Leonard Cottrell v. Alcon Laboratories
2017 U.S. App. LEXIS 20341
3rd Cir.2017Background
- Manufacturers and distributors of prescription eye drops packaged in fixed-volume bottles with dropper tips; labeling does not indicate treatment duration or number of doses.
- Drops dispensed into the eye have varying sizes determined by droplet tips; larger drops lead to waste and possible systemic exposure.
- Scientific studies show inferior fornix capacity 7–10 microliters; drops exceeding this are wasted or expelled, reducing patient benefit.
- Studies indicate optimal drop sizes are 5–15 microliters to maximize eye-site drug delivery and minimize waste and side effects.
- Plaintiffs, who paid for the medications, allege that defendants’ design and dropper sizes waste medication and cause economic injury; an example from a 2008 study quantifies waste and cost.
- The District Court dismissed the case for lack of standing; plaintiffs appealed, and the Third Circuit is reviewing standing, with CAFA jurisdiction acknowledged.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether plaintiffs have standing to challenge alleged unfair practices. | Plaintiffs claim legally protected economic interests from wasted medication. | Defendants contend plaintiffs lack injury in fact. | Yes; plaintiffs have standing. |
| Whether alleged injuries are concrete, particularized, and actual or imminent. | Plaintiffs’ economic harms are concrete and personal. | Defendants argue injuries are speculative arrangements of market effects. | Plaintiffs’ injuries are concrete, particularized, and actual. |
| Whether the pricing theory of injury is too speculative given pharmaceutical pricing dynamics. | Pricing by reducing bottle volume could lower overall costs. | Market dynamics make such a causal link speculative. | Pricing theory sufficiently plausibly supports standing. |
| Whether the reimbursement theory of injury is cognizable under standing analysis. | Wasted medication translates to recoverable economic injury. | Theory resembles fraud-based injury, not applicable here. | Reimbursement theory deemed compatible with standing. |
| Whether the case is preempted by federal law. | Preemption should not bar standing analysis at this stage. | Major changes to dropper design require FDA approval; preemption may apply. | Preemption not decided on appeal due to record insufficiency. |
Key Cases Cited
- Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992) (establishes the injury-in-fact standard for standing)
- Spokeo, Inc. v. Robins, 136 S. Ct. 1540 (2016) (injury-in-fact must be concrete and particularized)
- In re Schering Plough Corp. Intron/Temodar Consumer Class Action, 678 F.3d 235 (3d Cir. 2012) (standing analysis separate from merits; ascertain injury-in-fact components)
- Steel Co. v. Citizens for a Better Env’t, 523 U.S. 83 (1998) (distinction between standing and merits; jurisdictional dismissal not based on merits)
- Danvers Motor Co., Inc. v. Ford Motor Co., 432 F.3d 286 (3d Cir. 2005) (standing inquiry separates from merits; investigates injury-in-fact)
- Osborn v. Visa Inc., 797 F.3d 1057 (D.C. Cir. 2015) (economic theories at pleading stage may be acceptable if plausible)