“Off Label” Marketing

The U.S. Food and Drug Administration approves prescription drugs as safe and effective only for specific uses, in specific dosages, and for specific patient groups. When drug companies promote and market their drugs for other, unapproved uses (“off-label” promotion), Medicare fraud, Medicaid fraud, and False Claims Act liability all become concerns.

Case Examples

Many of the very largest whistleblower cases ever filed have been brought against large pharmaceutical companies for providing financial incentives to doctors to write off-label prescriptions and for training sales representatives to encourage off-label uses. As examples:

In November 2013, Johnson & Johnson agreed to pay $2.2 billion to resolve whistleblower claims that it illegally promoted drugs, including Risperdal, for off-label uses that federal health care programs did not cover, resulting in false claims being submitted to federal health care programs; The case included allegations that J & J had paid kickbacks both to physicians and to Omnicare, Inc., the nation’s largest pharmacy specializing in dispensing drugs to nursing home patients, to induce them to prescribe the company’s drugs. Sales representatives allegedly told doctors that if they wanted to receive paid speaking engagements, they needed to increase their prescriptions. Read more

In July 2012, GlaxoSmithKline PLC pled guilty and paid a record-setting $3 billion penalty to resolve whistleblower charges that it violated the False Claims Act by promoting drugs, including Paxil, Wellbutrin, and Avandia, for unapproved uses, suppressing information about safety concerns, and doling out millions of dollars in kickbacks to doctors to encourage unapproved uses. Glaxo also allegedly participated in publishing and distributing a misleading medical journal article, misrepresenting clinical results. Read more 

In September 2009, Pfizer paid $2.3 billion to resolve claims growing out of nine whistleblower suits charging it with marketing anti-inflammatory, antipsychotic, antibiotic, and anti-epileptic drugs for off-label uses. Read more

In January 2009, Eli Lily & Co. agreed to pay $1.4 billion to settle claims related to off-label marketing of the antipsychotic drug Zyprexa for uses not approved by the FDA, including allegations that it trained sales representatives to promote the drug by focusing on symptoms. Read more

If you have knowledge and solid evidence of fraud or false claims by a drug manufacturer, please contact our Chicago whistleblower attorneys. Consultations are free and confidential.