First Circuit Holds Subsequent FDA Approval Of Drugs For Pediatric Use Not Conclusive Proof Of Effectiveness At Time Of Sale So As To Preclude Fraudulent Marketing Claims, And Individualized Proof Of Causation Of Prescriptions And Drugs’ Ineffectiveness Not Required Where Claims Supported By Medical Literature And Expert Testimony -

In Painters & Allied Trades Dist. Council 82 Health Care Fund v. Forest Pharms., Inc., 915 F.3d 1 (1st Cir. 2019), numerous individual purchasers and third-party payors sued multiple antidepressant manufacturers in the United States District Court for the District of Massachusetts in a putative class action, alleging they misrepresented the drugs’ efficacy in marketing them for the non-FDA-approved or "off label" use of treating depression in multiple pediatric age groups, causing physicians to prescribe and plaintiffs to pay for ineffective drugs. Plaintiffs sought refund of the drugs’ full price through claims under the federal Racketeer Influenced and Corrupt Organizations Act ("RICO"), 18 U.S.C. § 1962, for harm caused by “a pattern of racketeering activity” that included violation of the federal mail and wire fraud statutes, 18 U.S.C. §§ 1341 and 1343, the Minnesota Unfair Trade Practices Act, which prohibits deceptive commercial acts, and the similar Minnesota Consumer Fraud Act, which forbids misrepresentation to consumers. The district court granted summary judgment, holding the RICO claims lacked evidence of injury and the state law claims were derivative of the RICO claims.