443 F.Supp.3d 259
D. Conn.2020Background
- Trulign Toric intraocular lenses (Class III, FDA PMA) manufactured by Bausch & Lomb were implanted in Mrs. Glover during 2014 cataract surgeries; she developed Z‑Syndrome and sustained serious visual and neurological injuries.
- Plaintiffs allege Bausch & Lomb knew of a unique risk of Z‑Syndrome, misled the FDA during approval, failed to conduct adequate post‑market surveillance and neglected to file adverse event reports, and that FDA‑approved labeling misled physicians and patients.
- Plaintiffs (Mrs. and Mr. Glover) asserted ten counts in a Second Amended Complaint, including common‑law fraud/omission, negligent misrepresentation, failure to warn, negligence, manufacturing defect, California statutory claims, and loss of consortium; defendants moved to dismiss under Rules 12(b)(2), 12(b)(6), and 9(b).
- Defendants sought dismissal on multiple grounds: lack of personal jurisdiction as to several corporate defendants, CPLA exclusivity (precluding common‑law product claims), federal preemption under the MDA/FDCA (express and implied), and pleading deficiencies; plaintiffs later sought leave to add a CUTPA claim.
- The Court dismissed all claims (some with prejudice), concluding plaintiffs failed to plead personal jurisdiction over several entities, many claims were barred by the Connecticut Product Liability Act or preempted by federal law, and remaining state‑law claims were insufficiently pleaded; leave to amend to add CUTPA was denied.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Personal jurisdiction over B&L Holdings, VPNA, VPI | Jurisdictional contacts of Bausch & Lomb may be imputed via alter‑ego and general business contacts in the U.S./CT | Entities are legally distinct; allegations are vague and conclusory | Dismissed for lack of personal jurisdiction; alter‑ego allegation insufficient |
| Personal jurisdiction over Bausch Health | Transfer order shows case could have been brought in CT; law‑of‑the‑case applies | No binding prior finding, but transfer implies jurisdiction | Bausch Health subject to personal jurisdiction under law‑of‑the‑case |
| Whether common‑law fraud/omission & negligent misrepresentation are barred by the CPLA | Claims arise from misrepresentations/labeling and failures to report adverse events and thus are separate torts | Such claims fall within product liability scope and are precluded by CPLA exclusivity | Counts One, Five, Six dismissed with prejudice as CPLA‑barred |
| Whether state failure‑to‑warn and related claims are preempted by the MDA/FDCA | Plaintiffs argue defendants had duties to warn and report that support state claims | FDA regulates labeling and adverse‑event reporting; state duties would impose different/additional requirements or be derivative of FDCA | Failure‑to‑warn and negligence claims (Counts Two and Four) dismissed with prejudice as expressly or impliedly preempted |
| Sufficiency of manufacturing‑defect claim | Plaintiffs assert the lens was not manufactured per FDA‑approved specifications and caused Z‑Syndrome | Defendants argue allegations are conclusory and plead no specific manufacturing departure | Manufacturing defect claim dismissed with prejudice for failure to plausibly plead a nonconforming manufacturing defect |
| Leave to amend to add CUTPA claim | Plaintiffs cite Soto and seek leave to plead CUTPA independent of CPLA | CUTPA claim challenges FDA‑approved labeling and would impose requirements different from FDCA | Motion to amend denied; CUTPA claim would be expressly preempted and futile |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (state law claims imposing requirements different from FDA requirements are expressly preempted under the MDA)
- Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (state‑law claims wholly dependent on FDCA violations are impliedly preempted)
- Ashcroft v. Iqbal, 556 U.S. 662 (pleading standard: factual allegations must state a plausible claim)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (plausibility pleading standard)
- In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200 (narrow category of state claims that parallel federal law but are not derivative)
- Stengel v. Medtronic Inc., 704 F.3d 1224 (discussion of FDA PMA process and post‑market reporting obligations)
- Pani v. Empire Blue Cross Blue Shield, 152 F.3d 67 (parallel state claims standard relative to federal regulatory scheme)
- Burger King Corp. v. Rudzewicz, 471 U.S. 462 (specific jurisdiction requires purposeful availment)
- World‑Wide Volkswagen Corp. v. Woodson, 444 U.S. 286 (minimum contacts and due process limits on jurisdiction)
- Int’l Shoe Co. v. Washington, 326 U.S. 310 (foundational minimum contacts test for personal jurisdiction)
- SPV Osus Ltd. v. UBS AG, 882 F.3d 333 (plaintiff must make a prima facie showing of jurisdiction pre‑discovery)
- Cuoco v. Moritsugu, 222 F.3d 99 (leave to replead may be denied as futile when defects are substantive)
- SFA Folio Collections, Inc. v. Bannon, 217 Conn. 220 (piercing corporate veil requires exceptional circumstances)
- DeWeerth v. Baldinger, 38 F.3d 1266 (law‑of‑the‑case doctrine applies to issues decided expressly or by necessary implication)