Prohias v. Pfizer, Inc.

• Decision Date: 29 May 2007
• Docket Number: No. 05 22658 CIV JORDAN.,05 22658 CIV JORDAN.
• Citation: 490 F.Supp.2d 1228
• Parties: Nilda PROHIAS, et. al., Plaintiffs v. PFIZER, INC., Defendant.
• Court: U.S. District Court — Southern District of Florida

Page 1228

490 F.Supp.2d 1228

Nilda PROHIAS, et. al., Plaintiffs v. PFIZER, INC., Defendant.

No. 05 22658 CIV JORDAN.

United States District Court, S.D. Florida, Miami Division.

May 29, 2007.

Craig R. Spiegel, Hagens Berman Sobol Shapiro LLP, Seattle, WA, Lance August Harke, Sarah Becket Clasby, Howard Mitchell Bushman, Harke & Clasby, Miami, FL, for Plaintiffs.

Barbara Wrubel, Skadden Arps Slate Meagher & Flom, New York City, Edward Walter Gerecke, Carlton Fields, Tampa, FL, Mark S. Cheffo, Skadden Arps Slate Meagher & Flom, Adam Jason Steinberg, Carlton Fields, Miami, FL, for Defendants.

ORDER ON PFIZER'S MOTION TO DISMISS OTIS CHARLES, ROBERT MARTIN, AND THE PENNSYLVANIA EMPLOYEES BENEFIT TRUST FUND

JORDAN, District Judge.

The plaintiffs filed a proposed nationwide class action, alleging that Pfizer engaged in false and misleading advertising of its cholesterol-lowering drug, Lipitor. Pending is Pfizer's motion to dismiss [D.E. 19]. On April 24, 2007, I entered an order addressing Pfizer's arguments against plaintiffs Nilda Prohias, Nancy Yost, the Teamsters Plan, and Health Care for All, and dismissed the complaint as to those plaintiffs' claims in their entirety. I now address Pfizer's motion to dismiss against the remaining plaintiffs: Otis Charles, Robert Martin, and the Pennsylvania Employees Benefit Trust Fund. For the reasons stated below, Pfizer's motion to dismiss as to these plaintiffs is GRANTED IN PART and DENIED IN PART.

I. FACTS¹

A. LIPITOR'S FDA APPROVALS

Pfizer is the manufacturer of Lipitor, the most widely prescribed statin for lowering cholesterol. It is undisputed that Lipitor successfully lowers cholesterol. Lipitor was first approved by the Food and Drug Administration ("FDA") in 1996, as an adjunct to diet, to reduce elevated LDL-C cholesterol in patients with primary hypercholesterolemia. See Complaint at ¶ 93. On July 10, 1998, the FDA approved Lipitor as an adjunct to diet to reduce elevated total cholesterol and elevated LDL-C cholesterol in all patients. Id. at ¶ 94. On July 30, 2004, Lipitor was approved for the first time for the prevention of cardiovascular disease in certain patients. Specifically, Lipitor received additional FDA labeling approval for reducing the risk of heart attacks "[i]n adults without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease, such as age ≥ 55 years, smoking, hypertension, low HDL-C, or a family history of early coronary heart disease." Id. at ¶ 96.

In sum, until July 30, 2004, Lipitor was not approved for any patients for reducing the risk of coronary heart disease ("CHD"). Rather, the FDA concluded that, notwithstanding the cholesterol-lowering benefits of Lipitor, the "relationship between Lipitor's lipid-lowering effect and its effect on cardiovascular diseases or survival is not known." Id. at ¶ 8. After July 30, 2004, Lipitor was approved for reducing the risk of heart attacks in adults with multiple risk factors, but its approval was still not extended to include "reduction in cardiovascular morbidity and mortality." Id. at ¶ 96.

B. PFIZER'S ADVERTISING CAMPAIGN FOR LIPITOR

Pfizer's print and television advertisements for Lipitor frequently show pictures of women or the elderly with their cholesterol numbers attached with text warning that "high cholesterol is a risk factor for heart disease." Complaint at ¶¶ 5-6; see id. at ¶ 107 (undated Lipitor advertisement claiming that high cholesterol is a risk factor for heart disease). The plaintiffs allege, however, that there is no scientific support for the claim that Lipitor reduces the risk of heart disease in women or elderly patients who do not already have heart disease or diabetes. The plaintiffs allege that the purpose of the advertisements is to create the impression that Lipitor protects against heart disease, thus misleading consumers as to the benefits of Lipitor. In particular, as a result of Pfizer's advertising campaign, 34% of the individuals polled in a recent survey indicated that they believe that Lipitor has been shown to prevent heart attacks. See id. at ¶ 91. The advertisements for Lipitor encourage consumers to ask their doctor if Lipitor is right for them, thus inducing them to visit a doctor.

Pfizer also engages in promotion of Lipitor to physicians. Specifically, Pfizer employs thousands of salespersons to call on physicians and promote Pfizer products by passing out literature and promotional materials regarding the benefits of Lipitor, including prevention of heart disease in women and elderly patients who have not been diagnosed with heart disease. Id. at ¶¶ 82-84.

