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

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

from Blogger

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