439 F.Supp.3d 131
S.D.N.Y.2020Background
- Plaintiff Marcia Sabol underwent 23 MRIs from 2007–2015 and received gadolinium-based contrast agents: Magnevist (Bayer), MultiHance (Bracco), and Omniscan (GE/GEHC).
- Sabol alleges gadolinium was retained in her body and caused fibrosis and systemic symptoms (cognitive impairment, pain, mobility issues, depression, etc.).
- She sued Bayer, Bracco, GE Healthcare Inc. (GEHC), and General Electric Company (GE Co.) for strict products liability (failure to warn) and negligence. McKesson was voluntarily dismissed earlier.
- Defendants moved to dismiss on grounds including lack of personal jurisdiction (Bracco, GEHC), improper venue (Bayer), and failure to state a claim / federal preemption under FDA labeling rules (Bayer, GE Co., GEHC).
- The Court dismissed claims for lack of personal jurisdiction as to Bracco and GEHC, dismissed claims against GE Co. for failure to allege parent-company liability, and dismissed claims against Bayer (and GE Co. as applicable) for failure to state a non-preempted warning claim.
- Court found venue in SDNY would be proper as to Bayer (many injections alleged at Mount Sinai) but dismissed Bayer on preemption/pleading grounds, rendering the venue dispute moot.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Personal jurisdiction over GEHC and Bracco | Each purposefully availed of NY by marketing/distribution in NY; plaintiff was NY resident and some injections occurred in NY | Contacts in NY unrelated to the injuries (relevant injections occurred in Florida); not at-home in NY | Dismissed for lack of specific personal jurisdiction; jurisdictional discovery denied |
| Failure to state a non-preempted failure-to-warn claim against Bayer (CBE/preemption) | Bayer acquired post-approval information showing gadolinium retention and harm in patients with normal renal function and should have changed label | Pre-2015 evidence did not provide "reasonable evidence of a causal association" required to unilaterally change FDA label; FDA did not link retention to adverse effects in normals | Dismissed: plaintiff failed to plead facts showing Bayer could have used CBE to lawfully change label; claims preempted / implausible causation allegations |
| Liability of GE Co. (parent) for GEHC acts | GE Co. is parent of GEHC; veil-piercing / alter-ego alleged | Allegations are conclusory; no factual allegations of control/domination to pierce corporate veil | Dismissed: complaint fails to allege facts plausibly supporting parent liability; would be dismissed on preemption grounds even if corporate veil were pierced |
| Venue as to Bayer | Substantial part of events occurred in SDNY (allegedly ≥14 injections at Mount Sinai) | Venue improper | Court found SDNY proper for Bayer under §1391(b)(2) based on plaintiff's letter, but disposition on merits rendered venue challenge moot |
Key Cases Cited
- DiStefano v. Carozzi N. Am., Inc., 286 F.3d 81 (2d Cir. 2001) (plaintiff bears burden to make prima facie showing of personal jurisdiction)
- Bank Brussels Lambert v. Fiddler Gonzalez & Rodriguez, 171 F.3d 779 (2d Cir. 1999) (forum-jurisdiction prima facie showing standard)
- In re Magnetic Audiotape Antitrust Litig., 334 F.3d 204 (2d Cir. 2003) (procedural standards for jurisdictional showing)
- Metro. Life Ins. Co. v. Robertson-Ceco Corp., 84 F.3d 560 (2d Cir. 1996) (two-step test: state long-arm statute then due process)
- Daimler AG v. Bauman, 571 U.S. 117 (2014) (limits on general jurisdiction; "at home" standard)
- Wyeth v. Levine, 555 U.S. 555 (2009) (preemption and FDA labeling—burden to show impossibility of compliance with both federal law and state-law duty)
- Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019) (FDA labeling standards and CBE context)
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (plausibility standard for complaints)
- Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) (Iqbal/Twombly pleading standard)
- Frontera Res. Azer. Corp. v. State Oil Co. of Azer. Republic, 582 F.3d 393 (2d Cir. 2009) (district court discretion to deny jurisdictional discovery)