18 CV 2134 (RJD)(VMS)
UNITED STATES DISTRICT COURT EASTERN DISTRICT OF NEW YORK
June 24, 2019
DEARIE, District Judge
MEMORANDUM & ORDER
DEARIE, District Judge:
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
BACKGROUND
In 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 MRIs.
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. ¶¶ 31-32, 34 (emphasis added). Instead, Plaintiff alleges that “claims to the public and healthcare providers” about the possibility of gadolinium retention “have been misleading and false” because they fail to “advise consumers and their healthcare providers of the causal relationship between linear [GBCAs] and gadolinium retention resulting in fibrosis,” id. ¶¶ 34, 40 (emphasis added). Plaintiff goes on to cite a number of medical studies relating to gadolinium retention, which Plaintiff claims expose Bayer‘s knowledge of the risks associated with gadolinium retention prior to 2015. For example, Plaintiff alleges a 1989 report showed that gadolinium remained in human tissue in the days following an MRI. Id. ¶ 50. By 2004, a “major study” revealed gadolinium deposition in patients with normal renal function. Id. ¶ 45. And, in 2013, Japanese researchers found evidence of gadolinium retention in the brains of patients with normal renal function, which was “confirmed by scientists at the Mayo Clinic in 2014.” Id. ¶¶ 70-71. Plaintiff alleges the Mayo Clinic study prompted the FDA to issue a “public safety alert” stating it was evaluating the risk of brain deposits from repeated exposure to GBCAs. Id. ¶¶ 71-72.
In 2017, two years after Plaintiff‘s treatments, “the FDA‘s medical advisory committee voted 13 to 1 in favor of adding a warning on [GBCA] labels that gadolinium can be retained in some organs, including the brain, even in patients with healthy kidneys.” Id. ¶¶ 73-74; Defs.’ Br., Ex. B, ECF No. 79-5. The amendment reflects new information supporting the fact of gadolinium retention in patients with normal renal function but does not reference any risks associated with gadolinium retention. Plaintiff claims Defendants’ failure to warn her and her healthcare providers of the risks associated with gadolinium retention in patients with normal renal function was “a substantial factor” in bringing about her injuries.
LEGAL STANDARD
In deciding a motion to dismiss, the court must “accept all allegations in the complaint as true and draw all inferences in the non-moving party‘s favor.” LaFaro v. N.Y. Cardiothoracic Grp., PLLC, 570 F.3d 471, 472 (2d Cir. 2009). Ultimately, the Complaint must allege sufficient facts which, taken as true, state a plausible claim for relief. Utts v. Bristol-Myers Squibb Co., 251 F. Supp. 3d 644, 656 (S.D.N.Y. 2017) (citing Keiler v. Harlequin Enterprises Ltd., 751 F.3d 64, 68 (2d Cir. 2014)). A claim is plausible when the pleaded factual content “allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). To do so, the Plaintiff must plead more than the mere possibility that she is entitled to relief, but need not go so far as to demonstrate that relief is probable. This “plausibility standard” requires the plaintiff state “more than labels and conclusions” or “a formulaic recitation of the elements of a cause of action.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007), and instead plead facts sufficient to “raise a reasonable expectation that discovery will reveal evidence supporting [her] claim for relief,” Pension Benefit Guar. Corp. ex rel. St. Vincent Catholic Med. Ctrs. Retirement Plan v. Morgan Stanley Inv. Mgmt. Inc., 712 F.3d 705, 729 (2d Cir. 2013). “[W]hen considering a preemption argument in the context of a motion to dismiss, the factual allegations relevant to preemption must be viewed in the light most favorable to the plaintiff. A district court may find a claim preempted only if the facts alleged in the complaint do not plausibly give rise to a claim that is not preempted.” Utts, 251 F. Supp. 3d at 672 (quoting Galper v. JP Morgan Chase Bank, N.A., 802 F.3d 437, 444 (2d Cir. 2015)).
