## Facts

- John Bowen, doing business as Asepsis, repaired the SteriSafe Handpiece Sterilizer, used to sterilize dental handpieces.
- Bowen also manufactured and marketed the SteriDot High Purity Water Ampule, an accessory intended to facilitate SteriSafe’s sterilization function.
- Sterilization Systems, Inc. began selling SteriSafe in 1993 without obtaining FDA approval; after a complaint, the FDA warned the company it could not market SteriSafe without approval.
- Sterilization Systems sought an exemption from premarket approval by claiming SteriSafe was substantially equivalent to a legally marketed device; the FDA denied the request on January 30, 1996.
- Despite repeated FDA warnings, Sterilization Systems continued to sell SteriSafe; it later filed for Chapter 11 bankruptcy, and Bowen left to form Asepsis.
- At Asepsis, Bowen continued repairing SteriSafe units and developed SteriDot without FDA clearance or approval.
- The United States sued under the Federal Food, Drug, and Cosmetic Act (FDCA), alleging SteriSafe and SteriDot were adulterated and that SteriDot was also misbranded.
- The district court found both products were “devices,” found adulteration (and misbranding as to SteriDot), enjoined Bowen from introducing or receiving SteriSafes or SteriDots in interstate commerce, and authorized the FDA to order a recall of units Bowen produced or repaired.

## Issues

1. Whether SteriSafe and SteriDot qualify as “devices” under the FDCA.
2. Whether the FDA acted arbitrarily and capriciously in classifying SteriSafe as a Class III device requiring premarket approval.
3. Whether the action had to be dismissed under Federal Rule of Civil Procedure 19 for failure to join Medident, Inc., the bankruptcy asset purchaser, as an indispensable party.
4. Whether the district court abused its discretion by authorizing the FDA to order a recall as part of equitable relief.

## Decision

- The Ninth Circuit affirmed the judgment in full.
- SteriSafe and SteriDot were “devices” because their intended use related to sterilization in dental care and disease prevention.
- The FDA’s Class III classification of SteriSafe, and its rejection of a substantial-equivalence theory, was not arbitrary or capricious.
- The district court did not abuse its discretion in declining to dismiss for nonjoinder because the relief targeted Bowen’s conduct and complete relief could be accorded among existing parties.
- Authorizing the FDA to order a recall was within the district court’s equitable discretion given ongoing FDCA violations involving unapproved devices.

## Legal Principles

- A product is a “device” under the FDCA when, based on intended use, it is used in the cure, mitigation, treatment, or prevention of disease, including by sterilizing instruments used in clinical care.
- New medical devices are presumed to be Class III unless exempted; Class III devices generally require FDA premarket approval before marketing.
- A Class III device is “adulterated” under the FDCA if it is marketed without premarket approval or a valid exemption.
- Rule 19 dismissal is not required when complete relief can be granted among existing parties and absent parties’ interests are not practically impaired by the judgment.
- In FDCA enforcement actions, district courts may issue broad injunctive relief, including recall authorization, when necessary to prevent continued distribution of adulterated or misbranded devices.

## Conclusion

The Ninth Circuit upheld FDCA enforcement against Bowen, holding that dental sterilization products and their accessories were regulated “devices,” that the FDA reasonably treated SteriSafe as an unapproved Class III device, that nonjoinder of an asset purchaser did not require dismissal, and that an injunction with FDA recall authority was a permissible equitable remedy for ongoing violations.


United States v. Bowen, 172 F.3d 682 (9th Cir. 1999)