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By: Staff Writers | Published: February 20th, 2012
A New Jersey jury determined last week that Johnson & Johnson failed to provide adequate warning that the antipsychotic Risperdal could cause diabetes, but found that there was insufficient evidence to hold the company liable for a Nebraska man’s illness.
The Risperdal lawsuit was filed by Gary Skala, who developed diabetes after taking the atypical antipsychotic medication in 1996.
The case is the first of about 400 such lawsuits to reach a jury. All of the complaints involve similar allegations that Johnson & Johnson failed to provide adequate warnings for consumers and the medical community that side effects of Risperdal may increase the risk of diabetes. However, each plaintiff must not only establish that Risperdal warnings were insufficient, but also that the medication did in fact cause their diabetes injury.
Following trial, the jury did agree that Johnson & Johnson should have provided better warnings to doctors and patients about the potential Risperdal side effects. However, they found that Skala failed to successfully link his diabetes to the drug.
According to a report by Bloomberg News, lawyers for Johnson & Johnson portrayed Skala during the trial as an overweight “couch potato” who also drank heavily. Skala was prescribed to Risperdal for major depression after a failed suicide attempt.
The decision comes about a month after Johnson & Johnson settled out of court with the state of Texas and a whistleblower who sued the company for illegal Risperdal marketing practices. Several weeks ago, reports indicated that the company had agreed to a $1 billion settlement with the federal government over similar charges.
Off-label marketing occurs when a drug company promotes the use of its drug for purposes other than those approved by the FDA, and is illegal. Doctors can prescribe a drug for any purpose they see fit, but companies cannot promote them for unapproved uses.
In 2009, Omnicare reached a settlement with DOJ over kickback charges. The DOJ investigators indicated that Johnson & Johnson paid Omnicare millions to push off-label use of Risperdal to nursing home doctors and hid the kickbacks as data fees, education fees and payments to attend Omnicare meetings. In January 2010, the DOJ filed a civil False Claims Act complaint against J&J.
Risperdal (risperidone) is manufactured by Janssen, a division of Ortho-McNeil-Janssen. The atypical antipsychotic is approved by FDA for the treatment of schizophrenia, bipolar disorder and autism, but it is often used among elderly with dementia and sometimes as a form of chemical restraint in nursing homes.