United States Ex Rel. Booker v. Pfizer, Inc.
847 F.3d 52
| 1st Cir. | 2017Background
- Pfizer settled FCA claims with DOJ in August 2009 and entered a Corporate Integrity Agreement (CIA) with HHS. Relators Booker and Hebron, former Pfizer sales reps, filed a qui tam FCA suit
- Relators alleged post-settlement misconduct: continued off-label promotion of Geodon (and kickbacks for Geodon and Pristiq), breach of the CIA (reverse false claims), and retaliation for whistleblowing (Booker's termination)
- None of the sovereigns intervened; relators amended repeatedly and sought discovery; district court dismissed the reverse-FCA claim and later granted summary judgment to Pfizer on the remaining claims
- Reverse-FCA theory: Pfizer failed to report a "Reportable Event" (Booker’s Jan. 5, 2010 email) under the CIA, avoiding stipulated-penalty obligations to HHS
- Off-label theory: relators contended Pfizer’s promotion caused false claims to be submitted to government programs; their proof consisted primarily of aggregate prescribing/expenditure data
- Retaliation theory: Booker says his termination (Jan. 6, 2010) was retaliation for reporting/promoting objections; district court found no protected FCA conduct shown
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Reverse-FCA liability based on CIA breach | Booker alleged his email was a "Reportable Event" under the CIA and Pfizer's failure to report avoided an obligation to pay stipulated penalties | Pfizer argued the CIA requires Pfizer to "determine" after investigation that an event is a probable violation before a Reportable Event exists; relators did not plead such a determination | Affirmed dismissal: relators failed to allege Pfizer made the requisite determination that triggered a Reportable Event, so no reverse-FCA claim pleaded |
| Off-label promotion → FCA liability (existence of actual false claims) | Relators argued aggregate Medicaid/NDI data and circumstantial evidence showed off-label prescriptions and thus false claims were submitted | Pfizer argued relators offered only aggregate data without identifying specific false claims, providers, times, amounts, or programs | Summary judgment for Pfizer affirmed: relators failed to produce competent evidence of actual false claims required under FCA at summary judgment |
| FCA anti-retaliation (Booker fired for reporting) | Booker says he objected to supervisory directions promoting off-label uses and was terminated in retaliation | Pfizer argued Booker's objections related to regulatory/marketing issues not tied to the knowing submission of false claims; also proffered nonretaliatory performance-based reasons for termination | Affirmed for Pfizer: relators failed to show Booker engaged in FCA-protected activity (i.e., actions reasonably likely to lead to an FCA suit alleging false claims) |
| Discovery and Rule 56(d) relief | Relators contend the district court improperly limited discovery and denied their Rule 56(d) request for more documents relevant to AKS / kickback theories | Pfizer contended relators had extensive discovery opportunities over six years and failed to identify likely productive additional evidence | Affirmed: district court did not abuse discretion; relators failed to show further discovery would likely produce material evidence |
Key Cases Cited
- John’s Insulation, Inc. v. L. Addison & Assocs., Inc., 156 F.3d 101 (1st Cir. 1998) (notice of appeal to final judgment encompasses earlier interlocutory orders that merge in that judgment)
- Karvelas v. Melrose-Wakefield Hosp., 360 F.3d 220 (1st Cir. 2004) (FCA liability requires proof of actual false claims; retaliation protection limited to conduct reasonably likely to lead to FCA action)
- In re Neurontin Mktg. & Sales Practices Litig. (Harden), 712 F.3d 60 (1st Cir. 2013) (aggregate data plus strong circumstantial evidence may suffice on causal link in RICO context; distinguished from FCA requirement of actual false claims)
- Lawton ex rel. U.S. v. Takeda Pharm. Co., 842 F.3d 125 (1st Cir. 2016) (Rule 9(b) and summary-judgment requirements for alleging and proving actual false claims in FCA cases)
- U.S. ex rel. Ge v. Takeda Pharm. Co., Ltd., 737 F.3d 116 (1st Cir. 2013) (aggregate expenditure data insufficient by itself to identify actual false claims under the FCA)