First Risperdal Trial Ends With Settlement

Amaris Elliott-Engel

2012-10-05 12:00:00 AM

The first trial in which evidence was taken in the mass tort litigation over Risperdal, the antipsychotic drug that plaintiffs have claimed causes males to grow breasts, was settled as part of a group of five cases that resolved this week for undisclosed amounts, according to the plaintiffs' lawyers and a statement from the drugmakers.

The case of A.B. v. Janssen Pharmaceuticals was in its second week of trial before Philadelphia Court of Common Pleas Judge Mark I. Bernstein. A staffer in Bernstein's chambers confirmed the settlement.

Plaintiffs co-counsel were Sheller P.C. of Philadelphia and Robert Hilliard of Hilliard Muñoz Gonzales in Corpus Christi, Texas.

Hilliard said it was in the best interest of their client to settle because the client needs surgery right away.

Defense counsel for that case was Laura H. Smith of Friday Eldredge & Clark in Arkansas and Drinker Biddle & Reath.

A jury was set to be picked Thursday in another case in front of Senior Judge Norman Ackerman that settled as part of the group of five and was going to be tried by Brian J. McCormick Jr. and Claudine Q. Homolash of Sheller P.C.

The first Risperdal case in Philadelphia to resolve settled after a jury was selected. Three of the six cases to be tried were chosen by plaintiffs, and three were picked by the defense, Stephen A. Sheller of Sheller P.C. said.

The maker of Risperdal, Janssen, is a Johnson & Johnson subsidiary.

"These cases do not settle for low numbers," Sheller said.

"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," Janssen said in a statement.

As of September 2, there were 86 Risperdal cases pending in the Philadelphia Court of Common Pleas, according to court statistics.

Sheller said that his firm has closer to 200 cases total of boys who allegedly grew breasts, or developed pituitary tumors or movement disorders.

The Risperdal litigation involves several novel legal issues.

Plaintiffs counsel are advancing the theory that Risperdal was negligently designed. The trial in A.B. did not get to that issue.

The Pennsylvania Superior Court ruled that drugmakers can be sued for the negligent design defect of their drugs. The case was taken up by the state Supreme Court, where the matter is pending, with oral arguments having taken place in September 2011.

Risperdal is not a biological drug for which no other design was possible, Sheller argued, and the design defect — that Risperdal raised the level of the hormone prolactin and led to the growth of female breasts in boys — could have been corrected. Other drugs in the same class as Risperdal do not cause abnormal levels of the hormone, Sheller argued.

"This product is by far the worst product that raised prolactin," he said.

According to Janssen, the FDA-approved prescribing information for Risperdal does state that the drug elevates the blood levels of prolactin, including with the side effect of males developing breasts and that 2.3 percent of 1,885 children and adolescents with autistic disorder or other psychiatric disorders had the male development of breasts in clinical trials.

"This medication is well supported by more than 20 years of extensive research and clinical studies that demonstrate its strong efficacy and safety profile," Teresa Mueller, a spokeswoman for Janssen, said in an email.

Another legal issue is whether Excerpta Medica, which organized continuing medical education regarding Risperdal and which the plaintiffs' lawyers say misrepresented the benefits and risks of Risperdal for children, including allegedly through ghostwritten materials, could face liability.

Sheller said he is not aware of another case in which such a medical communications company has faced liability.

The plaintiffs are planning on appealing the summary judgment entered in favor of Excerpta Medica, Sheller said.

Excerpta Medica's attorney, Stephen J. Imbriglia of Gibbons P.C., could not be reached immediately for comment.

Another legal issue is whether J&J CEO Alex Gorsky must testify regarding his role in the Risperdal marketing strategy.

Gorsky was subpoenaed to appear in three cases, McCormick said. Judge George W. Overton, who was to preside over the first case to settle, never ruled on the motion because the case settled, and Judge Arnold L. New, who supervises the court's mass torts program, ruled regarding Bernstein's and Ackerman's trials that Gorsky did not have to appear, McCormick said.

Gorsky has been named as an individual defendant in one Texas Risperdal case they just filed, Hilliard said.

Hilliard said that both sets of lawyers were able to talk to the jury in A.B. after the settlement, which came while the case was still in the middle of the plaintiff's presentation of evidence.

Hilliard said that some of the jurors told them it was clear that there was off-label marketing of Risperdal, that they were willing to consider a large award, and that it was "about money for the company."

Texas law allows punitive damages regarding children's injuries if the defendant's conduct involved a potential criminal offense, and plaintiffs' counsel argue that off-label marketing is a criminal offense, Sheller said.

"We think they were disturbed by the off-label marketing," Sheller said.

When asked to respond to what the plaintiffs' lawyers reported the jury as saying, Mueller said in an email, "It wouldn't be appropriate for us to comment on hearsay or speculation."

During his opening statement, Hilliard said that J&J marketed the antipsychotic drug to children and juveniles as part of a policy to increase the sales of Risperdal beyond the 1 percent of the population that has schizophrenia. However, defense counsel Smith said in her opening statement that the case was about one boy and the decision by his doctor to give him what is viewed as a "miracle" drug.

"During the time that it was actively promoted, our company policy was to promote Risperdal for its FDA-approved indication," Mueller said in an email. "From its initial approval in 1993 through 2002, that indication was the management of the manifestations of psychotic disorders. In March 2002, the FDA approved indication was changed to the treatment of schizophrenia, and in December 2003, the label was expanded to include the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder."

While J&J has said it is close to pleading guilty to a misdemeanor criminal charge regarding off-label marketing of Risperdal, that pending plea was not given to the jurors in the A.B. case, Sheller said.

The drug company representative in the area of North Texas where the plaintiff lived testified that it was "part of a national directive to push symptoms onto kids," Hilliard said, which meant suggesting to physicians that Risperdal could be used to treat mood and other disorders in children.

Hilliard said that until there is a jury verdict in a case at some point it will continue to be very hard to place a value on cases. "I think a jury is really going to hurt Johnson & Johnson at some point," he said.

But Hilliard said it is hard to assess the value of the psychological impact on a boy to grow breasts, including having double mastectomies.

"A Texas jury or Pennsylvania jury will eventually let everyone know the level of seriousness," Hilliard said.

Amaris Elliott-Engel can be contacted at 215-557-2354 or aelliott-engel@alm.com. Follow her on Twitter @AmarisTLI.