198 A.3d 1126
Pa. Super. Ct.2018Background
- Austin Pledger (born 1994) was prescribed Risperdal (risperidone) beginning in 2002 for behavioral symptoms of autism; physician warned of possible weight gain but Risperdal’s label then described gynecomastia as “rare.”
- Austin developed enlarged breasts while on Risperdal; plaintiffs alleged drug-induced gynecomastia caused by prolactin elevations and that Janssen concealed relevant data (including an internal "Table 21" showing increased risk).
- Plaintiffs sued Janssen in Philadelphia mass-tort litigation (filed 2012) alleging failure-to-warn negligence and punitive damages; trial began January 2015 and jury awarded $2.5 million to Austin in February 2015.
- Trial disputes included causation (drug-induced gynecomastia vs. puberty/obesity), adequacy of warnings under the learned-intermediary doctrine (Alabama substantive law applied), admissibility and substitution of experts mid-trial (Dr. Goldstein unavailable; plaintiffs substituted Dr. Mark Solomon), and scope of cross-examination with learned treatises.
- Post-trial matters: Janssen appealed denial of JNOV/new trial and other evidentiary rulings; plaintiffs appealed grant of partial summary judgment denying punitive damages (choice-of-law issue regarding New Jersey law).
Issues
| Issue | Pledger's Argument | Janssen's Argument | Held |
|---|---|---|---|
| Whether JNOV was required because plaintiffs failed to prove labeling-caused injury | Pledger: inadequate label and undisclosed internal data (Table 21) would have changed physician behavior and prevented injury | Janssen: prescribing physician had adequate knowledge (label noted prolactin increase) or later label updates broke causation | Court denied JNOV; evidence permitted reasonable jury finding that 2002 labeling omission caused injury |
| Whether plaintiffs could substitute experts mid-trial (Dr. Goldstein out; Dr. Solomon in) | Pledger: substitution due to extenuating circumstances (Goldstein’s unavailability/fears) and plaintiffs promptly produced new exam and deposition | Janssen: discovery violation and unfair surprise; sought exclusion/new trial | Court upheld substitution—trial court did not abuse discretion; circumstances excused nondisclosure and relief granted (no mistrial) |
| Admissibility/qualification of Dr. Solomon and methodology (diagnosis from photos, differential diagnosis) | Pledger: Solomon (plastic surgeon) used generally accepted differential-diagnosis methodology and clinical factors (history, photo, exam) to diagnose gynecomastia and causation | Janssen: Solomon not an endocrinologist; diagnosis from photo and lack of prolactin testing is unreliable/novel under Frye/Rule 702 | Court affirmed admissibility; methodology not novel, qualifications sufficient, weight for jury to decide |
| Cross-examination with learned treatises | Pledger: objected when Janssen sought to use an article Solomon had not relied upon | Janssen: needed to expose Solomon’s ignorance of literature to impeach qualification | Court found Janssen failed to lay foundation required for learned-treatise admissibility on cross; no reversible error |
| Jury instruction on proximate causation and concurrent causation | Pledger: instructions permitting liability where Janssen’s negligence contributed to harm were proper | Janssen: instruction omitted requiring plaintiffs to show a different warning would have prevented injury and improper concurrent-causation language | Court affirmed instructions as accurate under Alabama law; Janssen waived concurrent-causation objection at trial; instructions adequate overall |
| Plaintiffs’ appeal of punitive-damages summary judgment (choice of law) | Pledger: trial court should analyze conflict between New Jersey punitive-damages bar and plaintiffs’ home-state law (Alabama) | Janssen: New Jersey has dominant interest; plaintiffs waived detailed conflict record | Court reversed and remanded for individualized conflict-of-law analysis consistent with prior Superior Court decisions |
Key Cases Cited
- Stange v. Janssen Pharmaceuticals, Inc., 179 A.3d 45 (Pa. Super. 2018) (addresses admissibility of Dr. Solomon and Frye/Rule 702 issues for gynecomastia causation)
- Murray v. Janssen Pharmaceuticals, Inc., 180 A.3d 1235 (Pa. Super. 2018) (addresses learned-intermediary issues and conflict-of-law remand on punitive damages)
- Grady v. Frito-Lay, 839 A.2d 1038 (Pa. 2003) (sets standards for admissibility of expert scientific testimony under Frye/Rule 702)
- Trach v. Fellin, 817 A.2d 1102 (Pa. Super. 2003) (explains Frye applies to novel scientific evidence and distinguishes generally accepted methodologies)
- Cummins v. Rosa, 846 A.2d 148 (Pa. Super. 2004) (discusses differential diagnosis as an accepted methodology and remedy for erroneous admission is new trial)