914 F. Supp. 2d 259
E.D.N.Y2012Background
- Plaintiff alleges Pfizer marketed Lipitor off-label to patients not within the NCEP Guidelines, causing improper claims to Medicare/Medicaid under the False Claims Act.
- Judge Korman previously dismissed the Fourth Amended Complaint with leave to amend; this opinion addresses whether the failure to plead fraud with particularity is cured.
- Two Lipitor labels (2005 with NCEP chart, 2009 with chart omitted) are at issue; court analyzes whether NCEP Guidelines were mandatory or advisory in marketing.
- Court finds the NCEP Guidelines were advisory, not a mandatory restriction on marketing or reimbursement, and that the FDA did not restrict off-label prescribing through labeling.
- Consequently, the court grants Pfizer’s motion to dismiss the FCA claim, concluding there was no off-label marketing proven under the facts.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does the NCEP Guideline chart in Lipitor’s 2005 label restrict marketing? | Polonsky argues the chart imposed a mandatory restriction on promoting Lipitor to outside-Guideline patients. | Pfizer contends Guidelines are advisory and not prohibitive, and 2009 label shows no substantive change. | Guidelines are advisory; no marketing restriction found. |
| Does the absence of a chart in the 2009 label mean Lipitor marketing was off-label? | References to NCEP in 2009 label support a restrictive interpretation. | 2009 label merely references guidelines; not a substantive limitation. | 2009 label references do not create off-label marketing. |
| Can off-label marketing support FCA liability where FDA/Medicare do not prohibit prescribing outside guidelines? | Off-label marketing leads to false claims when reimbursed by government programs. | There is no prohibition in labeling or reimbursement; FCA cannot be used as back-door regulation. | No FCA liability for off-label marketing given advisory labeling and lack of prohibition. |
| Is the 2005 label's advisory NCEP content sufficient to establish false claims? | Any marketing based on the advisory chart could induce false claims. | Advisory content does not convert into a restrictive mandate; no false claims. | Advisory content does not establish false claims. |
| Did the FDA or public insurers’ inaction to restrict Lipitor outside Guideline ranges indicate liability under FCA? | Regulatory non-action does not imply misrepresentation; FDA/insurers could act but did not. | Regulatory inaction does not prove FCA liability. |
Key Cases Cited
- Carpenter v. Abbott Laboratories, Inc., 723 F. Supp. 2d 395 (D. Mass. 2010) (off-label marketing context in FDA labeling contrasted with claimed restrictions)
- United States v. Booker, 543 U.S. 220 (U.S. 2005) (mandatory guidelines concept discussed for definitional purposes)