US v. 22 Rectangular or Cylindrical Devices

• Decision Date: 12 January 1989
• Docket Number: Civ. No. 86-C-0486G.
• Parties: UNITED STATES of America, Plaintiff, v. 22 RECTANGULAR OR CYLINDRICAL FINISHED DEVICES, MORE OR LESS, * * * "THE STER-O-LIZER MD-200 * * *," ... HALOGENIC PRODUCTS COMPANY, a/k/a Ster-O-Lizer Manufacturing Company, a corporation and Tim Themy-Kotronakis, an individual. Defendants.
• Court: U.S. District Court — District of Utah

714 F. Supp. 1159

UNITED STATES of America, Plaintiff, v. 22 RECTANGULAR OR CYLINDRICAL FINISHED DEVICES, MORE OR LESS, * * * "THE STER-O-LIZER MD-200 * * *," ... HALOGENIC PRODUCTS COMPANY, a/k/a Ster-O-Lizer Manufacturing Company, a corporation and Tim Themy-Kotronakis, an individual. Defendants.

Civ. No. 86-C-0486G.

United States District Court, D. Utah, C.D.

January 12, 1989.

Mark A. Heller and Glen R. Dawson, Washington, D.C., for plaintiff.

William D. Appler, Washington, D.C., and Michael L. Deamer, Salt Lake City, Utah, for defendants.

MEMORANDUM DECISION AND ORDER

J. THOMAS GREENE, District Judge.

This matter came before the court on September 2, 1988, pursuant to the parties' respective cross Motions for Summary Judgment. The United States was represented by Mark A. Heller and Glen R. Dawson, and defendants were represented by William D. Appler and Michael L. Deamer. Counsel submitted memoranda and presented oral argument, after which the court took the matter under advisement. Being now fully advised, the court sets forth its Memorandum Decision and Order.

BACKGROUND

The government brought this action under the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301-392 (1972 & Supp. 1988) (the "Act"), for seizure and condemnation¹ and to enjoin alleged violations of the Act² by defendant Halogenic Products Corporation ("Halogenic"), a/k/a Ster-O-Lizer Manufacturing Corporation, and its president and sole owner, defendant Tim Themy-Kotronakis ("Themy"). At issue is the scope of the statutory definition of "device" as set forth in 21 U.S.C. § 321(h) (Supp.1988), and the extent of the Food and Drug Administration's ("FDA") regulatory authority under that definition. The specific item involved in this definitional controversy of first impression is a product manufactured and distributed by Halogenic, known as the MD-200 sterilizer ("sterilizer"), which purportedly has the capacity to sterilize disposable and nondisposable surgical instruments by submerging the instruments in a sodium water solution into which electrical energy is introduced. According to Themy, this electrolysis process separates the active chlorine radicals from the solution, and these radicals, together with an ozone by-product, function to kill spores and bacteria on surgical instruments.

The FDA conducted "good manufacturing practice" inspections at the Ster-O-Lizer facility in Salt Lake City, Utah, on five separate occasions between 1983 and 1987. At the conclusion of each inspection, the FDA provided written notification to Themy detailing the alleged good manufacturing practice violations that existed at the time of each inspection. On January 11, 1984, due to defendants' alleged failure to bring their conduct into compliance with the Act and the FDA regulations for good manufacturing practices for medical devices, 21 C.F.R. §§ 820.1-.198 (1988), the FDA issued a regulatory letter informing Themy that if corrective measures were not taken, the FDA was prepared to pursue regulatory action, including the pursuit of injunctive relief. On June 5, 1986, after it became apparent that Themy had no intention of complying with the FDA's requests, the MD-200 sterilizers were seized and attached by the United States Marshal pursuant to a warrant of arrest issued by the clerk of this court.

