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Deceptive Drug Marketing Claims Barred by California’s Safe Harbor Doctrine

3 Jun, 2014 By: Arthur Yoon, Jeffrey Richter

In the case of In re: Celexa and Lexapro Marketing and Sales Practice Litigation, the plaintiffs filed a lawsuit against Forest Laboratories Inc. for violation of the California Consumer Legal Remedies Act, Unfair Competition Law and False Advertising Law – alleging misrepresentation and concealment of material information about the efficacy of the anti-depressant drug Lexapro with respect to the treatment of major depressive disorder (MDD) in pediatric patients. Soon after the U.S. Food and Drug Administration (FDA) approved Forest’s application to market Lexapro for the treatment of MDD in adolescents, the 17-year-old son of the plaintiffs was prescribed Lexapro by his physician to treat his ongoing depression.

The plaintiffs alleged that the drug label for Lexapro, which was approved by the FDA in March 2009, was misleading and inadequate. A section of the label titled “Pediatric Use” stated, “Safety and effectiveness of Lexapro has been established in adolescents (12 to 17 years of age) for the treatment of major depressive disorder…” The label also referenced the two positive clinical studies that formed the basis of FDA approval for the adolescent indication and described both studies as showing “statistically significant greater mean improvement.”

The plaintiffs alleged they and their physician were misled into believing that Lexapro was more effective at treating adolescent MDD than it actually was. In connection with Forest’s application to market Lexapro to adolescents, the plaintiffs claimed that there were several problems with the design of the studies that Forest submitted to the FDA that cast doubts upon the drug’s positive results.

Forest sought dismissal of the lawsuit arguing that the California Safe Harbor Doctrine bars the plaintiffs' claims because the FDA is required by statute to decline to approve a new drug application if there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended or suggested in the proposed labeling of the drug. Forest further asserted that the FDA's regulations concerning prescription drug labeling provide further support for its argument that FDA approval of a drug label protects Forest from liability under state consumer protection law for statements or omissions within that label. The federal district court agreed.

The California Safe Harbor Doctrine bars certain claims brought under its unfair competition laws, when the action or conduct in question is either clearly barred or clearly permitted under another provision in the state law or under federal statutes and regulations. The doctrine, the court explained, reflects the judgment of the California Supreme Court that courts cannot use the state’s unfair competition law to second-guess or condemn actions the legislature permits.

Since Congress entrusted the FDA to determine whether or not there is substantial evidence of a drug’s efficacy for a particular indication, and further entrusted them to determine whether proposed drug labeling is false or misleading, then the FDA’s approval of a drug under both criteria gives the manufacturer a safe harbor from claims on that basis under state unfair competition laws, the court explained. Accordingly, since the FDA had approved Forest’s application to market Lexapro to adolescents for the treatment of MDD, the safe harbor doctrine barred the plaintiffs’ claims that Forest had violated the state’s unfair competition laws and the lawsuit was dismissed.

The court’s ruling, however, should not be relied upon by advertisers outside the context of the FDA’s approval process for a prescription drug. The safe harbor exception may not apply in other types of cases. Courts have held that safe harbor does not apply to FDA regulation of food and homeopathic remedies. In contrast to the insufficient regulatory frameworks for these products, the prescription drug industry is subject to comprehensive regulations promulgated by the FDA and a comprehensive process to evaluate the safety and efficacy of drugs. The availability of the safe harbor exception, therefore, needs to be examined on a case-by-case basis taking into account the specific regulations and process that the FDA may have established to evaluate the safety and efficacy of a particular product.

Jeffrey Richter and Arthur Yoon are attorneys at Blank Rome LLP. They can be reached at (424) 239-3400 or via E-mail at and

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