Dahl v. HEM Pharmaceuticals Corp.
| Decision Date | 13 October 1993 |
| Docket Number | 92-15093 and 92-15117,Nos. 91-16897,s. 91-16897 |
| Citation | 7 F.3d 1399 |
| Parties | Kristina Anne DAHL, M.D., Kanda Boykin, Karen Reitz, Carol Graham, Jack Swickard, Ward Karns, Cindy Stratton, Duff Lilly, Nora Jacobsen, Peter Frith, Kenneth E. Miller, Cindy Boren, Candance Rogers-Dickie, Karen Ferguson, Kim Phillips, Le Anne Hyneman, Cheryl Gates, Susan Thomas, Betty Guthrie, Ginger Oliver and Gino Oliveri, Plaintiffs-Appellees, v. HEM PHARMACEUTICALS CORPORATION, a Pennsylvania corporation; HEM Research, Inc., a Pennsylvania corporation, Defendants-Appellants. Kristina Anne DAHL, M.D., et al., Plaintiffs, and Carol Graham, Plaintiff-Appellant, v. HEM PHARMACEUTICALS CORPORATION, a Pennsylvania corporation; HEM Research, Inc., a Pennsylvania corporation, Defendants-Appellees. |
| Court | U.S. Court of Appeals — Ninth Circuit |
Michael G. Jones and Michael Arthur Walsh, Choate, Hall & Stewart, Boston, MA, for defendant/appellant/cross-appellee.
Gayle A. Brooks, Beasley, Holden & Brooks, Reno, NV, for all plaintiff/appellees except Lilly, Graham, and Dahl; Michael D. Rounds, McNally & Rounds, Reno, NV, for plaintiff-appellees, Phillips, Hyneman, Gates, Thomas, Guthrie, Barfield and Olivieri in No. 91-16897; Stephen Goba, Treumann, Goba & Podbelsek, Chicago, IL, for Carol Graham; Nancy K. Dahl, La Jolla, CA, for plaintiff/appellee Dahl; Duff Lilly, in pro per, plaintiff/appellee.
Appeal from the United States District Court for the District of Nevada.
Before: NORRIS, BEEZER and KLEINFELD, Circuit Judges.
Dahl and seventeen others, afflicted with chronic fatigue syndrome, enrolled in an experimental program to test a new medication. HEM Pharmaceuticals makes the medication, called Ampligen. The patients received the medicine as part of the testing procedure used by the Food and Drug Administration to determine whether a medicine is safe and effective. When the test was over, HEM ceased providing the medication to the patients. They sued for injunctive and other relief, claiming that HEM promised to continue providing Ampligen to them after the study ended if statistical analysis showed efficacy compared to placebo. The district court granted a preliminary injunction, requiring HEM to continue providing Ampligen for twelve months. Because HEM initially failed to comply with the injunction, the district court held it in civil contempt. HEM appeals, claiming that it should not have been so enjoined. One of the patients cross-appeals, claiming that the preliminary injunction should not have been limited to twelve months. We affirm.
New medicines go through several phases of clinical evaluation before general release onto the market. HEM conducted a clinical trial with 92 patients designed to evaluate the effectiveness, side effects, and risks of Ampligen, classified by the FDA as an "investigational new drug" not yet permitted to be sold freely as a prescription medication. The study was "double blind," which means that some patients got Ampligen, some got a placebo (saline solution), and neither the doctor nor the patient knew who was getting which. The Ampligen was administered as a liquid by slow injection into a vein. All the patients signed consent forms warning of the experimental status of Ampligen and possible side effects. Although the patients were free to withdraw at any time, if they remained in the study they were required to accept the risks of treatment, forgo other drugs, not become pregnant, and submit to uncomfortable testing.
The arrangement with the experimental subjects was that they would participate in the double-blind study for a year. This was to facilitate evaluation of the safety and effectiveness of Ampligen. After the double-blind phase of testing ended, they would be entitled to receive Ampligen for a full year at no charge. The consent forms included a conditional promise of additional Ampligen after the double-blind study was completed:
If statistical analysis of the endpoints show that Ampligen TM shows efficacy compared to placebo, then following completion of all termination procedures, you understand that if you received placebo on study, you will be offered Ampligen TM and will re- enter and follow the same protocol as if you had been randomized to receive Ampligen on study. If you received Ampligen TM on study, you understand that you will be offered continuation on Ampligen TM and will re-enter and follow the same protocol.
