Pharmadyne Laboratories, Inc. v. Kennedy, No. 79-1056

• Court: United States Courts of Appeals. United States Court of Appeals (3rd Circuit)
• Writing for the Court: Before SEITZ, Chief Judge, and VAN DUSEN and GARTH; VAN DUSEN
• Citation: 596 F.2d 568
• Parties: PHARMADYNE LABORATORIES, INC., Appellant, v. Donald M. KENNEDY, Commissioner of Food and Drug, United States Department of Health, Education and Welfare, and Frederick R. Carlson, Food and Drug Administration, District Director, Newark District Office, and United States Food and Drug Administration.
• Docket Number: No. 79-1056
• Decision Date: 14 March 1979

Page 568

596 F.2d 568 PHARMADYNE LABORATORIES, INC., Appellant,
v.
Donald M. KENNEDY, Commissioner of Food and Drug, United
States Department of Health, Education and Welfare, and
Frederick R. Carlson, Food and Drug Administration, District
Director, Newark District Office, and United States Food and
Drug Administration. No. 79-1056. United States Court of Appeals,
Third Circuit. Argued Feb. 21, 1979.
Decided March 14, 1979.

Page 569

Milton A. Bass (argued), Jacob Laufer, Bass, Ullman & Lustigman, New York City, for appellant.

Charles J. Walsh, Asst. U. S. Atty. (argued), Newark, N. J., and Eugene M. Pfeifer, Associate Counsel for Enforcement, Office of the Gen. Counsel, Food & Drug Administration, Rockville, Md., for appellees.

Eugene I. Lambert, Covington & Burling, Washington, D. C., for Hoechst-Roussel Pharmaceuticals, Inc., amicus curiae.

Before SEITZ, Chief Judge, and VAN DUSEN and GARTH, Circuit Judges.

OPINION OF THE COURT

VAN DUSEN, Circuit Judge.

This appeal arises from a January 10, 1979, order ¹ of the district court, denying plaintiff a preliminary injunction to restrain defendants from instituting or causing to be instituted any further seizure action against plaintiff's drugs under 21 U.S.C.A. § 334. ² After consideration of the record, we affirm the district court order, but on a different ground namely, that the district court had no jurisdiction to enjoin

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the FDA from carrying out multiple seizures. ³

The plaintiff in this case seeks an injunction preventing the FDA from commencing any further seizure actions against its drugs. The record reveals four seizure actions under 21 U.S.C.A. § 334 have already been started by the FDA, alleging Inter alia, that such drugs are adulterated and are new drugs. The plaintiff's position is that this court's decision in United States v. Articles of Drug, Lannett, supra, allows it to market its drugs without prior FDA approval insofar as their new drug status is concerned. ⁴ Therefore, plaintiff contends the FDA actions are improper and should be enjoined.

Aside from the fact that there are several factors that distinguish this case from Lannett, this court concludes that the district court should have denied plaintiff's request for injunctive relief because it lacked jurisdiction to grant that relief under decisions of the Supreme Court of the United States and other United States Courts of Appeal.

In Ewing v. Mytinger & Casselberry, 339 U.S. 594, 70 S.Ct. 870, 94 L.Ed. 1088 (1949), the Supreme Court held that district courts do not have jurisdiction to enjoin the FDA from commencing and prosecuting multiple seizure actions under 21 U.S.C.A. § 334. Accord, Abbott Laboratories v. Gardner, 387 U.S. 136, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1966); ⁵ Parke, Davis & Co. v. Califano, 564

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F.2d 1200 (6th Cir. 1977); Natick Paperboard Corp. v. Weinberger, 498 F.2d 125 (1st Cir. 1974). The Ewing Court held that the district court could not enjoin multiple seizures, even where, unlike this case, the district court found that the Government's intent was to harass and injure the manufacturer. ⁶

The courts that have dealt with this issue have concluded that the only forum Congress provided for a determination of the propriety of FDA seizures was in the seizure action itself. ⁷ The congressional intent in providing the FDA with the multiple seizure mechanism was to provide for a quick and complete removal of adulterated or misbranded drugs from the market. If the district court could enjoin the seizures, the public would be denied the speedy protection intended by Congress. In Ewing v. Mytinger & Casselberry, supra, the Supreme Court of the United States said at pp. 598 and 601-02, 70 S.Ct. at pp. 872-74:

"When the libels are filed the owner has an opportunity to appear as a claimant and to have a full hearing before the court. This hearing, we conclude, satisfies the requirements of due process.

"What we do today determines the jurisdiction of the District Court in all the cases in that category. If the court in the present case can halt all multiple seizures but one, so can the court in other cases. The means which Congress provided to protect consumers against the injurious consequences of protracted proceedings would then be seriously impaired. Congress weighed the potential injury to the public from misbranded articles against the injury to the purveyor of the article from a temporary interference with its distribution and decided in favor of the speedy, preventive device of multiple seizures. We would impair or destroy the effectiveness of that device if we sanctioned the interference which a grant of jurisdiction to the District Court would entail. Multiple seizures are the means of protection afforded the public. Consolidation of all the libel suits so that

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one trial may be had is the relief afforded the distributors of the articles." ⁸

(Footnotes omitted.)

As stated in the Parke, Davis case, Supra (564 F.2d at 1206), the issues raised in this case

". . . could have been raised in the enforcement proceedings. ( ⁹

"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. . . . 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....