Article co-authored by:
Pat Fogarty, SVP, Deputy General Counsel & Director of Litigation at AdvaMed
Sean Burke, Partner, Vice Chair of the Products Liability and Toxic Torts Trail Division at Duane Morris LLP
The Importance of 510(k) Evidence to Ensuring a Fair Trial
Since the onset of the COVID-19 pandemic, the Food and Drug Administration (“FDA”) has received more attention than perhaps ever before. While Americans anxiously awaited for approval of a COVID-19 vaccine, the FDA and its regulatory scheme were ever-present topics on the news and in social media. The American population’s newfound familiarity with the FDA is especially pertinent in a medical device litigation context. As litigators well know, jurors already enter a courtroom with preconceived notions of medical device companies, the FDA and the relationship between the two. So how will this newfound knowledge of the FDA influence juror opinions? Put another way, what would happen if a jury participating in a medical device trial failed to hear any reference to the FDA at all? Potentially, the results would be catastrophic to device manufacturers.
This is precisely the type of result Plaintiffs’ attorneys have sought to capitalize on ever since the Supreme Court’s decision in Medtronic, Inc. v. Lohr. Lohr dealt entirely with the issue of federal preemption. However, since it was handed down, the Plaintiffs’ bar has narrowed in on the Court’s distinction between evidence of 510(k) clearance and premarket approval (“PMA”), both FDA processes that enable a medical device to be marketed to the public. As a result, a growing number of courts have agreed with the plaintiffs’ position that any limited relevance of a 510(k) clearance is outweighed by the likelihood of juror confusion and prejudice created by its admission. Although both review processes are conducted by the FDA, they differ in substance and procedure. Clearance of a device under 510(k) requires “substantial equivalence” to an existing legally marketed device, whereas premarket approval is based on FDA review of a device completely new to market. Plaintiffs have relied on this language in Lohr in an attempt to delegitimize the 510(k) process and exclude any evidence of it at trial.
Admitting 510(k) Evidence at Trial
Two recent New Jersey pelvic mesh cases (Hyrmoc v. Ethicon and McGinnis v. C.R. Bard) squarely demonstrate the result of excluding such critical evidence. In both cases, the respective juries found the medical device defendants liable for injuries to plaintiffs, and awarded over $83 million dollars in damages. Of this amount, $68 million dollars was awarded in punitive damages alone, i.e. damages designed to “punish” the defendant. In both cases, neither trial judge allowed evidence of FDA clearance for fear it would cause juror confusion. Specifically, the judges were concerned that jurors would conflate FDA clearance with FDA premarket approval. Therefore, the trial judges barred any evidence that the pelvic mesh was cleared by the FDA.
On March 2, 2021, a New Jersey appellate court overturned these two verdicts, holding that the trial courts committed reversible error by excluding all evidence related to the FDA clearance process. During trial, Plaintiffs used the lack of FDA evidence to their unfair tactical advantage. This was particularly egregious in light of Defendants’ inability to counter any allegations of negligence or recklessness with evidence of FDA compliance. Further, the Court noted the unfairness of the evidence’s exclusion was exacerbated by the pandemic, given the increased understanding by the public of the FDA’s role in medical device review. Ultimately, the appellate Court held that the complete ban of 510(k) clearance evidence was unfairly prejudicial to Defendants.
This decision signaled a triumphant victory for medical device manufacturers. Not only does the decision lend credence to the legitimacy of the 510(k) process as an accepted FDA review mechanism, it further demonstrates an understanding of fairness, recognizing the substantial importance of FDA compliance evidence at trial, particularly in a COVID-19 world.
Fairness of FDA Evidence at Trial
Ultimately, a better understanding of the 510(k) process has a profound trickle-down effect on jurors and the overall outcome of trial. With current events in mind, jurors expect that device manufacturers complied with FDA regulations. Lack of any such evidence is immediately going to raise red flags and unfairly color the jury’s perception of the defendant. Indeed, the Hyrmoc Court based its reversal of the trial court’s exclusion of evidence largely on notions of fairness. Without evidence of FDA clearance, the jury was left with only one logical conclusion – the manufacturer acted recklessly and should be punished. With this in mind, we explore a number of the ways evidence of a company’s compliance with the 510(k) process impacts fairness at trial, and why it is so crucial to get this evidence admitted.
