Moussa Kouyate v. L. Perrigo Company, et al.

Summary

The United States District Court for the Western District of Michigan considers a motion to dismiss claims concerning Perrigo-branded benzoyl peroxide acne products allegedly containing benzene. The court holds that the plaintiff adequately alleged Article III standing, including standing to represent the proposed nationwide class. It dismisses the claims as preempted by the Federal Food, Drug, and Cosmetic Act because they would impose requirements beyond those established by the FDA monograph.

Holdings

1. A plaintiff adequately alleges an actual injury at the pleading stage when the complaint plausibly alleges that the products purchased were contaminated, even though the plaintiff did not test the specific units purchased.
2. Kouyate adequately alleged standing to represent proposed class members whose purchases occurred in other states and whose claims arose under different state laws because the alleged injuries were essentially the same.
3. Kouyate's state-law claims were preempted because success on those claims would impose labeling, ingredient, safety, or manufacturing requirements different from or additional to the requirements established by the FDCA and the FDA's acne-product monograph.
4. Benzene allegedly formed through thermal decomposition of benzoyl peroxide is not a 'decomposed substance' within the natural meaning of 21 U.S.C. § 351(a)(1).
5. The alleged benzene was not an inactive ingredient required to be listed under 21 C.F.R. § 201.66 because it was alleged to be an accidental byproduct rather than an ingredient intended for use in manufacturing the drug product.

Questions Presented

1. Whether Kouyate adequately alleged an actual injury sufficient for Article III standing when he did not test the specific product units he purchased.
2. Whether Kouyate had standing to assert claims on behalf of a proposed nationwide class involving products purchased in other states and claims arising under other states' laws.
3. Whether Kouyate's state-law claims were expressly or impliedly preempted by the Federal Food, Drug, and Cosmetic Act and its regulations.
4. Whether alleged benzene resulting from benzoyl-peroxide degradation constituted a decomposed substance, a misbranding issue, or an inactive ingredient requiring disclosure under federal law.
5. Whether alleged violations of current good manufacturing practices supplied a non-preempted basis for the state-law claims.

Disposition

dismissed