Approval of 510(k) Evidence in Medical Device Cases

The Appellate Court of New Jersey in its recent rulings in suits against Johnson & Johnson and C.R. Bard has allowed evidence on FDA 510(k) [21 U.S.C. § 360c, for the devices implanted by plaintiffs’ surgeons] clearance in medical device cases. The court has reversed these verdicts totaling $83 million over the charge of defects in the companies’ vaginal mesh products. According to the ruling “evidence of such authorization does have probative value in evaluating the company’s design and sale of the devices.” [ See also, Hrymoc v. Ethicon, Inc. Docket No., A-5151-17 and A-1083-18, March 2, 2021]. In separate trials before two judges, evidentiary rulings wrongly excluded evidence that the companies’ products received a designation known as Section 510(K) clearance from the Food and Drug Administration.

The court also stated that “[a]lthough several courts in other jurisdictions have chosen in their discretion to exclude such 510(k) evidence from jury trials involving the design and safety of mesh devices, we adopt the approach of other courts that have deemed such proof admissible with appropriate limiting instructions.” The decision further states “We are persuaded there is sufficient probative value of such evidence under N.J.R.E. 401 to justify informing the jurors, without extensive elaboration, that the products were reviewed by the FDA under the 510(k) clearance process before defendants’ sales in these cases. 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.” Id at 4.

Further to this, the court in an unusual move, invited amici to be part of the oral argument wherein Partner Dan Rogers was represented as the amici. The amici are the Product Liability Advisory Council, Inc., the HealthCare Institute of New Jersey, the Advanced Medical Technology Association, Chamber of Commerce of the United States of America, and the National Association of Manufacturers. No amici appeared on behalf of Plaintiffs and therefore with an agreement of counsel, one attorney addressed the FDA 510(k) evidence issue on behalf of all amici in an oral argument. Rogers, who submitted an amici brief with Partners Phil Goldberg and Katie Mastrucci, argued that the 510(k) review is a safety review and that courts can manage the introduction of such evidence rather than ban it. Hence, the court was persuaded by the brief and noted in its decision that “the court should not underestimate the intelligence and conscientiousness of jurors. The court believed that the revelation of the FDA’s 510(k) clearance of these devices can be conveyed to the jurors effectively and plainly without extensive elaboration. The subject need not devolve into a ‘mini-trial’ before the jury. The playing field can be leveled without a dramatic alteration of the overall contest.” Id at 47 and 48.

The court also awarded punitive damages in this case and found these damages important in cases of 510(k) evidence. It further stated that “[t]he inherent unfairness of the situation as it unfolded is perhaps most pronounced in connection with the punitive damages aspect of these cases.” Id at 43.

Similarly, In re Cook Medical, Inc., IVC Filters Mktg., Sales Practices and Prod. Liab. Litig., No. 1:14-ml-02570, 2018 WL 6617375, at 1-2 (S.D. Ind. Dec. 18, 2018), the court denied the plaintiff’s motion to exclude evidence of the product’s 510(k) clearance, explaining that the applicable test for design defect cases under state law “incorporates the concept of reasonableness, i.e., whether the manufacturer acted reasonably in choosing a particular product design,” and holding that “[a] factor the jury may consider in determining whether a manufacturer acted reasonably is whether it complied with federal regulations.” Id. at 1. The court further found that the probative value of the evidence outweighed any prejudicial effect. However, the court additionally held that the defendant would not “be permitted to present evidence or argument that the [device] was approved by the FDA or that clearance of the device through the 510(k) process constitutes a finding by the FDA that the device is safe and effective.” Id. at 2.

Additionally, it is advisable to manufacturers to seek their legal counsel’s advice regarding the effective ways to implement approval strategies for their products. They should always keep in mind future lawsuit risks and the societal perceptions reflected injuries. The lawyers of both sides should also keep an eye to detail on 510(k) legal matters because of the evolving consumer safety policy regulations.



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