The medical device industry’s largest national lobbying group, AdvaMed, is backing Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon in its appeal to the U.S. Supreme Court over a $3.3 million loss in a product liability lawsuit brought over its TVT-O pelvic mesh.
A jury in the U.S. District Court for Southern West Virginia awarded Jo Huskey and her husband damages of $3.3 million, finding in September 2014 that the TVT-O transvaginal sling caused her injuries and that the company failed to warn about the stress urinary incontinence treatment’s risks. A federal judge later shot down Ethicon’s bid to overturn the verdict and denied the company’s move for a new trial; Ethicon then appealed to the U.S. Court of Appeals for the 4th Circuit.
In January a 3-judge panel at the 4th Circuit denied the appeal, ruling that the Huskeys proved their case.
Today AdvaMed’s assistant general counsel, Matthew Wetzel, said the trade group filed an amicus curiae brief with the Supremes last week, asking them to review a lower court decision blocking the introduction of evidence that J&J met the FDA’s 510(k) clearance requirements.
“Representing much more than a disagreement over what evidence is admissible, the case provides a chance to restore fundamental principles of fairness and transparency in fact-finding efforts at trial,” Wetzel said in prepared remarks. “We are asking the court to grant a writ of certiorari to hear the case, which could reverse a trend of evidentiary decisions in the 4th Circuit and beyond that prohibit defendants in medical product liability cases from presenting evidence of a product’s 510(k) premarket clearance. In effect, such decisions prevent juries from hearing the full story, which is fundamentally unfair. Worse, it can result in FDA’s assessment of a product’s safety and effectiveness being supplanted by a court ruling.”
“We believe that the Supreme Court has an opportunity to level the playing field and give medical device manufacturers a fair shake at defending themselves,” added Ann Bunnenberg, president & COO of Electrical Geodesics and chairwoman of AdvaMed’s legal committee.