Monday, September 13, 2021

infant/child painkiller case dismissed as preempted

Youngblood v. CVS Pharmacy, 2021 WL 3700256, No. 2:20-cv-06251-MCS-MRW (C.D. Cal. Aug. 17, 2021)

Another infant/children acetaminophen consumer protection case. This one dismisses the claims as completely preempted by the FTCA.

Plaintiffs argued that their claims are consistent with the FDCA and FDA regulations because of the federal prohibitions on false or misleading labeling. However, a Tentative Final Monograph (TFM) issued by the FDA in 1988 and rendered a final administrative order under the FDCA in 2020 was more specific. TFM prescribes labeling requirements for over-the-counter analgesics for children, including acetaminophen. It directs that products for children between two and 12 years of age be labeled “for Children,” bear specific warnings for that age group, and provide specific dosing instructions for different age ranges. Products for “[c]hildren under 2 years” must bear the instruction “[c]onsult a doctor.” A drug complying with the TFM and general labeling regulations “is generally recognized as safe and effective and is not misbranded.”

One recent case with the same theory rejected preemption on the same grounds, while another found preemption. The court here found that the plaintiffs’ theory sought to do more than bring the packaging at issue in line with federal requirements. Plaintiffs complained that the infants’ product, which is labeled for children between two and three years of age, “does not state that it is ... the same medicine contained in the Children’s Product.” They sought “clear disclosures that there is no pharmacological distinction between ‘Infant’s Product’ and ‘Children’s Product’ and that the two products can be used interchangeably in a manner that is safe to infants and children alike.” They didn’t explain how these requirements were identical to the requirements of the 1988 TFM. A win for them would penalize CVS for not making “representations beyond what the 1988 TFM requires for children’s acetaminophen products.”

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