Mesh Medical Device News Desk, September 20, 2019 ~  With the potential for every state to file suit against J&J over violating consumer protection laws, this latest one is from the Attorney General’s office in West Virginia. It accuses the healthcare giant of deceiving residents of the state by fraudulently marketing pelvic mesh.

The case could end the sales of polypropylene pelvic mesh in West Virginia.

West Virginia’s Attorney General has filed a lawsuit against Johnson & Johnson (J&J) and its Ethicon division that makes surgical mesh.

AG Patrick Morrisey alleges the  companies deceptively marketed their pelvic and surgical mesh medical devices used to treat incontinence and prolapse in women, a violation of the state’s Consumer Credit and Protection Act.

The lawsuit was filed September 18 in Monongalia County Circuit Court. Here is the complaint.

Image: The Martinsburg Journal

Specifically, the lawsuit claims that J&J misrepresented the risks, safety and effectiveness of the products in marketing and educational materials sent to doctors and provided in patient brochures and in the product inserts.

The action does not state how many West Virginia woman may have been implanted with J&J’s mesh.

J&J launched personal meetings with end users (doctors) to sell its products and published medical articles, some written or co-written by doctors who are consultants or preceptors to the healthcare giant, the complaint says.

Complications among patients include mesh erosion, extrusion, and degradation, chronic pain, dyspareunia, chronic infection, a return of urinary incontinence, bleeding, recurrent prolapse, nerve injury, vaginal scarring, mesh shrinkage, emotional problems, chronic foreign body response to the mesh with resulting chronic inflammation. Included in the allegedly fraudulent marketing:

Defendants misleadingly implied that their TVT mesh had no erosion or tissue reactions when studies showed erosion rates as high as 19%.”

Defendants misrepresented that their mesh was “lightweight, soft and supple,” “remains soft and pliable,” and has less “bi-directional elastic property [that] allows adaptation to various stresses encountered in the body.”

Defendants knew research indicated failure rates as high as 40% one year after implantation; knew excision surgery may be required; and knew that the mesh material could degrade in the body, migrate, and/or cause a serious foreign body response. However, Defendants’ patient brochures misrepresented these risks stating that their mesh products were “permanent material,” with “permanent results that would support your urethra for the rest of your life.”

 

Mesh complications can last a lifetime and can involve the use of opioids to manage pain.

Polypropylene mesh product were first sold in West Virginia beginning in 1998.

Ethicon, the medical device division of J&J, sells a family of TVT products  – TVT (tension-free vaginal tape),  TVT-O (Obturator), TVT Exact, TVT Abbrevo and TVT Secur or TVT-S.

The larger meshes used to treat pelvic organ prolapse (POP) include Prolift, Prolift +M, (introduced in 2005 and 2008)  and Prosima (introduced in 2010). They come with additional “arms” to permanently tack the mesh deep into the body and are not removable.

Another POP mesh, Artisyn was introduced in 2012, but it was implanted through the abdomen rather than transvaginally.

J&J removed its larger POP meshes in mid-2012 in reaction to defective product lawsuits and one year after the FDA concluded that complications associated with POP mesh repair “are not rare.”

In addition, in West Virginia, Ethicon sells Gynemesh to treat both SUI and POP. That includes Gynemesh PSA and nonabsorbable Prolene Soft Mesh.

Gynemesh is sold in sheets, cut by the surgeon and used for sacrocolpopexy, a form of POP repair. Prolene is an identical polypropylene material used as a suture.

INFORMATION  MISSING

sling-the-mesh-campaign-300x209

Disintegrating J&J TVT mesh

Missing from the IFU concerning TVT slings from 1997 to 2012 include:

*Chronic foreign body reaction
*Defecatory dysfunction
*Detrimental impact on quality of life
*Dyspareunia
*Mesh Contracture
*Chronic Pelvic Pain
*Chronic groin pain
*Re-operations and removals
*Recurrence of incontinence
*Pain to partner during sex
*Sarcoma (cancer)
*Vaginal scarring
*Permanency/ difficulty with removal

Like the California AG’s pursuit of similar claims against J&J, Morrisey says the marketing materials consistently concealed or omitted entirely complications. For example, the U.S. Food and Drug Administration (FDA) never subjected the polypropylene pelvic mesh to clinical trials and the medical devices were not approved by the FDA for safety and efficacy.   Instead, they were cleared for marketing after an exchange of paperwork with the manufacturer.

The Consumer Credit and Protection Act is designed to protect consumers from abusive conduct such as exorbitant interest on loans and false advertising and promises to consumers. Here is the Act.

Morrisey seeks civil penalties and an injunction to stop deceptive marketing and sales of pelvic mesh products in the state.

Morrisey tells WV Metro News that when false information is presented to the end user, doctor, he cannot inform the patient in true informed consent.

“The company took away, effectively, the doctor’s ability to give sound advice and the woman’s ability to make an informed decision about whether to have a permanent mesh implant put into her body.”

“We believe that the company knew about many of these potential risks, but despite that, they omitted the information. So, we’re filing this case today, and we believe that the company needs to be held accountable under our consumer protection laws.”

California’s AG is currently in trial against  J&J over false and misleading marketing as well, a violation of that state’s consumer protection laws.

In April, Washington state secured $10 million settlement from J&J over deceptive practices, with the money to be returned to the plaintiffs. See MND on Washington state settlement here.

The Kentucky action was reportedly scheduled for September but has been adjourned with no new trial date.

The companies have entered into new tolling agreement with the remaining 43 states and the District of Columbia, which suspends the statute of limitations clock from running,  meaning more lawsuits could be on the horizon.

ETHICON RESPONSE  

Mindy Tinsley, a spokeswoman for Ethicon, said they plan to defend themselves from Morrisey’s lawsuit.

“Ethicon’s pelvic mesh surgical devices have helped millions of women around the world — including in West Virginia — find relief from the often debilitating impact of stress urinary incontinence and pelvic organ prolapse,” Tinsley said. “The Attorney General’s position is at odds with the views of leading doctors and medical groups, as well as the FDA. Ethicon acted appropriately and responsibly in the research, development and marketing of its pelvic mesh products, and the Company intends to defend vigorously against the claims asserted by the State.”

 


LEARN MORE:

WV AG News Release

J&J’s SEC Form 10-Q, June 30, 2019

West Virginia AG Complaint

MND, April 23, 2019, Washington State Settles on Eve of Trial with J&J Over the Cost of Pelvic Mesh Injuries

MND, Surgical Mesh Crisis: Regulatory Action & Inaction,