Tagged: 1st Cir.

First Circuit Rejects Fraud-on-the-FDA Theory of FCA Liability

Affirming an earlier order handed down by the United States District Court for the District of Massachusetts, the First Circuit recently denied Plaintiff D’Agostino leave to amend his complaint, finding the proposed claims were futile. D’Agostino, et al. v. EV3, Inc. et al., 2016 WL 7422943 (1st Cir. Dec. 23, 2016).  D’Agostino’s complaint alleges False Claims Act (“FCA”) violations related to the Onyx and Axium medical...

University of Massachusetts Medical School Not a “Person” Under FCA; 1st Circuit Adopts “Arm-of-the-State” Test

In an opinion issued on January 27, 2016, the United States Court of Appeals for the First Circuit affirmed the dismissal of a qui tam lawsuit against the University of Massachusetts, holding that the University was “indistinguishable” from a state agency and, therefore, not a “person” subject to potential liability under the False Claims Act, 31 U.S.C. 3729(a)(1)(A). Relator Michael Willette, an employee of the University’s...

First Circuit Permits Supplementation of Complaint to Cure First-to-File Jurisdictional Defects

The FCA first-to-file bar provides that if an action involving the same subject matter is already pending, “no person other than the Government may intervene or bring a related action based on the facts underlying the pending action.”  31 U.S.C. § 3730(b)(5).  Courts are thus deprived of jurisdiction to entertain opportunistic qui tam lawsuits based on facts similar to an already-filed lawsuit.  In May 2015, the...