TRENTON, N.J. (Legal Newsline) - The New Jersey Supreme Court has ruled it was wrong to bar a medical device company from explaining to jurors why it didn't perform clinical trials on pelvic mesh products while plaintiff lawyers frequently argued it was because the company was too callous.
Plaintiff Mary McGinnis won a $68 million verdict in Bergen County in 2018, but two appeals courts have now ruled the company should have been allowed to present evidence of the 510(k) process it went through to obtain approval from the Food and Drug Administration despite a lack of clinical trials.
The FDA determined its Avaulta and Align pelvic mesh devices were substantially equivalent to another device that had already been subject to a safety review and cleared for use. Supporters of C.R. Bard in the case, like the U.S. Chamber of Commerce, said the exclusion of that evidence threatened manufacturers who participate in good faith with regulators to assure safe production and marketing.
The New Jersey Supreme Court consolidated two cases - McGinnis' against C.R. Bard and Elizabeth Hrymoc's against Ethicon.
"(I)n a products liability claim premised not only on principles of negligence, but particularly on the reasonableness of a manufacturer's conduct in not performing clinical trials or studies, evidence of 510(k) clearance has significant probative value... that is not substantially outweighed by the risk of prejudice and potential juror confusion," the court ruled.
The trial judge worried introducing the evidence "would result in a mini trial about the strengths and weaknesses" of the FDA's 510(k) process. No references to the FDA or the process were made during trial.
Before trial, C.R. Bard said punitive damages shouldn't be allowed because its products were approved and recognized as safe by the FDA, but the trial judge rejected that argument. The $68 million verdict included $35 million in punitives.
Plaintiffs lawyers said C.R. Bard did not conduct clinical trials of its products while the company was unable to mention the FDA approval process for products similar to those already approved.
One plaintiff lawyer said: "I'm going to say it again. They didn't think they needed to do a clinical study with this to see what happened in actual women."
McGinnis alleged the Avaulta and Align devices implanted into her pelvic region in 2009 to support a sagging bladder caused tissue inflammation, rigid scarring, intense pain and loss of mobility. They had to be removed during subsequent surgeries.
Made of clear polypropylene, the device consists of a small central mesh with attaching arms and comes in a box kit. The implants were first put on the market in 2007.
The case caught the attention of several interest groups, like New Jersey's plaintiff lawyer group, the New Jersey Association for Justice. Supporting the defendant were groups like the Product Liability Advisory Council, the Healthcare Institute of New Jersey and the Advanced Medical Technology Association.
"On remand, if plaintiffs again claim that defendant acted unreasonably in failing to conduct clinical trials or studies, the trial court will, at the hearing on the parties' motions in limine, fashion appropriate jury instructions conveying the limited use of 510(k) evidence - to refute plaintiffs' claim that defendant acted unreasonably in failing to conduct clinical trials or studies," the decision says.