Kentucky has become the latest state to file a lawsuit accusing Johnson & Johnson of concealing severe risks and falsely marketing its vaginal mesh products. Earlier this year, California and Washington filed identical claims against the health care giant.
As in the earlier lawsuits, Kentucky claims Johnson & Johnson failed to disclose various problems caused by its devices, which were marketed to combat stress urinary incontinence and pelvic organ prolapse. Among the side effects cited were permanent pain with intercourse; a loss of sexual function; chronic inflammation; and permanent urinary or defecation dysfunction.
“The way this company clearly chose profits over people is outrageous,” Kentucky Attorney General Andy Beshear said in a statement. “My office has talked to victims whose lives have been devastated by this company’s deceitful practices.”
The lawsuit, filed on Monday, largely contains nearly identical language as the other suits, such as a quote from an unnamed woman who said she had “all kinds of problems with chronic pain, bleeding, dyspareunia (painful sex) … The pelvic pain was keeping me awake at night, and the only relief was to sit on a tennis ball. The thought of living like that, sitting on a ball, wearing a diaper, splinting my perineum to have a bowel movement, having infrequent miserable sex, and marital problems was almost more than I could bear.”
The interchangeable language is not surprising, given that a multistate investigation has been under way for a few years. In fact, Johnson & Johnson and its Ethicon unit, which sold the devices, signed tolling agreements with 47 states and the District of Columbia, which means the states still have the opportunity to decide whether to pursue litigation. This suggests still more state lawsuits may be filed.
As we noted previously, Ethicon sold more 787,200 devices nationally between 2008 and 2014. Worldwide, more than 2 million women have been implanted with the devices, according to the states. And the lawsuits point to thousands of alleged violations that may expose the company to potentially tens of millions of dollars in penalties. Ethicon agreed in 2012 to pull some devices off the market.
An Ethicon spokeswoman wrote us that the lawsuit is “unjustified, and the company plans to vigorously defend itself against the allegations. The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products.
“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 this lawsuit will keep women from obtaining treatment for the often debilitating symptoms of stress urinary incontinence.”
To date, Johnson & Johnson has lost six cases at trial, including two earlier this year in which juries awarded $13.5 million to one woman and $12.5 million to another. The company reversed an earlier verdict on appeal, and won two others. Several months ago, the company reportedly began talks to pay more than $120 million to resolve up to 3,000 lawsuits, although the status of the talks is unclear. About 50,100 lawsuits are filed in the US and about 500 overseas.
Meanwhile, the US Food and Drug Administration reclassified the devices as high-risk rather than moderate-risk, and required all device makers to submit data to support safety and effectiveness before they can market their products. The agency noted it had seen a “significant increase” in the number of reported adverse events associated with the mesh devices.
Most of us have waited years; I was even on Judge Goodwin’s docket in WV for January. Thanks to Jane Akre, I was able to check the docket to confirm and watch the cases, including mine. Then, many lawsuits were dismissed. J and J absolutely knew polypropylene was not for placement in humans but money triumphed over the health of tens of thousands of people. Thank you for writing on this extremely important negligence on the part of J and J. I hope to see a follow up story—I am interested in knowing if political contributions played a role. Thank you, Ed
Thank you for this story. The FDA has moved to reclassify POP mesh only (pelvic organ prolapse) which is the larger of the meshes. It gave industry 30 months to do so. Mesh for incontinence remains a “moderate risk” or class II. It is still backed by the medical establishment for the most part and used every day.
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