Janssen Pharmaceuticals to Pay $181M Over Deceptive Marketing Claims

In the largest multi-state consumer protection settlement with a pharmaceutical company, the State of Hawaii Office of Consumer Protection announced today that it joined with 35 other states and the District of Columbia in reaching a record $181 million settlement with Janssen Pharmaceuticals, Inc., which includes $2.7 million in settlement of Hawaii’s claims.

Janssen is a subsidiary of Johnson and Johnson.

In a suit filed today by the Office of Consumer Protection, the State alleged that Janssen improperly marketed the antipsychotic drugs Risperdal, Risperdal Consta, Risperdal M-Tab, and Invega.

Officials at OCP said it is unclear how many people throughout Hawaii used the drugs and noted that people using the medications in question will eventually be notified of the settlement through their insurer or healthcare provider.

“Consumers in Hawaii have the right to expect that their health and well-being—not profit—drives decisions about their care,” said Bruce Kim, executive director of the Office of Consumer Protection. “This settlement protects consumers and stops unscrupulous marketing practices.”

After an extensive four-year investigation, Janssen agreed to change not only how it promotes and markets its atypical anti-psychotics, but also agreed to refrain from any false, misleading, or deceptive promotion of the drugs.

In addition to the record setting payment, the settlement targets specific concerns identified in the investigation, including clearly disclosing the specific risks of each drug and presenting information about the drug’s effectiveness in a balanced manner.

The settlement agreement restricts Janssen from promoting its atypical antipsychotic drugs for “off-label” uses that the US Food and Drug Administration has not approved.

Federal law prohibits pharmaceutical manufacturers from promoting their products for off-label uses; although physicians may prescribe drugs for those uses. The State of Hawaii Office of Consumer Protection’s suit alleges that Janssen promoted Risperdal for off-label uses to both geriatric and pediatric populations, targeting patients with Alzheimer’s disease, dementia, depression, and anxiety, when these uses were not FDA-approved and for which Janssen had not established that Risperdal was safe and effective.

The suit alleges that Janssen engaged in unfair and deceptive practices when it marketed Risperdal for unapproved or off-label uses. Risperdal is among a class of drugs known as atypical or second-generation antipsychotics.

“Promoting drugs for unapproved, off-label uses is a potentially deadly practice that can threaten patients’ lives. This settlement will make drug manufacturers like Janssen think twice before exposing innocent patients to unacceptable risks,” Kim said.

For more information on this legal settlement, you can email the Office of Consumer Protection at ocp@dcca.hawaii.gov or call the DCCA Consumer Resource Center Hilo office, (808) 933-0910.