DISCUSSION
I. Motion to Dismiss Plaintiff‘s Failure-to-Warn Claims as Preempted
a. Legal Standard
Though Plaintiff claims that as of 2015 the Magnevist label should have warned against the risk of injury from gadolinium retention, Bayer argues it would have been impossible to implement such a warning using the “Changes Being Effected” (“CBE“) regulation, and thus Plaintiff‘s failure-to-warn claims are
“Newly acquired information” under the CBE regulation includes “data, analyses, or other information not previously submitted to the FDA, which may include (but is not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events, or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to the FDA.” Utts, 251 F. Supp. 3d at 659 (citing
b. Application
Bayer claims Plaintiff‘s failure-to-warn-claims are preempted principally because the Complaint is devoid of any plausible allegations of “newly acquired information” establishing a “causal association” between injections of Magnevist and a “clinically significant adverse reaction” in
Though “manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times,” drug manufacturers are nevertheless “limited in their ability to unilaterally change the labels on their products” because they must comply with the FDA‘s CBE regulation. Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699, 707 (2d Cir. 2019) (quoting Wyeth v. Levine, 555 U.S. 555, 579 (2009)). Plaintiff‘s allegations do not state a plausible claim that, in 2015, Bayer knew or should have known of “new information” indicating a “causal association” between exposure to Magnevist and a “clinically significant adverse reaction“—here, fibrosis—in patients with normal renal function. Plaintiff‘s allegations focus on gadolinium retention, which is not, by itself, the “clinically significant adverse reaction” Plaintiff complains of. To date, the incidence of any risks associated with gadolinium retention is inconclusive and is, at best, only marginally supported by data gathered after Plaintiff‘s Magnevist injections. For the Court to draw the reasonable inference that Bayer could have unilaterally amended the Magnevist label in compliance with the FDA‘s CBE regulation, the Complaint must plead more than the mere possibility that Magnevist caused Plaintiff‘s fibrosis and related injuries. And, the more recent scientific studies in Plaintiff‘s Second Amended Complaint, do not compel a contrary conclusion: not only were these studies published after Plaintiff received injections of Magnevist, but in any event, they do not plausibly allege the requisite causal connection under the FDA‘s regulatory scheme.
First, assuming Plaintiff points to “newly acquired information” since the FDA‘s approval of Magnevist in 1988, none of that information shows an “adverse reaction for which the evidence of a causal association satisfies the standard for inclusion in the labeling.”
Second, of the new studies cited in the Second Amended Complaint most are inconclusive regarding the risks, if any, associated with gadolinium retention and would not justify a unilateral label change. One explains that “to date, it remains unknown whether [GBCAs] induce toxic effects on the cellular function of human neurons,” SAC ¶ 6 & n.1, and another similarly concludes that “further studies are required to address possible clinical consequences of gadolinium deposition in the skin, brain and potentially other organs in patients with normal renal function,” SAC ¶ 9 & n.9. One study, electronically published after oral argument and not yet replicated, purports to uncover “the first evidence” that GBCA exposure causes “significant metabolic disorders and kidney injury in mice without renal insufficiency.” Catherine Do et al., Gadolinium-based Contrast Agents: Stimulators of Myeloid-Induced Renal Fibrosis and Major Metabolic Disruptors, Elsevier Toxicology and Applied Pharmacology (July 2019) (emphasis added); SAC ¶ 7, & n.2.
“The FDA has recognized that “exaggeration of risk, or inclusion of speculative or hypothetical risks, could discourage appropriate use of a beneficial drug . . . or decrease the usefulness and accessibility of important information by diluting or obscuring it.” Albrecht, 139 S. Ct at 1673; Utts, 251 F. Supp. 3d at 661 (citing Supplemental Application Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices, 73 Fed. Reg. 2848, 2851 (Jan. 16, 2008));
Even the cited month-old study finding a connection between exposure to GBCAs and “significant metabolic disorders and kidney injury in mice,” does not provide “well-grounded” or “sufficient evidence of a causal association between the drug and the information sought to be added.” Utts, 251 F. Supp. 3d at 659. The study has yet to be replicated, and only demonstrates an adverse reaction in mice. This dearth of evidence cannot be reconciled with the Supreme Court‘s recent decision in Albrecht, which explained that only “when the risks of a particular drug become apparent, the manufacturer has a duty to provide a warning that adequately describes the risk.” 139 S. Ct. at 1677. Indeed, the FDA contemplated that the CBE regulation would be used sparingly, noting it “would not allow a change to labeling to add a warning in the absence of reasonable evidence of an association between the product and an adverse event.” Supplemental Application Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices, 73 Fed. Reg. 2848, 2851 (Jan. 16, 2008) (allowing a unilateral change based only on “known hazards and not theoretical possibility,” “sufficient evidence of a causal association,” or “reasonable evidence of an association“); see also Wyeth, 555 U.S. at 571 (“requiring a manufacturer to revise its label to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug“). A single study performed on mice does not make a risk “apparent” or otherwise constitute “reasonable evidence of an association” between Magnevist and fibrosis. And, even if this study could adequately plead a causal association between Magnevist and “clinically significant adverse effects,” it was published after Plaintiff‘s exposure to Magnevist and thus cannot support a failure-to-warn claim based on what Bayer knew or should have known in 2015.
