A West Virginia judge who is presiding over tens of thousands of transvaginal mesh lawsuits has dealt defense lawyers for Johnson & Johnson’s Ethicon unit a legal setback in a ruling over the company’s Gynecare mesh.
U.S. District Judge Joseph R. Goodwin recently ruled against Ethicon lawyers in their attempts to present evidence to jurors about the Food and Drug Administration’s approval process because the evidence might confuse jurors.
Ethicon lawyers will not be able to argue that Gynecare mesh was safe because it was put on the marketplace after an expedited FDA approval process that involved Prolene sutures, which are composed of the same material but which underwent more intensive FDA scrutiny.
As The State Journal, West Virginia’s business newspaper reported:
“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.'”
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, Goodwin said in his ruling.
Legal experts say it would not be surprising for lawyers for victims in these mesh cases to use the same language and argue at trial that the Prolene suture and the transvaginal mesh 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,” the judge said in his ruling.
Goodwin is overseeing more than 37,000 transvaginal mesh lawsuits that have been assigned to him in a multidistrict litigation against such major manufacturers as Johnson & Johnson’s Ethicon unit, American Medical Systems, Boston Scientific, Coloplast, Cook Medical and C.R. Bard.
Transvaginal mesh was used in thousands of operations to mend weakening abdominal muscles in women as they aged and developed pelvic organ prolapse and urinary incontinence. The lawsuits claim the products were defective, the public was not adequately warned and they should be compensated for serious health problems they suffered.
Read more about mesh lawsuits.