Alabama Tissue Center of University of Alabama Health Service Foundation, P.C. v. Sullivan

Decision Date16 September 1992
Docket NumberNo. 91-2738,91-2738
Citation975 F.2d 373
PartiesALABAMA TISSUE CENTER OF THE UNIVERSITY OF ALABAMA HEALTH SERVICE FOUNDATION, P.C., an Alabama Corporation, American Red Cross Tissue Services, a Division of the American Red Cross, a California Corporation, Lifenet, a Virginia Corporation, et al., Petitioners, v. Louis W. SULLIVAN, Secretary of the United States Department of Health and Human Services and David Kessler, Commissioner of the United States Food and Drug Administration, Respondents.
CourtU.S. Court of Appeals — Seventh Circuit

George M. Burditt (argued), Alan I. Becker, Deborah B. Norton, Burditt & Radzius, Chicago, Ill., for petitioners.

Don O. Burley, Dept. of Justice, Consumer Litigation, Washington, D.C., Louis W. Sullivan, Washington, D.C., Margaret Porter, Dept. of Health & Human Services, Chief Counsel, Food & Drug Div., Rockville, Md., for respondents.

Before COFFEY and MANION, Circuit Judges, and SHABAZ, District Judge. *

SHABAZ, District Judge.

Six not-for-profit heart valve allograft processors filed a petition for review with this Court contesting the "Notice of Applicability of a Final Rule" ("NAFR") published by the Food and Drug Administration ("FDA") on June 26, 1991 at 56 Federal Register 29,177. The NAFR states that replacement heart valve allografts are subject to the final rule issued by the FDA on May 13, 1987, which requires the filing of a pre-market approval application ("PMA") for all preamendment replacement heart valves and their equivalents. A heart valve allograft is a human heart valve which has been processed and preserved so it can be stored until needed for implantation into a human recipient. Because we conclude that we lack jurisdiction to entertain the petition for review of the NAFR, we dismiss the petition.

BACKGROUND
Statutory Framework

Provisions establishing a detailed procedure for regulating medical devices were added to the Food, Drug and Cosmetic Act of 1938 by the Medical Device Amendments of 1976 ("FDC Act"). See 21 U.S.C. §§ 360c-360l. The FDC Act defines "device" as:

[A]n instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is--

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(3) intended to affect the structure or any function of the body of man or other animals, and

which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.

21 U.S.C. § 321(h) (emphasis added).

Medical devices are divided into three classes. 21 U.S.C. § 360c(a). Class III devices are the most regulated of the three and require premarket approval in accordance with 21 U.S.C. § 360e. See 21 U.S.C. § 360c(a)(1)(C). A Class III device, in relevant part, is one which cannot be classified as Class I or II for insufficient information to reasonably assure its safety and effectiveness and it "is purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of The FDA is required to classify a device in distribution before the enactment of the Medical Device Amendments of 1976 or substantially equivalent to a preamendment device. 21 U.S.C. § 360c. For such a device categorized as a Class III device, the FDA is first required to promulgate a regulation classifying the device pursuant to 21 U.S.C. § 360c(d)(1). The FDA must then promulgate a regulation to require premarket approval under 21 U.S.C. § 360e(b). The FDA cannot require an approved PMA for a preamendment device prior to thirty months after the classification regulation becomes effective or ninety days after the promulgation of the regulation requiring premarket approval, whichever is later. 21 U.S.C. § 351(f)(2)(B).

                human health...."  21 U.S.C. § 360c(a)(1)(C).   A Class III device can be exempted from premarket approval if an investigational device exemption ("IDE") is obtained pursuant to 21 U.S.C. § 360j(g)
                
Administrative Proceedings

In 1979 the FDA issued a proposed regulation classifying replacement heart valves as Class III medical devices pursuant to 21 U.S.C. § 360c. The FDA received no comments on the proposed regulation and accordingly it became final as proposed on February 5, 1980 ("1980 Regulation"). The 1980 Regulation defines "replacement heart valves" as:

[A] device intended to perform the function of any of the heart's natural valves. This device includes valves constructed of prosthetic materials, biologic valves (e.g., porcine valves), or valves constructed of a combination of prosthetic and biologic materials.

