Kraemer-Katz v. US Public Health Service, 94 Civ. 5829 (VLB).

872 F. Supp. 1235

Sharon KRAEMER-KATZ, Plaintiff, v. UNITED STATES PUBLIC HEALTH SERVICE, United States Food & Drug Administration; National Institutes of Health; National Institute of Arthritis and Musculoskeletal and Skin Diseases; name omitted Hospital; and two individual persons, Defendants.

No. 94 Civ. 5829 (VLB).

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

December 13, 1994.

Dennis G. Katz, Spring Valley, NY, for plaintiff.

Judith L. Mogul, Asst. U.S. Atty., New York City, for the U.S. and federal defendants.

Dewey Lee, New York State Dept. of Law, Poughkeepsie, NY, for state defendants.

MEMORANDUM ORDER

VINCENT L. BRODERICK, District Judge.

I

This case involves termination of administration of an investigational drug to a patient involved in a study of its possible use as a treatment for osteoporosis.¹ Plaintiff alleges that her participation in an investigational study of the drug was arbitrarily terminated by the treating hospital, resulting in her no longer receiving the medicine, which had been protecting her bone mass from now recurring loss. The reasons for plaintiff's termination as a subject of the testing program are controverted; plaintiff appears to have had a dispute with personnel of the hospital, leading to a malpractice suit based on conduct indirectly related to the study.

Plaintiff asks the court to order all of the federal and other institutions involved to continue to provide the drug, and requests an award of damages in the amount of five (5) million dollars. According to plaintiff, the federal agency defendants and their staff are liable for failure to insist that those hospitals and their staff conducting the tests of the drug, although private and nonfederal public sector bodies, continue to administer the drug to plaintiff. Plaintiff contends that failure to continue to provide the drug to her should lead to a cutoff of all federal funding to the institutions involved.

Plaintiff's memorandum of law, which is treated as a supplement to the complaint for this purpose, can be read as complaining that failure to provide plaintiff with administrative relief under the Federal Food, Drug and Cosmetic Act, as well as alleged improper termination by the hospital, is preventing provision of the drug to her and causing her to lose bone mass.

II

The United States Attorney has moved to dismiss the complaint for lack of subject matter jurisdiction, failure to state a claim, lack of standing, and lack of available relief which would assist plaintiff. The United States Attorney argues among other things that (a) no federal law requires any federal agency to insist that a patient continue to be provided with a drug being tested by a nonfederal agency, and (b) any failure of the hospital and other non-federal personnel or agencies is a violation solely of state, not federal law (no diversity of citizenship jurisdiction is claimed).

The complaint is dismissed in part under Fed.R.Civ.P. 12(b)(6) for failure to state a claim, as follows:

(a) the complaint is dismissed with respect to all claims against federal agencies and personnel except with respect to prospective relief under the Administrative Procedure Act if plaintiff can establish improper denial of administrative relief concerning any Federal Food, Drug and Cosmetic Act prohibition of provision of the drug to plaintiff;

(b) all damage claims against any federal agency or personnel are dismissed;

(c) all claims against any natural person federal defendant are dismissed.

The complaint will also be dismissed as to other defendants unless plaintiff establishes both a genuine issue of material fact with respect to state law claims and the appropriateness of exercise of supplemental jurisdiction over such claims under 28 U.S.C. 1367 rather than their remission to state court. The complaint will also be dismissed as to any natural person defendant remaining in the case unless plaintiff establishes that retention of such defendant is necessary to provide complete relief to plaintiff.

In order to proceed with the remaining federal claim, plaintiff must establish existence of a genuine issue of material fact concerning a claim for prospective relief under the Administrative Procedure Act from denial of a request for administrative relief by the United States Food and Drug Administration or other applicable federal agency. It is not necessary that the request for such administrative relief be made by any of the defendants if made by any other responsible medical practitioner or institution.

In sum, with respect to the federal defendants, plaintiff is permitted to seek prospective relief challenging any federal agency refusal to waive upon request any regulatory prohibition blocking her from continuing to receive an investigational medication previously administered to her as party of a study. Any claim that federal agencies or personnel must require a hospital or other administrator of a medical study to provide a drug is dismissed.

Discovery is stayed until a ruling is made with respect to viability of plaintiff's remaining claims. The defendant hospital must supply a statement to this court as of forty-five (45) days of the date of this memorandum order, as to whether or not any requests have been made to any federal agency seeking approval of, or waiver of any barrier to, continued administration of the drug involved to plaintiff.

