Court Opinion

ID: 9467745
Source: CourtListenerOpinion
Date Created: 2023-08-05 01:55:24.376283+00
Date Added: 2024-06-11T17:40:30.173206
License: Public Domain

ARNOLD, Circuit Judge,
dissenting.
The Food and Drug Act of 1906, 34 Stat. 768, 769, defines “drug,” in pertinent part, as “any substance or mixture of substances intended to be used for the cure, mitigation, or prevention of disease of either man or other animals.” This definition has been carried forward into present law without significant change. Section 201(g) of the Federal Food, Drug, and Cosmetic Act, 52 Stat. 1040, 21 U.S.C. § 321(g), now reads as follows:
(g)(1) The term “drug” means ... (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals ....
This case concerns animal biologies, admittedly used for the prevention or treatment of disease in animals. The particular product around which the dispute here centers is known as “porcine mastitis-metritis-arthri-tis-infertility bacterin.” This bacterin contains, among other ingredients, aluminum hydroxide, which, according to evidence introduced in the court below, was purchased by the plaintiff Grand Laboratories, Inc., from a chemical firm in New Jersey and then shipped to South Dakota for use in the manufacturing process.
There is thus no doubt, and the Court raises none, that the product involved here is within the literal definition of “drug” that Congress has adopted. As I read its opinion, the Court declines to apply the words of the statute as written for two main reasons: (1) the interpretation thus produced is unreasonable; and (2) Congress, by its actions in later years, primarily in 1913 and 1968, has showed that it really did not mean what it said in 1906. Because I cannot agree that the literal language of the statute should not be applied in the circumstances of this case, I respectfully dissent.
I start with the proposition, recently repeated by the Supreme Court, that
When we find the terms of the statute unambiguous, judicial inquiry is complete, except “in ‘rare and exceptional circumstances.’ ” TVA v. Hill, 437 U.S. 153, 187 n. 33, 98 S.Ct. 2279, 2298 n. 33, 57 L.Ed.2d 117 (1978) (quoting Crooks v. Harrelson, 282 U.S. 55, 60, 51 S.Ct. 49, 50, 75 L.Ed. 156 (1930)).
Rubin v. United States, - U.S. -, -, 101 S.Ct. 698, 700, 66 L.Ed.2d 633 (1981).1 That Court has affirmed this principle with special force in respect of the very definition at issue in this case. In United States v. An Article of Drug ... Bacto-Unidisk ...., 394 U.S. 784, 89 S.Ct. 1410, 22 L.Ed.2d 726 (1969), the question was whether a laboratory aid known as an antibiotic sensitivity disc, used in a screening test for help in determining the proper antibiotic drug to administer to patients, was a “drug” within the meaning of 21 U.S.C. § 321(g)(1)(B), notwithstanding the fact that it was used exclusively in laboratory work and never came in contact with any part of the patient’s body. The Supreme Court reversed holdings by two courts below that the antibiotic discs were not drugs. The Court said:
.. . Congress fully intended that the Act’s coverage be as broad as its literal language indicates ....
*736394 U.S. at 798, 89 S.Ct. at 1418. The Court also referred, ibid., to “the well-accepted principle that remedial legislation such as the Food, Drug, and Cosmetic Act is to be given a liberal construction consistent with the Act’s overriding purpose to protect the public health .... ”
The significance of this holding for present purposes is enhanced when it is recalled that the effect of a contrary holding in Bacto-Unidisk would probably not have been to exempt the discs from regulation altogether, since, if they had not been held to be “drugs,” they would almost certainly have been considered “devices,” and thus subject to regulation, though to a lesser extent, under another provision of the statute. Here, by contrast, the Court’s holding that animal biologies are not “drugs” leaves those substances, in cases where they are not actually shipped in their finished form across state lines, entirely free of all federal regulation.
