Meserey v. United States

• Decision Date: 16 November 1977
• Docket Number: No. Civil LV 76-218 RDF.,Civil LV 76-218 RDF.
• Citation: 447 F. Supp. 548
• Parties: Dr. James E. MESEREY, Plaintiff, v. UNITED STATES of America, and Department of Health, Education and Welfare, and F. David Matthews, Secretary of Department of Health, Education and Welfare, and Public Health Service of the Department of H. E. W., and Food and Drug Administration, and Stephen S. Gross, Director of San Francisco District of Food and Drug Administration, and Rod Chu, Compliance Officer, San Francisco District of Food and Drug Administration, and Dick Kluge, Assistant for Import Operations, Food and Drug Administration, and Alexander Schmidt, M. D., Commissioner of Food and Drug Administration, and United States Customs Service, and Vernon Acree, Commissioner of the United States Customs Service, and Albert G. Bergesen, Regional Commissioner of District 7 of United States Customs, and George K. Brokaw, Agent for said Albert G. Bergesen, and United States Treasury Department, and William E. Simon, Secretary of United States Treasury Department, Defendants.
• Court: U.S. District Court — District of Nevada

447 F. Supp. 548

Dr. James E. MESEREY, Plaintiff, v. UNITED STATES of America, and Department of Health, Education and Welfare, and F. David Matthews, Secretary of Department of Health, Education and Welfare, and Public Health Service of the Department of H. E. W., and Food and Drug Administration, and Stephen S. Gross, Director of San Francisco District of Food and Drug Administration, and Rod Chu, Compliance Officer, San Francisco District of Food and Drug Administration, and Dick Kluge, Assistant for Import Operations, Food and Drug Administration, and Alexander Schmidt, M. D., Commissioner of Food and Drug Administration, and United States Customs Service, and Vernon Acree, Commissioner of the United States Customs Service, and Albert G. Bergesen, Regional Commissioner of District 7 of United States Customs, and George K. Brokaw, Agent for said Albert G. Bergesen, and United States Treasury Department, and William E. Simon, Secretary of United States Treasury Department, Defendants.

No. Civil LV 76-218 RDF.

United States District Court, D. Nevada.

November 16, 1977.

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Edward R. Weinstein, Las Vegas, Nev., for plaintiff.

Lawrence J. Semenza, U. S. Atty. by Leland E. Lutfy, Asst. U. S. Atty., Las Vegas, Nev., for defendants.

MEMORANDUM OPINION AND ORDER GRANTING DEFENDANTS' MOTION FOR SUMMARY JUDGMENT AND DENYING PLAINTIFF'S MOTION FOR SUMMARY JUDGMENT

ROGER D. FOLEY, Chief Judge.

This matter has been submitted to the Court on defendants' motion for summary judgment, filed April 28, 1977, and on plaintiff's motion for summary judgment, filed June 3, 1977.

FACTS

This is a civil action for declaratory and injunctive relief, replevin and monetary damages brought by Dr. Meserey, plaintiff, against the United States, three federal agencies and various federal employees. This action is allegedly based upon the defendants' role surrounding the detention of certain homeopathic drugs sought to be imported into the United States under the authority of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq.

The homeopathic drugs in question were manufactured in this country and Great Britain. Evidently some of the drugs had been purchased in the United States, shipped to Canada, and now plaintiff seeks to effect admission without further interference with customs officials or the Food and Drug Administration. Approximately 2000 bottles of these drugs are being detained.

On March 14, 1976, these homeopathic drugs were imported with other personal effects of plaintiff to Las Vegas, Nevada. Customs officials in Las Vegas examined the shipment to determine if there were any violations of the Food and Drug Act, 21 U.S.C. § 381(a). From this examination it was determined that this shipment may be in violation of the Act. On March 30, 1976, samples of the drugs were sent to the District Office of the Food and Drug Administration in San Francisco where further examinations were performed by personnel in that office, Mr. Chu and Mr. Gross, defendants in this action.

This examination revealed that the drugs appeared to be misbranded within the meaning of 21 U.S.C. § 352(f) which requires directions for use and warnings on the label. Mr. Chu, according to his affidavit, made the following findings:

"1. Some of the samples did not correctly bear the names of the drugs listed or recognized in Homeopathic Pharmacopedia of the United States (Exhibit 2(a));

"2. The labels of some samples restricted dispensing by a licensed practitioner; plaintiff was not such a practitioner (Exhibit 2(b));

"3. Some samples failed to bear adequate directions for use (Exhibit 2(c));

"4. No sample bore warnings against inappropriate use (Exhibit 2(d)); and

"5. One label bore no directions for use whatsoever, and its label consisted merely of a typed white-gummed label with only the name of one unidentifiable drug (Exhibit 2(e))."

Based on the above findings, a notice of detention and hearing was issued on April 20, 1976, pursuant to 21 U.S.C. § 381(a). Accompanying this notice was a letter that requested plaintiff to supply the following information, which, if sufficient, would effect a release of the drugs: a) the composition of the preparations, b) the intended use of these preparations, and c) plaintiff's qualifications to receive and prescribe these preparations.

