United States District Court, D. Nevada
ORDER GRANTING THE BAYER DEFENDANTS' MOTION TO
DISMISS AND PLAINTIFFS' MOTION FOR LEAVE TO FILE
SUPPLEMENTAL AUTHORITY [ECF NOS. 32, 61]
P. GORDON UNITED STATES DISTRICT JUDGE
Ingeborg Klein and Karin Klein were injected with
gadolinium-based contrast agents (GBCAs) manufactured by the
defendants. ECF No. 1 at 5. The gadolinium was retained in
their bodies and resulted in “fibrosis in their organs,
skin, and bones, retained gadolinium in the neuronal nuclei
of her [sic] brain, and related injuries.”
Id. The Kleins filed this suit, asserting claims of
strict liability and negligence for failure to warn them of
the “risks of gadolinium retention.” Id.
Bayer Healthcare Pharmaceuticals Inc., Bayer Corporation, and
Bayer Health Care LLC (collectively, Bayer) manufacture,
market, and sell Magnevist, one of the GBCAs administered to
plaintiff Ingeborg Klein (Ingeborg). Id. at 2, 5.
Bayer moves to dismiss Ingeborg's claims, arguing that
(1) she fails to sufficiently plead personal jurisdiction;
(2) her claims are preempted by federal law; and (3) she does
not allege a cognizable injury and otherwise fails to meet
the pleading standard. I grant Bayer's motion because
Ingeborg fails to sufficiently plead personal jurisdiction
and Ingeborg's claims, as currently pleaded, are
preempted by federal law. However, I grant Ingeborg leave to
Magnevist “was the first gadolinium-based contrast
agent to reach the market after receiving [Food and Drug
Administration (FDA)] approval in 1988.” Id.
at 8. Ingeborg alleges that Bayer has “known since the
1980s that [Magnevist] could cause retention of toxic
gadolinium, ” as there have “been numerous case
reports, studies, assessments, papers, peer reviewed
literature, and other clinical data that have described
and/or demonstrated gadolinium retention in connection with
the use” of GBCAs. Id. at 6-7. Gadolinium
retention in patents with abnormal kidney function can result
in Nephrogenic Systematic Fibrosis. Id. at 10. The
FDA issued a black box warning for GBCA users with abnormal
kidney function in 2007, and a related Multidistrict
Litigation was resolved in 2015. Id.
case, however, Ingeborg alleges that gadolinium retention in
patients like her with normal kidney function can result in
fibrosis and other injuries, and that Bayer failed to warn
her of those risks. Ingeborg cites numerous studies dating
back to the 1980s demonstrating potential gadolinium
retention after a GBCA injection, developing into an emerging
consensus in 2013-14 that gadolinium could be retained after
a GBCA injection. Id. at 8-9, 11. In September 2017,
the FDA's medical advisory committee voted in favor of
adding a warning to GBCA labels that gadolinium could be
retained in some vital organs after a GBCA injection.
Id. at 11-12. Three months later, the FDA issued a
safety announcement warning of gadolinium retention in
patients with normal kidney function, but also stated that
“[g]adolinium retention has not been directly linked to
adverse health effects in patients with normal kidney
function.” ECF No. 33-1 at 2. The following year, Bayer
and other GBCA manufacturers issued a warning to patients
with normal kidney function that gadolinium could be retained
after a GBCA injection. ECF No. 1 at 12.
was injected with the GBCAs Magnevist, MultiHance, and
OptiMark prior to receiving MRIs. ECF No. 1 at 5. Ingeborg
had normal kidney function at the time of the injections, but
alleges that gadolinium retention in patients with normal
kidney function can cause fibrosis and other injuries.
Id. at 2, 5-7. Ingeborg alleges that the gadolinium
was retained in her organs and “resulted in fibrosis in
[her] organs, skin, and bones, retained gadolinium in the
neuronal nuclei of her brain, and related injuries.”
Id. at 2. Ingeborg claims that Bayer knew or should
have known of the risks associated with gadolinium retention
for patients with normal kidney function and failed to
include an appropriate warning on the Magnevist label.
Id. at 13-15. Ingeborg further alleges that she
would not have received a GBCA prior to her MRIs had she or
her healthcare providers been aware of such risks.
Id. at 6.
argues that Ingeborg fails to plead general or specific
personal jurisdiction because she includes only conclusory
allegations of Bayer's contacts with Nevada and does not
allege facts showing how these contacts relate to her claims.
Ingeborg responds that her complaint pleads facts showing
purposeful availment of the forum state and that her claim
arises out of Bayer's activities in Nevada.
no federal statute governs personal jurisdiction, the
district court applies the law of the forum state.”
Boschetto v. Hansing, 539 F.3d 1011, 1015 (9th Cir.
2008). Nevada's long-arm statute is co-extensive with
federal standards, so a court may exercise personal
jurisdiction if doing so comports with federal constitutional
due process. Nev. Rev. Stat. § 14.065(1); Walden v.
Fiore, 571 U.S. 277, 283 (2014). “For a court to
exercise personal jurisdiction over a nonresident defendant,
that defendant must have at least minimum contacts with the
relevant forum such that the exercise of jurisdiction does
not offend traditional notions of fair play and substantial
justice.” Schwarzenegger v. Fred Martin Motor
Co., 374 F.3d 797, 801 (9th Cir. 2004) (quotation
omitted). “There are two forms of personal jurisdiction
that a forum state may exercise over a nonresident
defendant-general jurisdiction and specific
jurisdiction.” Boschetto, 539 F.3d at 1016.
Ingeborg does not argue that general jurisdiction applies, so
I address only whether she has established specific
jurisdiction depends on an “activity or an occurrence
that takes place in the forum State and is therefore subject
to the State's regulation.” Goodyear Dunlop
Tires Operations, S.A. v. Brown, 564 U.S. 915, 919
(2011). “In contrast to general, all-purpose
jurisdiction, specific jurisdiction is confined to
adjudication of issues deriving from, or connected with, the
very controversy that establishes jurisdiction.”
Id. (quotation omitted). I apply a three-prong test
to determine whether specific jurisdiction exists: (1) the
defendant “must have performed some act or consummated
some transaction with the forum by which it purposefully
availed itself of the privilege of conducting business”
in the forum state; (2) the plaintiff's claims
“must arise out of or result from [those] forum-related
activities; and (3) the exercise of jurisdiction must be
reasonable.” Rio Props., Inc. v. Rio Int'l
Interlink, 284 F.3d 1007, 1019 (9th Cir. 2002).
defendant moves to dismiss for lack of personal jurisdiction
on the basis of written materials rather than an evidentiary
hearing, I must determine whether plaintiff's
“pleadings and affidavits make a prima facie showing of
personal jurisdiction.” Schwarzenegger, 374
F.3d at 800 (quotation omitted). In deciding whether a
plaintiff has met her burden, I must accept as true the
uncontroverted allegations in her complaint, but a plaintiff
cannot rest on the “bare allegations” of her
complaint. Id. (quotation omitted).