Source: https://law.justia.com/cases/federal/appellate-courts/F2/564/1200/83077/
Timestamp: 2019-10-20 19:23:10
Document Index: 618116516

Matched Legal Cases: ['§ 371', '§ 371', '§ 334', '§ 371', '§ 371', '§ 371']

Parke, Davis & Company, Plaintiff-appellee, v. Joseph A. Califano, Secretary of Health, Education Andwelfare, Donald Kennedy, Commissioner of Food Anddrugs, and the Food and Drugadministration, Defendants-appellants,andunited States of America, Appellant, 564 F.2d 1200 (6th Cir. 1977) :: Justia
Justia › US Law › Case Law › Federal Courts › Courts of Appeals › Sixth Circuit › 1977 › Parke, Davis & Company, Plaintiff-appellee, v. Joseph A. Califano, Secretary of Health, Education An...
Parke, Davis & Company, Plaintiff-appellee, v. Joseph A. Califano, Secretary of Health, Education Andwelfare, Donald Kennedy, Commissioner of Food Anddrugs, and the Food and Drugadministration, Defendants-appellants,andunited States of America, Appellant, 564 F.2d 1200 (6th Cir. 1977)
U.S. Court of Appeals for the Sixth Circuit - 564 F.2d 1200 (6th Cir. 1977) Argued June 14, 1977. Decided Oct. 26, 1977. Rehearing Denied Nov. 23, 1977
It is established in Abbott Laboratories v. Gardner, 387 U.S. 136, 87 S. Ct. 1507, 18 L. Ed. 2d 681 (1967), that Congress did not intend, in the enactment of the Food, Drug and Cosmetic Act and its amendments, to preclude all judicial review of final agency actions of the FDA except in the manner set forth in 21 U.S.C. § 371(f) (1).2 Construing the Food, Drug and Cosmetic Act together with the Administrative Procedure Act, the Court concluded that the action of the FDA in promulgating industry-wide regulations was subject to pre-enforcement review under the "saving clause" of 21 U.S.C. § 371(f) (6).3 It cannot be argued since Abbott Laboratories that district courts are totally without jurisdiction to conduct pre-enforcement review of agency actions. However, such review is limited.
In Abbott Laboratories the Supreme Court reaffirmed its earlier holding in Ewing v. Mytinger & Casselberry, 339 U.S. 594, 70 S. Ct. 870, 94 L. Ed. 1088 (1950), and distinguished the two cases. In Ewing the plaintiff had been subjected to eleven seizures and libel actions by the FDA within a three-month period. It brought suit to have declared unconstitutional a provision of the Act which authorized the commissioner to file multiple actions for condemnation of drug products upon a finding, without a hearing, of probable cause to believe the drugs were being marketed in violation of the Act. The Court held that due process was satisfied by provisions of the Act which permit the owner of the seized drugs to appear in the seizure action and have a full hearing in accordance with rules for proceedings in admiralty. The Court also noted that the owner of the seized drugs may procure consolidation of all pending seizure actions so that the issues may be decided at one trial. The section referred to in Ewing, now 21 U.S.C. § 334(b),4 also provides for removal of seizure actions to a district near the claimant's principal place of business, and for trial by jury of issues of fact.
Yet it has never been held that the hand of the government must be stayed until the courts have an opportunity to determine whether the government is justified in instituting suit in the courts. 339 U.S. at 599, 70 S. Ct. at 873.
This Court held that the owner could raise his constitutional, statutory, and factual claims in the libel actions themselves, and that the mere finding of probable cause by the Administrator could not be challenged in a separate action. 387 U.S. at 147, 87 S. Ct. at 1514.
When this action was filed in the district court Parke Davis had taken the necessary steps to obtain a final decision on its right to market Benylin over the counter by protesting the ruling that its supplemental NDA was not approvable. A hearing will be held before a final decision is rendered on that application, and the decision will be subject to judicial review by the appropriate court of appeals pursuant to 21 U.S.C. § 371(f) (1).
Parke Davis argues in this court that the district court did more than review the decision of the commissioner to initiate enforcement proceedings. It contends that the district court acted properly under the Administrative Procedure Act to prevent irreparable injury from an arbitrary and capricious action of the commissioner in seizing drug products which were being distributed over the counter as a matter of right following publication of the preliminary monograph without dissent. Parke Davis relies primarily on Upjohn Co. v. Finch, 303 F. Supp. 241 (W.D. Mich. 1969). In Upjohn the FDA revoked a certificate for marketing an antibiotic which had been approved for 12 years. No enforcement action was pending and no hearing was provided prior to revocation. Upjohn is distinguishable in at least two respects. First, the drug in question had been approved for sale this was not in dispute. In the present case Benylin has never received final approval as an over-the-counter drug. The "switch-over" proceedings are still in progress, and a hearing is scheduled. The OTC Review was concluded with a decision adverse to Parke Davis. Secondly, in this case enforcement proceedings were pending in other jurisdictions when the district court issued its injunctive orders. Every issue raised in this case, including the question of whether the OTC Review regulations deprived Parke Davis of due process rights by failing to provide for a hearing and failing to contain guidelines for the commissioner in determining whether to accept or dissent from a panel monograph, could have been raised in the enforcement proceedings.
Thus Parke Davis had an adequate remedy, and the district court erred in holding that it did not. Parke Davis had the same remedy which was available to the distributor in Ewing the statutory right to contest the seizure of its property in the libels, four of which had been filed before the injunction was entered in the present action. Parke Davis did not interpose defenses in any of these actions. These actions could have been consolidated for a single trial in a convenient district and Parke Davis could have raised the issues there which it sought to raise in the present action. In view of the fact that no final decision had been made on the supplemental NDA, "it would be commonplace for the (enforcement) court to await an appropriate administrative declaration before it acted." Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 652, 93 S. Ct. 2488, 2493, 37 L. Ed. 2d 235 (1973). Instead of following statutory procedures which the Supreme Court said in Ewing were designed to afford relief, Parke Davis elected to seek the extraordinary remedy of injunction. Though the district court had jurisdiction under the Administrative Procedure Act to consider the complaint of Parke Davis, insofar as it questioned the regulations and procedures of the FDA as contrasted with the mere decision to initiate enforcement proceedings, it was an abuse of discretion to enjoin the FDA in the circumstances of this case where pending enforcement actions provided an opportunity for a full hearing before a court. In short, this case is controlled by Ewing v. Mytinger & Casselberry rather than Abbott Laboratories v. Gardner and Upjohn Co. v. Finch.
21 U.S.C. § 371(f) (1) provides in part:
(f) (1) In a case of actual controversy as to the validity of any order under subsection (e) of this section, any person who will be adversely affected by such order if placed in effect may at any time prior to the ninetieth day after such order is issued file a petition with the United States court of appeals for the circuit wherein such person resides or has his principal place of business, for a judicial review of such order.
21 U.S.C. § 371(f) (6) provides: