Cacchillo v. Insmed Inc., Civil Action No. 1:10–CV–01199 (TJM/RFT).

CourtUnited States District Courts. 2nd Circuit. United States District Court of Northern District of New York
Writing for the CourtTHOMAS J. McAVOY
Citation833 F.Supp.2d 218
Decision Date29 June 2011
Docket NumberCivil Action No. 1:10–CV–01199 (TJM/RFT).
PartiesAngeline CACCHILLO, Plaintiff, v. INSMED INC., Defendant.

833 F.Supp.2d 218

Angeline CACCHILLO, Plaintiff,
v.
INSMED INC., Defendant.

Civil Action No. 1:10–CV–01199 (TJM/RFT).

United States District Court,
N.D. New York.

June 29, 2011.


[833 F.Supp.2d 222]


Kevin A. Luibrand, Luibrand Law Firm, PLLC, Latham, NY, for Plaintiff.

Cynthia E. Neidl, Stephen M. Buhr, Greenberg, Traurig Law Firm, Albany, NY, Robert P. Charrow, Greenberg, Traurig Law Firm, Washington, DC, for Defendant.


DECISION & ORDER

THOMAS J. McAVOY, Senior District Judge.
I. INTRODUCTION

Plaintiff commenced this action asserting claims pursuant to 42 U.S.C. § 1983 and New York State common law following her participation in a phase II clinical trial of Defendant's investigational drug IPLEX™ (“IPLEX”). Defendant now moves to dismiss the action on various grounds. Plaintiff has opposed the motion.

II. BACKGROUND

The general background of this case has been set forth by this Court in its decision on Plaintiff's motion for a preliminary injunction, see Oct. 25, 2010 Dec. & Ord., dkt. # 23, and by the Second Circuit Court of Appeals in its review of the preliminary injunction decision. See Cacchillo v. Insmed, Inc., 638 F.3d 401 (2d Cir.2011); see also May 11, 2011 Second Circuit Mandate, dkt. # 40. Familiarity with these opinions is presumed. Inasmuch as the matter is before the Court on a Rule 12 motion to dismiss, the following facts are taken from the Complaint and deemed to be true for purposes of the pending motion.

[833 F.Supp.2d 223]

Plaintiff Angeline Cacchillo, a New York resident, was diagnosed with Type 1 Myotonic Muscular Dystrophy (“MMD1” or “D1”) in July 2005. MMD1 is a degenerative genetic neuromuscular disease which, in laymen's terms, attacks the muscles' ability to retract once contracted and, over time, attacks the muscles themselves including those necessary for the heart, brain, respiratory and digestive systems to function. There is no treatment for MMD1 approved by the Food and Drug Administration (“FDA”).

Starting in November 2005, Insmed undertook a clinical trial to investigate the use of IPLEX for the treatment of MMD1 at the University of Rochester in Rochester, New York, a private research institution which receives public money as a National Institute of Health Center of Excellence for the treatment of, among other conditions, MMD1. In August 2007, while the initial phases of the MMD1 trial were ongoing, one of Mrs. Cacchillo' s physicians contacted Ronald D. Gunn, the CEO of Insmed to ascertain whether she would be eligible to participate in the MMD1 trial. After determining that she would be eligible for the MMD1 trial, Gunn approached Dr. Richard Moxley, the chief investigator of Insmed's MMD1 trial at the University of Rochester, to secure Mrs. Cacchillo a place in the ongoing phases of the MMD1 clinical trial.

As Mrs. Cacchillo considered participating in the MMD1 trial, she and her husband, Robert Cacchillo, went to Insmed's website. The website included a number of messages from Insmed indicating that those who participated in clinical trials of IPLEX would enjoy Insmed's support in securing continued access to IPLEX if IPLEX proved to be safe and effective for them. This included a number of press releases discussing Insmed's support for clinical trial subjects' efforts to secure continued IPLEX treatment, explanations of how patients could secure “compassionate use” of IPLEX through the FDA, and a link to the section of the FDA's website explaining how a clinical trial subject could apply for “compassionate use” of IPLEX.

