New York, NY: Johnson & Johnson (J&J) has agreed to pay $158 million to settle a lawsuit in Texas suit that alleges the company defrauded the state by misleading doctors about its antipsychotic drug Risperdal.
The deal will reportedly bring an end to claims that J&J marketed Risperdal off label - for unapproved uses - and downplayed health risks associated with the drug. Texas had originally sought at least $579 million in damages.
The settllement follows testimony given in court last week that included an expert eye witness stating that J&J hid data showing Risperdal could cause weight gain that could lead to diabetes. According to a report by Bloomberg " the witness also alleged that J&J had key study [ Study 113] results several years before it added warnings about weight gain to the drug's label."
In 2000, the Food and Drug Administration (FDA) begain investigating reports of potential links between atypical antipsychotics and diabetes, however J&J did not turn over results from Study 113 to the agency, or provide the FDA with results of two other studies that also showed similar diabetes risks for both Risperdal and Zyprexa, Bloomberg reports.
The witness also testified that J&J didn't hand over the results of Study 113 and the other research because, it claimed, the data were flawed. However, the witness pointed out that he considered Study 113 to be a high-quality trial and a "superb" example of scientific research.
Bloomberg notes in its report that J&J's unpublished studies were cited in a South Carolina case that brought a $327 million judgment against the pharmaceutical manufacturer. "It is apparent to this court that this information was not disclosed because if did not fit the marketing department's vision for the promotion and marketing of this drug," Judge Roger Couch wrote in a ruling (as quoted by Bloomberg).