PENNSYLVANIA RECORD

PHILADELPHIA - An Alabama man who developed breasts while using the antipsychotic drug Risperdal has been awarded a $2.5 million verdict by a Philadelphia Court of Common Pleas jury that decided against defendant Janssen Pharmaceuticals Tuesday afternoon.

Austin Pledger's suit is the first to go trial involving cases of gynecomastia manifesting in male users of Risperdal.

According to court testimony, Pledger's mother had asked their family doctor in 2002 for help with her autistic son's mood swings.

The drug would not be approved by the Food and Drug Administration for use in adolescents with autism until 2006, but the doctor told juries that a Janssen sales rep aggressively recommended prescribing Risperdal for such cases.

Witnesses testified that Janssen did not adequately provide warnings of the potential side effect of gynecomastia when pushing the prescription of the drug for off-label uses.

In November 2013, Johnson & Johnson, Janssen's parent company, agreed to pay more than $2.2 billion to resolve civil and criminal claims relating to allegations that the company marketed Risperdal or uses other than those approved by the FDA.

In the civil action, the government alleged that Janssen and J&J promoted Risperdal for uses that were not approved as safe and effective by the FDA from at least 1999 through 2005. The suit said that the defendants even established a specialized ElderCare sales force to promote Risperdal to older folks.

“This sales force promoted Risperdal in nursing homes to control agitation, aggression, and other behavioral disturbances in elderly dementia patients,” the government’s suit reads.

Janssen, the complaint stated, promoted Risperdal to control behavioral disturbances and conduct disorders in children and to treat attention deficit disorder and other off-label conditions. The government also maintained that Janssen promoted Risperdal for use in the general population to control mood and anxiety symptoms unrelated to any psychotic disorder.

Tuesday's jury award is for compensatory damages toward Pledger, who developed size 46 DD breasts as a teenager. Pennsylvania Supreme Court Justice Arnold New ruled in June 2014 that punitive damages would be prohibited in Risperdal cases. According to his published opinion, Janssen developed the marketing for the drug at the companies' New Jersey facilities, making it eligible for coverage under the state's Product Liability Act.

Pledger's complaint is one of thousands filed against Janssen in relation to the side effects of Risperdal. In Philadelphia, the 987 lawsuits logged at the Court of Common Pleas' Complex Litigation Center in 2014 eclipse the total number of all mass tort filings in 2013.