January 11, 2013 4th Circuit published opinion

United States ex rel Nathan v Tekeda Pharmaceuticals North America, Inc.

Nathan brought a False Claims Act suit alleging Tekeda was marketing drugs off label thus inducing doctors to prescribe the drugs and eventually have Medicare and Medicaid patients seek reimbursement or other payments for the drugs. The district court granted summary judgment to Tekada ruling there was no presentment of a claim to the government nor was there causation. It also denied a motion to allow a fourth amended complaint. The panel affirmed. It first held that the pleading standard for False Claims Act cases is the rigorous fraud pleading requirement of Federal Rule of Civil Procedure 9. Thus, plaintiffs must provide concrete facts which show a falsehood and a presenting of that false claim to the government. Mere recitation of a fraudulent scheme is not enough. Turning the allegations in the operative complaint, the panel held that all facts relied upon to prove presentment were general in nature, failed to indentify any prescriptions that were off label and presented to the government for reimbursement were speculative and thus implausible. Dismissal was thus proper. The panel finally held that Nathan had been provided clear notice of the deficiencies in his complaint and over two years to correct them. The principal of finality justified the decision to deny leave to further amend.


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