                                                                                                                           Opinions of the United
2008 Decisions                                                                                                             States Court of Appeals
                                                                                                                              for the Third Circuit


12-16-2008

Cheri Gunvalson v. PTC Therapeutics Inc
Precedential or Non-Precedential: Non-Precedential

Docket No. 08-3575




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"Cheri Gunvalson v. PTC Therapeutics Inc" (2008). 2008 Decisions. Paper 100.
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                                                           NOT PRECEDENTIAL




                  UNITED STATES COURT OF APPEALS
                       FOR THE THIRD CIRCUIT

                                No. 08-3575

JACOB GUNVALSON; CHERI AND JOHN GUNVALSON, AS GUARDIANS FOR
  JACOB GUNVALSON; CHERI AND JOHN GUNVALSON INDIVIDUALLY

                                      v.

                        PTC THERAPEUTICS INC,
                                                        Appellant

                 Appeal from the United States District Court
                         for the District of New Jersey
                           (Civil No. 2-08-cv-03559)
                 District Judge: Honorable William J. Martini

                         Argued: December 11, 2008

                      Before: McKEE and SMITH, and
                           ROTH, Circuit Judges

                     (Opinion filed: December 16, 2008)

JOHN G. HUTCHINSON, ESQ. (Argued)
JOHN J. LAVELLE, ESQ.
ELIZABETH M. ZITO, ESQ.
Sidley Austin LLP
787 Seventh Avenue
New York, New York 10019
KENNETH R. MEYER, ESQ.
Porzio, Bromberg & Newman, P.C.
100 Southgate Parkway
P.O. Box 1997

                                      1
Morristown, New Jersey 07962
ROBERT C. HEIM, ESQ.
JOHN S. GHOSE, ESQ.
Dechert LLP
2929 Arch Street
Philadelphia, Pennsylvania 19104
Attorneys for Appellant

MARC E. WOLIN, ESQ. (Argued)
JAKOB B. HAPLERN, ESQ.
Saiber LLC
One Gateway Center
Newark, New Jersey 07102
Attorneys for Appellees


                                        OPINION


McKEE, Circuit Judge:

       PTC Therapeutics, Inc. (PTC) appeals from the district court’s grant of the

Gunvalson’s motion for preliminary injunction.1 We assume the parties’ familiarity with

the facts and the record of prior proceedings, which we refer to only as necessary to

explain our decision. For the reasons that follow, we will now vacate the district court’s

order and remand for further proceedings.2

       1
         The court ordered PTC to provide the information Jacob’s physician needs to
apply 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
FDA for a protocol exception to the Phase 2a extension trial.
       2
        This Court will reverse a district court’s grant of preliminary injunction “only if
the court abused its discretion, committed an obvious error in applying the law, or made a
serious mistake in considering the proof.” Loretangeli v. Critelli, 853 F.2d 186, 193 (3d
Cir. 1988).

                                             2
                                                   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,

the Gunvalsons must plead facts establishing: “‘1) a clear and definite promise; 2) made

with the expectation that the promisee will rely upon it; 3) reasonable reliance upon the

promise; 4) which results in definite and substantial detriment.’” Commerce Bancorp,

Inc. v. BK Int’l Ins. Brokers, LTD., 490 F. Supp. 2d 556, 561 (D.N.J. 2007) (quoting

Lobiondo 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

       The district court erred in finding the Gunvalsons adequately alleged PTC and its

officers made clear and definite promises that Jacob would get PTC124 outside of the


       3
         Moveants for preliminary injunction must demonstrate: (1) a “reasonable
probability of eventual success” on the merits; (2) they “will be irreparably injured
pendente lite” if injunctive relief is denied; (3) “the possibility of harm to other interested
persons from the grant or denial of the injunction”; and (4) that “the public interest”
favors the relief. Bennington Foods LLC v. St. Croix Renaissance Group, LLP, 528 F.3d
176, 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.
       4
           Failing to demonstrate any one of the elements is fatal to their case.

                                                   3
clinical trials. The promises the Gunvalsons assert that PTC and its officers made to them

lack the requisite specificity and clarity required to succeed under the theory of

promissory estoppel. The district court focused on that statement of Claudia Hirawat,

PTC’s Vice President, to Mrs. Gunvalson that Jacob’s non-enrollment in Phase 2a trials

would not by itself preclude him from participating in all of PTC’s anticipated future

clinical trials for PTC124. This statement and other alleged statements by PTC officers

fail as a clear and definite promise because it asserts nothing conclusive about Jacob’s

participation in future trials or his access to PTC124.

       Moreover, the district court erred in finding the Gunvalsons reasonably relied on

the purported promises of PTC in not attempting to enroll Jacob in the Phase 2a trial. The

district court erred in its analysis by failing to recognize the Gunvalsons did not enroll

Jacob in the Phase 2a trial because Dr. Finkel, the principal investigator for the

Philadelphia area clinical trial, ruled Jacob ineligible based on the medical records Mrs.

Gunvalson provided him, and not because the Gunvalsons had been promised PTC124

via some other means. The records showed Jacob’s longstanding diagnosis with BMD,

rather than DMD.5 The records also showed impaired kidney function and evidence of

cardiac 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


       5
         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
not to enroll Jacob in the Phase 2a trials because they had no decision to make.6

                                             II.

       As we explained in open court following oral argument, we are sympathetic to the

plight of Jacob and his family. Similarly, we are moved by the Gunvalsons’ heroic efforts

on 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

clear and definite promise or detrimental reliance, requirements for a promissory estoppel

claim. Accordingly, because the Gunvalsons have not shown a reasonable probability of

success on the merits, the district court abused its discretion in granting the preliminary

junction. We will, therefore, vacate the order granting the preliminary injunction and

remand for further proceedings.




       6
        It is apparent from the record this is the real reason she did not attempt to enroll
Jacob in the Phase 2a trial, as Mrs. Gunvalson e-mailed a number of parties reporting her
disappointment upon hearing of his ineligibility.
