Health Law Daily Lipitor® prescriptions weren’t off-label because guidelines aren’t rules
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Wednesday, May 18, 2016

Lipitor® prescriptions weren’t off-label because guidelines aren’t rules

By Bryant Storm, J.D.

The FDA-approved label for Pfizer, Inc.’s cholesterol drug, Lipitor®, does not require physicians to prescribe the drug in compliance with National Cholesterol Education Program (NCEP) guidelines. The Second Circuit affirmed a district court’s dismissal of a former employee’s federal False Claims Act (FCA) (31 U.S.C. §3729) claims against the drug manufacturer, which alleged that the manufacturer promoted off-label use of the drug. The appellate court held that the NCEP guidelines were not incorporated into the drug’s label or made mandatory by the label. The Second Circuit reasoned that the district court “drew the proper inferences” when it held that the guidelines provided advice, “not mandatory limitation” (U.S. ex rel. Polansky v Pfizer, Inc., May 17, 2016, Jacobs, D.).

False claims. The former employee—a medical director for a Lipitor marketing committee—alleged that Pfizer was engaged in unlawful off-label promotion of Lipitor. Specifically, the former employee asserted that although Lipitor was only approved for use when a patient’s risk factors and cholesterol levels fell within a framework outlined in the NCEP guidelines, Pfizer promoted the use of the drug for patients whose cholesterol levels fell outside the guidelines. As a result, he alleged that the promotion caused physicians to write prescriptions for off-label uses of Lipitor and submit claims—false claims—that resulted in improper reimbursement by state and federal health care programs.

Retaliation. Earlier in the litigation, the Second Circuit dismissed the former employee’s claims that his employment was terminated in retaliation for his whistleblowing. In that decision, the Second Circuit held that it lacked jurisdiction over the retaliation claims because the trial court had not made clear whether it meant to dismiss all of the former employee’s claims or only the FCA claims. On remand, the district court clarified that it only intended to dismiss the fraud claims. As a result, the retaliation claims were not dismissed and remain before the district court (see Court ‘overlooks’ retaliation claims and closes door on fraud appeal, August 7, 2014).

Labeling. With respect to the labeling issue, the Second Circuit held that the NCEP guidelines do not constitute mandatory restrictions on prescribing practices for Lipitor. The court found that the NCEP guidelines were designed by scientists to serve as an advisory guidance, not as a legal restriction. In support of its position, the court highlighted that the drug’s 2009 label did not include the NCEP guidelines. The Second Circuit reasoned that there is an important distinction between marketing for an obviously off-label purpose, e.g., using Lipitor to “promote hair growth or cure cancer,” and marketing a drug for its FDA-approved use to a patient population that is neither expressly specified nor excluded by the label. The court also noted that it was skeptical as to whether the former employee would be able to identify an individual “who actually submitted a false claim.” The court noted that it decided the case on the guideline issue, and not the absence of an identified claim submission, however, the court considered the claim presentment issue “dubious.”

The case is No. 14-4774.

Attorneys: Nicholas F. Soares (Terris, Pravlik & Millian, LLP) and James M. Shaughnessy (Milberg LLP) for Jesse Polansky. Mark Cheffo (Quinn Emanuel Urquhart & Sullivan, LLP) for Pfizer, Inc.

Companies: Pfizer, Inc.

MainStory: TopStory CaseDecisions FDCActNews DrugBiologicNews FCANews FraudNews LabelingNews PrescriptionDrugNews QuiTamNews ConnecticutNews NewYorkNews VermontNews

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