J&J awaits jury verdict over Risperdal patient's breast development

Did Johnson & Johnson ($JNJ) hide Risperdal's potential to trigger breast growth in boys? Or did the drugmaker adequately disclose the potential side effect? A Philadelphia jury is literally out deliberating on these two questions.

After a trial lasting almost a month, lawyers for both sides summed up their arguments Friday. On the one side is a young man who developed breasts--size 46DD, according to Bloomberg--while taking J&J's antipsychotic drug. His attorneys argue that J&J's own data shows that the company knew about the risk, but didn't warn doctors or patients for years.

"When a pharmaceutical company is acting reasonably and prudently they investigate it, they report it, they tell the FDA, they tell the world," said the plaintiff's lawyer, Thomas Kline of Kline & Specter, as quoted by The Legal Intelligencer. "Nobody knew all this risk, except the insiders."

On the other is J&J's Janssen unit and its Risperdal brand, one of the company's top-selling drugs for years before it lost patent protection in 2012. Janssen's lawyers say the company's warnings were on the up-and-up and that the plaintiffs haven't proven Risperdal caused the young man's breast development.

The plaintiff's case represents "the height of cherry-picking" of scientific data, Janssen lawyer Diane Sullivan said during closing arguments. Sullivan also tried to discredit the plaintiffs' expert witnesses--including former FDA commissioner David Kessler--by calling them "regulars on the litigation circuit."

It's just one of some 1,250 similar lawsuits pending against J&J, which has already settled thousands of claims that Risperdal caused weight gain and diabetes. The company has also been fighting state court lawsuits alleging that J&J committed fraud when marketing Risperdal.

In 2013, J&J pleaded guilty to a misdemeanor violation of the Food, Drug and Cosmetic Act and agreed to pay $2.2 billion to settle off-label marketing allegations leveled by whistleblowers and backed by the U.S. Justice Department. According to the settlement, J&J allegedly pushed Risperdal to treat children and adolescents years before the drug was approved for pediatric use.

In addition to the $2.2 billion settlement J&J made in the federal whistleblower lawsuit, it also settled off-label marketing claims with 36 states and the District of Columbia over the marketing of Risperdal that topped $180 million--then with Texas for $158 million more.

J&J has also successfully fought off some verdicts, though. J&J lost a $1.2 billion verdict in Arkansas over similar claims, but the Arkansas Supreme Court tossed out the verdict. J&J also deflected a $257 million award in Louisiana after convincing the top court in that state that its marketing had not violated a state law.

- read The Legal Intelligencer article
- get more from Bloomberg

Special Report: Pharma's Top 11 Marketing Settlements

Suggested Articles

The company will commit $300 million over the next five years to hire more people of color and increase clinical trial diversity.

Moderna, after tapping almost $1 billion in federal funding, agreed to deliver 100 million doses of its vaccine candidate for up to $1.5 billion.

FDA advisors will question the clinical data and manufacturing for Mesoblast's Ryoncil, a cell therapy for pediatric acute graft vs. host disease.