U.S. v. Bowen

• Decision Date: 02 April 1999
• Docket Number: No. 98-56126,98-56126
• Citation: 172 F.3d 682
• Parties: 99 Cal. Daily Op. Serv. 2438, 1999 Daily Journal D.A.R. 3188 UNITED STATES of America, Plaintiff-Counter-Defendant-Appellee, v. John BOWEN, an individual dba Asepsis, Defendant-Counter-Claimant-Appellant.
• Court: U.S. Court of Appeals — Ninth Circuit

Page 682

172 F.3d 682

99 Cal. Daily Op. Serv. 2438, 1999 Daily

Journal D.A.R. 3188

UNITED STATES of America, Plaintiff-Counter-Defendant-Appellee, v. John BOWEN, an individual dba Asepsis Defendant-Counter-Claimant-Appellant.

No. 98-56126.

United States Court of Appeals Ninth Circuit.

Argued and Submitted March 3, 1999.

Decided April 2, 1999.

Earnest J. Franceschi, Jr., Los Angeles, California, for the defendant-counter-claimant-appellant.

Deborah M. Autor, United States Department of Justice, Washington, D.C., for the plaintiff-counter-defendant-appellee.

Appeal from the United States District Court for the Central District of California; William J. Rea, District Judge, Presiding. D.C. No. CV 98-00129-WJR.

Before: BROWNING, WIGGINS, and GRABER, Circuit Judges.

GRABER, Circuit Judge:

Defendant repairs the SteriSafe Handpiece Sterilizer (SteriSafe), which is used to sterilize dental handpieces. He also manufactures the SteriDot High Purity Water Ampule (SteriDot), an accessory used with SteriSafe. The government brought this action, claiming that both products are adulterated in violation of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. § 301 et seq., and that SteriDot also is misbranded in violation of the FFDCA. The district court agreed and enjoined defendant from introducing into, or receiving from, interstate commerce any SteriSafes or SteriDots. The district court also authorized the Food and Drug Administration (FDA) to order defendant to recall all such products that he had produced or repaired.

Defendant appeals, arguing that: (1) the district court erred by holding that these products are "devices" within the meaning of the FFDCA, (2) the FDA acted arbitrarily and capriciously by classifying SteriSafe as a class III device subject to pre-market approval, (3) the district court abused its discretion by failing to dismiss the action because of the government's failure to join a purportedly indispensable party, and (4) the district court abused its discretion by authorizing the recall of these products. We affirm.

FACTUAL AND PROCEDURAL BACKGROUND

Defendant served as a member of the board of directors and as president of Sterilization Systems, Inc. (Sterilization Systems). In 1993, Sterilization Systems began selling SteriSafe, a sterilizer for dental handpieces. Sterilization Systems did not seek the FDA's approval before marketing that product.

After a competitor of Sterilization Systems complained, the FDA informed Sterilization Systems that it could not market SteriSafe without first obtaining the FDA's approval. Thereafter, Sterilization Systems sought to have SteriSafe exempted from the FFDCA's pre-market approval requirements, arguing that SteriSafe was the substantial equivalent of a preexisting, legally marketed device. The FDA rejected that request on January 30, 1996. Despite repeated warnings from the FDA, Sterilization Systems continued to sell SteriSafe.

In December 1996, Sterilization Systems filed for Chapter 11 bankruptcy protection. Thereafter, defendant left Sterilization Systems to start an entity called Asepsis. At Asepsis, defendant continued to repair existing SteriSafes. He also developed and marketed SteriDot, an accessory to SteriSafe that "facilitates sterilization." Defendant did not obtain approval from the FDA to sell SteriDot.

On January 8, 1998, the government filed this action, seeking to prevent defendant from producing any more SteriDots and from repairing any more SteriSafes. Thereafter, both parties filed motions for summary judgment. The district court granted the government's motion for summary judgment. As part of its order, the district court enjoined defendant from introducing into, or receiving from, interstate commerce any SteriDots or SteriSafes. The district court also authorized the FDA to order defendant to recall all such products that he had produced or repaired.

STERISAFE AND STERIDOT ARE DEVICES

A. Standard of Review

Defendant argues that the district court erred by concluding that SteriSafe and SteriDot are "devices" as defined in 21 U.S.C. § 321(h). We review the district court's interpretation of law de novo. See United States v. Iverson, 162 F.3d 1015, 1019 (9th Cir.1998).

B. Analysis

"When interpreting a statute, this court looks first to the words that Congress used." Sanchez v. Pacific Powder Co., 147 F.3d 1097, 1099 (9th Cir.1998). "Rather than focusing just on the word or phrase at issue, this court looks to the entire statute to determine Congressional intent." Id.

