J&J Sued for Millions by Kentucky

Kentucky Attorney General Andy Beshear claims the medical device giant failed to disclose the hazards related to its surgical transvaginal mesh products.

Chris Newmarker

The state of Kentucky is seeking millions of dollars in damages from Johnson & Johnson over its Ethicon unit's transvaginal mesh marketing.

The civil lawsuit, filed this week in Franklin Circuit Court under Kentucky's Consumer Protection Act, claims more than 15,000 women in the state had the meshes implanted in them without J&J and Ethicon making them or their doctors aware of the hazards around the devices.

Kentucky Attorney General Andy Beshear said the company purposely misrepresented the host of adverse events associated with the meshes, including problems going to the bathroom, chronic pelvic pain, pain during sex, or complete loss of the ability to have sex. Such problems were either omitted or downplayed in J&J's marketing efforts, according to the lawsuit.

Beshear also had a problem with J&J supposedly marketing the meshes as "FDA approved," when they in fact had 510(k) clearance.

"The way this company clearly chose profits over people is outrageous," Kentucky Attorney General Andy Beshear said in a news release.

"My office has talked to victims whose lives have been devastated by this company's deceitful practices. We may not be able to give them back the lives they once had, but my office will do everything we can to hold this company accountable," Beshear said.

J&J in an emailed statement described the accusations as "unjustified," and promised to vigorously defend itself in court.

"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," the company statement said.

The Kentucky lawsuit comes about three months after state attorneys general in California and Washington state filed their own consumer protection lawsuits.

Thousands of people have filed their own lawsuits over the meshes, which were supposed to help women suffering from stress urinary incontinence and pelvic organ prolapse. J&J, whose Ethicon unit manufactured mesh for pelvic organ prolapse until 2012, has won some suits, and lost others. It continues to make mesh for urinary incontinence.

Other companies that have faced lawsuits over vaginal mesh products include American Medical Systems, Boston Scientific, C.R. Bard, Cook Medical, Endo Health, and Coloplast.

FDA meanwhile in January issued two orders related to the devices. One order reclassifies the devices as high-risk Class III devices, versus the previous moderate-risk Class II devices. The second order requires a PMA application for such devices.

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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[Image courtesy of Salvatore Vuono on FreeDigitalPhotos.net]