“Non habit-forming”

💡 This is the exact claim CVS prominently displayed on the front of its product packaging that the lawsuit alleges is false and misleading.

“Tolerance can develop in as little as 1–2 weeks, requiring users to take larger and larger doses for the same sedating effect, and causing dependency in users who find they need diphenhydramine to fall asleep.”

💡 This establishes the medical fact that contradicts CVS’s "non habit-forming" claim, showing how quickly dependency can develop.

“Diphenhydramine elicits a cocaine-like pattern of stimulation of dopamine transmission that can lead to misuse of medications containing diphenhydramine.”

💡 This reveals the serious addiction mechanism behind diphenhydramine that CVS failed to disclose to consumers.

“Among drug overdose deaths in 2017 that mentioned at least one specific drug on the death certificate, the ten drugs most frequently involved included fentanyl, heroin, cocaine, methamphetamine, alprazolam, oxycodone, morphine, methadone, hydrocodone, and diphenhydramine.”

💡 This places diphenhydramine in the same category as highly addictive and deadly drugs like fentanyl and heroin.

“Among 92,033 overdose deaths during 2019–2020, 13,574 (14.7%) were antihistamine-positive and 3,345 (3.6%) were antihistamine-involved. Nearly all antihistamine-positive and -involved deaths (13,475, 99.6%; 3,339, 99.8%, respectively) included first-generation H1 antihistamines, primarily diphenhydramine (9,645, 71.1%; 2,226, 66.5%, respectively).”

💡 This quantifies the deadly scale of diphenhydramine involvement in overdose deaths during a two-year period.

“In adults 65 years and older, long-term, frequent use of first-generation antihistamines like diphenhydramine is associated with development of dementia and Alzheimer’s due to their anticholinergic properties.”

💡 This reveals a long-term health consequence particularly affecting elderly consumers who may have relied on CVS’s false safety claim.

“Canadian Society of Allergy and Clinical Immunology recommends that first-generation antihistamines such as diphenhydramine should be considered for availability only on a behind-the-counter basis. The Global Allergy and Asthma European Network also supports implementing a prescription requirement for first-generation antihistamines like diphenhydramine.”

💡 Medical organizations internationally recognize diphenhydramine as dangerous enough to warrant restricted access, contradicting CVS’s safety claims.

“When Plaintiff took the Product as directed by Defendant, she developed a habit, contrary to the ‘non habit-forming’ claim.”

💡 This shows real-world harm where following CVS’s directions and relying on their label led directly to the outcome they claimed wouldn’t happen.

“Defendant knew, or should have known, that the ‘non habit-forming’ claim would lead reasonable consumers into believing that the Product was safe and would not result in habitual use based on internal conjoint and other marketing studies.”

💡 This establishes CVS conducted market research showing consumers would rely on this claim, demonstrating intentional deception.

“The ‘non habit-forming’ claim was and is material to reasonable consumers, including Plaintiff, in deciding to buy the Product – meaning that the Product’s ‘non habit-forming’ attributes are important to consumers and motivate them to purchase the Product.”

💡 This shows the false claim wasn’t just decorative but directly drove purchasing decisions and CVS’s profits.

“In making her purchase, Plaintiff paid a price premium due to Defendant’s false and misleading claim.”

💡 This establishes economic harm where consumers paid more money based on a lie about product safety.

“Defendant, as the manufacturer and marketer of the Product, had exclusive control over the ‘non habit-forming’ claim’s inclusion on the Product’s label, packaging, and advertisements – i.e., Defendant readily and easily could have stopped using the ‘non habit-forming’ claim to sell the Product.”

💡 This shows CVS had full control and could have easily removed the false claim but chose not to in order to keep profiting.

“Despite Defendant’s knowledge of the ‘non habit-forming’ claim’s falsity, and Defendant’s knowledge that consumers reasonably rely on the ‘non habit-forming’ claim in deciding to buy the Product, Defendant deliberately chose to market the Product with the ‘non habit-forming’ claim thereby misleading consumers into buying or overpaying for the Product.”

💡 This alleges CVS’s deception was not an accident but a deliberate business strategy despite knowing the truth.

“Today, the over-the-counter sleep-aid market is a global juggernaut, reaping nearly $65 billion a year – a number which is only continuing to rise.”

💡 This establishes the enormous financial incentive CVS had to falsely market its product in this lucrative market.

“According to the CDC, more than one third of American adults regularly don’t get enough of it.”

💡 This shows CVS targeted a massive vulnerable population desperate for sleep solutions, making the false claims particularly predatory.