Timeline Established for American Medical Systems Transvaginal Mesh Bellwether CasesJun 13, 2013
A timeline has been established for American Medical Systems’ bellwether cases in the transvaginal mesh multidistrict litigation (MDL) taking place in the Southern District of West Virginia. Thousands of transvaginal mesh lawsuits have been formulated into five MDLs pending in U.S. District Court for the Southern District of West Virginia.
According to a June 10th Pretrial Order issued to American Medical Systems Inc. by the U.S. District Court for the Southern District of West Virginia, presentations over the selection of bellwether cases must be made on June 25, 2013, with the court selecting five transvaginal mesh bellwether trials. Expert Discovery for the Bellwether Cases must be completed by September 25, 2013 (In Re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation, MDL No. 2325). The titles of the other four MDLs 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
Parker Waichman LLP represents defendants in the MDL who allege that these medical devices are defective and capable of causing serious injury. In fact, the U.S. Food and Drug Administration (FDA) reports that the most common complications associated with transvaginal mesh may include:
- Mesh erosion through the vagina (exposure, extrusion, or protrusion)
- Dyspareunia (pain during sexual intercourse)
- Organ perforation
- Urinary problems
The FDA has also stated that complications linked to transvaginal mesh implants are “not rare” and warned that use of transvaginal mesh devices may actually be more harmful when compared to alternative methods for treating pelvic organ prolapse (POP). The FDA has also asked 33 manufacturers, including Johnson & Johnson, to conduct post-market safety studies to investigate the effects of vaginal mesh on organ damage and other health concerns.
“On a daily basis, our nurses speak with women who suffer from the serious side effects and complications allegedly caused by their transvaginal mesh implant,” says Gary Falkowitz, Managing Attorney at Parker Waichman LLP. “We look forward to telling their stories so women can make better-informed decisions about whether to use this medical device as treatment for their pelvic organ prolapse and/or stress urinary incontinence.”
Perhaps the most debilitating adverse effect associated with the risk of erosion—meaning, when the transvaginal mesh travels through the body’s tissues—is that the mesh can become embedded in various areas within. This defect can necessitate the need for many surgeries to remove the device; however, erosion is typically so significant and widespread that the mesh cannot ever be completely removed.
The first transvaginal mesh lawsuit to reach trial recently led to an $11.1 million verdict in favor of the plaintiff and was the first lawsuit 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.
Transvaginal mesh devices are approved for the treatment of SUI and POP and were approved through an FDA fast-track process known as the 510(k). Under the 510(k), formal safety and efficacy reviews are neither required nor performed. The process has drawn mounting criticism over its association with controversial devices, such as transvaginal mesh.