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DEVITO v. HEM

December 23, 1988

DANIEL J. DEVITO, Plaintiff1
v.
HEM, INC.; DU PONT, INC.; HAHNEMANN UNIVERSITY; and THE FOOD AND DRUG ADMINISTRATION, Defendants



The opinion of the court was delivered by: RAMBO

 SYLVIA H. RAMBO, UNITED STATES DISTRICT JUDGE

 Background

 Defendants HEM, Inc. (HEM), and Du Pont, Inc. (Du Pont) are the "sponsors" of "clinical investigations" of an "investigational new drug" called Ampligen. See 21 C.F.R. § 312.3(b)(1988). The clinical investigations were conducted at defendant Hahnemann University's (Hahnemann) facilities. Defendant Food and Drug Administration (FDA) approved the clinical investigations of Ampligen under an Investigational New Drug exemption (IND) from the requirements of the Federal Food, Drug and Cosmetic Act (the Act). See 21 U.S.C. § 355(i); 21 C.F.R. §§ 312.1-.160 (1988). Plaintiff is a 38 year old man who has Acquired Immunodeficiency Syndrome (AIDS). He participated in three clinical investigations sponsored by HEM and Du Pont which were designed to test the efficacy of Ampligen in treating AIDS.

 The first of these investigations was called AMP101. All of the participants in AMP101 had been diagnosed as having AIDS Related Complex (ARC). The actual drug was administered to about half of the participants. The investigation was "double-blind," i.e., neither the patients nor the doctors conducting the investigation knew which patients were receiving Ampligen and which were receiving the placebo. As it turns out, plaintiff received the placebo and, unfortunately, progressed to AIDS by the end of the AMP101 investigation.

 The second and third clinical investigations in which plaintiff participated were called AMP101a and AMP101e, respectively. In those investigations, patients from the AMP101 investigation who had progressed to AIDS were given Ampligen. In mid-October 1988, while the AMP101e investigation was still being conducted, conclusions as to the results of the AMP101 investigation were reached by HEM and Du Pont. Those conclusions were that Ampligen had no proven efficacy whatsoever for the treatment of AIDS and that all testing of the drug should be terminated. Plaintiff received notice of the decision to terminate the clinical investigations in a letter given to him by one of the doctors at Hahnemann.

 Based upon those facts, plaintiff, proceeding pro se, filed a complaint, an "Application for TRO," and a petition to proceed in forma pauperis on October 18, 1988. His in forma pauperis application was granted that day and he was directed to serve all defendants. A hearing was held on October 24, 1988 at which time plaintiff was represented by counsel. At the hearing, plaintiff testified that while he was receiving Ampligen his condition improved and stabilized. Plaintiff also testified that he cannot resort to treatment with the drug AZT -- which has been used in treatment of other AIDS patients -- because the drug is too toxic for his system to tolerate. Despite the findings of HEM and Du Pont with respect to Ampligen, plaintiff is convinced the drug is keeping him alive.

 At the conclusion of the hearing, the court expressed its concern that the plaintiff set forth neither a cause of action nor any basis for this court's jurisdiction. Therefore, the court ordered a briefing to address those issues. Defendant FDA filed a motion to dismiss just prior to the hearing on October 24, 1988. On October 28, 1988, plaintiff filed a memorandum in support of his motion for a restraining order and in opposition to FDA's motion to dismiss (Plaintiff's Memorandum). All defendants filed responses to plaintiff's position on November 4, 1988. In addition, HEM and Hahnemann filed motions to dismiss. Because the motions to dismiss addressed the issue of jurisdiction, the court withheld ruling until those motions became ripe. Plaintiff filed no response to either HEM's or Hahnemann's motions.

 Discussion

 While plaintiff's claims involve a highly charged emotional issue, it is essential to bear in mind that he has two obstacles to overcome. First, he must demonstrate that this court has subject matter jurisdiction over this action. Second, he must meet the stringent criteria for obtaining the injunctive relief he requests. Since any plaintiff must establish subject matter jurisdiction to proceed in federal court, this plaintiff's ability to obtain any relief whatsoever necessarily depends upon his ability to establish subject matter jurisdiction. The court will discuss the issue of jurisdiction and consider its findings in the context of the criteria for obtaining injunctive relief.

 A. Subject Matter Jurisdiction

 The jurisdiction of federal courts is limited. Indeed, "Article III of the Constitution limits the 'judicial power' of the United States to the resolution of 'cases' and 'controversies.'" Valley Forge Christian College v. Americans United For Separation of Church and State, Inc., 454 U.S. 464, 471, 70 L. Ed. 2d 700, 102 S. Ct. 752 (1982).

 
At an irreducible minimum, Art. III requires the party who invokes the court's authority to "show that he personally has suffered some actual or threatened injury as a result of the putatively illegal conduct of the defendant," Gladstone, Realtors v. Village of Bellwood, 441 U.S. 91, 99 [60 L. Ed. 2d 66, 99 S. Ct. 1601] (1979), and that the injury "fairly can be traced to the challenged action" and is "likely to be redressed by a favorable decision," Simon v. Eastern Kentucky Welfare Rights Org., 426 U.S. 26, 38, 41 [48 L. Ed. 2d 450, 96 S. Ct. 1917] (1976).

 Id. at 472 (footnote omitted). After a thorough review of this matter, this court concludes that it does not have subject matter jurisdiction over this case because plaintiff has not shown any putatively illegal conduct of any of the ...


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