A federal appeals court last week refused to revive a lawsuit in which a former Pfizer employee alleged the company promoted off-label use of its Lipitor cholesterol pill. In doing so, however, the court also raised a question about the extent to which drug makers may be held responsible for causing federal health programs, such as Medicare and Medicaid, to overpay for a medicine.
Here’s the back story: Jesse Polansky, a former Pfizer medical director, contended the drug maker illegally marketed the best-selling pill by ignoring National Cholesterol Education Program guidelines. The guidelines stated the cholesterol-lowering drug should be prescribed only to certain patients, but Pfizer knowingly widened the market, according to his lawsuit, which was originally filed in 2004.
In doing so, he charged that Pfizer violated the False Claims Act. That’s because government health care programs generally do not reimburse prescriptions for so-called off‐label use, which refers to promoting a drug for uses not approved by regulators. Polansky contended that Medicare, Medicaid, and other government programs were essentially duped into paying for Lipitor prescriptions.
