Supreme Court Rejects Janssen’s Appeal of Risperdal Penalty

Company improperly marketed antipsychotic drug

The U.S. Supreme Court has declined to hear an appeal from Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, of a $124 million penalty imposed by South Carolina after a jury found that the company had improperly marketed the antipsychotic medication risperidone (Risperdal) and had concealed its risks, according to a Reuters report.

The court’s decision not to hear the appeal filed by Janssen means a South Carolina Supreme Court ruling from June 2015 that reduced the penalty to $124 million from $327 million remains intact. Janssen’s lawyers claimed that, among others things, the award violated the prohibition on “excessive fines” under the U.S. Constitution’s Eighth Amendment.

South Carolina filed its complaint in April 2007, seeking civil penalties on two claims. The first claim arose from the content of the written material of risperidone prescriptions since 1994. The second centered on alleged false information contained in a 2003 letter Janssen sent to South Carolina’s prescribing physicians.

Risperidone, launched in 1994, is currently indicated as a treatment for schizophrenia; as monotherapy or adjunctive therapy with lithium or valproate for the treatment of acute manic or mixed episodes associated with bipolar I disorder; and as a treatment for irritability associated with autistic disorder. The drug and other antipsychotic medications have been associated with adverse effects such as strokes, diabetes, and weight gain.

In February 2015, a jury in Philadelphia, Pennsylvania, decided that Johnson & Johnson must pay $2.5 million in damages for failing to warn that risperidone could cause gynecomastia in males. The lawsuit was brought by the family of an autistic boy who took the drug in 2002 and later developed size 46 DD breasts, according to a lawyer for the family.

It was the first lawsuit to go to trial claiming that the company hid the risks of gynecomastia; a handful of cases were settled out of court in previous years. The trial also served as a reminder that J&J had paid $2.2 billion in 2013 to resolve criminal and civil allegations of illegally marketing risperidone to children and the elderly.

Sources: Reuters; July 11, 2016; and Wall Street Journal; February 24, 2015.