The Transvaginal Mesh Litigation

Multidistrict litigation (MDL) is a consolidation of civil cases transferred from different jurisdictions around the country to a single U.S. District Court to achieve certain pre-trial efficiencies. All transferred cases must be marked by common fact questions, and are overseen by a federal judge. The aim of this consolidation is to preserve judicial resources, eliminate redundancies in the fact-finding process and prevent inconsistencies in rulings. An MDL permits for “tag-along” cases to be added to the litigation at later points in time. A judge in an MDL can dismiss certain counts in a lawsuit, but if a case is not dismissed or a settlement is not reached, it can be sent back (remanded) to its court of origin jurisdiction for trial.

In February 2012, MDL litigation against the mesh manufacturers began. This legal process streamlines hundreds of individual claims against the companies. The U.S. District Court for the Southern District of West Virginia is the site of the coordinated litigation for transvaginal pelvic mesh lawsuits and there are approximately 70,000 cases against different manufacturers. Judge Goodwin is the federal judge who oversees the consolidation of the transvaginal mesh cases in Charleston, West Virginia.

Defendants include :

• In re American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation (MDL 2325)
• In re Boston Scientific Corp., Pelvic Repair Systems Products Liability Litigation (MDL 2326)
• In re Coloplast Corp. Pelvic Support Systems Products Liability Litigation (MDL 2387)
• In re C.R. Bard, Inc., Pelvic Repair Systems Products Liability Litigation (MDL 2187)
• In re Ethicon, Inc., Pelvic Repair Systems Products Liability Litigation (MDL 2327)

Bellwether trials have been used in our legal system where there are large numbers of similar claims or lawsuits against the same defendant. A bellwether trial is a procedure where a representative case or cases are selected to be tried before a jury to assist the court and the parties in evaluating information and evidence, and possibly predicting future trends about a larger group of cases. Judge Goodwin is overseeing the bellwether trials.

The vaginal mesh litigation seeks financial compensation for women who have suffered serious and debilitating complications following surgical repair of pelvic organ prolapse and female stress urinary incontinence.

Women implanted with transvaginal mesh suffer the following side effects:

• Already had or need corrective surgery
• Infection
• Movement of the mesh
• Painful sexual intercourse
• Shrinkage of the mesh
• Urinary tract erosion
• Vaginal migration or movement
• Vaginal scarring
• Vaginal wall erosion

Women who filed transvaginal mesh lawsuits allege that mesh manufacturers “had a legal duty to ensure the safety and effectiveness of their pelvic mesh products,” but instead provided patients with “false and misleading information” about the products’ effectiveness and safety.

Lawsuits have claimed that:

• Companies misled the FDA, medical community and the public at large regarding the safety and efficacy of transvaginal products
• Companies failed to conduct testing and research to determine risks of surgical mesh used for female pelvic disorders
• Companies failed to establish methods that are safe and effective for removal of transvaginal mesh implants
• Companies concealed knowledge that their products could cause permanent and debilitating injuries
• Companies had a legal duty to insure the safety and effectiveness of their products but provided false and misleading information

Lawsuits accuse mesh manufacturers of :

• Actively and intentionally misleading the FDA, the medical community, patients and the public at large regarding the safety and effectiveness of transvaginal mesh products
• Failing to conduct proper testing and research to determine the risks of surgical mesh for use to treat female pelvic floor disorders
• Failing to establish safe and effective methods for removal of transvaginal mesh
• Failing to adequately warn of potential complications and injury

Some notable cases and settlements are :

• Bakersfield, CA couple were awarded a jury verdict of $5.5 million against C.R. Bard (2012)
• Atlantic City, NJ woman was awarded a jury verdict of $3.35 million against Ethicon (2013)
• Charleston, WV woman was awarded a jury verdict of $2 million against C.R. Bard (2013)
• An undisclosed number of lawsuits were settled by an agreement to pay $54 million by Endo Health Solutions, parent company of American Medical Systems (June 2013)