Halikas v. University of Minnesota
| Decision Date | 08 July 1994 |
| Docket Number | No. 4-94-CV-448.,4-94-CV-448. |
| Citation | 856 F. Supp. 1331 |
| Parties | James A. HALIKAS, M.D. v. The UNIVERSITY OF MINNESOTA; the Institutional Review Board — Human Subjects Committee, of the University of Minnesota; and its Members Susan A. Barry, M.D., Christopher C. Kuni, M.D., Richard W. Bianco, David R.P. Guay, Pharm.D., Martin L. Gunderson, Ph.d., J.D., Dale E. Hammerschmidt, M.D., and Judith E. Reisman, Ph.d. |
| Court | U.S. District Court — District of Minnesota |
Phillip R. Krass, Timothy Fitzgerald Moynihan, Krass Monroe & Moxness, Bloomington, MN, Melvin Bert Goldberg, William Mitchell College Of Law, St. Paul, MN, for plaintiff.
Mark Rotenberg, University of Minnesota, Gen. Counsel, Clifford Greene, Julie Fleming-Wolfe, John M. Baker, Greene, Espel, Minneapolis, MN, for defendants.
The plaintiff, a medical researcher, claims his rights have been violated and moves for a preliminary injunction, pursuant to Rule 65 of the Federal Rules of Civil Procedure ("Fed.R.Civ.P."). Jurisdiction is premised on 28 U.S.C. §§ 1331 and 1367. This matter has been briefed, and oral argument was heard on May 31, 1994. The Court, having been fully advised, denies plaintiff's motion.
The plaintiff, James A. Halikas, a Minnesota resident, is a medical doctor and a tenured professor in the University of Minnesota Medical School's Department of Psychiatry. Dr. Halikas's work is focused on medical teaching and drug treatment research.
The defendant, University of Minnesota ("the University"), is organized and operates pursuant to the Constitution and statutes of the state of Minnesota. The defendant, Institutional Review Board ("the IRB"), is a medical research review body established to assure compliance with University and federal drug research standards.1 The remaining defendants are individuals who constitute the University's IRB. The parties do not contest that the University's and the IRB's actions occurred under color of state law.
In the fall of 1992, Dr. Halikas applied to the University's IRB for authority to conduct medical experiments on human subjects. The experiments were designed to test a drug called Gamma Hydroxybutyrate ("GHB") as a possible aid in combatting opium, cocaine, and methadone/heroin addiction. The IRB approved. As part of its review process, the IRB approved Dr. Halikas's proposed informed consent forms. In the summer of 1993, after securing approval from the University and the IRB, the GHB opium addiction study ("GHB Opium Study") began. Most of the investigation's subjects were from Southeast Asia.
On August 4, 1993, a medical faculty member wrote a letter complaining about the GHB Opium Study. The letter was forwarded to the IRB. The letter questioned whether informed consent forms had been signed by the GHB Opium Study patients, whether Dr. Halikas coerced the subjects into GHB experimentation, or whether they were offered standard methadone treatment. Dr. Halikas was sent a copy of the August 4, 1993, letter the next day. Immediately thereafter, he voluntarily terminated the GHB Opium Study. Dr. Halikas formally notified the IRB of this cancellation on August 10, 1993.
On September 10, 1993, the University issued a press release over Dr. Halikas's objection. The press release indicated that the IRB had instituted an investigation concerning the GHB Opium Study. This announcement was made, although the IRB had not yet formally voted to proceed with an investigation. The IRB's formal investigation of the GHB Opium Study began on October 13, 1993. On November 12, 1993, prior to holding hearings, the IRB requested that Dr. Halikas shift his research load to another medical researcher. This action suspended all of Dr. Halikas's human subjects research.2
On October 19, 1993, the University notified the United States Food and Drug Administration ("FDA") of the IRB's suspension of Dr. Halikas's research.3 As a result of this notice, the FDA initiated its own GHB Opium Study investigation on October 21, 1993. Dr. Halikas retained counsel when he received notice of the FDA investigation.
As part of its investigation, the IRB committee heard testimony from two multi-lingual counselors who work with Southeast Asian patients. According to Dr. Halikas, the IRB incorrectly believed that these counselors translated for the GHB Opium Study. Dr. Halikas avers that these counselors worked on another chemical dependency program and were not involved with the GHB Opium Study. Dr. Halikas further asserts that he was not given notice of the time or place of the counselors' testimony. He claims that he repeatedly asked to hear and cross-examine witnesses in the investigation, but was denied this opportunity.
On December 7, 1993, the IRB provided Dr. Halikas with a written list of concerns arising from its inquiry and requested his response. The IRB sent a follow-up letter on December 28, 1993, again requesting Dr. Halikas's written or oral response. The concerns included an apparent failure to document the informed consent of all subjects, and failure to follow FDA regulations. According to the IRB, Dr. Halikas did not apprise the IRB of changes in, or departures from, the GHB Opium Study's protocol respecting drug dosages and scheduling.
Dr. Halikas and his lawyers were invited to meet with the IRB panel on January 31, 1994. He accepted, and testified for at least two hours. He described his research experience and methodology, and replied to the IRB panel's specific concerns. At this meeting, he again requested an opportunity to cross-examine the complainants and to review the IRB's documents. The IRB panel declined these requests. Dr. Halikas was informed that, prior to his testimony, no written records had been kept of the committee hearings.
The IRB panel issued its conclusions on March 21, 1994. The FDA issued its findings and report in April, 1994. These conclusions were communicated to Dr. Halikas and various agencies and departments within and outside of the University.
The University of Minnesota Board of Regents Policy on Indemnification ("Policy on Indemnification") provides that the University will assume financial responsibility for legal counsel when University researchers are subject to agency investigations. Beginning in October, 1993, and through the present date, Dr. Halikas has requested that the University pay his attorneys' fees and costs arising from the FDA investigation. The University has not paid the legal bills.
Dr. Halikas filed this action on May 18, 1994, asking the Court to enjoin the University from further disseminating the IRB investigation results and for a retraction of information already disseminated. Dr. Halikas also asks the Court to order the University to indemnify him for his attorneys' fees and costs. Dr. Halikas seeks redress, pursuant to 42 U.S.C. § 1983, for violations of due process guaranteed by the Fourteenth Amendment to the United States Constitution. He further asserts violations of 21 C.F.R. § 56.101 et seq.,4 and state contractual breaches. Dr. Halikas seeks injunctive relief, pursuant 28 U.S.C. §§ 2201 and 2202, and attorneys' fees and costs, pursuant to 42 U.S.C. § 1988.
An application for a preliminary injunction is analyzed using the factors set forth in Dataphase Systems, Inc. v. C.L. Systems, Inc., 640 F.2d 109 (8th Cir.1981). Under Dataphase, the Court must evaluate:
1) the threat of irreparable harm to the movant; 2) the state of balance between this harm and the injury that granting the injunction will inflict on other parties litigant; 3) the probability that movant will succeed on the merits; and 4) the public interest.
The Court, having considered the Dataphase factors, declines to grant the relief sought by Dr. Halikas.
Dr. Halikas contends that, absent an injunction, he will suffer irreparable damage to his reputation and career. It is his position that, as a result of the University's and the IRB's actions, he is no longer able to perform human medical research experiments. Dr. Halikas also claims he will suffer irreparable harm if the University does not pay his legal fees and costs asserting that, in the absence of reimbursement, he will be unable to defend himself before the FDA. In this regard, he seeks an order directing the University to follow its Policy on Indemnification.
The Court does not question that a research bar inflicts an injury upon Dr. Halikas. It is also likely that Dr. Halikas will be harmed by debarment from future research. But at the same time, the Court recognizes that Dr. Halikas voluntarily surrendered his GHB Opium Study on August 5, 1993, several months prior to the IRB's suspension. The Court also notes that, during oral argument, the University's counsel indicated that the IRB's suspension is not necessarily irrevocable and may be reversed upon application. The record does not reveal whether or not such an application has been made.
The United States Supreme Court has considered the loss of reputation caused by a denial of the opportunity to perform one's work in Sampson v. Murray, 415 U.S. 61, 91-92, 94 S.Ct. 937, 953-54, 39 L.Ed.2d 166 (1974). The Court held that loss of income and harm to reputation "falls far short of the type of irreparable injury which is a necessary predicate to the issuance of a temporary injunction." In the present case, the Court finds that the claimed harm to Dr. Halikas's reputation is not the kind of irreparable harm which may be remedied by injunctive relief.
Similarly, the claim for payment of attorneys' fees and costs does not invoke the Court's injunctive power. Such a loss is remediable in dollars. A dollar loss invokes the Court's legal powers, as opposed to its equitable powers. See Franklin v. Gwinnett County Public Schools, ___ U.S. ___, ___, 112 S.Ct....
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