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.
A recently filed pretrial order issued by Judge Joseph Goodwin noted that it was necessary for the parties involved to resubmit their bellwether selections to include more representative cases. This criterion affects the selection of cases to serve as bellwether trials in the transvaginal mesh Multidistrict Litigation (MDL) that involves device maker, Boston Scientific Corp. The MDL is in U.S. District Court, Southern District of West Virginia.
The parties were directed to submit revised bellwether selections by August 12, 2013, from which the Court will select six, not five, according to the Order. The Order also indicated that the three bellwether rounds remain scheduled for February 11, 2014; June 17, 2014; and September 9, 2014. According to Judge Goodwin’s parameters, only single-product cases will be eligible and each plaintiff’s age range should be from 40 to 60 years old at the time they received the implant.
“We are indeed pleased that this small speed bump regarding bellwethers has been overcome,” said Gary Falkowitz, Managing Attorney at Parker Waichman LLP. “Considering the kinds of injuries these medical devices are alleged to have caused, it is important that we continue moving forward.”
Thousands of transvaginal mesh lawsuits have been formulated into six MDLs that are pending in U.S. District Court for the Southern District of West Virginia. Including the Boston Scientific Corp., Pelvic Repair Systems Products Liability Litigation, there are six MDLs:
- In re: Boston Scientific Corp., Pelvic Repair Systems Products Liability Litigation, MDL No. 2326
- In Re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation, MDL No. 2325
- 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
- In Re Cook Medical, Inc., Pelvic Repair System Products Liability Litigation, MDL No. 2440
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.
The FDA has 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 also recently reported that the most common complications associated with transvaginal mesh may include:
- Exposure, extrusion, or protrusion (mesh erosion through the vagina)
- Pain during sexual intercourse (dyspareunia)
- Organ perforation
- Urinary problems
The first transvaginal mesh lawsuit to go to trial recently led to an $11.1 million verdict in favor of the plaintiff, Bloomberg News reported. That lawsuit was the first of 4,000 Gynecare Prolift cases expected to go to trial. Johnson & Johnson, maker of the Gynecare Prolift, was ordered to pay $3.35 million in compensatory damages and $7.76 million in punitive damages.