RISPERDAL

Risperdal is the brand name for risperidone, an atypical or “second generation” antipsychotic drug prescribed to treat schizophrenia and other manifestations of psychotic disorders. Defendants named in the consolidated litigation are the designers, developers, manufacturers, marketers, advertisers, distributors and/or sellers of the drug, including Johnson & Johnson (“J&J”) and its subsidiary, Janssen Pharmaceutica (“Janssen,” and together, “Defendants”). 

The exact mechanism of action of risperidone is not known, but, like other anti-psychotics, it is believed that risperidone affects the way the brain works by interfering with communication among the brain's nerves. Nerves communicate with each other by making and releasing chemicals called neurotransmitters. The neurotransmitters travel to other nearby nerves where they attach to receptors on the nerves. The attachment of the neurotransmitters either stimulates or inhibits the function of the nearby nerves. Risperidone blocks several of the receptors on nerves, including dopamine type 2, serotonin type 2, and alpha 2 adrenergic receptors. It is believed that many psychotic illnesses are caused by abnormal communication among nerves in the brain and that by altering communication through neurotransmitters, risperidone can alter the psychotic state.

On December 29, 1993, the FDA approved Janssen’s New Drug Application for Risperdal as a prescription drug used for the treatment of adults suffering from schizophrenia. In 2006, the FDA approved the use of Risperdal in children, specifically for the treatment of irritability associated with autistic disorders. The product label was also changed to state that Risperdal was “associated with higher levels of prolactin elevation than other antipsychotic agents.” Then, in 2007, FDA once more expanded the approved use of Risperdal to treat schizophrenia in adolescents ages 13-17, and for the short-term treatment of manic or mixed episodes of bipolar I disorder for children ages 10 to 17.

In addition to prescribing Risperdal in accordance with FDA approval, Defendants also promoted the drug’s off-label use. From the late 1990s and early 2000s, Janssen and J&J endorsed its product as a cure for stuttering, Tourette's syndrome, obsessive-compulsive disorder, attention deficit hyperactivity disorder (ADHD), OCD, anxiety, sleep difficulties, dementia, anger management, and depression. This was done despite the lack of FDA approval for use with children or adolescents for any purpose until 2006 and generic usage not beginning until approximately 2008. 

Risperdal has been linked to several serious side effects, most notably gynecomastia, the development of male breasts. This is because the drug has been found to increase a hormone called prolactin. Prolactin is a peptide hormone produced by the anterior pituitary gland that is primarily associated with lactation and plays a vital role in breast development. Gynecomastia has been reported in 2.3% of Risperdal treated patients.

Many young boys with Risperdal-associated gynecomastia undergo breast reduction and even mastectomies to correct the problem. Other side effects include lactation in girls who are not of child-bearing age and of women who are not pregnant or nursing has been seen with Risperdal use, Akathesia (restlessness), Akinesia (inability to move or hesitational movement), Tardive Dyskinesia (abnormal movement of face, shoulders, arms and legs), Parkinson’s like tremor, and Torticolis (stiffening of the tongue, which may cause difficulty breathing).

In 2006, the Journal of Clinical Psychopharmacology in 2006 found that 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.” The study also indicated that because the long-term effects of Risperdal were not well documented with particular regard to growth and a delay in puberty, and provided that the drug should be prescribed with caution to children and adolescents.

The Journal of Clinical Psychiatry also found that over 90% of Risperdal users have elevated prolactin levels at some point during treatment.

In 2013, Johnson & Johnson agreed to pay up to $2.2 billion to settle a decade-long investigation into illegal promotion of Risperdal between 1999 and 2005. The settlement, which was split between the federal government and multiple states, was the largest of its kind in U.S. history. Although the settlement did not require Johnson & Johnson to admit wrongdoing against pediatric patients, it brought attention to questionable sales and marketing practices.  At the heart of the investigation were claims that the company used aggressive marketing to get doctors to prescribe Risperdal to elderly dementia patients and children with disabilities. In particular, state and federal attorney generals alleged that Johnson & Johnson promoted Risperdal for pediatric use as early as 1994 despite not receiving approval for any Risperdal childhood use until 2006. They also claimed the company specifically disregarded FDA warnings not to promote the antipsychotic for childhood use.

Today, the Risperdal franchise, including a related medication Invega (paloperidone) continues to have combined sales of over $3 billion per year and Risperdal is estimated to have made about $40 billion for its maker Janssen Pharmaceuticals. 

Plaintiffs in these litigations allege that J&J/Janssen was aware of the known health risks to children and adolescents while marketing this drug, including for off-label usage. Further, Plaintiffs claim that J&J/Janssen was aware of various studies showing that Risperdal patients had significantly elevated prolactin levels.

Despite such knowledge, Plaintiffs argue that J&J/Janssen continued to actively market the drug to children and adolescents and failed to warn of the likelihood of gynecomastia as a serious side effect.