Written By Ashley Paterson and Adam Walji

In Bosco v Mentor Worldwide LLC, 2024 BCSC 1931, the plaintiffs alleged that Mentor's silicone gel-filled breast implants, MemoryGel, caused adverse health effects, including connective tissue disorders (CTDs) and autoimmune symptoms. They argued that Mentor did not adequately warn patients and surgeons about these risks and that Mentor breached consumer protection and competition legislation. Mentor consented to certain proposed common issues. The court agreed with Mentor that the remaining common issues should not be certified.

The contested common issues centered on whether alleged toxins were present in the breast implants and whether Mentor knew about them. The court stressed the lack of factual basis for these common issues, particularly due to the undefined scope of “toxins” as pleaded and the lack of evidence supporting the plaintiff’s allegation that the implants contained Toxins in quantities sufficient to cause adverse health effects.

Facts

The proposed class consisted of all persons who had been implanted with MemoryGel silicone gel-filled breast implants in Canada during the proposed class period. The central allegation was that the implants may cause the development of Autoimmune Syndrome Induced by Adjuvants due to silicone breast implants or “Breast Implant Illness” (collectively, BII), and CTDs such as rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s syndrome and systemic sclerosis. The plaintiffs also alleged that Mentor did not adequately warn class members and surgeons about the risks associated with the implants. Additionally, the plaintiffs accused Mentor of deceptive practices contrary to the Business Practices and Consumer Protection Act (BPCPA) and the Competition Act.

The contested common issues flowed from the allegation that there are heavy metals and/or volatile and extractable chemicals, or other toxins (the Toxins) in the implants. The plaintiffs questioned whether Mentor knew or should have known about the presence of the Toxins and whether they failed to warn or adequately warn class members and surgeons about these risks.

Mentor argued that there was no evidence to suggest that the plaintiffs had a valid claim regarding the contested common issues related to the disclosure of the alleged toxins. It also denied that any plaintiff had suffered any compensable injuries arising from the presence of platinum or any of the other alleged Toxins. The court, in its decision, emphasized the lack of factual basis for the plaintiffs' claims, particularly in relation to the contested common issues.

Decision

Section 4(1)(c) of the Class Proceedings Act, RSBC 1996, c 50, requires that the class members’ claims raise common issues. Evidence is required to establish some basis in fact for each of the proposed common issues that the plaintiffs seek to certify.

Evidentiary Concerns

Mentor objected to some of the evidence that the plaintiffs purported to rely upon, including an expert’s qualifications and opinions regarding platinum and information that manufacturers ought to disclose to patients about risks associated with the implants, a U.S. Food and Drug Administration (FDA) Guidance Document and hair element test results.

Mentor challenged the expert evidence, arguing that he had opined on matters beyond his expertise. The expert's report discussed potential platinum toxicity in silicone implants and the need for further long-term toxicology studies. However, during cross-examination, the expert admitted that he had not conducted any research on platinum, was unaware of any data indicating that long-term exposure to platinum in implants leads to adverse health effects and had not reviewed key documents about platinum in silicone breast implants that another expert had relied on in his report. The court determined that the expert did not have expertise in platinum and was not suitably qualified to provide expert opinion evidence about the disclosure obligations of medical device manufacturers. As a result, the expert's evidence on these issues was inadmissible, leaving no expert evidence to support the claim that platinum was present in or diffused from the implants in quantities sufficient to cause adverse health effects.

Mentor also objected to the admissibility of a document published by the FDA that provided non-binding recommendations on the format and content of labelling information for manufacturers of saline and silicone breast implants, given the risks associated with these implants. While the document was admissible as evidence that the FDA made these recommendations and that Mentor did not follow all of them, it was not admissible as evidence that the alleged Toxins could cause adverse health effects. The court noted the lack of expert evidence addressing what Mentor ought to have done in response to the recommendations outlined in the document.

The plaintiffs also sought to rely upon the results of hair element analyses of an anonymous individual who claimed that she had developed BII due to her implants and experienced significant symptom improvement after their removal. The court ruled that the hair element analyses were admissible as evidence that the anonymous individual had undergone these tests and received these results. However, there was no expert evidence to confirm the reliability of the testing methods used in the hair element analyses, nor any expert evidence to interpret the test results. Consequently, the court gave this evidence very limited weight.

Uncontested Common Issues

Mentor did not oppose the certification of twelve common issues. These issues related to whether the implants can cause specific CTDs and/or BII, whether Mentor breached its duty to class members in its post-market surveillance and/or monitoring of the implants with respect to these conditions, and whether Mentor’s acts or omissions were negligent or in breach of the consumer protection and competition legislation. Those issues will proceed to a common issues trial. The parties also agreed to defer certain common issues related to breach of consumer protection legislation in other provinces and damages until after the common issues trial.

Contested Common Issues

The contested common issues related to the alleged Toxins—whether the implants contain Toxins; whether Mentor knew about the Toxins; whether Mentor appropriately warned about the Toxins; and whether any of Mentor’s conduct was contrary to the BPCPA or the Competition Act.

Although the court accepted that the implants contained certain heavy metals, it found no basis in fact for certifying the contested common issues relating to the alleged Toxins. It specifically concluded that there was no basis in fact that the alleged Toxins are present or diffuse from the implants in sufficient quantities to cause adverse health effects. Of particular importance to the court was that the plaintiffs’ definition of the term “Toxins” was vague and overbroad, rendering it potentially unlimited in scope. The court also highlighted that the duty to warn only arises with respect to specific risks, not a general warning of potential harm without any reference to the specific risk. It concluded that the plaintiffs had not identified any specific risks associated with the presence of the alleged Toxins.

The court also denied certification of the contested common issues relating to the consumer protection and competition statutes. These common issues presumed that the alleged Toxins were present and/or diffuse from the implants in sufficient quantities to cause harm. Given the court's finding that there was no basis in fact as to the alleged presence of sufficient quantities of toxins to create adverse health effects, these issues were deemed not certifiable.

Key Takeaways

• Mentor consented to a considerable number of common issues. The court noted that Mentor’s consent was a reasonable concession in light of the Ontario Superior Court of Justice’s decision in Kibalian v Allergan Inc., 2022 ONSC 7116, where common issues related to failure to warn of three different health risks associated with silicone breast implants, including BII, were certified.
• Some basis in fact is not a superficial threshold. The contested common issues in this case were not certified because of the lack of admissible and persuasive evidence to support them.
• Importance of selecting the right expert. The court held that one expert’s evidence in connection with the contested common issues was inadmissible because the expert was not qualified to comment on the issues in question. This ultimately led to the court’s finding that there was no basis in fact to support the certification of the contested common issues.
• No workable methodology. Plaintiffs must demonstrate that there is one or more plausible ways in which general causation can be established. The Court concluded that there was no basis in fact that the data required to conduct a study currently exists and found that there was no workable method, based on available data, for proving that long-term exposure to gel bleed of silicone or platinum from breast implants causes adverse health effects.

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