McGrath v. Bayer Healthcare Pharmaceuticals Inc. et al

Filing 91

MEMORANDUM AND OPINION: Plaintiffs 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. Plaintiffs claims are dismissed. So Ordered by Judge Raymond J. Dearie on 6/24/2019. (Almonte, Giselle)

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF NEW YORK
X

DENISE MCGRATH,

Plaintiff,
MEMORANDUM & ORDER

- against 18 CV 2134(RJD)(VMS)
BAYER HEALTHCARE PHARMACEUTICALS

INC; BAYER CORPORATION; BAYER
HEALTHCARE LLC; BRACCO DIAGNOSTICS,INC;
and MCKESSON CORPORATION
Defendants.
X

DEARIE, District Judge:

Plaintiff Denise McGrath ("Plaintiff or McGrath") brings failure-to-wam 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, H 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) Plaintiffs failureto-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.

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. UK 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. K 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 ... ofthe risks posed by GBCAs." Id. KK 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 ofthe causal relationship between linear [GBCAs]and gadolinium
retention resulting in Jibrosis," id. KK 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 MRl. Id. K 50. By 2004, a "major study" revealed gadolinium deposition in
patients with normal renal function. Id. K 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. ^[1170-71. 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 Plaintiffs 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 ih^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 ofthe risks associated with gadolinium retention in patients with normal
renal function was "a substantial factor" in bringing about her injuries.

After the parties briefed Bayer's motion to dismiss, the Court heard oral argument and
pointed out that the absence in the Complaint of"newly-discovered scientific evidence" or
"literature that makes the causal connection" between gadolinium retention and fibrosis undercut

Plaintiffs failure-to-warn claims and made a strong case for preemption. May 3, 2019 Oral

Argument, ECF No. 87-1, at 10:25, 15:6-7. Plaintiff represented at oral argument that literature
making the requisite causal connection was available, and on May 27,2019,filed a Second
Amended Complaint. However,the added allegations do not plausibly allege the causal

connection required to justify a unilateral label change under the CBE regulation, and, in any
event, the information was not available in 2015 when Plaintiff was administered Magnevist.
Plaintiffthus fails to state a failure-to-warn claim that is not preempted: her allegations

regarding the causal association between Magnevist injections, gadolinium retention and a

significant adverse reaction—such as fibrosis—are conclusory and grounded in hypothesis rather
than scientific evidence capable of raising at least a reasonable expectation that Plaintiff is
entitled to the relief she seeks.
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-Mvers 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. labaL 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.

Twomblv,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 Stanlev

Inv. Mgmt. Inc.. 712 F.3d 705,729(2d Cir. 2013). "[Wjhen 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 Gainer v. JP Morgan Chase Bank. N.A., 802
F.3d437,444(2d Cir. 2015)).
DISCUSSION

I.

Motion to Dismiss Plaintiffs Failure-to-Wam Claims as Preempted

a. Legal Standard

Though Plaintiff claims that as of 2015 the Magnevist label should have wamed 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
Plaintiffs failure-to-warn claims are preempted by the CBE regulation and the FDA's warning

labeling scheme. The CBE regulation set forth in 21 C.F.R. § 314.70(c)(6)(iii) allows drug
manufacturers to change a drug label unilaterally, and without FDA preapproval,"if the changes
add or strengthen a contraindication, waming, precaution, or adverse reaction" or "add or

strengthen an instruction about dosing and administration that is intended to increase the safe
usage of the drug product in order to reflect newly acquired information." Id. If a plaintiff
shows that "defendants could unilaterally change the label... without FDA approval," the
burden shifts to the manufacturer to show "by clear evidence that the FDA would not have

approved the labeling change." Utts, 251 F. Supp. 3d at 661. On the other hand, a drug
manufacturer can show that a plaintiffs failure-to-wam claims are preempted by the FDA's

regulatory scheme for drug warnings "(1) by showing that it was prohibited by federal law from
[unilaterally] modifying the FDA-approved labeling; or(2) by presenting clear evidence that the
FDA would not have approved a change to the drug's label." Bvrd v. Janssen Pharm. Inc., 333

F. Supp. 3d 111, 120(N.D.N.Y. 2018)(emphasis added)(citing Amos v. Bioeen Idee Inc., 249
F. Supp. 3d 690,699(W.D.N.Y. 2017)).

"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 21 C.F.R. § 314.70(c)(6)(iii)); see_also id. at 661 ("Because
manufacturers may unilaterally update a drug's label if the change complies with the CBE
regulation, a state law failure-to-warn claim that depends on newly acquired information ... is

not preempted."). Moreover, newly acquired information "must provide reasonable evidence of
a causal association of a clinically significant adverse reaction linked to a drug." 21 C.F.R.

