Breast Growth Warnings Delay $2.2 Billion Risperdal Settlement

Earlier this fall, Johnson & Johnson negotiated a Risperdal settlement for an undisclosed sum with 21-year old Aaron Banks. Banks, who began taking the antipsychotic at age nine, developed gynecomastia, or male breast tissue, and held J&J liable for his condition and subsequent psychological trauma.

The Risperdal breast growth lawsuit was earmarked as a bellwether case in Pennsylvania state court but never made it to trial. And now, according to a report in the Wall Street Journal, the Department of Justice (DOJ) is demanding that J&J acknowledge adverse Risperdal side effects, and the drug’s causal link with breast growth in males.

The DOJ’s demands may postpone a $2.2 billion settlement between Risperdal manufacturer J&J and the federal government over illegal marketing of the drug for off-label uses.

At present, J&J faces dozens of product liability claims in state courts alleging Risperdal-induced gynecomastia. Though physically harmless to a male patient, the emotional and psychological consequences of developing breasts can be incredibly damaging. Individuals who’ve taken legal action say that J&J failed to adequately warn about gynecomastia risks, especially in pubescent boys. 

Insufficient warnings about Risperdal and gynecomastia

Risperdal labeling currently warns that unusual breast growth could be a side effect, but those who’ve filed a lawsuit contend that these risks were downplayed by J&J, as the packaging indicated that only 2.3 percent of adolescents in trials experienced breast growth due to increased levels of the hormone prolactin. Research into the side effects of antipsychotic medications has demonstrated that Risperdal disrupts hormonal balances leading to higher rates of male breast enlargement compared to other drugs in its class.

In September 2012, J&J began negotiating Risperdal breast growth lawsuit settlements with at least five plaintiffs who claimed the drug maker concealed its knowledge of severe side effects and promoted its use for unapproved disorders. Risperdal was FDA-approved in 1993 for the treatment of bipolar mania and schizophrenia. Since then it has been used to treat irritability in autistic children and other behavior disorders.

J&J pays kickbacks for off-label Risperdal uses

Johnson & Johnson’s marketing strategies have been under DOJ investigation since the pharmaceutical giant was found offering millions of dollars in kickbacks to push Risperdal use for off-label purposes.

In 2009, Omnicare, which supplies meds to nursing homes, settled with the DOJ for accepting an estimated $50 million in kickbacks for selling Risperdal to doctors in assisted care facilities.

Used as a chemical restraint in the elderly, Risperdal has since been linked to stroke and sudden death in aged patients with dementia. Some 16 deaths and 36 incidents of stroke have been linked to Risperdal use; a study published this year reported a higher rate of ischemic stroke in patients over the age of 64 who are exposed to the drug.

Increased litigation over Risperdal breast growth in boys

Among the 400 Risperdal lawsuits pending against Johnson & Johnson, at least 130 involve gynecomastia. Many of the young male plaintiffs have suffered intense emotional trauma and reduced self-esteem from the condition. Mastectomy and/or liposuction have been necessary to remove abnormal breast tissue in more severe cases.

Those who have filed a Risperdal breast growth lawsuit are requesting monetary damages for hospital expenses, surgical costs, mental anguish and other losses. If J&J concedes to the fact that it hid or downplayed the risks of gynecomastia to appease the DOJ and strengthens side effects warnings, this will have a huge impact on the outcome of future litigation.