Stange v. Janssen Pharm., Inc.

Robert C. Heim, Philadelphia, for Janssen Pharmaceuticals.

Charles L. Becker, Philadelphia, for Stange.

BEFORE: PANELLA, J., DUBOW, J., AND FORD ELLIOTT, P.J.E.

OPINION BY FORD ELLIOTT, P.J.E.:

Timothy Stange ("Stange"), plaintiff in the court below, and defendants, Janssen Pharmaceuticals, Inc. ("Janssen"), Johnson & Johnson, and Janssen Research & Development, LLC,¹ have taken cross-appeals from the judgment entered in favor of Stange in the amount of $535,106.17. Stange, who suffers from Tourette's syndrome, was prescribed Risperdal² and subsequently developed female breasts, a condition known as gynecomastia. Eventually Stange had to have surgery to remove his breasts. Stange alleged that Janssen negligently failed to adequately warn of the risk of gynecomastia associated with Risperdal use. Stange is one of over 5,500 claimants from around the country who chose to file suit in the Court of Common Pleas of Philadelphia County. Stange's case was coordinated in Philadelphia's Complex Litigation Center as a member case under the master docket captioned In Re: Risperdal Litigation , March Term 2010 No. 296, Case Management Order 1, docketed May 26, 2010. All of the cases in this mass tort involve male plaintiffs who

allege they developed gynecomastia as a result of ingesting Risperdal. After careful review, we affirm in part, reverse in part, and remand for further proceedings.

The trial court has briefly summarized the facts and procedural history of this case as follows:

In January 2006, Mr. Stange was twelve years old and living in Wisconsin. At that time, he began seeing Edward H. Kovnar, M.D. ("Dr. Kovnar"), a pediatric neurologist, for his Tourette syndrome. On February 7, 2006, Dr. Kovnar prescribed Risperdal to Mr. Stange. In February 2009, Dr. Kovnar discontinued Mr. Stange's use of Risperdal.

In August 2007, Mr. Stange's mother, Mrs. Stange, called his pediatrician, David Mueler, M.D. ("Dr. Mueler") to report that Timothy Stange was experiencing a stabbing pain in his left nipple. In April 2011, Dr. Mueler diagnosed Mr. Stange with gynecomastia and referred him to a plastic surgeon. In 2011, Dr. John H. Jensen ("Dr. Jensen"), a plastic surgeon, saw Mr. Stange and diagnosed him with gynecomastia. On July 16, 2012, Dr. Jensen performed a bilateral mastectomy on Plaintiff. The surgery was successful; however, Mr. Stange has permanent scars and has experienced pain in his chest. Prior to his surgery, Plaintiff was often teased by his classmates about having breasts.

In October 2006, the Federal [Food and] Drug Administration ("FDA") approved Risperdal, an antipsychotic drug, in pediatric and adolescent populations for symptoms associated with Autism. Prior to 2002, the Risperdal label did not convey a risk of gynecomastia. In 2002, the label indicated that Risperdal elevated prolactin levels but that, although disturbances such as gynecomastia may occur, the clinical significance is unknown for most patients. The ADVERSE REACTIONS section of the label indicated that gynecomastia was rare. In October 2006, the Risperdal label was updated as it was approved for children and adolescents. The label did not mention gynecomastia in the WARNINGS section. In the PRECAUTIONS section, the label indicated that Risperdal is "associated with higher levels of prolactin elevation than other antipsychotic agents." The label stated that gynecomastia has been "reported in patients receiving prolactin-elevating compounds." In August 2007, this information was included in the WARNINGS section. In both the October 2006 and August 2007 labels the "Pediatric Use" section stated: "In clinical trial in 1,885 children and adolescents with autistic disorder and other psychiatric disorder treated with risperidone... gynecomastia was reported in 2.3% of risperidone-treated patients."

Janssen knew that Risperdal elevated prolactin in children and adolescents and caused gynecomastia. In November of 2000, the interim results of one long-term open label trial (RIS–INT–41) established that 3.75% of boys taking Risperdal developed gynecomastia. In August 2001, the final results of RIS–INT–41 established that 5.5% of boys taking Risperdal developed gynecomastia. In September 2002, in a related study (RIS–INT–70), which was a year extension of RIS–INT–41, 12.5% of boys in the trial reported new or ongoing gynecomastia. These results indicated that gynecomastia was a frequent adverse event.

