Marketing of Drugs that Deviates from Voluntary Industry Standards Does Not Violate False Claims Act, Court Rules: United States of America et al v. Pfizer, Inc.

A federal court recently dismissed a lawsuit by the federal government alleging that a pharmaceutical company’s marketing activities violated the False Claims Act (FCA). The government claimed in U.S. ex rel Polansky v. Pfizer, Inc. that the company’s marketing of one of its drugs, which deviated from industry guidelines, constituted “off-label” marketing in violation of federal law. The court held that the industry guidelines were not legally-enforceable restrictions, and it further concluded that the government was trying to use the FCA to restrict marketing in a way that the regulatory agencies had chosen not to do. Since doctors often rely on pharmaceutical companies’ marketing to determine what drugs to prescribe and in what amounts, this decision could have a substantial impact on patient safety.

The pharmaceutical company Pfizer manufactures and markets the drug Lipitor as a treatment for high cholesterol. The company allegedly encouraged doctors, through its marketing materials and sale representatives, to prescribe the drug for patients whose cholesterol levels and heart disease risk factors were less than the guidelines established by the National Cholesterol Education Program (NCEP). The NCEP is a program of the National Institutes of Health, which works with a large number of organizations to raise awareness of the dangers of high blood cholesterol. The label produced by Pfizer in 2005 for Lipitor included the NCIP’s guidelines for drug intervention, but a new label introduced by Pfizer in 2009 did not include the guidelines.

The government’s lawsuit accused Pfizer of violating the FCA by essentially attempting to defraud Medicare and Medicaid. Those two programs do not reimburse prescriptions issued for off-label uses. According to the government’s theory, recommending Lipitor for use by any patient who falls outside of the NCEP’s guidelines would constitute an act of fraud.

A judge dismissed the case in 2009 with leave to amend the complaint. The recent hearing involved the government’s fifth amended complaint against Pfizer. A new judge, considering the defendant’s latest motion to dismiss, expressly rejected the “drastically elongated reach of the False Claims Act” used by the government. He noted that the NCEP’s guidelines were advisory in nature, and not intended to be a legal mandate for the use of Lipitor or any other drug. He used the United States Sentencing Guidelines as an analogy, citing commentators who pointed out that the term “mandatory guidelines” is in fact an oxymoron. The exclusion of the NCEP guidelines from the 2009 label was not an act of fraud, the judge concluded, but rather a demonstration that their inclusion on the 2005 label was entirely optional.

No one involved in this case claimed that Pfizer’s marketing of Lipitor outside the NCEP guidelines ever actually harmed a patient. The focus of the lawsuit was instead on the allegedly misleading nature of the marketing and the potential fraud on the Medicare and Medicaid systems. It seems difficult to argue with the court’s reasoning in dismissing the government’s claims in this case. That said, it leaves open the questions of how far a pharmaceutical company’s marketing can deviate from other industry guidelines.

The Maryland attorneys at Lebowitz & Mzhen can assist victims of medication errors, who have been injured by drugs prescribed, dispensed, or administered incorrectly. Contact us today online or at (800) 654-1949 for a free and confidential consultation to discuss your case.

More Blog Posts:

Third Circuit Addresses Issue of Standing in “Off-Label” Pharmaceutical Marketing Litigation, Pharmacy Error Injury Lawyer Blog, July 12, 2012
Court Rejects State Effort to Obtain Patient Data In Pharmacy Error Investigation, Pharmacy Error Injury Lawyer Blog, June 14, 2012
Glaxo Pays $750M in Settlement for Violations in Pharmaceutical Drug Manufacturing, Pharmacy Error Injury Lawyer Blog, November 23, 2010
Photo credit: ‘Cholesterol’ by BorisTM [Public domain], via Wikimedia Commons.

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