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UNITED STATES v. KORDEL, (N.D.Ill. 1946)

United States District Court, N.D. Illinois, E.D.
Jun 26, 1946
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Opinion Summary: United States v. Kordel (three cases) — N.D. Ill., June 26, 1946

Factual and Procedural Background

Three informations, comprising twenty counts, were brought against Laura Kordel and Lelord Kordel for alleged misbranding in violation of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.A. § 301 et seq. A stipulation of facts contained in the three informations was filed by Lelord Kordel (trading as Gotu Kola Distributors and as Lelord Kordel Products, and as Lelord Kordel Products and Nutrition Enterprises); the stipulation agreed the facts alleged in the informations for Lelord Kordel. The stipulation was not made by Laura Kordel and was not to be construed as admissions by her. With those stipulated facts, the only question tried was whether the violation had been proved by the evidence.

Legal Issues Presented

  1. Whether printed matter (booklets, pamphlets, circulars) that did not physically accompany drugs on their interstate journey nonetheless "accompany" the drugs within the meaning of Section 321(m) of the Federal Food, Drug, and Cosmetic Act so as to render the drugs misbranded.
  2. Whether the statutory language (particularly the word "accompany") should be strictly construed because the prosecution is criminal and the Act contains penal provisions, or whether the remedial purposes of the Act require a broader, purposive construction that applies even in criminal proceedings.

Arguments of the Parties

Defendants' Arguments

  • Defendants' counsel principally argued that because the booklets did not physically accompany the drugs in a number of the counts, they did not "accompany" the drugs within the meaning of Section 321(m) of the Act.
  • Defendants' counsel urged a strict construction of the word "accompany" on the ground that this is a criminal action and penal provisions of the Act must be strictly construed in favor of the defendant.

Government's Arguments

The opinion does not contain a detailed account of the government's specific argumentation in the trial transcript form, but the court's opinion reflects the government's position (implicit in the prosecution) that the statutory language should be construed in light of the remedial purpose of the Act and that "accompany" may be satisfied by a broader set of relationships between printed material and the drug product.

Table of Precedents Cited

Precedent Rule or Principle Cited For Application by the Court
United States v. Dotterweich, 320 U.S. 277 (1943) Purpose of the legislation should guide its construction; legislation touching public health should be treated as a working instrument of government rather than a collection of words. The court relied on this authority to support a purposive (liberal) construction of the Act despite its penal provisions.
United States v. Antikamnia Co., 231 U.S. 654 (1914) The purpose of the Act is to secure purity of food and drugs and to inform purchasers; provisions must be construed to effect that purpose. Used to reinforce that the Act's provisions are directed to consumer protection and should be construed to achieve that objective.
United States v. Schider, 246 U.S. 519 (1917) Same principle as Antikamnia: interpret the Act to secure purity and inform purchasers; construction should effect the Act's purpose. Supported the court's view that remedial purpose controls interpretation, not strict literalism in favor of defendants.
Taylor et al. v. United States, 3 How. 197 (1845) Distinction between penal laws and remedial laws; laws intended to prevent fraud or effect a public good, although imposing penalties, are to be construed to accomplish legislative intent rather than with the strictness of a penal statute. Quoted to justify applying liberal construction to remedial legislation even where penalties are imposed.
United States v. Lee, 7 Cir., 131 F.2d 464 (1942) Definition of "accompany" in the statutory context: meanings include "to go along with," "to go with or attend as a companion," and "to occur in association with"; labeling informs purchaser of article uses. The court adopted Lee's definitional approach to "accompany" and the view that labeling must be examined for its relationship to the article.
United States v. Research Laboratories, Inc., 9 Cir., 126 F.2d 42 (1942) Case dealing with the meaning/application of "accompany" (citation used as authority for definition and application); certiorari denied. Served as supporting authority along with Lee for a broader understanding of "accompany" beyond strict physical co-packaging.
United States v. 7 Jugs, etc., Dr. Salsbury's Rakos, D.C.Minn., 53 F. Supp. 746 (1944) Detailed analysis (by District Judge Joyce) of what constitutes "accompany" for labeling purposes — emphasizing common origin, common destination, interdependence, display and distribution together, and ultimate association. The court quoted the Rakos analysis at length and relied on its factors (common origin, common destination, interdependence, display/distribution/use together) to determine that booklets could "accompany" drugs despite not being physically shipped together.

Court's Reasoning and Analysis

The court began by identifying the nature and purpose of the Federal Food, Drug, and Cosmetic Act. Citing United States v. Dotterweich and other Supreme Court authorities, the court emphasized that the Act is remedial legislation designed to protect public health and to inform purchasers about food and drugs; therefore the Act's provisions should be construed to effect those purposes rather than by rigid literalism.

