Truss v. Bayer HealthCare Pharmaceuticals, Inc.

Background

Barbara Truss, Natalia Golson, Jack Kilgore, and Gabriela Pettibone brought a putative class action against Bayer Healthcare Pharmaceuticals, Inc.; Bayer Healthcare LLC; Beiersdorf, Inc.; and Beiersdorf North America, Inc. The plaintiffs alleged that Coppertone Water Babies SPF 50 sunscreen was labeled “Hypoallergenic & Gentle,” “dermatologically tested,” “gentle on baby’s skin,” and “free of oxybenzone,” even though testing allegedly found benzophenone in the product.

The plaintiffs alleged that benzophenone was a hazardous degradation byproduct of octocrylene, an active ingredient in the sunscreen. They claimed the product was mislabeled, misbranded, adulterated, and defective, and that they would not have bought it—or would have paid less for it—if they had known about the benzophenone. They asserted deceptive-practices, false-advertising, unfair-competition, breach-of-warranty, and unjust-enrichment claims under New York and California law.

The defendants moved to dismiss the second amended complaint under Rule 12(b)(6), which permits dismissal for failure to state a legally sufficient claim. They also challenged, under Rule 12(b)(1), the plaintiffs’ standing to seek injunctive relief.

Federal Preemption

The court held that the plaintiffs’ claims were expressly preempted by the Federal Food, Drug, and Cosmetic Act (FDCA) to the extent they were based on the product label’s failure to disclose benzophenone. The FDCA contains an express preemption provision for over-the-counter drugs, including sunscreen. That provision bars states from imposing labeling requirements that are different from, additional to, or not identical to federal requirements.

The court explained that federal regulations require disclosure of a drug product’s active and inactive ingredients. But the plaintiffs did not allege that the defendants manufactured the sunscreen to contain benzophenone. Under the federal definitions, the court therefore concluded that benzophenone was not an active or inactive ingredient requiring disclosure. The court also concluded that federal law did not require disclosure that octocrylene might degrade into benzophenone.

Because the labeling requirement sought by the plaintiffs would be additional to the federal requirements, the court dismissed the deceptive-practices, false-advertising, unfair-competition, and common-law claims to the extent they were based on the failure to disclose benzophenone.

“Free of Oxybenzone” and “Hypoallergenic” Labels

The court separately ruled that the plaintiffs had not adequately stated claims based on the “free of oxybenzone” label. The plaintiffs alleged that the product contained benzophenone, but they did not allege that it contained oxybenzone. Although they referred to benzophenone-3 as the same substance as oxybenzone, the court noted that the complaint described several distinct benzophenone compounds and did not allege that the product contained benzophenone-3. The court therefore dismissed the claims based on the “free of oxybenzone” statement.

The court also dismissed the claims based on the “Hypoallergenic & Gentle” label. The complaint did not identify which benzophenone compound was present. The studies cited by the plaintiffs either focused primarily on benzophenone-3, which the complaint did not allege was in the product, or did not establish that the benzophenone found in the product was an allergen. The court concluded that the plaintiffs had not plausibly alleged that the hypoallergenic statement was false or misleading. For the same reason, the court rejected the claims based on the statements that the product was “dermatologically tested” and “gentle on baby’s skin.”

Ruling

Judge Briccetti granted the motion to dismiss. The court stated that each of the plaintiffs’ claims had to be dismissed and directed the clerk to terminate the motion and close the case. The court did not reach the defendants’ challenge to the plaintiffs’ standing to seek injunctive relief because the claims were dismissed on other grounds. The opinion does not state that the dismissal was with or without prejudice.