The pending American Medical Systems’ bellwether cases, which are part of the transvaginal mesh multidistrict litigation (MDL) taking place in the Southern District of West Virginia, now have an established timeline. Thousands of transvaginal mesh lawsuits brought against device maker American Medical Systems, have been created into five MDLs pending in U.S. District Court for the Southern District of West Virginia.
A Pretrial Order dated June 10th was issued to American Medical Systems Inc. by the U.S. District Court for the Southern District of West Virginia. The order states that presentations concerning the selection of bellwether cases must be made on June 25, 2013; the court will select five transvaginal mesh bellwether trials. Also, expert discovery for these bellwether cases is to be finalized by September 25, 2013 (In Re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation, MDL No. 2325). 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
National law firm, Parker Waichman LLP, is representing defendants in the MDL who have alleged that these transvaginal mesh devices are defective and are also capable of causing significant injury. In fact, the U.S. Food and Drug Administration (FDA) has stated that some of the common complications associated with transvaginal mesh include:
- Mesh erosion through the vagina (exposure, extrusion, or protrusion)
- Dyspareunia (pain during sexual intercourse)
- Organ perforation
- Urinary problems
The FDA also stated that complications linked to transvaginal mesh implants are “not rare,” warning that use of these devices may be more harmful when compared to alternative methods for treating pelvic organ prolapse (POP). In fact, the agency has 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 issues.
“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 (POP) and/or Stress Urinary Incontinence (SUI).”
The most debilitating adverse effect associated with the risk of erosion (when the vaginal mesh travels through the body’s tissues) from transvaginal mesh involves the mesh embedding in various areas within the body. When this happens, many surgeries are often needed to attempt to remove the embedded mesh; however, erosion is typically so widespread and significant that the mesh cannot ever be entirely removed.
Recently, the first transvaginal mesh lawsuit to go to trial led to an $11.1 million verdict in favor of the plaintiff. This was the first of 4,000 Gynecare Prolift cases expected to reach trial. In this case, 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 stress urinary incontinence (SUI) and POP and were approved through an FDA fast-track process known as the 510(k). Under this route, formal safety and efficacy reviews are neither required nor performed, which has drawn mounting criticism over the 510(k)’s association with controversial devices such as transvaginal mesh.