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United States ex rel Polansky v. Pfizer

May 22, 2009

UNITED STATES OF AMERICA, ET AL. EX REL. JESSE POLANSKY, PLAINTIFF,
v.
PFIZER, INC., DEFENDANTS.



The opinion of the court was delivered by: Korman, J.

MEMORANDUM & ORDER

Beginning in April 2001, Dr. Jesse Polansky was employed by Pfizer as Director of Outcomes Management Strategies. He also served as the Medical Director for the Local Marketing Team Review Committee, which evaluates and approves the regulatory, legal, and scientific integrity of marketing programs for Pfizer's major metropolitan markets. One of Pfizer's drugs evaluated by the Committee on which Polansky served was Lipitor. Lipitor is a statin, a class of drugs that lowers cholesterol levels by blocking enzymes that are essential to cholesterol production.

Dr. Polansky's employment was terminated by Pfizer in 2003. Subsequently, in early 2004, Dr. Polansky filed a complaint in this case, which has been amended three times. The complaint alleges that Pfizer violated the False Claims Act ("FCA"), 31 U.S.C. § 3729 et seq. and various false claims provisions of state law,because of the manner in which it marketed Lipitor. The complaint also alleges that Pfizer violated Title VII, 42 U.S.C. § 2000e et seq. and New York law, because of the manner in which Polansky was terminated. I address the latter causes of action in a separate memorandum and order.

Specifically, with respect to the FCA claim, Polansky alleges that Pfizer pursued an off-label marketing scheme that caused federal and state health programs to pay false or fraudulent claims for reimbursement for prescriptions of Lipitor other than those indicated on its label. Under the Food, Drug, and Cosmetics Act ("FDCA"), 21 U.S.C. §§ 301-97, new pharmaceutical drugs cannot be introduced into interstate commerce unless the Food and Drug Administration ("FDA") finds that the drug is safe and effective for each of its intended uses. 21 U.S.C. § 355(a), (d). In the course of the approval process, the manufacturer must submit a "specimen[] of the labeling proposed to be used for such drug," to include all material facts and adequate warnings. Id. at § 355(b)(1)(F). The scientists at the FDA who review the proposed labels evaluate the information contained in them and reject a manufacturer's application where the drug label does not sufficiently comply with the requirements of the FDCA or is otherwise false or misleading. 21 C.F.R. §§ 312.125(b)(6) and (b)(8). All of the language found in a drug label is subject to FDA approval, and cannot be changed without further approval. Id. at § 601.12. While the FDA has approved Lipitor as an adjunct to diet to lower raised cholesterol, Lipitor's label contains the following caveat, upon which the FCA claim is predicated:

Therapy with lipid-altering agents should be a component of multiple-risk-factor intervention in individuals at increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol only when the response to diet and other non-pharmacological measures has been inadequate (see National Cholesterol Education Program (NCEP) Guidelines, summarized in Table 6).

(Compl. ¶ 50; Declaration of Adam B. Siegel, Ex. A, p. 8-9 ("Siegel Dec.")).

The NCEP Guidelines, to which the label makes reference, were promulgated under the auspices of the National Institutes of Health, National Heart, Lung and Blood Institute (Compl. ¶ 53, n.8) by an Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. (Compl. ¶ 53). Table 6 summarizes the NCEP Guidelines (the "Guidelines"), which provide the basis for FDA-approved indications for the treatment of persons with elevated levels of LDL cholesterol. They appear directly below the above-quoted paragraph on Lipitor's label, as part of the "Indications and Usage" section.

The Guidelines apply not only to Lipitor, but to all statins. The most recent NCEP Guidelines, known as ATP III, were issued in May 2001, and updated in July 2004. (Id.). The governing principle of the Guidelines is that the intensity of cholesterol-lowering drug treatment should be adjusted to the patient's absolute risk for coronary heart disease. (Compl. ¶ 54). Thus, the Guidelines categorize patients into one of four risk categories -- high, moderately high, moderate, and low to moderate -- depending on their number of cardiac risk factors and the calculation of the patient's risk of having a heart attack within ten years. (Id.). The Guidelines also set forth three LDL cholesterol goal levels and four LDL cholesterol cutpoint levels. (Compl. ¶¶ 58, 62). LDL cholesterol goals are the levels to which the Guidelines recommend patients aspire in a particular risk category, while LDL cholesterol cutpoints are the levels at which the Guidelines recommend statin therapy. (Compl. ¶ 59). So, for example, the Guidelines recommend that moderate risk patients aspire to achieve a goal LDL cholesterol level of under 130 mg/dL, and that patients initiate therapeutic lifestyle changes when their cholesterol exceeds 130 mg/dL. The cutpoint at which the Guidelines recommend initiating statin therapy is 160 mg/dL or over. (Compl. ¶¶ 62, 64).

The complaint alleges that Pfizer sought to unlawfully broaden the patient population for which Lipitor is recommended for moderate risk patients described above. (Compl. ¶ ¶ 63, 69). Pfizer allegedly did so by "the reiteration and combination of several false and misleading themes: (1) 'if you are not at your LDL goal, you should consider drug therapy;' (2) 'Get to Goal' with the use of Lipitor; (3) diet and exercise will not suffice to reduce your risk of heart disease; and (4) 'Lower [cholesterol] is better' (infinitely, and irrespective of risk category." (Compl. ¶ 72). These statements allegedly served to blur the distinction between goals and cutpoints and encouraged the onset of drug therapy among moderate risk patients at thirty LDL cholesterol points below the level recommended by the Guidelines. (Compl. ¶ 64).

Because the Guidelines are incorporated into Lipitor's label, Polansky alleges that promoting Lipitor therapy for patients outside these risk categories and cutpoints constitutes unlawful off-label promotion and, as such, off-label uses did not qualify for reimbursement under any federally-funded health care program. (Compl. ¶ 51-52). Consequently, Polansky alleges that "[e]ach prescription that was written as a result of defendant's illegal marketing practices represents a false or fraudulent record or statement. And, each claim for reimbursement for such off-label prescriptions submitted to a federal health insurance program represents a false or fraudulent claim for payment." (Compl. ¶ 226).

The complaint does not identify a single false claim or any doctor who received or viewed the Lipitor marketing materials, let alone any doctor who received or viewed these materials and then prescribed Lipitor to a patient for whom the Guidelines did not recommend statin therapy, on the mistaken belief that they did. Nor does the complaint identify any pharmacist who filled a prescription by such a physician, or any person who sought reimbursement for the cost of that prescription. The absence of such facts underlies Pfizer's motion to dismiss pursuant to Federal Rule of Civil Procedure 9(b).

DISCUSSION

I. The False Claims Act

Polansky filed the FCA action on behalf of the United States, sixteen states, and the District of Columbia. The FCA permits private persons (known as "relators"), to file a form of civil action (known as qui tam) against, and recover damages on behalf of the United States from, any person who:

(1) knowingly presents, or causes to be presented, to an officer or employee of the United States Government or a member of the Armed Forces of the United States a false or fraudulent claim for payment or approval;

(2) knowingly makes, uses, or causes to be made or used, a false record or statement to get a false or fraudulent claim ...


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