- District Court Dismisses False Claims Act Case against Pfizer: Criticizes Off-Label Marketing as Theory Underlying FCA Liability
- June 25, 2009 | Author: Michael E. Paulhus
- Law Firm: King & Spalding LLP - Atlanta Office
On May 22, in United States ex rel. Polansky v. Pfizer Inc., No. 04-cv-0704-ERK-SMG, 2009 WL 1456582 (E.D.N.Y. May 22, 2009), the Eastern District of New York dismissed, under Federal Rule of Civil Procedure 9(b)—with leave to re-plead—a False Claims Act (FCA) suit against Pfizer, in which a former employee alleged promotion of its cholesterol treatment Lipitor in an off-label manner. The court reviewed various theories of FCA liability; and, in dicta, it characterized the off-label promotion claim as “a tenuous theory underlying his FCA cause of action.” Id.at *10.
The opinion highlights the difficulty in pleading the myriad of causal steps required to prove liability based on an off-label promotion claim. The court found that the relator failed to plead with specificity to satisfy the heightened pleading requirements under Rule 9(b) because he did “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 [off-label]. . . .” Id. at *3. The court went on to explain that the complaint does not “identify any pharmacist who filled a prescription by such a physician, or any person who sought reimbursement for the cost of that prescription.” Id. Thus, the court dismissed the complaint with leave to replead. Id. at *11.
The court’s holding adds to the growing body of cases dismissing FCA off-label promotion claims under Rule 9(b). It also is notable for the comments expressed in dicta, which can be read as implicitly criticizing the reasoning of United States ex rel. Franklin v. Parke-Davis, 147 F. Supp. 2d 39 (D. Mass. 2001), the central case to recognize the novel use of the FCA to sanction a drug manufacturer for off-label promotional activities. The Polansky court explained, “[T]he mere fact that Pfizer may have been violating FDA regulations does not translate into liability for causing a false claim to be filed. ‘Violations of laws, rules, or regulations alone do not create a cause of action under the FCA. It is the false certification of compliance which creates liability when certification is a prerequisite to obtaining a government benefit.’” Id. at *7 (citation omitted). This case presented neither an express nor an implied false certification. Id. “Pfizer did not file any claims for reimbursement and made no implied certifications to obtain payment.” Id. Additionally, the court appeared to address a materiality/causation argument when it commented that because physicians commonly exercise medical judgment and prescribe drugs in an off-label manner, “the entities to which reimbursement claims are made could hardly be understood to have operated on the assumption that the physician writing the prescription was certifying implicitly that he was prescribing Lipitor in a manner consistent with [its labeling].” Id.
The court summarized its reasoning as follows:
“[T]he facts in this case are the opposite of the ‘archetypal qui tam FCA action,’ which is ‘filed by an insider at a private company who discovers his employer has overcharged under a government contract.’ They also bear no resemblance to other FCA actions that have been sustained ‘under theories of supplying substandard products or services; false negotiation, including bid rigging and defective pricing; and false certification.’”
Id. at *8 (citations omitted). The court did not base its decision on this reasoning; however, as it noted summary judgment would be a more “appropriate vehicle” for such a decision. Id. This decision could provide additional support for dismissing FCA off-label promotion allegations under Rule 9(b), and it may serve as helpful authority for defendants seeking to mount a direct challenge to the reasoning of Parke-Davis and FCA liability grounded on violations of FDA’s off-label promotion regulations.