Tutoki v. Celebrezze

• Decision Date: 23 January 1967
• Docket Number: No. 15701.,15701.
• Citation: 375 F.2d 105
• Parties: Michael TUTOKI, Vera Mae Jeffries, Frank J. Worachek, Howard Haney, C. Clarke Woods, Eugene L. Sydow, Chester C. Spease, and Chester J. Wojtowicz, Administrator of the Estate of Geraldine E. Roy, deceased, for and on behalf of Raymond Roy, Jr., surviving child, and Helen Mathews, surviving mother of Geraldine Roy, deceased et al., Plaintiffs-Appellants, v. Hon. Anthony J. CELEBREZZE, Hon. John W. Gardner, Successor to Anthony J. Celebrezze, Secretary, Department of Health, Education and Welfare, Melville H. Hosch, Regional Director, Department of Health, Education and Welfare, George F. Larrick, Commissioner, Federal Food and Drug Administration, John H. Guill, Jr., District Director, Federal Food and Drug Administration, and the United States of America, Defendants-Appellees.
• Court: U.S. Court of Appeals — Seventh Circuit

375 F.2d 105 (1967)

Michael TUTOKI, Vera Mae Jeffries, Frank J. Worachek, Howard Haney, C. Clarke Woods, Eugene L. Sydow, Chester C. Spease, and Chester J. Wojtowicz, Administrator of the Estate of Geraldine E. Roy, deceased, for and on behalf of Raymond Roy, Jr., surviving child, and Helen Mathews, surviving mother of Geraldine Roy, deceased et al., Plaintiffs-Appellants, v. Hon. Anthony J. CELEBREZZE, Hon. John W. Gardner, Successor to Anthony J. Celebrezze, Secretary, Department of Health, Education and Welfare, Melville H. Hosch, Regional Director, Department of Health, Education and Welfare, George F. Larrick, Commissioner, Federal Food and Drug Administration, John H. Guill, Jr., District Director, Federal Food and Drug Administration, and the United States of America, Defendants-Appellees.

No. 15701.

United States Court of Appeals Seventh Circuit.

January 23, 1967.

Luis Kutner, Robert R. Napoleon, Chicago, Ill., for appellants.

Edward V. Hanrahan, U. S. Atty., William J. Hurley, Asst. U. S. Atty., Chicago, Ill., for appellees, John Peter Lulinski, Asst. U. S. Atty., of counsel.

Before SCHNACKENBERG, KILEY and SWYGERT, Circuit Judges.

KILEY, Circuit Judge.

Plaintiffs appeal from a judgment dismissing their amended complaint seeking injunctive, declaratory and compensatory relief based on defendants' alleged arbitrary, unauthorized and unconstitutional conduct in prohibiting, under color of federal law, the interstate shipment of Krebiozen from Illinois to various states where plaintiffs live. We affirm.

The original plaintiff, now deceased, was Geraldine Roy, a cancer patient residing in Arizona. She filed the original complaint in April, 1965. On October 15 her death was suggested and a motion made to substitute the administrator of her estate as original plaintiff and to substitute Secretary John W. Gardner for Anthony J. Celebrezze. The motion was granted as to substitution of Secretary Gardner, but otherwise continued to January, 1966, when an amended complaint was filed with leave of court. The amended complaint substituted the administrator and named additional parties plaintiff. Defendant's motion to dismiss the amended complaint was allowed; judgment and this appeal followed.

In the first five counts of the amended complaint, plaintiffs, except the administrator, make virtually the same allegations as those made by Geraldine Roy in the original complaint. In the sixth count, the administrator of the estate of Geraldine Roy alleges a wrongful death claim under the Federal Tort Claims Act¹ on behalf of the surviving son and mother of Geraldine Roy.

The gist of the various claims is that defendants, under color of the Federal Food, Drug and Cosmetic Act of 1938,² prevented the interstate shipment of Krebiozen and are continuing to do so by their unconstitutional and unlawful acts, to the detriment of plaintiffs, who are cancer patients. Section 505(a) of the Federal Food, Drug and Cosmetic Act³ prohibits the interstate shipment of any new drug unless an application filed under section 505(b) is approved or the drug is exempted under section 505(i).

The plaintiffs allege that defendants, acting under color of law but beyond their authority, coerced Dr. Stevan Durovic, sponsor of the drug Krebiozen, into withdrawing his application for an exemption to ship Krebiozen interstate; that defendants have imposed discriminatory, harsh and severe standards in testing Krebiozen so that it cannot obtain approval and were predetermined to refuse Krebiozen an exemption; that as a result plaintiffs, advised by their physicians to receive treatment with Krebiozen, have been forced to leave their homes in other states of their residence and come to Illinois to receive the necessary treatment, which has benefited them; that as a result defendants by this conduct have subjected plaintiffs to irreparable injury through "cruel and unusual punishment," violated their constitutional rights and caused physiological, psychological and proprietary damage; and that plaintiffs have no adequate remedy at law.

In the first five counts plaintiffs seek a declaratory judgment with respect to their rights and defendants' liabilities, and a declaratory judgment that section 505 of the Act is unconstitutional as applied to them and to Krebiozen. They also seek an injunction to restrain defendants from enforcing the section 505 (a) prohibition against interstate shipment of Krebiozen. In the sixth count the administrator of the estate of Geraldine Roy seeks damages on behalf of her son and mother because of her alleged wrongful death resulting from defendants' alleged misconduct.

Defendants' motion to dismiss was based on grounds of want of jurisdiction over subject matter and parties; improper venue; adding additional parties in violation of Fed.R.Civ.P. 25 because the claims in counts one to five were extinguished at Geraldine Roy's death; sovereign immunity; the discretionary character of the alleged wrongful conduct of defendants; and failure to state a claim upon which relief can be granted.

The present posture of Krebiozen vis-a-vis the Food and Drug Administration (FDA) is that it is not approved under or exempted from section 505. The FDA has promulgated no order with respect to the drug, and no application of plaintiffs is pending before the agency.

An essential element of proof by plaintiffs would be a showing that if the FDA had passed upon Krebiozen according to statutory and constitutional standards, it would have been approved or exempted.⁴ The relief sought by plaintiffs therefore presupposes a determination by the district court that Krebiozen should be approved for interstate shipment or exempted from the prohibition pursuant to the standards Congress enacted in the Food, Drug and Cosmetic Act. This determination is a matter within the primary jurisdiction of the FDA. See Far East Conference v. United States, 342 U.S. 570, 72 S.Ct. 492, 96 L.Ed. 576 (1952).⁵ The district court has neither the facilities nor the expertise to pass on Krebiozen in the first instance. The possible conflict of a...