from sources outside of Pennsylvania.
20. On May 13, 1988, the United States advised Winkler that it intended to initiate the instant proceedings.
21. Tri-Bio immediately ceased the manufacture and distribution of Gentaject.
22. Tri-Bio and Winkler have not manufactured or distributed Gentaject since being notified of the current proceedings and they do not intend to manufacture or distribute Gentaject unless they are successful in their request for writ of certiorari pending in the United States Supreme Court.
23. By Consent Decree dated August 4, 1988, Tri-Bio stipulated to the entry of an Order enjoining it from further manufacture and distribution of Gentaject and agreed to permit the FDA access to its facilities for the purpose of insuring compliance with the said injunction.
This lawsuit arises out of the manufacture by Tri-Bio and Winkler of Gentaject, in violation of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq. Gentaject is an injectable antibiotic drug intended for use in day old chickens. On August 4, 1988, on the basis of a "Consent Decree of Preliminary Injunction" filed by the parties, this Court preliminarily enjoined Tri-Bio and Winkler from manufacturing and distributing Gentaject. We also authorized the United States Food and Drug Administration to inspect Tri-Bio's facilities to ensure compliance with the preliminary injunction. The United States seeks an order of this Court requiring Tri-Bio and Winkler to bear all the costs of any such inspections.
This Court's inherent equitable powers permit it to order Tri-Bio and Winkler to bear the costs of the inspections. Mitchell v. Robert DeMario Jewelry, Inc., 361 U.S. 288, 291-292, 4 L. Ed. 2d 323, 80 S. Ct. 332 (1960); Porter v. Warner Holding Co., 328 U.S. 395, 398, 90 L. Ed. 1332, 66 S. Ct. 1086 (1946).
The United States argues that since Tri-Bio and Winkler have manufactured and distributed Gentaject in violation of the Federal Food, Drug, and Cosmetic Act and since it is incumbent upon the United States to inspect Tri-Bio to ensure that Tri-Bio and Winkler comply with the preliminary injunction issued by this Court, we should require Tri-Bio and Winkler rather than the public to bear the costs of such inspections.
It is undisputed that during the pendency of this case and the companion cases to this case, neither Tri-Bio nor Winkler concealed or attempted to conceal from the United States that Tri-Bio was manufacturing and distributing Gentaject. In fact, during the pendency of the case at 86-0083, Tri-Bio regularly advised the United States that it was continuing to manufacture and distribute Gentaject. The United States never objected to Tri-Bio's manufacture or sale of Gentaject. It is further undisputed that upon notification from the United States that it intended to file the case now before us, Tri-Bio and Winkler agreed immediately to cease the manufacture and distribution of Gentaject. Moreover, in this case, Tri-Bio and Winkler specifically agreed to the entry of an order enjoining them from further manufacture or distribution of Gentaject.
In light of the foregoing, there is in our view no reasonable likelihood of future violations, and accordingly, no necessity that this Court exercise its inherent equitable powers to require Tri-Bio and Winkler to pay the cost of inspections to ensure that the preliminary injunction is obeyed. Inspections will in all probability be unnecessary. However, if inspections should be made, and if a violation should be determined, we will consider imposing whatever sanctions may be appropriate.
IV. Conclusions of Law.
1. There is no reasonable likelihood of future violations of the Act.
2. There exists no statutory authority that requires reimbursement to the United States for the costs of inspections to ensure compliance with the Federal Food, Drug, and Cosmetic Act.
3. Equity would not be served by an order requiring Winkler and Tri-Bio to reimburse the United States for the cost of inspections to ensure compliance with the Federal Food, Drug, and Cosmetic Act.
An appropriate order shall issue.
DATED: August 31, 1988
ORDER - August 31, 1988, Filed
The request of the United States that Tri-Bio Laboratories, Inc., and Dennis C. Winkler bear the costs of inspections of Tri-Bio Laboratories, Inc. to ensure compliance with the preliminary injunction issued by this Court enjoining Tri-Bio Laboratories, Inc. and Dennis C. Winkler from manufacturing and distributing Gentaject is denied.
© 1992-2004 VersusLaw Inc.