The New Jersey Appellate Division recently released a ruling broadly allowing 510(k) evidence in medical device cases.  Elizabeth Hrymoc, et al. v. Ethicon, et al.,  DOCKET NO. A-5151-17,   467 N.J.Super. 42 (Superior Court N.J., Appellate Division)(March 2, 2021).  Shook played a role in the case as the firm filed an amicus brief for AdvaMed, the National Association of Manufacturers, and the U.S. Chamber in the case.  In addition, in an unusual move, the court invited amici to be part of the oral argument. My partner Dan Rogers presented on behalf of the amici, which included PLAC and the HealthCare Institute of New Jersey. The argument explained that the 510(k) review is a relevant safety review and that courts can manage the introduction of such evidence rather than simply ban it.

Specifically, the court concluded that the two respective judges who tried these complex cases erred by categorically excluding any proof that defendants had obtained what is known as  a Section 510(k) clearance from FDA, see 21 U.S.C. § 360c, for the devices implanted by plaintiffs’ surgeons. The court concluded that such a total disallowance of such proof had the patent capacity to deprive defendants of a fair trial, most poignantly with respect to the state-of-mind and venal conduct issues that underlie a possible punitive damages awards.

Although some courts in other jurisdictions have chosen to exclude such 510(k) evidence from jury trials involving the design and safety of mesh devices, this NJ court favored the approach of other courts that have deemed such proof admissible with appropriate limiting instructions. E.g., In re Bard IVC Filters Prods. Liab. Litig., 289 F. Supp. 3d 1045, 1047-48 (D. Ariz. 2018). The court was persuaded there is sufficient probative value of such evidence under N.J.R.E. 401 to justify informing the jurors that the products were reviewed by the FDA under the 510(k) clearance process before defendants’ sales. The complete ban of such proof was unfairly and repeatedly capitalized upon by plaintiffs’ counsel at both trials, in a manner that easily could have given the jurors a skewed impression of the totality of circumstances.

The court was further persuaded that theoretical countervailing concerns under N.J.R.E. 403 about potential juror confusion and consumption of  time, while legitimate, could be capably addressed by the trial court through appropriate means.

The court concluded: “We should not underestimate the intelligence and conscientiousness of jurors…. It is wrong to presume the jury would not have been able to understand and follow a limiting instruction from the judge about the proper use of 510(k) evidence. Jurors have a sworn obligation and assumed capability to abide by the court’s guidance. Indeed, ‘one of the foundations of our jury system is that the jury is presumed to follow the trial court’s instructions.’ State v. Burns, 192 N.J. 312, 335, 929 A.2d 1041 (2007).” See 467 N.J. Super. at  79, 249 A.3d at 213.