The opinion of the court was delivered by: Patti Saris, District Judge
In this qui tam action, Relator Dr. David Franklin brings a claim under the False Claims Act, 31 U.S.C. § 3729 et seq., alleging that Defendant Parke-Davis (Franklin's former employer) promoted the drug Neurontin for uses not approved by the Food and Drug Administration, resulting in federal reimbursement payments for Neurontin prescriptions that were ineligible under Medicaid. Parke-Davis moves for summary judgment. The government, which has not intervened, has filed a Statement of Interest. After hearing, Parke-Davis's motion is DENIED. [ Page 2]
In its earlier opinion on Parke-Davis's motion to dismiss, the Court canvassed the history of this suit, the complaint's factual allegations, and the relevant law. United States v. Parke-Davis, 147 F. Supp.2d 39 (D. Mass. 2001). Presuming familiarity with that opinion, the Court here will limit the discussion to the select legal and factual issues upon which summary judgment turns.
1. Double-Falsehood Requirement under the FCA?
The False Claims Act ("FCA") imposes liability on any person who, inter alia:
(1) knowingly presents, or causes to be presented,
to an officer or employee of the United States
Government or a member of the Armed Forces of the
United States a false or fraudulent claim for
payment or approval; [or]
(2) knowingly makes, uses, or causes to be made or
used, a false record or statement to get a false or
fraudulent claim paid or approved by the Government
31 U.S.C. § 3729(a).
Parke-Davis argues that it can only be held liable under the FCA if Relator proves that Parke-Davis intentionally made a material false statement that led to the filing of a false claim. Under Parke-Davis's interpretation, the FCA contains a double falsehood requirement: An FCA plaintiff must prove a false statement that led to a false claim. Parke-Davis contends that [ Page 3]
Relator has failed to show that Parke-Davis made any material false statements.
Parke-Davis's legal argument is inconsistent with the text of the FCA. While § 3729(a)(2) contains a double-falsehood requirement ("knowingly makes, uses, or causes to be made or used, a false record or statement to get a false or fraudulent claim paid or approved by the Government") (emphasis added), FCA liability under § 3729(a)(1) arises when a defendant "knowingly presents, or causes to be presented . . . a false or fraudulent claim" (emphasis added). Thus, there is no double falsehood requirement under § 3729(a)(1): One will suffice. See Shaw v. AAA Eng'g & Drafting, Inc., 213 F.3d 519, 531 (10th Cir. 2000) ("Section 3729(a)(1) . . . requires only the presentation of a `false or fraudulent claim for payment or approval' without the additional element of a `false record or statement.'"); United States ex rel. Fallon v. Accudyne Corp., 921 F. Supp. 611, 627 (W.D. Wis. 1995) ("The primary distinction between a claim under section 2 and a claim under section 1 is that section 2 requires an affirmative false statement. To provide any distinct meaning to section 1 it is clear that no such express false statement is required.").
Because Relator has not limited his FCA claim to § 3729(a)(2), he need not show two falsehoods to prevail. Under § 3729(a)(1), Relator is not required to present evidence that [ Page 4]
Parke-Davis lied to physicians about Neurontin's off-label efficacy or safety to induce them to prescribe Neurontin for uses ineligible under Medicaid. Though such evidence would be probative as to whether Parke-Davis caused to be presented false Medicaid claims, truthful off-label marketing (ineligible for federal safe harbors) and financial incentives like kickbacks would suffice.
To be sure, the Court's earlier opinion on Parke-Davis's motion to dismiss focused on allegations of false ...