Attorney General George Jepsen and state Department of Consumer Protection Commissioner William Rubenstein announced that Connecticut has joined a $181 million dollar settlement agreement with Janssen Pharmaceuticals, Inc., a subsidiary of Johnson and Johnson.
Thirty-three other states and the District of Columbia also are participating in the agreement, the largest multi-state consumer protection settlement with a pharmaceutical company. It follows an extensive, four-year investigation and stems from allegations that Janssen improperly marketed the antipsychotic drugs Risperdal, Risperdal Consta, Risperdal M-Tab and Invega.
Connecticut’s share of the settlement is $3,539,549. Approximately $3.1 million will be paid into the General Fund; the remainder will be paid into the Office of the Attorney General and DCP consumer funds and the DCP’s prescription-drug monitoring program.
The complaint alleges that Janssen promoted Risperdal for off-label use to treat Alzheimer’s disease, dementia, depression, and anxiety, even though the U.S. Food and Drug Administration had not approved the drug for these purposes, nor had Janssen shown that Risperdal was safe and effective in treatment of these conditions.
"The law prohibits off-label marketing for a reason: to protect the health and safety of consumers. This settlement will require this company to follow the law and end the practice of off-label marketing for these drugs," Attorney General Jepsen said.
Consumer Protection Commissioner William Rubenstein said, "This is an appropriate settlement that will presumably send a message throughout the marketplace that promoting medications for off-label use is off-limits for drug companies."
The states alleged that Janssen’s marketing of Risperdal, among a class of drugs known as atypical or second-generation antipsychotics, for unapproved or off-label uses violated the law as an unfair and deceptive practice.
Federal law prohibits pharmaceutical manufacturers from promoting their products for off-label uses, although physicians may prescribe drugs for those uses.
As part of the settlement, Janssen has agreed to change not only how it promotes and markets its atypical antipsychotics, but the company also agreed to refrain from any false, misleading or deceptive promotion of the drugs.