In Re: Risperdal Litigation Appeal of: W.C.

Superior Court of Pennsylvania·Decided November 13, 2017·No. 2451 EDA 2015·Published

Opinion

J-A27024-16

2017 PA Super 356

IN RE: RISPERDAL LITIGATION : IN THE SUPERIOR COURT OF : PENNSYLVANIA W.C. : : Appellant : : : v. : : No. 2451 EDA 2015 : JANSSEN PHARMACEUTICALS, INC., : JOHNSON & JOHNSON COMPANY, : JANSSEN RESEARCH AND DEVELOPMENT, LLC

Appeal from the Judgment Entered June 30, 2015 In the Court of Common Pleas of Philadelphia County Civil Division at No(s): March Term, 2013, No. 01803, March Term, 2013, No. 01803

BEFORE: PANELLA, J., RANSOM, J., and FITZGERALD, J.

OPINION BY PANELLA, J. FILED NOVEMBER 13, 2017

Appellant, W.C., appeals from the judgment entered following a jury

trial in the Philadelphia County Court of Common Pleas in favor of Appellees,

Janssen Pharmaceuticals, Inc., Johnson & Johnson Company and Janssen

Research and Development, LLC.1 Appellant argues the trial court abused its

____________________________________________

 Former Justice specially assigned to the Superior Court.

1The caption in the notice of appeal listed M.C., Appellant’s mother, as an Appellant and Excerpta Medica, Incorporated, and Elsevier, Inc. as Appellees. See Notice of Appeal, 7/29/15. However, W.C., Janssen Pharmaceuticals, Inc., Johnson & Johnson Company and Janssen Research and Development, LLC, appear to be the only parties to the instant appeal. (Footnote Continued Next Page) J-A27024-16

discretion in denying his request for a new trial due to erroneous evidentiary

rulings at trial. We reverse and remand for a new trial limited to the issues

of causation and damages.

Appellees developed and manufactured risperidone, an atypical

antipsychotic, for the treatment of schizophrenia in adult patients. In 1993,

the Food and Drug Administration granted approval to Appellees to market

risperidone for this purpose. Appellees brought their product to market

under the brand name Risperdal.

In February 2002, at the age of six, Appellant was prescribed Risperdal

for the treatment of attention deficit disorder, attention deficit hyperactive

disorder, and oppositional defiant disorder.2 He remained on Risperdal,

periodically, until March 2007. At that point Appellant’s physician

discontinued Appellant’s use of the medication. At some time between 2006

and 2008, when Appellant was ten to twelve years old, Appellant’s mother,

M.C. (“Mrs. C”), alleged she observed Appellant suffering from unexplained

(Footnote Continued) _______________________

See Appellant’s Brief; Appellee’s Brief; Stipulation to Discontinue, 4/16/15. We have corrected the caption accordingly. 2 See U.S. Food & Drug Administration, Understanding Unapproved Use of

Approved Drugs “Off Label,” available at https://www.fda.gov/forpatients/other/offlabel/default.htm (last visited August 24, 2017).

-2- J-A27024-16

weight gain and gynecomastia.3 However, at that time, neither Appellant nor

Mrs. C informed Appellant’s medical providers of his condition.

On March 14, 2013, Appellant commenced this action by filing a

complaint. Appellant’s complaint was filed as part of the In re Risperdal®

mass tort program, and incorporated allegations found in the master

complaint.4 Appellant alleged his Risperdal usage caused his gynecomastia,

and raised claims against Appellees of (I) negligence; (II) negligent design

defect; (III) fraud; (IV) strict liability failure to warn; (V) strict liability

design defect; (VI) breach of express warranty; (VII) breach of implied

warranty; (VIII) violation of Pennsylvania’s Unfair Trade Practices and

Consumer Protection Law (“UTPCPL”), 73 P.S. § 201, et. seq.; (IX) unfair

and deceptive trade practices; (X) conspiracy; and (XI) punitive damages.

Mrs. C asserted claims for medical expenses incurred by a parent and loss of

consortium. Appellees denied all of Appellant’s and Mrs. C’s allegations.

Appellees later filed a motion for partial summary judgment on the

master docket disputing the validity of the punitive damages claim. The trial ____________________________________________

3 Merriam-Webster’s online dictionary defines gynecomastia as “excessive development of the breast in the male.” Available at http://merriam- webster.com/dictionary/gynecomastia (last visited August 23, 2017). 4 The In re Risperdal mass tort program was formed on May 26, 2010, as

a repository for the filings of pleadings, motions, orders, and other documents common to all Risperdal cases in the Philadelphia County Court of Common Pleas. See Case Management Order 1, 5/26/10, In Re Risperdal® Litigation, March Term 2010 No. 296.

-3- J-A27024-16

court granted Appellees’ motion and dismissed all plaintiffs’ claims for

punitive damages. The trial court then denied reconsideration.

Appellees filed a motion for summary judgment as to each count of

Appellant’s and Mrs. C’s complaint. Appellant and Mrs. C responded,

asserting that their claims were legally and factually sound, and therefore

not subject to dismissal on summary judgment. The trial court granted

Appellees’ motion in part, dismissing all claims against Appellees with the

exception of Appellant’s negligence claim.

Appellant’s jury trial for his remaining negligence claim began on

February 20, 2015. Appellant offered the testimony of eleven witnesses and

introduced approximately 200 exhibits in support of his contention that he

developed gynecomastia as a result of Appellees’ failure to notify physicians,

health care providers, and the FDA of the significant risk of gynecomastia

associated with the use of Risperdal in pre-pubescent males.

Pertinent to the instant appeal, Appellant offered the expert testimony

of Mark Solomon, M.D. He opined Appellant suffered from gynecomastia and

developed gynecomastia solely due to Risperdal ingestion during childhood.

See N.T., Trial, 3/3/15, Morning Session, at 37-38, 58. At the request of

Appellant’s counsel, Dr. Solomon performed a physical examination of

Appellant’s chest in front of the jury to demonstrate how he determined

Appellant was suffering from gynecomastia rather than chest enlargement

due to obesity. See id., at 39-35. During this examination, Appellant’s

counsel asked Dr. Solomon to analogize the amount of breast tissue

-4- J-A27024-16

Appellant had to either a softball or tennis ball. See id., at 43. Dr. Solomon

concluded that Appellant was suffering from the presence of breast tissue

approximately the size of a tennis ball. See id., at 44. On cross-

examination, Dr. Solomon was asked numerous questions about Appellant’s

visit to the emergency room in March 2013 for chest pain. Dr. Solomon

opined that a chest examination performed in the emergency department for

chest pain would not necessarily have led to the discovery of Appellant’s

gynecomastia. See id., at 105-113.

Through the introduction of seven witnesses and over eighty exhibits,

Appellees contested every aspect of Appellant’s negligence claim. Appellees

denied that Risperdal usage correlated to a significant risk of gynecomastia.

They further disputed that they had negligently failed to inform physicians,

health care providers, and the FDA of this significant risk. Further, and

relevant to the instant appeal, Appellees heavily contested Appellant’s claim

that he developed gynecomastia as a result of Risperdal usage. Rather,

Appellees argued Appellant never suffered from gynecomastia, and that any

chest enlargement was a result of weight gain.

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