Murray v. Janssen Pharm., Inc.

180 A.3d 1235

Nicholas MURRAY

v.JANSSEN PHARMACEUTICALS, INC.; Johnson & Johnson; Janssen Research & Development, LLC ; Excerpta Medica, Inc.; and Elsevier, Inc.

Appeal of: Janssen Pharmaceuticals, Inc.; Johnson & Johnson; and Janssen Research and Development, LLC

Nicholas Murray, Appellant

v.Janssen Pharmaceuticals, Inc.; Johnson & Johnson; and Janssen Research & Development, LLC ; Excerpta Medica, Inc.; and Elsevier, Inc. Appellees

No. 1172 EDA 2016

No. 1302 EDA 2016

Superior Court of Pennsylvania.

Argued July 25, 2017

Filed February 20, 2018

Reargument Denied April 18, 2018

Robert C. Heim, Philadelphia, for Janssen Pharmaceuticals, Johnson & Johnson and Janssen Research & Development.

Charles L. Becker, Philadelphia, for Murray.

BEFORE: BENDER, P.J.E., DUBOW, J., and MUSMANNO, J.

OPINION BY BENDER, P.J.E.:

Appellants/Cross–Appellees, Janssen Pharmaceuticals, Inc., Johnson & Johnson, and Janssen Research & Development, LLC (collectively referred to herein as "Janssen"),¹ appeal and Appellee/Cross–Appellant, Nicholas Murray, cross-appeals from the March 10, 2016 judgment entered in favor of Mr. Murray following a jury trial. We affirm in part, reverse in part, and remand for further proceedings.

Mr. Murray, a resident of Maryland, filed this action against Janssen in the Philadelphia County Court of Common Pleas, asserting, inter alia , that he developed gynecomastia —a condition where female breast tissue grows in males—as a result of using Janssen's drug, Risperdal.² He further alleged that Janssen negligently failed to warn physicians and health care providers of the risk of gynecomastia associated with Risperdal use. Mr. Murray's case was coordinated in Philadelphia's Complex Litigation Center as a member case in the mass tort program captioned In re Risperdal® Litigation , March Term 2010, No. 296. All of the cases in this mass tort action consist of male plaintiffs who allege they developed gynecomastia due to their Risperdal use.

The trial court summarized the facts adduced at the jury trial as follows:

[Mr. Murray], who is now twenty-one years old, was administered Risperdal by several of his treating pediatricians, namely, Mark Langfitt, M.D., and Arvoranee Pinit, M.D., beginning in April of 2003 and terminating at the request of [Mr. Murray's] mother[, referred to herein as Mrs. Murray,] on or about February of 2008. This drug was recommended by psychologist Richard Greenbaum, Ph.D., whom Dr. Langfitt had consulted because [Mr. Murray] had difficulty sleeping, most probably arising from what [Janssen's] expert, pediatric psychiatrist, Nadine Schwartz, termed "autism spectrum disorder." The drug was prescribed for [Mr. Murray] "off-label." It was not approved for pediatric use by the [Food and Drug Administration (FDA) ] until 2006, and then only for use with "irritability arising from autism."

Risperdal was approved by the FDA for schizophrenia in adults in the 1990s but was used off-label for pediatric patients until it was finally approved by the FDA in 2006. Although the drug is effective in treating certain mental health disorders, it has the propensity to create a hormonal imbalance in patients by increasing the levels of the hormone prolactin. This increase in prolactin levels can lead to what is termed hyperprolactinemia. In turn, this condition can lead to the development of breast tissue in males, termed gynecomastia.

It was undisputed that Janssen knew and was concerned about the fact that Risperdal could, by raising prolactin levels, lead to gynecomastia. They undertook studies to determine the relationship between hyperprolactinemia and gynecomastia prior to and during the time period [Mr. Murray] consumed the drug. [Mr. Murray's] counsel asserted that Janssen both knew about and encouraged the off-label use of Risperdal for children and adolescents, but failed to notify physicians, health care providers, or the FDA of the significant risk of gynecomastia that Janssen's own studies revealed. [Mr. Murray's] counsel pointed to a 2003 study commissioned and published by [Janssen], referred to at trial as the "Findling article" after the name of its lead author, who addressed long-term Risperidone treatment in children and adolescents. The final published version of the article concluded that there was no significant correlation between high prolactin levels and gynecomastia after taking Risperdal. Certain draft articles, however, referenced studies showing that during 8–12 weeks of use there was a high correlation between side effects and higher than normal prolactin levels. These studies showed that 7.8% of the children tested who suffered prolactin related side effects, including gynecomastia, had higher than normal prolactin levels as opposed to 2.9% of those with normal levels. This study did not appear in the final published article. It was argued at trial that the 8–12 week study should have been included in the article and the failure to do so indicated that [Janssen] knew of a significant risk but failed to inform the public. In addition, [Mr. Murray] presented a pooled study comprised of five separate studies undertaken by [Janssen]. One of these studies was an international study termed "INT–41[,]" ... which showed that after one year of use 24 out of 504, or 4.8%, of patients on Risperdal suffered from gynecomastia.

