Antitrust Law Daily Wrap Up, STATE UNFAIR TRADE PRACTICES—D. Mass.: Claims of deceptive marketing of anti-depressant medication barred by safe harbor, (Mar 7, 2014)

By Edward L. Puzzo, J.D.

California’s safe harbor doctrine barred claims that a drug company had violated state unfair competition laws by marketing anti-depressant medication which was less effective for young people than advertised, the federal district court in Boston has ruled (In re: Celexa and Lexapro Marketing and Sales Practices Litigation, March 5, 2014, Gorton, N.).

Background. Celexa and Lexapro are selective serotonin reuptake inhibitor (SSRI) anti-depressant drugs marketed by Forest Laboratories and Forest Pharmaceuticals. Soon after the Food and Drug Administration (FDA) approved Forest’s application to market both drugs for the treatment of major depressive disorder (MDD) in children and adolescents, the 17-year-old son of plaintiffs Randy Marcus and Bonnie Marcus was prescribed Lexapro by his physician to treat his ongoing depression. Plaintiffs allege they and their physician were misled into believing that Lexapro was more effective at treating adolescent MDD than it actually was.

They brought claims in the federal district court for the Central District of California, alleging that Forest misrepresented and concealed material information about the efficacy of Lexapro in treating major depressive disorder in pediatric patients, in violation of the California Consumer Legal Remedies Act (CLRA), Unfair Competition Law (UCL) and False Advertising Law (FAL). The matter was later transferred to this court by the Judicial Panel on Multidistrict Litigation. Forest moved to dismiss, alleging that the claims were barred by California’s safe harbor rule.

California’s safe harbor rule. The court explained that the California safe harbor doctrine bars certain claims brought under California’s 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 statues and regulations.

Forest argued that 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 to, or when its proposed labeling is false or misleading. Since the FDA approved the drug for its proposed use, Forest argued, the effect of the safe harbor doctrine is that Forest is protected from liability under state consumer protection law for statements or omissions within the approved drug label.

Plaintiffs responded that federal law prohibits the distribution of drugs labeled in a false or misleading way, and that the safe harbor doctrine would only apply if federal law specifically permitted Forest to conceal material information about a drug’s efficacy from consumers and prescribers.

FDA approval provides safe-harbor. The court endorsed Forest’s view. The safe harbor 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 declared.

Safe-harbor exceptions. The court acknowledged that certain safe harbor exceptions existed, but found that they did not apply in this instance. Courts have held that safe harbor does not apply to FDA regulation of food and homeopathic remedies. However, 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. Thus, this exception to safe harbor did not apply.

Other courts found that FDA approval did not provide safe harbor against state law claims based on advertising claims made prior to FDA approval. Those facts also did not apply here because plaintiff’s claims were based entirely on the marketing and sales of Lexapro after the FDA approved Forest’s application for an adolescent indication and a proposed label. Thus, the safe harbor applied to bar state law claims. Finally, the court acknowledged that Wyeth v. Levine, 555 U.S. 555 (2009) held that FDA approval of a drug label did not necessarily preempt state-law “failure to warn” claims. However, the court could find no authority permitting it to extend that holding to state consumer protection law claims.

Having found that the safe harbor doctrine barred these claims, and that no exception to its application existed, the court granted Forest’s motion to dismiss.

The case is Civil Action No. 13-11343-NMG.

Attorneys: Michael L. Baum (Baum, Hedlund, Aristei & Goldman, P.C.) for Randy Marcus. Edwin G. Schallert (Debevoise & Plimpton) for Forest Pharmaceuticals, Inc. and Forest Laboratories Inc.

Companies: Forest Pharmaceuticals, Inc.; Forest Laboratories Inc.

Cases: StateUnfairTradePractices CaliforniaNews MassachusettsNews