At BLG’s annual medical device webinar on Nov. 28, 2022, BLG product litigators Keegan Boyd, Josiane Brault, Beverley Moore, Edona Vila, and Glenn Zakaib were joined by Lana Varney from King & Spalding LLP to discuss the current state of medical device litigation, considerations for handling medical device claims in Canada and the U.S., and predictions for future trends.
The current state of medical device litigation in Canada and the U.S.
In the common law jurisdictions, we continue to see lawsuits being filed against medical device manufacturers and distributors across the country as both class actions and individual claims.
Ontario has historically been one of the main jurisdictions where class actions are commenced. Given recent changes to class proceedings legislation, including in Ontario, we are seeing class actions move towards provinces with more favourable class actions legislation, such as B.C. and Québec.
Québec is a leading market for life science and biotech companies in Canada, which may be a reason for the ongoing life science litigation in the province.
In the U.S., medical device liability litigation is in a slightly different state. For the most part, claimants do not seek class actions for medical device personal injury claims in the U.S. thanks to successful arguments by the defence that there is no common injury, given the diverse medical histories of claimants.
U.S. medical device claims are often advanced under what this known as the multi‑district litigation model (MDL model). This means hundreds or thousands of cases will commence in multiple jurisdictions before being consolidated in a single jurisdiction for pre-trial procedures, such as discovery or preliminary motions. The numbers of individual claims in the U.S. significantly exceeds what we have seen in Canada. For instance, one recent MDL involving medical device manufacturers grew to about 150,000 claims.
The term ‘mass tort’ refers to lawsuits that effectively pool together a group of plaintiffs, by combining the cases of many different claimants who are advancing claims against the same defendants. While mass tort litigation is a relatively new phenomenon in Canada, it has grown exponentially in the U.S. One notable factor leading to mass torts in the U.S. is the non‑stop advertising, especially on social media, that enable potential claimants to sign up with a simple click of a button.
The U.S. is also seeing an increase in the number of mass tort claims funded by venture capitalists and other litigation funders. These litigation funders are becoming extremely sophisticated at spreading litigation around the world, typically starting in the U.S. and moving to Canada and other jurisdictions, such Australia, South Africa and the U.K., where the evolving legal systems are now more favourable to advancing these types of claims.
Is there a shift from class action to mass torts in the context product liability claims involving devices in Canada? What does this mean for companies preparing for these kinds of claims?
In Canada, we are starting to see a trend towards a mass tort style of litigation, but we are still about 10 years behind the U.S. In the Canadian common law jurisdictions, we are seeing plaintiffs’ firms that would typically be commencing class actions, advancing a large number of individual actions in more of a mass tort approach.
We do not currently have MDL legislation in Canada, but we are seeing some cooperation between counsel in advancing mass torts for reasons of efficiency. Canadian firms often take the lead from counsel south of the border who are managing similar disputes so as to avoid duplicating efforts.
Prosecuting and litigating medical device patents
In Canada’s smaller market, it is rare for patents to be litigated here and not outside of the country. As a result, it is critical that strategy is consistent globally.
Canada’s discovery requirements are significantly smaller than the U.S., so, we can typically start with the U.S. discovery documents to reduce workload and give the other side only what’s relevant in the Canadian context. Patentees should waste no time in mapping out their litigation strategy with inventors and experts.
Québec law favours consumers. This means manufacturers face an increased risk of litigation. Pharmaceutical and medical device manufacturers are subject to a rigorous contractual regime that applies to safety defects and guarantees of quality.
We always recommend disclosing all material risks to consumers/patient. Like other jurisdictions in Canada, it is up to the treating physicians to obtain the patient’s informed consent after disclosing all inherent risks.
In litigation involving a manufacturing or safety defect in Québec, it is similarly important to join forces with other defendants in defending a plaintiff’s case. The law is already on the plaintiff’s side in Québec and you do not want to strengthen their case further. Joining forces also enables some efficiencies, such as sharing the cost of expert witnesses.
We also recommend coordinating the defence with those defending similar actions in other provinces and the U.S. and ensuring clients engage experienced counsel who are familiar with cross-border issues.
Tips for joint defence agreements
- Finalize agreements early on with the co‑defendants or other parties that may be future defendants.
- Make sure all defence counsel is hinged at the hip, as plaintiff’s counsel in the U.S. has learned how important it is to stay unified.
- Start with the company’s end goal, then work backwards to map the strategy to get there. If your client is not the target, you may want to avoid agreements that would require significant time and expense.
Overall medical device litigation trends
Both the U.S. and Canada have unique issues that should be monitored to mitigate risk and achieve better outcomes in medical device litigation.
- Sophisticated litigation funders are spreading potential risk across global jurisdictions, including Canada.
- Claims are shifting from “failure to warn” to “design defect” because of the cap on damage awards against doctors and the increase in doctors paying for their medical records.
- More sophistication of the plaintiffs’ bar, including using the media to spread misinformation.
- Regulatory agencies around the world may break from the FDA’s approach, and the plaintiffs’ bar may exploit those differences in global litigation.
- Mass torts are becoming more common and the added complexity of these proceeds will be top of mind for both counsel and clients defending these actions.
- Use of social media advertising will likely impact the medical device litigation landscape in Canada.
- Increased reporting of medical device issues by manufacturers and healthcare institutions could lead to more product advisories, product recalls and potential medical device litigation.
- Potential harmonization of digital health regulation with AI regulatory framework may well add an additional layer to emerging connected medical device litigation.
Get in touch
Medical device litigation changes are happening quickly on both sides of the border. Although Canada is still behind the U.S. in some respects, we can use trends in the U.S. to predict developments in the legal landscape in Canada.
If you are developing a product, looking for a disputes or risk management strategy, or interested in chatting about any of the topics covered by our panel, please reach out to any of the key contacts listed below.
*This webinar recording and transcript are available in English only.