119 F. Supp. 3d 22
D. Conn.2015Background
- Plaintiff Linda Mihok (individually and as executrix) sued Medtronic defendants and Greenwich Hospital in Connecticut state court after an implanted SynchroMed II catheter fractured, causing withdrawal and injury to decedent Michael Mihok.
- Complaint alleges Medtronic violated FDA Current Good Manufacturing Practice (CGMP) requirements (based in part on FDA Warning Letters) and that Greenwich sold/marketed and implanted the device, asserting CPLA, CUTPA, and loss-of-consortium claims.
- Medtronic removed the case to federal court asserting federal-question jurisdiction (Gunn/Grable theory) and diversity jurisdiction, claiming Greenwich was fraudulently joined (non-diverse defendant).
- Plaintiff moved to remand; the court analyzed (1) whether the state-law claims “necessarily raise” a substantial federal issue under Gunn v. Minton and (2) whether Greenwich was fraudulently joined such that diversity jurisdiction existed.
- The court held federal-question jurisdiction lacking because the federal issue (interpretation/application of FDA CGMP) was not sufficiently substantial to the federal system under Gunn-Grable, and rejected defendants’ fraudulent-joinder showing: under Connecticut law a products-liability claim against a hospital based on pre-procedure sale/marketing of a device was reasonably possible.
- Result: motion to remand granted; case remanded to Connecticut Superior Court; federal court closed the case.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether federal-question jurisdiction exists under Gunn-Grable | Claims rest on violations of federal CGMPs but are state-law remedies; state court can adjudicate parallel claims | Federal issue (CGMP interpretation/application) is necessarily raised, disputed, and substantial; federal forum needed | No federal-question jurisdiction: federal issue is not "substantial" to the federal system (Gunn-Grable prong 3 fails) |
| Whether FDA Warning Letters/CGMP allegations create substantial federal interest | FDA has spoken; state court can give appropriate deference and apply federal regulations | Warning letters are non-final but disputes over CGMP interpretation require federal forum and could affect national regulation | Court found the issue fact-specific, likely deferential to FDA, and not of systemic federal importance; remand appropriate |
| Whether diversity jurisdiction exists because Greenwich Hospital was fraudulently joined | Greenwich is a Connecticut defendant; plaintiff plausibly alleges Greenwich sold/marketed the device and thus may be liable under CPLA | Greenwich was only providing medical services/incidentally billed and therefore cannot be a "product seller" — joinder is fraudulent | Fraudulent joinder not established: reasonable possibility exists that Greenwich could be a product seller under Connecticut law; diversity lacking |
| Whether plaintiff’s CPLA claim against a hospital is legally impossible | Cites allegations that Greenwich sold/marketed the System and implanted it as the primary reason for surgery | Relies on Connecticut cases treating hospital provision of devices incident to services as non-sales (Ziehichi, Zbras, O’Dell) | Court: those authorities are distinguishable; at pleading stage claim against hospital is not legally impossible and survives fraudulent-joinder challenge |
Key Cases Cited
- Gunn v. Minton, 568 U.S. 251 (2013) (federal-question jurisdiction where state-law claim "necessarily raises" a substantial federal issue requires a four-part test)
- Grable & Sons Metal Prods., Inc. v. Darue Eng’g & Mfg., 545 U.S. 308 (2005) (examples of state claims that present substantial federal issues warranting federal jurisdiction)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (preemption framework for state claims challenging FDA‑approved medical devices)
- NASDAQ OMX Grp., Inc. v. UBS Sec., LLC, 770 F.3d 1010 (2d Cir. 2014) (Second Circuit found substantial federal issue where SEC statements and the national importance of exchanges were implicated)
- Briarpatch Ltd. v. Phoenix Pictures, Inc., 373 F.3d 296 (2d Cir. 2004) (fraudulent joinder standard: ignore non-diverse defendant only if no possibility of recovery under state law)
- Pampillonia v. RJR Nabisco, Inc., 138 F.3d 459 (2d Cir. 1998) (defendant bears heavy burden to prove fraudulent joinder)