Some 35,000 transvaginal mesh lawsuits filed against the device manufacturers allege the products are defective and have resulted in severe health issues, ranging from pain during sex, to erosion of vaginal tissue, infection, and even death.
The mesh is surgically implanted for treatment of pelvic organ prolapse (POP) or urinary incontinence. However, TVM allegedly causes bleeding and pain, and many women have required additional surgeries to have the TVM removed.The lawsuits have been consolidated into six separate multidistrict litigations. Monthly status meetings are held in Charleston, West Virginia, and involve between 50 and 125 attorneys.
The defendants include Bard, Johnson & Johnson and American Medical Systems. Here we present an update on the MDLs:
• US District Judge Robert Goodwin, who is overseeing the MDLs, had originally suggested individual trials of bellwether cases, which would be those most representative of all the lawsuits against the four manufacturers with the oldest and largest number of cases.
• This year, CR Bard, the manufacturer of Avaulta, Faslata, Pelvicol and PelviSoft products, was the first defendant to have lawsuits heard.
• On August 15, a jury awarded $2 million including punitive damages in the first of two Bard TVM lawsuits. Bard settled the second case out of court. The third lawsuit was abruptly withdrawn by the plaintiffs, and the final trial is set to begin on December 3, 2013.
• Other bellwether trials against American Medical Systems Inc., Ethicon Inc. and Boston Scientific Corp are scheduled for 2014.
• On June 14, American Medical Systems agreed to pay $54.5 million to settle some cases. However, the settlement didn’t resolve the majority of the more than 10,000 pending against American Medical’s subsidiary Endo Health Solutions Inc.
• Because a broad settlement of outstanding cases could take a long time, Judge Goodwin has indicated he wishes to speed up the process, and has asked attorneys to suggest a way to consolidate the remaining cases for trial.
• More lawsuits continue to be filed, and some attorneys for the plaintiffs estimate that there could be as many as 60,000 cases involving 80 products.
• Attorneys for the plaintiffs have proposed that Goodwin consolidate 20 cases from a select group of 200 against each of the defendants. These would, in the first stage, present evidence of product liability, and in the second, would hear the cases for damages.
• The defendants oppose the consolidation of the outstanding lawsuits, stating that many of the lawsuits fall short of the mark, and include claims with no-compensable injury, claims barred by the statute of limitations, misfiled claims and improperly filed claims.
Background
Also known as transvaginal slings, the specific complications associated with TVM include the following:
• mesh erosion into the vagina, bladder, intestines and uterus
• infection
• pelvic pain
• urinary problems, including recurrence of prolapse and/or incontinence
• development of urinary retention
• bowel, bladder and blood vessel perforation during insertion
• vaginal scarring
• dyspareunia (pain with sexual relations)
• fistulas and recurrence of prolapsed organs
• neuropathic pain
Some women have undergone additional surgical procedures, often to remove the mesh, along with IV therapy, blood transfusions and drainage of hematomas or abscesses.
TVM history & facts
• The US FDA approved the Avaulta transvaginal mesh device using a fast-track approval process known as 510(k) in 2005.
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• Since the device was approved, the FDA has received over a thousand reports of complications associated with surgical mesh.
• In October 2008, the FDA issued an alert about complications associated with transvaginal placement of surgical mesh to treat pelvic organ prolapse (POP) and Stress Urinary Incontinence (SUI). At the time, the FDA noted that in the previous three years, it received more than 1,000 reports from nine surgical mesh manufacturers of complications associated with their surgical mesh devices.
• On July 13, 2011, the FDA issued a public notice regarding the use of transvaginal mesh (TVM) for the treatment of POP and SUI. Doctors and their patients are now advised to consider alternatives to TVM.