Brenda Tinkham and her son, T.M., sued Janssen Pharmaceuticals and related companies for failing to warn of the risk of gynecomastia associated with the drug Risperdal. Gynecomastia is characterized by the growth of female breast tissue in males.
The Tinkhams filed suit in a Philadelphia County trial court. Many similar lawsuits have been filed against Janssen, including more than 5,000 that have been coordinated in Philadelphia’s Complex Litigation Center.
Texas doctors prescribed Risperdal when T.M. was seven years old after diagnosing attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD). The Food and Drug Administration (FDA) had approved Risperdal to treat adult schizophrenia. The FDA had not approved Risperdal for use in children or for the treatment of either ADHD or ODD.
The case went to trial, but the trial judge, applying Texas law, decided that much of the testimony of the Tinkham’s causation expert was inadmissible. The judge then dismissed the case for failure to prove causation. The Tinkhams appealed to the Pennsylvania Superior Court.
Expert Testimony Regarding Duty to Warn
The Tinkhams relied on the testimony of two expert witnesses. Dr. David Kessler, a former FDA commissioner and the former dean of Yale Medical School, testified that Janssen had a duty to warn patients of the risk that Risperdal could cause gynecomastia and that Janssen breached that duty.
Dr. Kessler reviewed the known risks that were associated with Risperdal in 2004, when it was prescribed to T.M. Risperdal had long been known to elevate prolactin levels associated with gynecomastia and other endocrine disorders. Janssen had acknowledged in an application to the FDA in 1996 that doctors were prescribing Risperdal to children for off-label uses (i.e., uses not approved by the FDA), including the treatment of ADHD.
The FDA denied Janssen’s application for approval of Risperdal to treat ADHD, noting the absence of substantial evidence that the drug was safe for pediatric use. Dr. Kessler testified that, despite the FDA’s refusal to approve Risperdal to treat ADHD in children, Janssen actively marketed Risperdal to doctors for that purpose.
Janssen’s warning label between 2002 and 2006 claimed that the effects of elevated prolactin levels were “unknown in most persons.” The label was updated in 2006 to state that hyperprolactinemia (an elevated level of the hormone that produces breast milk) was a “rare” side effect. In 2007, Janssen updated the label to acknowledge that Risperdal causes gynecomastia in 2.3% of patients. Dr. Kessler testified that the actual percentage of patients who develop the condition is significantly higher.
Based on studies, including some of Janssen’s internal studies and its internal emails, Dr. Kessler testified that Janssen was aware of the risk that Risperdal could cause gynecomastia by 2001. He opined that Janssen had an obligation at that time to warn patients of the risk. He also testified that Janssen manipulated study data to reduce the apparent risk and that it funded the publication of a misleading article regarding the study.
The physicians who prescribed Risperdal to T.M. testified that Janssen actively marketed Risperdal for the treatment of ADHD. One psychiatrist testified that he accepted an all-expenses-paid trip from Janssen to a seminar at which Risperdal was marketed for the purpose. The doctors also testified that they would not have prescribed Risperdal if they had known that gynecomastia was not a rare side effect.
Expert Testimony Regarding Causation
Dr. Mark Solomon, a plastic surgeon with expertise in gynecomastia and diseases of the breast, testified that T.M. suffered from gynecomastia. He also testified that Risperdal was the cause of T.M.’s gynecomastia. He based that opinion on studies showing that Risperdal can cause the condition, a review of T.M.’s medical records, and photographs taken in 2007 showing that T.M. had begun to develop breasts.
Janssen argued that under Texas law, general causation (the ability of a drug to cause an adverse condition) can only be proved by two epidemiological studies showing that taking a drug doubled the risk of developing the plaintiff’s condition in test subjects who are similar to the plaintiff. Janssen contended that Dr. Solomon did not rely on studies showing a doubled risk.
Janssen also discounted the photographic evidence because T.M. stopped taking Risperdal in 2008 and was not diagnosed with gynecomastia until 2010. The trial court agreed with Janssen and dismissed the lawsuit for failure to prove causation.
The question on appeal was whether Texas or Pennsylvania law governing proof of causation should have been applied. As a general rule, when a negligent act is committed in one state and a negligence lawsuit is commenced in a different state, a court will apply the substantive law of the state in which the negligent act occurred. The court nevertheless applies the procedural law of the state in which the lawsuit is heard.
Unlike Texas, Pennsylvania courts do not require two epidemiological studies that show a doubling of risk in patients similar to the plaintiff. The Pennsylvania court noted that if the risk of developing a condition is 1.5 times greater in patients who take a drug than in patients who don’t, that elevated risk might make it more probable than not that the drug causes the condition. The “more probable than not” standard of proof can be satisfied even in the absence of studies that prove a doubling of risk.
The Tinkhams argued that Texas law does not require epidemiological studies to establish general causation, but merely sets standards for those studies when they are relied upon. The appellate court noted precedent in support of that position but decided the case on different grounds.
The Admissibility and Sufficiency of Expert Testimony is Procedural
Is the sufficiency of expert evidence to establish causation a matter of substantive or procedural law? The Superior Court decided that plaintiffs have a substantive duty to prove causation, but the admissibility and adequacy of proof of causation are procedural issues.
The court held that Pennsylvania law governs whether an issue is substantive or procedural. The admissibility of expert evidence is, under Pennsylvania law, a procedural matter.
Pennsylvania (unlike Texas) follows the Frye standard for the admissibility of expert testimony. Pennsylvania generally allows juries to decide whether experts have given reliable testimony, provided that they use methodologies that are generally accepted in their field of expertise. Dr. Solomon’s testimony satisfied the Frye standard.
The court recognized that even if a judge admits expert evidence, Texas law allows the judge to review expert evidence at the end of the case to determine whether it would support a verdict in the plaintiff’s favor. Janssen characterized that review as substantive rather than procedural.
The Superior Court disagreed. In Pennsylvania, whether the evidence is sufficient to prove causation is a procedural inquiry. That holding is consistent with the general principle that the law of the state in which the trial is held determines whether a party has introduced sufficient evidence to support a verdict in its favor.
The substantive law of Texas holds drug companies liable for failing to warn patients about known side effects. When warnings have been approved by the FDA, the substantive law of Texas creates a presumption that the warnings are adequate. That presumption can be overcome by evidence that the drug company withheld relevant evidence from the FDA about side effects at issue in the case, or that the company promoted the drug for an off-label use. The evidence was sufficient to prove that both of those were true.
The substantive law of Texas also requires proof that a defective warning caused harm to the plaintiff. The court’s procedural review established that the expert and nonexpert evidence was sufficient to permit a jury to find that the improper warning caused T.M.’s gynecomastia. The trial court therefore erred by dismissing the case.