In recent weeks, U.S. District Judge Joseph Goodwin has ordered discovery to get started in hundreds of cases involving transvaginal mesh products. Judge Goodwin presides over federal multidistrict litigations (MDLs) against Johnson & Johnson, C.R. Bard, Inc., Boston Scientific Corporation, American Medical Systems, Coloplast Corporation, Cook Medical, Inc., and Neomedic International. Judge Goodwin ordered that discovery commence in 200 cases pending against C.R. Bard, Inc. and another 200 cases pending against Boston Scientific Corporation. These cases involve claims related to transvaginal mesh products used in the treatment of both pelvic organ prolapse and stress urinary incontinence.
Judge Goodwin has also ordered trials this fall in cases involving claims against Boston Scientific Corporation. In September, the claims of several Plaintiffs involving the Pinnacle, a pelvic organ prolapse product, will be tried in a consolidated proceeding. Similarly, in October, several cases involving the Obtryx, a stress urinary incontinence product, will be tried. Both of these trials will take place in the Southern District of Florida. A trial involving Johnson and Johnson’s TVT-O product is set to be tried before Judge Goodwin in August of this year. The TVT-O trial will take place in the Southern District of West Virginia. In addition to cases set for trial in federal court before Judge Goodwin, numerous cases are set for trial in state courts around the country.
In another significant development, medical device manufacturer Endo International PLC agreed to an $830 million settlement to resolve legal claims from women injured by the company’s transvaginal mesh devices. The settlement is subject to several conditions. But, if approved, it will resolve about 20,000 legal claims. Endo International is the parent company of American Medical Systems. American Medical Systems manufactured and marketed numerous transvaginal mesh devices used in the treatment of pelvic organ prolapse and stress urinary incontinence, including the Apogee and Perigee products, which were used to treat prolapse and are no longer being marketed. It should be noted that American Medical Systems’ stress urinary incontinence devices, Monarc and Sparc, remain on the market.
Thousands of women have experienced life-altering injuries as a result of these defectively designed mesh implants. It’s good to see that Endo is beginning to accept responsibility for harm done by its products. Hopefully other manufacturers will take similar steps soon but, until that day, lawyers in our firm remain resolute in their commitment to prosecute the claims of thousands of women who have been needlessly injured by these products.
It should be noted that transvaginal mesh devices were not tested in patients prior to their being approved for use. Instead, they were fast-tracked using a process whereby approval for new devices deemed “moderate risk” is granted if similar products are already on the market. However, in the face of rising reports of serious injuries linked to the devices, the FDA in late April proposed stricter regulation for the surgical mesh. The FDA proposed upgrading the mesh to a “high risk” status, which would require further pre-market testing for future transvaginal mesh products to prove safety and efficacy before approval is granted.
Thousands of women have filed claims alleging they suffered injuries after being implanted with transvaginal mesh. Transvaginal mesh is used to repair conditions such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh is implanted through the vagina and is used to shore up pelvic organs that have become displaced due to age, childbirth, hysterectomy or obesity. The most common problems with transvaginal mesh include erosion into surrounding tissue, chronic pain, painful intercourse, and infection. It can take numerous surgeries to remove the mesh and, even then, a full recovery may not be possible.
If you need more information on this litigation, contact Leigh O’Dell, a lawyer in our firm’s Mass Torts Section, at 800-898-2034 or by email at Leigh.Odell@beasleyallen.com. Leigh is serving on the Plaintiffs Steering Committee for the multidistrict litigations and she is the lead lawyer at Beasley Allen for these cases.
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