Acetaminophen MDL Judge Says OTC Warning Claims Not Preempted

  • Order

NEW YORK — Claims accusing Wal-Mart of failing to warn that prenatal exposure to acetaminophen can cause children to be born with autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) are not preempted, a New York federal judge has ruled, because over-the-counter drug makers could add such warnings to their labels.

In a Nov. 14 order, Judge Denise Cote of the U.S. District Court for the Southern District of New York explained there is nothing in the Food and Drug Administration’s regulations for OTC drug labeling that would prevent a manufacturer from adding pregnancy-related warnings to its label.

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