By a MetNews Staff Writer
A consumers’ class action lawsuit, under California law, alleging that CVS markets glucosamine supplements with false and misleading health claims as to benefits for joints, is not preempted by federal law, the Ninth U.S. Circuit Court of Appeals has held, reversing an order of dismissal.
“The district court’s ruling mistakenly broadened the FDCA preemption doctrine beyond acceptable public policy limits,” a memorandum opinion by a three-judge panel, filed Friday, declares.
The opinion reverses an order by District Court Judge Cathy Ann Bencivengo of the Southern District of California dismissing the putative class action, without leave to amend. She determined that plaintiff James Kroessler’s state law claims, under the Unfair Competition Law and the Consumer Legal Remedies Act, are preempted by the Federal Food, Drug, and Cosmetic Act (“FDCA”).
Bencivengo found, and the Ninth Circuit agreed, that representations by CVS about its supplement are “structure/function claims”—which relate to how the supplement is intended to affect the human body—as opposed to “disease claims” which tell of how the product will cure, treat or prevent a disease.
The Ninth U.S. Circuit Court of Appeals on Friday reinstated a putative class action In which it is asserted that glucosamine supplements sold by CVS do not have the promised health benefits. The diversity action, alleging causes of action under California statutes, is not preempted by federal law, a three-judge panel held.
Private actions against makers of supplements, which are not permitted under federal law, may proceed in state courts, it has been held, where state requirements parallel those set forth in the FDCA.
Under federal law, structure/function claims are permitted if they meet specified requirements, including the existence of substantiation for them. Bencivengo declared that Kroessler’s lawsuit would impermissibly “impose state-law requirements that differ from the federal requirements,” explaining:
“Although the FDCA requires manufacturers to have substantiation for their structure/function claims, California law does not allow private plaintiffs to demand substantiation for advertising claims.”
Ninth Circuit Opinion
District Court Judge Eric F. Melgren of the District of Kansas, sitting by designation, wrote the opinion reversing the order of dismissal. He said:
“[J]ust because California law prohibits private plaintiffs from forcing defendants to substantiate their advertising claims, that does not mean California law prohibits those plaintiffs from attacking defendants’ substantiation….[U]nder California law, a plaintiff retains the burden of production and the burden of proof but can nevertheless challenge a defendant’s substantiation.”
“CVS may attack the sufficiency of Kroessler’s evidence at summary judgment or trial—and it may well succeed at those stages. But at this stage, FDCA preemption does not prevent Kroessler’s state law claims from proceeding.”
Leave to Amend
Melgren also said Kroessler should be granted leave to amend his complaint to state a cause of action based on “implied” disease claims.
“Because Kroessler may have been able to ‘bolster’ his complaint with allegations of extra-label evidence showing that CVS’s glucosamine-based supplements present implied disease claims, the court erred by denying him leave to amend his complaint based on futility,” he wrote.
The case is Kroessler v. CVS Health Corp., 19-55671.
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