Kentucky Files Transvaginal Mesh Lawsuit Against J&J for Deceptive Marketing

Frankfort, KYKentucky’s attorney general has filed a civil lawsuit against Johnson & Johnson for deceptively marketing transvaginal mesh to more than 15,0000 women in Kentucky. Attorney General Andy Beshear said these women had transvaginal mesh implanted without being provided with sufficient information about complications that can lead to permanent disability.

The Kentucky lawsuit comes on the heels of the states of California and Washington filing lawsuits against the giant pharma company for similar reasons. All three accuse J&J of concealing and mispresenting to patients and doctors transvaginal mesh risks.

The Washington TVM lawsuit alleges that J&J violated the state's consumer protection law by selling 12,000 devices but never telling patients that the mesh can erode and cause complications. The state is seeking millions of dollars in penalties, according to the Wall Street Journal (May 2016). The Kentucky lawsuit seeks civil penalties of $2,000 per violation of the state's deceptive practices law, and $10,000 when aimed at consumers over 60 years old.

A statement in May announcing California's lawsuit said there are more than 35,000 personal lawsuits against the company. This staggering number begs the question: how can J&J afford not only individual lawsuits, but now these three (and likely more states to follow) civil suits? Johnson & Johnson has deep pockets, having sold 780,000 transvaginal mesh devices between 2008 and 2014. According to its second quarter financial report posted online, J&J sold $6.4 billion worth of medical devices worldwide.

Given these figures, it’s understandable that Attorney General Beshear accuses J&J of choosing profits over people. In a written statement and reported by CNN, 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."


Transvaginal Mesh FDA cleared, not FDA approved

The Kentucky lawsuit includes another misrepresentation: J&J said its transvaginal mesh products were sold once it got approval by the FDA, but the mesh devices were only cleared by the FDA and never approved.

The FDA in January 2016 issued two orders that will require surgical mesh used for pelvic organ prolapse (POP) repair to be approved before manufacturers can place them on the market. The mesh is reclassified from a moderate-risk device (class ll) to a high-risk one (class lll) and manufacturers have 30 months to submit a PMA for devices that are already on the market and they must prove that their products are safe and effective. Only then can the device be approved for marketing.

Previously, transvaginal mesh devices were only cleared by the FDA through its 510(k) process that doesn’t require clinical trials. Instead this process just requires manufacturers to show that their product is substantially equivalent to one already on the market. (Substantial equivalence means that companies are able to bypass a lengthy approval process when updating existing devices.) The transvaginal mesh devices were able to be 510(k) cleared because they were classified as a Class II medical device