In sum, the plaintiffs allege that Pfizer has engaged in a multifaceted advertising campaign to convince doctors and consumers that Lipitor reduces heart disease, even though there was not scientific evidence of such benefits.² Such misleading advertising, according to the plaintiffs, creates artificial demand for Lipitor and an artificial increase in Lipitor's price, thus causing economic injury to Lipitor purchasers. The plaintiffs do not allege that Lipitor failed to lower their cholesterol levels, or that they were physically injured in any way by taking Lipitor. Accordingly, the plaintiffs seek relief from Pfizer on three legal theories: (1) the consumer fraud acts of the several states, (2) unjust enrichment, and (3) negligent misrepresentation.

C. CLASS PLAINTIFFS ADDRESSED IN THIS ORDER

1. OTIS CHARLES

Mr. Charles is a resident of Miami-Dade County, Florida. He is 65 years old and has not been medically diagnosed with heart disease or diabetes. It is unknown whether Mr. Charles has multiple risk factors for CHD. Mr. Charles has paid for some or all of the purchase price of Lipitor prescribed to him, and seeks, in part, return of these funds. The parties agree that his claims are governed by Florida law.

2. ROBERT MARTIN

Mr. Martin is a resident of Franklin County, Massachusetts. He is 65 years old and has not been medically diagnosed with heart disease or diabetes. It is unknown whether Mr. Martin has multiple risk factors for CHD. Mr. Martin has paid for some or all of the purchase price of Lipitor prescribed to him, and seeks, in part, return of these funds. The parties agree that his claims are governed by Massachusetts law.

3. THE PENNSYLVANIA EMPLOYEES BENEFIT TRUST FUND

The Pennsylvania Employees Benefit Trust Fund (the "Fund") is a labor management trust fund duly organized under the laws of the Commonwealth of Pennsylvania. The Fund provides health care benefits, including prescription drug coverage to over 270,000 participants and beneficiaries, including active and retired employees of the Commonwealth. The Fund has paid for some or all of the purchase price of Lipitor prescribed to its beneficiaries. It alleges that if not for Pfizer's deceptive advertising campaign, it would have excluded Lipitor from approved formulary schedules, set a lower value in the formulary, or set a higher copay obligation. See Complaint at ¶ 137. Accordingly, the Fund seeks recovery of the money it paid to purchase Lipitor for its beneficiaries, and the money that it "overpaid" on account of Lipitor's inflated price.³ The parties agree that the Fund's claims are governed by Pennsylvania law.

II. LEGAL STANDARD

A motion to dismiss is granted only when the movant demonstrates "beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief." Conley v. Gibson, 355 U.S. 41, 45-46, 78 S.Ct. 99, 2 L.E d.2d 80 (1957). The factual allegations of the complaint are taken as true and construed in the light most favorable to the plaintiff. See McCulloch v. PNC Bank Inc., 298 F.3d 1217, 1220 (11th Cir.2002). The scope of the court's review of a motion to dismiss is limited to the four corners of the complaint. See St. George v. Pinellas County, 285 F.3d 1334, 1337 (11th Cir. 2002).

III. DISCUSSION

A. PREEMPTION AND THE SAFE HARBORS

Pfizer first argues that the plaintiffs' claims should be dismissed because they are preempted by federal law. Specifically, Pfizer contends that it is the exclusive province of the FDA to decide what information should or should not be included in Lipitor's label, and that any lawsuit that seeks to impose liability on Pfizer for advertisements that are consistent with the approved label directly conflict with the FDA's jurisdiction. To support its argument, Pfizer largely relies on the FDA's preemption position set forth in its Final Rule on "Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products," 71 Fed.Reg. 3922-97 (Jan. 24, 2006). Alternatively, Pfizer argues that it is protected from liability under the consumer fraud acts for advertisements that are consistent with Lipitor's FDA approved label. I agree and disagree in part with Pfizer. Specifically, I conclude that the plaintiffs' claims arising from pre-July 2004 advertisements are not preempted or protected by the safe harbor statutes, but that claims arising from post-July 2004 advertisements are preempted and protected by the safe harbor statutes.

(1) PRE-JULY 2004 ADVERTISEMENTS

The plaintiffs allege that, prior to July of 2004, Pfizer marketed Lipitor inconsistent with its FDA-approved label. In particular, prior to July 2004, Lipitor was not approved to reduce the risk of coronary heart disease in any group of people. In fact, according to the FDA's approval, its effect on CHD was unknown. The plaintiffs allege, however, that Pfizer advertised, contrary to its approved label, that Lipitor reduces the risk of coronary heart disease. Thus, based on the allegations in the complaint, the FDA has not approved Pfizer's advertisements either explicitly or implicitly by approving the statements on its label. Moreover, in this lawsuit, the plaintiffs seek advertising requirements that parallel the approved label. Under the FDA's own analysis, there is no conflict between...