The Court persuasively argues that the result advocated by the Food and Drug Administration here would be illogical, in that certain kinds of animal biologies, those shipped across state lines, would be regulated by the Department of Agriculture, whereas certain other kinds, those not shipped across state lines but composed in part of ingredients that had been so shipped, would be regulated by the Food and Drug Administration. The resulting regulatory scheme, to be sure, is not so symmetrical as it could be, and if one were casting a vote in Congress, the arguments for placing the regulation of all animal biologies in the Department of Agriculture, as opposed to the Food and Drug Administration, would be strong indeed. It seems to me, however, that judges should usually resist the temptation to superimpose their own ideas of reason and logic on the clear words of a congressional enactment. I cannot bring myself to believe that a literal construction of this statute would yield “results so manifestly unreasonable that they could not be attributed to congressional design .... ” United States v. Rutherford, 442 U.S. 544, 555, 99 S.Ct. 2470, 2477, 61 L.Ed.2d 68 (1979). It is no more reasonable, in my view, to conclude that Congress, despite the concededly unambiguous words of the 1906 statute, did not intend in that enactment to regulate animal biologies at all.
It is true that the construction of the statute I am arguing for leaves some questions unanswered about the subsequent conduct of the Congress. If, for example, animal biologies had already been regulated by the Act of 1906, why did Congress, in the Virus, Serum, Toxin Act of 1913, now codified as 21 U.S.C. §§ 151-58, subject those products, when shipped interstate, to regulation by the Department of Agriculture? The question is a fair one, and I do not know the answer. I do suggest, however, that when Congress enacts two provisions with respect to a given subject that appear to be inconsistent or conflicting, it is our duty to harmonize the provisions and to give effect to both of them to the extent possible. Here, the 1913 Act can be given full effect as written, without superseding the jurisdiction previously conferred over products of the kind at issue in this case by the 1906 Act. The Court rightly directs our attention to the Animal Drug Amendments of 1968, § 107 of which, 82 Stat. 342, is now codified at 21 U.S.C. § 392(b). This provision makes clear that the Food, Drug, and Cosmetic Act does not affect, modify, repeal, or supersede the Virus, Serum, Toxin Act of 1913. The Court reads these words as indicating a general intention on the part of Congress not to regulate animal biologies at all except as expressly provided in the 1913 Act. The words need not be so read. Their literal meaning is simply to leave the regulation of animal biologies shipped across state lines in the Department of Agriculture, where it had been since 1913. No reference is made to the Act of 1906, and no such reference should be implied, in view of the universally received doctrine that repeals by implication are not favored.
It is perfectly true, as the Court observes, ante, pp. 734-735, that Congress can act to fill the void created by this case, if it is a void. It is equally true that Congress could overrule a holding by the courts that the *737Food and Drug Administration has the power to regulate animal biologies sold intrastate. The real question is, who shall bear the risk that, for reasons of inertia or otherwise, Congress may not act at all? I would prefer that risk be borne by the private parties seeking to avoid all federal regulation, rather than by the public agency seeking to defend the public health. No doubt there are cases when the literal meaning of a statute is absurd, and we are not, in those instances, obliged to abandon our common sense. In most eases, however, the safer course is to apply the law as written, secure in the knowledge that if we do so we cannot justly be accused of usurpation, and that a power exists that can correct us. In short, I believe this is a case in which we should apply the aphorism of Mr. Justice Holmes that “we do not inquire what the legislature meant; we ask only what the statute means.” Holmes, Collected Legal Papers 207 (1920).
I would reverse the judgment below.2

. See also United States Railroad Retirement Bd. v. Fritz, - U.S. -, -, 101 S.Ct. 453, 463, 66 L.Ed.2d 368 (1980): “the language of the statute is clear, and we have historically assumed that Congress intended what it enacted.”

. The Court also argues, ante, p. 734, that “[s]ince 1938, the FDA has acknowledged in regulations that animal biologies subject to the Virus, Serum, Toxin Act of 1913 ‘shall not be deemed subject’ to the drug provisions of the FDCA.” As 1 understand the cited regulation, however, it did not disclaim altogether any FDA jurisdiction over animal biologies, but simply provided that “a new drug shall not be deemed subject to . .. the [FDC] Act, if it is subject to the [VSTA] .. .3 Fed.Reg. 1847, § 1.02 (1938). It is undisputed that the animal biologies at issue here are not subject to the VSTA. The clear implication of the Department of Agriculture’s 1938 regulation, therefore, is that these biologies are subject to the FDCA.