Suthers v. Amgen, Inc.

• Decision Date: 06 June 2005
• Docket Number: No. 05 CIV.4158(PKC).,05 CIV.4158(PKC).
• Citation: 372 F.Supp.2d 416
• Parties: Robert SUTHERS and Niwana Martin, Plaintiffs, v. AMGEN INC., Defendant.
• Court: U.S. District Court — Southern District of New York

372 F.Supp.2d 416

Robert SUTHERS and Niwana Martin, Plaintiffs, v. AMGEN INC., Defendant.

No. 05 CIV.4158(PKC).

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

June 6, 2005.

COPYRIGHT MATERIAL OMITTED

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

Dennis H. Tracey, III, Lauren Schultz Colton, Hogan & Hartson LLP, New York, NY, Mark D. Gately, Hogan & Hartson L.L.P., Baltimore, MD, for Defendant.

MEMORANDUM AND ORDER

CASTEL, District Judge.

Plaintiffs Robert Suthers and Niwana Martin are courageous individuals who participated in a research trial for an experimental treatment for Parkinson's Disease. The decision to participate in the trial was no small matter. It was accompanied by invasive surgery to implant a pump in the abdomen and catheters into the brain in order to deliver the treatment. Each knew that there was a 50/50 chance of receiving nothing more than a placebo through the first six months of the trial.

Though plaintiffs did receive placebos for the first six months of the study, Mr. Suthers and Ms. Martin eventually received the experimental treatment as part of a second follow-on study, and viewed it as greatly relieving their symptoms. The medical researcher supervising their participation reports that Mr. Suther was able to walk up to two miles a day and Ms. Martin was able to walk and run and had an improved sense of smell and greater control over facial muscles. To their disappointment and, in their view, physical detriment, the experimental trials have been discontinued.

They now bring suit seeking to compel the sponsor of the trial to resume the treatment. The sponsor, Amgen, Inc. ("Amgen"), maintains it had a legal right to terminate the experimental trials and, indeed, an ethical duty to do so because of data indicating that the treatment was neither safe nor effective.

By way of background, the experimental treatment at issue introduces into the brain a neurotrophic factor, specifically, glial-derived neurotrophic factor ("GDNF"). It holds the potential of stimulating the regeneration of the neurons that produce dopamine, a chemical that is present at diminished levels in those suffering from Parkinson's Disease.

Amgen selected New York University Medical Center ("NYU") as one of the investigation centers that would conduct independent studies into the safety and efficacy of GDNF. In that role, NYU recruited Mr. Suthers and Ms. Martin, and determined them eligible to participate. Mr. Suthers and Ms. Martin underwent the implantation surgery. As noted, they initially received placebos in a double-blind study. Thereafter, they were permitted to participate in an open label (i.e., not blind) study in which they were treated with GDNF.

Amgen terminated the second study when it discovered that the GDNF treatment produced antibodies that potentially neutralized the human body's naturally produced GDNF and risked worsening a patient's condition. It also received test data indicating that administration of GDNF in primates caused neurotoxic responses, and in humans yielded no statistically significant results over a placebo. Plaintiffs, supported by several medical researchers, believe that Amgen needlessly overreacted to the data, and that GDNF is safe and beneficial to many with advanced Parkinson's Disease, including themselves.

Plaintiffs commenced this action on April 26, 2005, naming Amgen as the sole defendant. This Court's jurisdiction is premised on diversity of citizenship, and none of plaintiffs' causes of action arise under federal law. Proceeding by order to show cause, the plaintiffs move for a preliminary injunction requiring defendants to "provide [the physician who conducted the research study at NYU] with GDNF" and "to allow him to administer it to plaintiffs...." Neither plaintiff has received GDNF treatment since September 2004.

Plaintiffs advance three legal theories to support their application for an injunction.¹ First, they claim that GDNF is beneficial to them, and that Amgen contracted with them to supply GDNF so long as it proved to be beneficial. Second, they argue that Amgen made promises, which they relied upon to their detriment by having the surgery necessary in order to deliver GDNF to their brains; these promises, they argue, are enforceable under a theory of promissory estoppel. Third, they assert that Amgen owes them a fiduciary duty, and has breached that duty by unreasonably denying them access to GDNF. Amgen denies that it made any such enforceable promises to the plaintiffs and denies that it stands in the position of a fiduciary.

