J&J Pays $2.2 Billion to Settle Gov’t Probe of Anti-Psychotic Medication; Risperdal Lawsuit Claims on the Rise
Johnson & Johnson has agreed to pay more than $2.2 billion to settle a government investigation that it marketed a drug named in Risperdal lawsuit filings to elderly patients with dementia, and for other uses not approved by the U.S. Food and Drug Administration (FDA), Bloomberg.com reports. The $2.2 million pact also resolves allegations that the company improperly marketed the antipsychotic Invega, as well as Natrecor, a heart drug.
According to an article published November 4th, the parent company of Janssen Pharmaceuticals Inc. will pay a $334 million fine and forfeit $66 million on criminal and civil charges alleging that the company marketed the antipsychotic drug, Risperdal, to the elderly, children and mentally-disabled without FDA approval. By also paying large sums to Omnicare Inc., a pharmacy for nursing homes, as well as physicians, Janssen “recklessly put at risk the health of some of the most vulnerable members of our society — including young children, the elderly, and the disabled,” said a U.S. Attorney General.
In its settlement of these charges, Janssen maintains that doing so does not indicate that the company is admitting that it intentionally put patients’ lives in danger. The settlement “is not an admission of any liability or wrongdoing, and the company expressly denies the government’s civil allegations,” Johnson & Johnson said.
Risperdal Gynecomastia Lawsuits Allege Male Breast Growth
Meanwhile, the company is continuing to face mounting charges over Risperdal from male patients who allegedly developed gynecomastia, or male breast growth, following use of the medication.
Risperdal is a drug approved to treat adults and adolescents with schizophrenia, bipolar disorder in adults and children between the ages of 10 and 17, and to reduce irritability in children. Additionally, its off-label uses include the treatment of ADHD, recent research shows.
A growing number of Risperdal gynecomastia lawsuits are being filed against Johnson & Johnson and Janssen, however, in Pennsylvania state court. In October 2012, Bloomberg reported that five cases had been settled by the company after being filed in the Philadelphia Court of Common Pleas.
Research over the past few years has strengthened the link between Risperdal and gynecomastia. According to a study published in 2006 in the Journal of clinical Psychopharmacology, the medication may cause the body to produce high amounts of prolactin, a hormone associated with breast development in boys and lactation in girls. Risperdal gynecomastia lawsuits allege that Johnson & Johnson failed to adequately warn consumers about the potential for its product to cause gynecomastia and other side effects, which may necessitate liposuction and mastectomy procedures to correct.
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