Transvaginal Mesh Settlements

Pelvic organ prolapse (POP) affects 3.3 million women in America, according to the National Association for Continence. While up to 50 percent of women who have given birth experience some degree of prolapse – pelvic organ descent or shifting – only about 10 to 20 percent experience adverse symptoms, such as protrusion, pain or urinary incontinence.

Transvaginal mesh devices have been implanted in millions of women for the treatment of POP since gaining FDA approval in the late 1990s. The aim of vaginal mesh implants is to provide reinforcement to natural tissue that has failed to support the bladder, uterus or bowel.

Mesh complications prompt revision surgeries

The International Urogynecological Association reports that mesh can be more effective than traditional surgery in certain circumstances – such as vaginal vault and bladder (cystocele) prolapse. “However, there is not much good evidence about how well this procedure works in the long term (over two years),” they remark, “and there is some concern regarding potential complications that are unique to permanent synthetic mesh placed through the vagina.”

These complications may include:

• Serious bleeding requiring blood transfusions
• Injury to the bladder, bowel or blood vessels
• Scarring and disfigurement
• Infection and abscess development
• Vaginal bleeding and discharge
• Mesh exposure through the vaginal skin
• Severe buttocks and groin pain
• Chronic vaginal pain and painful intercourse

Thousands of vaginal mesh lawsuits filed

However, a 2011 FDA safety memo indicated that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.” They said that 2,874 adverse reports were filed from 2008 to 2011 alone. Complaints ran the gamut from mesh erosion, protrusion into other tissues and infections, to painful intercourse, bleeding and damage to other organs.

So many women have filed lawsuits against mesh manufacturers that the cases have been organized into the following federal multidistrict litigation proceedings:

• MDL 2004: Mentor Corp. (Johnson & Johnson) ObTape Transobturator Sling Products – 514 cases*
• MDL 2187: C.R. Bard Pelvic Repair System Products – 5,275 cases*
• MDL 2325: American Medical Systems (Endo Health) Pelvic Repair System Products – 11,376 cases*
• MDL 2326: Boston Scientific Corp. Pelvic Repair System Products – 7,131 cases*
• MDL 2327: Ethicon (Johnson & Johnson) Pelvic Repair System Products – 11,376 cases*
• MDL 2387: Coloplast Corp. Pelvic Support Systems Products – 1,101 cases*
• MDL 2440: Cook Medical Pelvic Repair System Products – 133 cases*

*Note: Case information is based upon data from the Judicial Panel for Multidistrict Litigation as of November 18, 2013.

Plaintiffs are seeking compensation for past and future medical expenses, loss of income, loss of spousal consortium, as well as emotional pain and suffering. Inside sources say the number of claims could swell to 50,000 or more in the coming months and transvaginal mesh settlements have already been reached in a handful of cases.

Sympathetic juries award plaintiffs millions of dollars

The first vaginal mesh case went to trial in July 2012. Christine Scott was awarded $5.5 million for medical expenses, pain and suffering in a suit against C.R. Bard. Her husband received $500,000 for loss of consortium. Christine Scott was once an avid runner, but her dreams were dashed when she had to endure eight surgeries and nine other medical procedures related to the implantation of two Avaulta Plus mesh devices. Despite all the interventions, she continues to suffer from chronic pain, sexual dysfunction and continued incontinence. The Bakersfield jury found Bard officials were negligent in their handling of the devices, stating that they didn’t properly test the product before putting it on the market.

That same year, a New Jersey jury ordered Johnson & Johnson to pay $11.1 million in damages, including $3.35 million to 47-year-old plaintiff Linda Gross for “defective design and manufacture” of the product, and another $7.76 million in punitive damages for failing to fully disclose proper warnings and instructions. The plaintiff, a South Dakota nurse, had suffered mesh erosion, scar tissue, inflammation and neurologic compromise. It took 18 operations to repair the damage caused by the Gynecare Prolift vaginal mesh system.

Federal MDL vs. state court lawsuit

Plaintiffs have filed actions in state and district courts across the country. The majority of federal mesh lawsuits have been consolidated in one of the seven pending MDLs. Six of these MDLs are proceeding in the U.S. District Court for the Southern District of West Virginia, while the Mentor Corp. MDL is taking place in the Middle District of Georgia. Centralizing similar claims as part of an MDL makes pretrial proceedings more efficient, helping parties avoid duplicative discovery and inconsistent judicial rulings.

Some states, like California, have a mechanism known as multi-county litigation, which works similarly to MDL, but involves state court claims grouped together before a common judge. The state Supreme Court may decide to transfer cases to MDL if the state courts become overburdened. There are currently state-level transvaginal mesh claims pending in West Virginia and New Jersey.

Plaintiffs can also choose to file a class action lawsuit, where one common complaint is lodged against the defendant and a jury award or vaginal mesh lawsuit settlement is then split among the group. Currently, there are no class action suits pending against the manufacturers of pelvic mesh systems.

Compensation anticipated in vaginal mesh lawsuit settlements

It is impossible to predict exactly how much money plaintiffs may receive from jury awards or negotiate in settlements. When coming up with the final tally, judges and juries consider “compensatory damages,” which take into account the complication severity, the duration of the medical issues, the cost of revision surgeries, the extent that injuries disrupt day-to-day life, lost wages and medical expenses. On top of that, they may also consider punitive damages, which are designed to reform or deter the defendant from engaging in similar conduct. If early jury verdicts continue to be favorable to plaintiffs, it’s likely defendants will begin to offer transvaginal mesh settlements, rather than deal with a glut of lengthy, costly and embarrassing jury trials.

Recent transvaginal mesh settlements negotiated

In September 2013, a federal jury awarded plaintiff Donna Cisson $2 million in damages for injuries she sustained from Bard’s Avaulta mesh product. Two other plaintiffs settled with Bard for an undisclosed sum. Not surprisingly, lawyers for C.R. Bard, Endo Health Solutions, Boston Scientific, Coloplast Corp and Cook Medical told Bloomberg News that talks regarding vaginal mesh lawsuit settlements have officially begun.

“The liability seems pretty clear on these cases, so settlement makes sense,” University of Richmond product-liability law professor Carl Tobias told Bloomberg News. “Given how serious the injuries are and the number of cases, when you do the math, you can easily come up with a multibillion-dollar settlement.”