393 F.Supp.3d 161
E.D.N.Y.2019Background
- McGrath received Magnevist (a gadolinium-based contrast agent) in 2015 and later alleges gadolinium retention and resulting fibrosis, muscle pain, weakness, and cognitive symptoms.
- She claims Bayer and other defendants knew or should have known of gadolinium retention risks in patients with normal renal function but failed to warn patients and providers on the Magnevist label.
- Scientific literature after Magnevist’s 1988 approval documented gadolinium retention; some studies (mostly post-2015) explored possible harms but did not establish a clear causal link to fibrosis in humans.
- The FDA in 2017 added a label warning that gadolinium can be retained in some organs, but did not describe health risks from retention at that time.
- Bayer moved to dismiss, arguing plaintiff’s failure-to-warn claims are preempted by the FDA’s labeling regime (CBE regulation) because no "newly acquired information" in 2015 would have justified a unilateral label change, and alternatively that McGrath failed to plead a cognizable, foreseeable injury causally linked to Magnevist.
- The district court granted Bayer’s motion: plaintiff did not plausibly plead the causal association required for a CBE-based label change nor plausibly allege that injury was reasonably foreseeable to Bayer in 2015.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Preemption under FDA CBE regulation | McGrath: post-approval studies and reports show risks of gadolinium retention and thus support a label warning; Albrecht allows manufacturer-initiated changes | Bayer: no "newly acquired information" in 2015 established a causal link between Magnevist and clinically significant adverse effects, so unilateral label change was not permitted | Held: Preempted — plaintiff failed to plead the requisite causal association in 2015 to justify a CBE label change |
| Sufficiency of causal allegation between Magnevist, retention, and fibrosis | McGrath: retained gadolinium caused fibrosis and other injuries; cited studies and reports support causation | Bayer: cited studies show retention but do not establish causation or clinically significant adverse effects in humans in 2015 | Held: Dismissed — allegations are conclusory and do not plausibly establish causation |
| Whether gadolinium retention alone is a legally cognizable injury | McGrath: retention is a primary injury that caused fibrosis and other harms | Bayer: mere retention or risk of future harm is insufficient under NY tort law | Held: Court accepts fibrosis claim as cognizable but finds causation inadequately pleaded; retention alone insufficient to trigger duty to warn |
| Reasonable foreseeability of plaintiff’s injuries in 2015 | McGrath: numerous reports/studies made retention and its risks foreseeable | Bayer: available evidence in 2015 did not make health risks reasonably foreseeable | Held: Not reasonably foreseeable — duty to warn was not triggered based on 2015 knowledge |
Key Cases Cited
- LaFaro v. N.Y. Cardiothoracic Grp., 570 F.3d 471 (2d Cir.) (pleading standard; accept allegations as true on motion to dismiss)
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (plausibility standard for pleadings)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) (pleading must contain more than labels and conclusions)
- Wyeth v. Levine, 555 U.S. 555 (2009) (manufacturer labeling responsibility and preemption framework)
- Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019) (manufacturer may effect CBE change when reasonable evidence makes risk apparent)
- Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699 (2d Cir.) (preemption where new information justified unilateral label change)