In August of 2012, Johnson & Johnson paid a $181 million multi-state consumer protection settlement to resolve charges that the company marketed its antipsychotic drug Risperdal for off-label uses. In November of 2013, J&J paid $2.2 billion to resolve False Claims Act allegations related to misbranding of a number of drugs, including Risperdal. In the past month, the company faced two further blows related to Risperdal. A Philadelphia jury awarded $2.5 million to the plaintiff over J&J’s “failure to warn” about Risperdal side effects. This was the first such case to be heard by a jury, though hundreds of cases are pending in Philadelphia alone. The next day, the company was also ordered to pay $136 million to South Carolina under the state’s Unfair Trade Practices Act.
2.2 Billion Settlement
One of the chief complaints the DOJ raised in its 2013 settlement press release was related to how J&J subsidiary, Janssen, marketed Risperdal off-label in terms of patient population. “The complaint alleges that J&J and Janssen knew that Risperdal posed certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production,” stated the Department of Justice.
“Nonetheless…Janssen instructed its sales representatives to call on child psychiatrists, as well as mental health facilities that primarily treated children, and to market Risperdal as safe and effective for symptoms of various childhood disorders, such as attention deficit hyperactivity disorder, oppositional defiant disorder, obsessive-compulsive disorder and autism.”
Risperdal Side Effects Litigation
Risperdal was approved by the FDA in 1993 for use by adults with schizophrenia, and approved for the treatment of irritability in autism in children in 2006. However, Janssen sales representatives had already begun marketing to pediatricians before 2006, and allegedly knew about certain safety risks associated, including gynecomastia, or abnormal breast growth in young men.
In 2012, Johnson and Johnson settled the first case to go to trial in Philadelphia over claims Risperdal caused gynecomastia and has settled at least five other cases over allegations involving the drug.
In late February, J&J faced its first jury verdict regarding the side effect. The plaintiff, Austin Pledger, took Risperdal for behavioral symptoms related to autism and claimed to have developed gynecomastia from taking the drug. Jurors found the company negligent for failing to warn of the potential for gynecomastia, and awarded the plaintiff $2.5 million in damages.
“The jury in Philadelphia heard evidence that was never presented to the FDA by an American drug company,” said Philadelphia lawyer Thomas Kline, who represented the plaintiff. “If there was ever a clear failure-to-warn case, this was it.” (Philly.com)
What about the patient’s doctor? Pledger’s doctor, Jan Mathisen, testified that he was unaware of Jannsen’s study that suggested gynecomastia could result from use of the drug. When the drug was approved for children with autism disorder in 2006, he said that he did not read the entire revised label and would have wanted someone to tell him of the increased risk. He said many doctors were in the same boat.
Janssen attorney Diane Sullivan stressed that the company’s label did in fact adequately convey the risks of using the drug, despite the fact that the doctor claimed not to have seen them.
Former FDA Commissioner David Kessler—the plaintiff’s “star witness”—testified that Janssen did not do enough to warn patients, doctors, and the FDA when one of its own studies showed higher levels of the hormone prolactin, which can lead to gynecomastia. “If somebody is sending a sales rep into a doctor’s office, into a pediatric neurologist’s office, and doing it multiple times, you have an obligation to provide adequate direction,” Kessler said. “Tell the good. Tell the bad.”
The case is PP v. Ortho-McNeil Janssen Pharmaceuticals, 120401997, Court of Common Pleas Philadelphia County (Philadelphia).
South Carolina Supreme Court affirms $136 million award
Just a day after the Philadelphia jury award, the South Carolina Supreme Court affirmed a previous verdict against J & J under the Attorney General’s Unfair Trade Practices Act for “willfully failing to disclose known risks and side effects associated with Risperdal.” Though the original award of $256 million was reduced by the South Carolina Supreme Court to $136 million due to certain Statute of Limitation considerations, the amount is close to the entire 36 states consumer protection settlement three years ago related to Risperdal.
Bloomberg notes that the “ruling conflicts with decisions by two other state’s high courts. Last year, J&J persuaded supreme courts in Arkansas and Louisiana to throw out awards totaling $1.5 billion over deceptive-marketing claims tied to Risperdal.”
South Carolina alleged that J&J hid Risperdal’s safety and effectiveness information from doctors. But “[s]imilar arguments were made in cases filed by the states of Arkansas and Louisiana,” noted the Bloomberg writeup. “The Louisiana Supreme Court tossed out a $257.7 million award from 2010” [and] the “outcome was the same in Arkansas, where the state’s highest court wiped out a $1.2 billion award over Janssen’s marketing tactics.”
—-
The continuous Risperdal litigation shows that even a multi-billion dollar settlement is sometimes not the end of the road for manufacturers, even in the case of Risperdal, which continues to be an important treatment for schizophrenia, bipolar disorder, and symptoms of autism. It will be interesting to see what effect the plaintiff victory in Philadelphia will have on future damages cases going forward. It will also be important to keep an eye on various states bringing off-label marketing cases under their unfair trade statutes.