United States v. Articles of Food & Drug

449 F. Supp. 497
CourtDistrict Court, E.D. Wisconsin
DecidedApril 25, 1978
DocketCiv. A. No. 77-C-285
StatusPublished

This text of 449 F. Supp. 497 (United States v. Articles of Food & Drug) is published on Counsel Stack Legal Research, covering District Court, E.D. Wisconsin primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States v. Articles of Food & Drug, 449 F. Supp. 497 (E.D. Wis. 1978).

Opinion

DECISION AND ORDER

REYNOLDS, Chief Judge.

On Tuesday, April 4, 1978, through Thursday, April 6, 1978, on motion of the plaintiff United States of America, a hearing was held on an order to show cause why the defendants Mosinee Research Corp., U. S. Pharmaceuticals, Inc. (“U.S.P.I.”), Albert C. Iwen, Douglas R. Evers, John M. Couture d/b/a Product Distributors Co., Joseph J. Birkenstock, and Ralph D. Pennings should not be held in civil contempt of court for alleged violations of the injunction issued in this action on July 29, 1977, D.C., 441 F.Supp. 772, and in particular as to paragraphs 4 and 5 thereof.

Paragraphs 4 and 5 of said decree of injunction provide:

“4. Within thirty (30) days from entry of this injunction the defendants shall submit to the Honorable John W. Reynolds, Chief United States District Judge for the Eastern District of Wisconsin, an affidavit listing all distributors within defendants’ knowledge of amygdalin produced or distributed by defendants. Said affidavit shall also list all places where defendants have knowledge that any of their amygdalin or any component thereof is stored or held.
“5. All existing amygdalin and amygdalin components now held by defendants is held for sale in violation of the Federal Food, Drug and Cosmetic Act, and shall be forfeited forthwith to the United States in the custody of the United States Marshal. Defendants shall cooperate with the Marshal and shall forthwith turn over to him all articles of food or drug containing amygdalin now in their possession or control: This relief is granted in accordance with the Court’s inherent equity powers, and is intended to expeditiously remove all articles of food and drug containing amygdalin in [498]*498the defendants’ possession or control from interstate commerce. To enforce the terms of this decree, should defendants or their officers, agents, servants, employees and representatives, and any and all persons in concert and/or participation with them, or any of them, fail to cooperate with the Marshal in carrying out the terms of this order once they have notice of its contents, a Warrant Seizure & Monition is hereby authorized and issued for July 29, 1977, for 1423 Marshall Street in Manitowoc, Wisconsin, (the manufacturing plant of U. S. Pharmaceuticals, Inc.) and 13131 Janesville Road, Hales Corners, Wisconsin, (premises owned by John Couture and offices of Product Distributors Company). Upon application to this Court, further warrants of seizure and monition will be issued for other locations as required to carry out the terms of this injunction order.”

The defendants admit that they have not submitted an affidavit listing all distributors within their knowledge or all places within their knowledge where their amygdalin or any component thereof is stored as required by paragraph 4.

The five named defendants were present at the hearing on the order to show cause, and all of them testified at the hearing. In addition, the Government introduced evidence of an application by the defendant Pennings, prepared by the defendant Couture, for a trademark for a product called “Rectalin-17,” which is stated on the face of the application to contain amygdalin for use in interstate commerce. (See Exhibits 4, 5, 6, and 15.) The Government also introduced evidence obtained during a search conducted at the U.S.P.I. plant located at 1423 Marshall Street in Manitowoc, Wisconsin, on February 10, 1978. However, this evidence was thereafter suppressed on motion of the defendants and will not be considered by the Court in this decision and order, nor will testimony of the defendants be considered which the Court believes would not have been obtained absent the introduction of the subsequently suppressed evidence.

In relevant part, the defendant Couture testified that he has been the general counsel for U.S.P.I., a stockholder, and a director since its inception in February 1975; that U.S.P.I. did not have a list of regular distributors, but instead sent advertising fliers to health food stores listed in the yellow pages of the telephone book; that he did maintain files of customer correspondence from which a list might have been derived, but that those files disappeared from his office during the search by Food and Drug Administration (“FDA”) inspectors, conducted in July 1977 while he was out of the country. He also testified that since the Court’s order of July 29, 1977, he has made two or three sales of Rectalin-17, which contains amygdalin, which he obtained from the defendant Pennings in lots of approximately twenty vials each, to individuals in Wisconsin. Couture further stated that he has discussed with Pennings starting up a business for the sale of Rectalin-17 and has agreed to sell Rectalin-17 to persons in “desperate need” thereof.

With reference to the trademark application for Rectalin-17, Couture testified that it was filed in anticipation of the legalization of amygdalin products, and that he understood the statement therein to the effect that the Rectalin-17 was intended for use in interstate commerce to mean that it was being held for such use and not that it was being so used.

The defendant Couture further testified that as far as he is aware, no production of amygdalin by any of the defendants has occurred since July 29, 1977; however, experimentation with other materials such as apples, peaches, and barley has been conducted in an attempt to extract amygdalin. Finally, Couture testified that he has been involved in an attempt to incorporate a presently constituted partnership known as International American Corporation for the purpose of importing amygdalin from Taiwan and other places outside the United States to the Bahamas for the manufacture and sale of laetrile in the Bahamas. The five defendants in this action are the five [499]*499persons involved in establishing that corporation.

In relevant part, the defendant Birkenstock testified that he is a stockholder and director of U.S.P.I. and the owner of the factory building in Manitowoc, Wisconsin, in which laetrile was manufactured by U.S. P.I. prior to July 29, 1977. He stated that he was never involved in the day-to-day operation of the plant or the manufacture and sale of amygdalin; that since July 29, 1977, he is not aware that any amygdalin products have been produced by any of the defendants; that with reference to International American Corporation, he has never heard discussion of promoting or selling the laetrile to be produced in the Bahamas in the United States; and that he had never seen or heard of Rectalin-17 or Vitalin-17 until the court hearing on the order to show cause. Finally, Birkenstock testified that while he is currently the treasurer of U.S. P.I., the defendant Iwen has handled accounts for some time, and, in consequence, Birkenstock stated, he does not know if U.S.P.I. has generated any accounts receivable since July 29, 1977.

In relevant part, the defendant Pennings testified that he is a pharmacist and is a director and stockholder of U.S.P.I.; that he was formerly the president of U.S.P.I. but resigned because he wanted to experiment with developing liquid modalities of amygdalin, whereas U.S.P.I. was interested in solid forms; that he performed his experiments at the Pioneer Laboratories, which is owned by the Life Science Church of Damian and Cosmos, in Mosinee, Wisconsin; that in May and June 1977, the Pioneer Laboratories produced a lot of approximately 1,000 ampules of Va ounce each of Rectalin-17, which is a solution of 80% amygdalin in 10 cc.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

United States v. Articles of Food & Drug
441 F. Supp. 772 (E.D. Wisconsin, 1977)

Cite This Page — Counsel Stack

Bluebook (online)
449 F. Supp. 497, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-v-articles-of-food-drug-wied-1978.