United States: Adequate Warnings Plus No Warnings Causation Equals Summary Judgment For Defendants In Risperdal Gynecomastia Case

Last Updated: July 11 2018
Article by Rachel B. Weil

We love the unexpected. We loved standing up after what we thought was the finale of the fireworks show last night only to be left breathless by a stunning and unexpected encore. We loved walking in to a "quiet family dinner" for our recent advanced birthday to find the room filled with dear relatives and friends shouting "surprise." But sometimes it is nice when things happen just as they are supposed to (which, in the jurisprudential world, may actually be unexpected!), like they did in today's case, a terrific summary judgment decision out of the Eastern District of New York. (A shout out to Tom Kurland of Patterson, Belknap for the victory and for sending us the decision before it was available online.)

In Chandler v. Janssen Pharms. Inc., et al., — F.Supp. 3d —, 2018 WL 3212422 (E.D.N.Y June 29, 2018), the plaintiff, placed in foster care in 1996 when he was six years old, began taking Risperdal the next year after displaying aggression at school. He continued to have serious psychiatric and behavioral problems and to take Risperdal in gradually increasing doses, until 2009. That year, during a visit with his psychiatrist, the plaintiff complained that his breasts were enlarged. The psychiatrist recommended that the plaintiff stop taking Risperdal, which he observed was "probably responsible for the breast enlargement," and noted that he had been aware of the correlation between the drug and breast enlargement for several years. The plaintiff continued to see psychiatrists, and to take antipsychotic medications, until late 2012. In April 2014, he underwent bilateral mastectomies to remove his enlarged breast tissue. In March 2015, he filed suit alleging that the defendants failed adequately to wan about rate of incidence of gynecomastia (breast enlargement) in pediatric users of Risperdal. Specifically, although the label at all relevant times, had always included a Precaution about gynecomastia, the plaintiff alleged that gynecomastia should have been listed in the "Warnings" or "Adverse Reaction" section, and that gynecomastia rates were two to five times higher than the 2.3% rate listed in the label after October 2006, when Risperdal was approved for pediatric use. He alleged that his doctor would not have prescribed Risperdal if he had known about the higher incidence rate.

The defendants moved for summary judgment, arguing that the plaintiff had not produced admissible evidence that the Risperdal gynecomastia warning was inadequate. The defendants argued that the only "evidence" supporting the plaintiff's warnings claim was the two cherry-picked clinical studies that ostensibly demonstrated the higher incidence rate, a "contention that [was] inadmissible without expert testimony." Chandler, 2018 WL 3212422 at *6.

The court explained that, under the learned intermediary doctrine, a drug warning is "adequate as a matter of law if it clearly and unambiguously notifies the prescribing physician of the particular adverse reaction that forms the basis of the plaintiff's complaint." Id. (citations omitted). Because the Risperdal label always warned that the product could cause gynecomastia, the plaintiff could not prove that the label was inadequate. The court also rejected the argument that the label should have included an incidence rate for gynecomastia before the drug was approved for use in children, noting that the defendants "were clearly keeping abreast of knowledge" of the drug through available methods and were "taking steps to bring that knowledge to the attention of the medical profession." Id. (internal punctuation and citation omitted). Finally, the court held that the plaintiff had not produced admissible evidence that the gynecomastia incidence rate in the 2006 and 2007 labels was inadequate. The plaintiff relied on two studies (of eighteen conducted around the same time) that allegedly showed higher incidence rates, but the plaintiff "introduce[d] no expert testimony on the validity of [those] studies, either standing alone or compared to the other sixteen studies, or [on] the regulatory requirements of labeling." Id, at *8. Without an expert, the court held, the plaintiff could not opine on the "statistical or methodological differences between the studies or why the two studies he cited were correctly decided in comparison to the other sixteen." Id. Concluding, "To be clear, while the two studies could be evidence of higher incidence rates, the absence of an expert to interpret and validate them precludes their admission," id, the court held that Risperdal's gynecomastia warnings were adequate as a matter of law at all relevant times.

Warnings Causation

Though the defendants were entitled to summary judgment based on the adequacy of the warning, the court went on to consider the issue of warnings causation; in other words, whether a different warning would have changed the plaintiff's doctors' decisions to prescribe the drug. The court added, "if the treating physician is aware of the risks of a drug, independent of any warning by the manufacturer, such knowledge constitutes an intervening event relieving the manufacturer of any liability to a patient under a failure to warn theory." Id. at *10 (internal punctuation and citations omitted). In this case, both of the plaintiff's prescribing physicians knew of the possible correlation between Risperdal and gynecomastia "both before and during the time that they prescribed the drug" for the plaintiff. Id. One of the doctors testified that he wasn't sure he would have changed his prescribing decisions even if he knew the risk was higher. The other testified that, although he knew of the gynecomastia risk from other sources, he didn't read the label or advise the plaintiff of the risk, both of which constituted intervening causes, "severing the causal connection between Defendants' alleged failure to warn and Plaintiffs' injury." Id. (citation omitted). Finally, the court disregarded the plaintiff's guardian's affirmation to the effect that she would not have consented to the Risperdal prescription if the plaintiff's doctor had advised her of the gynecomastia risk. The court explained, "A failure to obtain informed consent might be a viable theory of liability against [a] physician or ... hospital," but neither was a party to the lawsuit. Because the plaintiff could not establish specific (warnings) causation, the court held that the defendants were entitled to summary judgment on that basis as well.

We love a good warnings decision, and we are delighted that we had the chance to bring this one to you. We hope you all had a great holiday.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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