Pledger v. Janssen Pharm., Inc.

• Decision Date: 31 October 2018
• Docket Number: No. 2187 EDA 2016,No. 2088 EDA 2016,2088 EDA 2016,2187 EDA 2016
• Court: Pennsylvania Superior Court
• Parties: Phillip PLEDGER, BY Benita PLEDGER, as Guardian of His Person and Conservator of His Estate, Appellee v. JANSSEN PHARMACEUTICALS, INC.; Johnson & Johnson; and Janssen Research & Development, LLC, Appellants Phillip Pledger, by Benita Pledger, as Guardian of His Person and Conservator of His Estate, Appellant v. Janssen Pharmaceuticals, Inc., Johnson & Johnson Co., and Janssen Research & Development, LLC, Appellees

198 A.3d 1126

Phillip PLEDGER, BY Benita PLEDGER, as Guardian of His Person and Conservator of His Estate, Appellee
v.
JANSSEN PHARMACEUTICALS, INC.; Johnson & Johnson; and Janssen Research & Development, LLC, Appellants

Phillip Pledger, by Benita Pledger, as Guardian of His Person and Conservator of His Estate, Appellant
v.
Janssen Pharmaceuticals, Inc., Johnson & Johnson Co., and Janssen Research & Development, LLC, Appellees

No. 2088 EDA 2016
No. 2187 EDA 2016

Superior Court of Pennsylvania.

Argued August 8, 2018
Filed October 31, 2018
Reargument Denied December 27, 2018

Robert C. Heim, Philadelphia, for Janssen Pharmaceuticals.

Charles L. Becker, Philadelphia, for Pledger.

BEFORE: STABILE, J., STEVENS, P.J.E.^* and STRASSBURGER, J.^**

OPINION BY STRASSBURGER, J.:

Janssen Pharmaceuticals, Inc., Janssen Research & Development, LLC, and Johnson & Johnson Company (collectively, Janssen)¹ appeal from the judgment of $2.5 million entered on June 8, 2016, after a jury found in favor of Phillip Austin Pledger (Austin), and his mother, Benita Pledger (collectively, the Pledgers), and against Janssen in this pharmaceutical failure to warn case. In addition, the Pledgers appeal from the July 11, 2014 order granting partial summary judgment in favor of Janssen on the Pledgers' punitive damages claim.² After review, we affirm in part, reverse in part, and remand for proceedings consistent with this opinion.

198 A.3d 1131

We provide the following background. Austin was born in 1994. In 2000, Austin, who was living with his parents about an hour outside of Birmingham, Alabama, was diagnosed as having autism.³ "In April 2002, Mrs. Pledger took Austin to meet Dr. Jan Mathisen, a pediatric neurologist in Birmingham[,]" in an effort to "relieve behavioral symptoms including temper tantrums." Trial Court Opinion, 8/11/2017, at 3; see N.T., 1/26/2015 (p.m.), at 44. Dr. Mathisen first saw Austin on April 22, 2002, and Dr. Mathisen and Mrs. Pledger discussed Austin's autism diagnosis and the potential for medication that may help him. At Austin's next visit, on June 17, 2002, Dr. Mathisen prescribed Risperdal⁴ to Austin.⁵ Dr. Mathisen warned Mrs. Pledger "that weight gain was possible" as a side effect of taking Risperdal. Trial Court Opinion, 8/11/2017, at 4 (citing N.T., 1/26/2015 (p.m.), at 57. Mrs. Pledger believed, however, that "this [risk] was acceptable because she thought [weight gain] could be mitigated by diet."Id.

Austin did indeed gain weight, and Mrs. Pledger noticed that about two-and-a-half months after Austin began taking Risperdal, he "started getting heavy around his nipples." N.T., 2/6/2015 (a.m.), at 71. A 2005 photograph of Austin with his shirt off reveals enlargement in his chest area. See Plaintiff's Exhibit 71.

Around November 2006, Mrs. Pledger sought to switch Austin to a different doctor, Dr. Donald Paoletti. Dr. Paoletti discontinued Austin's use of Risperdal in April 2007. The last time Austin saw Dr. Mathisen was in October of 2006, and Dr. Mathisen's last refill for Austin's Risperdal occurred on January 19, 2007.

Around October 2011, Mrs. Pledger saw a commercial on television about the potential for Risperdal to cause a condition called gynecomastia.⁶ She called the telephone number for the law firm on the television, and then sent in pictures of Austin as she was asked to do. It was at that time she learned that there may be a connection between Austin's Risperdal use and his large breasts.

In April 2012, the Pledgers filed a complaint against Janssen, which included claims asserting inter alia , Janssen's negligence in failing to warn physicians and patients that Risperdal could cause gynecomastia.⁷ That complaint also contained a

198 A.3d 1132

count for punitive damages. On February 10, 2014, Janssen filed a global motion for partial summary judgment with respect to several of the claims common to all cases, including the punitive damages claim. On July 11, 2014, the trial court granted partial summary judgment on inter alia , the punitive damages claim as to all cases.

