Johnson & Johnson unit Janssen Pharmaceuticals has agreed to pay out $181 million to settle claims in 36 US states regarding illegal marketing practices for its antipsychotic Risperdal.
The groups are accused of improperly promoting its Risperdal (risperidone) franchise and Invega (paliperidone) between 1998 and 2004 for uses that had not been given marketing clearance by the US Food and Drug Administration.
As part of the agreement, 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.
But it also stressed that the settlement "is not an admission of wrongdoing or violation of any law or regulation", and that it has agreed to proceed to "resolve the concerns of the attorneys general under state consumer protection laws and to avoid unnecessary expense and a prolonged legal process".
"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," commented Michael Yang, Janssen's president.
Nevertheless, New York Attorney General Eric Schneiderman reportedly said in a statement that the "landmark settlement holds the companies accountable for practices that put patients in danger, and serves as a warning to other pharmaceutical giants that they must play by one set of rules".
The US has been looking into the group's sales practices for its antipsychotics since 2004, and this latest settlement comes on the back of various other court battles claiming improper marketing conduct.
Back in April, the drugmaker was hit with a $1.1 billion fine after an Arkansas judge found it guilty of deceptive marketing.
Janssen was accused of sending marketing letters to more than 6,000 Arkansas doctors in 2003 claiming Risperdal’s superior safety compared with competing drugs, and it was claimed that false statements were made about its efficacy and side effects, and that the drug was marketed for unapproved uses.
An earlier settlement in Texas saw the company pay out $158 million to resolve claims of illegal marketing, while fines of $327 million and $258 million came out of cases in South Carolina and Louisiana, respectively, though these are being appealed.
Risperdal sales hit their peak in 2007 at $4.5 billion, but the drug pulled in just $527 million in 2010, taking a huge hit from generic competition.