- In re Oral Phenylephrine Marketing and Sales Practices Litigation, MDL No. 3089, currently pending in the Eastern District of New York
Senior Partner Nick Suciu has been appointed to the Plaintiff Executive Committee in a case against drug manufacturers that marketed over-the-counter oral phenylephrine-based nasal decongestants. Those products include Sudafed PE, phenylephrine-containing Mucinex products, Advil Sinus Congestion & Pain, NyQuil Severe Cold & Flu, up & up Daytime Severe Cold & Flu, and hundreds of others.
About the Case
Plaintiffs, purchasers of nasal decongestants, filed a class action lawsuit alleging that drug manufacturers misrepresented the potency of their over-the-counter phenylephrine-based nasal decongestants. Plaintiffs’ cases were consolidated in the Eastern District of New York as part of this multidistrict litigation, raising a number of state law claims and a federal claim under the Racketeer Influenced and Corrupt Organizations Act. Nick Suciu and other Bryson attorneys specifically contributed allegations targeting Defendants’ allegedly misleading “maximum strength” label statements. More specifically, Bryson and its clients alleged that, by placing the phrases “Maximum Strength” or “Max Strength” on certain products, defendants falsely claimed that their products work better than other oral nasal decongestants containing phenylephrine.
The Second Circuit Resurrects the “Maximum Strength” Claims
The district court entered judgment for the defendant drug manufacturers, concluding that the federal Food, Drug, and Cosmetic Act (“FDCA”) preempted plaintiffs’ state law claims. However, the Second Circuit reversed with regard to the “maximum strength” claims asserted by Bryson and its clients.
In a win for consumers, Plaintiffs successfully argued that drug manufacturers should not be immune when they voluntarily place misrepresentations regarding the potency of their products on the label of their over-the-counter drugs. More specifically, when a drug manufacturer places comparative potency claims (such as “maximum strength”) on its labels that are not required or expressly permitted by the FDCA, it must still comply with state and federal laws that similarly prohibit false and misleading statements on drug products.
Thus, the Second Circuit confirmed that holding defendant manufacturers liable for their purportedly false “Maximum Strength” claims would not impose state law requirements that diverge from federal requirements, as long as the state law requirements are identical to the FDCA’s misbranding prohibition.