The Kentucky Attorney General has filed suit against Johnson & Johnson and its Ethicon Inc. unit in state court, accusing them of deceptively marketing transvaginal mesh (TVM) devices and hiding from women and their doctor’s risks such as chronic pelvic pain. Attorney General Andy Beshear said in the complaint, which seeks millions of dollars in civil penalties under the state’s Consumer Protection Act, that J&J misrepresented that its products were approved by the U.S. Food and Drug Administration (FDA), when in fact they had only been cleared by the agency under its 510(k) process, which evaluates whether a product is substantially equivalent to one already on the market.
FDA-approved products undergo about 1,200 hours of review for their safety and efficacy, whereas the review for an FDA-cleared device only takes about 20 hours. J&J knew that representing that a device that had received FDA approval leads doctors and patients to believe that the product has been well-studied and scrutinized, the state attorney general said. The following is alleged in the complaint:
More than 15,000 women in Kentucky had transvaginal mesh implanted, but J&J and Ethicon failed to provide sufficient information about known risks so they and their doctors could make informed medical choices. In addition to chronic pelvic pain, those risks include urinary dysfunction, pain from sexual intercourse and the loss of sexual function entirely. J&J’s own staff urged the company to include more complete disclosures of the risks of the transvaginal mesh, but the company failed to do so. In 2005, Axel Arnaud, J&J’s medical director, proposed stronger warnings on the device in an email. Arnaud proposed including this 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.”
J&J never included the needed disclosure in its marketing or promotional materials. A J&J medical director noted that after their surgeries patients were reporting that they didn’t believe they had been provided adequate information before surgery on the possible complications, and that additional disclosures might be needed. But the company continued to conceal risks of those possible complications, according to the suit. Attorney General Beshear said in a statement:
The way this company clearly chose profits over people is outrageous. 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.
Seven separate multidistrict litigations (MDLs) comprising 70,000 cases against J&J and other companies are pending in West Virginia over the allegedly defective products. The FDA recently reclassified pelvic mesh devices such as those at issue in the suits as high-risk devices that must undergo the agency’s most stringent safety evaluation before hitting the market.
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