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PHILADELPHIA — (Mealey’s) A Pennsylvania state court jury on Feb. 24 awarded $2.5 million to the family of a man who claimed that the atypical antipsychotic drug Risperdal caused gynecomastia, or enlarged male breasts (P.P., et al. v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., et al., No. 120401997, Pa. Comm. Pls., Philadelphia Co.).
The compensatory verdict was returned by a jury in the Philadelphia County Common Pleas Court against manufacturer Janssen Pharmaceuticals Inc. and its parent company Johnson & Johnson after more than four weeks of testimony. The trial began Jan. 22.
A judge had previously said that punitive damages cannot be awarded.
Benita Pledger of Thorsby, Ala., sued Ortho-McNeil-Janssen Pharmaceuticals Inc. (now Janssen) on behalf of a minor identified as in court documents as P.P. but identified by the defendants as Austin Pledger. Plaintiff attorney Steven Sheller of Sheller P.C. in Philadelphia told Mealey Publications that the victim was 7-1/2 years old when he was prescribed Risperdal to treat his autism.
Sheller said the victim took Risperdal for five years before his doctor diagnosed him with gynecomastia and stopped the drug.
Sheller also said the trial is the first in which testimony was heard about internal company data showing that patients with abnormal levels of prolactin at eight to 12 weeks old are the most likely to suffer gynecomastia from Risperdal. Sheller said a defense witness testified that that information was never submitted to the Food and Drug Administration.
In a press statement, a Janssen spokesperson said: “We are disappointed and will consider all of our options going forward, including appeals. We firmly believe this verdict should be overturned.”
“As this case illustrates, autism can be incredibly difficult for individuals and their families, and we sympathize with the plaintiff, Austin Pledger, and his family,” the spokesperson said.
Janssen said that during the trial, it “presented abundant evidence showing that the FDA-approved label properly warned of the medication's potential side effects and the plaintiff's physician was aware of those side effects. The evidence also showed that Mr. Pledger was not harmed by using Risperdal and, in fact, his quality of life was significantly improved during the time he was taking Risperdal.”
Former FDA Commissioner
Plaintiff experts included Mark Solomon, M.D., and David Kessler, M.D. Kessler is a former FDA commissioner.
Judge Ramy I. Djerassi presided.
Prior to the jury’s deliberations, Janssen and Johnson & Johnson moved for a mistrial and a directed verdict.
Sheller indicated the verdict may be the first involving Risperdal and gynecomastia. He said he got two weeks into a trial several years ago in the Philadelphia County Common Pleas Court when the defendants settled his inventory of cases at the time.
The plaintiffs are represented by Brian J. McCormick Jr. of Ross Feller Casey in Philadelphia, Thomas J. Henry and Michael E. Henry of Thomas J. Henry Injury Attorneys in Corpus Christi, Texas, and Thomas R. Kline of Kline & Specter in Philadelphia and Christopher A. Gomez and Sheller of Sheller PC in Philadelphia.
The defendants are represented by Melissa A. Graff and Kenneth A. Murphy of Drinker, Biddle & Reath in Philadelphia; Thomas F. Campion of Drinker Biddle in Florham Park, N.J.; Siobhan A. Cullen of Drinker Biddle in Century City, Calif.; Stephen J. Finley Jr. of Gibbons in Philadelphia; Adam S. Tolin, Allison M. Brown and Diane P. Sullivan of Weil, Gotshal & Manges in Princeton, N.J.; and Jed Winer of Weil Gotshal in New York.
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