Pennsylvania Superior Court Grants New Trial in Risperdal Case.

Pennsylvania Superior Court Grants New Trial in Risperdal Case.

Recently, in T.M. and Brenda Tinkham (collectively referred to hereafter as “T.M.”) v. Janssen Pharmaceuticals, the Pennsylvania Superior Court granted T.M. a new trial in a claim involving Janssen’s alleged failure to warn of the risk of gynecomastia (formulation of female breast tissue in males) associated with Risperdal use in children. 

In 2004, T.M. was seven years old when he began acting out in school.  He was diagnosed with attention deficit hyperactivity disorder ("ADHD"), oppositional defiant disorder ("OD"), and depression. He was prescribed Risperdal, which was only approved by the FDA to treat adult schizophrenia. At this time, Risperdal was not approved by the FDA for use in children or for the conditions diagnosed, so his doctors prescribed it “off-label,” which can be customary and acceptable in the medical community. At the time of administration of Risperdal, it was known that Risperdal was associated with the development of gynecomastia. T.M. took the medication for over three years, and he ultimately developed breasts.

In 2013, T.M. filed suit against Janssen claiming that it failed to adequately warn of the risks of gynecomastia. During the trial, T.M. produced expert testimony to show that prior to T.M.’s use of the medication, Janssen asked the FDA to supplement Risperdal’s prescribing information to provide dosing for children, as it had become aware that Risperdal was being prescribed to adolescents for ADHD. The FDA refused to do this due to a lack of evidence to support the safety and efficacy of the medication for use in this population, and feared that the information would promote the use of the medication in the pediatric population. The evidence also showed that in 2004, when Risperdal was prescribed off-label for T.M., Janssen was actively marketing the drug to physicians for off-label use in children. In fact, Janssen's July 29, 2002 business plan listed strategic initiatives associated with gaining acceptance of the usage of antipsychotics in child and adolescent psychology.  This included "establishing Risperdal as having a favorable risk/benefit ratio" and "neutralizing safety and tolerability concerns.” However, T.M. claimed that Janssen was not advising physicians of the statistically significant association between the use of Risperdal and gynecomastia in children and adolescents. T.M.’s treating doctors testified that had they been provided with this information, they would not have prescribed Risperdal.

At the conclusion of T.M.’s presentation of evidence, Janssen moved for a compulsory non-suit (dismissal of case) claiming that under Texas substantive law, which applied to this case, T.M. failed to meet his burden to show that Janssen’s alleged inadequate warning caused his injury. More specifically, Janssen cited to Texas law, which imposed a specific requirement that a plaintiff introduce at least two epidemiological studies showing a statistically significant doubling of the risk, and evidence that the plaintiff is similar to the subjects of the studies, in order present a question of fact for the jury in a failure-to-warn case. T.M. argued that his causation evidence was admissible, reliable, and legally sufficient to go to the jury. The trial court agreed with Janssen and granted its request for compulsory non-suit, and T.M. appealed to the Pennsylvania Superior Court.

In analyzing the issue as to whether the trial court erred in granting the non-suit, the Superior Court cited to the pertinent part of Restatement (Second) of Conflicts of Law §135, which provides that, "The local law of the forum determines whether a party has introduced sufficient evidence to warrant a finding in his favor on an issue of fact." Thereafter, the court determined that T.M., in accordance with Texas substantive law had submitted sufficient evidence to rebut the presumption that its warnings, despite being approved by the FDA, were legally sufficient to support a claim of failure-to-warn. Moreover, the Court found that T.M. introduced sufficient evidence under Texas substantive law through Janssen’s own clinical trials and peer reviewed published studies that showed a statistically significant relationship between ingestion of Risperdal, elevated prolactin levels, and gynecomastia in young males like T.M. In light of the foregoing, the Court concluded that T.M.’s scientific evidence concerning causation was sufficiently reliable to survive a compulsory nonsuit under Pennsylvania procedural laws, and was legally sufficient to establish a claim for failure-to-warn under Texas substantive law.


Ty Smith explains Janssen Pharmaceuticals alleged failure to warn of the risk of gynecomastia (formulation of female breast tissue in males) associated with Risperdal use in children.