Lawyers USA Interviews Derek Potts Regarding Vaginal Mesh Litigation

Pelvic mesh litigation rising

Lawyers USA, Sylvia Hsieh
November 4, 2011

Product liability lawsuits alleging that vaginal mesh devices implanted in women are defective and that manufacturers failed to warn about their dangers are shaping up into a widespread mass tort.

The lawsuits involve dozens of manufacturers of various products intended to deal with weakened muscles surrounding organs in the pelvic area, a condition called pelvic organ prolapse.

There are already hundreds of cases around the country and plaintiffs’ lawyers say the number of calls they are receiving has picked up dramatically since the Food and Drug Administration issued an alert questioning the products’ safety and efficacy.

“These cases are expected to grow exponentially. Since the FDA warning came out in July, we have seen a huge volume of cases come into our office,” said Fidelma Fitzpatrick, an attorney at Motley Rice in Providence, R.I., and lead plaintiffs’ counsel in the consolidated state court cases in New Jersey against one of the manufacturers, C.R. Bard.

Fitzpatrick represents a California woman in one of the first of these cases scheduled for trial in April 2012.

Plaintiffs Ellen Ambroff and her husband Terry allege that after Ellen received the APOGEE synthetic mesh implant in June 2006, she was unable to sit, lie down or walk for extended periods of time, and required two additional surgeries that left her with “gross deformities” of the vagina and unable to control her bowel functions, perform household tasks or stay employed. The couple seeks compensatory and punitive damages against the manufacturer, American Medical Systems Inc.

In federal court, multidistrict litigation has formed in West Virginia against C.R. Bard.

“We currently represent women in 37 states as well as Canada and Europe and have over 500 cases that either have been or will be filed in the fairly near future, with more cases weekly,” said co-lead counsel of the federal MDL, Henry G. Garrard III, a partner at Blasingame, Burch, Garrard & Ashely in Athens, Ga.

C.R. Bard spokesperson Janine Kramer did not respond to questions seeking comment for this article.

“We’re talking about 20-some different products litigated in different spots. … There will be thousands of cases,” said Derek Potts of Potts Law in Kansas City, Mo., co-lead counsel for the plaintiffs in the federal multidistrict litigation, who said additional MDLs and consolidations are in the works.

The four biggest defendants are C.R. Bard, Johnson & Johnson, American Medical Systems Inc., and Boston Scientific. Attorneys for the four companies did not return calls seeking comment.

‘The mesh is a mess’

The lawsuits allege that the mesh products, made of the plastic polypropylene or bovine material, are incompatible with placement in a woman’s pelvic area and result in various complications, including eroding, migrating, adhering or poking through various organs.

“The mesh is a mess,” said Calvin Warriner, an attorney at Searcy Denny Scarola Barnhart & Shipley in West Palm Beach, Fla., who says the estimated number of vaginal mesh implants in women across the country is in the hundreds of thousands. “They put gazillions of these in women, they don’t work well, and as a result many, many, many women have problems.”

The vast majority of cases deal with products intended to prevent pelvic prolapse, in which weakened structures around organs such as the bladder, small bowel and rectal canal cause the vagina to bulge or invert. A minority of cases involve similar products inserted to treat urinary incontinence.

The primary allegation is that the mesh is not appropriate for the dynamic movement of a woman’s pelvic area.

“The pelvic area is not a static area. … We think the mesh is overengineered, too strong and too inelastic to mate with the elasticity of the pelvis,” said Garrard.

“It’s like putting a cheesegrater into a woman’s pelvis. The anatomy of a woman’s pelvis is it moves around a lot,” said Warriner.

Other complaints are that the products, both polypropylene and those made of bovine material, are incompatible with the pH and bacterial environment in the vagina, causing a vicious cycle of infection and inflammation.

Plaintiffs’ attorneys predict large damages in many of the cases.

“What we hear women complain about is that it hurts like hell, they can’t stand up or sit down, can’t have sex and a nasty brown discharge comes out of places it shouldn’t,” said Warriner, who added that many women have required multiple surgeries with little relief.

A California woman in a bellwether case set for trial in February alleges that she underwent nine surgeries to try to remove a C.R. Bard vaginal mesh product, according to her attorney Gene Lorenz of Gene Lorenz Law Office in Bakersfield, Calif.

“The injuries range from the horrible to the horrific,” said Fitzpatrick. She also said that the vast majority of plaintiffs’ spouses have loss of consortium claims based on “debilitating pain during intercourse, making marital relations difficult if not impossible.”

On the market, but not approved

As part of their allegations that the product is dangerously defective and manufacturers failed to warn of the risks, plaintiffs also allege that the manufacturers pushed the products through an expedited FDA process known as 510(k).

Under 510(k), a device maker can get the FDA to “clear” a product for market without going through the more rigorous premarket “approval” process if it shows that the product is “substantially” equivalent to an existing product, in this case hernia mesh.

But plaintiffs’ attorneys say the use is not the same and the manufacturers should have conducted more research before getting clearance.

“It’s totally different to put this in the pelvis and to use it in a hernia. … The vaginal tissue is not a big strong muscle, it’s fairly thin tissue. Our position is these mesh products do not deal with the motion and pressures native to the pelvis,” said Garrard.

According to a Bloomberg article published in Oct. 2011, the FDA awarded 510(k) approval to Johnson & Johnson for a vaginal mesh product based on its similarity to a Boston Scientific vaginal mesh system that had been pulled from the market amid safety complaints.

Lorenz, the attorney trying the first case, is seeking punitive damages from C.R. Bard on the theory that the company concealed studies, including a 2006 French government report, showing that the product causes severe damages.

“There was no mention in the 510(k) process by Bard that ‘Gee whiz, this product got shot down in France,’” said Lorenz.

Another criticism is that the vaginal mesh is inserted in a blind procedure, where doctors cannot see where they are anchoring the device.

“The area is very, very small and there is virtually no margin for error,” said Fitzpatrick.

According to Potts, over 90 percent of medical devices get on the market using the 510(k) process.

“Our argument is that for patient safety, they should have done clinical trials to test these out,” said Potts.

Potts added that because the FDA never approved the products, the 510(k) process also robs device makers of the argument in court that state law claims are preempted.

In September, an FDA advisory committee voted to change vaginal mesh products from a class 2 to a class 3 device, which would require manufacturers test the mesh on humans and go through the full approval process.