Janssen Pharmaceuticals, Inc. announces RISPERDAL® consumer protection settlement with 36 states and the District of Columbia
TITUSVILLE, NJ (August 30, 2012) Janssen Pharmaceuticals, Inc., a Johnson & Johnson company, announced a settlement and consent decree today 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®.
The company will pay approximately $181 million, an amount which has been previously accrued, as part of a consent decree to resolve state consumer protection law claims in the 36 states and the District of Columbia related to this matter. A 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 U.S. 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.
About Janssen Pharmaceuticals, Inc.
As a member of the Janssen Pharmaceutical Companies of Johnson & Johnson, Janssen Pharmaceuticals, Inc. is dedicated to addressing and solving some of the most important unmet medical needs of our time. Driven by our commitment to patients, we work together to bring innovative ideas, products, services and solutions to individuals with serious conditions, and to physicians throughout the world.
For more information on Janssen Pharmaceuticals, Inc. or its products, visit us at www.janssenpharmaceuticalsinc.com or follow us on Twitter at www.twitter.com/JanssenUS.
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(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Pharmaceuticals, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; significant adverse litigation or government action; impact of business combinations; financial distress and bankruptcies experienced by significant customers and suppliers; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; increased scrutiny of the health care industry by government agencies; changes in behavior and spending patterns of purchasers of health care products and services; financial instability of international economies and sovereign risk; disruptions due to natural disasters; manufacturing difficulties or delays; and product efficacy or safety concerns resulting in product recalls or regulatory action. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Janssen Pharmaceuticals, Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)
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