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Johnson & Johnson is ordered to pay $70m to boy who developed gynecomastia

BMJ 2016; 354 doi: https://doi.org/10.1136/bmj.i3846 (Published 11 July 2016) Cite this as: BMJ 2016;354:i3846
  1. Owen Dyer
  1. Montreal

Johnson & Johnson’s Janssen Pharmaceuticals division has been ordered by a Pennsylvania court to pay $70m (£54m; €63m) in damages to a young man who developed size 46DD breasts after taking the company’s antipsychotic drug risperidone (which it markets as Risperdal). Andrew Yount, 18, of Tennessee, began taking the drug when he was 5 years old, though it was not approved for use in children.

The jury found that Johnson & Johnson knew that the drug carried a risk of gynecomastia in men and boys but had “intentionally falsified, destroyed, or concealed records” to hide the link.

The company paid more than $2.2bn to US federal and state governments in 2013 to resolve criminal and civil charges of illegally promoting risperidone for unapproved uses, including for dementia in elderly patients in nursing homes and attention deficit disorder in children.1

But the company faces potentially even greater losses to individual plaintiffs. More than 1600 cases are still pending in Pennsylvania state courts, and at least 10 000 more people who took the drug have contacted lawyers across the United States.

To date the company has resisted calls for a global settlement. It has now fought five cases in Pennsylvania’s courts, losing four and achieving a split decision in one.

But the current settlement of $70m dwarfs the previous awards over risperidone, which ranged from $500 000 to $2.5m, and seemed to signal dwindling patience with the company’s litigation strategy.

“The jury got angry at these people—they don’t take responsibility,” said Stephen Sheller, one of Yount’s lawyers, outside the court. Another attorney for Yount, Jason Itkin, said that the verdict “sends a clear message to Johnson & Johnson that they have lost their way.”

Itkin added, “They targeted the most vulnerable among us—children with disabilities—and they sold a medicine that they knew would likely cause patients to become disfigured, and then they went through great lengths to cover their tracks. This verdict is a game changer. There are tens of thousands more cases to be tried in this litigation, and we think this verdict, along with the current track record, shows that Johnson & Johnson is exposed to a huge liability.”

A spokeswoman for the company said in a statement that “we sympathize with the plaintiff in this case and his family” but that the company would appeal, believing that the verdict was “not justified by the evidence” and that the award was “clearly excessive and far out of line with any factual assessment of actual damages.”

She added, “During the trial the jury heard evidence that the FDA approved label properly warned of Risperdal’s potential side effects, that the plaintiff’s physical condition was not caused by using the medication, and that the plaintiff benefited from using Risperdal.”

In 2006 the US Food and Drug Administration added a label to risperidone warning of the risk of gynecomastia.

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