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Once again, Johnson & Johnson has lost litigation trial in which a young man successfully claimed the company failed to warn that its Risperdal antipsychotic could cause him to grow breasts. A Pennsylvania state court jury late last week ordered the company to pay $500,000 to a Wisconsin man who developed breasts when he was 12 years old while taking the drug.

The health care giant has now lost all four trials in which its drug caused gynecomastia, which is typically caused by an imbalance of estrogen and testosterone. In three of the four verdicts, compensatory damages were awarded. In one trial, a jury found J&J failed to warn of the risks, but did not award punitive damages because a direct link between breast growth and Risperdal was not established.

The cases have drawn attention for a few reasons. For one, the trials have served as a reminder that J&J paid $2.2 billion nearly three years ago to resolve criminal and civil allegations of illegally marketing Risperdal to children and the elderly. Along with a manufacturing scandal involving recalls of countless over-the-counter medicines, the Risperdal episode sullied the company’s well-honed reputation.


In addition, former Food and Drug Administration commissioner David Kessler served as a paid expert witness in the first trial. He testified that J&J knew about the risks associated with Risperdal, but failed to disclose the data showing the extent to which youngsters may develop gynecomastia. In a report prepared for a 2012 case that was settled, Kessler wrote J&J had violated the law (you can read the report here, here, here and here).

When asked whether J&J plans to appeal the latest verdict, a spokeswoman wrote us that the company is considering its options.


“This is the worst of all worlds for J&J,” said Thomas Kline, an attorney who represented the Wisconsin man in the latest trial. “The company has now lost four failure-to-warn cases in a row. But the first three losses involved very significant disfigurement, and this latest case involved less disfigurement. These findings don’t bode well for the company.”

The health care giant faces approximately 8,000 such lawsuits filed in state and federal courts around the country, but whether this string of losses will prompt settlement negotiations is unclear.

On the one hand, the negative publicity surrounding the side effect attributed to Risperdal is clearly a liability. But J&J also follows a typical pharmaceutical playbook of fighting product-liability lawsuits, at least until a clear pattern is established. One expert says that it is probably too soon for the company to pursue a far-reaching settlement.

“J&J has not compiled a good track record … so far in the Risperdal trials, but relatively few cases have been tried to date,” said Carl Tobias, a professor at the University of Richmond law school, who tracks pharmaceutical industry litigation. “My sense is that J&J may be willing to have several more trials to see whether it can win some before it seriously considers the prospect of settling a number of cases.”