US District judge issues ruling on transvaginal mesh litigation - WOWK 13 Charleston, Huntington WV News, Weather, Sports

US District judge issues ruling on transvaginal mesh litigation

Posted: Updated:

The federal judge presiding over the transvaginal mesh multi-district litigation says details about how Johnson & Johnson's transvaginal mesh product reached the market can't be introduced as evidence because it could confuse the jury.

Transvaginal mesh was used to treat pelvic organ prolapse and urinary incontinence in women, but thousands who were implanted with it claim the product was defective and has caused them serious health problems, many times requiring surgery to reverse its effects.

J&J's Gynecare TVT, manufactured by its Ethicon division, was made of the same material used in Prolene sutures. The sutures had already gone through the U.S. Food & Drug Administration's pre-market approval process, and because of the product similarities J&J sidestepped a full pre-market review and instead used 510(k), an abbreviated process involving much more limited FDA scrutiny. The full pre-market approval process typically takes about 1,200 hours, compared to roughly 20 hours for the 510(k) review process.

U.S. District Judge Joseph R. Goodwin is managing more than 37,000 multi-district litigation cases involving transvaginal mesh products manufactured by six companies – American Medical Systems, Boston Scientific, Coloplast, Cook Medical and C.R. Bard, as well as J & J's Ethicon.

In multi-district litigation, similar cases filed in federal courts throughout the country are transferred to one district court which then manages discovery and pretrial motions. If the cases aren't dismissed and can't be settled through the multi-district litigation process, they'll be transferred back to the original court of record for trial. 

In his 21-page ruling, U.S. District Judge Joseph R. Goodwin said keying on the nuances of the regulatory process "poses a substantial risk of misleading the jury and confusing the issue." While the Prolene suture was approved by FDA for use as a non-absorbable surgical suture, Goodwin said the agency "did not categorically approve Prolene filament for use in medical devices."

"Ethicon would like the court to determine that because the FDA found polypropylene is safe to use as a suture, it is automatically safe to use in transvaginal mesh," he said. "Although purportedly constructed of the same material, it is a different product, used in a different manner, for a different purpose."

But Goodwin said just because the Prolene filament was deemed safe for sutures doesn't necessarily mean the same can be said for its use in transvaginal mesh.

"Essentially, Ethicon argues that because the FDA confirmed the safety and effectiveness of the Prolene suture, and the TVT is composed of the same material as the Prolene suture, the plaintiffs should be barred from arguing that the Prolene material is defective," Goodwin wrote. "At first glance, this argument appears to have some merit — after all, the FDA gave the Prolene suture its stamp of approval and confirmed its safety and efficacy."

Goodwin said  Ethicon's argument ignores the fact that the Prolene suture and the TVT are two entirely different medical devices that went through different FDA processes. 

"Although Ethicon represents that the products are primarily composed of the same material, it does not automatically follow that the material is safe in both devices," he said.