Date: 04-04-2011

Case Style: Angeline Cacchillo v. Insmed, Inc.

Case Number: 10-4630-cv

Judge: Wesley

Court: United States Court of Appeals for the Second Circuit

Plaintiff's Attorney: KEVIN A. LUIBRAND, Albany, N.Y., for Plaintiff-Appellant

Defendant's Attorney: ROBERT P. CHARROW (Laura Metcoff Klaus, Cynthia E. Neidl, on the brief), Greenberg Traurig LLP, Washington, D.C., for Defendant-Appellee.

Description: Plaintiff-Appellant Angeline Cacchillo appeals from an 8 October 22, 2010 order of the United States District Court 9 for the Northern District of New York (McAvoy, J.) denying 10 Cacchillo’s motion for a preliminary injunction for lack of 11 standing. For the reasons stated below, we find that 12 Cacchillo has standing to pursue a preliminary injunction 13 and that her claim, contrary to Defendant-Appellee Insmed 14 Inc.’s (“Insmed”) suggestion, is ripe for review. We 15 nevertheless AFFIRM because Cacchillo has not met her burden 16 to obtain the preliminary injunction because she has not 17 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. Page 3 of 12 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 11 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. 20 Cacchillo moved for a preliminary injunction requiring 21 Insmed to: 22 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. Page 4 of 12 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 event 13 that Angeline Cacchillo’s application is 14 granted by the FDA, to provide Angeline 15 Cacchillo IPLEX . . . .” 16 17 Insmed opposed the motion, arguing, among other things, 18 that Cacchillo lacked standing to pursue a preliminary 19 injunction because her injury cannot be redressed when the 20 remaining stores of IPLEX have already been committed to ALS 21 patients. The district court agreed and denied Cacchillo’s 22 motion. 23 On appeal, Insmed contends that Cacchillo cannot 24 establish either standing or ripeness to pursue a 25 preliminary injunction. We disagree, but nevertheless 26 affirm the district court’s opinion on the ground that 27 Cacchillo has not shown that she is likely to succeed on the 28 merits.1 Page 5 of 12 1 Discussion 2 A. Standing 3 Generally, “[s]tanding is a federal jurisdictional 4 question ‘determining the power of the court to entertain 5 the suit.’” Carver v. City of New York, 621 F.3d 221, 225 6 (2d Cir. 2010) (quoting Warth v. Seldin, 442 U.S. 490, 498 7 (1975)). In particular, “a plaintiff must demonstrate 8 standing for each claim and form of relief sought.” Baur v. 9 Veneman, 352 F.3d 625, 642 n.15 (2d Cir. 2003). Thus, in 10 order to seek injunctive relief, a plaintiff must show the 11 three familiar elements of standing: injury in fact, 12 causation, and redressability. Summer v. Earth Island 13 Inst., 129 S. Ct. 1142, 1149 (2009) (citation omitted). We 14 review the legal questions of whether a plaintiff has 15 standing de novo. Shain v. Ellison, 356 F.3d 211, 214 (2d 16 Cir. 2004). 17 A plaintiff’s burden to demonstrate standing increases 18 over the course of litigation. Lujan v. Defenders of 19 Wildlife, 504 U.S. 555, 561 (1992). “[E]ach element [of 20 standing] must be supported in the same way as any other 21 matter on which the plaintiff bears the burden of proof, 22 i.e., with the manner and degree of evidence required at the Page 6 of 12 1 successive stages of the litigation.” Id. When a 2 preliminary injunction is sought, a plaintiff’s burden to 3 demonstrate standing “will normally be no less than that 4 required on a motion for summary judgment.” Lujan v. Nat’l 5 Wildlife Fed’n (Lujan I), 497 U.S. 871, 907 n.8 (1990). 6 Accordingly, to establish standing for a preliminary 7 injunction, a plaintiff cannot “rest on such ‘mere 8 allegations,’ [as would be appropriate at the pleading 9 stage] but must ‘set forth’ by affidavit or other evidence 10 ‘specific facts,’ which for purposes of the summary judgment 11 motion will be taken to be true.” Lujan, 504 U.S. at 561 12 (internal citation omitted). 