Johnson & Johnson’s Janssen Pharmaceuticals unit on Thursday announced that it will pay approximately $181 million under a settlement and consent decree with 36 U.S. states and the District of Columbia regarding previously disclosed allegations that it improperly promoted and marketed Risperdal (risperidone). Janssen reaffirmed as part of the settlement that 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 drugmaker noted that the settlement is not an admission of wrongdoing or violation of any law or regulation and that all parties agreed the payment is not considered a fine or penalty. Janssen president Michael Yang commented that “we have chosen this path to achieve a prompt and full resolution of these state claims.” The company added that it “takes its obligation to ensure the safe and appropriate use of its medications very seriously” and has a system in place to ensure that its marketing policies are followed. Florida Attorney General Pam Bondi said the agreement “sends a message to all pharmaceutical companies that these practices will not be tolerated.”
In July, sources suggested that Johnson & Johnson agreed to pay as much as $2.2 billion to resolve claims made by the US government and some states regarding the marketing of Risperdal and other drugs, including a criminal fine of as much as $600 million for the illegal promotion of Risperdal. The sources noted at the time that the final sum of the payout would depend on which states agreed to the settlement.
Johnson & Johnson noted that today’s settlement is separate from the agreement in principle reached with the U.S. Department of Justice earlier this month to settle three civil False Claims Act matters that are pending in U.S. court regarding the sales and marketing of Risperdal, Invega (paliperidone) and Natrecor (nesiritide), as well as allegations that Omnicare was provided with rebates and other payments regarding several products.