Suit Over Pfizer Lipitor Labels Gave Judge ‘Paine’

BROOKLYN, N.Y. (CN) - A federal judge invoked Thomas Paine's "Common Sense" in dismissing allegations that Pfizer illegally marketed its cholesterol-fighting drug Lipitor.

In her fifth complaint against Pfizer under the False Claims Act, former employee Dr. Jesse Polansky faulted the pharmaceutical company for encouraging doctors to overprescribe the drug for patients not at risk for heart disease.

U.S. District Judge Brian Cogan dismissed the fifth amended complaint on Thursday.

In his 13-page order, Cogan said that Lipitor's 2005 and 2009 labels rivaled the length of Paine's 1776 pamphlet "Common Sense," and that they were too technical to mislead consumers.

"This is not the piece of paper affixed to the outside of a pill bottle, or one of the accordion-style informational attachments a pharmacist attaches to the pill canister when he fills the prescription," the order states. "The 2009 label, for example, which is the shorter of the two, has over twenty single-spaced pages of small font- approximately the same length as Thomas Paine's 'Common Sense.' Indeed, outside of the pharmaceutical industry, it would more properly be characterized as a pamphlet or a brochure. Among a wealth of other information, it describes the drug's chemical structure, its active mechanism, its 'pharmacodynamics,' 'pharmacokinetics,' and the results of various clinical studies. Although a consumer (who probably never sees it) might be able to understand parts of the label, much if not most of the document is only within the ken of a doctor, pharmacist, or biochemist." (Parentheses in original.)

Cogan described the allegation that Pfizer illegally urged doctors to prescribe it for patients who did not meet the National Cholesterol Education Program, or NCEP, guidelines for its use.

"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," the order states. "However, change the number in the sales pitch to 125 mg/dL, or even 129mg/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. Of course, plaintiff's alleged 'false statements' are not as de minimis as this illustration, but there is no logical place to draw a line on plaintiff's theory. According to plaintiff, any marketing of the drug for patients outside the guidelines' range is 'off-label marketing,' resulting in the filing of false claims under the False Claims Act."

Ultimately, the judge explicitly deferred to Pfizer's argument.

"Defendant puts its [sic] best: Off-guideline does not equate to off-label. Having determined that the NCEP Guidelines in the 2005 label, and the passing reference to them in the 2009 label, were merely informational and advisory rather than restrictive limitations, I hold that defendant has not engaged in off-label marketing, and has therefore not violated the [False Claims Act]," the order states.

Polansky's lawyer did not immediately respond to a request for comment.

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