13 Here, Cacchillo’s injury in fact is that in breach of 14 an alleged agreement between herself and Insmed, she has not 15 received Insmed’s support in preparing her compassionate use 16 application. As set forth in Cacchillo’s affidavit, this 17 injury is concrete and particularized: Cacchillo seeks a 18 specific document from Insmed that she contends is required 19 for her compassionate use application. This injury is 20 actual, and not conjectural or hypothetical, because 21 Cacchillo does not have the document to which she currently 22 claims entitlement. Insmed’s lack of support is no less an Page 7 of 12 1 injury because Cacchillo additionally hopes to receive both 2 Insmed’s support and, ultimately, FDA approval. 3 Cacchillo’s injury is unquestionably caused by Insmed. 4 Cacchillo does not have a document from Insmed because 5 Insmed has declined to provide it. 6 Finally, Cacchillo’s injury is redressable because she 7 seeks relief directly from Insmed that is within the court’s 8 authority to order. See Sprint Commc’ns Co. v. APCC Servs., 9 Inc., 554 U.S. 269, 273-74 (2008) (defining redressability 10 as an inquiry asking whether “it is ‘likely’ and not ‘merely 11 speculative’ that the plaintiff’s injury will be remedied by 12 the relief plaintiff seeks in bringing suit” (some internal 13 quotation marks omitted)). Cf. Allen v. Wright, 468 U.S. 14 737, 758 (1984) (finding redressability lacking where it was 15 “entirely speculative” whether respondents’ desired remedy – 16 an injunction against the IRS – would remedy their alleged 17 injury – failure of their children to receive a desegregated 18 public education). Here, the court could redress 19 Cacchillo’s injury directly by ordering specific performance 20 on the alleged underlying contract. That is, the court 21 could redress Cacchillo’s failure to receive the document 22 from Insmed by ordering Insmed to provide her with the 23 document. Page 8 of 12 1 In opposition, Insmed argues that Cacchillo’s injury is 2 not redressable because the court cannot order Insmed to 3 provide Cacchillo with a document stating that Insmed will 4 provide her with IPLEX when all of the remaining IPLEX has 5 already been promised to ALS patients. Yet, whether Insmed 6 has any unallocated IPLEX or whether Cacchillo’s claim to 7 IPLEX supercedes that of the ALS patients are both questions 8 that go to the merits of Cacchillo’s claims, not her 9 standing to bring those claims. If we accepted Insmed’s 10 invitation to view the alleged unavailability of IPLEX as a 11 barrier to redressability, then Insmed’s mere assertion that 12 it cannot supply IPLEX would deprive the court of 13 jurisdiction to assess the validity of Insmed’s defenses. 14 Redressability does not permit us to wade so deeply into the 15 merits. See Steel Co. v. Citizens for a Better Env’t, 523 16 U.S. 83, 89 (1998) (explaining that the “nonexistence of a 17 cause of action [is not a] proper basis for a jurisdictional 18 dismissal”). 19 Based on the foregoing, Cacchillo has standing to 20 pursue her motion for a preliminary injunction. 21 B. Ripeness 22 Insmed also contends that Cacchillo’s claims are not 23 ripe. We disagree. Page 9 of 12 1 Ripeness “is peculiarly a question of timing.” Thomas 2 v. Union Carbide Agric. Prods. Co., 473 U.S. 568, 580 3 (1985). A claim is not ripe if it depends upon “contingent 4 future events that may not occur as anticipated, or indeed 5 may not occur at all.” Id. at 580-81. 6 In addition to requiring a commitment from Insmed to 7 supply her with IPLEX if her compassionate care application 8 is approved, Cacchillo’s compassionate care application 9 requires a physician to agree to act as Cachillo’s sponsor 10 and investigator. See 21 C.F.R. §§ 312.3 (defining 11 “sponsor” and “investigator”), 312.305 (setting forth the 12 current requirements for a compassionate use application). 