Janssen Pharmaceuticals, Inc., a Johnson & Johnson company, has agreed to pay approximately $181 million for the settlement and consent decree with 36 states and the District of Columbia regarding previously disclosed allegations related to promotional and marketing practices for its atypical antipsychotic prescription medication - Risperdal.
According to a company press release the designated portion of the total amount will be paid to each state participating in the settlement.
The settlement is not an admission of wrongdoing or violation of any law or regulation. The company agreed to the settlement to resolve the concerns of the attorneys general under state consumer protection laws and to avoid unnecessary expense and a prolonged legal process. All parties have acknowledged that the payment is not a fine or penalty.
“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, president, Janssen Pharmaceuticals, Inc.
As part of the settlement, Janssen reaffirmed it would not promote any of its atypical antipsychotics for off-label uses or make any false or misleading claims related to those products. The company takes its obligation to ensure the safe and appropriate use of its medications very seriously and has a system in place to ensure that marketing and promotion policies are followed.
In addition to the District of Columbia, the 36 states participating in the settlement are: Alabama, Arizona, Colorado, Connecticut, Delaware, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, Wisconsin and Wyoming.
Risperdal continues to help patients around the world who suffer from the debilitating effects of schizophrenia and bipolar mania.
This multi-state consumer fraud settlement is separate and distinct from the recent disclosure made by Johnson & Johnson concerning an agreement in principle with the Department of Justice (DOJ) to settle three civil False Claims Act matters that are pending in US courts: the sales and marketing of Risperdal and Invega; the sales and marketing of Natrecor; and allegations that Omnicare, Inc. was provided with rebates and other payments regarding Risperdal and other products. With this agreement in principle with the DOJ, issues remain open that must be resolved before they can be finalized.