Lessons learned from COVID-era medical device regulation

Grant Worden (00:07): Hello and welcome to the next installment in Torys’ eight-part medical device series, “So you're coming to Canada, eh? An overview of Canada's laws affecting the medical device industry”. I'm joined today by Niki Mantini and Denise Ramsden, who will be speaking about lessons learned during the COVID-19 pandemic.

Grant Worden (00:26): Denise, let me start with you. In normal times, pre-COVID times, what regulatory approvals did medical device manufacturers require in order to sell their products in Canada?

Denise Ramsden (00:37): So you needed a licence of some form, and there's a number of different products that are classified as medical devices in Canada. So things like face masks, gloves, to ventilators and COVID tests. And these different products obviously have different levels of risk. So they're classified differently by the Canadian regulator, depending on that risk level. So for something like a medical face mask, that's Class I, medical gloves or Class II, and then things like COVID tests and ventilators are Class III or IV. So for Class I devices, a little bit lower risk, you need something called a Medical Device Establishment Licence or “MDEL” to import and sell in Canada. For Class II, III and IV devices, you typically need something called a Medical Device Licence, as well as quality qualifications called “MDSAP”.

Grant Worden (01:26): And when the COVID pandemic hit Canada in March of 2020, what changed with respect to the regulation of medical devices?

Denise Ramsden (01:33): As I'm sure everyone heard on the news around the world, countries everywhere were struggling to get medical devices. We sort of went through a progression. First it was things like masks and gloves and ventilators, and then we moved on to COVID-19 tests. So Health Canada set up a few different channels to get medical devices into Canada quickly. One key avenue early on was that if you had a medical device that didn't fully meet the Canadian requirement, so maybe it was a US device, it had US labelling, but it didn't have French on it or something like that, you could have it added to a list that Health Canada was maintaining, and then that device could be imported into Canada just by letting Health Canada know you were bringing it in. Health Canada was also processing medical device establishment licences very quickly. Normally, that could take a few months. They were doing it in one day. They would do a virtual inspection of your facility and documentation. And then as a more formal pathway, they also started issuing “interim order authorizations”, which is a little bit like a medical device licence or what the FDA was issuing EUAs. So there was more information that was provided, but much more flexible than the typical process. You didn't have to hold the quality certifications that you would normally have to, your labeling might not need to have French, you could submit information to Health Canada on a rolling basis, which normally wouldn't be the case. And that avenue is actually still available right now for certain devices like COVID tests that are still something we need today.

Grant Worden (03:04): And Niki, Denise has discussed Health Canada's typical pre-COVID licensing requirements and how they changed during the pandemic. As far as you're aware, have there been any consequences as a result of those changes from a product liability perspective?

Nicole Mantini (3:20): So Grant, I don't think we’ve seen any direct fallout as yet in terms of high-profile class actions or anything like that. But the potential is absolutely there and certainly even prior to the pandemic, we had been seeing growing numbers of class action and product liability claims pertaining to medical devices as the limitations periods for things that happened in 2020 start to expire, now that we're in 2022, we may start seeing an increase in these types of claims. One thing to note is, unlike other jurisdictions in Canada, we don't have a doctrine of preemption to apply to preclude product liability for a device on the basis that it was approved by the regulator. So any time you have a deviation from a normal process of regulatory oversight and review, you are creating the potential for perceived liability as Health Canada now moves back into its ordinary operations, we might see that some of these approvals and licences that were issued will be amended or changed. And, you know, those are the kinds of things that could trigger liability, and certainly amendments to a product's labelling or the conditions for its use could give rise to a legal claim. For instance, the addition of a warning or a risk to a label could be relied upon by a future plaintiff to suggest that the prior labeling was deficient. Something more significant, like a recall, could certainly trigger a liability risk if that comes down the pipeline. You know, one good indicator for manufacturers sometimes that people may be looking to seek out class action or product liability litigation, is to look at what's happening in other jurisdictions. We're starting to see some whispers of class action litigation in the US relating to some of these devices.

Nicole Mantini (04:56): And another thing you might want to be aware of is if people are starting to file access to information requests pertaining to your devices. If someone's starting to look into the regulatory review process by the regulator, that can be a good indication that they might be thinking about commencing an action.

Grant Worden (05:15): Niki In the US, around the commencement of the COVID pandemic, the federal government passed legislation to give manufacturers some protection in the form of the PREP Act and also the CARES Act. Were there any similar legislative developments in Canada at either the federal or provincial levels?

Nicole Mantini (05:33): Yeah, so federally the Canadian government hasn't passed any equivalent protection for liability for medical device manufacturers. There are some processes in place at the provincial level, though. At province level, including in Ontario, there's legislation that limits liability for COVID-19 infection or exposure to any person, corporation or other entity that has acted or made a good faith effort to act in accordance with public health guidelines or laws. I think it remains to be seen how far reaching that protection is going to be. For example, if you're a manufacturer who makes a mask, for example, or another form of PPE, if someone contracted COVID-19 while wearing it, are you going to be protected as long as you met all of the regulatory requirements for that device? Is that going to fall under the scope of those protections? We just don't know that yet.

Grant Worden (06:29): And Denise, what lessons did the response to the COVID-19 pandemic offer to both manufacturers and to legislators or regulators?

Denise Ramsden (06:39): So I think it really taught us that both industry and the regulators can work collaboratively as opposed to litigation. They don't actually have to be on opposite sides of an issue. So we saw situations where Health Canada was willing to reach out very proactively to industry during the pandemic. Health Canada was obviously under pressure to get devices into Canada, so that was different from normal course, but they were willing to engage with industry and problem solve. And they were also flexible in terms of giving way to authorizations from other countries. And one big one was that they were willing to receive materials on a rolling basis. So Canada, for example, has extra requirements around bilingual labelling. They would let a manufacturer submit English only materials and then get the French in place once they had approval and knew they were going to be able to move forward in Canada. So hopefully we'll see that type of collaboration going forward.

Grant Worden (07:37): Niki, with respect to the response to COVID-19, what lessons were offered to manufacturers with respect to risk management?

Nicole Mantini (07:46): From a regulatory perspective, increased flexibility and collaboration are great because they get needed products to the market faster. But the trade off could be that these processes, which may be perceived to streamline or shorten regulatory review, are going to be subject to greater scrutiny from the public or from potential plaintiffs. And so the same degree of vigilance in terms of regulatory compliance, processes and record keeping are still warranted for manufacturers. They may even be optically more important in these kinds of expedited circumstances. Another interesting lesson that we may still have to learn is without clear legislative protections, federally, balancing the need to provide companies with incentives to respond to public health emergencies, with the need to protect the health and safety of the public is something that may fall into the realm of the courts. And we'll have to see whether this is going to have an impact on for example, the legal standard of care when it comes to negligence and tort. That standard is usually reasonableness. But what might be reasonable in a public health crisis is maybe going to be subject to adjustment.

Grant Worden (08:46): Thanks Niki, and thanks Denise, and thank you for joining us here today. We hope you'll join us for the next installment in our eight-part series, “So you're coming to Canada, eh? An overview of laws that impact the medical device industry”.