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Pfizer Pays $2.3 Billion to Settle Allegations Of Illegal Off-Label Marketing Practices

As a result of multiple whistleblower lawsuits, Pfizer, Inc. has paid a hefty price to settle allegations of defrauding Medicare, Medicaid, and other government-funded health care programs. Attorneys from Kenney& McCafferty represented the whistleblowers in the cases, which concerned Pfizer’s marketing of four of its drugs — including Geodon and Zyvox.

In the case of Geodon, Pfizer agreed to pay $300 million to resolve allegations that it engaged in off-label marketing for the anti-psychotic medication. Geodon is FDA-approved only to treat patients ages 18-65 diagnosed with schizophrenia or acute manic or mixed episodes associated with bipolar disorder. According to the whistleblower suit, Pfizer illegally promoted use of Geodon for a variety of off-label conditions, including depression, mood disorder, anxiety, aggression, dementia, ADHD, OCD, autism, and PSD. The company also marketed the drug for pediatric, adolescent and geriatric patients.

The allegations were made in a qui tam lawsuit filed by K&M attorneys, Brian Kenney and Tavy Deming, on behalf of Harrisburg psychiatrist, Dr. Stefan Kruszewski. According to Kenney, Pfizer targeted children to expand off-label use and maintained more than 250 child psychiatrists on its payroll.” Kenney stated that “the intent of paying so many child psychiatrists was to gain a foothold within the fastest growing market for antipsychotics — children.”

Geodon’s most dangerous side effect is its potential to affect the heart’s rhythm, a condition known as QT prolongation, which can greatly increase the risk of sudden cardiac death. The company’s off-label promotion of the drug was deemed especially dangerous, because its safe use by children had not been evaluated or approved.

In a case filed by Ronald Rainero, a former Pfizer sales manager from New Jersey,

Pfizer also agreed to pay $100 million to resolve allegations that it improperly marketed its antibiotic, Zyvox. The drug was marketed for a variety of off-label conditions beyond the specific types of infections for which it was FDA-approved. The complaint alleged that Pfizer made and/or disseminated unsubstantiated and/or false representations or statements about the safety and efficacy of Zyvox in order to further the off-label campaigns.

According to K&M’s Deming, even though it is illegal for drug makers to engage in off-label promotion, they find ways to do so because there is so much money to be made from the practice. As Pfizer discovered, there can also be a stiff penalty.

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