§201.57(c)(6)(i)(emphasis added). A clinically significant adverse reaction "ha[s] a significant
impact on therapeutic decision-making, such as a risk that is potentially fatal or otherwise
seriousy Id.(emphasis added). The FDA imposes this standard because it "recognize[s] that
exaggeration of risk, or inclusion ofspeculative or hypothetical risks, could discourage

appropriate use of a beneficial drug ... or decrease the usefulness and accessibility ofimportant
information by diluting or obscuring it. Indeed, labeling that includes theoretical hazards not

well-grounded in scientific evidence can cause meaningful risk information to lose its
significance." Utts. 251 F. Supp. 3d at 659(emphasis added)(citing 73 Fed. Reg. 2848, 2851
(Jan. 16.200811: see also Merck Sham & Dohme Corp. v. Albrecht. 139 S.Ct. 1668, 1673

(2019). As a result,"the CBE regulation requires that there be sufficient evidence of a causal

association between the drug and the information sought to be added"—here, between Magnevist
injections and a warning regarding the risks of gadolinium retention, such as fibrosis. Utts, 251
F. Supp. 3d at 659.

b. Application

Bayer claims Plaintiffs failure-to wam-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 patients with normal kidney function. Specifically, Bayer argues the allegations in
the Complaint that cite to studies relating to "mere retention of trace amounts of gadolinium in
patients' bodies after using GBCAs" do not plausibly allege any risks associated with
gadolinium retention or otherwise constitute a "clinically significant adverse reaction"
warranting a label change under the CBE regulation. On the other hand, Plaintiff relies on the

Supreme Court's recent decision in Merck Sharp & Dohme Corp. v. Albrecht. 139 S.Ct. 1668
(2019)to argue there is no "clear evidence" the FDA would have rejected a warning articulating
"the risks" associated with gadolinium retention. Plaintiff also contends that "the relief[she]

seeks is dependent upon a fact-intensive record that can only be developed through discovery"
and Bayer's arguments do not otherwise fit within the "narrow exception to the rule against
preemption" in failure-to-wam product liability cases. PI. Br., ECF No. 82, at 7-8.
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-Mvers Souibb Co.. 919 F.3d 699,707(2d Cir. 2019)(quoting Wveth v.

Levine. 555 U.S. 555, 579(2009)). Plaintiffs 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. Plaintiffs 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 Plaintiffs 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 GEE regulation, the Complaint must plead more

than the mere possibility that Magnevist caused Plaintiffs fibrosis and related injuries. And, the
more recent scientific studies in Plaintiffs 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." 21

C.F.R. § 314.70Ccy6yiii¥A): see also Albrecht. 139 S.Ct. at 1673. Instead, the evidence only

builds upon the fact that following exposure to Magnevist, gadolinium can be retained in patients
with normal renal function, but it does not identify any risks associated with gadolinium

retention. For example. Plaintiff describes a 2004 study in which "gadolinium was shown to be
deposited in the resected femoral heads(bones)of people who had undergone gadolinium MRI
studies" and subsequent studies that "continue[] to indicate that gadolinium remains within
people's bodies long after the suggested half-life." SAC ^ 52. Similarly, Plaintiff described a
2013 study finding "evidence of retained gadolinium in the brains of patients with normal renal
function," including "hyperintense signals in critical areas of the brain." Id.f 70.

Reports and studies that discuss thefact of gadolinium retention but do not reach any
conclusions regarding the adverse effects or risks associated with gadolinium retention in

patients with normal renal function "do not plausibly allege the existence of newly acquired
information that could have justified Defendants' revising the [Magnevist] label through the
CBE regulation." Gibbons. 919 F.3d at 708. To the contrary, though "historical literature

indicates gadolinium retention in healthy patients is occurring...r/ie clinical consequences of
deposition remain unknown.''^ JE Huckle et al., Gadolinium Deposition in Humans: When did We
Learn That Gadolinium was Deposited in Vivo?. Invest Radiology(2016)(emphasis added);

SAC ^ 44 & n.11. While the Complaint includes more than "conclusory and vague" references to
"reports" and "studies" that compelled the Second Circuit to conclude preemption was warranted
in Gibbons, it helps precious little to mount scientific minutiae on top of technical jargon if that
information ultimately does not plead a plausible causal association between Magnevist and
adverse effects, like fibrosis. Compare with Gibbons. 919 F.3d at 708 ("reports of serious

hemorrhaging" and "numerous studies" that "confirm the problematic bleeding events" revealed
no new or more significant risks and thus unilateral label change was warranted). Because
Plaintiffs failure-to-wam claims depend upon Bayer's failure to warn of the risks of gadolinium

retention, plausible allegations that relate only to thefact of gadolinium retention do not suffice.
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.l, 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 H 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 Mveloid-Induced Renal
Fibrosis and Maior Metabolic Disruptors. Elsevier Toxicology and Applied Pharmacology (July
2019)(emphasis added); SAC H 7,& n.2.

