The COVID-19 pandemic is creating a new set of medical device litigation challenges — but also a chance for an industry reset. One of Greenberg Traurig’s top medtech litigation lawyers shares her insights.
[Gavel image from Unsplash. Coronavirus image from WHO]
Sara Thompson doesn’t take any guff when she tells people that she defends medical device and pharmaceutical companies from lawsuits.
“I say, ‘I sleep great at night because the companies I represent make things that can save and sustain life,’” said Thompson, who is vice chair of the Pharmaceutical, Medical Device & Health Care Litigation Practice at Greenberg Traurig.
Thompson thinks the case in defense of medtech is even stronger now that Americans and people around the world desperately need medical devices, drugs and vaccines to overcome the COVID-19 pandemic.
“Both drug and device companies want to help. A lot of our clients are developing ventilators, or they’re making their ventilators open-source. They’re contributing parts, and they’re contributing manufacturing space,” Thompson recently told Medical Design & Outsourcing.
Thompson summed it up: “I think it’s changing public perceptions in a way that once we get to trials will also be interesting. There’s going to be a lot of reverberations of this for a long time, I would say.”
Most commentators agree that COVID-19 is creating a new normal, and medtech litigation is no exception. Improved public perception is but one of a number of changes taking place. Here are five other ways Thompson sees the space evolving:
1. Companies are reevaluating litigation
For now, many medical device companies have taken a sales hit as health providers scale back on elective procedures and people even hold off on potentially necessary procedures amid the pandemic. CEOs of major companies have said in recent earnings calls that they expect revenue to recover later this year, but Thompson also sees them reevaluating the situation when it comes to lawsuits.
“We’re seeing our clients say, ‘Is this something we should reconsider in our strategy? Do we want to just resolve this case now? Should we reconsider a previous settlement?” Thompson said.
It’s all about adapting a litigation strategy to meet the medtech industry’s changing realities, according to Thompson.
“Some companies may be thinking, ‘We may not have the budget to go to trial anytime soon.’ So those worries could impact our assumptions and plan.”
2. More leeway to defer cases
Tighter budgets make medical device company officials less eager to go to trial right now, but Thompson also sees the pandemic giving them stronger arguments to get cases deferred down the road.
Judges care about the context when a lawyer is making a case. It may be necessary, for example, to reschedule a corporate employee’s deposition for a later date because the employee is focused on an essential program related to COVID-19.
“That really moves the needle for judges in a way that just saying that discovery would cause a business disruption often does not,” Thompson said.
3. Lawsuit immunity isn’t a given amid pandemic
The FDA has granted a host of emergency use authorizations during the pandemic to boost the availability of needed medical devices, virus and antibody tests, pharmaceuticals and more. Thompson suspects courts will be fleshing out for some time how much lawsuit immunity the FDA granted with its EUAs.
“Whenever there’s an intention that an immunity or a preemption (will) be broad, you always have very creative plaintiffs’ attorneys who try to find the cracks or the contours of that,” Thompson said.
There’s an exception for willful or wanton conduct, for example. “How’s that going to work? What are examples going to be?”
A company, for example, may have had a product on the market for another use, and then it received an EUA for a COVID-specific use. “Let’s say plaintiffs were raising design issues prior to all of that happening. Does the immunity apply to those claims? If the EUA is later revoked, does the immunity still apply? Those are real open questions for us to figure out,” Thompson said.
“There are a lot of really interesting and novel legal issues that we’re going to be litigating for the next few years.”
4. Less litigation tourism
It should also be easier for medical device and pharmaceutical companies to defend themselves from lawsuits. That’s because “litigation tourism” appears to be on its way out after the U.S. Supreme Court’s ruling in Bristol-Myers Squibb v. Superior Court of California, San Francisco County. The 2017 decision makes it much harder for lawyers to shop for plaintiff-friendly courts in which to file their lawsuits, Thompson said.
“It’s not impossible if you have a plaintiff who lives there or has experienced an injury there, or if you have a defendant who’s either incorporated in or has their principal place of business there. But you’re not going to have a company located in Minnesota, being named in a case in a West Virginia state court when there’s no connection to the venue.”
5. Sales rep training is more important than ever
More than a decade has gone by since the Supreme Court’s Riegel v. Medtronic decision, which found that federal medical device regulation laws provide lawsuit protections for devices with FDA premarket approval.
Since then, plaintiff lawyers have focused less on a device’s design, warnings or performance and more on a company’s conduct, especially when it comes to sales representatives, according to Thompson. “Plaintiffs may allege the sales representative trained a doctor, and if so, did they train the doctor how to use a device in a way that led to or allegedly led to the injury? Or did the doctor have a sales representative directly interacting with a patient in some impermissible way?”
Courts are scrutinizing adverse event reporting, too.
As medical device companies rethink how they market products to health providers during the pandemic and beyond, it’s more important than ever that they make sure their sales reps know what conduct is appropriate and err on the side of caution when deciding whether to report problems, Thompson said.