Four bellwether cases have been selected for American Medical Systems Inc.’s multidistrict litigation (MDL) involving, according to a July 1 pretrial order issued by the U.S. District Court for the Southern District of West Virginia. The four bellwether cases, which involve issues over transvaginal mesh devices, are:
- Lisa Fontes, et al. v. American Medical Systems, Inc. 2:12-cv-02472
- Joann Serrano v. American Medical Systems, Inc., et al. 2:12-cv-03719
- Debbie K. Jilovec v. American Medical Systems, Inc. 2:12-cv-05561
- Mary Weiler, et al. v. American Medical Systems, Inc. 2:12-cv-05836
The first bellwether trial is scheduled to begin on December 3, 2013. The second is scheduled for May 6, 2014. According to the order, U.S. District Judge Joseph R. Goodwin, will decide the trials’ chronological schedule.
“Nailing down the bellwethers gets us that much closer to the beginning of the first trial,” said Gary Falkowitz, Managing Attorney at Parker Waichman LLP. “With the dangers allegedly associated with these products, I would not be surprised if these bellwether trials result in plaintiff verdicts.”
Thousands of transvaginal mesh lawsuits have been formulated into five MDLs pending in U.S. District Court for the Southern District of West Virginia. In addition to In Re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation, MDL No. 2325, the titles of the other four are:
- In Re: Boston Scientific Corp., Pelvic Repair Systems Products Liability Litigation, MDL No. 2326
- In Re: C.R. Bard, Inc., Pelvic Repair Systems Products Liability Litigation, MDL No. 2187
- In Re: Ethicon, Inc., Pelvic Repair Systems Products Liability Litigation, MDL No. 2327
- In Re: Coloplast Corp., Pelvic Support Systems Products Liability Litigation, MDL No. 2387.
Transvaginal mesh devices were approved to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP), conditions most commonly caused by weakened pelvic muscles. Vaginal mesh devices are supposed to help correct these conditions by providing additional strength to the pelvic walls. The vaginal mesh devices were approved through a U.S. Food and Drug Administration (FDA) fast-track process known as the 510(k). Under the 510(k), a formal review for safety and efficacy is neither required nor performed. Because the 510(k) route has been used to gain clearance for transvaginal mesh and other controversial devices, the process has drawn increasing criticism.
Thousands of women were recipients of transvaginal mesh devices and, now, the devices have come under intense scrutiny as many women who were implanted with these devices are reporting complications allegedly related to their defects. The FDA reports that the most common complications associated with transvaginal mesh device implants may include:
- Mesh erosion through the vagina (also called exposure, extrusion, or protrusion)
- Pain during sexual intercourse (dyspareunia)
- Organ perforation
- Urinary problems
The FDA has also stated that complications linked to transvaginal mesh implants are “not rare” and warned that use of such devices may actually be more harmful when compared to alternative methods for treating POP. The FDA has also asked 33 manufacturers to conduct post-market safety studies in order to investigate the effect of vaginal mesh on organ damage and other health concerns.
Recently, the first transvaginal mesh lawsuit to go to trial led to an $11.1 million verdict, in favor of the plaintiff. That lawsuit was the first of 4,000 Gynecare Prolift cases expected to go to trial. Johnson & Johnson was ordered to pay $3.35 million in compensatory and $7.76 million in punitive damages.