Johnson and Johnson faces lawsuit over vaginal mesh devices

The US states of California and Washington have filed a suit against the drug and device maker Johnson and Johnson, alleging that the company hid its knowledge about potential adverse effects, some of which were permanent, associated with its vaginal mesh devices used to treat pelvic prolapse and stress incontinence.

“It’s difficult to put into words the horrific injuries and pain many women are still suffering as a result of Johnson and Johnson’s deception,” said Bob Ferguson, Washington state attorney general. “They believed they were making informed medical decisions, but that was impossible when Johnson and Johnson was spreading inaccurate information about its products’ risks, essentially duping doctors into using their own patients as clinical trials.”

In a simultaneous announcement California’s attorney general, Kamala Harris, said, “Johnson and Johnson put millions of women at risk of severe health problems by failing to provide critical information to doctors and patients about its surgical mesh products.”1

Nearly 790 000 of the devices were sold in the United States, and over two million were sold worldwide. This included about 42 000 in California and 12 000 in Washington state. The two states led an investigation on behalf of 46 states and the District of Columbia, but there is no word yet on legal action by these other states.

Ferguson said that Johnson and Johnson had neglected to tell doctors and patients that the mesh may cause chronic inflammation as the body rejects the foreign material, may harbour persistent infections in its weave, and may protrude into an organ or through the vaginal wall in a process called erosion.

One patient, Dawna Hankins, attended the Washington press conference, telling reporters that her doctor had suggested using the implant to control her stress incontinence when she was undergoing hysterectomy. “I was not told that there would be chronic urinary tract infections. I was not told that I would have long-term pelvic pain and I was not told that after the mesh is put in, it becomes part of my body,” she said.

Washington’s attorney general read from an email what another patient’s doctor had written to Johnson and Johnson before attempting a surgical repair. “She will likely lose any coital function as her vaginal length is now 3 cm, and there is mesh extruding literally everywhere,” the doctor wrote. “This patient will have a permanently destroyed vagina.”

Ethicon, the Johnson and Johnson unit that marketed the devices, rejected the allegations of deceit in a statement. “The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products,” the company said. “The use of implantable mesh is often the preferred option to treat certain female pelvic conditions, including pelvic organ prolapse and stress urinary incontinence, and is backed by years of clinical research. Ethicon is concerned that the attorney general’s decision to file its lawsuit will keep women from obtaining treatment for the often debilitating symptoms of stress urinary incontinence.”

Earlier this year the US Food and Drug Administration reclassified vaginal mesh devices as high risk devices instead of moderate, noting that they were linked to a higher rate of complications than traditional surgery.

Johnson and Johnson faces lawsuits from around 35 000 patients in the United States, as well as other cases in Australia, Belgium, Canada, England, Israel, Italy, the Netherlands, Scotland, and Venezuela, the company’s securities filings showed. It recently lost the first two of its US cases to be resolved, as juries awarded punitive damages of $13.5m (£9.2m; €12.1m) and $12.5m. Other companies facing large scale litigation over vaginal mesh devices are the Massachusetts company Boston Scientific and the Irish manufacturer Endo International.

Endo International has already set aside $1.6bn to settle claims against its American Medical Systems (AMS) unit, but it said this month that it would vigorously resist paying extra damages to women who it said were encouraged to undergo unnecessary removal surgeries by “a pyramid of businessmen, doctors and lawyers.” In a legal filing in West Virginia, AMS accused this group of “orchestrating the exploitation of unsophisticated medical and legal consumers and seeking to perpetuate a fraud.”