Court Limits Use of False Claims Act Qui Tam Suits Regarding Product Safety Issues

Summary: Relators bringing safety-based False Claims Act (FCA) qui tam suits continue to face skepticism from the courts. In US ex rel. Ge v. Takeda Pharmaceutical Co., No. 10-11043, 2012 US Dist. LEXIS 156752 (D. Mass. Nov. 1, 2012), Judge 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 (FDCA), resulted in the submission of false claims for reimbursement in violation of the FCA. The court found that the relator’s complaint failed to state a claim under Rule 12(b)(6) because compliance with post-marketing adverse event reporting requirements is not a material precondition to payment for drugs by government healthcare programs.