November 14, 2013 – As part of this month’s landmark Risperdal settlement between Johnson & Johnson (J&J) and the federal government, internal documents have been released suggesting the company’s Janssen division may have hidden clinical trial data about the drug’s serious side effects. The Department of Justice (DOJ) has released internal documents of researchers expressing concern over Janssen withholding clinical trial data that showed poor outcomes for Risperdal (risperidone), while appearing to cherry pick information that presented the medicine in a more positive light. Risperdal, which is prescribed for the treatment of schizophrenia and bipolar disorder, has recently been linked to gynecomastia, tardive dyskinesia, type 2 diabetes, and other serious side effects.
Free Risperdal Lawsuit Evaluation: If you or a loved one has been injured by Risperdal, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of Risperdal and we can help.
What’s the Problem?
The new documents surfaced after the Justice Department got J&J to plead guilty to marketing Risperdal for unapproved indications, including for use as a chemical restraint for elderly people with dementia. The illegal marketing came despite warnings by the U.S. Food & Drug Administration (FDA) which indicated that atypical antipsychotics like Risperdal could increase the risk of death in patients suffering from dementia. J&J was also accused of paying kickbacks to physicians that prescribed Risperdal and other medications made by the company.
The documents include internal J&J e-mails regarding a clinical trial known as ‘RIS 232,’ which appears to have looked at the safety and effectiveness of Risperdal. A partially redacted version of one of these e-mails reads:
“Janssen has been sitting on the trial results for a long time. Yet it has a moral and ethical responsibility to publish results quickly and in a way that can be understood and makes clinical sense. It has an obligation to publish not just the clinical efficacy data which should very well be informative and supportive of the use of risperidone if considered properly, but also the safety data, including events that have been labeled in the past as ‘cerbrovascular adverse events’ and death.”
Another e-mail written by a J&J researcher appears to describe four pooled studies, one of which showed poor results that the company decided to keep under wraps.
“At this point, we must be concerned that this gives the strong appearance that Janssen is purposely witholding (sic) the findings from RIS 232,” the researcher warns. “I really do have to speak out and urge that Janssen avoids embarrassment and accusations about suppressing information that is relevant to providers and consumers.”
The research was finally published in 2006; Risperdal was approved by the FDA in 1994.
Risperdal Health Concerns
In addition to concerns that Risperdal could cause death in elderly dementia patients, the Justice Department’s investigation revealed that the drug was also prescribed to children and the mentally ill in nursing homes for ‘off-label’ indications. To date, Risperdal has been linked to a large number of serious side effects including:
- Production of prolactin
- Pituitary tumors
- Tardive Dyskinesia
- Neuroleptic Malignant Syndrome (NMS)
- Increased risk of sudden death from heart attack
- Diabetes, hyperglycemia and other blood sugar side effects
- Weight gain, potentially rapid and extreme
- Suicide, suicidal thoughts
- Bone loss
- Increased mortality in the elderly with dementia and related psychosis
Risperdal Gynecomastia Lawsuits
J&J is currently facing a growing number of Risperdal gynecomastia lawsuits alleging that inadequate warnings were provided about the risk that young boys may experience the development of breasts after taking the drug. Some plaintiffs have alleged that they developed breasts as large as a 38D cup after taking Risperdal, with many cases resulting in the need for breast removal surgery (mastectomy). The psychological impact of growing breasts can have a devastating effect on boys, greatly impacting their quality of life.
Do I Have a Risperdal Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Risperdal lawsuits. We are handling individual litigation nationwide and currently accepting new Risperdal side effects cases in all 50 states.
Free Risperdal Lawsuit Evaluation: If you or a loved one has been injured by Risperdal, you should contact our law firm immediately. You may be entitled to compensation by filing a Risperdal suit and we can help.