A third appellate decision today about FDCA preemption….it’s definitely clerk turnover season!
After studies started casting doubt on the notion that oral phenylephrine (oral PE) was an effective nasal decongestant, consumers across the country and a retail pharmacy sued drug manufacturers under the theory that the manufacturers had produced, marketed, and sold “nasal decongestants containing the active ingredient oral PE, despite having known since at least 2016 that oral PE does not, in fact, decongest.” The cases were consolidated and transferred to New York, where a district court dismissed the plaintiffs’ state-law claims as preempted by the FDCA and their RICO claims for lack of standing.
In today’s decision in Yousefzadeh v. Johnson & Johnson Consumer Inc., the Second Circuit largely affirmed, finding that the majority of the consumer plaintiffs’ state-law claims were preempted by the FDCA, since the manufacturers were following the FDA’s labeling requirements. The court did, however, allow state-law claims to move forward as to the manufacturers use of “maximum strength” or “max strength” on their products, finding that the FDA had not required or blessed the use of those terms, and thus there was no preemptive shield. The court also remanded for further consideration claims related to non-monograph, brand-name drugs because, for those drugs, the manufacturers may have been able to make labelling changes under the FDA’s “changes-being-effected” regulation.
As to the RICO claims, the court held that the plaintiffs lacked a cause of action under RICO as indirect purchasers.
