In Johnson & Johnson v. State of California, No. No. 22-447 (US SCt, February 21, 2023) the US Supreme Court denied J&J’s petition for certiorari, declining the opportunity to untangle fair notice and deceptive marketing issues in a pelvic-mesh lawsuit. As a result, J&J was left with a $344 million verdict. In April 2019, the FDA ordered the end of sales of pelvic mesh, that was used to treat a common ailment called pelvic organ prolapse. The move came in response to a tide of lawsuits brought against manufacturers of the technology by women who alleged serious complications from its use in surgery.
California allows consumers, or state regulators on behalf of consumers, to sue businesses for failing to warn of a product’s risks. In 2016, California’s AG sued Ethicon, a pelvic-mesh manufacturer owned by Johnson & Johnson, accusing the company of marketing the devices to women and doctors in the state without sufficient warning of possible side effects. The California laws relied on by the AG impose a fine for each act of “unfair competition” or “false advertising,” but they do not define what counts as a single violation. Determining that every marketing statement that failed to fully detail the risks of pelvic mesh was a violation ? including written materials like pamphlets, newsletters, and hospital kits, as well as oral communications at sales fairs and business lunches ? a state court estimated that Ethicon violated the laws over 270,000 times in California between 2008 and 2017.
The California Appellate Court determined that oral-communication violations would not stand, holding that there was no evidence of what Ethicon executives and sales representatives actually said when discussing pelvic mesh across the state. But it upheld the written-material violations, maintaining the trial court’s award of $1,250 per violation ? half of the maximum of $2,500 allowed under California law ? the appeals court ordered Ethicon to pay over $300 million to the state.
After the California Supreme Court refused to hear its appeal, Ethicon and its parent company unsuccessfully asked the Supremes to decide whether the California laws gave them “fair notice” of the extent of civil penalties they might face as a consequence of doing business there. Ethicon argued that the state court determined the number of written materials on pelvic mesh it shipped to California based on roving extrapolation, without any evidence of how many of those materials actually ended up in the hands of consumers. But in any event, the company contended, it suffered the real injury from insufficient warning of possible risks, due to the laws’ vague language regarding “violation[s].”