93 F.4th 33
1st Cir.2024Background
- Plaintiffs, more than two dozen individuals, sued Genzyme Corporation for injuries alleged from Genzyme’s handling of a Fabrazyme drug shortage (2009–2012), the only FDA-approved treatment for Fabry disease at the time.
- Plaintiffs claim that as a result of reduced/contaminated doses, they suffered physical, financial, and health injuries (including worsening symptoms, sensitization, and financial loss).
- Previous related class actions (Hochendoner, Adamo) were consolidated and dismissed for lack of standing, except for claims by one plaintiff, later settled.
- Plaintiffs refiled in 2020, arguing that prior class actions, an Indiana “savings” statute, and a tolling agreement tolled or extended the limitations period for their claims.
- The district court dismissed most plaintiffs for lack of standing, dismissed the remaining four on the merits, but rejected Genzyme’s statute-of-limitations defense for some claims.
- On appeal, the First Circuit held all plaintiffs had standing, affirmed dismissal with prejudice for four (time-barred), reversed dismissal for the other twenty-two (not time-barred/still need to resolve limitations and Rule 12(b)(6) defenses).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Article III Standing | Allege specific injuries tied to defective doses/contaminants | Insufficient specificity; injuries not plausibly linked | Plaintiffs allege sufficient, individualized harm for standing |
| Subject Matter Jurisdiction (CAFA/§1332) | Met CAFA’s requirements for class actions | Lacks diversity/jurisdiction if class action fails | Jurisdiction exists at least at filing; CAFA jurisdiction premature issue |
| Statute of Limitations (Tolling – Class Action) | Prior class action tolls period for later individual suits | Indiana law doesn’t follow American Pipe tolling | No tolling under Indiana law for these claims |
| Statute of Limitations (Savings Statute/Journey’s) | Indiana law saves otherwise untimely refiled claims | Not same claim—new facts, new injuries | Statute does not apply to new, materially different claims |
| Tolling Agreement | Tolling agreement revives expired claims | Only pauses; doesn’t revive expired claims | Tolling agreement paused, but didn’t revive already expired claims |
Key Cases Cited
- Hochendoner v. Genzyme Corp., 823 F.3d 724 (1st Cir. 2016) (lack of specific injury allegations results in failure to establish Article III standing)
- Garside v. Osco Drug, Inc., 976 F.2d 77 (1st Cir. 1992) (product liability claims require individualized plausible claims of harm)
- Crown, Cork & Seal Co. v. Parker, 462 U.S. 345 (1983) (class action filing can toll limitations for putative class members, but only per federal law)
- American Pipe & Const. Co. v. Utah, 414 U.S. 538 (1974) (establishes tolling principle for federal class actions, but not incorporated by state law automatically)