993 F. Supp. 2d 1007
E.D. Mo.2014Background
- Plaintiff Francine Thompson filed a putative class action under Missouri law after purchasing Restasis single-use ophthalmic vials, alleging the manufacturer overfills vials (≈14 drops) so consumers must buy more medicine than they can lawfully/usefully use (label directs single use and discard after opening).
- Plaintiff alleges overfilling is unnecessary, raises price, and causes economic harm; she asserts claims under the Missouri Merchandising Practices Act (MMPA), unjust enrichment, and money had and received, seeking damages and injunctive/declaratory relief.
- The FDA reviewed Restasis’s New Drug Application and explained that additional volume aids correct administration and is needed for product stability; FDA guidance states decreases in fill volume require a prior-approval supplement.
- Defendants moved to dismiss under Rule 12(b)(6) (failure to state a claim), argued Rule 9(b) and ascertainable-loss defects, and alternatively argued federal preemption because reducing vial fill would require FDA approval and thus make state-law compliance impossible.
- The court considered publicly available FDA memoranda and guidance on the motion-to-dismiss record, evaluated MMPA ascertainable-loss (benefit-of-the-bargain) doctrine, and analyzed impossibility preemption under Supreme Court precedent (PLIVA and Bartlett).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether complaint states an MMPA claim (ascertainable loss) | Thompson: overfilling forces purchasers to pay for unused medication, causing economic loss | Defendants: label discloses single-use; plaintiff received what she bargained for; no ascertainable loss alleged | Court: Dismissed — plaintiff failed to plead ascertainable loss; benefit-of-the-bargain received |
| Whether Rule 9(b) or Twombly/Iqbal pleading standards defeat the complaint | Thompson: claims are not fraud-based; Defendants’ FDA materials are outside the pleadings | Defendants: allegations implausible given FDA rationale; heightened pleading applies if fraud alleged | Court: Considered FDA public records; found complaint otherwise deficient on merits (ascertainable loss) without needing 9(b) outcome |
| Whether FDA materials render plaintiff’s theory implausible on face of complaint | Thompson: FDA materials are outside the pleadings and do not defeat plausibility | Defendants: FDA stated overfill is needed for dosing and stability, undermining claim of no valid reason for overfill | Court: FDA memo did not alone make claim implausible but did inform analysis; still proceeded to MMPA analysis |
| Whether state-law claims are preempted by federal law (impossibility preemption) | Thompson: defendants cannot meet burden to show FDA would have rejected a fill-volume reduction; factual issue exists | Defendants: changing fill volume is a major change requiring FDA prior approval; thus compliance with state duty impossible without agency permission | Court: Held preemption applies — reducing fill is a major change requiring prior FDA approval, so state-law duties are preempted |
Key Cases Cited
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (pleading standard for plausibility)
- Ashcroft v. Iqbal, 556 U.S. 662 (application of plausibility standard and rejecting conclusory allegations)
- PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (generic-drug claims preempted where federal law bars independent label changes)
- Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (preemption extends to design/change claims because major changes require FDA approval)
- Freightliner Corp. v. Myrick, 514 U.S. 280 (state-federal conflict and impossibility preemption principles)