## Facts

- Dr. David Franklin, a former Parke-Davis “medical liaison,” brought a qui tam action under the False Claims Act (FCA) alleging a fraudulent marketing scheme involving Neurontin (gabapentin).
- Neurontin was FDA-approved for adjunctive therapy for partial seizures; Franklin alleged Parke-Davis promoted it for multiple unapproved (off-label) uses, including monotherapy for epilepsy, neuropathic pain, and bipolar disorder.
- The alleged campaign used sales messaging, medical liaison outreach to prescribers, speaker programs, and alleged kickbacks to increase off-label prescribing.
- Franklin alleged Parke-Davis expected and intended that increased off-label prescriptions would be reimbursed by government payors, including Medicaid and the Veterans Administration (VA).
- The United States declined to intervene after receiving the relator’s disclosures; Parke-Davis moved to dismiss under Rules 9(b) and 12(b)(6).
- Franklin agreed to drop two counts; other counts included theories tied to Neurontin marketing, some allegations involving VA sales mechanics, and separate allegations involving Accupril.

## Issues

1. Whether the complaint alleged fraud with sufficient particularity under Federal Rule of Civil Procedure 9(b) for FCA claims premised on an off-label marketing scheme.
2. Whether the complaint stated an FCA claim under Rule 12(b)(6) where the defendant did not itself submit reimbursement claims but allegedly caused third parties to submit them.
3. Whether FCA liability may rest on off-label promotion only when tied to false or nonreimbursable claims for government payment, rather than functioning as indirect enforcement of FDA regulatory requirements.

## Decision

- The court granted in part and denied in part the motion to dismiss.
- The court held that the relator adequately pled (including under Rule 9(b)) a core FCA theory that Parke-Davis’s off-label promotion foreseeably caused submission of false claims for reimbursement to Medicaid and the VA.
- The court declined to require the relator, at the pleading stage, to identify specific claim dates and amounts allegedly submitted by third parties where such billing details were largely outside the relator’s access and the complaint otherwise described the scheme with specificity.
- The court dismissed certain counts (including allegations involving Accupril and some claims premised on VA-related sales) where the pleadings failed to connect alleged misconduct to the submission of false claims with sufficient detail and/or failed to state an FCA claim.

## Legal Principles

- Rule 9(b) in FCA cases requires the “who, what, when, where, and how” of the alleged fraud, but particularity may be satisfied by detailed allegations of a company-wide fraudulent scheme and its mechanics when specific billing records are not reasonably available to the relator at the pleading stage.
- The FCA reaches not only those who submit false claims but those who “cause” them to be submitted; a defendant may be liable where it knowingly implements conduct intended to generate government-reimbursed claims and submission is a foreseeable result.
- Off-label prescribing by physicians is not itself unlawful; the FCA inquiry is whether false or fraudulent claims for government payment were submitted.
- The FCA is not a substitute enforcement mechanism for the FDCA; FCA claims must be tied to government payment (e.g., that the claims were nonreimbursable or otherwise false under applicable reimbursement rules), not merely to regulatory violations in drug promotion.

## Conclusion

The court permitted the relator’s principal FCA claims to proceed where the alleged off-label promotional scheme plausibly and foreseeably caused submission of false or nonreimbursable reimbursement claims to federal payors, while dismissing counts that were insufficiently particularized or lacked a concrete nexus between the challenged conduct and false claims for government payment.


United States ex rel. Franklin v. Parke-Davis, 147 F. Supp. 2d 39 (D. Mass. 2001)