Kentucky has become the third state to file a civil lawsuit against Johnson & Johnson alleging deceptive marketing of transvaginal surgical mesh used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Kentucky Attorney General Andy Beshear will seek millions in penalties for violating the state’s Consumer Protection Act. Kentucky also asks for reasonable costs and fees and for a trial by jury.
“The way this company clearly chose profits over people is outrageous,” Beshear said, announcing the lawsuit in mid-August. “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.”
“I do not tolerate those who misrepresent their product by lying or lying by omission to Kentuckians.”
It’s estimated more than 15,000 Kentucky women have been implanted with polypropylene surgical mesh without the sufficient information to weigh the risks versus benefits.
In making his announcement, Mr. Beshear said the New Brunswick, New Jersey-based healthcare company repeatedly violated the rules against deceptive marketing of surgical mesh medical devices including transvaginal mesh.
For example, J&J marketing called these devices “minimally invasive” with “minimal risk” without disclosing the permanent debilitating complications, the complaint says.
“The company concealed and misrepresented to doctors and patients the risks such as chronic pelvic pain, urinary and or defecatory dysfunction, pain with intercourse, loss of sexual function and the potential irreversible nature of these complications.”
J&J’s concealment of the severity of risks is even more egregious, says Beshear, because women suffering from pelvic organ prolapse (POP) or stress urinary incontinence (SUI) could have had a non-mesh surgical alternative, none of which are life-threatening.
J&J also represented that its pelvic mesh products had been “FDA approved.” In reality, the pelvic meshes are cleared under an antiquated loophole in the FDA rules called the 510(K) clearance, which allows marketing of a device similar to one already on the market.
On repeated occasions the company ignored warnings from J&J insiders who said there was a real risk of repeat surgeries and of dyspareunia, or painful sex. Johnson & Johnson refused to change the product warnings to include this information, said Beshear.
While the TVT Obturator, TVT (tension free tape), TVT Exact, Gynemesh PS, Abbrevo, Exact and Artisyn remain on the market, TVT Secur, Prosima Pelvic Floor Repair System, Prolift and Prolift +M Pelvic Floor Repair System are no longer sold in the United States after the company quietly removed the transvaginal surgical meshes from the market in 2012.
Last May, the AGs office in both California and Washington State filed similar consumer protection violation lawsuits against J&J over deceptive marketing of pelvic meshes in those states. Any monies resulting from the litigation will be returned to the individual states.
Johnson & Johnson has the greatest number of product liability lawsuits filed in the U.S. with 35,000 filed on the consolidated proceedings in the Southern District Court of West Virginia, and another 15,000 or so filed in individual state courts. Additionally, J&J is facing civil lawsuits filed by women harmed by transvaginal pelvic mesh in Australia, Israel, Canada, Scotland, among other countries.
Kentucky’s AG Beshear is asking all women who reside in Kentucky and may have a transvaginal surgical mesh that is causing complications to contact his office at 502-696-5389.