1 43 F.3d 540 (6th Cir. 2006) [hereinafter Abney II].

2 Abney II, 443 F.3d at 543.

3 See id.

4 Id.

5 The district court reports that Amgen supported the 2001 study, but that principal investigators at UKMC “initiated and designed the study, drafted the protocol, and administered the drug.” Abney v. Amgen, Inc., 2005 WL 1630154 (E.D. Ky. July 08, 2005) at *1 [hereinafter Abney I].

6 See id. The Court reports that this Phase II clinical trial evaluated GDNF's safety and efficacy, but Phase II trials typically focus on efficacy, while Phase I trials focus on safety.

7 Abney I, 2005 WL at *1 n.3.

8 The distinction arguably affects the result, since the Court later bases its decision partly on the fact that, contrary to the Phase II study carrying out Amgen's protocol, “the principal investigators [at UKMC] drafted and implemented the [p]rotocol for the study themselves, not Amgen.” See Abney II, 443 F.3d at 548-49.

9 See id. at 544.

10 See id.

11 Id. (noting that the Unified Parkinson's Disease Rating Scale quantified improvements).

12 Id.

13 Id.

14 Id.

15 Id.

16 Id. at 545 (“‘compassionate use’ … mean[s] use of a drug even if the drug is proven unsafe”).

17 Id.

18 Id. at 544.

19 See id.; Abney I, 2005 WL 1630154 *1, *1 n.3 (E.D. Ky. July 08, 2005).

20 See Abney II, 443 F.3d at 544 (noting that “it is unclear what naturally occurring GDNF does”).

21 See id. at 545; cf. Implantable Device Containing GDNF Secreting Cells for Treating Nerve Damage and Methods of Use, U.S. Patent No. 6015572 (issued January 18, 2000 from a division of a continuation-in-part (“CIP”) of a chain of CIPs reaching back to Sep. 20, 1991).

22 See id. at 543.

23 See id. at 545. A court may grant a preliminary injunction only if the moving party demonstrates that the following factors weigh in favor of granting the motion: “(1) the plaintiffs’ likelihood of success on the merits; (2) whether the plaintiff may suffer irreparable harm absent the injunction; (3) whether granting the injunction will cause substantial harm to others; and (4) the impact of an injunction upon the public interest.” Id. at 546-47.

24 See id. at 547-51; see also Abney I, 2005 WL 1630154, *1, *5 (E.D. Ky. 2005).

25 See 372 F.Supp.2d 416 (S.D.N.Y. 2005) (denying volunteers’ preliminary injunction pending claims for breach of contract, promissory estoppel, and breach of fiduciary duty); see also Abney II, 443 F.3d at 546 (noting that the plaintiffs in Suthers withdrew a subsequent appeal).

26 See id. at 547. A footnote suggested that aside from any contract, the consent form's provision allowing Amgen to terminate the study for scientific reasons, and the clinical trial agreement's provision allowing “Amgen to terminate ‘immediately upon written notice’” would block the Volunteers from succeeding on the breach of contract claim. Id. at n.5.

27 Id. at 549-50 (quoting Abney I, 2005 WL at *9 (emphasis in original)).

28 See id. at 548-49 (noting that the UKMC study left the principal investigators in charge of executing the study, drafting and implementing the protocol, the highly specialized UKMC doctors, the study's UKMC locus, UKMC's set fee, and Amgen's sponsorship apart from control over the study).

29 Id. at 549 (emphasis in original).

30 Id. at 550 (explaining that, in general, a fiduciary relationship exists where one party trusts in another under circumstances showing both parties agreed that the fiduciary would act primarily for the other's benefit in connected matters). Compare Morreim, E. Haavi, The Clinical Investigator as Fiduciary: Discarding a Misguided Idea, 33 J. L. Med. & Ethics 586, 588-89CrossRefGoogle Scholar (arguing that the physician most likely qualifies as a fiduciary when acting as a volunteer's advisor and in a situation allowing flexibility to carry out advice promoting the volunteer's best interest; noting that “[t]he most obvious areas open for investigator “advising” would concern the decisions whether to enroll in or drop out of the study”).

31 Id. (emphasis added).

32 Abney II, 443 F.3d at 550; Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807, 846, 850-51 (Md. 2001).

33 See Abney II, 443 F.3d at 550-51.

34 See id. at 551 (citing 21 C.F.R. §§ 56.101, 56.103 (2005) as imparting on IRBs duties of protection and continued review); but see Withers v. University of Kentucky, 939 S.W.2d 340, 343 (Ky. 1997) (holding that under Kentucky's constitution, “the University of Kentucky is entitled to sovereign immunity,” which insulates UKMC from tort and certain breach of contract judgments).

35 Id. at 551 n.6, 553 (Norris, J., concurring).

36 The court emphasized the subjective quality of evidence on record, characterizing it as showing that the Volunteers “subjectively felt an improvement in their symptoms [and that] the principal investigators believe GDNF to be a safe and effective treatment.” See Abney II, at 552.

37 Id. at 552.

38 Id.

39 Id. at 553.

40 The Volunteers might reply, however, that this decision could not threaten the FDA's authority since the FDA already exercised that authority in granting a compassionate use exception.

41 Others would consider the injunction's affects on the public interest in accurate, informative clinical trial results. See, e.g., Morreim, supra note 31, at 590 (asserting that “The investigator's first allegiance is already pegged on something else, namely, the research protocol and on the ‘third parties’ (future patients) who will be helped by it.”); but see Grimes v. Kennedy Krieger Institute, Inc., 782 A.2d 807, 858 (“Of special interest to this Court, the Nuremberg Code, at least in significant part, was the result of legal thought and legal principles, as opposed to medical or scientific principles, and thus should be the preferred standard for assessing the legality of scientific research on human subjects.”); War Crimes Comm'n, U.N., Trials of War Criminals before the Nuremberg Military Trials under Control Council Law No. 10 (1952); Online Exhibitions | The Doctors Trial | Nuremberg Code Excerpt, http://www.ushmm.org/research/doctors/Nuremberg_Code.htm (publishing the Nuremberg Code online).