On May 26, 2005, I held a hearing on plaintiffs' motion. Each side relied upon written, sworn proof and other documentary evidence, and elected not to call live witnesses. For the reasons set forth below, I conclude that, as to the three claims asserted, plaintiffs have shown neither a likelihood of success nor a sufficiently serious showing of merits to warrant the extraordinary relief of a preliminary injunction. Therefore, I deny plaintiffs' motion.

The Research Trials of GDNF

GDNF is a naturally occurring protein found in the human body. It stimulates the neurons that produce dopamine, a chemical that is produced in lower amounts by persons with Parkinson's Disease.² A Colorado biotechnology company, Synergen Inc., developed a recombinant form of GDNF as a possible treatment for Parkinson's Disease. (Complaint ¶ 11) Seeing promise in GDNF's potential to treat the disease, Amgen purchased Synergen Inc. in 1994 for approximately $250 million. (Perlmutter Aff. ¶ 5) According to Michael Hutchinson, M.D., Ph.D., researchers were "confounded by the issue of how to effectively deliver [GDNF] to the human brain," until Dr. Steven S. Gill, neurosurgeon at Frenchay Hospital in Bristol England, devised a process by which a system of pumps and catheters implanted in the patient delivered GDNF directly to a patient's brain. (Hutchinson Cert. ¶¶ 10-13) In 2000 and 2001, Amgen supported two open-label studies into this method for delivering GDNF. (Perlmutter Aff. ¶¶ 15-18)

Based on the apparent clinical improvements in these small studies, in 2003 Amgen sponsored a "randomized, double-blind, placebo-controlled clinical trial of GDNF ... [of] patients with advanced Parkinson's disease...." (Perlmutter Aff. ¶ 19) Amgen identified the study with protocol number 20020168 ("the '168 Study").

Amgen selected eight sites to participate in the '168 Study.³ (Masterman Aff. ¶ 8) NYU was one of the participating institutions, and Dr. Hutchinson served as the site's principal investigator. (Masterman Aff. ¶ 8; Hutchinson Cert. ¶¶ 1, 16) The protocol for the '168 Study indicates that the principal investigators were to determine the eligibility of study participants. ('168 Study Protocol at 21-23) According to the affidavit of Donna Masterman, M.D., the associate director of medical sciences at Amgen, patients in the '168 Study "were largely recruited from the patient populations of the principal investigators." (Masterman Aff. ¶ 7) There is nothing in the record or in the parties' arguments indicating that Amgen directly recruited the plaintiffs or any other participants.

As is the case with trials of candidate drugs or treatments, the '168 Study was designed to ensure the independence of the investigators and their research institutions from the influence of the sponsor of the trial. The '168 Study Protocol provided for confidentiality of the study participants' identities. ('168 Study Protocol at 53-54) Patients were identified to Amgen only by their initials, or by a study subject number. ('168 Study Protocol at 53)

The plaintiffs in this action, Mr. Suthers and Ms. Martin, were two of the participants in the '168 Study. Under regulations known as the "Common Rule," 45 C.F.R. § 46.101 et seq., a subject participating in a human research trial must provide his or her informed consent.⁴ The plaintiffs signed such a consent document. (Suthers Cert. ¶ 10; Martin Cert. ¶ 10) In the case of the '168 Study, it was a 22-page document, each page of which bears the heading "Office of Institutional Board of Research Associates, NYU School of Medicine," and notes that "[t]he purpose of the research is to determine the potential benefits of liatermin in Parkinson's disease and to find out if patients can tolerate any potential side effect of liatermin."⁵ ('168 Consent Doc. at 1) It describes the process by which catheters are inserted into the patient and placed into the part of the brain affected by Parkinson's Disease. ('168 Consent Doc. at 2) It notes that subjects will be treated either with GDNF or a placebo in the form of "a weak salt solution." ('168 Consent Doc. at 2) "It is expected that your participation in this study will take a minimum of 10 months (a 3-month eligibility evaluation period, 6 months of receiving liatermin or placebo, and a 1-month follow-up)." ('168 Consent Doc. at 3) ('168 Consent Doc. at 9) The consent document also informed the participant of the possibility that the study may be terminated by its sponsor:

The Principal Investigator may also 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: 1) a serious adverse reaction to drug therapy; 2) the need for treatment that is not allowed in the study; or 3) termination or cancellation of the study by the sponsor.

('168 Consent Doc. at 20) (emphasis added).

The '168 consent document held open the possibility that once the study concluded, all participants might be eligible to receive GDNF: "Participants who complete 6 months of treatment may be invited to participate in a separate extended treatment study, which guarantees, if you are eligible to be enrolled, that you will receive...