Cytori Therapeutics, Inc. v. Food & Drug Administration
404 U.S. App. D.C. 447
| D.C. Cir. | 2013Background
- FDA must approve new medical devices; Cytori sought approval for Celution 700 and StemSource 900 using adipose tissue as stem cell source.
- FDA concluded Celution/StemSource were not substantially equivalent to any marketed device, pushing them to premarket approval.
- Cytori challenged FDA under the Administrative Procedure Act as arbitrary and capricious and not reasonably explained.
- FDA argued Cytori filed in wrong court and defended its merits determination.
- Court held this appeal is proper direct review of FDA’s substantial equivalence determination and that FDA’s decision was reasonable and reasonably explained; petitions denied.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does the court have direct-review jurisdiction? | Cytori argues direct review under 360g(a)(8) | FDA contends district court jurisdiction | Court has direct-review jurisdiction over non-substantial equivalence determinations. |
| Is Cytori’s non-equivalence order reviewable under 360c(i)? | Not substantially equivalent should be reviewable under 360c(i) | Negative determinations are not made ‘pursuant to’ 360c(i) | Non-equivalence order is reviewable under 360c(i) if it uses 360c(i) criteria. |
| Was FDA’s substantial-equivalence decision reasonable under APA? | Intended use and technology not meaningfully different | Fat-derived cells differ in tissue type; safety data issues; technology differs | FDA reasonably concluded Celution/StemSource fail 360c(i) criteria. |
Key Cases Cited
- Watts v. SEC, 482 F.3d 501 (D.C. Cir. 2007) (direct-review jurisdiction under statute; APA framework used for final disposition)
- Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (U.S. 1983) (arbitrary-and-capricious standard for agency rulemaking)