Page 1 of 12 10-4630-cv Cacchillo v. Insmed, Inc.
UNITED STATES COURT OF APPEALS 1 2 FOR THE SECOND 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 ANGELINE CACCHILLO , 14 15 Plaintiff-Appellant , 16 17 –v.– 18 19 INSMED , INC ., 20 21 Defendant-Appellee

. 22 23 24 25 Before: 26 WESLEY , CHIN , and LOHIER , JR ., 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 AFFIRMED . 34 35 36 37 KEVIN A. LUIBRAND , Albany, N.Y., for Plaintiff38 Appellant

. 39 40 ROBERT P. CHARROW (Laura Metcoff Klaus, Cynthia E. 41Page 2 of 12 Neidl, on the brief ), Greenberg Traurig LLP, 1 Washington, D.C., for Defendant-Appellee

. 2 3 4 5 WESLEY , 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. 24Page 3 of 12 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

221Cacchillo’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. Page 4 of 12 (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 28Page 5 of 12 **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 22Page 6 of 12 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 22Page 7 of 12 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. 23Page 8 of 12 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. 23Page 9 of 12 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 212In 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. Page 10 of 12 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 18Page 11 of 12 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 21Page 12 of 12 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. SeeRestatement 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**

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