After determining that Mrs. Cacchillo would be unable to enroll in the current phase of the MMD1 trial, Gunn directed Mrs. Cacchillo to contact Insmed's Clinical Study Manager Christine O'Neil so that O'Neil could have Mrs. Cacchillo enroll in Phase IIB of the MMD1 trial. O'Neil worked closely with Mrs. Cacchillo to match her up with one of the sites at which the upcoming Phase IIB of the MMD1 trial was to take place. O'Neil indicated to Mrs. Cacchillo that Insmed supported the efforts of clinical trial subjects to continue IPLEX treatment where it was shown to be safe and effective in treating individual subjects. O'Neil also worked closely with Mrs. Cacchillo in her applications to participate in Phase lIB of the MMD1 trial at both Ohio State University (“SU”) and the University of Rochester. Mrs. Cacchillo was accepted into the OSU study.

Mrs. Cacchillo went to OSU's Clinical Research Coordinator Amy Bartlett on April 7, 2008. Neither O'Neil nor any other person ever explained to Mrs.Cacchillo the contours of OSU's legal relationship with Insmed. The close relationship between OSU and Insmed left Mrs. Cacchillo with the impression that they were partners in the MMD1 trial. The April 7 meeting was mandated by FDA regulation for the purpose of making clinical trial subjects aware of their rights and obligations as clinical trial subjects. During this meeting, Mrs. Cacchillo asked Mrs. Bartlett whether Insmed would assist her in continuing to receive IPLEX upon the conclusion of her participation in theMMD1 trial. Mrs. Bartlett assured Mrs. Cacchillo that Insmed would support

[833 F.Supp.2d 224]

Mrs. Cacchillo in continuing IPLEX treatment if IPLEX was found to be safe and effective for her and that as a matter of custom, biopharmaceutical research companies like Insmed supported such efforts.

Mrs. Cacchillo's participation in the MMD1 trial lasted from May 2008 to October 2008 and through it she experienced a near total recovery of her day-to-day functionality without suffering any side effects. Where she had once been able to withstand only a few minutes of light activity, had been unable to keep her chin from her chest without assistance, and could not dress herself, by October 2008, Mrs. Cacchillo was able to spend a day shopping, manipulate buttons and zippers, and walk with her head held up. This improvement was documented by Dr. Victoria Lawson, Assistant Professor of Neurology at OSU and the doctor who oversaw Mrs. Cacchillo's participation in the MMD1 trial, as well as Bartlett and Mrs. Cacchillo's personal physician, Dr. Peter Rienzi.

As Mrs. Cacchillo's participation in the MMD1 trial was ending in September 2008, Dr. Victoria Lawson approached Insmed to confirm that IPLEX had been safe and effective for Mrs. Cacchillo and to secure Insmed's support in either enrolling her in a new phase of the MMD1 trial or by providing a statement of support so that Dr. Lawson could submit Mrs. Cacchillo's compassionate use application to the FDA. Insmed declined on the grounds that it was not clear whether Mrs. Cacchillo had received IPLEX or a placebo during the trial. Later, in July 2009, after it had been confirmed that Mrs. Cacchillo had been receiving IPLEX and not a placebo, Dr. Lawson again sought Insmed's support for Mrs. Cacchillo's compassionate use application to the FDA. Insmed again declined, this time because the MMD1 trial did “not allow for open label extension use” and regulations would “not allow [Insmed] to set up a treatment IND without positive phase 2 results ....”

Plaintiff's suit, which seeks both equitable and legal relief, presents nine causes of action: (1) violation of her constitutional right to equal protection (seeking equitable relief and damages); (2) fraud (seeking damages); (3) negligent misrepresentation (seeking damages); (4) breach of contract (seeking equitable relief and damages); (5) intentional infliction of emotional distress (seeking damages); (6) assumption of duty (seeking equitable relief and damages); (7) breach of fiduciary duty (seeking equitable relief and damages); (8) negligence (seeking equitable relief and damages); and (9) unjust enrichment (seeking equitable relief and damages). Plaintiff also seeks attorneys fees and punitive damages.