After the double-blind study, HEM applied for permission to proceed with what the FDA calls a "treatment IND." IND is an FDA acronym for "investigational new drug application." 21 C.F.R. § 312.3(b). The application, had it been granted, would have allowed the use of Ampligen "in the treatment of patients not in the clinical trials." 21 C.F.R. § 312.34(a). This procedure can be used for an experimental new drug if the disease is serious and there is no satisfactory alternative treatment. 21 C.F.R. § 312.34(b). The FDA rejected the application for safety reasons, but allowed the next phase in clinical trials, an open label study, where the doctor and patient know that the patient is receiving Ampligen.
FDA has completed its review of the treatment IND and has concluded that the data do not support expansion of ampligen treatment at this time. Therefore, the application has been placed on clinical hold until outstanding issues and concerns can be resolved.
In addition to numerous deficiencies in the application, the agency is concerned particularly about the serious and potentially life-threatening reactions that were observed during the study, and the conduct of the study in general. These serious reactions included acute hepatic (liver) toxicity, severe abdominal pain and irregular heartbeat.
In a letter to the company ... FDA Commissioner David A. Kasslar, M.D., said that HEM's study results involving 92 patients are preliminary and that data submitted thus far to FDA are incomplete and inadequate for FDA to assess safety and effectiveness in CFS. He emphasized that it was important for CFS sufferers to know that the significant side effects associated with Ampligen would have to be weighed against any claimed benefit before the drug could be approved for wide-spread use. FDA will continue to work closely with the manufacturer in an effort to resolve all issues.
. . . . .
An "open label" study of Ampligen in patients with CFS will be allowed to continue.
FDA Talk Paper T91-63 (Oct. 4, 1991) 1
Thus, the FDA prohibited use of Ampligen on patients not in the clinical trials, but expressly allowed it for those who were.
We have jurisdiction over this interlocutory appeal of a preliminary injunction under 28 U.S.C. § 1292 (1988).
We raised the issue of mootness sua sponte and obtained supplemental briefs. It appeared to us after argument that the one-year supply ordered by the preliminary injunction would have run its course before the case was decided. We would have no jurisdiction to review the preliminary injunction if it had been fully performed, and could have no further effect. Northwest Envt'l. Defense Ctr. v. Gordon, 849 F.2d 1241, 1244 (9th Cir.1988). But the case is not moot after all.
First, the injunction still may affect conduct by HEM for some of the patients. Graham cross appeals, claiming that the district court erred in putting a one year limit on the preliminary injunction. A second patient, Hyneman, has not yet begun treatment, so if he claims treatment, he is entitled to a year of Ampligen under the injunction. A third, Rogers-Dickie, began treatment considerably after it was ordered, and so has time left under the preliminary injunction.
Also, the validity of the injunction affects HEM, even for the patients who have received their year of Ampligen. HEM has been held in contempt and fined for violating the preliminary injunction. The civil contempt order entered against HEM depends on the validity of the preliminary injunction. In re Merrill Lynch Relocation Management, Inc., 812 F.2d 1116, 1119 (9th Cir.1987) (). The contempt order is not before us, but our decision on the validity of the preliminary injunction will determine whether it stands. We have been faced with this situation before, in Trans International Airlines v. International Brotherhood of Teamsters, 650 F.2d 949, 955 (9th Cir.1980). In that case we reviewed a preliminary injunction, even though the underlying dispute was settled and no further conduct was governed by the injunction, because the civil contempt order issued pursuant to that injunction would fall if we found the injunction to be in error. Id. Thus, because of the effect of this appeal on the civil contempt order, there is a live dispute.
HEM makes two arguments: first, that the judicial process should have been suspended pending completion of the administrative process for reviewing the safety and efficacy of Ampligen by the FDA; second, that it had no contractual obligation to supply Ampligen at no charge for a year. The district judge was required to balance the probability of success on the merits with the possibility of irreparable injury. Associated General Contractors of Cal. v. Coalition for Economic Equity, 950 F.2d 1401, 1410 (9th Cir.1991). The grant or denial of a preliminary injunction will be reversed only where the district court abused its discretion or based its decision on an erroneous legal standard or on clearly erroneous findings of fact. Senate of Cal. v. Mossbacher, 968 F.2d 974, 975 (9th Cir.1992). Also, this injunction required affirmative conduct by Ampligen--it must provide Ampligen and inject it into the veins of the petitioners who want it. Such "mandatory preliminary relief" is subject to heightened scrutiny and should not be issued unless the facts and law clearly favor the moving par...
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