United States v. Pfizer, Inc.
9 F. Supp. 3d 34
D. Mass.2014Background
- Relators (Booker and Hebron), former Pfizer sales reps, allege post‑2009 off‑label and non‑compendium promotion of Geodon and Pristiq that caused false claims to federal and state healthcare programs; Booker also alleges retaliatory termination.
- Case filed July 13, 2010 as a qui tam action under the federal False Claims Act (FCA) and the FCAs of 25 states plus D.C.; government declined to intervene.
- Pfizer moved to dismiss, asserting among other defenses the FCA first‑to‑file bar, the public disclosure bar, failure to plead falsity, insufficiency under Rule 9(b), and that its Corporate Integrity Agreement (CIA) did not create a reverse‑false‑claim obligation.
- The court narrowed plausible federal FCA theories to: (1) claims based on off‑label, non‑compendium Geodon prescriptions for children/adolescents, bipolar maintenance, and excessive dosage; and (2) claims induced by alleged kickbacks (for Geodon and Pristiq).
- State FCA claims premised solely on off‑label/non‑compendium reimbursement were dismissed for lack of state‑specific pleading about reimbursement policies; state claims based on kickbacks were allowed to proceed.
- Booker’s retaliation claim under 31 U.S.C. § 3730(h) survived at the pleading stage (protected investigations/reports; proximate temporal link to termination).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| First‑to‑file bar (31 U.S.C. § 3730(b)(5)) | Prior related suits were not pending when this action filed, so bar inapplicable | Prior qui tam complaints disclose same essential facts and should bar later suit | Bar inapplicable — statute requires prior action be "pending" when later suit filed; court follows weight of circuit authority refusing to extend bar to dismissed prior suits |
| Public disclosure bar / Original‑source exception (31 U.S.C. § 3730(e)(4)) | Relators added independent, material information (post‑settlement continuation of off‑label Geodon promotion) and provided it to government before filing | Prior public complaints (Kruszewski, Westlock) publicly disclosed substantially the same scheme | Public disclosure provision could apply, but relators plausibly allege original‑source status (independent, material knowledge and pre‑filing disclosure), so claims not dismissed on that ground |
| Falsity of claims for off‑label/non‑compendium uses (federal v. state FCAs) | Off‑label non‑compendium prescriptions are not reimbursable under federal statutes; claims thus false | States and Part D plans may exercise discretion to reimburse off‑label non‑compendium uses; not categorically false | For federal FCA: plausible that some false claims resulted (because some states restrict reimbursement). For state FCAs: relators must plead state‑specific reimbursement rules; claims based solely on federal policy insufficient |
| Reverse false claims based on CIA (31 U.S.C. § 3729(a)(1)(G)) | Pfizer’s failure to report CIA "reportable events" avoided stipulated penalties, creating an obligation to pay the government | The CIA only made penalties discretionary (OIG must determine to impose), so no concrete obligation to pay existed | Dismissed: CIA reporting duties do not itself create an obligation to pay; any payment obligation depended on OIG’s discretionary decision to impose penalties |
| Kickbacks as basis for falsity (Anti‑Kickback statute) | Payments to speaker‑physicians induced prescriptions; claims arising from those prescriptions are false | Need to plead payments exceeded fair market value or other specifics to show illegal kickbacks | Court allowed kickback‑based theory to proceed; complaint sufficiently alleged speaker program, payments, targeting of high prescribers, and increases in prescriptions after payments |
| Particularity under Rule 9(b) | Provided representative claims, physician targets with high Medicare/Medicaid populations, dates, and payment details for speaker program | Allegations are not specific enough as to many off‑label uses and Pristiq promotion; insufficient to link to particular false claims | Pleading survives for limited Geodon uses (children/adolescents, bipolar maintenance, excessive dosage) and for kickback theory; Pristiq allegations and other off‑label uses lacked required particularity and were dismissed as pleaded |
| Retaliation (31 U.S.C. § 3730(h)) | Booker investigated/reported off‑label promotion and compliance concerns; termination was because of protected activity | Pfizer contends conduct may be regulatory complaints only | Survives: Booker’s reporting was sufficiently tied to potential FCA claims and alleges Pfizer knew and terminated him shortly thereafter |
Key Cases Cited
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (plausibility standard for Rule 12(b)(6) pleadings)
- U.S. ex rel. Duxbury v. Ortho Biotech Prods., L.P., 579 F.3d 13 (1st Cir. 2009) (first‑to‑file doctrine and Rule 9(b) context for qui tam suits)
- New York v. Amgen Inc., 652 F.3d 103 (1st Cir. 2011) (fraudulent promotion alone does not automatically make third‑party reimbursement claims false)
- U.S. ex rel. Poteet v. Medtronic, Inc., 552 F.3d 503 (6th Cir. 2009) (public disclosure bar limits; additional similar time‑period allegations may add little)
- U.S. ex rel. Karvelas v. Melrose‑Wakefield Hosp., 360 F.3d 220 (1st Cir. 2004) (protected activity and retaliation framework under the FCA)
- Bahrani v. Conagra, Inc., 465 F.3d 1189 (10th Cir. 2006) (reverse false claims analysis where obligation to pay arises)
- Allison Engine Co. v. U.S. ex rel. Sanders, 553 U.S. 662 (2008) (interpreting intent and scope of § 3729 prior to FERA amendments)
- U.S. ex rel. Ge v. Takeda Pharm. Co., 737 F.3d 116 (1st Cir. 2013) (Rule 9(b) pleading limits in FCA off‑label/false‑claim context)
- U.S. ex rel. Rost v. Pfizer, Inc., 507 F.3d 720 (1st Cir. 2007) (FCA is not a general‑purpose anti‑fraud statute; limits of off‑label promotion theory)