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Klein v. Bayer Healthcare Pharmaceuticals, Inc.

United States District Court, D. Nevada

August 21, 2019

INGEBORG KLEIN, et al., Plaintiffs
v.
BAYER HEALTHCARE PHARMACEUTICALS, INC., et al., Defendants

          ORDER GRANTING THE BAYER DEFENDANTS' MOTION TO DISMISS AND PLAINTIFFS' MOTION FOR LEAVE TO FILE SUPPLEMENTAL AUTHORITY [ECF NOS. 32, 61]

          ANDREW P. GORDON UNITED STATES DISTRICT JUDGE

         Plaintiffs 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. at 2.

         Defendants 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 amend.

         I. BACKGROUND

         Bayer's 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.

         In this 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.[1] 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.

         Ingeborg 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.

         II. ANALYSIS

         A. Personal Jurisdiction

         Bayer 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.

         “When 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.

         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).

         When a 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).

         i. ...


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