In pelvic-mesh lawsuit, justices asked to untangle fair notice and deceptive marketing

Petitions of the week

The Petitions of the Week column highlights a selection of cert petitions recently filed in the Supreme Court. A list of all petitions we’re watching is available here.

In April 2019, the Food and Drug Administration ordered the end of sales of pelvic mesh, a medical device marketed to help women with certain urinary or vaginal conditions, 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. This week, we highlight cert petitions that ask the court to consider, among other things, whether one manufacturer should have known it could be liable for hundreds of millions of dollars for advertising and selling pelvic mesh in California.

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 attorney general 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 attorney general 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 state appeals court jettisoned the oral-communication violations, 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.

In Johnson & Johnson v. California, Ethicon and its parent company ask the justices 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 argues 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 contends, it suffered the real injury from insufficient warning of possible risks, due to the laws’ vague language regarding “violation[s].”

A list of this week’s featured petitions is below:

Johnson & Johnson v. California
22-447
Issues: (1) Whether a robust fair notice standard applies to California’s Unfair Competition Law and False Advertising Law given the severe civil penalties at stake, the risk of chilling protected speech, and the criminal penalties involved; and (2) whether Ethicon had fair notice that it faced hundreds of millions of dollars in civil penalties under these statutes for materials sent to California, but not proven to have reached consumers.

Shields v. Kentucky
22-450
Issue: When, if ever, a preliminary hearing provides an “adequate opportunity” for cross-examination under the Sixth Amendment’s confrontation clause.

Loper Bright Enterprises v. Raimondo
22-451
Issues: (1) Whether, under a proper application of Chevron v. Natural Resources Defense Council, the Magnuson-Stevens Act implicitly grants the National Marine Fisheries Service the power to force domestic vessels to pay the salaries of the monitors they must carry; and (2) whether the court should overrule Chevron, or at least clarify that statutory silence concerning controversial powers expressly but narrowly granted elsewhere in the statute does not constitute an ambiguity requiring deference to the agency.

United States v. Hakim
22-464
Issue: Whether a defendant’s erroneous pretrial self-representation categorically constitutes structural error, thereby requiring automatic vacatur of the convictions, where the defendant had counsel at trial and did not irretrievably lose any rights or defenses in the interim.