Cacchillo v. Insmed, Inc.

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10-4630-cv
Cacchillo v. Insmed, Inc.
UNITED STATES COURT OF APPEALS 1
2
F OR THE S ECOND C IRCUIT 3
4
5
6
August Term, 2010 7
8
(Argued: March 15, 2011 Decided: March 23, 2011) 9
10
Docket No. 10-4630-cv 11
12
13
A NGELINE C ACCHILLO , 14
15
Plaintiff-Appellant, 16
17
–v.– 18
19
I NSMED , I NC ., 20
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Defendant-Appellee. 22
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24
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Before: 26
W ESLEY , C HIN , and L OHIER , J R ., Circuit Judges. 27
28
Appeal from an order of the United States District 29
Court for the Northern District of New York (McAvoy, J.) 30
entered on October 22, 2010, denying Plaintiff-Appellant 31
Angeline Cacchillo’s motion for a preliminary injunction. 32
33
A FFIRMED . 34
35
36
37
K EVIN A. L UIBRAND , Albany, N.Y., for Plaintiff- 38
Appellant. 39
40
R OBERT P. C HARROW (Laura Metcoff Klaus, Cynthia E. 41

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Neidl, on the brief), Greenberg Traurig LLP, 1
Washington, D.C., for Defendant-Appellee. 2
3
4
5
W ESLEY , Circuit Judge: 6
Plaintiff-Appellant Angeline Cacchillo appeals from an 7
October 22, 2010 order of the United States District Court 8
for the Northern District of New York (McAvoy, J.) denying 9
Cacchillo’s motion for a preliminary injunction for lack of 10
standing. For the reasons stated below, we find that 11
Cacchillo has standing to pursue a preliminary injunction 12
and that her claim, contrary to Defendant-Appellee Insmed 13
Inc.’s (“Insmed”) suggestion, is ripe for review. We 14
nevertheless AFFIRM because Cacchillo has not met her burden 15
to obtain the preliminary injunction because she has not 16
shown the requisite likelihood of success on the merits. 17
Background 18
Cacchillo suffers from Type 1 Myotonic Muscular 19
Dystrophy (“MMD1”). From February 2008 to August 2008, 20
Cacchillo took Insmed’s drug IPLEX while participating in a 21
clinical trial for MMD1 patients. Cacchillo felt her 22
condition greatly improved while on IPLEX and brought this 23
action in part because she hopes to resume taking IPLEX. 24

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The Food and Drug Administration (“FDA”) has not 1
approved IPLEX for general use. As a result, Cacchillo 2
cannot resume IPLEX treatment unless she receives a special 3
authorization – known as a “compassionate use” exception – 4
from the FDA. Cacchillo contends that before she may file a 5
compassionate use application, Insmed – as the manufacturer 6
of IPLEX – must provide her with a form to be forwarded to 7
the FDA stating that Insmed will provide Cacchillo with 8
IPLEX in the event her application is approved. Insmed has 9
refused to participate in this process. Further 10
complicating matters, IPLEX is no longer produced, only 11
limited stores of IPLEX remain and, according to Insmed, all 12
remaining IPLEX has been committed to patients with 13
amyotrophic lateral sclerosis (“ALS”). 14
Cacchillo asserts that Insmed agreed to support her FDA 15
compassionate use application and is now in breach of that 16
agreement. Cacchillo commenced this action asserting claims 17
pursuant to 42 U.S.C. § 1983 and New York State common law 18
challenging Insmed’s refusal to support her application. 19
Cacchillo moved for a preliminary injunction requiring 20
Insmed to: 21
22

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1 Cacchillo’s standing to pursue her additional claims and
pleas for relief has not yet been considered by the district
court and is not before us on appeal. See 28 U.S.C. § 1291.
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(1) “provide to Angeline Cacchillo a 1
written statement directed to the United 2
States Food and Drug Administration . . . 3
in a form customary for such submissions 4
supporting the ‘compassionate use’ of . . 5
. IPLEX for Angeline Cacchillo, stating 6
that Insmed, Inc. will, without 7
reservation, provide Angeline Cacchillo 8
the medication IPLEX at cost upon the 9
granting of her compassionate use 10
application by the FDA;” and (2) 11
“directing Insmed, Inc., in the event 12
that Angeline Cacchillo’s application is 13
granted by the FDA, to provide Angeline 14
Cacchillo IPLEX . . . .” 15
16
Insmed opposed the motion, arguing, among other things, 17
that Cacchillo lacked standing to pursue a preliminary 18
injunction because her injury cannot be redressed when the 19
remaining stores of IPLEX have already been committed to ALS 20
patients. The district court agreed and denied Cacchillo’s 21
motion. 22
On appeal, Insmed contends that Cacchillo cannot 23
establish either standing or ripeness to pursue a 24
preliminary injunction. We disagree, but nevertheless 25
affirm the district court’s opinion on the ground that 26
Cacchillo has not shown that she is likely to succeed on the 27
merits. 1
28

