By David Yucht, J.D.
Claims alleging that a pharmaceutical company failed to warn that Magnevist® may cause fibrosis were preempted by federal regulation.
A federal court in New York found that a patient did not plead a plausible causal association that was known in 2015 between Magnevist®, a gadolinium-containing contrast agent that was administered to her during an MRI, and fibrosis, a condition she later developed. Consequently, the patient’s claims against the manufacturer were preempted and, therefore, dismissed. The court also found that the patient failed to state a plausible claim that her injury was reasonably foreseeable as a result of her exposure to Magnevist (McGrath v. Bayer Pharmaceuticals, Inc., June 24, 2019, Dearie, R.).
Magnevist, a gadolinium-containing MRI contrast agent, was approved by the U.S. Food and Drug Administration in 1988. In 2015, a patient received an injection of Magnevist and alleged that tests performed one to three months afterward confirmed that she retained gadolinium in her body. She claimed that as a result, she suffered from fibrosis and other injuries caused by the presence of gadolinium in her body. She cited medical studies relating to gadolinium retention to show that the manufacturer 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 product’s label. She asserted that the manufacturer made misleading claims about the possibility of gadolinium retention because it failed to advise of the causal relationship between gadolinium-containing MRI contrasts and gadolinium retention resulting in fibrosis. She claimed that had she been aware of such risks, she would not have exposed herself to the product.
In 2017, two years after the patient’s treatments, the FDA's medical advisory committee voted to add a warning on labels that gadolinium can be retained in organs, including the brain, in patients with healthy kidneys. The resulting amendment reflected new information supporting the fact of gadolinium retention in patients but did not reference risks of gadolinium retention. The patient here brought failure-to-warn strict liability and negligence claims against the manufacturer. The manufacturer moved to dismiss, asserting that the patient’s failure-to-warn claims were preempted by FDA labeling regulations, and that she failed to state a plausible claim that she suffered a legally cognizable injury, or that her injury was reasonably foreseeable.
Preemption. The court found that the failure-to-warn claims were preempted. The court noted that although manufacturers are responsible for their drug labeling, they are "limited in their ability to unilaterally change the labels on their products" because of FDA regulations. Here, the allegations did not state a plausible claim that, in 2015, the manufacturer knew or should have known of "new information" indicating a "causal association" between exposure to its product and fibrosis in patients with normal renal function. The allegations focused on gadolinium retention, which was not, by itself, the "clinically significant adverse reaction" the patient complained of. The incidence of any risks associated with gadolinium retention is inconclusive and is, at best, only marginally supported by data gathered after the patient’s Magnevist injections. Here, the patient did not plead a plausible claim that the FDA would have permitted the manufacturer to change the Magnevist label to reflect risks associated with gadolinium retention.
Foreseeability. The court also found that the patient failed to state a plausible claim that injury was reasonably foreseeable as a result of her exposure to Magnevist. Although the patient pleaded a legally cognizable injury that adequately put the manufacturer on notice of her claim, she did not plausibly plead causation—i.e., that her injuries were caused by the manufacturer's failure to warn her of the risks associated with gadolinium retention—or that such injuries were reasonably foreseeable. In the same way that she failed to plead a "causal association" between any new information regarding gadolinium retention and an "adverse effect," she failed to plead that such an adverse effect was "reasonably foreseeable" based on what the manufacturer knew or should have known in 2015. Absent a causal link between gadolinium retention and a cognizable injury like fibrosis, her injury was not "reasonably foreseeable" and, thus, the manufacturer's duty to warn was never triggered.
The case is No. 18 CV 2134 (RJD)(VMS).
Attorneys: Todd A. Walburg (Lieff Cabraser Heimann & Bernstein, LLP) for Denise McGrath. Rodney Michael Hudson (Drinker Biddle & Reath LLP) for Bayer Healthcare Pharmaceuticals Inc., Bayer Corp. and Bayer Healthcare LLC.
Companies: Bayer Healthcare Pharmaceuticals Inc.; Bayer Corp.; Bayer Healthcare LLC
MainStory: TopStory PreemptionNews WarningsNews DrugsNews CausationNews NewYorkNews
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