UPDATE: May 5, 2020: West Virginia Attorney General Patrick Morrisey said Monday the state reached a settlement with Johnson & Johnson regarding allegations related to certain medical device marketing by the company and its subsidiaries.
The $3.9 million settlement covers claims that Ethicon misrepresented the safety and effectiveness of its surgical mesh products, and that DePuy deceptively and unlawfully marketed, promoted and sold certain models of metal-on-metal hip replacement systems. J&J and its subsidiaries denied the allegations.
- West Virginia Attorney General Patrick Morrisey is suing Johnson & Johnson and subsidiary Ethicon for "unlawful, unfair and deceptive" marketing of surgical mesh products for pelvic organ prolapse and stress urinary incontinence per a complaint filed Wednesday in the circuit court of Monongalia County.
- Morrisey, on behalf of West Virginia, is seeking civil penalties and a permanent injunction to keep the companies from "marketing, advertising, promoting, offering for sale, distributing or selling" their surgical mesh products in the state. The complaint notes that the companies stopped selling transvaginal mesh products for POP in 2013. Earlier this year, the few remaining manufacturers with PMAs for transvaginal meshes indicated for POP were required by FDA to cease sale and distribution of the products immediately due to safety concerns.
- An Ethicon spokesperson said the company "intends to defend vigorously against the claims asserted by the State."
Similar complaints were made against J&J and Ethicon by Kentucky in August 2016 and by Mississippi in October 2017, according to the company's quarterly U.S. Securities and Exchange Commission document filed July 29. The filing also said the trial date for the Kentucky case was scheduled for this September but has been adjourned without a new trial date being set. It also said the companies "have entered into a new tolling agreement with the remaining 43 states and the District of Columbia."
Tolling agreements waive the right to seek a lawsuit's dismissal based on the expiration of the statute of limitations.
The mesh products in question were designed for individuals with pelvic organ prolapse and stress urinary incontinence, conditions caused by weakened or damaged muscles and tissues in the pelvic floor area.
Over the years, J&J's products and similar ones from other manufacturers have been the subject of adverse event reports describing erosion or exposure of the devices, in some cases leading to pain, scarring, infection and other complications. The complaint said mesh removal is the only treatment option for most continuing mesh complications and more than 30% of women require more than one surgery to deal with complications.
Among West Virginia's allegations are that J&J misrepresented some of the devices as FDA-approved when, in fact, they were cleared through the less rigorous 510(k) premarket pathway. The complaint also alleges the defendants concealed or omitted material facts as to the full range of complications associated with their pelvic mesh products in advertising, practice aids and instructions for use.
Johnson & Johnson said it will defend itself against the claims.
"Ethicon’s pelvic mesh surgical devices have helped millions of women around the world — including in West Virginia," the company said in a statement shared with MedTech Dive by Ethicon spokesperson Mindy Tinsley. "Ethicon acted appropriately and responsibly in the research, development and marketing of its pelvic mesh products."
As of June 30 there were 24,800 plaintiffs with direct claims in pending lawsuits with respect to J&J pelvic meshes, the company disclosed in an SEC filing.
J&J was one of many manufacturers that got out of the pelvic mesh business after FDA opted in 2012 to require any manufacturer of urogynecologic surgical mesh for POP to carry out postmarket surveillance studies, or '522s.' In total, 34 companies received 522 orders, and by April of this year, when the agency ordered remaining products in the category off the market, only Boston Scientific and Coloplast were affected.