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Action Not Barred Based on Product Meeting FDA Standards, Ninth Circuit Declares
Opinion Says Judge Fitzgerald Improperly Axed Suit at Pleading Stage Based on Deciding Factual Disputes
By a MetNews Staff Writer
The Ninth U.S. Circuit Court of Appeals yesterday reversed an order dismissing with prejudice, for lack of standing, an action brought by a woman alleging that the sunscreen lotion she bought is carcinogenic, holding that the judge erred in finding that because the product meets federal standards, it is necessarily safe and that the claim lacks viability.
Judge Michael W. Fitzgerald of the Central District of California had tossed the lawsuit brought by a woman, under California’s False Advertising Law and other state statutes, against makers, marketers and distributors of Banana Boat sunscreen products, asserting that they contain dangerous levels of benzene, contrary to the defendants’ representations that the lotions and sprays are safe.
Fitzgerald determined that because the Food and Drug Administration authorizes (“FDA”) the use of benzene in small specified quantiles, which are not exceeded in the sunscreens, the complaint “does not allege facts that tend to show a non-speculative increased health risk” from using the products “or actual economic harm” from having spent money buying them. Therefore, he concluded, there is no actual “case or controversy,” required under Article III of the U.S. Constitution for standing to bring an action in federal court.
The Ninth Circuit disagreed.
Classic Song
“In his 1997 classic spoken-word song, Everybody’s Free (To Wear Sunscreen), Baz Luhrmann advises his audience to ‘Wear sunscreen,’ telling listeners that it helps prevent skin cancer and that ‘[t]he long-term benefits of sunscreen have been proved by scientists,’ ” Circuit Judge Salvador Mendoza Jr. wrote in yesterday’s opinion, observing: “Today, Plaintiff Beth Bowen calls Mr. Luhrmann’s advice into question….”
He declared:
“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.”
Plaintiff’s Burden
Mendoza said that Fitzgerald “mistakenly required Bowen to show that Banana Boat was noncompliant with FDA guidelines in order to establish injury under an economic-harm theory.” Bowen’s actual burden, under California law, the jurist wrote, is to show that she paid more for the sunscreens than she would have absent the false representations upon which she relied.
He also declared that Fitzgerald “improperly weighed disputed evidence” in determining that the level of benzene used in Banana Boat sunscreen products is “safe.”
Note was made that the FDA does not vouch for the safeness of benzene in the small quantiles used in the products, as the defendants argued and Fitzgerald found, and that it actually “tells manufacturers not to put benzene in drugs unless doing so is unavoidable.”
The case is Bowen v. Energizer Holdings, Inc., 23-55116.
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