Getting hit with lawsuits isn’t an if, but a when for medical device developers and manufacturers. A veteran Greenberg Traurig lawyer shares advice for staying secure.
As with pharmaceutical companies and health providers, medtech is emerging from the COVID-19 pandemic with a great deal of goodwill, says Ginger Pigott, a Greenberg Traurig shareholder. Pigott has seen the industry’s improved image helping device companies with juries, mock juries and the litigation process in general.
But don’t bet on the trend lasting.
“I’ve been practicing for 30 years, and it goes in that cycle all the time,” Pigott said in a recent interview with Medical Design & Outsourcing. (Pigott will moderate a panel about building startups to last at DeviceTalks West, Oct. 19-20, 2022 in Santa Clara, California.)
In fact, Pigott suspects the present economic uncertainty will cause an uptick in lawsuits. “When the economy goes into where it seems to be heading, we often see an uptick in litigation because people are struggling. Whether it is business disputes or product liability claims, we often see a rise in filings that seems linked to a change in the economy.”
Over her career, Pigott has gone from entirely handling litigation to also consulting with medtech companies about how they can reduce risk. Here are three general pieces of advice from Pigott for how medical device companies can better protect themselves:
1. Have solid quality and regulatory processes
Pigott often goes over the landscape in which a particular medtech company is competing, not only to understand competitors but also the potential liability risk. For example, when a particular type of product is the source of significant litigation across an industry of competitors, even other innovators in the same field who use different products to treat the same medical condition have to understand the litigation risk. The main risk comes from the presence and attention of experienced attorneys evaluating claims and they might take advantage of what they believe is applicable industry experience by targeting or bringing your company into the litigation. This is why it is so important to make sure your company is set up to do what it takes to have a robust quality and regulatory process. You must take into account the likelihood a litigation lawyer will be looking at your processes and your files.
“We look at, ‘What are your procedures? How do you understand and process the adverse event data when it comes in?’ The way companies report can also be a source of risk if it is carelessly worded, such as adopting language from a reporting source without qualifying properly about what the company knows at that time. Oftentimes people writing medical device reports are busy and focused on the priority of compliance and not necessarily thinking about how it might be viewed under the lens of litigation.”
Pigott talks through procedures and how various regulatory documents work so companies are prepared. That includes their sales representatives and clinical specialists, too.
FDA regulatory approval can provide some liability protection, particularly where devices have Premarket Approval (PMA) status, but lawyers love it when they see there’s a salesperson involved. “You can almost see them thinking, ‘Sweet. Maybe I can get around that by alleging sales rep negligence.’”
2. Communications practices are key
Pigott recalled a client that was trying to track down the source of some failures with an implantable device. A multidisciplinary crew from manufacturing, regulatory and other departments met to get to the bottom of the problem. “They’re saying, ‘Go back to your desk. Let’s really think about what this could be.’ So some guy goes back, and he sits down, and he types up this email of, ‘Maybe it’s this. Maybe it’s that. Maybe it’s the other thing.’ Just a total brain dump. It was brainstorming, none of which he had looked [into further].”
Once the problem became the subject of a lawsuit, the email became a key piece of evidence for the plaintiffs. “Months and months later, when these documents get produced, this looks like a list of terrible, outrageous things that are existing on the manufacturing floor that were never actual facts.”
The lesson of the story is that medical device companies need to train their employees so that they’re aware that their communications could become evidence in a litigation. It might even be years later, when the people who made the communications aren’t around anymore or don’t remember ever sending a particular email in the first place.
“What we don’t want to do is tell companies, ‘Don’t ever communicate.’ Because that doesn’t help either. They have to be able to communicate,” Pigott said. “What we do want to say is, ‘When you communicate, you have to be aware, and you can avoid creating documents that are actually not true, that are misleading or incomplete.’”
Good etiquette in communications can help, too. Pigott recalled a CEO who was a wonderful leader who cared about his company and its products — but he also occasionally dropped an F-bomb in communications. “It’s just a little piece, but it made a difference.”
3. Diverse leadership goes a long way
“Diverse teams are going to be more effective, more innovative,” Pigott said.
She’s also found that juries respond better when they can see a company is run by a diverse group of people, not just a bunch of older white men.
“I’ve personally experienced change in who I’m working with in these companies — how many more women, how many more people of diverse backgrounds, people of different abilities, people who come from all different categories.”