Earlier this month, a Philadelphia jury ordered Johnson & Johnson (J&J) and its subsidiary Janssen Pharmaceuticals to pay a Tennessee man and his family $70 million over side effects caused by popular antipsychotic Risperdal.
The plaintiff took Risperdal as a child to treat a behavioral disorder, but the drug caused him to develop a condition called gynecomastia, which is the growth of female breast tissue in males. The jury found J&J and Janssen negligent in failing to warn patients and doctors of the risks associated with the drug.
After the multimillion-dollar verdict, attorneys for J&J and Janssen filed a post-trial motion requesting either a new trial or a reversal of the verdict on the grounds that plaintiffs had been allowed to present irrelevant and prejudicial evidence.
One such piece of evidence was the taped testimony of former FDA Commissioner David Kessler. Mr. Kessler had testified in previous Risperdal trials that J&J and Janssen intentionally obscured clinical trial data presented to the FDA to deemphasize the link between Risperdal and gynecomastia. Internal emails from Janssen support Mr. Kessler’s testimony that the company knew about the increased risk of developing gynecomastia, but withheld this information from the FDA.
The defense also took issue with the charge that J&J and Janssen has committed fraud by marketing Risperdal for off-label uses of the drug in children. This is surprising considering J&J agreed to pay the U.S. Justice Department a whopping $2.2 billion in 2013 for just that reason – to settle criminal claims that the company illegally marketed Risperdal for use in children and the elderly.
The judge presiding over the case found the defense’s arguments inadequate, and outright rejected the request for a new trial or reversed verdict. The rejection is likely devastating for J&J and Janssen, currently facing more than 1,700 additional lawsuits in the Risperdal litigation. While the companies will continue to fight these lawsuits asserting they are guilty of no wrongdoing, they certainly have a lot to answer for.