214 A.3d 709
Pa. Super. Ct.2019Background
- T.M., began taking Risperdal off-label as a child (age 7) and developed gynecomastia after ~3.5 years of use; Plaintiffs sued Janssen for negligent failure to warn and fraud.
- Plaintiffs tried the case in Pennsylvania state court; Texas substantive law governs the merits (including the Texas Products Liability Act rebuttable presumption that FDA-approved labeling is adequate).
- Plaintiffs presented expert proof (Dr. David Kessler) based largely on Janssen’s own clinical studies showing elevated prolactin and a statistically significant association with prolactin-related adverse events including gynecomastia in boys. Plaintiffs’ causation expert (Dr. Mark Solomon) examined T.M. and concluded Risperdal caused his gynecomastia.
- Janssen obtained a compulsory nonsuit at the close of Plaintiffs’ case, arguing Plaintiffs failed under Texas standards (Havner/Garza) to present scientifically reliable causation proof—specifically, lacking two epidemiological studies showing a doubling of risk and similarity to study subjects.
- The trial court applied Texas’s Havner/Garza framework and granted nonsuit. Plaintiffs appealed to the Pennsylvania Superior Court.
- The Superior Court held that whether expert evidence is sufficient to survive nonsuit is a procedural matter governed by Pennsylvania law (Frye/Pa.R.E. 702), reversed the nonsuit, and remanded for a new trial.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the trial court properly entered a compulsory nonsuit for lack of scientifically reliable causation evidence | Frye/Pennsylvania governs admissibility/sufficiency of expert evidence; Plaintiffs had sufficient evidence (Janssen studies, experts) to reach a jury | Texas substantive law (Havner/Garza) controls sufficiency; plaintiffs had no two epidemiological studies showing >2.0 relative risk and thus no evidence of general/specific causation | Reversed: adequacy of proof to survive nonsuit is procedural and governed by Pennsylvania law; evidence was sufficient to make a prima facie failure-to-warn case and nonsuit was improper |
| Whether Havner/Garza require two epidemiological studies showing a doubling of risk as a substantive threshold in this case | Not applicable under Pennsylvania procedural rules; Havner is a Texas reliability test for epidemiology only when Texas procedure governs | Havner/Garza impose substantive evidentiary requirements for causation under Texas law that bar the case absent such studies | Court: Havner/Garza are Texas standards; but because Pennsylvania procedure governs the sufficiency/nonsuit question, those Texas-only “no-evidence” reweighing requirements should not control the nonsuit determination here |
| Whether Plaintiffs rebutted Texas’s TPLA presumption (FDA-approved label was adequate) | Plaintiffs produced evidence of Janssen’s off-label promotion to pediatric prescribers and evidence Janssen withheld/misrepresented prolactin/gynecomastia data to the FDA | Janssen argued plaintiffs failed to show promotion caused off-label use or that withheld information was causally related to injury | Held: Plaintiffs produced sufficient evidence to rebut the statutory presumption (promotion and withholding claims supported by testimony and Janssen’s own studies) |
| Admissibility exclusion of Dr. Solomon’s testimony about specific studies not listed in his report (fair scope issue) | Plaintiffs argued Janssen had prior access and was not prejudiced; the exclusion was improper | Janssen argued lack of fair notice violated Pa.R.C.P. 4003.5, justifying exclusion | Court did not reach merits of this evidentiary exclusion on appeal (remanded); noted preservation rules and that offer of proof is required to preserve exclusion error |
Key Cases Cited
- Pledger v. Janssen Pharms., Inc., 198 A.3d 1126 (Pa. Super. 2018) (background on corporate relationships among defendants)
- Murray v. Janssen Pharm., Inc., 180 A.3d 1235 (Pa. Super. 2018) (context of coordinated Risperdal litigation and gynecomastia claims)
- Merrell Dow Pharm., Inc. v. Havner, 953 S.W.2d 706 (Tex. 1997) (Texas standard re: scientific reliability of epidemiological evidence and the ‘‘doubling of the risk’’ threshold)
- Merck & Co. v. Garza, 347 S.W.3d 256 (Tex. 2011) (application of Havner to exclude epidemiological evidence that did not meet Havner standards)
- E.I. du Pont de Nemours & Co. v. Robinson, 923 S.W.2d 549 (Tex. 1995) (Robinson factors for assessing scientific evidence reliability under Texas law)
- Stange v. Janssen Pharm., Inc., 179 A.3d 45 (Pa. Super. 2018) (Pennsylvania view on procedural evidence issues and Frye)
- Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (U.S. 1993) (federal standard for judicial gatekeeping of scientific evidence)
- Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012) (learned intermediary doctrine for pharmaceutical failure-to-warn claims)
- Foley v. Pittsburgh-Des Moines Co., 68 A.2d 517 (Pa. 1949) (forum law governs whether an issue is procedural or substantive)