action against Advanced Bionics LLC and related defendants over allegedly defective cochlear implants.
   
• Causation posed a central evidentiary challenge, since the plaintiff and a fellow class member each had complex, overlapping medical histories.
   
• Justice Morgan required production of full medical records for the plaintiff and Patric Boon before certification could proceed on a complete record.
   
• Certification was granted, but the class definition was narrowed to implant patients who experienced an objectively verifiable "hard failure" and underwent revision surgery.
   
• Negligent manufacturing was dropped as a pleaded cause of action, while negligent design, failure to warn, and failure to recall proceeded as certified claims.
   
• Divided success on certification led the court to reduce the plaintiff's costs award by half on fees, plus a smaller adjustment to disbursements.

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Facts of the case

Paul Pedersen brought a proposed class action against Advanced Bionics LLC, National Hearing Services Inc. (c.o.b. Connect Hearing Canada), Advanced Bionics AG, and Sonova Canada Inc. over cochlear implants that Pedersen alleged were defectively designed. The claim centered on devices that permitted seepage of bodily fluids into the electrode array, causing short-circuiting, degraded performance, and, in some cases, complete failure requiring invasive revision surgery. Evidence in the record indicated that up to 50% of the defendants' cochlear implants had failed in this manner. On February 18, 2020, Advanced Bionics LLC voluntarily withdrew unimplanted devices from the market, and Health Canada issued a Type II Medical Device Recall effective the same date, after having discovered the manufacturing defect during failure analysis of an explanted device on March 26, 2019. The plaintiff's certification motion was supported by affidavits from Pedersen himself and from a putative class member, Patric Boon [referred to as "Boone" in paragraphs 13–17 of 2026 ONSC 2239], both of whom described hearing loss, subsequent implant failure, and difficult revision surgeries. Before certification was decided, the defendants brought a motion for production of Pedersen's and Boon's complete medical records, including pre-existing conditions dating back five years before their respective implant surgeries, arguing that the amended predominance requirement in the Class Proceedings Act made this fuller disclosure necessary. After certification was granted in April 2026, the court invited submissions on costs, given that Pedersen's success in obtaining certification had been substantially narrowed by the court's modifications to the proposed class and claims.

Policy and legislative provisions at issue

The certification motion was governed by section 5(1) of the Class Proceedings Act, 1992, SO 1992, c. 6, which sets out the cause of action, identifiable class, common issues, preferable procedure, and representative plaintiff requirements for certification. Particular attention was paid to section 5(1.1)(b), a more recently enacted provision requiring that common issues "predominate over any questions affecting only individual class members." The court also considered section 5(1)(b) regarding the scope of the proposed class definition, and section 25 of the Act, which allows for summary procedures to resolve individual issues following a common issues trial. Beyond the CPA, the analysis touched on the Food and Drugs Act, R.S.C. 1985, c. F-27, and the Medical Devices Regulations, S.O.R./98-282, concerning the defendants' alleged failure to identify and disclose risks associated with the implants. The Family Law Act, R.S.O. 1990, c. F.3, s. 61, was relevant to derivative claims proposed on behalf of family members of implanted patients. On the earlier production motion, the court addressed the scope of relevant medical disclosure required to properly assess commonality and preferability at the certification stage.

Reasoning and analysis

On the production motion, Justice Morgan held that it was for the court, not the affiants, to determine the relevance of undisclosed medical information, particularly where Pedersen had already deposed that his own treating physician disagreed with him about whether certain symptoms were related to his implant. The court found that without full medical records, it would be impossible to properly assess whether the plaintiffs' symptoms stemmed from co-morbidities rather than device failure, and ordered production of the outstanding records for both Pedersen and Boon. On certification, the court found that the defendants' concession of a viable design-negligence claim was sufficient to satisfy the cause-of-action requirement under section 5(1)(a), and that failure-to-warn and failure-to-recall claims could stand alongside it, since a duty to warn may supplement rather than replace a design-negligence claim. The proposed class definition was found to be overly broad because it would have included patients whose devices had never failed; the court narrowed the definition to require an objectively measurable "hard failure," consistent with the evidence given by the plaintiff's expert, Dr. Richard Gurgel. On the newly enacted predominance requirement in section 5(1.1)(b), the court concluded that it imposes a stricter standard than existed previously, and that individual issues would have predominated over common ones if the claim proceeded as originally framed, given the extensive and idiosyncratic medical histories of the plaintiff and Boon. However, because the plaintiff's counsel had agreed to limit the class to hard-failure patients who underwent revision surgery, and to restrict damages to a common base level of bodily injury with only limited additional medical costs left for individual assessment, the court found the predominance and preferable procedure requirements were satisfied. The common issues proposed by the plaintiff were largely approved as pleaded, with the sole modification being removal of the word "manufacturing" from one issue, since that cause of action had been abandoned. Pedersen was confirmed as an appropriate representative plaintiff. On costs, the court applied the principle that divided success must be reflected in the costs award, given that certification was granted but on a significantly narrower class and claim than originally sought.

Ruling and overall outcome

The court ordered production of Pedersen's and Boon's medical records in the earlier motion, finding that a complete record was necessary before certification could be properly assessed. The action was ultimately certified, with Pedersen confirmed as representative plaintiff, but on a narrowed class limited to patients whose cochlear implants suffered a hard failure and who underwent revision surgery, and with negligent manufacturing removed as a pleaded cause of action. On costs, Justice Morgan accepted the defendants' submission that the plaintiff's divided success warranted a 50% reduction in legal fees, from $381,077.02 to $190,538.51 (including HST), along with a reduction in disbursements from $96,823.47 to $92,220.55 (including HST) to account for duplicated travel expenses. The defendants were ordered to pay the plaintiff costs of the certification motion in the all-inclusive amount of $282,759.06.