Off-label marketing

Off-label marketing and qui tam (whistleblower) lawsuits

Many of the largest pharma companies in the world -- GlaxoSmithKline, Pfizer, Cephalon and more -- have paid hundreds of millions and even billions of dollars to settle whistleblower cases involving off-label marketing.

Pharmaceutical companies may be liable under the False Claims Act if they promote the use of prescription drugs for unapproved (off-label) indications for Medicare patients. Providing physicians with drug marketing information that is misleading or false also may expose a pharmaceutical manufacturer to False Claims Act liability.

Federal regulations require drug companies to seek approval from the U.S. Food and Drug Administration to market drugs to doctors for particular illnesses. To get that approval, the drug companies must provide data proving that a drug is safe and effective for those illnesses. However, doctors still can prescribe drugs for unapproved uses if they believe those drugs would be helpful for a patient.

Phillips & Cohen represented former pharma company employees in two separate off-label cases that were the major components of the two largest healthcare fraud settlements in the U.S.: One by GlaxoSmithKline for $3 billion in 2012 and the other by Pfizer for $2.3 billion in 2009.

The whistleblower case against Glaxo alleged that the pharma giant had engaged in corrupt nationwide schemes to push sales of Advair, Wellbutrin, Imitrex and other popular prescription drugs for off-label uses, that it used improper financial inducements to market its drugs and that it misrepresented the safety and efficacy of those drugs.

In the Pfizer case, the whistleblower lawsuit alleged that Pfizer promoted the prescription painkiller Bextra for off-label uses and in doses that far exceeded what the FDA had approved. This put patients at risk for serious health problems such as heart attack, stroke and pulmonary embolism. The lawsuit also said that Bextra paid doctors kickbacks in various ways to influence them to prescribe and endorse Bextra for these "off-label" uses. Out of the total $2.3 billion settlement, Pfizer paid $1.8 billion to settle Phillips & Cohen's whistleblower lawsuit and a related criminal fine -- which was the largest criminal fine ever levied for any type of crime.