Thousands of product liability suits have been filed against Johnson & Johnson alleging that the company failed to warn consumers that women’s use of talcum powder can cause ovarian cancer. Based on the same failure-to-warn theory, Mississippi’s Attorney General has filed a state consumer protection action against Johnson & Johnson seeking millions of dollars in civil penalties. The Food and Drug Administration (FDA), however, after extensive review of scientific data, and exercising its comprehensive regulatory authority under the Food, Drug, and Cosmetic Act (FDCA), has determined that providing an ovarian cancer warning on cosmetic talcum powder products is scientifically unwarranted and should not be required.
Johnson & Johnson v. Mississippi, ex rel. Lynn Fitch, Attorney General of Mississippi, No. 21-348 (Supreme Court) (petition stage)
Read the Amicus Brief:
Whether the cosmetic-related provisions of the federal Food, Drug, and Cosmetic Act expressly and/or impliedly preempt a state-law consumer protection action based on failure to provide a warning that the Food and Drug Administration has determined is scientifically unwarranted and should not be required.
Whether a “presumption against preemption” is applicable.
The FDCA contains an express preemption provision that prohibits a State from establishing “any requirement for labeling or packaging of a cosmetic that is different from or in addition to, or that is not otherwise identical with, a requirement specifically applicable to a particular cosmetic or class of cosmetics” under the Act. 21 U.S.C. § 379s(a). The purpose of this provision is to maintain national labeling uniformity by vesting the FDA with exclusive authority over the content of cosmetic product labeling, including what warnings should be provided to prevent a product from being “misbranded.” Although product liability suits are exempt from this particular preemption provision, consumer protection actions brought by a state attorney general are not.
The Mississippi Supreme Court rejected Johnson & Johnson’s preemption arguments, and now Johnson & Johnson has filed a certiorari petition seeking U.S. Supreme Court review.
ALF’s Amicus Brief:
ALF, joined by co-amicus DRI, filed an amicus brief urging the Court to grant certiorari. The brief was authored by ALF Executive Vice President & General Counsel Larry Ebner, who volunteers as Vice Chair of DRI’s Center for Law and Public Policy and is Immediate Past Chair of DRI’s Amicus Committee.
The amicus brief argues that in addition to being expressly preempted, the Mississippi AG’s suit is impliedly preempted by direct operation of the Constitution’s Supremacy Clause, Art. VI, cl. 2. This is because the suit is predicated on a state-law duty that logically contradicts federal law since the ovarian cancer warning that the State claims is required under state law is the same warning that FDA has determined is not required under federal law.
In addition, the amicus brief contends that no “presumption against preemption” is applicable to logical contradiction preemption, which is derived directly from the Supremacy Clause. If state law logically contradicts federal law, the Supremacy Clause automatically preempts the state law.
The Petition for a Writ of Certiorari was denied on December 13, 2021.
Lawrence S. Ebner, ALF Executive Vice President & General Counsel.