By David Yucht, J.D.
Federal drug labeling laws did not preempt this claim because the regulatory scheme would not have "clearly" prevented the pharmaceutical companies here from warning about the statistically significant increase in frequency and severity of gynecomastia in boys taking Risperdal.
A state appellate panel in Pennsylvania upheld a jury award of $70,000,000 in favor of a boy who developed female-like breasts as a result of taking Risperdal™ to treat his psychiatric condition. Tennessee law, which applied here, provides a liability cap of $750,000 except in cases involving the concealment of evidence. The appellate court found that the jury was properly charged concerning damages and legally inferred that the at-issue pharmaceutical companies had concealed negative clinical studies. The appellate court also vacated and remanded the trial court’s dismissal of punitive damages claims and required the trial court to consider conflict of law principles with respect to Tennessee and New Jersey and how they bear on punitive damages claims (A.Y. v.Janssen Pharmaceuticals, Inc., November 26, 2019, Stevens, C.).
A four-year-old boy diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) and Oppositional Defiant Disorder (ODD) was prescribed Risperdal by a pediatric psychiatrist. The psychiatrist did not warn his mother about the risk of gynecomastia, an enlargement of breast tissue in males. The doctor indicated that at that time, she was not aware that there was a significant risk of gynecomastia. One and one-half years later, the doctor took him off Risperdal because of the increased size of the boy’s breasts. When she believed the gynecomastia had gone down, she put the boy back on Risperdal. Several years later, the Risperdal was again discontinued because of significant weight gain. After struggling with mental illness, the boy was once again put back on Risperdal at 16 years of age but had to be taken off when he developed hypertension. It was re-prescribed a short time later.
In 2013, the boy’s mother saw an advertisement discussing gynecomastia from Risperdal use. She contacted an attorney and his treating physicians. His doctor first learned about gynecomastia from the boy’s mother. Immediately after, the mother sued Janssen Pharmaceuticals Inc. and other pharmaceutical companies alleging 13 causes of action including negligence, negligence–design defect, fraud, strict product liability–failure to warn, strict product liability–design defect, and conspiracy. Applying New Jersey law, the trial court dismissed claims for punitive damages. The trial court concluded that the law of Tennessee, the boy’s home state, applied to the substantive claims. A jury returned a verdict in favor of the boy. The jury found that the pharmaceutical companies negligently failed to adequately warn of the risk of gynecomastia associated with Risperdal use and that their negligence was a cause in bringing about the boy’s gynecomastia. The jury awarded $70,000,000.00 in compensatory damages [see Products Liability Law Daily’s July 1, 2016 analysis]. The trial court denied the companies’ post-trial motion for relief [see Products Liability Law Daily’s July 27, 2016 analysis]. The companies appealed and the boy’s representatives cross-appealed.
Warnings—preemption—proximate cause. The appellate court found that federal drug labeling laws did not preempt the Tennessee tort law claim. It found that the federal regulatory scheme would not have "clearly" prevented the pharmaceutical companies here from warning about the statistically significant increase in frequency and severity of gynecomastia in boys taking Risperdal. Moreover, the appellate court upheld the jury’s proximate cause finding. To establish proximate causation in a pharmaceutical failure-to-warn case, under Tennessee law, one must show that additional warnings to a learned intermediary would have prevented the injuries. The court noted that the boy’s physicians amply testified that they would have chosen a different course of treatment had the pharmaceutical company disclosed on the Risperdal label the significantly heightened risk of gynecomastia that existed for juvenile boys. Moreover, at the time the boy was first prescribed Risperdal, the pharmaceutical companies knew that Risperdal posed a significant increased risk of gynecomastia to juveniles. Here, evidence showed that the label not only failed to state with the correct degree of intensity the nature of the risk, it failed altogether to state the heightened risk that the company, through administration of its own clinical trials, knew applied to juvenile boys.
Evidence—specific acts. The appellate court agreed with the trial court’s decision precluding specific act evidence, as the pharmaceutical companies were still able to inform the jury that the boy demonstrated "very serious symptoms" and that Risperdal for juveniles with his diagnoses was shown to help with highly aggressive, impulsive, explosive, and violent outbursts. This expert proffer, therefore, fairly characterized the boy’s condition and enabled the framing of the theory of the case that the mother faced a dilemma between risking a relapse in her son’s very serious mood disorder from Risperdal cessation and exacerbating gynecomastia from Risperdal continuation.
Compensatory damages. The appellate court also upheld the jury’s compensatory damages award. The appellate court noted that "[t]he assessment of damages is peculiarly within the province of the fact finder and an award will not be upset on appeal unless it is so excessive as to shock the conscience of the court or it is clearly based on partiality, prejudice or passion." Tennessee law imposes a limit on non-economic damages of $750,000. However, the facts of this case came under a statutory exception for personal injury actions in which a defendant intentionally falsified, destroyed, or concealed records containing material evidence with the purpose of wrongfully evading liability. A reasonable inference arose that the pharmaceutical companies persisted in concealing clinical study results pertaining to gynecomastia. Here, the trial court properly instructed the jury that it was required to consider whether the companies had acted in such a way to wrongfully evade liability.
Punitive damages. The appellate court vacated and remanded the trial court’s dismissal of punitive damages claims and required the trial court to consider conflict of law principles with respect to Tennessee and New Jersey and how they bear on punitive damages claims. In entering a global summary judgment order in favor of the pharmaceutical companies on the issue of punitive damages in the Risperdal litigations, the trial court determined that New Jersey had a greater interest than Pennsylvania in the application of punitive damages, and the New Jersey Products Liability Act did not permit the recovery of punitive damages. The appellate court subsequently held in related litigations that the trial court was required to consider conflict of law principles with respect to New Jersey and each Risperdal consumer’s home state, which it had not yet done here.
The case is No. J-A19031-19.
Attorneys: Charles Lyman Becker (Kline & Specter, P.C.) for A.Y. Kenneth A. Murphy (Drinker Biddle & Reath, LLP) for Janssen Pharmaceuticals Inc., Johnson & Johnson and Janssen Research & Development, LLC. Stephen J. Imbriglia (Gibbons P.C.) for Excerpta Medica, Inc.
Companies: Janssen Pharmaceuticals Inc.; Johnson and Janssen; Janssen Research & Development, LLC; Excerpta Medica, Inc.
MainStory: TopStory DamagesNews DrugsNews WarningsNews ExpertEvidenceNews CausationNews PreemptionNews DesignManufacturingNews PennsylvaniaNews
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