The U.S. Food and Drug Administration’s (FDA) two orders issued this week, reclassifying transvaginal mesh (TVM) as a high-risk device for treating Pelvic Organ Prolapse (POP) and ordering manufacturers to submit a rigorous premarket approval (PMA) application demonstrating safety and effectiveness within the next 30 months, are, according to the agency’s press announcement, based on thousands of reports of adverse events related to mesh used for urogynecological procedures in the past several years.
“The FDA ruling confirms what we have been seeing from Plaintiffs in this litigation – transvaginal mesh used to treat pelvic organ prolapse is responsible for serious, chronic injuries for the women in which it was implanted,” says Leigh O’Dell, a principal with Beasley, Allen, Crow, Methvin, Portis & Miles, P.C., who has been appointed to the Plaintiffs’ Steering Committees for the multidistrict litigation (MDLs) against seven transvaginal mesh manufacturers.
The U.S. Judicial Panel on Multidistrict Litigation granted motions to create consolidated multidistrict litigation (MDLs) against seven transvaginal mesh manufacturers: American Medical Systems, Inc.; Boston Scientific Corp.; C.R. Bard; Coloplast; Cook Medical; Johnson & Johnson and Neomedic International under Chief Judge Joseph R. Goodwin in the U.S. District Court for the Southern District of West Virginia.
Also included in the FDA’s press announcement was a list of the steps that the agency has taken since 2008 “to warn doctors and patients about the use of surgical mesh for transvaginal POP repair.”
Law360 reported that Plaintiffs attorneys say patients would likely use the FDA decision to hit back at any potential arguments by manufacturers that the agency had not previously found the products unsafe.
These orders by the FDA should make for positive changes in the future manufacturing and marketing of TVM devices, but as of yet it is unknown how they might impact the litigation involving these thousands of women who have already undergone procedures and reported serious injuries and complications.
“The biggest tragedy in these cases is that these injuries could have been avoided, if this product had been properly tested, and patients and doctors had been fully informed about the risk involved in using transvaginal mesh,” O’Dell says.
She believes the FDA should expand the warnings to include mesh used for other urogynecological procedures. “The FDA should focus the same scrutiny on devices used to treat stress incontinence, classify those devices as high risk and require manufacturers to conduct clinical trials. We suspect that the results of those clinical trials will further establish that the risks of chronic pain and urinary dysfunction are unacceptably high and that polypropylene mesh is an unsuitable product to be implanted in the female pelvis,” she says.
According to Law360, experts say that Defendants’ attorneys have plausible grounds for excluding the FDA’s current rulings from evidence, in an attempt to subdue their impact on the litigation. The FDA’s 510(k) clearance of the device was deemed not relevant to the case and excluded from the evidence in the first bellwether trial in the MDL in 2013, in which plaintiff Donna Cisson won against C.R. Bard Inc.
Attorneys are at odds about how much impact the Fourth Circuit Court’s decision may have on the future admissibility of FDA-related evidence in the courtroom. Some believe that this will set a precedent to be followed.