## Facts

- Ethicon, Inc. manufactured VICRYL poly(glycolide/L-lactide) absorbable surgical sutures within a broader generic device type of poly(glycolide/L-lactide) absorbable sutures.
- Under the Medical Device Amendments to the FDCA, medical devices are regulated in Classes I–III, with Class III subject to the most stringent controls and Class II regulated through “special controls,” including performance standards.
- Poly(glycolide/L-lactide) absorbable sutures were originally classified as Class III devices.
- After multi-year study, review of scientific and clinical literature, and consultation with an expert advisory panel, FDA issued a regulation reclassifying the generic device type from Class III to Class II.
- The advisory panel unanimously recommended Class II reclassification, citing the sutures’ safety and effectiveness history and the feasibility of controlling key performance characteristics through standards.
- Ethicon sought administrative reconsideration and then filed suit, arguing FDA lacked adequate evidence about manufacturer-specific “manufacturing variables” and failed to meet statutory and procedural requirements for reclassification.
- Ethicon requested declaratory and injunctive relief to invalidate the reclassification and require rescission of actions taken under it.
- The matter was presented on cross-motions for summary judgment on the administrative record; a competitor, United States Surgical Corporation, intervened in support of FDA.

## Issues

1. Whether FDA’s reclassification of poly(glycolide/L-lactide) absorbable sutures from Class III to Class II was supported by “sufficient information” and “valid scientific evidence” under the FDCA.
2. Whether FDA complied with required reclassification procedures, including advisory panel consultation and notice-and-comment rulemaking.
3. Whether the reclassification regulation was arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law under the APA.

## Decision

- The court granted summary judgment for FDA, the HHS Secretary, and the intervenor, and denied Ethicon’s summary judgment motion.
- The court upheld the Class II reclassification regulation, finding it consistent with the FDCA’s substantive and procedural requirements.
- The court held the agency action was not arbitrary or capricious under APA review, given the administrative record and expert support.

## Legal Principles

- Under APA arbitrary-and-capricious review, a court asks whether the agency considered relevant factors and avoided clear error of judgment; it does not substitute its policy or scientific views for the agency’s.
- Courts give substantial deference to FDA’s scientific and technical judgments in medical device classification and reclassification decisions.
- The FDCA permits FDA to reclassify a generic device type based on valid scientific evidence supporting class-wide safety and effectiveness, including evidence that critical performance parameters can be controlled through performance standards and other special controls.
- The FDCA does not require exhaustive, manufacturer-by-manufacturer data as a prerequisite to generic reclassification when FDA reasonably concludes that standards can address safety and effectiveness risks associated with product variability.
- Compliance with advisory panel consultation and notice-and-comment procedures, coupled with reasoned responses to objections in the record, supports upholding a reclassification rule against procedural challenges.

## Conclusion

The court sustained FDA’s decision to reclassify poly(glycolide/L-lactide) absorbable sutures from Class III to Class II, holding that FDA reasonably relied on scientific literature, clinical experience, and unanimous expert panel advice, followed required procedures, and acted within the bounds of deferential APA review despite asserted manufacturing-variability concerns.


Ethicon, Inc. v. Food & Drug Admin., 762 F. Supp. 382 (D.D.C. 1991)