Trejo v. Johnson
13 Cal. App. 5th 110
Cal. Ct. App. 5th2017Background
- Christopher Trejo took OTC Motrin (ibuprofen) and developed Stevens-Johnson Syndrome / Toxic Epidermal Necrolysis (SJS/TEN); he sued McNeil (manufacturer) and Johnson & Johnson on failure-to-warn and design-defect theories.
- Plaintiff's failure-to-warn claim: Motrin label lacked specific reference to early SJS/TEN symptoms (skin reddening, rash, blisters); FDA issued a class label change in 2005 adding those symptoms.
- Plaintiff's design-defect theory: defendants should have marketed dexibuprofen (an isomer) instead of racemic ibuprofen; dexibuprofen was not FDA-approved in the U.S.
- Jury verdicts: McNeil liable for negligent failure to warn (but not strict liability failure to warn), and liable on negligent and strict-design-defect claims under the consumer-expectation test (not risk-benefit); J&J liable on strict-design-defect (consumer-expectation only).
- Appeal holdings: the court reversed negligent failure-to-warn verdict as irreconcilable with the not-guilty strict-liability failure-to-warn finding; found design-defect claims (based on substituting dexibuprofen) preempted under Bartlett; held consumer-expectation test inapplicable because the design issue required technical balancing beyond common juror knowledge.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Consistency between negligent and strict-liability failure-to-warn verdicts | Trejo: negligent finding stands; negligence and strict liability are distinct | McNeil: negligent verdict is fatally inconsistent with not liable on strict liability | Reversed negligent failure-to-warn verdict — special verdicts inconsistent; new trial on failure-to-warn claims against McNeil mandated |
| Completeness of negligent-failure-to-warn special verdict form | Trejo: existing questions and instructions suffice; omission immaterial | McNeil: form omitted essential element — whether a reasonable manufacturer would have warned | Reversed on alternative ground: verdict form defective for omitting question whether a reasonable manufacturer under same/similar circumstances would have warned |
| Design-defect theory (should have sold dexibuprofen) — federal preemption | Trejo: design claim viable despite FDA approval; dexibuprofen safer alternative | Defendants: state-law design-imposed duty to substitute active ingredient is impossible because FDA approval and new-drug rules prohibit unapproved reformulation; Bartlett preempts | Design-defect claims based on substituting dexibuprofen preempted under Bartlett; those claims cannot be retried |
| Applicability of consumer-expectation test for design defect | Trejo: ordinary consumers would not expect SJS/TEN from Motrin — consumer-expectation applies | Defendants: design question involves complex technical, feasibility and risk-benefit issues beyond common knowledge | Consumer-expectation test inapplicable here because resolving design defect required expert-driven balancing of feasibility, risk, and benefit; instruction was reversible error for those strict-liability findings |
Key Cases Cited
- Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (U.S. 2013) (state-law design duties that would require altering or stopping sale of an FDA‑approved drug can be preempted as impossible to comply with federal law)
- Brown v. Superior Court, 44 Cal.3d 1049 (Cal. 1988) (prescription drug manufacturers not strictly liable for design defects when drug properly prepared and accompanied by warnings known or knowable)
- Ramirez v. Plough, Inc., 6 Cal.4th 539 (Cal. 1993) (FDA safety judgments deserve serious consideration on whether withdrawing a drug was required; summary judgment posture distinguished from jury trial)
- Oxford v. Foster Wheeler LLC, 177 Cal.App.4th 700 (Cal. Ct. App. 2009) (special‑verdict negligence cannot stand when inconsistent with special‑verdict strict‑liability finding)
- Valentine v. Baxter Healthcare Corp., 68 Cal.App.4th 1467 (Cal. Ct. App. 1999) (strict‑liability duty to warn is broader than negligence duty; a verdict of no strict liability can preclude negligent‑warning liability)
- Soule v. General Motors Corp., 8 Cal.4th 548 (Cal. 1994) (consumer expectation test applies only when ordinary consumers can form minimum safety expectations; complex technical balancing requires expert-driven risk‑benefit analysis)
- Morson v. Superior Court, 90 Cal.App.4th 775 (Cal. Ct. App. 2001) (allergic/idiosyncratic reactions and medical‑chemical design questions fall beyond ordinary consumer expectations and require expert analysis)