191 A.D.3d 1365
N.Y. App. Div.2021Background:
- Plaintiff Joseph Barone brought a products-liability suit alleging an unsafe class III ophthalmic device and inadequate warnings.
- Morcher GmbH is a German manufacturer of the device; FCI Ophthalmics, Inc. is an independent distributor based in Massachusetts; Bausch & Lomb is another defendant (not an appellant here).
- Morcher and FCI moved to dismiss the amended complaint; Supreme Court (Monroe County) denied those motions.
- Defendants appealed the denial of their motions to dismiss; the Appellate Division considered personal jurisdiction over Morcher and federal preemption as to FCI.
- The appellate court reversed, holding that New York lacked jurisdiction over Morcher and that FCI’s claims were preempted by the Medical Device Amendments (MDA).
Issues:
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether New York has personal jurisdiction over Morcher (German manufacturer) | Barone argued Morcher’s product reached New York via distribution and therefore jurisdiction exists | Morcher argued it manufactured in Germany and sold through an independent MA distributor, without purposeful New York contacts | Court held plaintiff failed to make a prima facie showing of minimum contacts; dismissed Morcher for lack of jurisdiction |
| Whether state-law claims against FCI (distributor) are preempted by the MDA | Barone contended failure-to-warn claims parallel FDA regulations and thus are not preempted | FCI argued the device is a regulated class III device and state-law claims that add to federal requirements are preempted | Court held most common-law claims are preempted; failure-to-warn claims did not rest on an FDA reporting regulation and thus were preempted as adding to federal requirements; dismissed FCI |
Key Cases Cited
- International Shoe Co. v. Washington, 326 U.S. 310 (establishes minimum contacts due process test)
- LaMarca v. Pak-Mor Mfg. Co., 95 N.Y.2d 210 (jurisdictional inquiry under CPLR 302 and due process)
- J. McIntyre Machinery, Ltd. v. Nicastro, 564 U.S. 873 (limits jurisdiction for foreign manufacturers absent purposeful availment)
- Aybar v. Goodyear Tire & Rubber Co., 175 A.D.3d 1373 (plaintiff’s prima facie burden in opposing CPLR 3211(a)(8) motion)
- Darrow v. Hetronic Deutschland, 119 A.D.3d 1142 (jurisdictional analysis for foreign manufacturer)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (MDA preempts state requirements that are different from or in addition to federal ones)
- Mitaro v. Medtronic, Inc., 73 A.D.3d 1142 (application of MDA preemption in New York)
- Doe v. Bausch & Lomb, Inc., 443 F. Supp. 3d 259 (discusses scope of FDA-based parallel claims and reporting regulations)