III. DISCUSSIONa. Rule 12(b)(1)—Lack of Subject Matter Jurisdiction—Standing

Defendant argues that Plaintiff lacks constitutional standing to seek either equitable or legal relief in this matter. As the Second Circuit concluded, however, Plaintiff does have standing to seek “a specific document from Insmed that she contends is required for her compassionate use application” and which Defendant allegedly promised to her. Cacchillo, 638 F.3d at 404. “[T]he court could redress Cacchillo's injury directly by ordering specific performance on the alleged underlying contract. That is, the court could redress Cacchillo's failure to receive the document from Insmed by ordering Insmed to provide her with the document.” Id.; see also id. at 405 (“Based on the foregoing, Cacchillo has standing to pursue her motion for a preliminary injunction.”). By the same reasoning, Cacchillo's injury could be redressed indirectly by an award of monetary damages under one of the theories on which she proceeds. Accordingly, Defendant's

[833 F.Supp.2d 225]

motion to dismiss for lack of standing is denied.

b. Rule 12(b)(2)—Lack of Personal Jurisdiction

Defendant moves pursuant to Fed.R.Civ.P. 12(b)(2) to dismiss on the ground that the Court lacks personal jurisdiction over it. “A plaintiff bears the burden of demonstrating personal jurisdiction over a person or entity against whom it seeks to bring suit.” Penguin Group (USA) Inc. v. American Buddha, 609 F.3d 30, 34 (2d Cir.2010) (citing In re Magnetic Audiotape Antitrust Litig., 334 F.3d 204, 206 (2d Cir.2003) ( per curiam )). In order to survive a motion to dismiss for lack of personal jurisdiction brought before discovery is conducted, as is the case here, “a plaintiff must make a prima facie showing that jurisdiction exists.” Thomas v. Ashcroft, 470 F.3d 491, 495 (2d Cir.2006). “Such a showing entails making ‘legally sufficient allegations of jurisdiction,’ including ‘an averment of facts that, if credited [,] would suffice to establish jurisdiction over the defendant.’ ” Penguin Group, 609 F.3d at 34–35 (quoting In re Magnetic Audiotape, 334 F.3d at 206 (internal quotation marks and ellipsis omitted)). The Court is to accept all averments of...

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2 practice notes
  • Sandstone Springs, LLC v. Virag Distribution, LLC, 21-CV-541S
    • United States
    • United States District Courts. 2nd Circuit. United States District Court of Western District of New York
    • July 29, 2022
    ...(Docket No. 4, Compl. ¶¶ 47-52). Specific performance is a form of relief for breach of contract, see, e.g. Cacchillo v. Insmed Inc., 833 F.Supp.2d 218, 236 (N.D.N.Y. 2011). To obtain specific performance, Plaintiff must establish its willingness and ability to perform its remaining obligat......
  • Cicel (Beijing) Sci. & Tech. Co. v. Misonix, Inc., 2:17-cv-1642 (ADS)(SIL)
    • United States
    • United States District Courts. 2nd Circuit. United States District Court (Eastern District of New York)
    • October 7, 2017
    ...products. Complaint ¶ 74. Specific performance isPage 11 a type of remedy, not an independent claim. Cacchillo v. Insmed Inc., 833 F. Supp. 2d 218, 236 n.18 (N.D.N.Y. 2011); DiPilato v. 7-Eleven, Inc., 662 F. Supp. 2d 333, 345 (S.D.N.Y. 2009). Under New York law, the Plaintiff is required t......
2 cases
  • Sandstone Springs, LLC v. Virag Distribution, LLC, 21-CV-541S
    • United States
    • United States District Courts. 2nd Circuit. United States District Court of Western District of New York
    • July 29, 2022
    ...(Docket No. 4, Compl. ¶¶ 47-52). Specific performance is a form of relief for breach of contract, see, e.g. Cacchillo v. Insmed Inc., 833 F.Supp.2d 218, 236 (N.D.N.Y. 2011). To obtain specific performance, Plaintiff must establish its willingness and ability to perform its remaining obligat......
  • Cicel (Beijing) Sci. & Tech. Co. v. Misonix, Inc., 2:17-cv-1642 (ADS)(SIL)
    • United States
    • United States District Courts. 2nd Circuit. United States District Court (Eastern District of New York)
    • October 7, 2017
    ...products. Complaint ¶ 74. Specific performance isPage 11 a type of remedy, not an independent claim. Cacchillo v. Insmed Inc., 833 F. Supp. 2d 218, 236 n.18 (N.D.N.Y. 2011); DiPilato v. 7-Eleven, Inc., 662 F. Supp. 2d 333, 345 (S.D.N.Y. 2009). Under New York law, the Plaintiff is required t......

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