Maya v. Johnson & Johnson, 97 A.3d 1203

Background

Three-year-old Brianna Maya developed a rash, then rapidly progressive Stevens–Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) after receiving OTC Children’s Motrin (ibuprofen) and shortly thereafter an antibiotic (Pediazole); she suffered severe, lifelong injuries.
Mother, Alicia Maya, read the Motrin label and followed pediatrician Dr. Brewer’s advice to alternate Motrin and Tylenol; she testified she would have stopped Motrin or not purchased it had the label warned of "rash/blisters" or instructed to "stop use."
Plaintiffs sued McNeil‑PPC for negligent failure to warn (plus other claims); after a nine‑week jury trial, jury awarded $10 million on the negligent failure to warn claim and found for McNeil on design defect and punitive damages.
McNeil appealed, raising claims including preemption/label drafting by FDA, failure‑to‑prove causation (that stronger warnings would have prevented further dosing), evidentiary rulings, jury instructions (heeding presumption, concurrent causes, instruction about other drugs/manufacturers), and alleged counsel misconduct.
Trial court denied post‑trial relief; the appellate court reviewed the record under the standard that evidence must be viewed in the light most favorable to the verdict winner and will disturb verdicts only in clear cases.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Failure to warn / FDA drafting of label (preemption)	Motrin manufacturer owes continuous duty to maintain adequate warnings; label lacked specific SJS/TEN language and did not tell consumers to stop use at rash onset.	FDA drafted the Allergy Alert and rejected McNeil’s proposed stronger language; McNeil cannot be negligent for not adding warnings the FDA did not require.	Court rejected preemption defense; manufacturer remains responsible for label contents (Wyeth principle). Jury question on negligence appropriate.
Causation: would added warnings have prevented/mitigated injury	Mrs. Maya testified she would not have purchased or would have stopped Motrin at first rash; experts opined earlier cessation improves prognosis.	Mrs. Maya relied on Dr. Brewer’s advice and would have followed the physician, so a label change would not have altered outcome.	Held there was sufficient evidence for a reasonable juror to find that an adequate warning would have prevented several later doses and likely lessened injury.
Admission/exclusion of evidence re: physician’s personal SJS history	Plaintiffs suggested Dr. Brewer was unaware of rash→SJS link; McNeil sought to show Dr. Brewer had SJS previously to rebut that claim.	Evidence of Dr. Brewer’s prior SJS would show she knew rash significance and thus would have advised stopping Motrin.	Exclusion upheld: deposition showed physician didn’t know ibuprofen caused SJS; prior SJS did not prove she knew rash always precedes SJS and was therefore irrelevant.
Heeding presumption jury instruction	Plaintiffs could benefit but plaintiffs’ testimony made presumption unnecessary; jury could infer plaintiff would heed an adequate warning.	McNeil argued trial court’s announced (but not given) plan to instruct on heeding presumption affected defense closing and prejudiced McNeil.	Failure to give the presumption was not reversible error: omission was waived by defense (no timely objection/reopen) and presumption was unnecessary given direct testimony.
Concurrent/concurring‑causes instruction (multiple agents)	Plaintiffs argued Motrin could have substantially contributed even if another agent also contributed.	McNeil objected to allowing consideration of combined causation absent testimony of multiple‑agent causation.	Instruction allowed: evidence supported possibility that Motrin and another agent (e.g., sulfisoxazole) combined to cause SJS/TEN; concurrent cause instruction proper.
Jury instruction about other drugs/manufacturers (word omitted)	Plaintiffs used comparators (other drugs withdrawn, AERs) relevant to defective design and notice.	McNeil requested an instruction that jury may NOT consider other drugs/companies; trial court instead (apparently) stated jury MAY consider them, causing defense exceptions.	Any erroneous phrasing was harmless: instruction related mainly to claims the jury resolved for McNeil; no prejudice shown requiring new trial.
Evidentiary rulings: post‑2000 AERs, rejected FDA warnings, ads, foreign regulatory matters	Plaintiffs used AERs, later labels, ads, and foreign matters to show notice, feasibility of warnings, and corporate knowledge.	McNeil argued post‑injury AERs and foreign/regulatory matters were irrelevant and prejudicial.	Court allowed limited use: AERs admitted for notice (not causation); rejected‑warning evidence and foreign matters were constrained by jury instructions; admission not reversible error.
Counsel misconduct / request for new trial	Plaintiffs emphasized company size, attorneys, and argued systemic regulatory failures, but jury still found for McNeil on other claims.	McNeil argued inflammatory "David vs Goliath" themes and repeated improper questions prejudiced jury.	Denied: trial court (which observed trial) found no incurable prejudice; verdicts for McNeil on two claims undermined claim of passion‑based verdict.

Key Cases Cited

Wyeth v. Levine, 555 U.S. 555 (manufacturers remain responsible to craft and maintain adequate labels)
Cochran v. Wyeth, Inc., 3 A.3d 673 (Pa.Super. 2010) (proximate cause in failure‑to‑warn requires showing adequate warning would have prevented use)
Daniel v. Wyeth, 15 A.3d 909 (Pa.Super. 2011) (jury may decide adequacy of pre‑market testing/labeling despite FDA compliance)
Coward v. Owens‑Corning Fiberglas Corp., 729 A.2d 614 (Pa.Super. 1999) (heeding presumption doctrine explained)
Lonasco v. A‑Best Products Co., 757 A.2d 367 (Pa.Super. 2000) (discussion of rebuttable heeding presumption)
Lilley v. Johns‑Manville Corp., 596 A.2d 203 (Pa.Super. 1991) (concurrent causes and substantial contributing factor principles)