"The FDA has recognized that "exaggeration ofrisk, or inclusion of speculative or

hypothetical risks, could discourage appropriate use of a beneficial drug...or decrease the
usefulness and accessibility ofimportant 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, Biologies, and Medical Devices, 73 Fed. Reg. 2848, 2851 (Jan.
16, 2008)); 21 C.F.R. § 201.57(c)(6)(i). Thus, to ensure that only "scientifically accurate

information appears in the approved labeling" the FDA prefers a more cautious approach, and
finds that because "labeling that includes theoretical hazards not well-grounded in scientific
evidence can cause meaningful risk information to lose its significance," there must be

'''sufficient evidence of a causal association between the drug and the information sought to be
added." Utts. 251 F. Supp. 3d at 659. Studies concluding it "remains unknown whether GBCAs
induce toxic effects" and that "further studies are required to address possible clinical

consequences of gadolinium deposition...in patients with normal renal function" do not
constitute reasonable or well-grounded scientific evidence of"clinically significant adverse

effects" under the CBE regulation. To find otherwise would permit the "inclusion of speculative
or hypothetical risks" absent "sufficient evidence of a causal association between [Magnevist]
and [the risks associated with gadolinium retention]," and based instead on the bare and

10

conclusory allegation that Plaintiff suffers from fibrosis as a result of gadolinium retention. Idat 659; Matrixx Initiatives, Inc. v. Siracusano, 563 U.S. 27,44(2011)("The fact that a user of a

drug has suffered an adverse event, standing alone, does not mean that the drug caused that
event").

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, Biologies, 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

11

Plaintiffs exposure to Magnevist and thus cannot support a failure-to-warn claim based on what
Bayer knew or should have known in 2015.
Finally. Plaintiffs 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 offemur 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 not compelling, causal association—the
kind of causal association the FDA contemplated before a drug company could unilaterally

amend a warning under the CBE regulation. For the reasons set forth above, such a causal
connection is absent here and because Bayer could not have amended the warning under the
CBE regulation, this Court need not even consider whether there is clear evidence the FDA
would not have approved a change to Magnevist's label. Ultimately, the allegations in the

Complaint that Plaintiffs "adverse reaction" resulted from exposure to Magnevist are based on
Plaintiffs own conclusory allegations, unsupported by medical evidence available at the time of
Plaintiffs Magnevist injections. Accordingly, the Complaint fails to state a plausible claim that

12

Bayer could have unilaterally changed its label under the CBE regulation, and Plaintiffs failureto-wam claim is preempted.

11.

Motion to Dismissfor Failure to State a Claim

Alternatively, Bayer claims that Plaintiff fails to state a failure-to-wam 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) Plaintiffs strict liability and negligence claims are too vague and

sprawling to pass muster under Fed. R. Civ. P. 8. Plaintiff responds that she has adequately
alleged (i) gadolinium retention as a "primary injury" which "causes fibrosis in organs, bone, and
skin ... and deposits in the neuronal nuclei of the brain" and (ii) that gadolinium retention was
reasonably foreseeable in light of the "numerous case reports, studies, assessments, papers, peer
reviewed literature, and other clinical data."

"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 wam 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 wam,

(ii) the manufacturer breached the duty to wam in a manner that rendered the product defective,
i.e.. reasonably certain to be dangerous,(iii) the defect was the proximate cause of the plaintiffs
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

13

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
offuture 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. Plaintiffs

failure-to-warn claim is premised on Bayer's failure to warn of the risks associated with

gadolinium retention, like fibrosis, but she repeatedly claims that the gadolinium retained in her
body actually resulted in fibrosis, not merely risk of fibrosis. Bayer relies on Caronia v. Philip
Morris USA.Inc.. 5 N.E. 3d 11, 14(N.Y. 2013), where Plaintiffs failed to plead a legally

cognizable injury by alleging exposure to carcinogens in cigarettes put them at risk of developing
lung cancer. However here. Plaintiff alleges an actual physical injury—fibrosis—occurred as a
result of Defendants' failure to warn her ofthe risks associated with gadolinium retention.
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 plaintiffs failure-to-warn claim as preempted because she

14

"fail[ed] to link the purported violation to her injury"). Absent a causal link between gadolinium
retention and a cognizable injury like fibrosis, Plaintiffs injury was not "reasonably foreseeable"
and thus Bayer's duty to warn was never triggered.
CONCLUSION

Plaintiffs 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. Plaintiffs claims are dismissed.
SO ORDERED.

Dated: Brooklyn, New York

June^jj ,2019

s/ Raymond J. Dearie
RAYMOND J. DEARIE

United States District Judge

15