"The promotion of non-approved uses by a manufacturer, because it undercuts the system and safeguards of drug regulation, is concerning," wrote Kessler, a pediatrician and lawyer who headed the FDA from 2000 to 2007. "The promotion of non-approved uses by a manufacturer of powerful drugs is more concerning. The promotion of non-approved uses in the most vulnerable children of powerful drugs is most concerning. Janssen's promotion of Risperdal, a powerful drug, for non-approved uses in the most vulnerable children is deeply troubling."
All the cases resolved Thursday involved boys or men who had been prescribed Risperdal and grew breasts in their youth.
There are more than 400 individual Risperdal lawsuits pending around the country, with more than 80 filed in Philadelphia. Thursday's settlement might lead to settlements in some of those.
J&J, based in New Brunswick, N.J., with divisions in the Philadelphia region, is in litigation on several levels. Though appeals are pending, it has lost cases in Louisiana ($258 million), South Carolina ($327 million), and Arkansas ($1.2 billion) in which the company was alleged to have promoted Risperdal inappropriately through taxpayer-funded Medicaid systems. J&J won its Pennsylvania case. After six days of trial testimony, it paid $158 million to settle in Texas.
The company also is negotiating with the federal government on a case, with reports suggesting that J&J might pay more than $2 billion. Previously, the company agreed to pay $181 million to settle similar litigation with 36 states.
"It's a sad commentary with what goes on with our prescription drugs," said Stephen Sheller, whose Philadelphia law firm has been involved in many of the local cases. "The community of medical professionals such as psychiatrists and child psychiatrists needs to reexamine their use of these drugs. I filed a petition with the FDA to revoke the approval of Risperdal for children."
The FDA first approved Risperdal in 1993 for adults suffering from schizophrenia and bipolar disorder; there was no approval for use in children until 2006. Doctors can prescribe any drug but the maker can promote it only for uses approved by the FDA.
"During the time that it was actively promoted, our company policy was to promote Risperdal for its FDA-approved indication," a Janssen spokeswoman said in a statement. "Since the early 1990s, Risperdal has improved the lives of countless people throughout the world who suffer from the devastating effects of serious mental illness."
On Thursday morning, there was activity in two of the cases at City Hall.
On the sixth floor, lawyer Brian McCormick, who was guiding Donna Barney's suit on behalf of her son, met with J&J lawyers and Judge Norman Ackerman to finalize the settlement. Afterward, Barney described her son, one of 11 foster children she has raised, as an excellent student, "but the problem is with the bullying and being tormented."
Four floors below, Judge Mark Bernstein delayed the resumption of a different trial, which began Sept. 24. Once the deal was done, Bernstein brought the jury into court, thanked them for their service, and explained that this case, like about 95 percent of the thousands of suits flowing through the court, had ended with a negotiated settlement.
Jennie Rolen, mother of the boy involved in Bernstein's trial, declined comment.
J&J lawyers had objected to Kessler's being added to the witness list in the Barney case, and his report makes clear why. He wrote that his fellow doctors were naive and unduly swayed by drug-company promotional messages, including those spread through supposedly neutral continuing-education events and through written material generated by the company. Instead of trying to skirt FDA rules, he wrote, drug companies should do more than laws require.
"A drug company," Kessler wrote, "has a responsibility, independent of what FDA directs it to do, to alert physicians and patients to the risks that were unknown to or poorly understood by the FDA, but were known to the company."
Contact David Sell at 215-854-4506 or firstname.lastname@example.org, or follow on Twitter @phillypharma. Read his blog at www.philly.com/phillypharma.