Kentucky seeks millions of dollars in penalties from Johnson & Johnson
The lawsuit seeks millions of dollars in civil penalties under Kentucky’s Consumer Protection Act that prohibits companies from false, misleading, deceptive or unfair acts or practice in trade or commerce.
Transvaginal mesh is a synthetic woven fabric implanted through the vagina to treat common pelvic floor conditions that 30 to 50 percent of all women experience.
In Kentucky, more than 15,000 women had transvaginal mesh implanted without Johnson & Johnson and Ethicon providing sufficient information about the known hazards so women and their doctors could make informed treatment decisions, according to the lawsuit.
“The way this company clearly chose profits over people is outrageous,” Beshear said. “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.”
Beshear said Johnson & Johnson failed to follow recommendations by its own staff to include more complete disclosures of the risk.
According to the lawsuit, in 2005 Johnson & Johnson’s medical director emailed the company to propose stronger warnings on the product for doctors and patients.
The email from the medical director proposed the following disclosure: “WARNING: Early clinical experience has shown that the use of mesh through a vaginal approach can occasionally/uncommonly lead to complications such as vaginal erosion and retraction which can result in an anatomical distortion of the vaginal cavity that can interfere with sexual intercourse.”
Another of the company’s medical directors noted in 2006 that post-operative patients were reporting that they did not believe they were provided adequate information prior to surgery on the possible adverse complications and that additional disclosures might be needed.
Johnson & Johnson failed to fully incorporate this information into any of its marketing or promotional materials, according to the lawsuit.
In fact, Beshear said the company purposely concealed and mispresented to doctors and patients many of the risks of adverse events associated with the devices, which include chronic pelvic pain, urinary and/or defecatory dysfunction, pain with sexual intercourse or total loss of sexual function.
The company also represented to doctors that the products were “FDA approved” when in fact they were only “FDA cleared” – a significantly different and less rigorous evaluation. ■