Stange, T. v. Janssen Pharmaceuticals
179 A.3d 45
Pa. Super. Ct.2018Background
- Timothy Stange, prescribed Risperdal (risperidone) as an adolescent for Tourette’s, developed gynecomastia and underwent bilateral mastectomy; he sued Janssen claiming negligent failure to warn and strict liability for failure to warn.
- Trial court dismissed most claims on summary judgment but permitted negligent-failure-to-warn and strict-liability-failure-to-warn claims to proceed; jury found Janssen negligent and awarded $500,000 compensatory plus delay damages for a $535,106.17 judgment.
- Evidence at trial showed Janssen had internal study data and meta-analysis results indicating elevated prolactin and non-trivial rates of gynecomastia in boys, but public labeling and promotional materials downplayed the risk.
- Plaintiff’s causation expert (Dr. Solomon) used differential diagnosis to attribute Stange’s gynecomastia to Risperdal despite lacking contemporaneous prolactin tests; defense argued the methodology and conclusions were speculative.
- Defense invoked learned-intermediary and physician-knowledge defenses (prescribing doctor testified he knew neuroleptics could raise prolactin and believed gynecomastia was rare/temporary).
- Coordinating judge had earlier entered a global partial summary judgment barring punitive damages under New Jersey law; Stange (a Wisconsin resident) challenged the global application and sought instruction on future emotional distress; the Superior Court affirmed in part, reversed in part, and remanded on punitive-damages choice-of-law.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Admissibility of expert causation testimony | Dr. Solomon’s differential-diagnosis opinion that Risperdal caused gynecomastia was reliable and sufficient without prolactin testing. | Expert lacked scientifically reliable methodology as applied and conclusions were speculative; Frye/FRE challenges. | Court: differential diagnosis is a generally accepted method; trial court did not abuse discretion admitting the testimony; weight for jury. |
| Proximate cause / learned intermediary | Janssen’s inadequate warnings caused the physician not to know the heightened risk; had he known, he would have chosen another drug. | Prescribing physician knew neuroleptics raise prolactin and would have prescribed regardless; thus inadequate label did not cause injury. | Court: sufficient evidence that Janssen’s misleading labeling concealed material risk and that physician would have chosen differently; proximate cause for jury. |
| Jury instruction on combined (joint) negligence | (Plaintiff did not press separate argument) | Janssen argued combined-negligence instruction could mislead jury to hold Janssen solely liable even if physician contributed by failing to read label or prescribing knowing the risk. | Court: Instruction accurately stated Wisconsin law on combined negligence and proximate-cause principles; no reversible error. |
| Punitive damages choice-of-law and future emotional distress instruction | Stange: trial court should have conducted plaintiff-specific choice-of-law (Wisconsin) before entering global NJ punitive-damages bar; also sought instruction on future emotional distress from bullying. | Janssen: global application of New Jersey (or Pennsylvania) law appropriate; plaintiff failed to prove future emotional distress was reasonably certain. | Court: Remanded punitive-damages issue for plaintiff-specific choice-of-law analysis (Griffith factors); rejected instruction on future emotional distress because plaintiff failed to prove reasonably certain future harm. |
Key Cases Cited
- Polett v. Public Communications, Inc., 83 A.3d 205 (Pa. Super. 2013) (standard for JNOV and appellate review of post-trial motions)
- Drake Mfg. Co. v. Polyflow, Inc., 109 A.3d 250 (Pa. Super. 2015) (standards for reviewing directed verdict and JNOV)
- Daniel v. Wyeth, 15 A.3d 909 (Pa. Super. 2011) (Rule 702 expert qualification and assistance to the jury)
- Grady v. Frito-Lay, Inc., 839 A.2d 1038 (Pa. 2003) (proponent must show Frye requirements for novel scientific evidence under Rule 702)
- Trach v. Fellin, 817 A.2d 1102 (Pa. Super. 2003) (Frye limited to novel scientific evidence; differential diagnosis not novel)
- Cummins v. Rosa, 846 A.2d 148 (Pa. Super. 2004) (differential diagnosis admissibility and Frye inapplicability)
- Griffith v. United Air Lines, Inc., 203 A.2d 796 (Pa. 1964) (choice-of-law framework combining government-interest and Restatement contacts)