638 F.3d 401 (2nd Cir. 2011), 10-4630-cv, Cacchillo v. Insmed, Inc.

Docket Nº:10-4630-cv.
Citation:638 F.3d 401
Opinion Judge:WESLEY, Circuit Judge:
Party Name:Angeline CACCHILLO, Plaintiff-Appellant, v. INSMED, INC., Defendant-Appellee.
Attorney:Kevin A. Luibrand, Albany, NY, for Plaintiff-Appellant. Robert P. Charrow (Laura Metcoff Klaus, Cynthia E. Neidl, on the brief), Greenberg Traurig LLP, Washington, D.C., for Defendant-Appellee.
Judge Panel:Before: WESLEY, CHIN, and LOHIER, JR., Circuit Judges.
Case Date:March 23, 2011
Court:United States Courts of Appeals, Court of Appeals for the Second Circuit

Page 401

638 F.3d 401 (2nd Cir. 2011)

Angeline CACCHILLO, Plaintiff-Appellant,


INSMED, INC., Defendant-Appellee.

No. 10-4630-cv.

United States Court of Appeals, Second Circuit.

March 23, 2011

Argued: March 15, 2011.

Page 402

Kevin A. Luibrand, Albany, NY, for Plaintiff-Appellant.

Page 403

Robert P. Charrow (Laura Metcoff Klaus, Cynthia E. Neidl, on the brief), Greenberg Traurig LLP, Washington, D.C., for Defendant-Appellee.

Before: WESLEY, CHIN, and LOHIER, JR., Circuit Judges.

WESLEY, Circuit Judge:

Plaintiff-Appellant Angeline Cacchillo appeals from an October 22, 2010 order of the United States District Court for the Northern District of New York (McAvoy, J. ) denying Cacchillo's motion for a preliminary injunction for lack of standing. For the reasons stated below, we find that Cacchillo has standing to pursue a preliminary injunction and that her claim, contrary to Defendant-Appellee Insmed Inc.'s (" Insmed" ) suggestion, is ripe for review. We nevertheless AFFIRM because Cacchillo has not met her burden to obtain the preliminary injunction because she has not shown the requisite likelihood of success on the merits.


Cacchillo suffers from Type 1 Myotonic Muscular Dystrophy (" MMD1" ). From February 2008 to August 2008, Cacchillo took Insmed's drug IPLEX while participating in a clinical trial for MMD1 patients. Cacchillo felt her condition greatly improved while on IPLEX and brought this action in part because she hopes to resume taking IPLEX.

The Food and Drug Administration (" FDA" ) has not approved IPLEX for general use. As a result, Cacchillo cannot resume IPLEX treatment unless she receives a special authorization— known as a " compassionate use" exception— from the FDA. Cacchillo contends that before she may file a compassionate use application, Insmed— as the manufacturer of IPLEX— must provide her with a form to be forwarded to the FDA stating that Insmed will provide Cacchillo with IPLEX in the event her application is approved. Insmed has refused to participate in this process. Further complicating matters, IPLEX is no longer produced, only limited stores of IPLEX remain and, according to Insmed, all remaining IPLEX has been committed to patients with amyotrophic lateral sclerosis (" ALS" ).

Cacchillo asserts that Insmed agreed to support her FDA compassionate use application and is now in breach of that agreement. Cacchillo commenced this action asserting claims pursuant to 42 U.S.C. § 1983 and New York State common law challenging Insmed's refusal to support her application. Cacchillo moved for a preliminary injunction requiring Insmed to:

(1) " provide to Angeline Cacchillo a written statement directed to the United States Food and Drug Administration ... in a form customary for such submissions supporting the ‘ compassionate use’ of ... IPLEX for Angeline Cacchillo, stating that Insmed, Inc. will, without reservation, provide Angeline Cacchillo the medication IPLEX at cost upon the granting of her compassionate use application by the FDA; " and (2) " directing Insmed, Inc., in the event that Angeline Cacchillo's application is granted by the FDA, to provide Angeline Cacchillo IPLEX...."

Insmed opposed the motion, arguing, among other things, that Cacchillo lacked standing to pursue a preliminary injunction because her injury cannot be redressed when the remaining stores of IPLEX have already been committed to ALS patients. The district court agreed and denied Cacchillo's motion.

On appeal, Insmed contends that Cacchillo cannot establish either standing or ripeness to pursue a preliminary injunction.

Page 404

We disagree, but nevertheless affirm the district court's opinion on the ground that Cacchillo has not shown that she is likely to succeed on the merits.1


A. Standing

Generally, " [s]tanding is a federal jurisdictional question ‘ determining the power of the court to entertain the suit.’ " Carver v. City of New York, 621 F.3d 221, 225 (2d Cir.2010) (quoting Warth v. Seldin, 422 U.S. 490, 498, 95 S.Ct. 2197, 45 L.Ed.2d 343 (1975)). In particular, " a plaintiff must demonstrate standing for each claim and form of relief sought." Baur v. Veneman, 352 F.3d 625, 642 n. 15 (2d Cir.2003). Thus, in order to seek injunctive relief, a plaintiff must show the three familiar elements of standing: injury in fact, causation, and redressability. Summers v. Earth Island Inst., 555 U.S. 488, 129 S.Ct. 1142, 1149, 173 L.Ed.2d 1 (2009) (citation omitted). We review the legal questions of whether a plaintiff has standing de novo. Shain v. Ellison, 356 F.3d 211, 214 (2d Cir.2004).

A plaintiff's burden to demonstrate standing increases over the course of litigation. Lujan v. Defenders of Wildlife, 504 U.S. 555, 561, 112 S.Ct. 2130, 119 L.Ed.2d 351 (1992). " [E]ach element [of standing] must be supported in the same way as any other matter on which the plaintiff bears the burden of proof, i.e., with the manner and degree of evidence required at the successive stages of the litigation." Id. When a preliminary injunction is sought, a plaintiff's burden to demonstrate standing " will normally be no less than that required on a motion for summary judgment." Lujan v. Nat'l Wildlife Fed'n (Lujan I), 497 U.S. 871, 907 n. 8, 110 S.Ct. 3177, 111 L.Ed.2d 695 (1990). Accordingly, to establish standing for a preliminary injunction, a plaintiff cannot " rest on such ‘ mere allegations,’ [as would be appropriate at the pleading stage] but must ‘ set forth’ by affidavit or other evidence ‘ specific facts,’ which for purposes of the summary judgment motion will be taken to be true." Lujan, 504 U.S. at 561, 112 S.Ct. 2130 (internal citation omitted).

Here, Cacchillo's injury in fact is that in breach of an alleged agreement between herself...

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