20. January 2012 11:42
Johnson & Johnson has agreed to pay $158 million to settle a US lawsuit brought by the state of Texas, alleging that it promoted off-label use of its antipsychotic drug Risperdal (risperidone) and misled doctors about its risks.
Witnesses stated that J&J officials concealed data indicating the drug posed a high risk of weight gain and type 2 diabetes, and that it instructed its sales force to promote the drug’s off-label prescription for minors.
The settlement is the latest chapter in the ongoing dispute over J&J’s marketing of Risperdal in the USA (for more details, click here).
The state of Texas had originally sought $579 million in damages, but the company’s payment is reported to settle the dispute – though several other states, including most recently Massachusetts, intend similar lawsuits.
In the Texas court hearing, Harvard Medical School psychiatrist Joseph Glenmullen said that a clinical trial, Study 113, found that about half of people given Risperdal developed diabetes after a year of therapy. In 2000, when the FDA investigated potential links between antipsychotics and diabetes risk, J&J did not provide the results of Study 113 and two related studies.
Earlier in the trial, the court saw an internal memo instructing J&J’s sales representatives to “flood clinics with Risperdal stuff” as part of a 2004 campaign to increase off-label prescriptions for the drug in children and adolescents.
In his final ruling, Judge Roger Couch said of the Study 113 data: “It is apparent to this court that this information was not disclosed because it did not fit the marketing department’s vision for the promotion and marketing of this drug.”