Johnson & Johnson ($JNJ) is fighting more than 1,500 legal claims that its antipsychotic Risperdal triggered breast development in boys, and the company has landed on the wrong side of a jury verdict in several of them so far.
The same thing happened Friday in a Philadelphia court. The difference, this time, is that the jury smacked J&J with a $70 million damages award--many times larger than previous awards in similar cases.
In the first of these cases to go to trial, a jury handed $2.5 million to the plaintiff, a teenager who had developed 46DD breasts after taking Risperdal. Another verdict, last November, included $1.75 million in damages.
First-to-trial "bellwether" cases are closely watched as indicators of a potential settlement--or lack of one. Because of its size, this latest verdict could increase the pressure on J&J to come to an agreement with the rest of the plaintiffs.
But J&J, for its part, says it will challenge the award.
“We believe this 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,” Janssen, the J&J subsidiary that makes Risperdal, said in an emailed statement.
The plaintiff's lawyers in this latest case aren't counting on a settlement, either. "So far J&J seems intent on trying these cases and remains tone deaf to the clear reactions of the juries when presented with the truth," said Jamie Sheller of Sheller P.C., which represents the anonymous teen plaintiff, referred to as A.Y. in court documents.
The claims in these cases are similar: The male plaintiffs say they developed breasts, a condition called gynecomastia, after using the J&J antipsychotic as boys. J&J knew for years that the drug could cause gynecomastia, the plaintiffs say, but kept the data to itself rather than telling the FDA. The agency added a warning about the condition to Risperdal's official label in 2006.
In one case, a Philadelphia jury decided that J&J had failed to warn doctors that the drug could cause boys to develop breasts, but also determined that the plaintiff didn’t prove his gynecomastia was caused by Risperdal.
J&J has traveled a long legal road with the antipsychotic drug, which once brought in billions in annual branded sales but has since gone generic. In 2013, the company agreed to shell out $2.2 billion to settle off-label marketing allegations by the Justice Department and several U.S. states over claims that J&J pushed the drug for use in children and teens before the FDA approved pediatric indications.
The drugmaker also settled marketing claims with 36 states and the District of Columbia over Risperdal marketing for more than $180 million, plus another settlement in Texas for $158 million. Earlier this year, the U.S. Supreme Court declined to take up J&J’s final appeal of a $124 million penalty for Risperdal marketing in South Carolina.
The South Carolina decision survived that state's top court in a ruling last year, in which Justice John Kittredge backed the decision at trial but lowered the $327 million penalty to $136 million. The fine was later lowered again to the final $124 million.
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