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Discussion 1
A. Standing 2
Generally, “[s]tanding is a federal jurisdictional 3
question ‘determining the power of the court to entertain 4
the suit.’” Carver v. City of New York, 621 F.3d 221, 225 5
(2d Cir. 2010) (quoting Warth v. Seldin, 442 U.S. 490, 498 6
(1975)). In particular, “a plaintiff must demonstrate 7
standing for each claim and form of relief sought.” Baur v. 8
Veneman, 352 F.3d 625, 642 n.15 (2d Cir. 2003). Thus, in 9
order to seek injunctive relief, a plaintiff must show the 10
three familiar elements of standing: injury in fact, 11
causation, and redressability. Summer v. Earth Island 12
Inst., 129 S. Ct. 1142, 1149 (2009) (citation omitted). We 13
review the legal questions of whether a plaintiff has 14
standing de novo. Shain v. Ellison, 356 F.3d 211, 214 (2d 15
Cir. 2004). 16
A plaintiff’s burden to demonstrate standing increases 17
over the course of litigation. Lujan v. Defenders of 18
Wildlife, 504 U.S. 555, 561 (1992). “[E]ach element [of 19
standing] must be supported in the same way as any other 20
matter on which the plaintiff bears the burden of proof, 21
i.e., with the manner and degree of evidence required at the 22

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successive stages of the litigation.” Id. When a 1
preliminary injunction is sought, a plaintiff’s burden to 2
demonstrate standing “will normally be no less than that 3
required on a motion for summary judgment.” Lujan v. Nat’l 4
Wildlife Fed’n (Lujan I), 497 U.S. 871, 907 n.8 (1990). 5
Accordingly, to establish standing for a preliminary 6
injunction, a plaintiff cannot “rest on such ‘mere 7
allegations,’ [as would be appropriate at the pleading 8
stage] but must ‘set forth’ by affidavit or other evidence 9
‘specific facts,’ which for purposes of the summary judgment 10
motion will be taken to be true.” Lujan, 504 U.S. at 561 11
(internal citation omitted). 12
Here, Cacchillo’s injury in fact is that in breach of 13
an alleged agreement between herself and Insmed, she has not 14
received Insmed’s support in preparing her compassionate use 15
application. As set forth in Cacchillo’s affidavit, this 16
injury is concrete and particularized: Cacchillo seeks a 17
specific document from Insmed that she contends is required 18
for her compassionate use application. This injury is 19
actual, and not conjectural or hypothetical, because 20
Cacchillo does not have the document to which she currently 21
claims entitlement. Insmed’s lack of support is no less an 22

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injury because Cacchillo additionally hopes to receive both 1
Insmed’s support and, ultimately, FDA approval. 2
Cacchillo’s injury is unquestionably caused by Insmed. 3
Cacchillo does not have a document from Insmed because 4
Insmed has declined to provide it. 5
Finally, Cacchillo’s injury is redressable because she 6
seeks relief directly from Insmed that is within the court’s 7
authority to order. See Sprint Commc’ns Co. v. APCC Servs., 8
Inc., 554 U.S. 269, 273-74 (2008) (defining redressability 9
as an inquiry asking whether “it is ‘likely’ and not ‘merely 10
speculative’ that the plaintiff’s injury will be remedied by 11
the relief plaintiff seeks in bringing suit” (some internal 12
quotation marks omitted)). Cf. Allen v. Wright, 468 U.S. 13
737, 758 (1984) (finding redressability lacking where it was 14
“entirely speculative” whether respondents’ desired remedy – 15
an injunction against the IRS – would remedy their alleged 16
injury – failure of their children to receive a desegregated 17
public education). Here, the court could redress 18
Cacchillo’s injury directly by ordering specific performance 19
on the alleged underlying contract. That is, the court 20
could redress Cacchillo’s failure to receive the document 21
from Insmed by ordering Insmed to provide her with the 22
document. 23

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In opposition, Insmed argues that Cacchillo’s injury is 1
not redressable because the court cannot order Insmed to 2
provide Cacchillo with a document stating that Insmed will 3
provide her with IPLEX when all of the remaining IPLEX has 4
already been promised to ALS patients. Yet, whether Insmed 5
has any unallocated IPLEX or whether Cacchillo’s claim to 6
IPLEX supercedes that of the ALS patients are both questions 7
that go to the merits of Cacchillo’s claims, not her 8
standing to bring those claims. If we accepted Insmed’s 9
invitation to view the alleged unavailability of IPLEX as a 10
barrier to redressability, then Insmed’s mere assertion that 11
it cannot supply IPLEX would deprive the court of 12
jurisdiction to assess the validity of Insmed’s defenses. 13
Redressability does not permit us to wade so deeply into the 14
merits. See Steel Co. v. Citizens for a Better Env’t, 523 15
U.S. 83, 89 (1998) (explaining that the “nonexistence of a 16
cause of action [is not a] proper basis for a jurisdictional 17
dismissal”). 18
Based on the foregoing, Cacchillo has standing to 19
pursue her motion for a preliminary injunction. 20
B. Ripeness 21
Insmed also contends that Cacchillo’s claims are not 22
ripe. We disagree. 23