Impact of Compliance Evidence
The importance of FDA compliance evidence at trial cannot be overstated. This evidence demonstrates not only that the FDA reviewed the medical device and cleared it to market, but also that the device manufacturer complied with all necessary requirements before selling the product to the public. As a result, compliance evidence directly combats any allegations that the device manufacturer acted unreasonably, irresponsibility, or recklessly. Without this evidence, the potential for prejudice to the device defendant is astronomical. This is precisely what happened in Hyrmoc and McGinnis. Throughout the trials, Plaintiffs continually and strategically emphasized Defendants’ alleged “failure” to conduct clinical trials. They argued for the imposition of punitive damages as a way to incentivize Defendants to conduct these trials in the future. By precluding the introduction of 510(k) clearance evidence, the device manufacturers were unable to defend against such gross mischaracterizations. Specifically, they were unable to explain that 510(k) submissions do not require companies to conduct clinical trials because the device has already been proven to be substantially equivalent to a predicate device. By not being able to offer a complete explanation to the jury, the Defendants were significantly prejudiced in their ability to adequately defend themselves.
The risk of prejudice to defendants is especially pertinent when we consider juror expectations. Indeed, jurors expect that medical device manufacturers comply with the FDA. In a recent survey conducted by Litigation Insights, nearly 80% of jury-eligible participants agreed that “it is critically important for companies to be in compliance with all safety standards set by government agencies.” In fact, 70% of these participants agreed that “meeting safety standards set by government agencies is just the bare minimum.” Juries expect that at the very least, device manufacturers go through the necessary approval channels for their products before marketing them to the public. These expectations are only bolstered by prospective jurors’ newfound familiarity with the FDA. Therefore, the complete absence of any reference to the FDA will certainly raise red flags to a jury – as noted by the Court in Hyrmoc. Without this evidence, a jury is only left with one conclusion – that the defendant proceeded to market its product to the public without seeking FDA review or approval. The punitive damages awards in Hyrmoc and McGinnis are proof enough that absence of this evidence substantially and irreparably prejudices the device defendant.
There are also future implications on fairness to consider by courts barring 510(k) clearance evidence at trial. In 2017 alone, 82% of the devices cleared or approved by the FDA were cleared by the 510(k) process. With this staggering number, it becomes clear why Plaintiffs have attempted to delegitimize the process and why they are pushing so hard to exclude it at trial. By allowing such exclusion, courts are furthering plaintiffs’ narrative that the 510(k) process is somehow less effective at reviewing the safety and efficacy of a device and potentially adding to juror doubt on the FDA review process. Contrary to plaintiffs’ assertions, 510(k) review is not simply a shortcut to circumvent more rigorous FDA review. Often this process involves a long-standing dialogue between the manufacturer and the FDA to clear up any questions or concerns the FDA may have about the product. The exclusion of this evidence has an extremely detrimental effect on public confidence in the FDA to adequately conduct a review of a device’s safety. By allowing 510(k) clearance evidence to be introduced at trial, courts are permitting manufacturers an opportunity to explain their step by step compliance with the 510(k) process, while better educating the jury and perhaps restoring public confidence in the FDA and its regulatory authority.
The COVID-19 pandemic has profoundly changed public attitudes, perceptions and expectations of the life sciences industry in numerous ways. The average juror is more educated about the FDA, clinical trials, manufacture to market timelines, and regulatory compliance than ever before. With this knowledge comes an expectation that medical device and pharmaceutical companies have – at the very least – complied with FDA regulations before marketing their products to the public. Therefore, at a trial involving medical devices, it is paramount to a fair trial that device manufacturers are permitted to introduce evidence of their compliance with FDA pre-market requirements. As we have seen in the recent New Jersey verdicts, absence of this evidence has a substantially detrimental effect on device defendants and undermines the fairness of the entire proceeding. Hopefully, in light of the recent Hyrmoc decision, 510(k) clearance will continue to be viewed as a critical piece of evidence, necessary to ensure a fair trial.