Pfizer Faces Lawsuit Alleging Illegal Marketing of Lipitor
A New Jersey employee-insurance fund on Monday filed a lawsuit against Pfizer, alleging the drug maker defrauded state and federal Medicaid programs, as well as private health insurers, by deliberately marketing cholesterol drug Lipitor to expand its use beyond what has been approved by FDA, the Wall Street Journal reports. The lawsuit, filed by a Teamsters union health insurance fund, alleges that beginning in 2001, the company illegally tried to persuade physicians to prescribe the drug to patients with low to moderate heart-disease risk, despite FDA's approval of Lipitor only for higher-risk patients because of a risk of side effects.
Federal guidelines recommend lifestyle changes instead of drugs in most moderate-risk cases. The suit also alleges that Pfizer misrepresented the drug's potential to Wall Street investors by claiming "millions more potential patients than would be expected under the government guidelines," the Journal reports.
The suit, which alleges civil fraud and racketeering, seeks unspecified damages and "could be followed by an additional half-dozen such suits, seeking to represent all employee-health insurers," according to the Journal. A Pfizer spokesperson said the company had not been able to review the complaint, adding, "Physicians and their patients should work together to determine the best individual approach to lowering and maintaining their cholesterol at the appropriate level."
According to the Journal, the lawsuit "spotlights the practice of off-label marketing of drugs for uses beyond those approved by regulators." Separately, federal prosecutors are reviewing Pfizer's alleged off-label marketing "because of the billions of dollars spent on Lipitor every year by Medicaid and the states," the Journal reports.
Susan Winkler, health care fraud chief for the U.S. attorney in Boston, has said that there likely will be more such prosecutions, as well as an increasing number of the government's civil fraud cases, that seek to recover Medicaid dollars paid for off-label uses (Wilke/Hensley, Wall Street Journal, 3/28).