Gurley, B. v. Janssen Pharmaceuticals, Inc.
113 A.3d 283
Pa. Super. Ct.2015Background
- Haley Powell (patient) was prescribed Topamax (by Janssen) from March 2006 until she stopped in December 2007 after learning she was pregnant; her son Brayden was born with a unilateral cleft lip and related oral defects.
- Plaintiffs sued Janssen for negligent failure to warn physicians of Topamax’s risk of birth defects (state-law products-liability failure-to-warn claim).
- Pretrial: court granted partial summary judgment for Janssen on several claims and barred plaintiffs from arguing Janssen could unilaterally change Topamax’s FDA pregnancy category; plaintiffs were still allowed to argue Janssen could have sought a label change from the FDA.
- Jury trial resulted in a verdict for plaintiffs: $10,955,000 (non-economic and future health care), later increased by delay damages to a judgment of $11,655,294.62. Janssen appealed.
- On appeal Janssen raised three principal issues: federal preemption of the state failure-to-warn claim; insufficiency of causation evidence; and excessiveness of the noneconomic damages award. The Superior Court affirmed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Federal preemption of state failure-to-warn claim | Janssen could have or should have warned; state-law duty enforceable | Federal regulation preempts because Janssen could not unilaterally change FDA labeling/pregnancy category | Court: Wyeth controls; no preemption as plaintiffs did not rely on unilateral pregnancy-category change and absent clear evidence FDA would have rejected a warning, state claim stands |
| Causation (learned intermediary; prescription obtained via mother’s Rx) | Dr. Warner would have considered a cleft risk and likely not prescribed Topamax had he known; Haley took Topamax continuously | Haley obtained some pills under her mother’s prescription and dosage differences break causation link to Dr. Warner | Court: Sufficient evidence (physician testimony and patient use) to submit causation to the jury; Janssen’s arguments do not defeat proximate cause |
| FDA would have rejected a labeling change | Plaintiffs’ proposed warning was reasonable and would have influenced prescribing | FDA previously declined Janssen’s PPI language; that is clear evidence FDA would not have approved a warning linking Topamax to oral clefts | Court: Janssen’s cited PPI history did not show clear evidence FDA would have rejected a prescriber-label warning about clefts; preemption not established |
| Excessiveness of noneconomic damages | Brayden’s ongoing treatments and future surgeries justify large award | The repaired cleft and modest visible scarring do not support $10.62M noneconomic award; remittitur warranted | Court: Award not excessive given severity, permanence, objective evidence, ongoing treatments; trial court did not abuse discretion |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (2009) (state failure-to-warn claims are not preempted where manufacturer could have strengthened warnings under FDA regulations absent clear evidence FDA would have forbidden the change)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (federal preemption may apply differently to generic manufacturers because they must match brand labeling)
- Maya v. Johnson & Johnson, 97 A.3d 1203 (Pa. Super. 2014) (Wyeth applied in Pennsylvania to reject preemption defense to a brand-name failure-to-warn claim)
- Braun v. Wal–Mart Stores, Inc., 24 A.3d 875 (Pa. Super. 2011) (standards for JNOV review and deference to jury verdict)
- Renna v. Schadt, 64 A.3d 658 (Pa. Super. 2013) (standard for reviewing excessiveness/remittitur of jury noneconomic-damage awards)