Products Liability Law Daily Texas law on admissibility of scientific evidence misapplied in Risperdal injury case
Wednesday, July 17, 2019

Texas law on admissibility of scientific evidence misapplied in Risperdal injury case

By Leah S. Poniatowski, J.D.

The procedural law of the forum, Pennsylvania, should have been applied when determining the admissibility of expert testimony.

A failure-to-warn and fraud lawsuit filed against the manufacturer and distributor of the prescription drug Risperdal that had been disposed on a nonsuit motion was given another chance in a new trial given the trial court’s error in applying Texas evidentiary standards in lieu of Pennsylvania law, which should have been applied as the law of the forum, a Pennsylvania appellate panel ruled, vacating the nonsuit motion (Tinkham v. Janssen Pharmaceuticals, July 16, 2019, Seletyn, J.).

A seven-year-old boy who had been diagnosed with attention deficit hyperactivity disorder, oppositional defiant disorder, and depression was prescribed Risperdal by his pediatric psychiatrist in Texas. At the time, Risperdal had not been approved by the U.S. Food and Drug Administration for use in children or for treatment of the boy's disorders. Also known at the time of the prescription was that the drug caused increased prolactin levels related to gynecomastia and other issues. After using Risperdal for approximately two years, the boy developed breasts. The family filed a lawsuit against Janssen Pharmaceuticals, Inc., Johnson & Johnson, and Janssen Research & Development, LLC ("Janssen"), alleging fraud and that the drug manufacturer negligently failed to provide adequate warnings of the risk of gynecomastia.

Family’s case. The family relied on two scientific experts to offer testimony in support of their cause of action. One expert—a physician with a specialty in pediatric medicine and public health—based his opinion on the manufacturer's business plan, the drug's label, and the manufacturer's two long-term studies. He determined that there was causal connection between the drug and development of gynecomastia, and that the manufacturer failed to warn prescribing physicians or the FDA. He also stated that the manufacturer had made misrepresentations to the FDA with respect to Risperdal’s safety.

Another expert, a plastic surgeon with gynecomastia and breast disease expertise, concluded that Risperdal caused the boy's gynecomastia. He based his medical opinion on a medical examination of the boy, the boy’s family history and medical records, and the medical literature about the drug. The expert ruled out other possible causes of the boy's condition, but he did not identify the two studies on which he had based his opinion in his expert report.

The boy's psychiatrists testified that Janssen actively promoted using Risperdal off-label for children, which had persuaded them to prescribe it in the present case, but that they were not aware of the frequent risk of gynecomastia. Similarly, the boy's mother testified that if she had known of the risk, she would not have agreed to administer the drug to her son.

Trial court. At the close of the case, Janssen moved for a nonsuit, alleging that under the Texas Products Liability Act, the family did not provide sufficient evidence to rebut the presumption that the FDA-approved warning was adequate or that the plastic surgeon's opinions fell below Texas’s requirement for general or specific causation vis-a-vis scientific reliability; namely, that the opinion be based on two epidemiological studies demonstrating statistically significant doubling of the relative risk.

The family argued that not only did Texas law not require proof of epidemiological studies when proving causation, but that the requirements were not substantive and, thus, were not governed by Texas law. The trial court ruled in favor of Janssen, holding that Texas law applied on the issue of the sufficiency of expert scientific testimony with respect to medical causation and strictly construing Texas case precedent to require two epidemiological studies showing a doubling of the relative risk and that the plaintiff be similarly situated to the study participants. Because the plastic surgeon did not introduce studies demonstrating a doubling of the risk or that the boy was similarly situated to the study subjects, the family's failure to warn claim failed, the trial court held. The family appealed the trial court’s decision.

Causation evidence standard. The key issue was whether the sufficiency of causation evidence was procedural or substantive, the appellate court explained. There was no dispute that as the procedural rules of forum state, Pennsylvania, applied and that the substantive law of Texas applied. The appellate court held that under both Pennsylvania and Texas law, the law of the forum governs the issue of whether an issue is substantive or procedural. Under Pennsylvania law, procedural law "is the set of rules which prescribe the steps by which the parties may have their respective rights and duties judicially enforced," and Pennsylvania law holds that questions of evidence are to be determined under the forum's law. Thus, Pennsylvania law should have been applied when evaluating whether the scientific evidence of causation was sufficient to sustain the cause of action, the appellate court instructed.

Unlike Texas, Pennsylvania courts only require that an expert's conclusions be derived from generally accepted principles and sound scientific research. Consequently, Janssen would be entitled to a compulsory non-suit only if it was clear that the family did not establish a cause of action. Texas substantive law recognizes that a drug manufacturer may be liable for a patient's injuries based on a failure to warn. The presumption that a manufacturer is not liable if the FDA-approved the warnings accompanying the drug can be rebutted on a showing that the manufacturer withheld or misrepresented material information to the agency that was causally related to the injury or that the manufacturer recommended off-label use of the drug.

The appellate court agreed with the family that it presented evidence of off-label use of the drug and that one of its experts testified that the manufacturer had withheld or misrepresented information about the incidence of gynecomastia in children. The appellate court also found that the medical literature and the manufacturer's studies demonstrated a statistically significant correlation between use of the drug and the occurrence of elevated prolactin levels and gynecomastia. Additionally, the boy's treating psychiatrists and his mother testified that they would not have given him Risperdal had they been aware of the risk, and that other causes of the condition had been ruled out. Therefore, the lower court erred when it entered the nonsuit for Janssen, the appellate court concluded, vacating the lower court's order and remanding the matter for a new trial.

The case is No.184 EDA 2018.

Attorneys: Thomas R. Kline (Kline & Specter, P.C) for T.M and Brenda Tinkham. Kenneth Alonzo Murphy (Drinker Biddle & Reath LLP) for Janssen Pharmaceuticals Inc. and Johnson & Johnson.

Companies: Janssen Pharmaceuticals Inc; Johnson & Johnson

MainStory: TopStory WarningsNews CausationNews ExpertEvidenceNews EvidentiaryNews PennsylvaniaNews TexasNews

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