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Johnson & Johnson Emails Show Possible Risperdal Off-Label Marketing
November 25, 2008
An article in today's edition of the Wall Street Journal reported that internal company emails produced in a lawsuit against Johnson & Johnson suggest that Johnson & Johnson planned funding for a research institute to focus on use of the antipsychotic drug Risperdal by children well before the FDA approved Risperdal for patients that young.
Emails Show Off-Label Promotion
The emails in question, which circulated Johnson & Johnson's Janssen Unit in 2001 and 2002, raise issues of whether the company used the research institute to illegally market an off-label use of Risperdal, which wasn't approved for use in children until 2007. Risperdal, also known by its generic name risperidone, has been linked to side effects including serious weight gain and diabetes.
According to data presented at an FDA panel last week, Risperdal was being prescribed to thousands of teens and younger children before it was approved in mid-2007 for use in children and adolescents with bipolar disorder. In 2007, Risperdal was prescribed to nearly 300,000 children and adolescents for diagnoses which included attention-deficit disorder (ADD), a condition for which Risperdal is not approved.
The FDA doctors' panel said that antipsychotics, such as Risperdal, have been overprescribed to children and adolescents.
Risperdal Lawsuits Being Filed
Now several patient plaintiffs have filed Risperdal lawsuits against Johnson & Johnson over alleged injuries caused by Risperdal. The internal Johnson & Johnson company emails were provided to a New Jersey court as part of an effort by the plaintiffs to force psychiatrist Joseph Biederman, who proposed and ultimately headed the institute that J&J funded, to testify.
J&J Responds with Public Statement
In a statement, Johnson & Johnson said it helped to fund the research center in 2002 "with an objective to conduct rigorous clinical trials to clarify appropriate use and dosing of Risperdal in children." Johnson & Johnson also noted that some of those uses were later approved by the FDA, but it said the company only promotes its medications for FDA-approved indications.
Still, the internal Johnson & Johnson emails suggest that the company's marketing staff were involved in creating the Risperdal research institute and that company officials helped to write and evaluate research work done by Dr. Biederman and his associates. A court has ordered Dr. Biederman to undergo a deposition on January 10, 2009 as part of the New Jersey lawsuit.
Risperdal Side Effects Lawyer
If your child has been injured by Risperdal, contact our Risperdal side effects attorneys today for a confidential and free case evaluation.
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