Earlier this year, a former Pfizer exec amended his whistleblower lawsuit accusing the drugmaker of illegally scheming to boost Lipitor sales by misrepresenting product labeling and federal cholesterol guidelines; using misleading educational programs for doctors, and unlawful sampling kickback schemes that resulted in off-label marketing that allegedly defrauded Medicaid and Medicare.

Jesse Polansky, who was director of outcomes management from April 2001 until July 2003, claims “thousands of physicians have prescribed Lipitor to millions of patients for whom drug therapy is not recommended, and for whom the medication could be dangerous. Millions of those improper prescriptions were ultimately paid for by various government healthcare plans, the suit charges. And in a newly filed brief, Polansky notes that a statistical analysis of the NHANES, or the National Health and Nutrition Examination Survey database, found 18 percent of all Lipitor prescriptions paid for by the government were for off-label uses.

Not surprisingly, Pfizer filed a motion seeking to have the case dismissed, but last week, the US Department of Justice filed what is called a Statement of Interest that picks apart portions of Pfizer’s argument. Although the federal government declined to intervene, or join, Polansky’s suit, the act of filing the brief underscores the interest in how the courts go about interpreting and enforcing the False Claims Act.

You may recall that various drugmakers - including Pfizer, Bristol-Myers Squibb, Eli Lilly, AstraZeneca, Allergan and Forest Laboratories - have paid huge fines for violating that law.

And so the feds seize on several nuanced, but important aspects of the law in analyzing Pfizer’s argument against Polansky. For instance, in its motion last June, Pfizer made several arguments, one of which was that Polansky failed to allege any legally false claim because he did not submit evidence that the drugmaker ever suggested specific claims filed with federal health programs were, in fact, for approved use or reimbursable. “This is an objective question and is not, as defendant argues, a ’subjective interpretation of defendant’s legal duties’ that preclude a finding of falsity,” the feds write.

The feds go on to say Pfizer is wrong to suggest the claim must contain a separate ‘conscious and deliberate lie’ in order to be a false claim. The government brief maintains the law only requires that Pfizer “presented or caused the presentment of a false claim,” not that Pfizer made a false statement or lied on the claim itself. And material omissions can be troublesome, too. An example would be when a sales rep fails to mention evidence that “does not support safety or efficacy for the unapproved use or that the FDA has specifically denied approval for that indication.”

Pfizer is also taken to task for suggesting a subequent label change for Lipitor absolved it from false claims. “If a claim wwas false when it was submitted in 2004, a label change five years later does not transform that false claim into a reimbursable one. To hold otherwise would be to render federal health care program restrictions on coverage meaningless. It also would undermine the gatekeeping role of the federal government in protecting public health as well as the public fisc in ensuring that, based on the information available at the time, only indications that have been FDA-approved or are sufficiently supported by scientific literature as safe and effective are reimbursed.”

Interestingly, Pfizer also argued that federal health care programs are part of the problem, because these do not require certain info on claims forms that may have allowed the programs to prevent the payment of non-covered claims, the feds write, before adding that “the government processes millions of claims for payment by federal health programs each year, and requiring it, as Pfizer apparently suggests, to examine every claim it pays for potential underlying misconduct is patently unreasonable.”

And finally, the feds take exception to Pfizer’s argument that Polansky failed to show specific evidence of specific false claims, a high hurdle known as Rule 9b. For their part, the feds maintain “in evaluating such matters on a case-by-case basis, the strength of the inference of fraud on the government may be measured by, for example, factual or statistical evidence tending to show fraud beyond possibility.” This apparently refers to Polansky’s analysis of off-label use of Lipitor.

pic thx to katerha on flickr