The manufacturer of the controversial antipsychotic medication Risperdal has agreed to pay $5.9 million to make a lawsuit filed by Montana state officials go away.
Risperdal, which has been linked to gynecomastia — enlarged breast growth in juvenile and adult males — and other serious side effects has been at the center of several civil and criminal lawsuits recently.
In the Montana case the state Attorney General’s Office said that the medication’s manufacturer, Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, agreed to settle a state lawsuit alleging that illegal marketing practices were used that misled patients and physicians.
The settlement also restricts Janssen from making misleading claims in the promotion of its drugs in the future and present information about the benefits and risks of its product in a balanced manner in promotional materials. Janssen did not admit wrongdoing through the settlement.
The two companies also paid out $1.67 billion recently over civil and criminal charges filed by the U.S. Justice Department over similar allegations.
Food and Drug Administration officials and federal prosecutors cited numerous illegal acts and imposed a $400 million criminal fine because the companies introduced introducing Risperdal as a misbranded drug into interstate commerce.
In both cases government officials charged that company officials failed to reveal to patients and health care professionals of serious side effects, including the possibility that some patients might develop gynecomastia, a medical condition in which males suffer enlarged breasts.
In addition to these government cases, hundreds of Risperdal breast-growth lawsuits have been filed in state and federal courts across the country seeking compensation for the medical costs, pain and suffering and other expenses these victims claim to have suffered from use of the drug.
Montana Attorney General Tim Fox announced that his office will use most of the proceeds from the settlement to pay for a new prescription drug abuse prevention program, mental health services and mental health programs in the state, and ongoing consumer protection services.
In 2008, the Attorney General’s Office filed a lawsuit against Janssen Ortho LLC and Janssen Pharmaceuticals, Inc. (collectively, “Janssen”) over its illegal unfair and deceptive marketing of Risperdal, an atypical antipsychotic drug used to treat certain psychological disorders in adults.
Janssen actively deceived Montana physicians and consumers when it promoted Risperdal as safe and effective for a variety of conditions, when in fact, Janssen was aware of dangers associated with its drug that it hid from the public.
“This settlement is not only significant in terms of the amount of money Montana will receive, but also in that it protects our citizens from being prescribed Risperdal based on the types of false statements Janssen previously made to our healthcare providers,” Attorney General Fox said.
The Attorney General also thanked other state officials and said: “Thanks to their diligence on the behalf of Montana’s consumers and taxpayers, a pharmaceutical giant has been held accountable for deceptive marketing practices, and a significant recovery of the State’s public resources has been realized.”