(CN) - Parents in California cannot compel manufacturers to replace FDA-approved labels of antidepressant Lexapro, which they say overstates the effectiveness of the drug, the 1st Circuit ruled.
Randy and Bonnie Marcus filed a class action in Los Angeles Federal Court in May 2013, claiming Forest Laboratories Inc. and Forest Pharmaceuticals Inc. falsely advertised antidepressant medication Lexapro, in violation of state consumer protection laws.
The couple says they bought Lexapro to treat their adolescent son's depression in April 2009, based on its FDA-approved label, only to find it no more effective than a placebo.
According to the complaint, the FDA's standards for approving antidepressants are "minimal," as the agency accepted "flawed" and "fraudulent" data from studies of Lexapro and Celexa, another selective serotonin reuptake inhibitor.
The Marcuses say that "data was manipulated to create the appearance of statistical significance" in the Celexa study, while the Lexapro study showed a clinically insignificant difference between that drug and a placebo for acute treatment of depression in adolescents.
The plaintiffs seek a permanent injunction on behalf of all Californians who purchased Lexapro for an adolescent from March 2009 to present, and assert violations of the state's Consumer Legal Remedies Act, False Advertising Law, and Unfair Competition Law.
The Judicial Panel on Multidistrict Litigation transferred the case to Massachusetts as part of In re Celexa and Lexapro Marketing and Sales Practices Litigation.
The Massachusetts court then granted Forest's motion to dismiss, relying on Federal Food, Drug, and Cosmetic Act preemption and California's safe harbor doctrine.
The 1st Circuit affirmed the lower court's ruling Friday, finding that federal law impliedly preempts the Marcuses' claims because the Federal Food, Drug, and Cosmetic Act prohibits Forest from independently changing its FDA-approved label.
The judge tossed aside the plaintiffs' request that Forest change Lexapro's label, which federal law says must reflect "newly acquired" information.
"We find only two fleeting references to academic articles published after the FDA's approval of the Lexapro label," Judge William Kayatta, said, writing for the three-judge panel. "Plaintiffs make no claim that these two academic articles are based on new data. They instead contend that these two studies are metaanalyses that were not included in Forest's submission to the FDA."
The judge later added: "We can find no precedent - and plaintiffs point to none - that would have allowed Forest to use the [changes being effected] CBE procedure to alter the FDA label in the manner that plaintiffs allege is necessary so as to render it not 'misleading.' Indeed, plaintiffs seem to concede this in their prayer for relief, as they ask the court to 'direct[] Forest to seek FDA approval of a new [drug] label.'
"Plaintiffs are thus stymied: Forest could not independently change its label to read as plaintiffs say it should have read in order to comply with California law," the ruling continues. "That construction of California law upon which plaintiffs rely - even assuming it is correct notwithstanding the safe harbor doctrine - is therefore preempted by federal law."
Actavis, which acquired Forest last year, reportedly earned more than $4.63 billion in revenue in 2014.
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