224 A.3d 1
Pa. Super. Ct.2019Background
- A.Y., born 1999, was prescribed Risperdal (risperidone) off-label at age 4½ and developed persistent gynecomastia; plaintiffs sued Janssen for failure to warn and related claims.
- Janssen had internal clinical data (Table 21) and studies by the early 2000s showing elevated prolactin and higher rates of gynecomastia in juvenile males but did not disclose that data on the label or to the FDA.
- The trial court applied Tennessee substantive law to the claims; a jury found Janssen negligent for failing to warn A.Y.’s healthcare providers and awarded $70,000,000 in compensatory damages (molded to $76,661,027.40 including delay damages).
- Janssen appealed, arguing federal preemption, lack of proximate causation under the learned-intermediary doctrine, evidentiary and jury‑instruction errors, misapplication of Tennessee’s damage cap, and excessiveness of damages.
- The Superior Court affirmed the judgment on Janssen’s appeal, rejecting preemption and causation challenges and upholding evidentiary and charge rulings; it reversed the grant of partial summary judgment on punitive damages and remanded for a conflict‑of‑law analysis between Tennessee and New Jersey.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Federal preemption of state failure‑to‑warn claim | State tort duty to require a pediatric gynecomastia warning; CBE mechanism available; no FDA refusal shown | Impossibility preemption: federal law/regulations limit off‑label warnings and only FDA may require such warnings | Preemption defense fails; Janssen did not prove it was impossible to comply with both federal law and Tennessee law; Wyeth/Albrecht framework supports no preemption here |
| Proximate causation / learned intermediary | Physicians lacked knowledge of heightened juvenile risk; an adequate warning to physicians would have changed prescribing and prevented injury | Physicians knew risks or mother continued/resumed treatment, so label deficiency did not proximately cause harm | Evidence supported plaintiffs on proximate causation; testimony showed physicians would have acted differently; some alternative arguments waived by Janssen |
| Exclusion of Dr. Greeson testimony and limits on expert testimony about benefits/acts | (Janssen) testimony would show mother would have continued Risperdal despite warnings; expert could show benefits and lack of emotional harm | Trial court: testimony attenuated or speculative, and expert lacked foundation to opine on plaintiff's emotional state from records | No abuse of discretion; exclusions were not prejudicial given other testimony about benefits and A.Y.’s emotional harm |
| Jury instruction on the learned intermediary rule | Janssen sought explicit instruction that warnings are owed to physicians (not patients) and jury must assess physician awareness | Plaintiffs: pattern Tennessee instruction and verdict form sufficiently directed jury to healthcare providers | Charge and verdict form, read together, adequately informed jury that warnings were measured against physicians; no reversible error |
| Tennessee non‑economic damages cap and concealment exception | Plaintiffs invoked statutory exception (intentional falsify/destroy/conceal records to wrongfully evade liability) to avoid $750,000 cap based on concealment of Table 21 and reanalysis | Janssen argued exception applies only to in‑case discovery spoliation, not pre‑litigation concealment | Court properly instructed jury on concealment exception; sufficient evidence supported letting jury decide whether exception applied |
| Excessiveness of compensatory damages | Plaintiffs: permanent disfigurement, lifelong humiliation, loss of enjoyment warrant large non‑economic award | Janssen: $70M is grossly excessive and unsupported (no physical pain, little economic loss) | No abuse of discretion; jury’s award for permanent disfigurement and emotional harm sustained |
| Punitive damages—conflict of law (plaintiffs' cross‑appeal) | Trial court erred applying New Jersey law (which bars punitive awards) without considering plaintiffs’ home‑state (Tennessee) interest | Janssen relied on trial court’s choice of New Jersey law | Reversed and remanded: trial court must analyze conflict‑of‑law principles between Tennessee and New Jersey before deciding availability of punitive damages |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (2009) (manufacturers bear primary responsibility for labeling; CBE mechanism and preemption standards)
- Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019) (clarifies manufacturer duty to update warnings and the demanding standard for impossibility preemption)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (presumption against preemption in fields of traditional state regulation)
- Altria Group, Inc. v. Good, 555 U.S. 70 (2008) (starts preemption analysis with presumption against displacement of state police powers)
- Lake v. Memphis Landsmen, LLC, 405 S.W.3d 47 (Tenn. 2013) (discusses preemption and the role of state regulatory interests)
- Pittman v. Upjohn Co., 890 S.W.2d 425 (Tenn. 1994) (articulates Tennessee learned intermediary doctrine)
- Hassett v. Dafoe, 74 A.3d 202 (Pa. Super. 2013) (discusses presumption against federal preemption under Pennsylvania law)