J&J Unit Loses Quick Appeal Bid in Tylenol-Autism Warning Suit

Johnson & Johnson Consumer Inc. can’t immediately appeal a ruling that rejected its preemption defense in litigation alleging prenatal exposure to Tylenol caused a child’s autism.

The J&J unit hasn’t identified a disputed legal issue that would allow an appeal at this point in the litigation, the US District Court for the Southern District of New York said Thursday.

Cherise Chapman alleged the company didn’t adequately caution pregnant women like herself about the risks of acetaminophen pain relief products like Tylenol, long marketed as the only safe pain relievers for use during pregnancy.

Chapman blames Tylenol for her child’s autism spectrum disorder and attention-deficit/hyperactivity disorder. Her suit is part of multidistrict litigation against manufacturers and retailers that was combined before Judge Denise L. Cote.

In April, Cote rejected JJCI’s argument that Chapman’s claims are barred by federal regulations for how over-the-counter drugs are marketed. She denied a similar dismissal motion by Walmart Inc. last November.

At the time Chapman took Tylenol, the label contained one FDA-required warning related to pregnancy: “If pregnant or breast-feeding, ask a health professional before use.”

But there is no indication that the pregnancy warning is the exclusive warning allowed by federal regulations, Cote’s April ruling said. The claims therefore aren’t preempted because a manufacturer can follow the federal rule while complying with a state-law duty that also requires more specific warning about acetaminophen use during pregnancy, she said.

Other courts haven’t addressed the preemptive effect of the pregnancy warning regulation, but that doesn’t suggest that there is a substantial ground for disagreement about the legal conclusions at issue, the court said here.

Cote also denied JJCI’s bid for a quick appeal on a different ruling that said the plaintiffs adequately supported allegations that in utero exposure to acetaminophen causes ASD and ADHD, and JJCI knew of the risk.

The company hasn’t identified a question of law that could merit immediate appeal or shown that allowing a quick appeal would advance the end of the litigation, Cote said.

Whether current scientific research permits the plaintiffs to proceed with this litigation will be resolved in the near future as evidentiary proceedings are set to take place later this year, she said.

The US government has been invited to submit views on the plaintiffs’ proposed pregnancy warning. If it says such a change would result in a misbranding of acetaminophen, the parties will be given the opportunity to address the preemptive effect, the court said previously.

Keller Postman LLC, Watts Guerra LLC, and Lanier Law Firm represented the plaintiff. Barnes & Thornburg LLP; Skadden, Arps, Slate, Meagher & Flom LLP; and Kirkland & Ellis LLP represented JJCI.

The case is In re Acetaminophen ASD/ADHD Prod. Liab. Litig., S.D.N.Y., No. 1:22-mc-03043, 8/3/23.