n a blow to Johnson & Johnson, the company was ordered last Friday to pay $70 million to a male Tennessee teenager who claimed its Risperdal antipsychotic pill caused him to grow enlarged breasts. The finding by a Pennsylvania state court jury was not only the latest, but it is the biggest defeat to date in what has become another sprawling litigation over the drug.
In reaching its decision, the jury found that J&J failed to properly warn Risperdal could cause gynecomastia, which is the abnormal development of large mammary glands in males. Moreover, the jury also determined that the company “intentionally falsified, destroyed, or concealed records” that Risperdal could cause boys to develop breasts.
Last week’s verdict, which only included compensatory damages, dwarfs the $2.5 million that was awarded last year to an Alabama man, who sued J&J after he developed size 46 DD breasts. The latest case was brought by Andrew Yount, who was born in 1998, and was given Risperdal in 2003 to treat a psychiatric problem, according to one of his attorneys.
“This verdict will help thousands of children, and boys and their families be made aware of the dangers of this drug,” said Stephen Sheller, an attorney who represented the Tennessee teenager and has filed more than 1,500 lawsuits of an estimated 10,000 such cases against J&J in mostly state courts around the country.
The cases have garnered attention for a couple of reasons. For one, J&J has a bad track record when it comes to marketing Risperdal, which was first approved in 2002 to treat schizophrenia.
In 2013, the company paid more than $2.2 billion to resolve criminal and civil charges of illegally promoting the drug for unapproved uses, such as to combat dementia in elderly nursing home patients and to help children cope with attention deficit disorder, among other things. However, until late 2006, Risperdal was not approved for children for any reason and the US Food and Drug Administration had repeatedly warned the company about its marketing.
Moreover, former FDA commissioner David Kessler served as a paid expert witness for the plaintiffs’ attorneys and he testified J&J knew about the risks associated with Risperdal, but failed to disclose the data showing the extent to which youngsters may develop gynecomastia.
And in a report prepared for a 2012 case that was settled, Kessler wrote that J&J’s Janssen Pharmaceuticals unit, which marketed the drug, had violated the law (you can read the report here, here, here and here). For this reason, Sheller maintained that federal authorities should take further action against the company.
A J&J spokeswoman sent us a note saying the company sympathizes with the teen and his family, but believes the verdict “is not justified by the evidence, and that the award is clearly excessive and far out of line with any factual assessment of actual damages.” She noted that J&J argued the product labeling warned of the risk and that the teen’s breasts were not caused by the drug. She added that J&J may appeal the decision.
So far, J&J has lost four trials in which Risperdal, one of its biggest-selling drugs, was blamed for gynecomastia. Another case ended in a split decision — a state court jury decided there was not enough evidence to determine whether the drug caused a male teenager to develop breasts, but did agree that J&J failed to provide adequate warnings that Risperdal could cause boys to develop enlarged breasts.
Two more lawsuits are scheduled to go to trial later this month — one in state court in Pennsylvania and another in state court in California. Whether the company will be inspired to begin settlement talks is unclear. J&J did settle nearly 80 cases in the fall of 2012, shortly before the first such trial over gynecomastia was scheduled to begin.
“They have to be concerned with a jury verdict that large, along with the other losses,” said Carl Tobias, a professor at the University of Richmond law school, who tracks pharmaceutical industry litigation. “This only gives plaintiffs and their lawyers more encouragement to keep going and file more suits. And it seems there are a fair number of cases out there that they could lose.”
There is another issue in play, which is the venerable J&J reputation. The health care giant has portrayed itself as a trustworthy corporate brand, but has endured several episodes that have sullied its well-honed image. These include a manufacturing scandal involving recalls of countless over-the-counter medicines, such as Tylenol, and more than 1,000 lawsuits alleging J&J failed to warn — especially African-American women — that its talcum powder may cause ovarian cancer.
“The auto industry reached big settlements over liability and to some extent, these are a function of big public relations concerns,” Tobias continued. “J&J capitalizes on being a company that people are confident in and think they have to be worried about their reputation, which might lead them to settle, as well. These cases can take on a life of their own.”