The submissions plaintiff is permitted to make by this memorandum order shall be provided within forty (40) days of the date of this memorandum order based upon information available to plaintiff without discovery except as noted above.²

Except as outlined above, the United States Attorney's motion is denied without prejudice.

III

Because of the importance of investigational pharmaceutical testing, it is important to set forth at the outset those rulings now made finally or tentatively which will function to protect those conducting such tests:

(a) No damage suits against any federal agencies or personnel are authorized.

(b) Federal law does not require anyone conducting such testing to continue anyone in a testing program or to continue to provide the product being tested.

Unless otherwise shown, it also appears that for reasons outlined below, federal law precludes any state law requirement that participation in a federally sponsored drug testing program entitles a participant to continue to receive the drug being tested, although breach of contract claims under state law may, if independently viable and not barred by defenses not mentioned above, be pursued.

IV

The court has subject matter jurisdiction under 28 U.S.C. 1331 over claims arising under federal law. See Bowen v. Massachusetts, 487 U.S. 879, 108 S.Ct. 2722, 101 L.Ed.2d 749 (1988).

A procedural framework for private suits challenging federal agency action or inaction was established by the Administrative Procedure Act, permitting challenge to be brought in the district courts where a private party is adversely affected by final agency action claimed to be contrary to law. 5 U.S.C. § 702; see Abbott Laboratories v. Gardner, 387 U.S. 136, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967). The APA constitutes a waiver of sovereign immunity with respect to equitable relief but not damages where a violation of federal law supporting relief under the Act can be shown. Alabama v. Bowsher, 734 F.Supp. 525 (D.D.C.1990); see Bowen, supra. APA coverage, however, is not necessary for subject matter jurisdiction under 28 U.S.C. § 1331. Air Courier Conference v. Postal Workers, 498 U.S. 517, 523 n. 3, 111 S.Ct. 913, 917 n. 3, 112 L.Ed.2d 1125 (1991); Califano v. Sanders, 430 U.S. 99, 105, 97 S.Ct. 980, 984, 51 L.Ed.2d 192 (1977).

Existence of subject matter jurisdiction does not necessarily mean that relief can be granted. See Bell v. Hood, 327 U.S. 678, 66 S.Ct. 773, 90 L.Ed. 939 (1946). A violation of law and appropriateness of the relief are both necessary for that purpose. See Webster v. Doe, 486 U.S. 592, 108 S.Ct. 2047, 100 L.Ed.2d 632 (1988).

Monetary relief beyond recovery for confiscatory acts raising constitutional questions or recovery authorized by specific statutes may have adverse effects on the deep-pocketed federal Treasury. In part for this reason, suits against federal agencies for damages in their regulatory as distinct from proprietary capacity is limited to situations where a statute expressly or impliedly so indicates. United States v. Mitchell, 463 U.S. 206, 103 S.Ct. 2961, 77 L.Ed.2d 580 (1983).³

V

In order to protect the public from unsafe or ineffective pharmaceuticals, the federal Food, Drug and Cosmetic Act requires advance approval of New Drug Applications by the United States Food and Drug Administration prior to their distribution. See United States v. Generix Drug Corp., 460 U.S. 453, 103 S.Ct. 1298, 75 L.Ed.2d 198 (1983). The delays inherent in the testing necessary for approval has been recognized as presenting a problem requiring reasonable steps to expedite action where feasible and to minimize resultant hardships. Burroughs Wellcome Co. v. Schweiker, 649 F.2d 221 (4th Cir.1981); Drug Price Competition and Patent Term Restoration Act of 1984, Public Law 98-417, 98 Stat. 1585; see Westwood v. Cohen, 838 F.Supp. 126 (S.D.N.Y.1993).

Where other effective treatments are unavailing, prescription of medications not yet approved for general distribution have been authorized for compassionate reasons, especially since 1980. See 21 U.S.C. 355; 21 C.F.R. 312; Hearings before the Subcommittee on Health, Committee on Energy & Commerce, 97th Cong., 1st Sess. 49 (March 9, 1991); Ahern, "Drug Approval in the United States and England," 17 Suffolk Transnational L Rev 93 (Winter 1994); Henry, "Problems With Pharmaceutical Regulation in the United States," 14 J Legal Medicine 617 & n 51 (Dec.1993); Panel Discussion, 45 FDC LJ # 4 at 327 (1990).⁴

The Food and Drug Administration has thus increasingly recognized that a rigid...