Donna Cisson already had lost some control of her bladder. But when her problems began interfering with her sex life, she turned to a specialist who diagnosed her with pelvic organ prolapse—a condition that can cause urinary incontinence or pain, sometimes during sex.

In 2009, Cisson underwent surgery in Georgia to implant a transvaginal mesh device to solve the problem. Instead, she began suffering from bleeding and pain during sex, plus bladder spasms, and had to undergo another two surgeries to remove the device. She and her husband sued the device manufacturer, C.R. Bard Inc., in 2011, claiming the company knew about the problems associated with its product but failed to adequately warn doctors.

The case is the first to go to trial of about 20,000 lawsuits filed over transvaginal mesh products, which are used to treat stress urinary incontinence and pelvic organ prolapse. The cases are pending in multidistrict litigation before U.S. District Judge Joseph Goodwin in Charleston, W.Va. Goodwin will oversee Cisson’s trial, which is scheduled to begin on Monday.

The litigation has expanded significantly during the past year. Goodwin, who has had the Bard cases since 2010, was handed four additional MDLs last year against defendants Ethicon Inc., a division of Johnson & Johnson; American Medical Systems Inc.; and Boston Scientific Corp. On August 6 of last year, Goodwin received another group of cases against Coloplast Corp., and on June 11, a sixth against Cook Medical Inc.

The next status conference in all the litigation is scheduled for August 1.

In addition to the federal docket, thousands more cases are pending in state courts across the country, two of which have resulted in jury verdicts during the past year.

“There are a number of problems with these products in a number of areas,” said Harry Bell of The Bell Law Firm in Charleston, who is co-liaison counsel. “I have heard this is the largest MDL ever, when you consider all six of them together, with the number of cases. So it’s pretty significant in size.”

Federal warnings

The litigation accelerated after the U.S. Food and Drug Administration issued a safety warning in 2011 that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare,” referring to pelvic organ prolapse. The FDA had issued a public health notification about the products in 2008.The FDA asked manufacturers to submit additional studies of the safety and effectiveness of the products.

In the Bard MDL, Goodwin has separated the trials into groups based on the medical problems the devices were designed to treat. There are four trials in the first group, starting with Cisson’s case, all involving Bard’s Avaulta Plus or Avaulta Solo polypropylene mesh devices, used to treat pelvic organ prolapse. The women in all four cases allege they had to undergo revision surgeries to remove the devices. The second trial, scheduled for July 29, involves a North Carolina woman, and a third, scheduled for August 19, was brought by a woman in Wisconsin. The fourth case, scheduled for trial on September 9, involves a Mississippi woman.

A second group of trials against Bard involve women who were implanted with devices to treat stress urinary incontinence.

“The Company intends to vigorously defend its Avaulta product at issue in that litigation, as well as in the subsequent trials,” Scott Lowry, vice president and treasurer of C.R. Bard, wrote in an emailed statement to the NLJ.“Surgical procedures using medical devices have known complications. Despite those known complications, the transvaginal mesh devices at issue have all been cleared by the FDA and have never been recalled. The FDA cleared the devices as safe and effective when used in accordance with their instructions. After considering the evidence presented, we believe the jury will find that Bard properly designed the device and also properly warned physicians of all known complications associated with the implantation of surgical mesh.”

In Cisson’s case, Bard won dismissal of some claims on summary judgment. Bard attorney Lori Cohen, chairwoman of the pharmaceutical, medical device & health care litigation practice at Greenberg Traurig in Atlanta, had argued in court documents that Cisson had failed to provide enough evidence of a manufacturing defect and that Bard had provided adequate warnings about the device to her physician. She also argued that Cisson’s obesity, and her reluctance to take a prescribed cream after her implantation surgery, contributed to her problems.

Additionally, she argued that punitive damages were unnecessary since Cisson had not shown evidence of “egregious and outrageous behavior,” but that if they remained part of the case, the potential damages should be decided during a second trial given the “graphic nature of Plaintiffs’ alleged injuries.”

Cisson’s attorney, Henry Garrard III, a partner at Blasingame Burch Garrard & Ashley in Athens, Ga., argued that Bard went to “significant lengths” to conceal that its device contained a material prohibited for use in humans. The product’s design also came with “significant medical risks,” he wrote. Bard released the device into the market without conducting its own clinical trials while, at the same time, obtaining information through animal testing that showed “serious complications.”

On June 4, Goodwin allowed Bard to put on evidence of Cisson’s obesity and failure to take a prescribed cream as a potential defense and threw out some of the claims, including manufacturing defect. But he found that Cisson had provided enough evidence that Bard failed to warn doctors about the device’s problems. He rejected Bard’s attempt to eliminate the potential for punitive damages, finding “there are genuine issues of material fact as to whether the warnings provided by Bard were adequate.” But he bifurcated potential punitive damages from the case.

Neither Garrard nor Cohen returned calls for comment.

