Thursday, November 22, 2012

Court Rejects Attempt to Stretch Off-Label Marketing Liability to Prescriptions Outside Drug Label Guidelines

In US ex rel. Polansky v. Pfizer, 2012 WL 5595933 (E.D.N.Y., Nov. 15, 2012), U.S District Judge Cogan rejected a relator’s attempt to stretch False Claims Act liability for the “off-label marketing” of drugs to include instances where physicians prescribe prescription drugs to patients outside of the drug label guidelines.

In Polansky, the relator brought a qui tam pursuant to the False Claims Act alleging that Pfizer illegally marketed its cholesterol lowering drug, Lipitor, to patients whose “risk profiles fell outside” the recommended parameters for using cholesterol lowering drugs that are set forth in the National Cholesterol Education Program Guidelines (NCEP Guidelines) and which are referenced in Lipitor’s “label". Simply stated, the relator contended that the label which accompanied Lipitor (which the Court described as the size of a “pamphlet” or “brochure”) “restricts the prescription of Lipitor to patients within the NCEP Guideline range.”

The relator, stated the Court, appeared to be arguing that “any marketing of the drug for patients outside the Guidelines’ range is ‘off-label marketing,’ resulting in the filing of false claims . . .” Applying the relator’s theory, the Court explained:  

Thus, if a Pfizer representative told a doctor that he should prescribe Lipitor to any of his patients who smoke and have a bad family cardiac history (i.e., two risk factors) and LDL levels of 131 mg/dl or more that advice would be proper because that patient falls within the Guideline range. However, change the number in the sales pitch to 125 mg/dl, or even 129 mg/dl, and any prescription issued by a doctor who relied on that advice, and which Medicare or Medicaid subsequently reimbursed, would constitute a false claim. 
Dismissing the relator’s 5th Amended Complaint with prejudice, the Court held that the "False Claims Act, even in its broadest application, was never intended to be used as a back-door regulatory regime to restrict practices that the relevant federal and state agencies have chosen not to prohibit. . . . . . Off-guideline does not equate to off-label.” The Court provided three chief reasons in support of its holding. First, the Court noted that the NCEP Guidelines are, in fact, non-compulsory, advisory, guidelines: there is nothing in the drug’s label or the Guidelines themselves which transforms the NCEP Guidelines into a mandatory limit. “[A]s long as Pfizer markets the drug to lower cholesterol,” the Court observed, “it is doing what the label permits.” Second, the Court observed that the FDA could have very easily included restrictive language in its label –as it “commonly requires” -- limiting the use of Lipitor only to those patients who fall within the Guidelines, but it did not. Third, the Court found that other regulatory authorities such as Medicare and state Medicaid programs had not passed any regulations or restrictions that prevented a physician from prescribing statins when he or she finds that a patient would benefit from lowered cholesterol.

As we saw in the Renal Care Group case, the Polansky case is another instance where courts apply a common sense analysis and refuse to permit the False Claims Act to be used as a “back-door regulatory regime.”

A. Brian Albritton 
November 22, 2012

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