In the world of prescription drugs, Lipitor is the king with over $10 billion in annual sales.
Only one day after the Food and Drug Administration (FDA) approved the drug for additional populations, a federal class-action was filed in U.S. District Court in Boston, Massachusetts by Community Catalyst and Health Care For All claiming that Pfizer marketed Lipitor to reduce cholesterol in patient populations that had not been covered in clinical trials.
The suit also alleges that Pfizer engaged in a massive campaign to convince both doctors and patients that Lipitor is a useful treatment for nearly everyone with elevated cholesterol, even though no studies have shown it to be effective for women and those over 65 years of age who do not already have heart disease or diabetes.
In particular, the suit claims that Pfizer violated state consumer protection laws by promoting Lipitor as preventing heart disease in women or people over 65 who did not have heart disease and diabetes when it did not have studies to support such a claim.
Pfizer, however, announced that the FDA approved the drug for patients with Type 2 diabetes and those without diabetes who did not have heart disease but who had one or more risk factors for the condition other than high cholesterol. These include high blood pressure, family history, being over 55, smoking, and obesity.
The approval was based on two clinical trials involving more than 13,000 patients, Pfizer said.
The plaintiffs allege that Pfizer’s advertising of the drug created billions of dollars in unnecessary drug spending among the two patient groups. They cited a study of 2,000 women, which concluded that those taking Lipitor actually suffered 10% more heart attacks than those taking a placebo.
The lawsuit seeks reimbursement for women and seniors and third-party payers who bought Lipitor “unnecessarily.” Lipitor sales amounted to $10.86 billion in 2004, almost 21% Pfizer’s total revenue and, although it is not clear how much of that figure is attributable to the two groups that are the subjects of the class-action, damages could run into the billions if the suit is successful.