Suthers v. Amgen Inc.

Decision Date19 April 2006
Docket NumberNo. 05 Civ. 4158(PKC).,05 Civ. 4158(PKC).
Citation441 F.Supp.2d 478
PartiesRobert SUTHERS and Niwana Martin, Plaintiffs, v. AMGEN INC., Defendant.
CourtU.S. District Court — Southern District of New York

Alan C. Milstein, Alan Carl Milstein, Michael Dube, Sherman, Silverstein, Kohl, Rose & Podolsky, Pennsauken, NJ, for plaintiffs.

Dennis H. Tracey, III, Lauren Schultz Colton, Hogan & Hartson L.L.P.(NYC), New York, NY, Mark D. Gately, Hogan & Hartson L.L.P.(MD), Baltimore, MD, for defendant.

MEMORANDUM AND ORDER

CASTEL, District Judge.

Plaintiffs have brought suit against Amgen Inc. ("Amgen"), a pharmaceutical company owning the rights to an experimental treatment for Parkinson's disease. The plaintiffs, Robert Suthers and Niwana Martin, participated in a clinical trial of the treatment conducted by a board certified neurologist who is on the faculty of the New York University School of Medicine ("NYUSOM"). Plaintiffs consider the treatment to be beneficial to them. Amgen elected to terminate the clinical trial and, in their complaint, plaintiffs seek a permanent injunction requiring Amgen to supply NYUSOM with the means to continue the experimental treatment, as well as money damages. After a hearing, I denied plaintiffs' motion for a preliminary injunction in a written opinion, 372 F.Supp.2d 416 (S.D.N.Y.2005), and familiarity therewith is assumed.

Defendant Amgen now moves to dismiss all six claims alleged in the complaint; breach of contract, breach of the implied covenant of good faith and fair dealing, promissory estoppel, breach of fiduciary duty, negligence and violation of N.Y. General Business Law § 349. In addition to its 105 numbered paragraphs, the complaint annexes and incorporates 9 "certifications" of witnesses and a 22-page informed consent form.

I approach this motion keeping in mind that Rule 8, Fed.R.Civ.P., requires no more than notice pleading. See Swierkiewicz v. Sorema N.A., 534 U.S. 506, 512, 122 S.Ct. 992, 152 L.Ed.2d 1 (2002). Post-Swierkiewicz, the Supreme Court has upheld the grant of a motion to dismiss under Rule 12(b)(6) where the allegations of the complaint were inconsistent with the existence of a viable claim on the part of the plaintiff. See Domino's Pizza, Inc. v. McDonald, ___ U.S. ___, 126 S.Ct. 1246, 163 L.Ed.2d 1069 (2006); Town of Castle Rock v. Gonzales, 545 U.S. 748, 125 S.Ct. 2796, 162 L.Ed.2d 658 (2005); Tenet v. Doe, 544 U.S. 1, 125 S.Ct. 1230, 161 L.Ed.2d 82 (2005). See also Pugel v. Bd. of Trustees of Univ. of Ill., 378 F.3d 659, 665 (7th Cir.2004) ("This court is not obligated by the standard of review to disregard factual allegations that undermine a plaintiffs claim."). In reviewing the allegations of the complaint, I have accepted all factual allegations as true and have drawn all reasonable inferences in plaintiffs' favor. I nevertheless conclude that plaintiffs' allegations negate the existence of a viable cause of action in any of the six asserted claims and, accordingly, grant Amgen's motion to dismiss.

The Allegations of the Complaint

Plaintiffs Suthers and Martin both suffer from Parkinson's Disease, a progressive neurodegenerative disorder. An individual with Parkinson's experiences a loss of dopaminergic neurons in his or her brain, which causes tremors, shaking, slow movement and muscle stiffness and rigidity. (Compl. ¶ 8) Existing treatments for the disease replace dopamine in the brain. (Id. ¶ 9) While this temporarily masks the symptoms of Parkinson's, it does not prevent the death of those brain cells that produce dopamine. (Id. ¶¶ 9, 10)

In the early 1990s, a Colorado biotechnology company, Synergen, designed a protein called glial cell line-derived neutropic factor ("GDNF") as an alternative treatment for Parkinson's. (Id. ¶ 11) Preliminary results indicated that GDNF could cause the growth of dopamine-producing brain cells and thus provide a more effective treatment for Parkinson's. (Id. ¶ 13) In 1994, defendant Amgen acquired Synergen for $240 million. (Id. ¶ 14)

Dr. Steven S. Gill of Frenchay Hospital in Bristol, England, designed a means of delivering GDNF to the brains of Parkinson's sufferers. (Id. ¶ 16) In his design, pumps are surgically implanted in a patient's abdomen and catheters are threaded through the patient's chest, neck and head, thus delivering GDNF directly to the brain. (Id. ¶ 17) Dr. Gill conducted two Phase I studies of the system on a total of fifteen patients, none of whom experienced any adverse events. (Id. ¶¶ 18-19; Hutchinson Cert., attached as Compl. Ex. A, ¶¶ 13-14)

