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Angeline Cacchillo v. Insmed

March 23, 2011

ANGELINE CACCHILLO, PLAINTIFF-APPELLANT,
v.
INSMED, INC., DEFENDANT-APPELLEE.



Appeal from an order of the United States District Court for the Northern District of New York (McAvoy, J.) entered on October 22, 2010, denying Plaintiff-Appellant Angeline Cacchillo's motion for a preliminary injunction.

The opinion of the court was delivered by: Wesley, Circuit Judge:

10-4630-cv

Cacchillo v. Insmed, Inc.

Argued: March 15, 2011

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

AFFIRMED.

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.

18 Background

19 Cacchillo suffers from Type 1 Myotonic Muscular 20 Dystrophy ("MMD1"). From February 2008 to August 2008, 21 Cacchillo took Insmed's drug IPLEX while participating in a 22 clinical trial for MMD1 patients. Cacchillo felt her 23 condition greatly improved while on IPLEX and brought this 24 action in part because she hopes to resume taking IPLEX.

1 The Food and Drug Administration ("FDA") has not 2 approved IPLEX for general use. As a result, Cacchillo 3 cannot resume IPLEX treatment unless she receives a special 4 authorization - known as a "compassionate use" exception - 5 from the FDA. Cacchillo contends that before she may file a 6 compassionate use application, Insmed - as the manufacturer 7 of IPLEX - must provide her with a form to be forwarded to 8 the FDA stating that Insmed will provide Cacchillo with 9 IPLEX in the event her application is approved. Insmed has 10 refused to participate in this process.

Further complicating matters, IPLEX is no longer produced, only 12 limited stores of IPLEX remain and, according to Insmed, all 13 remaining IPLEX has been committed to patients with 14 amyotrophic lateral sclerosis ("ALS").

15 Cacchillo asserts that Insmed agreed to support her FDA 16 compassionate use application and is now in breach of that 17 agreement. Cacchillo commenced this action asserting claims 18 pursuant to 42 U.S.C. § 1983 and New York State common law 19 challenging Insmed's refusal to support her application.

Cacchillo moved for a preliminary injunction requiring Insmed to:

1 (1) "provide to Angeline Cacchillo a 2 written statement directed to the United 3 States Food and Drug Administration . . . 4 in a form customary for such submissions 5 supporting the 'compassionate use' of . 6 . IPLEX for Angeline Cacchillo, stating 7 that Insmed, Inc. will, without 8 reservation, provide Angeline Cacchillo 9 the medication IPLEX at cost upon the 10 granting of her compassionate use 11 application by the FDA;" and (2) 12 "directing Insmed, Inc., in the ...


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