Gustavesen v. Alcon Laboratories, Inc.
272 F. Supp. 3d 241
D. Mass.2017Background
- Plaintiffs (seven consumers from MA/NY) brought a putative class action against multiple brand and generic manufacturers/distributors of prescription ophthalmic drops, alleging the droppers were intentionally designed to deliver drops (2–3× larger than the eye can absorb) that waste medicine and increase systemic exposure.
- Causes of action: state consumer-protection claims (Mass. Ch. 93A plus analogous laws in other states) and restitution-type claims (unjust enrichment / money had and received) across multiple jurisdictions.
- Defendants filed an Omnibus Motion to Dismiss (arguing lack of Article III injury, preemption, and failure to state claims) and a Generic Motion (arguing additional preemption principles for generics). Plaintiffs sought to add FDA documents; the court denied most of that supplementation.
- Central legal dispute: whether FDA law and agency guidance preempt state-law duties that would require altering the approved dropper tip (a change to the container/container-closure system) without FDA preapproval.
- Court held that changes to the size/shape of a dropper tip for a sterile drug qualify as “major changes” under FDA regulations/guidance, which require prior FDA approval; because private parties cannot independently implement such changes, plaintiffs’ state-law design/consumer-protection and restitution claims were preempted under the impossibility-preemption doctrine.
- Result: Omnibus Motion allowed; case dismissed. Generic Motion rendered moot; plaintiffs’ request to file supplemental exhibits denied.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether plaintiffs’ state-law claims are preempted by federal law (impossibility preemption) | State law can require safer/less-wasteful dropper design; defendants could have or should redesign dropper tips to deliver ≤15 µL | FDA regs and guidance treat changes to container/container-closure systems for sterile products (including dropper size/shape) as “major changes” requiring prior FDA approval, so defendants cannot unilaterally comply with such state duties | Held preempted: plaintiffs’ claims conflict with federal law because defendants cannot independently make the required changes without FDA approval; dismissal granted |
| Whether claims based on pre-approval conduct (i.e., manufacturer should have initially submitted a different design) avoid preemption | Plaintiffs: duties to design safer products before approval are not preempted; pre-approval design claims should survive | Defendants: such a theory is too attenuated or would amount to a “never-start-selling” rule that Bartlett and Pliva reject; marketing a redesigned product would still require FDA approval | Court favored defendants (aligning with Pliva/Bartlett/Yates): pre-approval alternative is insufficient to avoid impossibility preemption |
| Whether generics face additional, specific preemption (sameness duty) | Plaintiffs argued claims apply across brand and generic defendants | Generic Defendants argued generic-specific FDA duties (sameness) bar state-law design claims | Moot — court dismissed all claims on broader impossibility-preemption grounds, making the Generic Motion unnecessary |
| Whether plaintiffs may supplement the record with FDA documents showing agency practice | Plaintiffs sought to add FDA letters/labels to show the FDA sometimes allowed container changes via CBE | Defendants argued most documents are not proper on a 12(b)(6) record and do not change the legal interpretation of FDA guidance | Denied: court excluded private communications, considered public FDA materials, and concluded the proffered exhibits did not alter the regulatory interpretation supporting preemption |
Key Cases Cited
- Wyeth v. Levine, 555 U.S. 555 (2009) (CBE regulation can authorize unilateral safety label changes; preemption requires clear evidence FDA would have rejected change)
- Pliva, Inc. v. Mensing, 564 U.S. 604 (2011) (generic manufacturers’ duty of ‘‘sameness’’ can create impossibility preemption because they cannot unilaterally change labels)
- Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013) (state design-defect duties that would require altering generic drug composition or labeling conflict with federal law; ‘‘stop-selling’’ option does not avoid preemption)
- Eike v. Allergan, 850 F.3d 315 (7th Cir. 2017) (post-approval judicial second-guessing of FDA’s safety/efficacy determination for atypical eye-drop sizes is improper)
- Allentown Mack Sales & Serv., Inc. v. N.L.R.B., 522 U.S. 359 (1998) (courts should not substitute informal agency practice for the agency’s official position when interpreting regulations)