[Mr. Murray's] counsel, through its expert, David M. Kessler, M.D., also cited other studies indicating that [Janssen] knew that there was a significant risk of gynecomastia in male children and adolescents but failed to warn healthcare providers. Dr. Kessler asserted that the data submitted to the FDA was done so by Janssen in such a fashion as to diminish the risk of gynecomastia.

Dr. Kessler also argued that the information contained in the Rispersal [sic ] label vastly understated the risk. Two labels were at issue: one from 2002 and another from 2006. The 2002 label stated that there were insufficient studies concerning the effects of the use of Risperdal in children and adolescents. This label provided that gynecomastia was a "rare" side effect, which is defined by the FDA as something that occurs in 1 in every 1,000 cases. The label also stated that Risperdal did not increase prolactin any greater than other antipsychotic drugs in its class. Dr. Kessler argued that the risk was actually much greater than this, and he alleged that [Janssen] knew much more about the risk of gynecomastia arising from use of Risperdal than what was contained in the label. As a result of the Findling draft and the INT–41 study in particular, Dr. Kessler testified that [Janssen] knew that its drug Risperdal increased prolactin levels greater than other drugs in its class and this in turn lead [sic ] to a greater risk of gynecomastia in children and adolescents. By contrast[,] the 2006 label, which represented the FDA's approval of the use of Risperdal for children and adolescents suffering from irritability from autism, contained the admonition that Risperdal actually increased the prolactin levels greater than other drugs in its class. The 2006 label also provided that the reported rate of gynecomastia was 2.3% arising from the 1885 participants in the eighteen studies submitted to the FDA by [Janssen]. Dr. Kessler concluded that Janssen knew about this information contained in the 2006 label well before and during the time [Mr. Murray] took the drug. Consequently[,] he concluded that [Janssen] was negligent in failing to adequately advise physicians/health care providers of the significant risk of gynecomastia arising from the use of Risperdal.

The defense vigorously contested every aspect of [Mr. Murray's] negligence claim. [Janssen] denied that there [was] any significant risk of gynecomastia from the use of Risperdal. It presented testimony from Danielle Coppola, M.D., who had been employed at Janssen since 2005 and who had worked with safety issues involving Risperdal. She opined that when taking into consideration the time period in which the subjects of the studies were on the drug[,] the risk of gynecomastia was minimal. Janssen further denied that the studies cited by [Mr. Murray] indicated that Janssen knew or had reason to know that the risk of gynecomastia was any greater than rare (as indicated in the 2002 label) during the time period [Mr. Murray] took the drug. [Janssen] maintained that the omitted prolactin study contained in the Findling draft and the INT–41 study did not tell the full story. The Findling draft, in what was termed "Table 21[,]" ... contained data showing high prolactin levels only at 8–12 weeks of use. Janssen asserted that this data was not included in the final article because it merely showed high prolactin levels over this short period of time. Other studies show that prolactin levels usually rise after initial use of the drug and then diminish over time, and thus this one study involving an 8–12 week time period was irrelevant and insignificant when compared to the overall use of the drug. In addition, the INT–41 study was only one of five contained in the pooled studies. It was also only one of eighteen studies sponsored by Janssen. Analyzing all the studies, and considering the fact that gynecomastia occurs frequently during puberty without the use of Risperdal, [Janssen] argued that [it] had reasonably concluded that gynecomastia was not a significant risk. [It] alleged that the contents of the 2006 label were the result of a culmination of additional studies and did not reflect what was known when [Mr. Murray] was first prescribed the drug. [Janssen] further argued that a risk/benefit analysis indicated that the benefit from the use of Risperdal clearly outweighed any risk of gynecomastia. Despite [Janssen's] contentions[,] the jury, by a vote of eleven to one, decided the issue of negligence in favor of [Mr. Murray].

Causation was hotly contested as well. On this issue of causation, the jury found in favor of [Mr. Murray] by a vote of ten to two. [Mr.

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