A.Y. v. Janssen Pharm. Inc.

224 A.3d 1

A.Y. and B.A.Y.

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

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

A.Y. and B.A.Y. Appellant

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

No. 3058 EDA 2016

No. 3059 EDA 2016

Superior Court of Pennsylvania.

Argued August 7, 2019

Filed November 26, 2019

Reargument Denied January 30, 2020

Robert C. Heim, Philadelphia, for Janssen.

Charles L. Becker, Philadelphia, for A.Y.

BEFORE: PANELLA, P.J., KUNSELMAN, J., and STEVENS^* , P.J.E.

OPINION BY STEVENS, P.J.E.:

Janssen Pharmaceuticals, Inc., Janssen Research & Development, LLC, and Johnson & Johnson Company (collectively, "Defendants/Appellants" or "Janssen") appeal from the judgment of $70 million entered on September 8, 2016, after a jury found in favor of A.Y. and his mother, B.A.Y. (collectively, "Plaintiffs/Appellees") and against Janssen in this pharmaceutical failure to warn case. In addition, Plaintiffs/Appellees have filed a cross-appeal from the June 10, 2016 order granting partial summary judgment in favor of Defendants/Appellants on Plaintiffs/Appellees' punitive damages claim.

On Defendants/Appellants' appeal, we affirm. On Plaintiffs/Appellees' cross-appeal, we reverse and remand for the trial court to consider conflict-of-law principles with respect to New Jersey and Appellees' home state of Tennessee in a manner consistent with this decision.

The trial court opinion aptly sets forth the record-based procedural history and relevant facts, as follows:

PROCEDURAL HISTORY

On April 15, 2013, Plaintiffs A.Y. and [B.A.Y., "Mother,"] filed a Complaint against Defendants Janssen Pharmaceuticals Inc., Johnson & Johnson, Janssen Research & Development, LLC, Elsevier, Inc., and Excerpta Medica Inc. Appellees' Complaint alleged the following thirteen causes of action: (1) negligence, (2) negligent-design defect, (3) fraud, (4) strict product liability – failure to warn, (5) strict product liability – design defect, (6) breach of express warranty, (7) breach of implied warranty, (8) violation of Pennsylvania Unfair Trade Practices and Consumer Protection Law, 73 P.S. § 201-1 et seq., (9) unfair and deceptive trade practices, (10) conspiracy, (11) punitive damages, (12) medical expenses incurred by parent, and (13) loss of consortium.

By Order dated May 2, 2014, the Honorable Arnold L. New ruled that New Jersey Law applied to the issue of punitive damages and that New Jersey law barred the award of punitive damages. On June 2, 2014, Plaintiffs filed a Motion for Reconsideration of the Honorable Arnold New's May 2, 2014 Order barring the award of punitive damages. On June 9, 2014, Defendants filed an Answer to Plaintiff's Motion for Reconsideration. On July 18, 2014, Plaintiff's Motion for Reconsideration was denied.

On November 4, 2015, the Honorable Arnold New approved a stipulation dismissing the action as to Defendants Excerpta Medica, Inc., and Elsevier Inc. On April 14, 2016, remaining Defendants, Janssen Pharmaceuticals, Inc., Johnson & Johnson, and Janssen Research & Development, LLC, filed a motion for summary judgment.

On May 5, 2016, Plaintiffs filed an Answer to Defendant's Motion for Summary Judgment. On May 11, 2016, Defendants filed a Reply.

On June 10, 2016, the Honorable Arnold New ruled that Tennessee Law applies to Plaintiffs' substantive claims [because Plaintiffs live in Tennessee and allege causes of action arising in Tennessee]. Plaintiffs' claims for: negligence, negligent design defect, strict liability—failure to warn, strict liability—design defect, breach of express warranty, breach of implied warranty [were deemed] subsumed into two claims: (a) Product Liability action because Risperdal was defective and (b) Product Liability action because Risperdal was unreasonably dangerous.^{[ ]}

The Honorable Arnold New further ruled that Defendants' Summary Judgment [motion] was granted as to the following causes of action: (A) product liability action because Risperdal was defective, (B) fraud, (C) Pennsylvania's Unfair Trade Practices and Consumer Protection Law, (D) unfair and deceptive trade practices (under the Tennessee Consumer Protection Act), (E) conspiracy, and (F) loss of consortium. Defendant's Motion for Summary Judgment was denied as to all other causes of action.

On June 16, 2016, a jury trial commenced in this matter; the Honorable Paula A. Patrick presided. On July 1, 2016, the jury returned a verdict in favor of the Plaintiffs. The jury found that Defendants negligently failed to adequately warn Plaintiffs of the risk of gynecomastia associated with Risperdal ™ use and Defendants' negligence was a cause in bringing about A.Y.'s gynecomastia. The jury awarded Plaintiffs compensatory damages in the amount of $70,000,000.00 (seventy million dollars). On July 5, 2016, the jury's verdict was entered.

