Bellwether Trial Date Set for AMS Mesh Lawsuits
Thousands of women have filed lawsuits in federal court alleging serious injuries from vaginal mesh products. Cases have been brought against six major manufacturers: American Medical Systems (AMS), C.R. Bard, Boston Scientific, Ethicon, Cook Medical, and Coloplast.
In order for the judicial system to efficiently handle the lawsuits initiated against each manufacturer, the Judicial Panel consolidated the cases into six separate multidistrict litigations (MDLs). Judge Joseph R. Goodwin in the U.S. District Court for the Southern District of West Virginia was assigned to preside over the legal proceedings for the vaginal mesh MDLs. The first trials for AMS mesh lawsuits are scheduled to begin in December 2013.
Life-threatening transvaginal mesh complications
The vaginal mesh devices were approved by the FDA to treat stress urinary incontinence and pelvic organ prolapse. Most mesh manufacturers weren’t required to conduct clinical studies that demonstrated their vaginal mesh devices were safe and effective since they were deemed substantially equivalent to other products that were approved by the FDA. Since entering the market, post-marketing data and FDA adverse event reports revealed that women have suffered severe transvaginal mesh complications. Side effects linked to the vaginal mesh devices include abdominal pain, infections, mesh erosion, organ perforation, vaginal scarring, and pain during sexual intercourse. Some patients also experienced a recurrence of pelvic organ prolapse and urinary incontinence.
The FDA received nearly 4,000 adverse event reports regarding transvaginal mesh devices from 2005 through 2010. In July 2011, the FDA issued a warning to patients and healthcare providers about the serious health risks associated with mesh products and advised them that complications were not a rare occurrence. There wasn’t any scientific evidence that suggested the surgical mesh devices were more effective than non-surgical methods for treating stress urinary incontinence and pelvic organ prolapse. In January 2012, the FDA ordered several manufacturers to conduct clinical trials to further evaluate the safety and efficacy of vaginal mesh products.
Transvaginal mesh lawsuits
Prior to the FDA’s warning, many patients may not have been able to link their medical problems to defects with the mesh devices. After the FDA publicly announced the risks of pelvic mesh products, product liability lawsuits quickly began to accumulate in federal and state courts. To date, over 20,000 lawsuits have been filed against vaginal mesh manufacturers.
The complaints accuse the manufacturers of negligence, designing a defective medical product, fraudulent concealment, and failure to conduct sufficient clinical tests as well as other allegations. The plaintiffs state that the manufacturers knew or should have known that the surgical mesh implants were not safe for their intended use. The legal complaints also allege that the manufacturers did not fulfill their duty to adequately warn patients and healthcare professionals about the health risks.
Federal trials for AMS mesh lawsuits
There are currently more than 6,000 cases pending in the AMS multidistrict litigation. On July 1, 2013, a pre-trial order filed in the U.S. District Court for the Southern District of West Virginia revealed the first series of four AMS mesh lawsuits that are eligible to go to trial. According to the court document, the first trial is scheduled to start on December 3, 2013 and another trial will begin on May 6, 2014. After hearing from the attorneys handling the four lawsuits, Judge Goodwin will decide which of the cases will go to trial in December.
There is speculation that AMS may try to settle the lawsuits before the trial starts; an article in Bloomberg News stated that a $54.5 million settlement was reached for some of the vaginal mesh lawsuits. According to a securities filing, AMS set aside the money for an undisclosed number of legal disputes regarding the vaginal mesh devices. AMS executives disputed the implication that they plan on settling any of the claims included in the vaginal mesh MDL in West Virginia. They contend that they will defend those pending cases and any new cases that are filed.
- FDA: Update on Serious Complications Associated with Transvaginal Placement for Surgical Mesh for Pelvic Organ Prolapse http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm
- FDA: Urogynecologic Surgical Mesh Implants http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/urogynsurgicalmesh/
- Bloomberg: Endo Health Unit Pays $55 Million in Vaginal Mesh Accord http://www.bloomberg.com/news/2013-06-21/endo-health-unit-pays-55-million-in-vaginal-mesh-accord.html