681 F.Supp.3d 803
S.D. Ohio2023Background:
- Filshie Clips, a Class III medical device approved by the FDA via PMA in 1996, are titanium clips used for tubal ligation and designed to remain implanted permanently.
- Amy Arnold underwent tubal ligation with Filshie Clips in 2003, experienced chronic pelvic pain beginning shortly thereafter, and a migrated clip was identified in 2022.
- Defendants: Femcare Ltd. (UK manufacturer), CooperSurgical, Inc. (US distributor/marketer), The Cooper Companies, Inc. (TCC, parent), and Utah Medical Products, Inc. (UTMD, later U.S. distributor). CooperSurgical did not contest jurisdiction.
- Arnold sued under Ohio strict products-liability law (design defect, manufacturing defect, failure to warn), alleging defendants concealed higher migration rates and failed to report adverse events to FDA.
- Defendants moved to dismiss for lack of personal jurisdiction (TCC, UTMD, Femcare), for shotgun pleading, and on preemption grounds under the FDCA/MDA and Buckman; Femcare separately moved to strike certain exhibits.
- Court disposition summary: TCC dismissed for lack of jurisdiction; UTMD subject to jurisdiction; Femcare jurisdictional dismissal denied without prejudice and limited jurisdictional discovery granted; Counts I (design) and II (manufacturing) dismissed as preempted; Count III (failure to warn) survives against CooperSurgical, UTMD, and Femcare; Femcare’s strike motion denied as moot.
Issues:
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Personal jurisdiction over TCC | TCC purposefully availed or is alter-ego of CooperSurgical | TCC had no contacts with Ohio; affidavits deny involvement; no alter-ego facts | Dismissed TCC for lack of personal jurisdiction; alter-ego not shown; no jurisdictional discovery granted |
| Personal jurisdiction over UTMD | UTMD sold/marketed/distributed Filshie Clips in U.S./Ohio since 2019 and its post-2019 conduct contributed to delayed discovery/injury | UTMD had no involvement with the 2003 implantation and thus lacks relevant contacts | Jurisdiction found proper over UTMD; motion to dismiss for lack of jurisdiction denied |
| Personal jurisdiction over Femcare | Femcare retained distribution/marketing control (exclusive agreement), supplied materials and personnel, and tracked U.S. sales → targeted U.S./Ohio market; requests limited discovery | Femcare affidavit denies directing sales or targeting Ohio; no Ohio contacts | Motion denied without prejudice; limited jurisdictional discovery granted to probe Femcare’s contacts with Ohio |
| Shotgun pleading (Rule 8) | Complaint alleges all counts against all defendants with factual allegations specific to each count | Complaint is impermissibly vague and adopts prior paragraphs making it a shotgun pleading | Court finds complaint not a shotgun pleading; Rule 8 satisfied; motion to dismiss on that ground denied |
| Preemption of design & manufacturing claims (Counts I & II) | Claims premised on failure to report subsequent adverse event data and duties parallel Ohio law, so not preempted | Claims seek requirements different from or in addition to FDA PMA; essentially fraud-on-the-FDA → preempted (express and/or implied) | Counts I and II dismissed as preempted (Riegel express preemption and Buckman implied preemption apply); fraud-on-FDA allegations impliedly preempted |
| Preemption of failure-to-warn claim (Count III) | Failure-to-warn alleges post-PMA duty to warn under Ohio law based on information acquired after approval (parallel duty) | Any state duty to warn beyond FDA requirements would be preempted (Cupek) | Failure-to-warn claim survives dismissal at pleading stage; not preempted now—may be addressed later after discovery |
Key Cases Cited
- Riegel v. Medtronic, 552 U.S. 312 (2008) (PMA-based federal requirements preempt state design and manufacturing tort claims)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (private fraud-on-FDA claims are impliedly preempted because FDCA enforcement is exclusively federal)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (PMA process and federal oversight for medical devices explained)
- Ford Motor Co. v. Mont. Eighth Jud. Dist. Court, 141 S. Ct. 1017 (2021) (claims must arise out of or relate to defendant’s contacts for specific jurisdiction)
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (plausibility standard for Rule 12(b)(6) pleadings)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (pleading must state a plausible claim)
- World-Wide Volkswagen Corp. v. Woodson, 444 U.S. 286 (1980) (minimum contacts and reasonable anticipation of being haled into court)
- Third Nat’l Bank v. WEDGE Group, 882 F.2d 1087 (6th Cir. 1989) (forum contacts and due process analysis)
- Bird v. Parsons, 289 F.3d 865 (6th Cir. 2002) (three-part specific jurisdiction test in Sixth Circuit)
- Kemp v. Medtronic, 231 F.3d 216 (6th Cir. 2000) (fraud-on-FDA and Buckman preemption discussion; post-approval failure-to-warn survives in some circumstances)
- Cupek v. Medtronic, 405 F.3d 421 (6th Cir. 2005) (state claims requiring warnings beyond PMA-mandated warnings may be preempted)
- Asahi Metal Indus. Co. v. Superior Court, 480 U.S. 102 (1987) (reasonableness factors in specific jurisdiction analysis)