Johnson & Johnson, which paid more than $2 billion to resolve a criminal probe over its antipsychotic drug Risperdal, knew the medicine caused boys to develop female breasts and failed to alert regulators, doctors and patients, a lawyer argued.
J&J kept quiet about research showing Risperdal caused abnormal breast development in boys to protect billions of dollars in sales of the drug, an attorney for the parents of an autistic man who developed size 46 DD breasts while on the medicine told a jury Friday. J&J misled the U.S. Food and Drug Administration about the antipsychotic’s safety, he added.
“All of you know something the FDA still doesn’t know and that is the increased statistical risk of kids on Risperdal” developing abnormal breasts, the lawyer, Thomas Kline, told jurors during closing statements at a Philadelphia trial over the drugmaker’s handling of the product.
J&J, based in New Brunswick, New Jersey, faces more than 1,000 cases over the Risperdal side effect in state court in Philadelphia. The current case is the first in which a jury will decide whether J&J and its Janssen unit are liable for mishandling the medicine.
In 2012, the company settled the first case to go to trial in Philadelphia over claims Risperdal caused gynecomastia, or abnormal breast development, and has settled at least five other cases over allegations involving the drug.
A lawyer for J&J and Janssen countered in her closing statement that the companies’ executives properly warned patients, doctors and health regulators about Risperdal’s risks and didn’t illegally market the drug.
Diane Sullivan, the drugmakers’ attorney, said Kline hadn’t produced sufficient evidence to conclusively prove Risperdal caused gynecomastia in boys.
“They don’t have the science. They don’t have the evidence to support this case,” Sullivan said. “You don’t stay in business as long as Janssen has without doing medicine the right way.”
Risperdal also has been linked to excessive weight gain and diabetes. The drug, once J&J’s biggest seller, generated worldwide sales of $24.2 billion from 2003 to 2010, reaching $4.5 billion in 2007. After that, J&J lost patent protection and sales declined.
In 2013, J&J agreed to pay $2.2 billion to resolve criminal and civil probes into allegations that it illegally marketed the drug to children and the elderly. The settlement, which also includes marketing claims about two other J&J drugs, was one of the largest U.S. health-fraud penalties in history.
The accord resolved probes by federal officials and attorneys general in 45 states into allegations the company marketed the drug for unapproved uses. While doctors may prescribe an approved drug for any reason, companies can market them only for purposes authorized by the FDA.
During the almost month-long trial, jurors heard testimony from former FDA Commissioner David Kessler, who said Janssen funded a 2001 study that showed about 4 percent of boys given Risperdal developed abnormal breasts that were “probably or very likely” caused by the drug.
J&J didn’t include that information in any safety label until 2006, when the drug was approved for use in children, even though doctors had been writing off-label prescriptions of the medication for children for at least five years, Kessler added.
Although doctors may prescribe drugs for uses not approved as safe and effective by government regulators, companies are forbidden to market them for off-label uses.
Sullivan sought to paint Kessler as a “hired gun” for consumers suing the company over Risperdal since he left government service in 1997.
Lawyers for the 20-year-old Alabama man who developed female breasts while taking Risperdal contend his doctor would have never prescribed the antipsychotic drug if J&J had disclosed the risks of the side effect.
“All they had to do was tell the truth,” Kline said. “It’s so unfair and so tragic when all they had to do was do the right thing.”
The man’s lawyers are seeking damages for disfigurement and emotional distress tied to dealing with the abnormal breasts, according to court filings. The family was barred in a pretrial ruling last year from seeking punitive damages.
The case is PP v. Ortho-McNeil Janssen Pharmaceuticals, 120401997, Court of Common Pleas Philadelphia County (Philadelphia).