Austin's case proceeded to a jury trial beginning January 20, 2015, and did not conclude until February 24, 2015. There were numerous issues in the case, all of which were vigorously contested by both the Pledgers and Janssen. By way of overview, the Pledgers sought to prove that Janssen "had discovered a significant risk of gynecomastia among boys who ingested Risperdal for eight through twelve weeks and had demonstrated elevated prolactin levels while taking the drug."⁸ Trial Court Opinion, 8/11/2017, at 5. According to the Pledgers, despite Janssen knowing that information, it did not communicate this risk to the FDA or to doctors prescribing Risperdal. In support of this claim, the Pledgers presented testimony of their expert, Dr. David Kessler, Federal Drug Administration (FDA) commissioner from 1991-1997.

Dr. Kessler testified that data collected at Table 21 showed [a] statistically significant side effect among children taking Risperdal between 8 and 12 weeks. In Dr. Kessler's opinion, Table 21 showed that children taking Risperdal within this time period, and had elevated prolactin levels, were 7.8 percent more likely to develop gynecomastia than children taking Risperdal whose prolactin level had remained normal.

Id. at 5-6 (citing N.T., 1/29/2015 (p.m.), at 30-35).

Janssen acknowledged that Table 21 was never shared with the FDA. N.T., 2/11/2015 (p.m.), at 114. Moreover, because this information was never shared with the FDA, and was not on Risperdal's label in 2002 at the time Dr. Mathisen prescribed Risperdal to Austin, Dr. Mathisen believed "any association between Risperdal and gynecomastia was rare" and never checked "Austin's prolactin levels" or examined him for gynecomastia. Trial Court Opinion, 8/11/2017, at 6 (citing N.T., 1/26/2015 (p.m.), at 104). Dr. Mathisen further testified that "he would have discussed the relationship between Risperdal and gynecomastia with Mrs. Pledger had he known of the data in Table 21." Id. In addition, Mrs. Pledger testified that had she known about the risk of gynecomastia, she would not have permitted Austin to take Risperdal. N.T., 2/6/2015 (a.m.), at 58-59.

Janssen also vigorously contested causation; in other words, Janssen claimed that Austin's large chest area was not caused by his taking Risperdal. In order to prove that Austin did indeed have gynecomastia caused by Risperdal, the Pledgers presented the testimony of Dr. Mark Solomon.⁹

Dr. Solomon explained his medical opinion that the diagnosis of [ ] gynecomastia depends on the presence of

198 A.3d 1133

breast tissue and he explained that breast tissue is biologically not the same as fat tissue. He showed the jury the difference using medical slides. Dr. Solomon stated breast tissue growth does not go away on its own since it does not come from obesity which is characterized by fat cells that grow and recede depending on weight. Dr. Solomon testified that his own physical examination of Austin confirmed the presence of breast tissue inside Austin's breasts. Dr. Solomon said Austin had been on Risperdal for several years and his medical records had reported no other causal agent. He said female breasts in boys develop from the center and then spread outwards. The areola grows first and then breast tissue multiplies around the areola to form gynecomastia. Dr. Solomon told the jury that a picture of Austin shows what he termed "end stage growth." Pointing at the 2005 picture of 11[-]year[-]old bare[-]chested Austin coming out of a swimming pool, Dr. Solomon testified, "That's a full breast. That's not a little nipple out pouch. In 2005, he was 11 that would be the beginning of puberty. So if it were pubertal in origin, you would see a little pouch of a nipple, not an outline of a breast." (N.T., 2/9/[20]15, [at] 66.)

Trial Court Opinion, 8/11/2017, at 27-28.

Janssen conceded that Austin had gynecomastia, but also contended that Austin had a condition called pseudogynecomastia, "a disease category diagnosed by some physicians who link obesity and fat to the development of feminine looking breasts in boys." Id. at 28. According to defense expert, Dr. Tom Vaughn, III, an endocrinologist, Austin had both gynecomastia and pseudogynecomastia. N.T., 2/18/2015 (a.m.), at 105. Dr. Vaughn testified that pseudogynecomastia is "obesity... in the chest, and sometimes it can look very much like breast tissue." Id. at 104. Dr. Vaughn stated that Risperdal caused Austin's weight gain, which caused his pseudogynecomastia. Id. at 107. In addition, Dr. Vaughn testified that he could not tell from the 2005 picture whether Austin had gynecomastia or pseudogynecomastia at that point. N.T., 2/18/2015 (p.m.), at 13.

In addition to the foregoing, Janssen suggested that even if Austin's large chest area at that time were gynecomastia, it was not caused by Risperdal. Dr. Vaughn testified that Austin's gynecomastia was not caused by Risperdal, but instead was caused by puberty. N.T., 2/18/2015 (p.m.), at 33-37.

On the other hand, the Pledgers relied upon Dr. Solomon's testimony. He testified that

to a reasonable degree of medical certainty ... Austin's ingestion of Risperdal caused his gynecomastia.... Dr. Solomon said he

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