Pharmadyne Laboratories, Inc. v. Kennedy
Decision Date | 14 March 1979 |
Docket Number | No. 79-1056,79-1056 |
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. |
Court | U.S. Court of Appeals — Third Circuit |
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.
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 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 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:
(Footnotes omitted.)
As pointed out in Natick, supra (at 127 of 498 F.2d), this case presents an A fortiori situation for application of Ewing because, unlike Ewing, the record here contains evidence that the products involved are harmful to health (see note 8 above). The Natick court used this language at pages 127-28 of 498 F.2d:
"(T)he Abbott Laboratories decision, far from undercutting Ewing, expressly reaffirmed this earlier decision as 'quite clearly correct.' 387 U.S. at 147 (87 S.Ct. at 1507). The several distinctions noted by the Court between the promulgation of industry-wide regulations at issue in Abbott Laboratories and the recommendations of seizure proceedings under § 334 need no further elaboration here. See id. (387 U.S.) at 146-148 (87 S.Ct. 1507), 4 Therefore, we conclude that the district court lacked jurisdiction to grant injunctive relief.
Therefore, this court will affirm the district court's refusal to grant injunctive relief based on the district court's lack of jurisdiction to grant injunctive relief on the facts in this record. 10 Costs will be taxed against appellant.
1 The basis for the district court's decision was that, even if the Food and Drug Administration (FDA) had litigated without success a similar issue in United States v. Articles of Drug, Lannett, 585 F.2d 575 (3d Cir. 1978), this case came within the exceptions to the estoppel rationale set forth in Blonder-Tongue v. University Foundation, 402 U.S. 313, 91 S.Ct. 1434, 28 L.Ed.2d 788 (1971), which was relied on by plaintiff-appellant. Therefore, the district court held that an injunction preventing the FDA from seizing the plaintiff's drugs would not be within the Blonder-Tongue doctrine. The district court also enumerated other factors in its decision not to exercise its discretion to grant equitable relief (610a-4 to 610a-7).
2 21 U.S.C.A. § 334(a)(1) and (b) (1978) provide in part:
3 The district court, in its opinion, used the following language in stating the basis for its jurisdiction to grant injunctive relief:
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