On July 8, 2016, Plaintiffs filed a Post-Trial Motion for Delay Damages. On August 10, 2016, Plaintiffs' Motion for Delay Damages was granted. Plaintiffs were awarded $6,661,027.40 in Delay Damages. The jury verdict of $70,000,000.00 was molded to add Delay Damages of $6,661.027.40 for a total verdict of $76,661,027.40. On September 7, 2016, judgment was entered in this matter.

On September 9, 2016, Defendants filed an Appeal to the Superior Court from decisions dated July 1, 2016, July 5, 2016, July 25, 2016, and August 10, 2016.

On September 13, 2016, Plaintiffs filed a cross-appeal to the Superior Court from decisions dated May 2, 2014, July 18, 2014, and July 25, 2016. On September 22, 2016, Plaintiffs filed a Statement of Errors Complained of on Appeal pursuant to Pa.R.A.P. 1925(b). On October 12, 2016, Defendants filed a Statement of Errors Complained of on Appeal pursuant to Pa.R.A.P. 1925(b).

FACTUAL BACKGROUND

Risperdal (risperdone) is an antipsychotic medication belonging to a class of drugs which [has] become known as "atypical" or "second generation" ("SGA") antipsychotics. Risperdal was originally developed and approved for use in the treatment of symptoms associated with schizophrenia. The adverse effects associated with Risperdal are: rapid weight gain, hyperprolactinemia, gynecomastia (abnormal development of breasts in males), galactorrhea (lactation), pituitary tumors, microadenomas of the pituitary gland, breast cancer, osteoporosis, decreased bone mineral density, metabolic syndrome, dyslipidemia, hypertension, diabetes mellitus, diabetic ketoacidosis (DKA), hyperosmolar coma, hyperglycemia, glucose dysregulation, insulin insufficiency, insulin resistance, pancreatitis, tardive dyskinesia, extrapyramidal symptoms, involuntary movement disorders, dyskinesia, dystonia, akatisia, parkinsonism, neuroleptic malignant syndrome (NMS) and/or other related conditions. Risperdal is designed, developed, tested, labeled, packaged, distributed, marketed, and sold throughout the United States by the Janssen Defendants.

On December 29, 1993, Janssen obtained approval from the Food and Drug Administration ("FDA") to market Risperdal oral tablets for the treatment of "manifestations of psychotic disorders" (schizophrenia ) in adults. In September 2000, the FDA requested that the label be changed to more clearly indicate that Risperdal was only approved for use in treating schizophrenia in adults. In October 2006, Risperdal was approved for the treatment of irritability associated with autistic disorder in children and adolescents (between the ages of 5 and 16), including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums and quickly changing moods. Risperdal has not been approved for children younger than 5 or those older than 16 years old for irritability associated with autistic disorder.

The prescribing of drugs "off-label" occurs when a drug is prescribed by a medical professional for use beyond those contained in the drug's FDA-approved uses. This includes prescribing a drug for a condition not indicated on the label, treating the indicated condition at a different dose or frequency than specified in the label, or treating a different patient population. An example of off-label use is the treatment of a child with the drug when the drug is approved to treat adults.^{[ ]}

Plaintiff A.Y. was born in 1999. [A.Y.] was diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) and Oppositional Defiant Disorder (ODD). In August of 2003, when A.Y. was four and a half years old, he was prescribed Risperdal by Dr. Deniz Eker, a pediatric psychiatrist. Eker Dep. 2/8/16, at 31-32. At the time Dr. Eker prescribed Risperdal to A.Y., she did not warn A.Y.'s mother about the risk of gynecomastia. Dr. Eker stated that she would have warned A.Y.'s mother, but Dr. Eker did not know at the time that there was such a significant risk of gynecomastia from elevated prolactin. Id. at 56, 61.

In January 2004, four months after [A.Y.] began taking Risperdal, A.Y.'s mother went to Doctor Eker and expressed concern that A.Y.'s breasts were enlarging. Id. at 65. Dr. Eker then began tapering the Risperdal because she was concerned about gynecomastia. Id. at 66.

In February 2005, after the initial tapering, Dr. Eker noted that A.Y.'s breasts were getting big and that she was discontinuing Risperdal because A.Y. had gynecomastia. Id. Dr. Eker testified that when she first noticed gynecomastia, she began tapering off from the Risperdal but would have stopped it immediately if she had been properly informed about the risk of gynecomastia from Risperdal. Id. Dr. Eker believed gynecomastia was much less frequent and that A.Y.'s development of female breasts (at five years old) was a rare occurrence. When Dr. Eker believed the gynecomastia had gone down, she put A.Y. back on Risperdal. Id. at 76-77.

Dr. Eker transferred A.Y.'s psychiatric care to Dr. Michael Hughes in the first half of 2005. Id

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