372 F. Supp. 3d 141
W.D.N.Y.2019Background
- Plaintiff Joseph Barone sued Bausch & Lomb (B&L), Morcher GmbH, and FCI after an implanted Crystalens (a Class III, PMA-approved medical device) and capsular tension ring allegedly malfunctioned, causing injury.
- Plaintiff alleges B&L knew about a defect called "Z syndrome" and failed to timely report adverse events to the FDA as required by 21 C.F.R. § 803.50(a), thereby depriving doctors and patients of information in the MAUDE database.
- Claims: strict liability, negligent failure to warn, breach of warranty, negligence, and defective design/manufacture; B&L's alleged duty and breach are pleaded as parallel state-law claims relying on alleged violations of federal reporting requirements.
- B&L removed to federal court asserting federal-question jurisdiction under Grable (substantial federal issue) and moved to dismiss on preemption grounds under the MDA/FDCA; the court raised subject-matter jurisdiction sua sponte.
- The court applied the Gunn/Grable four-part test (necessarily raised; actually disputed; substantial; federal-state balance) and found the first two prongs satisfied but concluded the federal issue was not "substantial" to the federal system and that exercising federal jurisdiction would disrupt the federal-state balance.
- Result: the case was remanded to New York State Supreme Court, County of Monroe, for lack of subject‑matter jurisdiction.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether federal-question jurisdiction exists under the "substantial federal question" doctrine (Gunn/Grable) | Barone: state-law claims necessarily raise a federal issue because they rest on alleged violations of FDA reporting rules; jurisdiction proper because first Gunn factors met | B&L: dispute over compliance with FDCA/MDA is federal and substantial given comprehensive federal regulation of PMA devices; federal forum needed; preemption defense further supports jurisdiction | Court: first two Gunn prongs satisfied (necessarily raised, actually disputed), but third prong (substantial) not met; remand granted for lack of subject-matter jurisdiction |
| Whether the federal issue is "actually disputed" | Barone: whether B&L violated FDA reporting duties is in dispute but not a matter of statutory interpretation | B&L: disputes about whether federal duties were violated justify federal adjudication | Court: satisfied—parties dispute whether B&L complied with federal law, so the federal issue is actually disputed |
| Whether the federal issue is "substantial" to the federal system as a whole | Barone: federal reporting regulations are implicated and thus significant | B&L: PMA devices are heavily regulated; allowing state suits would undermine federal regulatory scheme and create nonuniform regulation | Court: not substantial—dispute is fact-specific, does not challenge FDA action or federal statute validity, and does not implicate the federal government's enforcement interests in the way Grable/Smith did |
| Whether exercising jurisdiction would disrupt the federal‑state balance or require invoking complete preemption | Barone: claims are pleaded as parallel state-law duties; no federal private right exists so state forum appropriate | B&L: federal expertise and uniformity justify federal adjudication; urges treating state claims as federal for jurisdiction | Court: exercising jurisdiction would disrupt the balance; Congress left parallel state remedies intact and did not provide a federal private right—complete preemption does not apply |
Key Cases Cited
- Grable & Sons Metal Prods. v. Darue Eng'g & Mfg., 545 U.S. 308 (establishes "substantial federal question" framework)
- Gunn v. Minton, 568 U.S. 251 (articulates four-part test for Grable jurisdiction)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (MDA express preemption; allows parallel state-law duties that "parallel" federal requirements)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (implied preemption where state-law claim rests solely on alleged FDCA violation)
- Merrell Dow Pharm. Inc. v. Thompson, 478 U.S. 804 (absence of federal private right bears on federal-question jurisdiction)
- Empire Healthchoice Assurance, Inc. v. McVeigh, 547 U.S. 677 (federal issue substantiality and federal-state balance considerations)