Key Takeaways

• The Appellate Division recently ruled in Hrymoc v. Ethicon Inc., et al., that it was an reversible error for judges in two separate product liability trials involving pelvic mesh medical devices to bar evidence pertaining to the defendants’ compliance with FDA regulations

• The ruling permits manufacturers and sellers to admit evidence of FDA compliance to establish their product is substantially equivalent to a product previously approved by the FDA

• The ruling will also make it more difficult to obtain punitive damage awards against manufacturers and sellers where there is evidence of FDA compliance

The New Jersey Appellate Division recently ruled in Hrymoc v. Ethicon Inc., et al., that it was an reversible error for judges in two separate product liability trials involving pelvic mesh medical devices to bar evidence pertaining to the defendants’ compliance with FDA regulations. The Appellate Division vacated both juries’ substantial compensatory and punitive awards for the plaintiffs, and remanded back to the trial court to reconsider the admission of the FDA evidence, particularly as it pertained to the punitive damage claims. These trials were only the second and third pelvic mesh cases in New Jersey to be tried to a verdict. It is expected that the plaintiffs will petition the New Jersey Supreme Court for review, to conclusively determine this important issue.

The FDA has regulatory control over medical devices. Medical devices are categorized as a Class I, II, or III device, depending upon the degree of regulation necessary to provide reasonable assurance of the device’s safety and efficacy. New medical devices introduced after the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, must go through the FDA’s rigorous premarket approval process. Premarket approval is not required if the device is a type of device that was in commercial distribution prior to May 20, 1976, and is substantially equivalent to another such device or the device was substantially equivalent to a type of device that was reclassified into Class I or Class II after May 1976.  Surgical mesh devices were designated Class II medical devices in 1988 and were reclassified as Class III devices in 2016.

A manufacturer seeking to market a new medical device for which premarket approval is not required must go through a process known as 510(k) clearance. The defendants submitted notifications to the FDA for 510(k) approval, and the FDA approved the defendants’ 510(k) submissions, finding the mesh devices were substantially equivalent to prior mesh devices.

At trial, the plaintiffs moved to exclude any evidence referring to the FDA 510(k) approval. The trial courts agreed with plaintiffs’ motions because the 510(k) approval was not equivalent to the premarket approval process and it related to whether the device was substantially similar to another device, not that particular device’s safety. During the trial, the plaintiffs repeatedly established that the defendants did not perform any clinical studies; allowing the jury to infer the defendants ignored safety concerns when manufacturing and marketing their mesh devices. Without being able to cite to the FDA 510(k) process to explain why clinical studies were unnecessary, the jury was left with the impression that the defendants were reckless and disregarded safety, an important factor when determining whether punitive damages are appropriate.

The Appellate Division reversed the trial courts’ evidentiary rulings, reasoning the FDA evidence was relevant to establish that a “device manufacturer obtained regulatory authorization to market the product at issue” and such approval has “probative value in evaluating the company’s design and sale of the devices.” Furthermore, evidence of the 510(k) approval process was not more prejudicial than probative under N.J.R.E. 403. To the contrary, the evidence’s exclusion created severe prejudice to the defendants because plaintiffs’ argued they were reckless in manufacturing and marketing the mesh devices without performing clinical trials. The Appellate Division concluded the “complete ban on any disclosure of the 510(k) clearance process to the jurors and the manner in which plaintiffs took undue tactical advantage of that exclusion, had the clear capacity to lead to possibly unjust results.”

Rather than categorically banning such evidence, like some other jurisdictions, the Appellate Division instructed trial courts “to explore whether a limited amount of 510(k) evidence, through a well-crafted stipulation or a modest presentation of evidence by both sides, along with a cautionary instruction from the judge, could help assure a fair trial.”

The Hrymoc opinion raises several important considerations that will likely be addressed by the Supreme Court. First, the opinion strongly indicates that evidence of the 510(k) approval process is always admissible, but never explicitly makes that determination. Instead, the Appellate Division left it to the trial courts to determine what evidence would be needed to assure a fair trial. If the plaintiffs omit the clinical trial argument in the second trial, it is possible that the evidence could be admissible for the punitive damages phase of the trial, but not the liability phase. Defendants should argue the Appellate Division provided guidance for appropriate limiting instructions because the evidence is admissible regardless of the plaintiffs’ argument.

The plaintiffs may also argue that the Appellate Division improperly relaxed Rule 2:10-2 in remanding for a new trial. Trial errors are disregarded unless they are of such a nature to “have been clearly capable of producing an unjust result,” but the Appellate Division required a new trial because the evidence “had the clear capacity to lead to possibly unjust results.” It even recognized that given the nature of the proofs, it is “conceivable” new juries might come to “comparable verdicts,” but these comments were made to explain that regardless of the outcome, the defendants were not provided a “fair opportunity” to prevent relevant evidence.

For more information or immediate guidance, contact:

• Thaddeus J. Hubert IV
• David J. O’Connell
• David S. Osterman
• Or another member of our Product Liability group