Finally, Plaintiff‘s eleventh-hour attempt to rely on the Supreme Court‘s decision in Albrecht to avoid preemption and resurrect her claims is misplaced. In Albrecht, the drug manufacturer “conceded that the FDA‘s CBE regulation would have permitted [it] to try to change the label to add a warning before [the FDA required it to do so in] 2010.” 139 S. Ct. at 1675. Here, on the other hand, Bayer argues, and the Court agrees, that Plaintiff has not pleaded a plausible claim that the CBE regulation would have permitted Bayer to change the Magnevist label to reflect risks associated with gadolinium retention. Indeed, in Albrecht, before the FDA required the drug manufacturer to update its warning, the manufacturer “performed a statistical analysis of [the drug‘s] adverse event reports, concluding that these reports revealed a statistically significant incidence of femur fractures” and “about the same time, [the manufacturer] began to see numerous scholarly articles and case studies documenting possible connections between long-term [drug] use and atypical femoral fractures.” Id. at 1674. In Albrecht, this medical evidence revealed a reasonable, if
II. Motion to Dismiss for Failure to State a Claim
Alternatively, Bayer claims that Plaintiff fails to state a failure-to-warn claim under negligence or strict liability theories because (i) retention of gadolinium is not alone a legally cognizable injury under New York tort law, (ii) the complained of “fibrosis and related injuries” were not reasonably foreseeable, (iii) “related injuries” are too vague to satisfy Rule 8 pleading requirements and (iv) Plaintiff‘s strict liability and negligence claims are too vague and sprawling to pass muster under
“Under New York law failure to warn claims are identical under strict liability and negligence theories.” DiBartolo v. Abbott Labs., 914 F. Supp. 2d 601, 611 (S.D.N.Y. 2011). Accordingly, “a pharmaceutical manufacturer has a duty to warn of all potential dangers in its prescription drugs that it knew, or, in the exercise of reasonable care, should have known to exist.” Id. A manufacturer will thus incur liability where (i) the manufacturer had a duty to warn, (ii) the manufacturer breached the duty to warn in a manner that rendered the product defective, i.e., reasonably certain to be dangerous, (iii) the defect was the proximate cause of the plaintiff‘s injury and (iv) the plaintiff suffered loss or damage. Bee v. Novartis Pharmaceutical Corp., 18 F. Supp. 3d 268, 282 (E.D.N.Y. 2014) (citing McCarthy v. Olin Corp., 119 F.3d 148, 156 (2d Cir. 1997)). Moreover, “a manufacturer has a duty to warn against latent dangers resulting from foreseeable uses of its product of which it knew or should have known.” Id. “This duty is a continuous one, and requires that the manufacturer be aware of the current information concerning the safety of its product.” Id.
Though Plaintiff pleads a legally cognizable and specifically articulated injury that adequately put Defendants on notice of her claim, she does not plausibly plead causation—that her injuries were caused by Bayer‘s failure to warn her of the risks associated with gadolinium retention—or that such injuries were reasonably foreseeable to Bayer. Bayer contends “a threat of future harm is insufficient to impose liability against a defendant in a tort context,” but Bayer mischaracterizes the nature of the physical harm Plaintiff alleges in her Complaint. Plaintiff‘s failure-to-warn claim is premised on Bayer‘s failure to warn of
Plaintiff nevertheless fails to state a failure-to-warn claim because she has not adequately pleaded that her injuries were caused by Bayer‘s failure to warn or were otherwise reasonably foreseeable to Bayer. In the same way Plaintiff fails to plead a “causal association” between any new information regarding gadolinium retention and an “adverse effect“, e.g., fibrosis, she similarly fails to plead that such an adverse effect was “reasonably foreseeable” based on what Bayer knew or should have known in 2015. Burkett v. Smith, 2014 WL 1315315, at *6 (E.D.N.Y. Mar. 31, 2014) (dismissing plaintiff‘s failure-to-warn claim as preempted because she “fail[ed] to link the purported violation to her injury“). Absent a causal link between gadolinium retention and a cognizable injury like fibrosis, Plaintiff‘s injury was not “reasonably foreseeable” and thus Bayer‘s duty to warn was never triggered.
CONCLUSION
Plaintiff‘s failure-to-warn claims are preempted because she does not plead a plausible causal association between Magnevist and fibrosis that Bayer knew or should have known about in 2015. Alternatively, Plaintiff fails to state a plausible claim that injury was reasonably foreseeable to Bayer as a result of her exposure to Magnevist. Plaintiff‘s claims are dismissed.
SO ORDERED.
Dated: Brooklyn, New York
June 24, 2019
RAYMOND J. DEARIE
United States District Judge
s/ Raymond J. Dearie