Cacchillo v. Insmed, Inc.
2011 U.S. App. LEXIS 5852
| 2d Cir. | 2011Background
- Cacchillo has Type 1 Myotonic Muscular Dystrophy and participated in Insmed's IPLEX clinical trial from Feb to Aug 2008.
- She alleges IPLEX improved her condition and seeks to resume treatment via FDA compassionate-use authorization.
- FDA approval for IPLEX is not general; compassionate-use requires Insmed to provide a supporting form to the FDA upon request.
- Insmed refused to participate, and IPLEX is no longer produced with remaining supply pledged to ALS patients.
- Cacchillo claims an agreement with Insmed to support her compassionate-use application and seeks a preliminary injunction demanding a supporting document and IPLEX delivery if approved.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Standing for injunctive relief | Cacchillo has injury in fact, causation, and redressability via Insmed’s promised document. | Injury is not redressable because IPLEX remaining is allocated to ALS patients; standing lacking. | Cacchillo has standing to pursue the injunction. |
| Ripeness of the injunction claim | Complaint alleges a current pledge to support her application and an existing sponsor. | Ripeness requires concrete sponsor/investigator; no sponsor evidence from Insmed. | Claim is ripe for consideration. |
| Likelihoo d of success on the merits | Insmed promised support for compassionate-use application and related documents. | No concrete evidence of an enforceable promise; mere site statements and agent’s statements are insufficient. | No likelihood of success on the merits. |
| Redressability and the underlying remedy | Court could compel Insmed to provide the document and perform promised actions. | Remedies depend on IPLEX availability and ALS allocations; redressability uncertain. | Redressability supports standing but does not ensure relief; merits defeat remains. |
| Impact of substantial delay or maturity of claims | Immediate action warranted to enable compassionate-use process. | Equitable and practical considerations weigh against injunction given uncertain efficacy and supply. | Court affirmed district court on standing/ripeness but upheld denial on merits. |
Key Cases Cited
- Summers v. Earth Island Inst., 555 U.S. 488 (2009) (standing elements for injunctions; redressability considerations)
- Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992) (standing burden for each claim; progressive evidentiary standard)
- Lujan v. Nat'l Wildlife Fed'n (Lujan I), 497 U.S. 871 (1990) (summary judgment-like standard for standing at early stages)
- Sprint Commc'ns Co. v. APCC Servs., Inc., 554 U.S. 269 (2008) (redressability and direct relief considerations)
- Allen v. Wright, 468 U.S. 737 (1984) (athief concerns about redressability; limitations on remedy)
- NXIVM Corp. v. Ross Inst., 364 F.3d 471 (2d Cir. 2004) (flexibility to affirm on alternative grounds)
- Thomas v. Union Carbide Agric. Prods. Co., 473 U.S. 568 (1985) (ripeness; timing and contingent future events)
- Shain v. Ellison, 356 F.3d 211 (2d Cir. 2004) (standing de novo on appeal; standard of review)