A woman who claims taking Tylenol while pregnant caused her son's autism can't sue the makers of the pain relief medication, after an Alameda County judge ruled the science is not at all clear enough on the question to allow plaintiffs to attempt to extract payouts from the manufacturer.
On May 5, Alameda County Superior Court Judge Karin Schwartz granted summary judgment to Kenvue Brands LLC, the maker of Tylenol-brand acetaminophen pain medications, and supermarket operator Safeway Inc., which sells store-brand and generic versions of the medication.
The companies had been sued in 2024 by plaintiff Ashley Davey and her son, identified only as M.D.
They were represented by attorney Elise R. Sanguinetti, of the firm of Arias Sanguinetti, of San Francisco.
According to court documents, Davey had taken Tylenol and generic acetaminophin while pregnant with her son in 2018 and 2019. M.D. was later diagnosed with autism spectrum disorder.
Davey had initially sued Kenvue, a company spun off from Johnson & Johnson, in New York City federal court, as part of a mass tort over the alleged prenatal harmful effects of Tylenol and its generic equivalents.
Davey's lawsuit, along with nearly 400 others, were tossed by a federal judge presiding over the consolidated action after the judge determined the scientific evidence behind their claims were insufficient.
Davey, however, then sued Kenvue and Safeway in Alameda County court, again claiming her son's autism diagnosis was caused by the prenatal exposure to acetaminophin.
She and her lawyers based their lawsuit on a warning Kenvue had attached to acetaminophin products, which directed women who are pregnant or breastfeeding to consult with their doctors before taking acetaminophin.
A trial date had been tentatively set for mid-April in the case.
However, Kenvue and Safeway moved instead for summary judgment, under which they asked the judge to rule in their favor before a trial.
Judge Schwartz then sided with the defendants, ruling, similarly to her federal colleague, that the scientific evidence allegedly showing a link between autism and prenatal ingestion of acetaminophin "was neihter known nor knowable" in 2018-2019, "and indeed remains a matter of considerable uncertainty to this day."
The judge further rejected the plaintiffs' assertion that a conflict between a stricter California label warning law and federal law should allow them to sue under state law.
Schwartz ruled federal law should prevail in the case, as federal regulations seek to establish a "single national pregnancy nursing warning" to "help ensure that consumers receive clear, unambigious, and consistent information on the labeling of (over-the-counter) drugs concerning use by pregnant or nursing women" and avoid "differing state requirements" which "could conflict with the Federal warning, cause confusion to consumers, and otherwise weaken the Federal Warning."
Since the company's label warnings comply with federal rules and the scientific evidence is unclear, at best, the judge said the companies cannot be sued for failure to warn about the alleged autism risk.
"... The state of the scientific knowledge before, after, and during the time of Ms. Davey's pregnancy with M.D., regarding any link between ingesting (acetaminophin) while pregnant and development of (autism) in offspring, was and remains profoundly uncertain and conflicting," Schwartz wrote. "While the (Food and Drug Administration) and independent medical organizations reviewed relevant studies and addressed the questions and concerns, the FDA repeatedly determined the evidence was inconclusive, and the studies did not warrant a warning, beyond the direction to consult a medical professional, of a specific risk posed by (acetaminophin) and development of (autism.)
"The extensive reviews establish as a matter of law that the existence of any causal link was neither known nor scientifically knowable."
In response to the ruling, Kenvue issued a statement through a spokesperson, saying: "he court’s ruling granting this motion aligns with the position of the U.S. Food and Drug Administration and leading medical organizations that have thoroughly evaluated this matter – the science does not support causation, and the labeling on acetaminophen products is appropriate. We advise expecting mothers to speak to their healthcare professionals before taking any over-the-counter medications, including acetaminophen."