Addressing the defendants' contention that the word "accompany" must be strictly construed because this is a criminal prosecution, the court rejected an interpretation that would give the word different meanings depending solely on whether a proceeding was civil or criminal. The court explained the distinction between purely penal laws and remedial laws that impose penalties, quoting Taylor et al. v. United States to demonstrate that remedial statutes intended to prevent public wrongs are not to be constricted with the strictness ordinarily applied to penal statutes.

On the specific issue of what "accompany" means in the Act, the court turned to appellate and district court authority (United States v. Lee; United States v. Research Laboratories; and the Rakos decision). It adopted the analytical approach that "accompany" must be understood in the context of the relationship between an article (drug) and its labeling. The court highlighted the Rakos factors (as articulated by District Judge Joyce), which the opinion quoted and summarized: among the relevant factors are interdependence of the drug and the printed material, common origin, common destination, display, distribution and use together, and the ultimate expectation that the printed matter will serve the purpose of labeling.

The court expressly stated that the mere fact that products and booklets were shipped at different times, by different routes, or received at different times should not be dispositive. What matters is whether the total relationship between the printed material and the drugs demonstrates that there was sufficient accompaniment to render the drugs misbranded within the statutory scheme.

Applying these principles to the stipulated facts, the court found that the booklets were shipped by the defendant, sent to the same consignee as the drugs, displayed, and intended to be distributed in relation to the drug products; the printed matter was false and misleading; and, given their common origin and intended ultimate association with the products, the booklets met the statutory concept of "accompanying" the drugs for purposes of misbranding prosecution.

Holding and Implications

Holding: The court found Lelord Kordel guilty of violating the misbranding provisions of the Federal Food, Drug, and Cosmetic Act. The court discharged Laura Kordel because the evidence was insufficient to support a conviction against her.

Implications:

  • The direct effect of the decision is a conviction of Lelord Kordel and the discharge of Laura Kordel for lack of sufficient evidence.
  • The court's reasoning applies a purposive, remedial construction of the Act's misbranding provisions and adopts an understanding of "accompany" that looks to the functional relationship (common origin, destination, interdependence, display and distribution together) between printed matter and a drug product rather than requiring strict contemporaneous physical co-packaging during interstate shipment.
  • The opinion does not state that it establishes any novel rule of law beyond applying existing precedents and district-court analyses to the stipulated facts; it focuses on the direct effect on the parties rather than announcing a new, broader precedent.

Source: United States District Court, N.D. Illinois, E.D., opinion by District Judge La Buy, June 26, 1946 (provided text).

Show all summary ...

LA BUY, District Judge.

There are three informations, comprising twenty counts, brought against Laura Kordel and Lelord Kordel for violation of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.A. § 301 et seq., by misbranding. A stipulation between Lelord Kordel trading as Gotu Kola Distributors and as Lelord Kordel Products, and as Lelord Kordel Products and Nutrition Enterprises, has been filed wherein the facts contained in the three informations are agreed. This stipulation is not made by Laura Kordel and is not to be construed as admissions by her.

With the stipulation of facts as stated in the informations, the only question tried by the court was whether the violation has been proved by the evidence.

The main contention of defendants' counsel is that since the booklets did not, in a number of counts, physically accompany the drugs they did not therefore "accompany" the drug within the meaning of Section 321(m) of the Act. Defendants' counsel urges a strict construction of the word "accompany" since this is a criminal action and that the penal provisions of the Federal Food, Drug and Cosmetic Act be strictly construed.

It is necessary first to determine the nature of the statute before us. The United States Supreme Court in the case of United States v. Dotterweich, 1943 320 U.S. 277, 64 S.Ct. 134, 136, 88 L.Ed. 48, said: "The purposes of this legislation thus touch phases of the lives and health of people which, in the circumstances of modern industrialism, are largely beyond self-protection. Regard for these purposes should infuse construction of the legislation if it is to be treated as a working instrument of government and not merely as a collection of English words." Also, in United States v. Antikamnia Co., 1914, 231 U.S. 654, 34 S.Ct. 222, 58 L.Ed. 419, and United States v. Schider, 1917, 246 U.S. 519, 38 S.Ct. 369, 370, 62 L.Ed. 863: "The purpose of the act is to secure the purity of food and drugs and to inform purchasers of what they are buying. Its provisions are directed to that purpose and must be construed to effect it."

It is apparent, therefore, that the purpose of the law is the ever-insistent consideration in its interpretation. Congress by enacting it intended to promote honesty and fair dealing in trade and secure to the public pure and wholesome food and drugs and there must be a reasonable construction to carry out the intention of Congress. This being "remedial legislation", the rule of liberal construction is to be followed irrespective of its penal provisions.

