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From Products Liability Law Daily, November 1, 2018

$2.5M damage award in Risperdal® case survives challenge; further proceedings on punitive damages ordered

By Miriam A. Friedman, J.D.

A trial court presiding over a pharmaceutical failure to warn case concerning a child who had developed gynecomastia allegedly caused by his taking the antipsychotic drug, Risperdal®, to treat his autism did not err in denying the drug manufacturer’s motion for judgment notwithstanding the verdict (JNOV), based on the conduct of the prescribing physician; did not abuse its discretion in rulings regarding the patient’s expert witness; and did not err in its jury instruction on causation, the Pennsylvania Superior Court ruled. However, the court did held that the lower court erred in dismissing the patient’s punitive damages claim. Therefore, the appellate court affirmed the lower court’s judgment in favor of the patient, and reversed and remanded for further proceedings on the issue of punitive damages (Pledger v. Janssen Pharmaceuticals, Inc., October 31, 2018, Strassburger, E.).

As a child, the patient was prescribed Risperdal to treat his autism, and he took the drug over the course of five years. After he ceased taking the drug, the patient, via his mother, sued its manufacturers, Janssen Pharmaceuticals, Inc., Janssen Research & Development, LLC, and Johnson & Johnson Company, asserting, inter alia, negligence in failing to warn physicians and patients that the drug could cause gynecomastia. The case was included in a mass tort program captioned at In re Risperdal Litigation, and the trial court granted partial summary judgment on the punitive damages claim as to all cases.

At trial, the jury returned a verdict in favor of the patient, concluding that the manufacturer was negligent in not adequately warning the patient’s physician about the risk of gynecomastia and that this negligence was a cause of the patient’s gynecomastia. The jury awarded $2.5 million in damages. Both parties appealed.

Denial of motion for JNOV. The appellate court found that at the time the physician initially prescribed the drug, he had no reason to believe that it would have any different effect on the patient’s prolactin level than any other drug in its class. Because this was "clearly not substantially the same" knowledge that the risk was actually many times what the physician reasonably believed it to be, the court concluded that the trial court did not err in denying JNOV on this basis. The court found further that the trial court did not err in denying JNOV based upon the final refill, by which time further warnings had been issued, because the evidence indicated the damage had already been done prior to that point. Finally, because the record supported the conclusion that a different warning would have changed the physician’s prescribing behavior and the injury could have been prevented, the court ruled that the trial court did not err in denying JNOV based upon the conduct of the physician.

Expert testimony. The Pennsylvania Superior Court additionally determined that although the patient’s expert was not disclosed within the appropriate timeframe, the trial court’s conclusion that the manufacturer purposely waited until the middle of trial to raise the issue that resulted in a need for substitution of the patient’s expert was supported by the record. As such, the trial court did not err or abuse its discretion in permitting the mid-trial change in experts, due to "extenuating circumstances beyond the control of" the patient. The appellate court also found that the trial court did not err in qualifying the witness as an expert. Furthermore, as the superior court found in a prior decision, the expert’s methodology "was not novel" and was "a generally accepted methodology in the medical community." Finally, the court concluded that the trial court did not err by not permitting the manufacturer’s counsel to cross-examine the expert about an article he had not read or about a "learned treatise" because she had "failed to ask whether the treatise was a standard work in the field."

Jury instruction. Although the manufacturer challenged the trial court’s causation jury instruction on appeal, the superior court found that the manufacturer had failed to preserve this issue at trial. Moreover, the appellate court’s review of the instruction found no error. Rather, the jury instructions "reflected accurately" the relevant issue of whether the information initially provided by the manufacturer to the prescribing physician was adequate, and whether a different warning would have changed his prescribing behavior at that time.

Punitive damages. Citing its earlier decisions in two prior cases, Stange v. Janssen Pharmaceuticals, Inc., 179 A.3d 45 (Pa. Super. 2018), and Murray v. Janssen Pharmaceuticals, Inc., 180 A.3d 1235 (Pa. Super. 2018) [see Products Liability Law Daily’s January 10, 2018 analysis and February 21, 2018 analysis, respectively], which were part of the Risperdal litigation, the appellate court concluded that it was "required to remand for the trial court to consider conflict-of-law principles" with respect to New Jersey and the patient’s home state of Alabama on the issue of punitive damages and which state’s law applied. The court, thus, reversed the order of the trial court granting partial summary judgment in favor of the manufacturer on this issue.

The cases are Nos. 2088 EDA 2016 and 2187 EDA 2016.

Attorneys: Stephen A. Sheller (Sheller, PC) for Phillip Pledger. Kenneth A. Murphy (Drinker Biddle & Reath, LLP) and Judy L. Leone (Dechert LLP) for Janssen Pharmaceuticals, Inc., Johnson & Johnson and Janssen Research & Development, LLC.

Companies: Janssen Pharmaceuticals, Inc.; Johnson & Johnson; Janssen Research & Development, LLC

MainStory: TopStory WarningsNews CausationNews ExpertEvidenceNews DamagesNews DrugsNews PennsylvaniaNews

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