Relators Face Difficulty Pursuing Safety-Based FCA Suits

Law360, New York (November 16, 2012, 1:06 PM EST) -- Relators bringing safety-based False Claims Act qui tam suits continue to face skepticism from the courts. In U.S. ex rel. Ge v. Takeda Pharmaceutical Co., No. 10-11043, 2012 US Dist. LEXIS 156752 (D. Mass. Nov. 1, 2012), Judge Dennis Saylor dismissed a relator’s qui tam complaints alleging that the pharmaceutical manufacturer’s failure to submit post-marketing adverse events, as required by the Food, Drug and Cosmetic Act, resulted in the submission of false claims for reimbursement in violation of the FCA. The court found that the relator’s...
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