Gustavsen v. Alcon Laboratories, Inc.
903 F.3d 1
1st Cir.2018Background
- Plaintiffs (Massachusetts and New York residents) sued manufacturers of prescription eye drops, alleging bottles dispense unnecessarily large drops (24–52 µL) vs. optimal 5–15 µL, causing wasted medication and potential adverse systemic effects.
- Plaintiffs alleged economic injury (overpayment) — up to $500–$1,000 per year per patient — and asserted state-law claims for unfair trade practices and unjust enrichment across multiple states.
- Defendants moved to dismiss for lack of Article III standing and, separately, on federal preemption grounds: they argued any required change to bottle dispensers would be a "major" change under FDA regulation 21 C.F.R. § 314.70(b) and therefore requires prior FDA approval, making state-law remediation impossible.
- The district court held plaintiffs had Article III standing but dismissed the state-law claims as preempted; plaintiffs appealed.
- The First Circuit affirmed: it found plaintiffs plausibly alleged economic injury for standing, and held that redesigning the dispenser to change drop volume is a "major" change under 21 C.F.R. § 314.70(b)(2)(vi), so state-law claims requiring such a change are preempted.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Article III standing | Plaintiffs alleged concrete, particularized economic harm from overpaying due to large drops | Injury speculative because savings depend on manufacturers not raising prices or FDA/physician actions | Plaintiffs have standing: plausible out-of-pocket loss alleged; causation and redressability met |
| Preemption (major vs. non-major change) | Requiring smaller drops is a design change not necessarily requiring FDA pre-approval; past industry changes occurred without approval | Changing dispenser drop volume is a "major" change under 21 C.F.R. § 314.70(b)(2)(vi) (container closure system that controls drug delivery) and thus requires FDA approval | Change fits the regulatory category for major changes; state-law requirements to effect that change are preempted |
| Interpretation of 21 C.F.R. § 314.70(b)(2) scope | The provision should be read narrowly; only type/composition changes (not metering characteristics) are covered | The regulation covers container-closure-system changes that control amount delivered; drop size is an amount-control characteristic | Court reads (b)(2) as listing major-change categories; container-closure changes that control dose amount are major |
| Reliance on agency practice/instances of past approvals | Plaintiffs point to examples where drop size changes were implemented or processed as moderate/minor | Defendants say isolated approvals or non-enforcement by mid-level reviewers don't override regulation's plain meaning | Court gives limited weight to sporadic agency actions; grants primacy to regulatory text and guidance indicating container-closure systems that control delivered amount are major changes |
Key Cases Cited
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (preemption when private party cannot comply with state law without federal pre-approval)
- Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (impossibility preemption in pharmaceutical context)
- Wyeth v. Levine, 555 U.S. 555 (manufacturer can avoid preemption only by clear evidence FDA would have rejected change)
- In re Celexa & Lexapro Mktg. & Sales Practices Litig., 779 F.3d 34 (First Circuit preemption principles for FDA-regulated products)
- Cottrell v. Alcon Labs., 874 F.3d 154 (Third Circuit decision reaching similar standing/conclusion)
- Eike v. Allergen, 850 F.3d 315 (Seventh Circuit decision addressing similar claims)
- Lujan v. Defenders of Wildlife, 504 U.S. 555 (standing fundamentals)