MEMORANDUM & ORDER Plaintiff Denise McGrath (“Plaintiff or McGrath”) brings failure-to-warn strict liability and negligence claims against Bayer Pharmaceuticals (“Bayer”), Bracco Diagnostics and McKesson Corporation (together, “Defendants”) relating to injuries sustained as a result of exposure to Magnevist, an FDA-approved gadolinium-based contrast agent (“GBCA”), administered to patients to enhance the quality of MRIs. Plaintiff claims that prior to receiving Magnevist she was “never warned about the risks of gadolinium retention” for patients with normal renal function or advised of alternative treatment options. Second Amended Complaint (“SAC”), ECF No. 86, 10. Plaintiff alleges that she retained gadolinium in multiple organs causing “fibrosis in organs, bone, and skin” as well as “muscle pain, muscle weakness, brain fog and other injuries.” Id. 5. Bayer moves to dismiss the Complaint because (i) Plaintiff’s failure-to-warn claims are preempted by the FDA’s regulatory scheme governing pharmaceutical labeling, and (ii) Plaintiff fails to state a plausible claim that she suffered a legally cognizable injury, or that her injury was reasonably foreseeable. For the reasons that follow, Bayer’s motion to dismiss is granted.BACKGROUNDIn 2015, Plaintiff received at least one injection of Magnevist and alleges that tests performed anywhere from one to three months following the injection confirmed she retained gadolinium in her body. Id.
3-4, 10. Plaintiff claims she now suffers from fibrosis, muscle pain, muscle weakness, brain fog and other unspecified injuries caused by the presence of toxic levels of gadolinium in her body. Id. 5. Plaintiff further claims Defendants knew or should have known of the risks associated with gadolinium retention for patients with normal renal function, and failed to include an appropriate warning on the Magnevist label. Plaintiff alleges that had she been aware of such risks, she would not have exposed herself to GBCAs prior to undergoing MRls.Following the FDA’s approval of Magnevist in 1988 Plaintiff claims that notwithstanding numerous “reports, studies, assessments, papers, peer reviewed literature, and other clinical data” describing gadolinium retention, Bayer nevertheless failed to warn “Plaintiff and her healthcare providers…of the risks posed by GBCAs.” Id.
