District Court Rejects Fraud-on-the-FDA Theory of False Claims Act Liability


In an opinion that continues a welcome trend in False Claims Act cases, Judge Saylor of the United States District Court for the District of Massachusetts has dismissed a relator’s FCA complaint for failing to plead facts demonstrating that a manufacturer’s breach of the Food & Drug Administration’s (“FDA”) adverse event reporting requirements resulted in any false claims against federal health care programs. United States ex rel. Ge v. Takeda Pharmaceuticals U.S.A., Inc. (Nos. 10-11043-FDS; 11-10343-FDS) (Nov. 1, 2012). Judge Saylor’s opinion, like other recent opinions of Judges Gorton and Stearns in the District of Massachusetts, reflects an appropriate judicial resistance to attempts to convert any and all alleged regulatory violations into liability under the FCA, especially when the agency in question has broad discretion in how to respond to regulatory non-compliance.

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