The FFDCA applies only to a device, which is defined as

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

....

(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[.]

21 U.S.C. § 321(h)(2) (emphasis added).

Under the plain wording of the statute, an instrument that sterilizes dental handpieces satisfies the "device" requirement. Specifically, "[t]he sterilizing of a medium implies complete destruction of all germs in it." Webster's New Int'l Dictionary 2472 (unabridged 2d ed.1954) (emphasis in original). A germ is "any microorganism, esp., any of the pathogenic bacteria; a microbe; a disease germ." Id. at 1051. Thus, a sterilization instrument's purpose is to destroy disease-causing germs. Because SteriSafe sterilizes dental handpieces, it is "an instrument ... which is ... intended for use in the ... mitigation ... or prevention of disease[ ] in man." 21 U.S.C. § 321(h)(2).

Additionally, the term "device" includes any accessory to an instrument intended for use in the prevention of disease. See 21 U.S.C. § 321(h) (device means "an instrument, ... including any component, part, or accessory.") (emphasis added). Defendant has admitted that SteriDot is an accessory of SteriSafe. Accordingly, SteriDot also is a device.

Our reading of the statute comports with relevant regulatory interpretations, as well as with the words of the statute itself. The FFDCA charges the Secretary of Health and Human Services with the responsibility to enforce the Act, see 21 U.S.C. § 371(a), a responsibility that the Secretary has delegated, in turn, to the FDA, see 21 C.F.R. § 5.10. Pursuant to that grant of authority, the FDA has a longstanding policy that medical and dental sterilization instruments (and their accessories) are "devices." This longstanding policy has manifested itself in two ways.

First, the FDA has adopted regulations classifying many types of sterilization instruments as devices. See 21 C.F.R. § 880.6850 (sterilization wrap); 21 C.F.R. § 880.6860 (ethylene oxide gas sterilizer); 21 C.F.R. § 880.6870 (dry-heat sterilizer); 21 C.F.R. § 880.6880 (steam sterilizer or autoclave). Most importantly here, the FDA has adopted regulations classifying certain dental sterilizers as devices:

A boiling water sterilizer is an AC-powered device that consists of a container for boiling water. The device is intended to sterilize dental and surgical instruments by submersion in the boiling water in the container.

21 C.F.R. § 872.6710 (boiling water sterilizer).

An endodontic dry heat sterilizer is a device intended to sterilize endodontic and other dental instruments by the application of dry heat. The heat is supplied through glass beads which have been heated by electricity.

21 C.F.R. § 872.6730 (endodontic dry heat sterilizer).

Second, the FDA has an internal policy classifying other medical and dental sterilization instruments as devices. An administrative agency's internal interpretation of a statute that it administers is entitled to deference so long as it is "sufficiently rational." See Young v. Community Nutrition Inst., 476 U.S. 974, 981, 106 S.Ct. 2360, 90 L.Ed.2d 959 (1986) ("We find the FDA's [longstanding internal] interpretation of § 346 to be sufficiently rational to preclude a court from substituting its judgment for that of the FDA."). As noted, the wording of the Act demonstrates that dental sterilization instruments fall clearly under the definition of "devices." The FDA's regulations have classified similar sterilization instruments as "devices." In the circumstances, the FDA's internal determination that other sterilization instruments also are devices is "sufficiently rational."

Our interpretation also is supported by what little precedent there is in this area. See United States v. Various Articles of Device Identified in Attachment "A," 814 F.Supp. 31, 31 (E.D.Tenn.1992) ("[T]he Court finds that Sporicidin's disinfecting products are devices within the meaning of the FFDCA, 21 U.S.C. § 321(h) because they are intended for the mitigation and prevention of disease in man...."); United States v. 22 Rectangular or Cylindrical Finished Devices, 714 F.Supp. 1159, 1166 (D.Utah 1989) ("[T]he FDA's inclusion of surgical instrument sterilizers within its device jurisdiction is rational....").

In summary, the wording of the statute, the FDA's regulations, the FDA's internal interpretation, and precedent all demonstrate that a sterilizer for dental handpieces is a "device" as that term is defined in 21 U.S.C. § 321(h). That being so, both SteriSafe and its accessory SteriDot are within the jurisdiction of the FFDCA.

Defendant nevertheless posits three reasons why SteriSafe and SteriDot are not devices. First, defendant argues that the government failed to prove that dental handpieces transmit disease and, thus, that SteriSafe actually prevents disease. Such proof is not required.

Congress had two purposes in enacting the FFDCA: (1) to regulate products that actually prevent disease, and (2) to regulate products that falsely claim that they prevent disease. Because of those dual concerns, the only question under the FFDCA is whether the intended use of the product is to prevent disease, not whether the...