In 2003, Amgen sponsored a double-blind Phase II trial of Dr. Gill's procedure for delivering GDNF. (Compl.¶ 20, 33-34) The trial involved 34 patients at multiple sites, including NYUSOM. (Id. ¶ 20) The Institutional Review Board ("IRB") of NYUSOM approved the trial protocol, which provided that the trial would begin by implanting pumps in subjects' abdomens and drilling holes in their skulls. (Id. ¶¶ 23-24) Once this stage had been completed, one half of the subjects would receive GDNF for six months and the other half would receive a placebo. (Id. ¶ 24)

Both plaintiffs signed documents indicating their informed consent to their participation. (Id. ¶27-28) In the first six months of the study, each of the two plaintiffs received a placebo. (Id. ¶ 33) Neither plaintiff knew that he or she was part of the placebo group, and neither plaintiff experienced any benefit during the six-month period of the study. (Id. ¶ 34) The informed consent form signed by plaintiffs (Compl. Ex. J at 2) stated that, at the end of the six months, a study participant "may be invited to participate in a separate extended treatment study, which guarantees, if you are eligible to be enrolled, that you will receive liatermin and not a placebo." (Id. at 3)1 In addition, the form stated that the "Principal Investigator may ... decide to withdraw you from the study under certain circumstances. Some possible reasons for withdrawing a subject from the study would be deteriorating health or other conditions that might make continued participation harmful to you. These include events such as ... termination or cancellation of the study by the sponsor." (Id. at 20)

At the end of the six-month study, both plaintiffs began to receive GDNF as participants in the extended treatment study. (Compl.¶ 36) Suthers began receiving GDNF on March 30, 2004, and Martin began receiving the treatment on April 4, 2004. (Id. ¶39, 41) Plaintiffs allege that they "then experienced marked improvement" in their condition. (Id. ¶ 37) Plaintiffs have attached as exhibits to their complaint certifications by physicians who treated them during this period, asserting that GDNF was "safe and of benefit to the plaintiffs." (Id. ¶ 42; Hutchinson Cert. ¶ 30; Penn Cert., attached as Compl. Ex. D, ¶ 26; Gash, et al. Afft, attached as Compl. Ex. E, ¶ 3)

In August 2004, defendant received the results of primates studies in which four of seventy GDNF-supplied subjects exhibited cerebral toxicity. (Compl.¶ 47) Shortly thereafter, defendant announced that it was terminating the clinical trial. (Id. ¶ 49) The principal investigator at the NYUSOM site, Michael Hutchinson, M.D., Ph.D., disputed the findings of the primate studies, contending that the test subjects had received dosages at least ten times higher than what would have been given to a human and that the cause of the cerebral toxicity was the abrupt withdrawal of GDNF. (Hutchinson Cert. ¶ 32) Dr. Hutchinson and other physicians involved in the clinical trial have maintained that GDNF is safe and effective. (Compl. ¶ 54; Hutchinson Cert. ¶¶44-45; Penn Cert. ¶¶ 38-39)

Representatives of Amgen argued that any reported benefits to human subjects were a result of a placebo effect and that GDNF is not an effective treatment. (Compl.¶ 53) The complaint alleges that the conditions of Suthers, Martin and other Parkinson's sufferers involved in the trial worsened in the months following the end of the trial and reverted to their state prior to the administration of GDNF. (Id. ¶¶59-66; Exhibit C ¶21) Plaintiffs seek to continue receiving GDNF, and they allege that defendant's decision to terminate the clinical trial was "unreasonable and contrary to its fiduciary, contractual, and ethical obligations to the plaintiffs." (Id. ¶¶ 67-69)

The Standard on this Motion

In deciding a motion to dismiss pursuant to Rule 12(b)(6), `Fed.R.Civ.P., the Court must accept all well-pleaded factual allegations as true and draw all reasonable inferences in favor of plaintiff. "Dismissal is not appropriate `unless it appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief.'" Chance v. Armstrong, 143 F.3d 698, 701 (2d Cir.1998) (quoting Conley v. Gibson, 355 U.S. 41, 45-46, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957)). "At the 12(b)(6) motion stage, the issue is not whether a plaintiff is likely to prevail ultimately, but whether the claimant is entitled to offer evidence to support the claims. Indeed it may appear on the face of the pleading that a recovery is very remote and unlikely but that is not the test.'" Id. at 701 (citations omitted).

Plaintiff's complaint is to be judged by a notice pleading standard. See Swierkiewicz, 534 U.S. at 512, 122 S.Ct. 992. The complaint "must simply `give the defendant fair notice of what the plaintiffs claim is and the grounds upon which it rests,'" and does not require a claimant to set out factual details on which the claim rests. Id. (quoting Conley, 355 U.S. at 47, 78 S.Ct. 99). See also Pelman v. McDonald's Corp., 396 F.3d 508, 511 (2d Cir.2005) (noting that a complaint need only satisfy the "bare-bones notice-pleading requirements of Rule 8(a)" to survive a motion to dismiss).

Although the Court is limited to facts as stated in the complaint, it may consider exhibits to the complaint, or documents incorporated by reference into the complaint, without converting the motion into one for summary...

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