The state of Connecticut will receive more than $3.5 million as part of the nation’s largest ever multi-state consumer protection settlement with a pharmaceutical company. In total, 33 states and the District of Columbia will receive $181 million following a settlement with Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson.
The pharmaceutical company settled claims of improper marketing and advertising of the powerful anti-psychotic drugs Risperdal, Risperdal Consta, Risperdal M-Tab and Invega. Officials allege that Janssen Pharmaceuticals promoted Risperdal for off-label uses, such as the treatment of Alzheimer’s disease, that the U.S. Food and Drug Administration had not approved.
The settlement follows an extensive four-year investigation.
“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,” Connecticut Consumer Protection Commissioner William Rubenstein said in a statement.
Risperdal is used to treat mental illnesses including schizophrenia, bipolar disorder and irritability associated with children and adolescents with autism. Invega, which is derived from Risperdone, is also marketed for the treatment of schizophrenia and bipolar mania.
The states’ complaint claimed that Janssen Pharmaceuticals, from 1998 through at least 2004, promoted Risperdal for unapproved uses, including dementia in elderly patients, schizophrenia and bipolar disorder in children and adolescents, and depression, anxiety, obsessive compulsive disorder, conduct disorder, post-traumatic stress disorder and Alzheimer’s disease.
Further, the complaint alleged that Janssen Pharmaceutical concealed and misrepresented information regarding the side effects and efficacy of Risperdal, thereby putting patients at risk.
Federal law prohibits pharmaceutical manufacturers from promoting their products for off-label uses, although physicians may prescribe drugs for those uses.
Connecticut’s share of the settlement is $3,539,549. Approximately $3.1 million will be paid into the state’s general fund. The remaining money will go to consumer funds in the Office of the Attorney General and the state Department of Consumer Protection as well as the state Department of Consumer Protection’s prescription drug monitoring program.
The Titusville, New Jersey-based Janssen Pharmaceuticals did not admit any wrongdoing, instead stating it wanted to avoid a prolonged and expensive legal battle. “We have chosen this path to achieve a prompt and full resolution of these state claims and to ensure we continue to focus on our mission of providing medicines to meet the significant unmet needs of many people who suffer from mental illness,” said Michael Yang, Janssen Pharmaceutical’s president, in a statement.
According to company officials, the multi-state settlement is separate from a disclosure made last month by Janssen’s parent company, Johnson & Johnson, concerning an agreement in principle with the Justice Department to settle three civil matters regarding the sales and marketing of Risperdal and Invega, the sales and marketing of the respiratory drug Natrecor, and allegations that the drug dispensing company Omnicare Inc., of Kentucky was provided with rebates regarding Risperdal and other products.
In 2009, Omnicare agreed to pay $90 million to resolve a separate probe. The government said Johnson & Johnson made illegal payments to Omnicare between 1999 and 2004 and that Omnicare’s annual sales of Risperdal nearly tripled to $280 million over that period.
In the latest settlement agreement, Janssen is prohibited from promoting the drugs for off-label uses; providing samples to health care providers whose clinical practices are inconsistent with FDA-approved labeling of the antipsychotics; awarding grants to health care professionals based on their prescribing habits; and presenting information from studies that are not scientifically sound.
Further, the settlement requires Janssen to report clinical research about Risperdal or Invega in an accurate and objective manner; clearly disclose the specific risks identified in the black-box warning on its labels; establish policies to ensure that financial incentives are not given to marketing and sales staff that encourage or reward off-label marketing; and disclose on its web site a searchable listing of all health care providers who received any payments from Janssen.
In Connecticut, Assistant Attorney General Thomas Saadi handled this matter for the state Attorney General’s Office along with Assistant Attorney General Phillip Rosario, head of the Consumer Protection Unit.•