GUNVALSON et al v. PTC THERAPEUTICS, INC.

Filing 32

MANDATE of USCA as to 25 Notice of Appeal (USCA), Notice of Appeal (USCA) filed by PTC THERAPEUTICS, INC. (Attachments: # 1 letter, # 2 opinion)(Craven, Shannon)

N O T PRECEDENTIAL

U N IT E D STATES COURT OF APPEALS F O R THE THIRD CIRCUIT N o . 08-3575 J A C O B GUNVALSON; CHERI AND JOHN GUNVALSON, AS GUARDIANS FOR JACOB GUNVALSON; CHERI AND JOHN GUNVALSON INDIVIDUALLY v. P T C THERAPEUTICS INC, A p p e lla n t A p p ea l from the United States District Court f o r the District of New Jersey (C iv il No. 2-08-cv-03559) D is tric t Judge: Honorable William J. Martini A rg u e d : December 11, 2008 B e f o re : McKEE and SMITH, and R O T H , Circuit Judges (O p in io n filed: December 16, 2008) J O H N G. HUTCHINSON, ESQ. (Argued) J O H N J. LAVELLE, ESQ. E L IZ A B E T H M. ZITO, ESQ. S id le y Austin LLP 7 8 7 Seventh Avenue N e w York, New York 10019 K E N N E T H R. MEYER, ESQ. P o rz io , Bromberg & Newman, P.C. 1 0 0 Southgate Parkway P .O . Box 1997 1

M o rris to w n , New Jersey 07962 R O B E R T C. HEIM, ESQ. J O H N S. GHOSE, ESQ. D e ch e rt LLP 2 9 2 9 Arch Street P h ila d e lp h ia , Pennsylvania 19104 A tto r n e y s for Appellant M A R C E. WOLIN, ESQ. (Argued) J A K O B B. HAPLERN, ESQ. S aib e r LLC O n e Gateway Center N e w a rk , New Jersey 07102 A tto r n e y s for Appellees

OPINION

McKEE, Circuit Judge:
P T C Therapeutics, Inc. (PTC) appeals from the district court's grant of the G u n v a ls o n 's motion for preliminary injunction.1 We assume the parties' familiarity with th e facts and the record of prior proceedings, which we refer to only as necessary to e x p la in our decision. For the reasons that follow, we will now vacate the district court's

order and remand for further proceedings.2
The court ordered PTC to provide the information Jacob's physician needs to a p p ly for a single-use investigational new use drug application (IND) with the FDA, and, if the FDA denies this application, ordered PTC to submit a treatment protocol to the F D A for a protocol exception to the Phase 2a extension trial. This Court will reverse a district court's grant of preliminary injunction "only if th e court abused its discretion, committed an obvious error in applying the law, or made a s e rio u s mistake in considering the proof." Loretangeli v. Critelli, 853 F.2d 186, 193 (3d C ir. 1988). 2
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I. In granting the Gunvalsons' motion for preliminary injunction, the district court found the Gunvalsons had a reasonable probability of success on the merits of their promissory estoppel claim.3 We disagree with this finding and conclude the district court abused its discretion.
To succeed on the merits of their promissory estoppel claim under New Jersey law, th e Gunvalsons must plead facts establishing: "`1) a clear and definite promise; 2) made w ith the expectation that the promisee will rely upon it; 3) reasonable reliance upon the p ro m is e ; 4) which results in definite and substantial detriment.'" Commerce Bancorp, In c . v. BK Int'l Ins. Brokers, LTD., 490 F. Supp. 2d 556, 561 (D.N.J. 2007) (quoting L o b io n d o v. O'Callaghan, 815 A.2d 1013, 1020 (N.J. Super. Ct. App. Div. 2003)). The

Gunvalsons have failed to adequately plead two of the requirements ­ a clear and definite promise and reasonable reliance.4
T h e district court erred in finding the Gunvalsons adequately alleged PTC and its o f f ic e rs made clear and definite promises that Jacob would get PTC124 outside of the

Moveants for preliminary injunction must demonstrate: (1) a "reasonable p ro b a b ility of eventual success" on the merits; (2) they "will be irreparably injured p e n d e n te lite" if injunctive relief is denied; (3) "the possibility of harm to other interested p e rso n s from the grant or denial of the injunction"; and (4) that "the public interest" f a v o rs the relief. Bennington Foods LLC v. St. Croix Renaissance Group, LLP, 528 F.3d 1 7 6 , 179 (3d Cir. 2008) (internal citations omitted). The district court focused its determination on the first prong of the preliminary injunction standard. We will do the same here.
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Failing to demonstrate any one of the elements is fatal to their case. 3

c lin ic a l trials. The promises the Gunvalsons assert that PTC and its officers made to them la c k the requisite specificity and clarity required to succeed under the theory of p ro m iss o ry estoppel. The district court focused on that statement of Claudia Hirawat, P T C 's Vice President, to Mrs. Gunvalson that Jacob's non-enrollment in Phase 2a trials w o u ld not by itself preclude him from participating in all of PTC's anticipated future clin ical trials for PTC124. This statement and other alleged statements by PTC officers fa il as a clear and definite promise because it asserts nothing conclusive about Jacob's p a rtic ip a tio n in future trials or his access to PTC124. M o re o v e r, the district court erred in finding the Gunvalsons reasonably relied on th e purported promises of PTC in not attempting to enroll Jacob in the Phase 2a trial. The d istric t court erred in its analysis by failing to recognize the Gunvalsons did not enroll J a c o b in the Phase 2a trial because Dr. Finkel, the principal investigator for the P h i la d e l p h ia area clinical trial, ruled Jacob ineligible based on the medical records Mrs. G u n v a ls o n provided him, and not because the Gunvalsons had been promised PTC124 v ia some other means. The records showed Jacob's longstanding diagnosis with BMD, ra th e r than DMD.5 The records also showed impaired kidney function and evidence of c a rd ia c problems, which alone would have foreclosed his participation in the trial. Accordingly, the Gunvalsons could not rely on any statements of PTC officers to decide
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A diagnosis of DMD was a prerequisite for the Phase 2a trials. Dr. Brenda Wong, primary investigator for the Cincinnati trials, subsequently found Jacob did have DMD, but this determination is of no consequence to the Gunvalsons' decision at that time to enroll Jacob in the trial. 4

n o t to enroll Jacob in the Phase 2a trials because they had no decision to make.6 II. A s we explained in open court following oral argument, we are sympathetic to the p lig h t of Jacob and his family. Similarly, we are moved by the Gunvalsons' heroic efforts o n behalf of their son and others afflicted with this devastating disease. Nevertheless, we are constrained by the law to conclude that the Gunvalsons cannot demonstrate either a c le a r and definite promise or detrimental reliance, requirements for a promissory estoppel c la im . Accordingly, because the Gunvalsons have not shown a reasonable probability of su cc ess on the merits, the district court abused its discretion in granting the preliminary ju n c tio n . We will, therefore, vacate the order granting the preliminary injunction and r e m a n d for further proceedings.

It is apparent from the record this is the real reason she did not attempt to enroll J a c o b in the Phase 2a trial, as Mrs. Gunvalson e-mailed a number of parties reporting her d is a p p o in tm e n t upon hearing of his ineligibility.

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