MORGANTOWN — State Attorney General Patrick Morrisey has filed suit against Johnson & Johnson and two of its subsidiaries alleging it engaged in deceptive marketing practices to promote its line of potentially dangerous synthetic surgical mesh products used in pelvic surgeries in women.
Morrisey announced the suit – filed Wednesday in Monongalia County Circuit Court – during a Wednesday press conference.
The company, he said, “took away doctors’ ability to give sound advice and women’s ability to make informed decisions.” We believe that the company knew about many of these potential risks. … We are deeply concerned that the conduct involved today has deeply impacted many people’s lives.”
Johnson & Johnson, the suit explains, makes and sells medical devices, pharmaceuticals and consumer goods. The two named subsidiaries, Ethicon and Ethicon US, make the polypropylene meshes designed to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women.
The line of meshes, begun in 1998 and expanded over the years, includes TVT, Gynemesh, Prolift, Prosima System and Artisyn.
According to the complaint, the complications associated with meshes used in transvaginal repair are mesh erosion into other pelvic organs; extrusion, exposure or protrusion; severe and chronic pain, including during intercourse; infection; urinary dysfunction; bleeding and organ perforation; recurrent prolapse; neuromuscular problems; vaginal scarring or shrinkage; emotional problems; chronic foreign body response and inflammation; mesh shrinkage; permanent pain during intercourse; and defecatory dysfunction.
“The risk of mesh-related complications is lifelong and can arise years after surgical insertion,” the suit says. Cancer is also a possible complication but the true risks of that may not be apparent for another decade or more.
Johnson’s marketing to doctors and consumers, the complaint says, deliberately misrepresented and concealed the known risks, even after the companies’ own experts alerted them and suggested they revise their advertising.
Jonson allegedly used two questionable studies to promote the safety of their products. One was by the inventor of the TV procedure, who was promised financial rewards if his study produced positive results. In the other study, more than half of the authors, including the TVT inventor, were paid consultants for Johnson; it promoted the safety of a device not evaluated in the study.
Johnson also allegedly wrongly marketed the mesh products as “FDA approved” when they weren’t. FDA has three levels of regulation: exempt from applying; clearance through Premarket Notification; and Premarket Approval.
Clearance and approval are vastly different. For clearance, the maker must demonstrate the product is substantially equivalent to one already on the market. It requires only 20 hours of review. Approval requires 1,200 hours of review to assure safety and efficacy.
Johnson’s mesh products were cleared but not approved; but Johnson nonetheless allegedly advertised them as approved.
Similar multidistrict litigation is underway in northern Ohio federal court, pursued by a number of states.
Morrisey however, chose to pursue the same route he has for pharmaceutical litigation, filing in state court for violations of the state Consumer Credit and Protection Act. His staff has been assembling the case in-house for a couple of years, he said.
Morrisey is asking the court to rule that Johnson has violated state consumer law regarding false and misleading market; to issue permanent injunctions for Johnson to stop the unlawful marketing, disclose any new information about serious risks, issue truthful and accurate promotional materials and disclose authors of future studies; and to levy civil penalties for every violation.
“We want to make sure we protect women in our state,” he said. He didn’t have a specific number of West Virginians who might be affected, but estimated “many thousands.” He urged anyone who believes they may be affected by mesh complications to call the office consumer hotline at 800-968-8808.
Tweet David Beard @dbeardtdp Email dbeard@dominionpost.com