The government filed an amended complaint in this action alleging, among other things: (1) that the surgical instrument sterilizers are "adulterated" within the meaning of 21 U.S.C. § 351(h) (1972 & Supp.1988)³ in that they are not produced under current good manufacturing practices which are required to assure safe and effective devises under 21 U.S.C. § 360j(f)(1) (Supp.1988);⁴ and (2) that the sterilizers are "misbranded" under 21 U.S. C. § 352(o) (1972 & Supp.1988)⁵ in that they have not been subject to premarket notification to the FDA under 21 U.S.C. § 360(k) (1972 & Supp.1988).⁶ After the defendants answered the amended complaint and some discovery was conducted, the parties entered into a stipulation, dated December 16, 1987. Pursuant to that stipulation, the defendants "admit the allegations of the Amended Complaint, thereby withdrawing any denials in the Answer ... except that the claimant/defendants continue to deny the Amended Complaint's allegation that the Ster-O-Lizer MD-200 is a medical device within the meaning of 21 U.S.C. § 321(h)." Stipulation, 86-C-486G. By way of the same stipulation, the parties also agree that "resolution of the issue of whether the Ster-O-Lizer MD-200 is a medical device within the meaning of 21 U.S.C. § 321(h) will determine the allocation of judgment in this case, and ... that if the government or the claimant/defendants prevail on this issue, judgment and remedy should be entered in favor of the prevailing party." Id. Accordingly, if the sterilizer is a "device" within the definition of the Act, then the defendants have admitted that the device is adulterated and misbranded and that they have violated the law, as alleged in the complaint. If, on the other hand, the sterilizer is not a "device," the Act itself is totally inapplicable, and the government is not entitled to any of its requested relief.

ANALYSIS

I. THE DEVICE ISSUE

The Medical Device Amendments to the Food, Drug and Cosmetic Act were enacted by Congress in 1976 to provide for the safety and effectiveness of medical devices intended for human use and other purposes. Medical Device Amendments of 1976, Pub.L. No. 94-295, 90 Stat. 539 (codified at 21 U.S.C. §§ 360c-360k (Supp. 1988)). The amendments authorize the FDA to exercise specific regulatory powers pursuant to complex administrative procedures. However, before a product may be subject to the FDA's regulatory powers, it must be deemed to be a "device," which the Act defines as

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagant, or other similar or related article, including any component part, or accessory, which is —

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(3) intended to affect the structure or any function of the body of man or other animals, and

which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.

21 U.S.C. § 321(h) (Supp.1988).⁷ Under the statute, the definition of a device has three parts, and a product may be a device if it fits within any portion of the provisions of 21 U.S.C. § 321(h)(1)-(3).⁸

Lack of Administrative Classification

Defendants' first argument is that it is inappropriate for the FDA to attempt to classify a product as a medical device in a litigated enforcement proceeding where it has failed to classify the device administratively. The court does not agree. Defendants' classification argument is irrelevant to the "device" issue presented here.⁹ Section 321(h) defines the scope of all products that are devices under the Act. Significantly, that statute does not discriminate between devices that are classified and devices that are not classified. Indeed, classification occurs only after a product is deemed to be a device; classification is not meant to determine whether a product is a device, but rather to determine the degree of regulation necessary to assure a product's safety and effectiveness once it is characterized as a device.¹⁰ Not only does the language of the statute itself fail to support defendants' classification claim, but persuasive case law also does not support that position.¹¹ Accordingly, the court concludes that it is not necessary that it be determined in an administrative proceeding that a product is a device before the FDA can bring a litigated enforcement action to stop device misbranding and adulteration.

Lack of Direct Contact with Patient

Defendants next argue that the surgical instrument sterilizer is not a device within the meaning of Section 321(h) because it does not directly come in contact with patients. Defendants' interpretation of the term "device" would exclude from the definition any product used in the diagnosis, treatment or prevention of disease so long as the product does not directly contact the human body. This court declines to interpret section 321(h) in such a narrow and restrictive manner. A product "`need not be the only agent in an allegedly curative process to be a device within the definition.'" United States v. An Article of Device, Toftness Radiation Detector, 731 F.2d 1253, 1258 (7th Cir.), cert. denied, 469 U.S. 882, 105 S.Ct. 249, 83 L.Ed.2d 186 (1984) (quoting United States v. Article of device, Hubbard Electrometer, 333 F.Supp. 357, 360 (D.D.C.1971)). Indeed, even device "accessories" and "components" intended for use in devices standing alone, constitute devices. See 21 U.S.C. § 321(h) (Supp.1988).¹²

The direct contact argument was expressly addressed and rejected by the Supreme Court in United States v. An Article of Drug, Bacto-Unidisk, 394 U.S. 784, 89 S.Ct. 1410, 22 L.Ed.2d 726 (1969). In that case, the Court held that the term "drug," defined in 21 U.S.C. § 321(g) (1972) as including "articles intended for use in the diagnosis, care, mitigation, treatment, or prevention of disease in man,"¹³ was broad enough to include an antibiotic sensitivity disc used as a screening test in determining the proper antibiotic drug to administer to patients, so as to subject the disc to the FDA's premarket clearance regulations. Id. at 798, 89 S.Ct. at 1418. The Court rejected the defendant's contention that the disc was not covered by the Act because of its indirect relationship to the treatment of patients, stating:

Respondent's primary contention

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