WASHINGTON (Legal Newsline) - Johnson & Johnson has asked the U.S. Supreme Court hear its appeal of a $70 million jury verdict over its antipsychotic drug Risperdal, saying it is impossible to comply with state and federal law at the same time in such cases.
A Philadelphia jury in 2016 awarded a Tennessee man and his mother tens of millions of dollars in damages over claims J&J failed to provide a warning that Risperdal could cause gynecomastia, or abnormal swelling of the breasts, in young boys. The label listed gynecomastia as a potential reaction in adults but J&J argues it couldn’t unilaterally include language about the risk to boys because the Food and Drug Administration hadn’t yet approved Risperdal for use in children.
FDA regulations prohibit companies from promoting or even discussing off-label uses of drugs, even though physicians are free to prescribe them to whomever they want.
In its petition for certiorari, J&J says the Supreme Court needs to declare whether so-called “impossibility preemption” should have blocked this lawsuit from proceeding in state court. The U.S. Constitution’s Supremacy Clause says that federal law controls when there is a conflict with state law.
“The decision below puts the entire pharmaceutical industry to an impossible Hobson’s Choice: modify your label and risk federal prosecution for misbranding, or face untold billions of dollars in state-tort judgments for failing to do so,” J&J says in its appeal.
A Pennsylvania appeals court upheld the $70 million verdict in 2019, citing the Supreme Court’s 2009 decision in Wyeth v. Levine, which held that state court juries can award damages against companies for failing to increase the warnings on drug labels beyond the language the FDA has approved. The Pennsylvania Supreme Court last year refused to hear an appeal of that verdict. Another Philadelphia jury ordered J&J to pay $8 billion in a Risperdal case in 2019, and the company faces another 10,000 lawsuits in Pennsylvania alone.
In its request for certiorari and related filings, J&J says the Supreme Court needs to clear up widespread misunderstanding of the Wyeth decision. While that ruling – passed 5-4 with conservative Justice Clarence Thomas joining the court’s liberal wing – appeared to doom the preemption defense in drug-labeling cases, it hinged upon a specific provision in the law called “changes being effected” or CBE that allows manufacturers of brand-name drugs to add warnings when they obtain new clinical information about dangerous side effects.
The FDA prohibits generic drug makers from utilizing the CBE mechanism, however. The Supreme Court followed up Wyeth in 2011 with Pliva v. Mensing, ruling that impossibility preemption prohibits the very same state-law claims against generics that the plaintiffs successfully pursued in Wyeth.
The plaintiffs in Mensing argued the generic makers could have asked the FDA for permission to change the label but the Supreme Court said that is the wrong analysis. The proper question is whether a private party can independently do under federal law what state law demands. To read the law any other way would open the possibility of arguing generic makers could do any number of things to strengthen the label, including convincing the FDA to interpret its regulations differently or petitioning Congress to change the law, the court ruled in the 5-4 decision, this time with Justice Thomas joining the conservatives.
While it seems strange that the plaintiffs in Mensing would have had a case if they’d taken a brand-name drug of the generic, that is because brand-name manufacturers can use the CBE process and generic companies cannot, the court ruled.
“It is not this Court’s task to decide whether the statutory scheme established by Congress is unusual or even bizarre,” the majority wrote, citing a 2009 decision.
The Risperdal litigation presents a similar question, J&J argues with the support of the Pharmaceutical Research and Manufacturers of America, the U.S. Chamber of Commerce and others. The FDA imposes strict restrictions on drug manufacturers including limiting marketing and other communications to authorized uses of drugs.
The FDA encourages off-label prescribing as well, J&J argues, but if companies unilaterally add warnings about those off-label uses that would imply FDA approval, J&J argues. J&J, like most other manufacturers, has been tagged with hefty fines and court verdicts over allegedly illegal promotion of off-label uses, demonstrating the risk of operating outside of the FDA’s narrow rules on communicating about prescription drugs.