393 F.Supp.3d 912
C.D. Cal.2019Background
- Five plaintiffs sued Mentor Worldwide and NuSil entities after alleged injuries and implant failures from Mentor MemoryGel silicone breast implants; claims asserted: negligence/negligence per se, failure to warn, and manufacturing defect.
- Mentor obtained FDA premarket approval for MemoryGel implants with post‑approval study requirements; plaintiffs allege violations of FDA reporting and study obligations and manufacturing nonconformities.
- Case removed by Mentor to federal court on diversity grounds; plaintiffs moved to remand asserting the forum‑defendant rule because NuSil LLC (a California citizen) had not been served before removal.
- Mentor argued NuSil LLC was fraudulently joined because it is merely a holding company that did not manufacture or supply the silicone; Mentor supported this with sworn testimony and amended public filings.
- The Court held NuSil LLC was fraudulently joined (disregarded for diversity), denied remand, and addressed Mentor’s 12(b)(6) challenge, finding plaintiffs’ state‑law claims preempted by the Medical Device Amendments (MDA) and dismissing the complaint with prejudice.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Availability of federal jurisdiction / removal under §1441(b)(2) | Remand because forum defendant (NuSil LLC) was a California defendant and removal occurred before service | §1441(b)(2) bars removal only when an in‑state defendant has been both properly joined and served prior to removal; NuSil not served | Removal proper: §1441(b)(2) did not bar removal because NuSil LLC had not been properly served at removal |
| Joinder of NuSil LLC | NuSil LLC is a manufacturer/supplier and properly joined | NuSil LLC is a passive holding company with no manufacturing role (fraudulent joinder) | NuSil LLC fraudulently joined; its citizenship disregarded for diversity |
| Preemption — failure to plead parallel FDA‑based claims | Alleged Mentor failed to report adverse events and violated FDA manufacturing/post‑approval study requirements, supporting state claims | MDA preempts state requirements different from or in addition to federal ones; plaintiffs failed to plead specific federal violations or causation | Claims preempted: plaintiffs did not plead concrete, parallel federal violations or causation; failure‑to‑report and manufacturing claims dismissed |
| Leave to amend | Discovery is needed to develop allegations; amendment could cure defects | Plaintiffs already failed to plead plausibly; amendment would be futile | Leave to amend denied as futile; complaint dismissed with prejudice |
Key Cases Cited
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (standards for plausible pleading)
- Ashcroft v. Iqbal, 556 U.S. 662 (pleading standard — legal conclusions vs. factual allegations)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (MDA express preemption of state requirements that differ from federal PMA requirements)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (implied preemption for claims that are essentially enforcement of the FDCA)
- Puerto Rico v. Franklin Cal. Tax‑Free Trust, 136 S. Ct. 1938 (where statute expressly preempts, presumption against preemption does not apply)
- Grancare, LLC v. Thrower, 889 F.3d 543 (fraudulent joinder and standards for resolving joinder disputes)
- Stengel v. Medtronic, Inc., 704 F.3d 1224 (MDA parallel‑duty analysis under §360k and limits on failure‑to‑warn claims)
- Hamilton Materials, Inc. v. Dow Chem. Corp., 494 F.3d 1203 (standard of proof for fraudulent joinder)