COGAN
Kirk E. Chapman, Milberg LLP, Frederick M. Morgan, Morgan Verkamo LLC, for Plaintiff. Mark Steven Cheffo, Skadden, Arps, Slate, Meagher & Flom LLP, for Defendant.
MEMORANDUM DECISION AND ORDER
COGAN, District Judge.
Before the Court is defendant's motion to dismiss plaintiff's Fifth Amended Complaint in this qui tam action under the False Claims Act (“FCA”) 31 U.S.C. § 3729 et seq. Plaintiff alleges that Pfizer has engaged in an illegal marketing campaign for its popular statin Lipitor. According to plaintiff, defendant misrepresented the patient populations to whom the drug should be prescribed by encouraging doctors to prescribe Lipitor to lower their patients' cholesterol even when the patients' risk factors for cardiac heart disease and their cholesterol levels failed to indicate that they needed drug intervention according to the National Cholesterol Education Program Guidelines (“NCEP Guidelines” or “Guidelines”). Plaintiff argues that by marketing the drug to patients not within these Guidelines, defendant improperly induced physicians to prescribe the medication, pharmacists to fill the prescriptions, and Medicare and Medicaid to pay for the drug for those patients. Since Medicare and Medicaid do not reimburse off-label prescriptions, plaintiff contends the claims submitted as a result of defendant's conduct constitute violations of the False Claims Act.
Judge Korman, to whom this case was assigned previously, dismissed the Fourth Amended Complaint with leave to amend. See U.S. ex rel. Polansky v. Pfizer, Inc., No. 04–cv–0704 (ERK), 2009 WL 1456582 (E.D.N.Y. May 22, 2009). Familiarity with Judge Korman's decision dismissing the Fourth Amended Complaint is assumed, and I will therefore not repeat his thorough discussion of the background of plaintiff's claim, the FDCA, 21 U.S.C. §§ 301–97, the False Claims Act, 31 U.S.C. § 3729 et seq., the FDA approval process, and the NCEP Guidelines upon which plaintiff's case wholly relies. Suffice it to say that the FDA requires that drugs be accompanied by FDA approved labels announcing, inter alia, adequate directions for use. 21 CFR § 201.5. These directions must indicate the purposes for which the drug has been found to be both safe and effective.
Although Judge Korman's decision was based on plaintiff's failure to plead fraud with particularity under Federal Rule of Civil Procedure 9(b), he was not subtle in raising doubts about plaintiff's theory of liability—doubts which might not be cured by more specific pleading. Nevertheless, he provided plaintiff with the opportunity to address his pleading deficiencies, thus not foreclosing the possibility that plaintiff could potentially state a plausible claim.
Plaintiff may or may not have remedied his Rule 9(b) problem, but the issues to which Judge Korman alluded remain and are, in my view, fatal to the claim. Specifically, in arguing that its label restricts the prescription of Lipitor to patients within the NCEP Guideline range, plaintiff has attempted to turn an advisory snippet into a prohibitory mandate—one that would relieve government insurers of the obligation to pay for drugs that doctors believe certain of their patients need, and that the patients themselves want, in order to improve their health.
This case has been pending so long that two labels are now at issue: one approved in 2005 and a second approved in 2009. The only difference between the labels relevant to this case is the omission of a NCEP Guidelines chart from the 2009 label. Both sides agree that the 2009 revisions did not effect a substantive change in the labeling of Lipitor, but Pfizer contends that the 2009 revision substantiates its argument that the NCEP Guidelines have always played a limited role in the context of the label.
To fully understand the labels, it is necessary to examine them in their totality and to appreciate their underlying purpose. It should first be noted that only people immersed in the pharmaceutical industry would refer to this document as a “label.” This is not the piece of paper affixed to the outside of a pill bottle, or one of the accordion-style informational attachments a pharmacist attaches to the pill canister when he fills the prescription. The 2009 label, for example, which is the shorter of the two, has over twenty single-spaced pages of small font—approximately the same length as Thomas Paine's Common Sense. Indeed, outside of the pharmaceutical industry, it would more properly be characterized as a pamphlet or a brochure. Among a wealth of other information, it describes the drug's chemical structure, its active mechanism, its “pharmacodynamics,” “pharmacokinetics,” and the results of various clinical studies. Although a consumer (who probably never sees it) might be able to understand parts of the label, much if not most of the document is only within the ken of a doctor, pharmacist, or biochemist.
As Judge Korman noted, the case turns on the effect of the information in the recommended NCEP Guidelines. These Guidelines appeared in the “Indications and Usage” section of the 2005 label but do not appear in the 2009 label. In the 2005 label, the NCEP Guidelines appeared as follows: