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Halikas v. University of Minnesota, 856 F.Supp. 1331 (D.Minn. 1994)

Plaintiff, James A. Halikas, M.D. (“Dr. Halikas”), was a medical doctor, researcher and a tenured professor in the University of Minnesota Medical School's Department of Psychiatry. Dr. Halikas focused on medical teaching and drug treatment research. Defendant, The University of Minnesota (“the University”), was organized and operated pursuant to the Constitution and Minnesota statutes. The other defendant, Institutional Review Board—Human Subjects Committee of the University of Minnesota (“the IRB”), was a medical research review body established to assure compliance with University and federal drug research standards. The remaining defendants were the individual IRB members (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.). On May 18, 1994, Dr. Halikas filed an action against the University and the IRB regarding the investigation and suspension of his drug study involving human subjects. Dr. Halikas asked the Court 1) to enjoin the University from further disseminating the IRB investigation results, 2) for a retraction of information already disseminated, and 3) to indemnify him for his attorneys' fees and costs.

Background In 1992, Dr. Halikas requested permission from the University's IRB to conduct human subjects research—participants were mostly from Southeast Asia. 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 the GHB opium addiction study (“GHB Study”) and the proposed informed consent forms. In 1993, the GHB Study began.

On August 4, 1993, a medical faculty member wrote a complaint letter about the GHB Study. The complaint examined whether the human research subjects 1) signed the informed consent forms; 2) were coerced into the GHB Study; or 3) were offered standard methadone treatment. The complaint was forwarded to the IRB; and Dr. Halikas received a copy the next day. Dr. Halikas voluntarily terminated the GHB Study, and notified the IRB of the cancellation on August 10, 1993.

On September 10, 1993, over Dr. Halikas’s objection, the University issued a press release that the IRB was investigating the GHB Study. The announcement was made before the IRB voted to proceed with an investigation. Then, the IRB's formal investigation of the GHB Study began on October 13, 1993. On November 12, 1993, the IRB requested that Dr. Halikas transfer his research load to another medical researcher, and that that lead to the suspension of Dr. Halikas's research.

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. As a result, the FDA initiated its own investigation on October 21, 1993. Dr. Halikas hired a lawyer when he received notice of the FDA investigation.

As part of its investigation, the IRB heard testimony from two multi-lingual counselors who work with the human research subjects from Southeast Asia. According to Dr. Halikas, the IRB incorrectly believed that the counselors translated for the GHB Study. Dr. Halikas maintained that the counselors worked on another chemical dependency program and were not involved with the GHB Study. Dr. Halikas asserted that he was not given notice of the time or place of the counselors' testimony. He claimed that he repeatedly asked to hear and cross-examine witnesses in the investigation, but was denied the opportunity.

On December 7, 1993, the IRB gave Dr. Halikas a written list of issues arising from its investigation and requested his response. The IRB sent a follow-up letter on December 28, 1993 requesting Dr. Halikas's written or oral response. The concerns included the failure to document the informed consent of all human research subjects, and failure to follow FDA regulations. According to the IRB, Dr. Halikas did not inform the IRB of changes regarding the the GHB Study's protocol regarding 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 addressed the IRB’s concerns. At the meeting, Dr. Halikas asked to cross-examine the complainants and to review the IRB's documents. The IRB panel declined the requests. Dr. Halikas was told that prior to his testimony, no written records were kept of the committee hearings.

On March 21, 1994, the IRB panel issued its conclusions. In April 1994, the FDA issued its findings and report. The 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”) provided that the University would assume financial responsibility for legal counsel when University researchers are subject to agency investigations. Beginning in October 1993, Dr. Halikas requested that the University pay his attorneys' fees and costs arising from the FDA investigation, but the University did not pay.

Rules Dr. Halikas moved for a preliminary injunction pursuant to Rule 65 of the Federal Rules of Civil Procedure (“Fed.R.Civ.P.”). Dr. Halikas sought 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 asserted violations of 21 C.F.R. § 56.101 and stated contractual breaches. Dr. Halikas sought injunctive relief, pursuant 28 U.S.C. §§ 2201 and 2202, and attorneys' fees and costs, pursuant to 42 U.S.C. § 1988. Jurisdiction was premised on 28 U.S.C. §§ 1331 and 1367.

Analysis An application for a preliminary injunction was 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 evaluated: 1) the threat of irreparable harm to the movant; 2) the state of balance between the harm and the injury that granting the injunction would inflict on other party litigants; 3) the probability that the movant would succeed on the merits; and 4) the public interest. Dataphase, 640 F.2d at 114. The Court declined to grant the relief sought by Dr. Halikas.

1) The Threat of Irreparable Harm to Dr. Halikas Dr. Halikas contended that without an injunction, his reputation and career would suffer irreparable damage. He stated that as a result of the University's and the IRB's actions, he was unable to perform human subjects research. Dr. Halikas also claimed he would suffer irreparable harm if the University did not pay his legal fees and costs because without reimbursement, he would be unable to defend himself before the FDA. Therefore, he sought an order directing the University to follow its Policy on Indemnification. The Court did not deny that the present or a future research bar would inflicted injury on Dr. Halikas. However, the Court noted that on August 5, 1993, Dr. Halikas voluntarily surrendered his GHB Study several months prior to the IRB's suspension. The Court also noted that, during oral argument, the University's counsel stated that the IRB's suspension could be reversed upon application. The record did not reveal whether an application had been made.

The United States Supreme Court 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 this case, the Court found that the claimed harm to Dr. Halikas's reputation was not the kind of irreparable harm that could be remedied by injunctive relief.

Additionally, the claim for payment of attorneys' fees and costs did not invoke the Court's injunctive power. Such a loss is remediable in dollars. A dollar loss invoked the Court's legal powers, as opposed to its equitable powers. See Franklin v. Gwinnett County Public Schools, 503 U.S. 60, ––––, 112 S.Ct. 1028, 1038, 117 L.Ed.2d 208 (1992); Federal Deposit Insurance Corp. v. Faulkner, 991 F.2d 262, 265 (5th Cir.1993).

Consequently, the Court found that the first Dataphase factor weighed against the issuance of a preliminary injunction.

2) The Balance of the Injury to Dr. Halikas and That Inflicted on the Defendants The Court took judicial notice of the University of Minnesota Medical School's worldwide fame in medical research. See Rule 201, Federal Rules of Evidence. Such an institution has a great—and protectable—interest in assuring the integrity and humanity of its research investigations. An IRB is the vehicle through which a medical research institution maintains this integrity and humanity.

In this Court's view, an unwarranted intrusion into the IRB's supervisory efforts would inflict grievous harm upon the University and its vital function. The IRB’s self-governed supervision (limited by its own procedures, the law, and federal regulations) protects vulnerable populations. The Court found that the IRB operated within its limits.

Dr. Halikas worked with vulnerable populations—some did not speak English. The IRB determined that the population may not have been properly advised about withdrawing from the GHB Study. During oral argument, plaintiff's counsel admitted that Dr. Halikas exceeded the maximum GHB dosage allowed under the GHB Study's research protocol and there was no indication that Dr. Halikas seasonably notified the IRB of the departure. The Court found that a protocol departure, concerning an experimental drug administered to an unknowing human subject, is not an insignificant event.

Federal regulations require that an IRB report any suspension or termination of IRB research approval. The report includes the reasons given to the research, the institutional officials, and the FDA. 21 C.F.R. § 56.113. Granting Dr. Halikas's motion would require the IRB to violate this regulation and would undermine its protections.

The Court determined that an injunction would impair the IRB's ability to protect the public. The balance of injury weighs strongly against issuance of the injunction.

3) Probability of Success on the Merits In considering injunctive relief and the Dataphase factors, the likelihood of success on the merits was preeminent. S & M Constructors, Inc. v. Foley Company, 959 F.2d 97, 98 (8th Cir.) cert. denied, 506 U.S. 863, 113 S.Ct. 184, 121 L.Ed.2d 129 (1992). According to the Court’s record, Dr. Halikas had only a slight chance of prevailing on the merits. The IRB was created by federal regulations. Under 21 C.F.R. § 56.108(a), the IRB must employ written procedures “for conducting its initial and continuing review of research and for reporting its findings and actions to the researcher and the institution.” Those written procedures were contained in the University’s General Assurance Agreement. As such, the Court found that the Code of Federal Regulations and the University of Minnesota General Assurance Agreement defined the due process standards applicable to human subjects research. While Dr. Halikas pointed to the University's tenure code and its hospital by-laws, they were not part of the federal regulatory scheme, and the IRB was not bound by those procedures.

The Court found that the IRB was in sufficient compliance with the procedures in the University’s General Assurance Agreement and the applicable federal regulations to satisfy the required procedural due process. Dr. Halikas received multiple written notices of the charges against him, and a copy of the letter that started the investigation. Dr. Halikas was notified that he could have counsel present during the IRB proceeding, and he did. He testified before the IRB for more than two hours. He was invited to provide written documentation to the IRB and to identify persons who would support his position. While Dr. Halikas complains that he was denied the opportunity to hear and cross-examine witnesses and to review the IRB's documents, these procedures are not required under the applicable rules.

An IRB proceeding is not a federal criminal prosecution. An IRB proceeding is governed by contracts and federal regulations that do not require the full array of criminal procedural rights. See, Meleen v. Hazelden Foundation, 740 F.Supp. 687 (D.Minn. 1990) aff'd, 928 F.2d 795 (8th Cir.1991). Dr. Halikas voluntarily entered into an employment contract and conducted his research under the guidance of the University and its research-regulatory management.

The probability of success on the merits factor works against the issuance of a preliminary injunction.

4) Public Interest The public has a great interest in maintaining the integrity of institutional research on human subjects—especially for the vulnerable, non-English speaking, largely immigrant population. IRB supervision of biomedical studies protects human research subjects. The Court found that barring the IRB from transmitting the results of its investigation would endanger the public and hinder this essential function. Under these circumstances, the Court found that the public interest strongly favored a denial of the injunction. Therefore, after considering all the Dataphase factors, the Court declined to grant a preliminary injunction.

If Dr. Halikas had a claim against the University for damages resulting from contractual or procedural violations, that claim would not be properly placed in the presiding Court. A federal court cannot award past damages against a state institution. Schuler v. University of Minnesota, 788 F.2d 510, 516 (8th Cir.1986), cert. denied 479 U.S. 1056, 107 S.Ct. 932, 93 L.Ed.2d 983 (1987). The Eleventh Amendment to the United States Constitution would bar the claim. Dr. Halikas's case was analogous to Sherman v. Curators of the University of Missouri, 16 F.3d 860 (8th Cir.1994), where the Court held that the Eleventh Amendment barred a plaintiff from suing a state university for damages in federal court.

Conclusion On May 31, 1994, oral argument was heard. On Dr. Halikas’s motion for preliminary injunction, the District Court Judge Rosenbaum held that: 1) harm to reputation and alleged harm to researcher's ability to defend himself in connection with federal investigation was not the type of irreparable harm that could be remedied by injunctive relief; 2) balance of injury weighed against granting injunctive relief; 3) the researcher failed to establish likelihood of success on merits of due process challenge to procedures employed by university and board; and 4) public interest in maintaining integrity of institutional research on human subjects weighed against granting injunctive relief.

On July 8, 1994, the Court ordered that: 1) Dr. Halikas’s motion for a preliminary injunction was denied, and 2) Dr. Halikas’s claim for damages was dismissed without prejudice.

Halikas v. University of Minnesota, 856 F.Supp. 1331 (D.Minn. 1994)