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Court denies CVS’s motion to dismiss in mislabeling lawsuit over 'non-drowsy' medicines

ST. LOUIS RECORD

Friday, December 27, 2024

Court denies CVS’s motion to dismiss in mislabeling lawsuit over 'non-drowsy' medicines

Federal Court
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ST. LOUIS — A federal court has denied CVS Pharmacy’s motion to dismiss a class-action lawsuit alleging that the company misled consumers by labeling certain over-the-counter (OTC) cough and flu medicines as "non-drowsy" despite containing an ingredient that allegedly causes drowsiness. 

The ruling allows plaintiff Amy Newport’s claims under the Missouri Merchandising Practices Act (MMPA) to proceed, the Nov. 20 opinion in U.S. Eastern District of Missouri, Eastern Division stated.

The lawsuit claims CVS Pharmacy and CVS Health Corporation marketed their store-brand cough and flu medicines as "non-drowsy" despite containing dextromethorphan hydrobromide (DXM), an ingredient Newport alleges is scientifically proven to cause drowsiness. 

Newport argues she purchased the medicines at a premium price based on misleading labeling, believing they would not induce drowsiness.

Newport seeks to represent a class of similarly affected consumers, asserting that the labeling violates state consumer protection laws. 

Initially, she included claims for breach of warranty, breach of implied contract and unjust enrichment but has since voluntarily withdrawn those claims, focusing solely on the MMPA violations.

CVS’s Defense and Motion to Dismiss
CVS moved to dismiss the case, arguing that Newport’s claims were preempted by federal law under the Federal Food, Drug and Cosmetic Act (FDCA).

According to CVS, the FDCA establishes federal requirements for drug labeling, and Newport’s lawsuit seeks to impose state-level obligations that conflict with federal standards. 

CVS also contended that the U.S. Food and Drug Administration (FDA) has determined that DXM does not require a drowsiness warning and that the "non-drowsy" label complies with federal regulations.

Additionally, CVS challenged the plausibility of Newport’s allegations, asserting that her complaint lacked sufficient evidence to show DXM causes drowsiness.

The court rejected CVS’s preemption argument, finding that Newport’s claims did not impose obligations beyond federal requirements but instead paralleled federal law’s prohibition against false or misleading labeling. 

The court noted that the FDA has not explicitly endorsed or mandated "non-drowsy" labeling for DXM-containing drugs.

CVS’s decision to add the label was voluntary, making it subject to scrutiny under consumer protection laws.

The court also determined that Newport’s allegations regarding DXM’s potential to cause drowsiness were sufficiently detailed to survive the pleading stage. 

Newport cited scientific evidence supporting her claim that the "non-drowsy" label was deceptive, which the court deemed adequate for proceeding with discovery.

The ruling allows Newport to pursue her case and potentially establish whether CVS’s labeling practices violated consumer protection laws. 

"The Court finds that Plaintiff’s state law claims are not preempted by federal law," U.S. District Judge Henry Edward Autry wrote in the opinion. "As alleged, Plaintiffs’ state law claims are parallel to the requirements of the FDCA. Further, Plaintiff sufficiently alleges that DXM causes drowsiness, and her Complaint states a claim under the MMPA. Finally, the Court declines to address at this point in the proceedings whether Plaintiff can pursue claims on behalf of consumers in other states and the District of Columbia."

Newport is represented by Daniel F. Harvath of Harvath Law Group in St. Louis.

CVS is represented by Michael Kevin Underhill of Shook Hardy & Bacon in San Francisco; and Emily M. Weissenberger of Faegre Drinker of Faegre Drinker in San Francisco.

Neither party replied to requests for comment before publication of this story.

U.S. District Court for the Eastern District of Missouri case number: 4:24-cv-00252

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