Tuesday, October 15, 2024

9th Circuit refuses to kick out claim over benzene in sunscreen on standing

Bowen v. Energizer Holdings, Inc., --- F.4th ----, 2024 WL 4352496, No. 23-55116 (9th Cir. Oct. 1, 2024)

Bowen sued Energizer for false advertising, alleging that its Banana Boat sunscreen was adulterated with dangerous levels of benzene, a carcinogen that scientists have determined can cause cancer.

Energizer moved to dismiss under Rule 12(b)(1), arguing that there was no Article III standing because Bowen’s allegations that small amounts of benzene in sunscreen are unsafe were false. The district court held that “[i]n light of the [FDA] guideline permitting 2 [parts per million] of benzene in sunscreen, [Bowen] does not allege facts that tend to show a non-speculative increased health risk or actual economic harm” arising from her purchase of Banana Boat products. This was a premature resolution of the merits issue. “Although a district court faced with a factual challenge to its exercise of jurisdiction may resolve disputed facts as to purely jurisdictional questions, it may not do so when those jurisdictional questions are intertwined with the merits of a claim. When the jurisdictional and merits issues are inseparable, the court must treat a factual attack on jurisdiction as a motion for summary judgment and construe disputed issues of fact in favor of the nonmoving party. Applying that standard here, Bowen has adequately established an injury in fact for purposes of Article III.” Remanded.

Bowen had one bottle of the sunscreen tested at a lab, revealing that it contained 0.29 parts per million (“ppm”) of benzene. A non-party pharmacy also allegedly tested various Banana Boat products and found that they too contained benzene, including a bottle with more than 0.1 ppm of benzene.

Bowen alleged that “[b]enzene is a carcinogen that can cause cancer in humans,” and that “the application of sunscreen specifically increases the absorption rate of benzene through the skin.” A Yale researcher, clinician, and professor of dermatology allegedly opined that “[t]here is not a safe level of benzene that can exist in sunscreen products,” given the large surface area of the human body and the amount of sunscreen needed to properly cover it. This contamination allegedly has led to public concern and voluntary recalls of Banana Boat products.  

Looking to documents produced or relied on by the FDA, the district court determined that they “impl[y] that manufacturers like Defendants may continue to release products that are adequately tested and contain less than 2 ppm of benzene.” It further held that Bowen’s “alleged economic harm”—i.e., that she paid more than she would have had she known that Banana Boat contained benzene—“is premised on the speculative notion that the presence of 0.29 ppm of benzene, or any potential presence of benzene, makes the sunscreen unsafe.”

Bowen’s allegations relating to standing weren’t “separable from the merits of the case,” but rather “intertwined with an element of the merits of the plaintiff’s claim,” such that the district court was required to “leave the resolution of material factual disputes to the trier of fact.”

When plaintiffs in a false advertising case “ ‘contend that [they] paid more for [a product] than they otherwise would have paid, or bought it when they otherwise would not have done so’ [because of a false claim or misleading omission] they have suffered an Article III injury in fact.” Whether the statements they relied on were materially false was also a merits issue. These allegations weren’t separable from the merits.

The district court thus “mistakenly required Bowen to show that Banana Boat was noncompliant with FDA guidelines in order to establish injury under an economic-harm theory.” Her alleged overpayment was the harm, not the safety/risk profile. In addition, to find 0.29 ppm benzene “safe” was to improperly weigh disputed evidence. The court of appeals pointed out that, even without considering Bowen’s countervailing evidence, the FDA hardly blessed the presence of benzene at any level in the relevant documents. Its guidance was that benzene “should not be employed in the manufacture of ... drug products because of their unacceptable toxicity or their deleterious environmental effect. However, if their use is unavoidable in order to produce a drug product with a significant therapeutic advance, then their levels should be restricted” to 2 ppm, “unless otherwise justified.” That “caveat-laden” guidance was hardly a safety endorsement. “Faced with two sunscreens in the skincare aisle of a pharmacy—one with benzene, the other with no benzene—it is perfectly reasonable that the consumer would avoid the product containing benzene, as Bowen alleges that she would have absent Defendants’ alleged false advertising.”

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