If you’re working on a medical device that’s new and unprecedented, you might be a prime target for government litigation, according to Harvey Silverglate, a Cambridge attorney who specializes in civil liberties litigation, criminal defense and student rights.
Federal laws in regard to medical device safety, he argues, are sometimes so vague and complicated that it’s impossible to defend against an accusation of wrongdoing. Technologies and techniques that stray from the status quo are especially vulnerable because they are not well understood by the government officials and judges who ultimately decide how to treat them.
A company accused by the FDA may face hefty fees or an involuntary recall, but Silverglate is more concerned about the people who get chewed up and spit out by the system.
Health Benefit Consultants, Share Your Expert Insights in Our Survey
MassDevice Staff Website The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
“Life sciences and medical devices have become a minefield with regard to regulation and prosecution by the FDA,” Silverglate said. “It’s an extraordinarily dangerous environment that you can’t believe until they come knocking at your door.”
At an MIT Enterprise Forum presentation on Wednesday night, Silverglate laid the situation bare for concerned industry leaders. The government, he argued, has leverage that keeps medical manufacturers from defending themselves against felony accusations.
One such form of leverage is the threat of debarment due to a criminal conviction, a penalty defined by a 1992 amendment of the Food and Drugs Act. A debarred entity is disqualified from selling to government-funded health programs, which effectively keeps the entity from working with a majority of U.S. hospitals.
“Being debarred puts you out of business instantly,” Silverglate said, which gives the government the power to, “get any company to plea guilty to any case.” The FDA hasn’t debarred a company to date. They have, however, debarred nearly 100 individuals.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Silverglate illustrated the point by telling the story of Lee Leichter, once the head of regulatory affairs for U.S. Catheter & Instrument, a division of C.R. Bard (NYSE:BCR). In 1990, Leichter was charged with 392 separate felony counts for allegations that USCI failed to seek a supplement to its pre-market approval for a heart catheter; Silverglate defended him in court.
The catheters were considered to be on the cutting edge at the time, but modifications were made in response to unanticipated misuse of the devices when doctors failed to follow label instructions during angioplasty procedures. USCI’s understanding of the regulation was that because the issues were not inherent in the device, they did not qualify as reportable events under FDA rules.
USCI negotiated a plea deal and moved on, but Leichter and two other USCI executives went to trial, ready to argue that they had produced a device that was both safe and effective according to the “risk-reward calculus” defined by the FDA. After all, no device is absolutely safe and no device is absolutely effective, but a balance between the two is sought to ensure that the inherent risks of any device is worth the benefits that it holds for a patient.
During the trial, prosecutors characterized “safety” as “freedom from danger or risks” and “effective” as “having the definite or desired effect,” obscuring the risk-reward balance that all medical devices are federally reviewed by. The judge instructed the jury to disregard the federally outlined definitions for “safe” and “effective,” and to focus on whether the defendants had withheld information from the FDA. Leichter was indicted in 1993.
After another eight years of hearings, Leichter finally cleared his name when the Federal Court of Appeals found that the lower court judge failed to properly explain relevant regulations to the jury. In the mean time, Leichter had lost several jobs and his family in the tumult.
Unfortunately there wasn’t much that Silverglate could recommend to avoid prosecution. The only defense is to be prepared for an investigation:
- Never delete anything. Missing emails can be considered an obstruction of justice, and the absence of a message may look worse than whatever you were trying to get rid of.
- Keep detailed records at every step of the process, including your intentions and your understanding of the regulations that you’re working under. “Even if you make the wrong judgment,” said Silverglate, “the fact that you’re documenting it will help you show that you’re acting in good faith.”
- If you’re approached by investigators, say absolutely nothing. Call a lawyer right away, and make sure that the interview is recorded, even if it means the investigators refuse to continue with the interview.
Perhaps most importantly, Silverglate encouraged the audience to make noise and bring the issue to the attention of Congress. Until regulations are made sufficiently clear and explicit, the government has enormous flexibility to interpret regulations in ways that are favorable to the cases they pursue.
“There’s no defense because there’s no definition,” Silverglate said.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
