California’s Safe Harbor Doctrine Bars Class Action Against Lexapro Makers, Federal Judge Rules

BOSTON — California’s safe harbor doctrine shields the makers of Lexapro from claims that they concealed information concerning the efficacy of the drug in treating major depressive disorder in pediatric patients, a Massachusetts federal judge has ruled.

Where the FDA approves a label for a certain indication, the safe harbor provision applies to bar a claim that the label was false or misleading, Judge Nathaniel M. Gorton of the U.S. District Court for the District of Massachusetts ruled in a March 5 order.

Bonnie and Randy Marcus filed a class action accusing Forest Laboratories Inc. and Forest Pharmaceuticals Inc. of …