FRANKFORT, Ky. (AP) — The Kentucky Attorney General has filed a lawsuit against Johnson and Johnson and its medical device unit, claiming the companies conducted a deceptive marketing campaign for a vaginal mesh implant.
The lawsuit is seeking thousands of dollars for each patient who had the procedure.
Attorney General Andy Beshear alleged in the lawsuit that the company concealed and mispresented to doctors and patients many of the risks associated with the devices. The devices, which are intended to treat common pelvic floor issues, are the subject of tens of thousands of lawsuits in the U.S.
Beshear said in a news release that more than 15,000 women in Kentucky had transvaginal mesh implanted without being provided with sufficient information about the hazards. Complications can lead to a woman being permanently disabled, or unable to work, the lawsuit said.
The plastic mesh is used to treat pelvic organ prolapse, a condition that involves organs such as the bladder, bowel and uterus shifting, often after childbirth, a hysterectomy or menopause. The U.S. Food and Drug Administration this year re-labeled the products high risk instead of moderate and announced new federal scrutiny for them.
In an emailed statement, Johnson & Johnson subsidiary Ethicon Inc. called the lawsuits "unjustified."
"The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products," the company said. "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."
The lawsuit filed by Beshear's office alleges the companies violated a state law against deceptive marketing practices. It seeks civil penalties of $2,000 for each violation of the law, and $10,000 for each violation targeted to consumers over age 60.