Lawsuit Alleges AMS Vaginal Mesh Injuries

Another lawsuit has been filed alleging injuries due to a transvaginal mesh product. This lawsuit was brought on behalf of a Pennsylvania woman who alleges a vaginal mesh product manufactured by American Medical Systems (AMS) caused her injuries.

According to the complaint, the woman was implanted with the SPARC and IntePro LLP Y-Sling in May 2011 and alleges that these devices are defective and caused her serious and, possibly, permanent injuries. The lawsuit also alleges that the defendant was aware of these defects yet neglected to warn consumers in order to protect its financial interests. The plaintiff is suing for pain and suffering, emotional distress, and economic loss, and also seeks compensation for punitive damages.

Thousands of transvaginal mesh lawsuits have been filed in the United States and many have been consolidated into five multidistrict litigations (MDLs) that are now pending in U.S. District Court for the Southern District of West Virginia:

• In Re: American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation, MDL No. 2325
• In Re: Boston Scientific 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.

According to a June 10, 2013, Pretrial Order issued to AMS, presentations regarding the selection of Bellwether Cases are scheduled for June 25, 2013, with the court expected to select five transvaginal mesh bellwether cases.

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 U.S. Food and Drug Administration (FDA) reports that the most common complications associated with transvaginal mesh surgery may include:

• Mesh erosion through the vagina (exposure, extrusion, or protrusion)
• Pain
• Infection
• Bleeding
• Dyspareunia (pain during sexual intercourse)
• Organ perforation

According to a July 13, 2011, U.S. Food and Drug Administration (FDA) safety alert, complications linked to vaginal mesh implants are “not rare” and the use of such devices may actually be more harmful compared to alternative methods for treating POP. The FDA also asked 33 manufacturers, including Johnson & Johnson, to conduct post-market safety studies to investigate the effect of vaginal mesh on organ damage and other health concerns.

The first transvaginal mesh lawsuit to go to trial led to an $11.1 million verdict in favor of the plaintiff according to Bloomberg News. Johnson & Johnson was ordered to pay $3.35 million in compensatory damages and $7.76 million for punitive damages and was the first of 4,000 Gynecare Prolift cases expected to go to trial.

This recent lawsuit was filed by the national law firm Parker Waichman LLP on May 17, 2013 in the U.S. District Court for the Southern District of West Virginia (Case No. 2:13-cv-11742; MDL No. 2325). American Medical Systems, Inc. has been named as the defendant.