Hochendoner v. Genzyme Corporation
823 F.3d 724
| 1st Cir. | 2016Background
- Fabry disease is a rare genetic disorder; Mt. Sinai developed and licensed an enzyme replacement therapy (Fabrazyme) to Genzyme, which was the sole FDA-approved supplier in the U.S.
- From 2009–2012 Genzyme experienced manufacturing problems and shortages, rationed doses, and had at least one batch contaminated with particulate matter; some supply was diverted to Europe.
- Two consolidated class actions (Hochendoner and Adamo) sued Genzyme (and Mt. Sinai, later dropped) asserting multiple claims based on three theories: progression (return of baseline disease due to lack of full dosing), acceleration (reduced dosing caused accelerated/affirmative harm), and contaminant (harms from particulate-contaminated drug).
- The district court dismissed all claims under Rule 12(b)(6); on appeal plaintiffs challenge only the dismissals of the acceleration and contaminant theories.
- The court of appeals held that, except for named plaintiffs James Mooney and his wife, the complaints failed to plausibly plead Article III injury-in-fact (particularized, concrete harm) for the acceleration and contaminant claims and thus dismissed those plaintiffs for lack of standing.
- The court vacated and remanded Mooney’s claims for the district court to decide on the merits (Mooney alleged anaphylactic reaction upon resuming full-dose treatment tied to prior reduced dosing). The court directed the district court to clarify that dismissal for lack of standing operates without prejudice as to acceleration and contaminant claims; progression claims remain dismissed with prejudice.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Article III standing for acceleration & contaminant claims | Complaints sufficiently allege that named plaintiffs took Fabrazyme and suffered or are at risk of accelerated disease or harms from adulterated drug | Complaints lack plaintiff-specific facts linking any named plaintiff to accelerated injury or receipt of contaminated doses; thus no standing | Dismissed for lack of Article III standing for all named plaintiffs except Mooneys (complaints fail to plead particularized, concrete injury for these theories) |
| Particularized pleading requirement (injury-in-fact) | Generalized allegations about class-wide harms suffice to confer standing | Standing must be shown plaintiff-by-plaintiff and claim-by-claim; ‘‘standing is not dispensed in gross’’ | Court requires plausible, plaintiff-specific factual allegations for each claimed injury; generalized group allegations insufficient |
| Mooney’s individual claims | Mooney alleges specific facts: reduced dosing, later anaphylactic reactions on resuming full dose, and wife’s derivative consortium claim | Genzyme contends Mooney’s theory merely repackages a duty-to-supply theory and fails under Ohio law | Mooney (and spouse) plausibly alleged an injury-in-fact tied to anaphylactic reaction; dismissal of their claims vacated and remanded for district court to address merits and applicable law |
| Leave to amend & effect of dismissal | Plaintiffs urged leave to amend to add plaintiff-specific injuries | Genzyme noted plaintiffs had earlier opportunities and did not move to amend; district court did not err in not sua sponte ordering amendment | No abuse of discretion in not sua sponte granting leave to amend; dismissal for lack of Article III standing will operate without prejudice, progression claims remain dismissed with prejudice |
Key Cases Cited
- Katz v. Pershing, LLC, 672 F.3d 64 (1st Cir. 2012) (pleading facts incorporated by reference; standing review principles)
- Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992) (injury, causation, redressability standard; burden of pleading standing)
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (plausibility standard for pleadings)
- Spokeo, Inc. v. Robins, 578 U.S. 330 (2016) (concreteness and particularization requirements for injury-in-fact)
- Warth v. Seldin, 422 U.S. 490 (1975) (standing confines judiciary to cases and controversies; distinct from merits)
- Karvelas v. Melrose-Wakefield Hosp., 360 F.3d 220 (1st Cir. 2004) (district court not required to sua sponte grant leave to amend when none requested)