November 4, 2013 – Healthcare giant Johnson & Johnson (J&J) has agreed to resolve criminal and civil investigations into the marketing of the antipsychotic drug Risperdal (risperidone) and other widely-prescribed drugs by paying over $2.2 billion, one of the largest penalties ever levied against a company for healthcare fraud. According to the agreement, J&J’s Janssen division will plead guilty to misbranding Risperdal for unapproved uses, as well as for paying kickbacks to physicians and to Omnicare Inc., the largest pharmacy for nursing homes. In addition to the marketing issues with Risperdal, the drug has also recently been linked to gynecomastia, a condition characterized by abnormal breast growth in young men that occurs when estrogen and testosterone levels are thrown out of balance.
Risperdal Lawsuit Update 11/14/13 – 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. Click here to learn more.
Free Risperdal Lawsuit Evaluation: If you or a loved one developed gynecomastia after taking 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.
Johnson & Johnson to Settle Risperdal Marketing Case
According to the Department of Justice, Janssen Pharmaceuticals marketed Risperdal to physicians with elderly dementia patients as a way to treat a variety of ailments including anxiety, agitation and depression, even though the drug had only been approved to treat schizophrenia. Between March 2002 and December 2003, federal officials said Janssen created written sales brochures for the company’s ElderCare sales force that downplayed any mention that it had only been cleared for use in patients with schizophrenia.
Janssen has agreed to plead guilty to a misdemeanor charge, and admitted to marketing Risperdal to dementia patients who had not been diagnosed with schizophrenia. The company will pay criminal fines totaling $485 million, as well as an additional $1.72 billion to settle civil cases with the federal government and 45 states. The fine also settles allegations that J&J improperly marketed a newer antipsychotic medication, Invega (paliperidone), as well as the heart failure drug Natrecor (nesiritide).
“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” said Attorney General Eric Holder. “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud. And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people.”
Risperdal Linked to Gynecomastia
In addition to the marketing problems over Risperdal, the drug has also recently been linked to gynecomastia. It is believed that the medication blocks dopamine, which causes the pituitary gland to release prolactin. Prolactin is a hormone that controls breast growth in women and growth hormones in men. When prolactin levels are raised (a condition known as hyperprolactinemia), it can cause the abnormal growth of male breast tissue. According to a 2006 study published in the Journal of Clinical Psychopharmacology,
“Risperidone administered to adolescents at doses commonly used for the treatment of psychotic symptoms can strongly increase prolactin levels, with clinical consequences such as gynecomastia and/or galactorrhea. Given that the long-term effects of antipsychotic drug-induced hyperprolactinemia are not well documented, especially regarding osteopenia, infertility, growth, and pubertal delay, risperidone should be administered with caution to children and adolescents.”
Signs and symptoms of Risperdal-induced gynecomastia may include:
- Enlargement of male breasts (may be uneven)
- Growth of glandular breast tissue
- Breast tenderness
- Nipple discharge
Johnson & Johnson is currently facing more than 420 lawsuits filed on behalf of individuals who were allegedly injured by Risperdal, including at least 130 gynecomastia complaints. In September 2012, the first Risperdal gynecomastia lawsuit was settled for an undisclosed amount. The plaintiff in that case, Aaron Banks, was prescribed Risperdal between 1999-2004, beginning when he was just nine years old. Banks reportedly developed enlarged breast tissue and required surgical intervention to treat the condition.
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 gynecomastia cases in all 50 states.
Free Risperdal Lawsuit Evaluation: If you or a loved one developed gynecomastia after taking Risperdal, you should contact our law firm immediately. You may be entitled to compensation by filing a Risperdal gynecomastia suit and we can help.