13 Insmed argues that Cacchillo’s claim is not ripe because she 14 does not have a sponsor or investigator. Yet, Cacchillo 15 avers in her Complaint that two doctors are “ready and eager 16 to commence and support [her] compassionate use 17 application.” Insmed has produced no evidence to the 18 contrary. As a result, Cacchillo’s claim for a preliminary 19 injunction is ripe for our consideration. 20 C. Merits Analysis 21 Although the district court denied Cacchillo’s motion 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. Page 10 of 12 1 for lack of standing, we may affirm its decision “on any 2 ground supported by the record.”2 NXIVM Corp. v. Ross 3 Inst., 364 F.3d 471, 476 (2d Cir. 2004). 4 A party seeking a preliminary injunction must show “(a) 5 irreparable harm and (b) either (1) likelihood of success on 6 the merits or (2) sufficiently serious questions going to 7 the merits to make them a fair ground for litigation and a 8 balance of hardships tipping decidedly toward the party 9 requesting the preliminary relief.” Citigroup Global Mkts., 10 Inc. v. VCG Special Opportunities Master Fund Ltd., 598 F.3d 11 30, 35 (2d Cir. 2010). The burden is even higher on a party 12 like Cacchillo that seeks “a mandatory preliminary 13 injunction that alters the status quo by commanding some 14 positive act, as opposed to a prohibitory injunction seeking 15 only to maintain the status quo.” Id. at 35 n.4 (internal 16 quotation marks omitted). A mandatory preliminary 17 injunction “should issue only upon a clear showing that the 18 moving party is entitled to the relief requested, or where Page 11 of 12 1 extreme or very serious damage will result from a denial of 2 preliminary relief.” Id. (internal quotation marks 3 omitted). 4 Here, even assuming Cacchillo has established that she 5 will suffer irreparable harm, she has not met her burden to 6 show that she has a likelihood of success on the merits. 7 Cacchillo’s claims hinge on Insmed’s alleged promise to 8 support Cacchillo’s compassionate care application. Yet, 9 Cacchillo has no evidence that such an agreement existed 10 beyond her own vague recollection. Cacchillo has not 11 described in any detail what exactly Insmed allegedly 12 promised her; Cacchillo asserts only that (1) on its 13 webpage, “Insmed stated that it supported clinical trial 14 subjects’ compassionate use applications;” and (2) a 15 clinical research coordinator not employed by Insmed “told 16 [Cacchillo] that Insmed would support [Cacchillo’s] 17 application.” 18 Cacchillo’s description of the alleged agreement is 19 problematic for at least three reasons. First, Cacchillo’s 20 recollection of the contents of Insmed’s website is belied 21 by Insmed’s exhibits showing that its website contained no Page 12 of 12 1 such statements. Second, Cacchillo offers no theory of 2 agency by which the clinical research coordinator’s alleged 3 statement would be binding upon Insmed. See Restatement 4 (Second) of Agency § 27 cmt. b (explaining that only a 5 principal’s acts – and not those of an agent – may create 6 apparent authority). Third, Cacchillo’s vague descriptions 7 of the alleged agreement, without more, strongly suggest 8 that Cacchillo is not likely to establish that Insmed agreed 9 to support her compassionate use application even if, as 10 happened in the present case, Insmed concluded that the drug 11 at stake is ineffective and better allocated to other 12 patients. 13 Based on the foregoing, Cacchillo has not met her 14 burden to establish that she is entitled to a mandatory 15 preliminary injunction.

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See: http://www.ca2.uscourts.gov/decisions/isysquery/0943b2de-7780-4ee4-9f65-48c932cdefea/5/doc/10-4630_opn.pdf#xml=http://www.ca2.uscourts.gov/decisions/isysquery/0943b2de-7780-4ee4-9f65-48c932cdefea/5/hilite/

Outcome: For the foregoing reasons, the order of the district court is hereby AFFIRMED.

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