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.
Please see full alert below for more information.
Firefox recommends the PDF Plugin for Mac OS X for viewing PDF documents in your browser.
We can also show you Legal Updates using the Google Viewer; however, you will need to be logged into Google Docs to view them.
Please choose one of the above to proceed!
LOADING PDF: If there are any problems, click here to download the file.