United States ex rel. Polansky v. Pfizer, Inc.
2016 U.S. App. LEXIS 8974
| 2d Cir. | 2016Background
- Relator Jesse Polansky, a former Pfizer medical director, alleged Pfizer promoted Lipitor for patients outside the NCEP cholesterol-guideline framework, causing government payors to reimburse off-label prescriptions in violation of the False Claims Act (FCA) and state analogs.
- Polansky's theory: the NCEP Guidelines were incorporated into Lipitor’s FDA-approved label and therefore noncompliance rendered prescriptions off-label and reimbursement claims false.
- The NCEP Guidelines (advisory, 2001) set LDL goals, initiation and drug-therapy cutpoints by risk category but expressly stated they are not mandatory and that clinical judgment may override them.
- Lipitor’s label referenced the Guidelines pre-2009 (including a summary table) and retained a brief parenthetical reference in the 2009 label; the 2009 label omitted the summary table but was otherwise substantively the same and FDA-approved.
- District courts dismissed Polansky’s FCA claims: Judge Korman for failure to plead fraud with particularity; Judge Cogan (adopted by this panel) concluded the label did not make the Guidelines mandatory, so off-label marketing could not be established as a matter of law.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether NCEP Guidelines were incorporated into and made mandatory by Lipitor’s FDA-approved label | Guidelines were incorporated via label references and table, making use outside Guidelines off-label | Label references are advisory; FDA did not make Guidelines mandatory; 2009 label omission shows non-mandatory status | Held: Guidelines are not incorporated as mandatory; label does not limit approved use to Guideline-specified patients |
| Whether alleged off-label promotion could support FCA liability (implied false certification) | Pfizer’s marketing induced prescriptions for off-label uses, causing false claims to government payors | Even if marketing occurred, physicians may permissibly prescribe off-label; reimbursement claims do not necessarily imply certification of on-label use | Held: FCA claims fail because premise (label-mandated Guidelines) implausible; court did not reach full implied-certification rule but rejected claim on label interpretation |
| Whether Rule 9(b) pleading particularity was satisfied | Operative complaint attempted to cure prior defects and pleaded scheme details | Complaint still lacked particularized examples of false claims | Court adopted Judge Cogan’s analysis and affirmed dismissal on label-ground; did not decide the circuit split on Rule 9(b) requirement for specific false claims |
| Whether FCA should be used to regulate clinical prescribing practice | FCA can address fraudulent misrepresentations causing false claims | FCA is not a substitute for FDA regulatory choices; relator cannot use FCA to impose restrictions agencies declined to require | Held: FCA cannot be used as a back-door means to impose labeling/regulatory limits that FDA did not impose; dismissal affirmed |
Key Cases Cited
- United States v. Caronia, 703 F.3d 149 (2d Cir. 2012) (FDA does not bar all off-label promotion; speech-based limits raise First Amendment concerns)
- Wyeth v. Levine, 555 U.S. 555 (2009) (drug labeling approved by FDA governs indications and cannot be altered without approval)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (complaint must state a plausible claim to survive dismissal)
- Mikes v. Straus, 274 F.3d 687 (2d Cir. 2001) (implied false certification applies when statute/regulation expressly conditions payment on compliance)
- United States ex rel. Bledsoe v. Cmty. Health Sys., Inc., 501 F.3d 493 (6th Cir. 2007) (Rule 9(b) requires pleading actual false claims with particularity)
- United States ex rel. Nathan v. Takeda Pharms. N. Am., Inc., 707 F.3d 451 (4th Cir. 2013) (relator must allege specific false claims when defendant’s conduct could but need not have led to false claims)
- United States ex rel. Grubbs v. Kanneganti, 565 F.3d 180 (5th Cir. 2009) (complaint may survive without detailing actual claims by alleging scheme plus reliable indicia that claims were submitted)
- Foglia v. Renal Ventures Mgmt., LLC, 754 F.3d 153 (3d Cir. 2014) (adopts Grubbs approach regarding Rule 9(b) and false-claims pleading)