21 C.F.R. § 870.3925(a).

The FDA then issued a proposed regulation in 1986 requiring (i) the filing of a PMA or a product development protocol ("PDP") for preamendment replacement heart valves and their equivalents; and (ii) an approved PMA or a declared and completed PDP for any other replacement heart valve prior to commercial distribution. The FDA received only one comment and that was unrelated to the proposed regulation. None of the petitioners commented. The regulation, which amended the 1980 Regulation, was finalized on May 13, 1987 ("1987 Regulation"). See 21 C.F.R. § 870.3925(c). The 1987 Regulation required the filing of a PMA or a PDP for preamendment replacement heart valves and their equivalents by December 9, 1987. Id.

In 1989, perhaps with some reason for doing so, the FDA began notifying the industry of its intent to subsequently regulate heart valve allografts, believing it to be within its authority pursuant to the prior regulation. For example, in October 1989 the Center for Devices and Radiological Health of the FDA participated in a workshop on human heart valves sponsored by the American Association of Tissue Banks. Further, on August 20 and 21, 1990 the Circulatory System Devices Panel, an advisory committee of the FDA, held a public hearing to assist the heart valve allograft processors in subsequently complying with the premarket approval. The FDA's proposed guidelines concerning the regulation of heart valve allografts were discussed at this meeting.

On June 26, 1991 the FDA published the NAFR. The summary of the NAFR states:

The Food and Drug Administration (FDA) is issuing a notice to clarify that replacement heart valve allografts, devices, are subject to a final rule that was issued by FDA on May 13, 1987, requiring the filing of a premarket approval application (PMA) for all preamendment replacement heart valves, and those substantially equivalent to replacement heart valves. PMA's or investigational device exemptions (IDE's) will be required as described herein.

56 Fed.Reg. 29,177. The NAFR required an approved PMA or IDE to be "in effect" by August 26, 1991. The FDA has extended the "effective date" to June 30, 1992, which has been further extended by the Court pending its decision.

Petitioners have also filed a second action challenging the NAFR in the United States District Court for the Northern District of Illinois.

Litigation

Petitioners, six not-for-profit heart valve allograft processors, filed a petition for review of the NAFR with this Court on July 25, 1991. Subsequently, petitioners filed a motion for a stay of administrative action pending review and a motion to supplement the record on review. Respondents filed a motion to dismiss for lack of jurisdiction. We denied petitioners' motion for a stay and ordered that all other issues be heard by the merits panel. On June 26, 1992 petitioners filed a motion for stay pending the decision of this Court which was granted.

DISCUSSION

As a preliminary matter, we deny Petitioners' Motion to Supplement the Record on Review pursuant to Rule 16 of the Federal Rules of Appellate Procedure and 28 U.S.C. § 2112. The minutes of the various panels and subcommittees of the FDA appear to be neither material nor complete. The notes concerning a 1987 telephone conversation involving an FDA employee is data not included in any statutory definition of the record on review.

The threshold question is whether we have jurisdiction to entertain the petition to review the NAFR. The jurisdictional issue overlaps the merits. We restrict our analysis to a discussion of only those issues necessary to resolve the issue of jurisdiction.

"Federal courts of appeals are not courts of general jurisdiction; they possess only the jurisdiction conferred upon them by acts of Congress." Russell v. LEAA, 637 F.2d 354, 355 (5th Cir.1981); see also 9 James W. Moore et al., Moore's Federal Practice p 215.02 (2d ed. 1992). The jurisdiction of the United States courts of appeals to directly review the action of administrative agencies is "specially conferred by legislation relating specifically to the determinations of such agencies made subject to review, and prescribing the manner and extent of review." AFL v. NLRB, 308 U.S. 401, 404, 60 S.Ct. 300, 302, 84 L.Ed. 347 (1940).

The FDC Act contains specialized provisions for judicial review of "discrete agency actions." Cutler v. Hayes, 818 F.2d 879, 887 n. 61 (D.C.Cir.1987). "Agency action taken under sections silent in this respect is directly reviewable in a district court under some appropriate head of its jurisdiction, for courts of appeals have only such jurisdiction as Congress has chosen to confer upon them." Id.

Under 21 U.S.C. § 360g(a) the courts of appeals are granted jurisdiction to review a limited group of regulations or orders concerning medical devices. Any person who is adversely affected by such a...

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