While Cisson’swill be the first in federal court to go to trial, juries in at least two state courts have rendered verdicts. A jury in Bakersfield, Calif., awarded a woman and her husband $5.5 million in damages on July 20. Christine Scott and her husband had alleged injuries against Bard caused by its Avaulta device.

Lowry wrote in his email that Bard has appealed the Scott verdict on the ground that the trial was “impacted by reversible error which led the jury to reach an incorrect result.” In its June 6 opening brief before California’s Fifth District Court of Appeal, Bard attorney Michael Brown, a partner in Reed Smith’s Los Angeles office, wrote that the errors included certain rulings at trial that allowed Scott to introduce evidence of other transvaginal mesh litigation.

Earlier this year,a jury in Atlantic City, N.J., awarded more than $11 million to a woman in South Dakota who had sued Johnson & Johnson and its Ethicon unit after undergoing 18 operations in six years following implantation its Gynecare Prolift device. The award included $3.35 million in compensatory damages, issued on February 25 for failing to warn her surgeon about the risks, and $7.76 million in punitive damages, granted on February 28.

The jury did not find that Johnson & Johnson, based in New Brunswick, N.J., had negligently designed its product.

“If you matched up the statements they gave patients and doctors, against internal documents in deposition testimony, we were able to show things they were telling patients and doctor weren’t true, and they knew it wasn’t true,” said Adam Slater of Mazie Slater Katz & Freeman in Roseland, N.J., who tried the case for Linda Gross. Specifically, Johnson & Johnson failed to warn about problems that could destroy a young woman’s sex life, he said.

Atlantic County, N.J., Superior Court Judge Carol Higbee, who is overseeing the coordinated transvaginal mesh litigation in New Jersey state courts, has yet to rule on Johnson & Johnson’s motion for a new trial, said Slater, who is co-liaison counsel in the proceeding.

Ethicon spokesman Matthew Johnson wrote in an email to the NLJ that the punitive damages award “is unsupported by the evidence presented at trial and we are vigorously pursuing an appeal.” The Johnson & Johnson subsidiary also is appealing the jury verdict and compensatory damages, he wrote.

“Ethicon acted appropriately and responsibility in the research, development and marketing of the Prolift pelvic organ prolapse repair kit,” he added. “While we are always concerned when a patient experiences medical conditions like those suffered by the plaintiff, all surgeries for pelvic organ prolapse present risks of complications. For more than a decade, Ethicon has invested in the research, development and clinical study of products to treat a wide range of pelvic disorders. Ethicon’s devices are among the most studied products for these conditions.”

Higbee also is overseeing a coordinated proceeding against Bard, which is based in Murray Hill, N.J., and has scheduled the first trial in that litigation for September 23.

“We do not believe that either the Scott trial, which involved a Bard transvaginal mesh product, or the Gross trial, which involved a competitor’s transvaginal mesh product, are representative of the vast majority of the cases that have been filed,” Lowry wrote in his email.

In the federal litigation against Ethicon, both sides plan to submit bellwether selections by July 25.

More mesh litigation

At least two cases against American Medical Systems are scheduled to go to trial on December 3. On July 1, Goodwin approved four cases as bellwethers, all involving women who had a transvaginal mesh device implanted for treatment of stress urinary incontinence. Goodwin, who has scheduled another round of cases involving treatment of pelvic organ prolapse for next year, ordered lawyers on both sides to submit a schedule for selecting those cases by July 12.

American Medical Systems, a unit of Endo Pharmaceutical Holdings Inc. in Chadds Ford, Pa., also faces litigation in state courts in Minnesota and Delaware, and Boston Scientific has cases pending in state court in Massachusetts.

Goodwin plans to select five bellwether cases for trial in the federal litigation against Boston Scientific by August 8.

The litigation against Coloplast, a division of Denmark’s Coloplast A.S., involves eight products, most of them bladder sling devices, said Robert Salim, a partner at Salim Beasley of Natchitoches, La., one of the plaintiffs’ attorneys leading the Coloplast litigation.

“They knew from their research they were going to have problems,” he said of Coloplast. “They didn’t provide proper warnings to the medical community and also had very, very inadequate training on how the put the product in.”

Coloplast attorney Lana Varney, a partner at Norton Rose Fulbright in Austin, Texas, and spokesman Simon Augustesen declined to comment. In court documents, Coloplast has denied the allegations.

Cook Medical, the latest company to be sued, has fought to differentiate itself from the other defendants in the litigation over mesh devices.

“We are pretty adamant that we shouldn’t even be in this litigation,” said Cook Medical attorney Douglas King, a partner at Wooden & McLaughlin in Indianapolis. Unlike its competitors, he said, Cook Medical’s devices are made from pig intestines, not a synthetic material.

“That’s a big deal because what happens with these synthetics that are typically made out of polypropylene or other plastic is they get hard, rigid, they erode into the tissue and can cause a woman—because these are repairs of the female anatomy—problems and pain,” King said. “It typically has to be surgically removed.”

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