Lipitor Whistleblower Loses Appeal
A whistleblower who claimed that Pfizer induced false claims for its Lipitor because it marketed the drug as appropriate for patients whose risk factors and cholesterol levels are outside the National Cholesterol Education Program guidelines, has lost an appeal to the 2nd Circuit Court of Appeals. Dr. Jesse Polansky, who was Pfizer medical director for a committee that reviewed the marketing strategy for certain drugs, including Lipitor, had appealed the dismissal of his case twice for two different reasons by a New York federal court.
Polansky, who was joined by the Justice Department in the suit, claimed that because the drug’s labeling made reference to the guidelines, they were incorporated in the labeling and thus had to be followed. He argued that since doctors wrote Lipitor prescriptions for patients whose risk factors and cholesterol levels were outside the guidelines, payments from federal health programs ended up being for off-label uses.
A three-judge appeals court panel adopted one of the opinions from the lower court that held that the guidelines were only recommendations and were advisory, not mandatory. They noted that the guidelines themselves “expressly disclaimed prescriptive force” and said that their “general guidance” “need not hold for individual patients” and “should not override” a doctor’s clinical judgment about appropriate treatment of a particular patient.
The panel also noted that where the labeling does impose cholesterol-level restrictions, it is only for pediatric patients. And that, the judges said, makes more conspicuous the absence of a similar restriction for adults and “shows how easily FDA could have mandated compliance with the guidelines with respect to all patients if it wanted to do so.”