A Philadelphia jury awarded $2.5 million to a twenty year old man whose family claimed he developed female-like breasts (gynecomastia) from taking the antipsychotic drug Risperdal for five years from ages eight to thirteen.
Stephen A. Sheller, attorney for the family: “We are encouraged to see this day come, after ten years of our pursuing justice for the boys and young men who have suffered the severe, debilitating, and psychologically stigmatizing effects of the antipsychotic, Risperdal” said Sheller. “Maybe the drug companies will think again before they illegally market drugs for unapproved populations.”
Risperdal, manufactured by Johnson & Johnson, was originally approved in 1993 to treat psychotic disorders in adults. “On March 3, 2002 the approved use was narrowed to treatment of schizophrenia only,” said the U.S. Department of Justice Department in a press release after J&J agreed to pay $2.2 billion to settle one criminal charge and other allegations that it illegally promoted Risperdal for unapproved uses.”(1) Sheller was the attorney for the whistleblower who brought the allegations to the DOJ.
Sheller, P.C. is the first firm that investigated the link between Risperdal and gynecomastia. With litigator Thomas Kline, we are personally representing clients from across the country and litigating cases now.
If you suspect your son has this condition, contact us immediately for a consultation. Some law firms advertising Risperdal cases, including those with TV advertisements, do not personally represent the boys and young men.
Talk to us and tell us your son’s story: call 800-883-2299 or write using the inquiry form on this page.
According to court documents, Johnson & Johnson concealed studies that showed a statistically significant association between the elevation of prolactin levels in children who are on Risperdal with the development of gynecomastia. J&J documents produced in the trial detailed the specific sales tactics of the company, including safety information on “Leave Behind” material given to doctors that contradicted the drug’s label.
“Frankly, I wasn’t thinking of the money, I was just thinking of my son.”
The young man’s mother, Benita Pledger, was overjoyed at the verdict, according to Sheller and others in the courtroom. She was unsure of the outcome, and didn’t realize until the decision was read that the lawyers could not suggest a monetary outcome for the verdict. She said “Frankly, I wasn’t thinking of the money, I was just thinking of my son.”
Pledger was reluctant to try Risperdal for her son who was suffering behavior problems as a condition of his autism. She contacted J&J to ask for safety details, but received little according to court documents. The J&J pharmaceutical sales rep visited the young man’s pediatric neurologist that prescribed the medication 21 times in 4 years to discuss Risperdal’s use in children off label, illegal at the time. The representative left 16,000 doses of the drug with the doctor according to transcripts of the trial.
See the Wall Street Journal story “Johson & Johnson Loses Trial Over Risperdal and Male Breasts”
“The most important thing for me, as someone who worked for the FDA, as a physician and as somebody who served on the boards of pharmaceutical companies, is you tell the truth and you tell the whole truth,” said former FDA Commissioner David Kessler, testifying on behalf of the plaintiff. “You tell the whole story. You make sure the data supports the message. What they want to convey doesn’t match what the data shows and to me, that doesn’t tell the whole story. Make sure the FDA knows and make sure the doctors know. Tell them the good and the bad.”
The court barred punitive damages in this matter based on what plaintiff’s attorneys say was a misapplication and interpretation of New Jersey law.
Trial attorney Thomas R. Kline said “In my 37 years of trying product liability and drug cases, I have not seen the likes of the misconduct that I’ve seen in this case.” Sheller attorney Christopher Gomez was also trial lawyer for the family.
Sheller petition to revoke FDA approval for use of Risperdal in children
The drug is now approved for use in children and adolescents, but Sheller submitted a petition to the FDA to revoke the Risperdal’s approval for this age group.(2) Documents detailing the severity of the drug’s side effects were known to Sheller from discovery and depositions obtained during preparation for the individual trials, according to the petition. Under confidentiality and protective order, Sheller could not submit the documents but requested the FDA obtain the documents directly, according to the complaint. The FDA did not, and denied the petition. Sheller, joined by the law firm Duane Morris, have appealed the FDA’s decision.
Sheller’s firm has just begun another gynecomastia Risperdal trial, also being heard in the Philadelphia Court of Common Pleas. Six previous Sheller Risperdal trials for gynecomastia in Philadelphia ended in settlement, two were trials under way but were settled prior to conclusion.
In this case, there were no offers from Johnson & Johnson to settle.
The case is P.P. et al. v. Janssen Pharmaceuticals Inc. et al., case number 120401997, in the Philadelphia County Court of Common Pleas.
About Stephen A. Sheller and Sheller, P.C.
Sheller, P.C. represents plaintiffs injured by defective and dangerous drugs, devices, and consumer products nationwide as well as whistleblowers reporting corporate and government fraud. Founded by Stephen A. Sheller and in practice since 1977, Sheller, P.C. has challenged some of the largest corporations in the United States, including pharmaceutical and medical device companies, auto, tobacco and others.
The firm’s off-label marketing and federal and state False Claims Act qui tam whistleblower cases have recovered more than $6.25 billion for the U.S. Government and taxpayers to date, including some of the largest in U.S. history. (3,4,5,6,7,8)
- http://www.justice.gov/opa/pr/johnson-johnson-pay-more-22-billion-resolve-criminal-and-civil-investigations
- http://www.regulations.gov/index.jsp#!docketDetail;D=FDA-2012-P-0857
- United States ex rel. Torres et al. v. Shire Specialty Pharmaceuticals et al., No. 08-4795 (E.D. Pa.)
- United States ex. rel. Starr, et al. v. Janssen Pharmaceutica Prods., L.P., No. 04-1529
- United States ex. rel. Rudolph, et al. v. Eli Lilly and Company, No. 03-943
- United States ex. rel. Rainero, et al. v. Pfizer, Inc., No. 07-11728
- United States ex. rel. Wetta, et al. v. AstraZeneca Corp., No. 04-0379
- United States ex rel. Gavin v. Sarasota Pain Associates, P.A. and Steven Y. Chun, M.D., 6:11-cv-583-T-23TBM (M.D. Fla. 2014)
