Janssen appeals $76M Risperdal verdict

Pharmaceutical company argues verdict was “blatantly excessive;” plaintiffs challenge court order preventing punitive damage awards

Oct. 18, 2016 – San Diego, CA — Janssen Pharmaceuticals appealed a $70 million verdict awarded to a Tennessee teen who suffered abnormal breast growth after taking the drug company’s antipsychotic medication Risperdal.

Andrew Yount was awarded $70 million in compensatory damages by a jury in the Philadelphia Court of Common Pleas in July of this year.

Talcum powder lawsuitsThe two-week-long trial culminated on July 1 when the jury handed down the verdict in favor of Yount, who sued Janssen Pharmaceuticals and its parent company Johnson & Johnson over allegations the companies’ antipsychotic drug Risperdal caused him to grow abnormally large breasts, a condition known as gynecomastia, and that the companies failed to warn about the drug’s potential risks.

Yount’s was one of thousands of similar lawsuits consolidated in a mass tort program in the Philadelphia state court and the fifth to go before a jury. His $70 million award, the fourth verdict to be handed down in favor of plaintiffs, was increased to more than $76 million when the court tacked on an additional $6.6 million in delayed damages in August.

Janssen Pharmaceuticals appealed the jury’s verdict on Sept. 9 and submitted a Statement of Errors detailing the grounds of its appeal Oct. 12 as required by the court.

The pharmaceutical company argued the court should have ordered a new trial or repealed the $76 million verdict it deemed “excessive” based on the evidence.

“In light of the minimal evidence regarding damages in this case …, the jury’s award cannot rationally be understood as anything other than a punitive award given the gross disproportion between the evidence of harm and the amount of the verdict,” attorneys for Janssen wrote in the statement.

Janssen called the verdict “excessive in nature” and argued it was “so blatantly excessive that a new trial was required.” Citing Tennessee code — which caps non-economic damages at $750,000 unless there is evidence a defendant falsified, destroyed or concealed evidence to avoid liability — Janssen contended the damages awarded in Yount’s case were not subject to the cap exception.

In spite of two documents submitted into evidence during trial which plaintiffs maintain Janssen withheld from the FDA, the company argued there was no evidence it falsified, destroyed or concealed evidence to evade liability in this case.

The Johnson & Johnson division also called for an appeal of the verdict based on a lack of evidence presented by plaintiffs at trial. It contended Yount’s attorneys failed to establish that the Risperdal warning was inadequate or that the company could lawfully change the label to include added warnings.

The company asserted it was unable to provide additional warnings about Risperdal’s risks of gynecomastia on the drug label because the U.S. Food and Drug Administration has “explicitly stated that gynecomastia is not a serious adverse event” and, therefore, would probably not approve the label change.

Janssen said it was also prohibited from updating labels to include risks in patients for whom the drug was not approved. Risperdal was not cleared for use in children until 2006 and, at the time, the company said the FDA would have had to initiate any warnings for off-label use.

Not only did the pharmaceutical division argue plaintiffs lacked certain evidence, it maintained other evidence relating to Yount’s overall mental health was improperly excluded from the trial. The company said a complete mental health picture was necessary to determine whether the benefits of Risperdal outweighed its risks.

“It is undisputed that almost every prescription medication, including Risperdal, carries some risk of side effects. In determining whether a medication is appropriate for a particular patient, the physician must weigh the potential side effects against the needs of the patient and the potential benefit to him from the medication. The Court committed fundamental error tainting the entire trial by allowing Plaintiffs to present a one-sided description of this process, focused only on risks, while preventing Defendants from fully explaining why [Yount] needed Risperdal and the factors that his physicians needed to consider when making that decision.”

Risperdal is an antipsychotic medication used to treat symptoms of mental health disorders, including schizophrenia, bipolar disorder and autistic disorder.

The drug came under fire after reports of abnormal breast growth in boys began to surface, and researchers linked the antipsychotic to an increased level of prolactin in some patients.

Andrew Yount began taking Risperdal in 2003 at the age of 5, according to a report by the New Jersey-based newspaper New Brunswick Today. At the time, Risperdal was not approved for use in children or adolescents.

In 2013, Johnson & Johnson was found negligent in illegally marketing Risperdal and other pharmaceutical drugs for unapproved uses, including in children and elderly patients. The conglomerate was ordered to pay $2.2 billion, the third-largest settlement reached between the U.S. Department of Justice and a pharmaceutical company to date.

Johnson & Johnson was a named defendant in the current case, along with its pharmaceuticals divisions Janssen and Janssen Research & Development. As the first named defendant, Janssen argued the court should reverse the verdict in regards J&J and Janssen R&D since the jury was instructed to render a verdict only for Janssen, according to the company’s statement to the court.

The company now awaits a decision from the court.

The case is A.Y. et al. vs Janssen Pharmaceuticals Inc. et al. (130402094) in the Philadelphia Court of Common Pleas.

Plaintiffs appeal decision of court applying New Jersey punitive damages law to all Risperdal cases in Philly mass tort

Oct. 18, 2016 – San Diego, CA – Attorneys for plaintiff Andrew Yount submitted an appeal to the Philadelphia Superior Court last month, objecting to the Court of Common Plea’s decision barring any issuance of punitive damages as a matter of New Jersey law.

Plaintiffs submitted their appeal Sept. 13, more than two years after the court initially granted in part Janssen’s motion for summary judgment regarding plaintiff’s claims for punitive damages.

The court reasoned that New Jersey law applied to all Risperdal cases in the Philadelphia mass tort litigation as it relates to issues of punitive damages, and said defendants could not incur punitive liability.

Yount’s attorneys asked the Superior Court to reconsider the lower court’s ruling, and said “ample evidence supported a claim of punitive damages against Defendants.”

The case is A.Y. et al. vs Janssen Pharmaceuticals Inc. et al. (130402094) in the Philadelphia Court of Common Pleas.