Plaintiff's response letter failed to provide sufficient information to effect a release of the drugs. Plaintiff also contacted Mr. Chu over the telephone to attempt to secure a release of the drugs. According to Mr. Chu's affidavit, on May 18, 1976, plaintiff personally visited Mr. Chu's office to seek admittance of his drugs. At that time plaintiff was informed that he could effectuate release four ways: a) relabeling, b) returning the drugs to Canada at his own expense, c) sifting through the articles, under the supervision of an FDA employee, segregating those drugs which are not misbranded from those which are; and/or d) destroying the drugs.

All of these methods were rejected by the plaintiff. On July 27, 1976, plaintiff was sent a notice of refusal of admission, and on October 21, 1976, plaintiff instituted this action. Plaintiff filed an administrative claim for his damages on December 23, 1976.

JURISDICTION

As plaintiff seeks a determination by this Court as to the validity and enforcement of 21 U.S.C. § 321(g) and § 381, he properly asserts jurisdiction of this Court under 28 U.S.C. § 1337 which provides review for cases "arising" under acts relating to commerce. Rutherford v. United States, 399 F.Supp. 1208 (D.Okl.1975).

DISCUSSION

I. CONSTITUTIONALITY OF TITLE 21 § 321(g) AND § 381 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

A. § 321(g)

Plaintiff contends that the definition of the word "drug" in 21 U.S.C. § 321(g)(1)(A) that states (in part) articles listed in the Homeopathic Pharmacopoeia shall be considered "drugs" is overbroad in that homeopathic remedies, according to his complaint, "no matter how old, are not dangerous to anyone, including children, no matter what condition a person is in, and no dosage, no matter how high, is unsafe to anyone."

The Supreme Court has stated:

". . . it is clear from § 201 as amended § 321(g) that the word `drug' is a term of art for the purposes of the Act, encompassing far more than the strict medical definition of that word." United States v. An Article of Drug * * * Bacto-Unidisk, 394 U.S. 784, 793, 89 S.Ct. 1410, 1415, 22 L.Ed.2d 726 (1969).

At page 798, 89 S.Ct. at page 1418 the Court further stated:

". . . we think, that Congress fully intended that the Act's coverage be as broad as its literal language indicates — and equally clearly, broader than any strict medical definition might otherwise allow."

The Court continued:

". . . we are all the more convinced that we must give effect to congressional intent in view of 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 . . ."

Thus, the Supreme Court has ruled that the Act's coverage "be as broad as its literal language indicates" and, therefore, there is no merit in plaintiff's allegation that the statute is overbroad.

Assuming arguendo that § 321(g)(1)(A) could be declared overbroad, § 321(g)(1)(B) also defines a drug as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; . . ." Plaintiff states in paragraph 14 of his complaint that he would inform users of the proper dosage and potential dangers of the homeopathic remedies. In his opposition to defendants' motion for summary judgment (page 9, lines 11-12), plaintiff states "these remedies, and homeopathic physicians, treat the patient, not just the disease." By plaintiff's own admission, homeopathic remedies are used in the treatment of diseases in man, and therefore his remedies fall squarely within § 321(g)(1)(B).

Plaintiff argues his remedies are completely harmless to anyone in any condition in any dosage. This argument, even if true, will not preclude a finding that his remedies are "drugs" within the meaning of the Act. Regardless of the actual physical effect of the product, once it is established that its intended use brings it within the drug definition, it will be deemed a drug for purposes of the Act. United States v. An Article . . . Sudden Change, 409 F.2d 734, 739 (2nd Cir. 1969).

In Flemming v. Florida Citrus Exchange, 358 U.S. 153, 166, 79 S.Ct. 160, 168, 3 L.Ed.2d 188 (1958) the Court stated:

"The Federal Food, Drug, and Cosmetic Act is a detailed and thorough piece of legislation. Its treatment of many public health and food problems is quite specific, and of course it is the duty of the courts in construing it to be mindful of its approach in terms of draftsmanship. Here again, in our construction of this explicit Act, we must be sensitive to what Congress has written, and recall that `It is for us to ascertain — neither to add nor subtract, neither to delete nor to distort.'"

From the preceding discussion, it is clear that whenever there is a problem of construction, the duty of the courts is to liberally construe provisions of the Act, being mindful of its overriding purpose to protect the public health. In the instant case, this Court is not confronted with a problem of construction or interpretation. Plaintiff seeks to strike down the Act's definition of the term "drug" because he alleges his remedies are safe and therefore the statute is overbroad. Under the Act, the safety of an article is not the determining factor. Instead, the determination under the Act is based upon the articles listing in the Pharmacopoeia or its intended use.

Obviously, plaintiff's remedies fall squarely within two subsections of the Act which define the word "drug." It would be error for this Court to strike down the...