In 2002, Janssen conducted a post hoc meta-analysis of five trials studying prolactin levels in children and adolescents, including RIS–INT–41. In May 2002, as put forth in Table 21 of this meta-analysis (hereinafter, "Table 21"), the data

showed that there was a statistically significant association (p=0.0158) at weeks 8–12 of Risperdal use in children and adolescents whose prolactin levels were above the upper limit of normal with the risk of subsequently developing gynecomastia. The findings contained within Table 21 were included in the July 2002 draft of the article but were excluded from a subsequent draft of the article in October 2002 after the "statistical documentation protocols" were changed. The changed protocols resulted in the disappearance of a statistically significant association. The final article, published in November 2003, stated that there was "no correlation found between SHAP and prolactin levels even when male gynecomastia during puberty was included." [Footnote 1]

[Footnote 1] "SHAP" refers to "side effects hypothetically attributable to prolactin."

Janssen did not report the information in Table 21 to the FDA in its application process. Instead, the Defendants reported that there was no specific or significant finding of concern relating to prolactin elevation. Prior to Risperdal's indication for use in adolescents in 2006, the Defendants promoted the use of Risperdal in children and adolescents. Following the FDA's approval for Risperdal in pediatric and adolescent populations in October of 2006, sales representatives were instructed to give out brochures referred to as "Leave–Behind" material. The Leave–Behind material discussed the new autism approval in children but failed to contain the new safety information from the updated label, and actually contained information contrary to the 2006 label.

Trial court opinion, 5/23/16 at 2–5 (citations to the record omitted).

On April 12, 2013, Plaintiff, Timothy Stange ("Mr. Stange"), commenced the above-captioned action by filing an Abbreviated Individual Complaint for Risperdal Litigation and Adoption by Reference ("Short–Form Complaint"), which alleged that Defendants, Janssen Pharmaceuticals, Inc. ("Janssen") and Johnson & Johnson, failed to provide an adequate warning as to certain risks associated with the use of Risperdal, a brand name for the prescription drug risperidone. Plaintiff pled various theories and counts, including negligence for design defect, and fraud, strict product liability for failure to warn and design defect, breach of express and implied warranties, violation of the Pennsylvania Unfair Trade Practices and Consumer Protection Law, violation of the Wisconsin Deceptive Trade Practices Act, and conspiracy.

On September 22, 2015, Judge Arnold New granted summary judgment in favor of Defendants and against Plaintiff on all of Plaintiff's claims except for negligent failure to warn and strict product liability for failure to warn claims.

A jury trial commenced on October 15, 2015, which was presided over by the Honorable Kenneth J. Powell, Jr. On December 11, 2015, the jury returned a verdict finding that the Defendants negligently failed to warn adequately of the risk of gynecomastia associated with Risperdal use and that the Defendants' negligence was a cause in bringing about Mr. Stange's gynecomastia. The jury awarded compensatory damages in the amount of $500,000.00.

All parties filed Post–Trial Motions, which this Court denied on January 5, 2016. That same day, this Court granted Plaintiff's Motion for Delay Damages and molded the jury's verdict to add delay damages in the amount of

$35,106.17 for a total verdict of $535,106.17. On February 10, 2016, this Court approved the parties' stipulation that Plaintiff will not seek to execute on the judgment during the pendency of the appeal, and judgment was entered in favor of the Plaintiff in the amount of $535,106.17.

On March 7, 2016, the Defendants filed a timely Notice of Appeal. On March 8, 2016, this Court ordered the Defendants to submit a Statement of Matters Complained of on Appeal pursuant to Pa.R.A.P. 1925(b). On March 10, 2016, Plaintiff filed a Notice of Appeal. On March 17, 2016, this Court ordered Plaintiff to submit a Statement of Matters Complained of on Appeal pursuant to Pa.R.A.P. 1925(b). On March