Mr. Justice Story in Taylor et al. v. United States, 1845, 3 How. 197, 11 L.Ed. 559, stated this principle as follows: "In one sense, every law imposing a penalty or forfeiture may be deemed a penal law; in another sense, such laws are often deemed, and truly deserve to be called remedial. The judge was, therefore, strictly accurate, when he stated that `It must not be understood that every law which imposes a penalty is, therefore, legally speaking, a penal law, that is, a law which is to be construed with great strictness in favor of the defendant. Laws enacted for the prevention of fraud, for the suppression of a public wrong, or to effect a public good, are not, in the strict sense, penal acts, although they may inflict a penalty for violating them.' And he added, `It is in this light I view the revenue laws, and I would construe them so as most effectually to accomplish the intention of the legislature in passing them.' The same distinction will be found recognized in the elementary writers, as, for example, in Blackstone's Commentaries * * * and Bacon's Abridgement * * * and Comyns' Digest * * * and it is also abundantly supported by the authorities."

The word "accompany" has been defined in a number of cases. See United States v. Lee, 7 Cir., 1942, 131 F.2d 464, 143 A.L.R. 1451; United States v. Research Laboratories, Inc., 9 Cir., 1942, 126 F.2d 42, certiorari denied 317 U.S. 656, 63 S.Ct. 54, 87 L.Ed. 528; United States v. 7 Jugs, etc., Dr. Salsbury's Rakos, D.C.Minn., 1944, 53 F. Supp. 746, 755. An excellent analysis was made by District Judge Joyce in the Rakos case supra. He said:

"The word `accompany' as used in Section 201(m)(2) was said in United States v. Lee, 7 Cir., 1942, 131 F.2d 464, 466, 143 A.L.R. 1451, to mean: `The word "accompany" is not defined in the Act, but we observe that among the meanings attributed to the word are "to go along with," "to go with or attend as a companion or associate," and "to occur in association with," Webster's New International Dictionary, 2d Ed.' Naturally, the meanings of accompany will vary in connection with subject matter. `Accompany' as used in this Act is used to describe a relationship between an article of drug and its labeling. Since there `can be no question that among the usual characteristics of labeling is that of informing a purchaser of the uses of an article to which the labeling relates' (United States v. Lee, 131 F.2d at page 466), the booklets here involved should be scrutinized from this viewpoint. * * *

"The stipulation clearly shows that the printed matter and the drugs had a common origin. They had a common destination in that both were intended to come together in the stores of dealers in Achilles' territory. They were interlocking units of a distributional scheme the objective of which was ultimate association and distribution together. There was actual, physical association together in the stores of dealers and actual distribution together in connection with purchases by farmers. It is fair to conclude that these booklets were prepared, shipped and distributed to dealers with the ultimate expectation and intention on the part of the Laboratories that they would serve the purpose of labeling for the three articles of merchandise here involved. Without the booklets, the products themselves lacked labeling, at least in so far as informing purchasers of the purposes and uses of the remedies. The mere fact that the products were shipped at different times, over a different route and were received at a different time from the booklets should not be permitted to confuse or obscure the substance of the matter. * * *

"What is vital are such factors as interdependence of the drug and the booklets, common origin, common destination, display, distribution and use together. These determine whether there has been that degree of accompaniment which provides the necessary `misbranded' status under Section 304(a) [ 21 U.S.C.A. § 334(a)]. The mere fortuitous circumstance of an absence of physical association between the booklets and drugs during the interstate journey of the drugs does not in my opinion control."

It is contended by defendant that the above cited cases were brought under libels of information for the condemnation of the articles involved; that these were civil proceedings; that the present case involves the criminal aspects of the statute and the definition should therefore be differently construed. To adhere to defendant's construction would result in a strange situation wherein under the same statute and the same section, a single word would have a different meaning dependent only on the nature of the action brought. This interpretation would defeat the enforcement of the statute and the court cannot subscribe to such a proposition. Furthermore, the element of forfeiture in a statute is as much a penal provision as is the one imposing a penalty.

These booklets were shipped by the defendant. The drugs and booklets were sent to the same consignee. They were displayed and were intended to be distributed in relation to the drug. The booklets, pamphlets, or circulars were false and misleading.

From the evidence and proof in the trial of this case, the court finds the defendant Lelord Kordel guilty of violating the misbranding provisions of the Act. As to the defendant, Laura Kordel, the court is of the opinion the evidence is insufficient to support a conviction and she is therefore discharged.