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Ripeness “is peculiarly a question of timing.” Thomas 1
v. Union Carbide Agric. Prods. Co., 473 U.S. 568, 580 2
(1985). A claim is not ripe if it depends upon “contingent 3
future events that may not occur as anticipated, or indeed 4
may not occur at all.” Id. at 580-81. 5
In addition to requiring a commitment from Insmed to 6
supply her with IPLEX if her compassionate care application 7
is approved, Cacchillo’s compassionate care application 8
requires a physician to agree to act as Cachillo’s sponsor 9
and investigator. See 21 C.F.R. §§ 312.3 (defining 10
“sponsor” and “investigator”), 312.305 (setting forth the 11
current requirements for a compassionate use application). 12
Insmed argues that Cacchillo’s claim is not ripe because she 13
does not have a sponsor or investigator. Yet, Cacchillo 14
avers in her Complaint that two doctors are “ready and eager 15
to commence and support [her] compassionate use 16
application.” Insmed has produced no evidence to the 17
contrary. As a result, Cacchillo’s claim for a preliminary 18
injunction is ripe for our consideration. 19
C. Merits Analysis 20
Although the district court denied Cacchillo’s motion 21

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2 In light of the unusual facts of this case, the parties
pressed the Court at oral argument to consider Cacchillo’s
entitlement to a preliminary injunction rather than remand the
case to the district court.
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for lack of standing, we may affirm its decision “on any 1
ground supported by the record.” 2 NXIVM Corp. v. Ross 2
Inst., 364 F.3d 471, 476 (2d Cir. 2004). 3
A party seeking a preliminary injunction must show “(a) 4
irreparable harm and (b) either (1) likelihood of success on 5
the merits or (2) sufficiently serious questions going to 6
the merits to make them a fair ground for litigation and a 7
balance of hardships tipping decidedly toward the party 8
requesting the preliminary relief.” Citigroup Global Mkts., 9
Inc. v. VCG Special Opportunities Master Fund Ltd., 598 F.3d 10
30, 35 (2d Cir. 2010). The burden is even higher on a party 11
like Cacchillo that seeks “a mandatory preliminary 12
injunction that alters the status quo by commanding some 13
positive act, as opposed to a prohibitory injunction seeking 14
only to maintain the status quo.” Id. at 35 n.4 (internal 15
quotation marks omitted). A mandatory preliminary 16
injunction “should issue only upon a clear showing that the 17
moving party is entitled to the relief requested, or where 18

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extreme or very serious damage will result from a denial of 1
preliminary relief.” Id. (internal quotation marks 2
omitted). 3
Here, even assuming Cacchillo has established that she 4
will suffer irreparable harm, she has not met her burden to 5
show that she has a likelihood of success on the merits. 6
Cacchillo’s claims hinge on Insmed’s alleged promise to 7
support Cacchillo’s compassionate care application. Yet, 8
Cacchillo has no evidence that such an agreement existed 9
beyond her own vague recollection. Cacchillo has not 10
described in any detail what exactly Insmed allegedly 11
promised her; Cacchillo asserts only that (1) on its 12
webpage, “Insmed stated that it supported clinical trial 13
subjects’ compassionate use applications;” and (2) a 14
clinical research coordinator not employed by Insmed “told 15
[Cacchillo] that Insmed would support [Cacchillo’s] 16
application.” 17
Cacchillo’s description of the alleged agreement is 18
problematic for at least three reasons. First, Cacchillo’s 19
recollection of the contents of Insmed’s website is belied 20
by Insmed’s exhibits showing that its website contained no 21

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such statements. Second, Cacchillo offers no theory of 1
agency by which the clinical research coordinator’s alleged 2
statement would be binding upon Insmed. See Restatement 3
(Second) of Agency § 27 cmt. b (explaining that only a 4
principal’s acts – and not those of an agent – may create 5
apparent authority). Third, Cacchillo’s vague descriptions 6
of the alleged agreement, without more, strongly suggest 7
that Cacchillo is not likely to establish that Insmed agreed 8
to support her compassionate use application even if, as 9
happened in the present case, Insmed concluded that the drug 10
at stake is ineffective and better allocated to other 11
patients. 12
Based on the foregoing, Cacchillo has not met her 13
burden to establish that she is entitled to a mandatory 14
preliminary injunction. 15
Conclusion 16
For the foregoing reasons, the order of the district 17
court is hereby AFFIRMED. 18

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