The New Jersey Appellate Division issued a decision on March 2, 2021 in Hrymoc v. Ethicon, Inc., Nos. A-5151-17, A-1083-18, 2021 N.J. Super. Unpub. LEXIS 337 (App. Div. Mar. 2, 2021) that may substantially impact the landscape of litigation for medical device manufacturers in New Jersey. The Appellate Division reversed and remanded two plaintiffs’ verdicts in New Jersey pelvic mesh multi-county litigation, and held that the trial courts committed reversible error by excluding all evidence related to FDA 510(k) clearance, overturning two verdicts totaling over $83 million dollars in the process. The decision makes clear that the wholesale exclusion of evidence related to FDA 510(k) clearance denies manufacturers the right to a fair trial.
Hrymoc was the consolidated appeal of two separate jury verdicts from pelvic mesh litigation in 2018. The underlying McGinnis case centered on two pelvic mesh devices designed and manufactured by C.R. Bard. The underlying Hrymoc case was regarding the Prolift pelvic mesh device manufactured by Ethicon, Inc. The pelvic mesh devices at issue in both cases were Class II medical devices that were approved by the FDA through the 510(k) process, which allows the FDA to clear a product for market if the product is found to be “substantially equivalent” to a product already on the market.
While the cases did involve the application of different law (McGinnis was brought under North Carolina product liability law and Hrymoc was brought under the New Jersey Product Liability Act, with both plaintiffs seeking punitive damages under New Jersey law), both cases saw the plaintiffs move in limine to preclude defendants from introducing evidence that the FDA had cleared the devices through the 510(k) process. The Hrymoc trial court granted the motion, holding that 510(k) clearance did not equate to a finding by the FDA of the product’s safety and efficacy. Despite a North Carolina statute requiring submission of government standard evidence, the McGinnis trial court held that 510(k) clearance was not a government standard since it did not result in a finding of the device’s safety and efficacy. Further, the trial court ruled the evidence was excludable under N.J.R.E. 403 because any probative value of the evidence was substantially outweighed by the potential prejudice and confusion it would cause jurors. The McGinnis trial court also denied a motion for summary judgment as to the punitive damages claim, as it found that the 510(k) clearance did not constitute approval, licensure, or a general recognition of safety by the FDA, which would have precluded punitive damages under the New Jersey Products Liability Act.
The juries in both cases found in favor of the plaintiffs, including an award of $5million in compensatory damages and $10 million in punitive damages in the Hrymoc matter, and $33 million in compensatory damages and $35 million in punitive damages in the McGinnis matter.
Defendants from the underlying cases filed appeals to overturn the jury verdicts on multiple grounds, but the primary argument advanced was that the trial courts erred when excluding all 510(k) evidence from both the liability and the punitive damages phases of the trials. Defendants argued the exclusion of this evidence during the liability phase of the trial precluded defendants from explaining to the jury that certain product decisions were made in compliance with the FDA’s regulations. Defendants argued that the exclusion of this evidence during the punitive damages phase of the trial prohibited them from explaining and defending the decision making behind their actions.
The Appellate Division found that the trial courts’ exclusion of 510(k) evidence deprived the defendants of a fair trial during both phases of the trial. The court’s analysis began by noting that 510(k) clearance is “not a plenary determination of that device’s safety and effectiveness,” but rather it merely represents the FDA’s finding that the device is substantially equivalent to an already existing device. However, the court did find that 510(k) evidence did show that the manufacturer obtained regulatory authorization to market the product, and therefore the evidence had “probative value in evaluating the company’s design and sale of the devices.” The court noted that an evaluation to determine if the probative value of a defendant’s evidence was substantially outweighed by the factors under N.J.R.E. 403 required an analysis of the evidence that was to be presented in each case. The court determined that the unfairness caused by the exclusion of the 510(k) evidence was particularly prominent during the punitive damages phase of the trials, as defendants were not permitted to present evidence that explained the reasoning for their decisions. While the court did not find that the Products Liability Act mandated the admission of such evidence in every medical device trial, the court expressed substantial concerns that the exclusion of this evidence had the potential to cause jurors to improperly presume that a medical device manufacturer sold a product without any oversight or regulatory clearance.
The court determined that the fairest approach for a trial court to take was to ascertain “whether a limited amount of 510(k) information, through a well-crafted stipulation or a modest presentation of evidence from both sides, along with a cautionary instruction from the judge could help assure a fair trial.” The court concluded that limitations regarding the presentation of 510(k) evidence could be best addressed by trial courts in a fulsome pretrial evidentiary proceeding.
The court vacated the jury awards in the matters at hand, as the underlying trial courts had not properly considered the prejudicial effect of excluding all 510(k) evidence on defendants’ ability to defendant against both the product liability and punitive damages claims. The matters were remanded for new trials, but the trial courts were not categorically required to admit 510(k) evidence at the new trials. Rather, the trial courts were to conduct Rule 104 hearings during which they should “deeply reconsider” the exclusion of such evidence. The Appellate Division also determined that the Products Liability Act did not preclude punitive damages claims in product liability cases involving 510(k) medical devices, as 510(k) clearance did not include the FDA’s independent evaluation of the device for safety and efficacy. Therefore, 510(k) clearance does not constitute a finding of the FDA’s approval or licensure of a device and is not a general recognition that the device is safe.
The language used by the Appellate Division in this decision can be used to show the probative value that is found in 510(k) evidence. Further, this decision can be used to show that the exclusion of 510(k) evidence has the potential to deprive medical device manufacturers of a fair trial against both product liability claims and punitive damages claims. This decision signals to trial courts that it is proper to explore all measures short of excluding evidence, and is an endorsement of conducting Rule 104 hearings to put limitations in place to eliminate concerns regarding the admission of 510(k) evidence. As this decision has been appealed to the New Jersey Supreme Court, we will continue to keep you updated of any further developments.