The U.S. Supreme Court denied an appeal by Johnson & Johnson of a ruling requiring the company to pay $302 million in penalties to California for deceptive marketing of pelvic mesh implants that can cause serious vaginal pain and physical damage.

Since the late 1990s, Ethicon has manufactured, marketed, and sold pelvic mesh products intended to treat two conditions that can affect women stress urinary incontinence (SUI) and pelvic organ prolapse (POP).

In 2008, the U.S. Food and Drug Administration (FDA) issued a public health notification alerting health care providers about complications from pelvic mesh implants used to treat SUI and POP. And in 2011, the FDA issued an update to its public health notification.

In 2012, the FDA ordered Ethicon to conduct postmarket surveillance studies for one of its SUI devices (TVT-Secur) and three of its POP devices (Prolift, Prolift-M, and Prosima). Instead of conducting these postmarket surveillance studies. Ethicon stopped selling the products commercially.Ethicon’s competitors continued to sell pelvic mesh products for transvaginal repair of POP, even after Ethicon stopped selling most of its POP devices.

However, in April 2019, the FDA concluded there was not a reasonable assurance of safety and effectiveness for any commercially available pelvic mesh products intended for transvaginal repair of POP. Therefore, the FDA ordered all remaining manufacturers of surgical mesh intended for transvaginal repair of POP to stop selling and distributing such products.

During the relevant timeframe, Ethicon disseminated three categories of communications giving rise to the violations at issue here: (1) instructions for use (IFUs); (2) marketing communications directed to California doctors; and (3) marketing communications directed to California patients.

In 2016, the California Attorney General filed an enforcement action against Johnson & Johnson on behalf of the People of the State of California. The case stemmed from a multistate investigation into J&J subsidiary Ethicon Inc’s marketing of pelvic mesh devices.

The operative complaint alleged Ethicon disseminated deceptive advertisements relating to its pelvic mesh products and violated the unfair competition law (UCL) (Bus. & Prof. Code,[1] § 17200 et seq.) and 121,844 violations of the false advertising law (FAL) (§ 17500 et seq.). It requested injunctive relief, civil penalties of $2,500 for each UCL violation occurring on or after October 17, 2008, and civil penalties of $2,500 for each FAL violation occurring on or after October 17, 2009.

After a nine-week bench trial, the trial court issued an extremely thorough, 128-page statement of decision finding Ethicon liable for 153,351 UCL violations and 121,844 FAL violations.

Johnson & Johnson, Ethicon, Inc., and Ethicon US, LLC (collectively, Ethicon), appealed an adverse judgment following a bench trial. The trial court levied nearly $344 million in civil penalties against Ethicon for willfully circulating misleading medical device instructions and marketing communications that misstated, minimized, and/or omitted the health risks of Ethicon’s surgically implantable transvaginal pelvic mesh products.

Ethicon’s primary contention on appeal was that the trial court applied the wrong legal standards under the UCL and FAL Ultimately the California Court of Appeal decided that substantial evidence supported the findings regarding Ethicon’s written marketing communications, but not its oral marketing communications in the published decision of The People v Johnson and Johnson e.al. 77 Cal.App.5th 295 (April 2022).

The judgment was modified, and the civil penalties awarded to the People are reduced from $343,993,750 to $302,037,500. The judgment was affirmed as modified. The parties are to bear their own appellate costs.

The U.S. Supreme Court denied Johnson & Johnson’s Petition For a Writ Of Certiorari of this $302 million judgment on February 21, 2023. J&J had argued to the Supreme Court that state consumer protection laws like California’s are too vague, exposing companies to unpredictable state lawsuits.

JNJ said the Supreme Court’s rejection of the case will lead to continued “uneven, unclear, and unfair enforcement that harms consumers and businesses.”