Sabol v. Bayer Healthcare Pharm., Inc.

• Decision Date: 12 February 2020
• Docket Number: 18 Civ. 11169 (VM)
• Parties: Marcia SABOL, Plaintiff, v. BAYER HEALTHCARE PHARM., INC., et al., Defendants.
• Court: U.S. District Court — Southern District of New York

439 F.Supp.3d 131

Marcia SABOL, Plaintiff,

v.BAYER HEALTHCARE PHARM., INC., et al., Defendants.

18 Civ. 11169 (VM)

United States District Court, S.D. New York.

Signed February 12, 2020

Curtis Brooks Cutter, Cutter Law, P.C., Sacramento, CA, Daniel C. Burke, Bernstein Liebhard, LLP, New York, NY, for Plaintiff.

Edward Dumoulin, Jennifer L. Greenblatt, Goldman Ismail Tomaselli Brennan & Baum LLP, Chicago, IL, Jiun Wen Teoh, Foley Hoag LLP, Robb William Patryk, Hughes Hubbard & Reed LLP, Beth S. Rose, Sills Cummis & Gross, P.C., New York, NY, Brian Lucas Spadora, Vincent Robert Lodato, Sills Cummis & Gross, P.C., Newark, NJ, Paul S. Penticuff, Thomas N. Sterchi, Baker, Sterchi, Cowden, & Rice, Kansas City, MO, Michael Lawrence O'Donnell, Jeremy Moseley, Wheeler Trigg O'Donnell LLP, Denver, CO, Stephen G. Traflet, Tracie A. Sundack & Associates, L.L.C., White Plains, NY, for Defendants.

DECISION AND ORDER

VICTOR MARRERO, United States District Judge.

Plaintiff Marcia Sabol ("Sabol") brings this action against defendants Bayer Healthcare Pharmaceuticals, Inc., Bayer Corporation, and Bayer Healthcare LLC (together, "Bayer"); Bracco Diagnostics, Inc. ("Bracco"); and GE Healthcare Inc. ("GEHC") and General Electric Company ("GE Co.," and together with GEHC, "GE") (collectively, "Defendants").¹ Sabol brings two causes of action in her amended complaint: strict product liability under a failure to warn theory, and negligence.

(See "Amended Complaint," Dkt. No. 64 ¶¶ 124-69.)

Before the Court are the pre-motion letters submitted by Defendants seeking leave to file a motion to dismiss the Amended Complaint. The Court construes such letters as motions to dismiss the Amended Complaint² pursuant to Rule 12(b)(2), (3) and (6) of the Federal Rules of Civil Procedure (" Rule 12(b)(2)," " Rule 12(b)(3)," and " Rule 12(b)(6)") (the "Bayer Motion," the "Bracco Motion," and the "GE Motion") (collectively, the "Motions"). For the reasons set forth below, the Motions are GRANTED in part and DENIED as moot in part.

I. BACKGROUND ³

Gadolinium, a heavy metal, is a type of contrast agent. Contrast agents are injected into the body before an MRI procedure to enhance the imaging. Between May 2007 and July 2015 Sabol underwent twenty-three MRIs, and before each MRI a technician injected her with one of Defendants' gadolinium-based contrast agents: Magnevist

(made by Bayer), MultiHance (made by Bracco), or Omniscan (made by GE) (the "Contrast Agents"). Gadolinium is toxic, but the Contrast Agents are intended to "pass[ ] through and eventually [be] eliminated from the body, mainly by the kidneys, after the MRI." (Amended Complaint ¶ 46.)

Sabol filed her lawsuit on November 30, 2018, alleging that the Contrast Agents did not, as intended, pass through her body, but rather were retained, causing serious injuries. (See "Complaint," Dkt. No. 1.) She alleges that gadolinium remains permanently in key organs, bones, and skin, causing fibrosis and the following symptoms, among others: "cognitive impairment, pain, impaired mobility, bone and joint pain, muscle pain, numbing sensation in extremities, burning sensation, depression, and anxiety." (Amended Complaint ¶ 4.) Her suit rests on the contention that, after the FDA approved the Contrast Agents, the manufacturers learned additional information about the risks of gadolinium retention that they should have disseminated. Sabol faults the Defendants for issuing warnings about the Contrast Agents only to patients with chronic, severe kidney disease

or acute kidney injury and not warning that Contrast Agents may be retained even by patients with normal kidney function. The Amended Complaint brings causes of action against all Defendants for (1) strict product liability (failure to warn) and (2) negligence.

1. Bayer's Motion to Dismiss

Consistent with the Court's Individual Practices, Bayer and Sabol exchanged letters regarding Bayer's anticipated motion to dismiss the Complaint.

By letter dated February 25, 2019, Bayer argued that the Complaint should be dismissed for three reasons. (See "Bayer February 25 Letter," Dkt. No. 44.) Bayer's first argument for dismissal is that the Court lacks personal jurisdiction over it. Bayer notes that New York is not its place of incorporation or principal place of business; furthermore, Sabol does not allege Bayer did anything more than develop Magnevist

, which then reached New York through the nationwide stream of commerce. (See

id. at 1-2.) Bayer next argues that, for similar reasons, the Southern District of New York is an improper venue. (See

id. at 2.) Bayer's third contention is that the Complaint fails to state a claim because "gadolinium retention" is not a legally cognizable injury, and Sabol's other alleged injuries -- "fibrosis" and "related injuries" -- are preempted by Magnevist's FDA-approved label. (See

id. at 2-3.) Similarly, Bayer states that Sabol's injuries were not foreseeable, because neither the FDA nor the medical community recognize fibrosis as a side effect of Magnevist in individuals who, like Sabol, have normal kidney function. (See

id. at 3.)

By letter dated March 4, 2019, Sabol responded to Bayer's February 25 Letter. (See "March 4 Letter to Bayer," Dkt. No. 48.) Sabol argues that the Complaint makes out a prima facie showing of personal jurisdiction because she alleges that she was injected with the Contrast Agents in New York and also that Bayer has had significant contact with the state. (See id. at 1-2.) Next, in support of her contention that the Complaint states a claim for relief, Sabol argues first that the Complaint adequately alleges that she was physically, mentally, and economically damaged as a result of Bayer's conduct (see id. at 2); second, that Bayer did, in fact, acquire new information about Magnevist

post-FDA approval sufficient to allow it to amend the label, meaning that her claims are not preempted (see

id. at 3); and third, that in light of the information Bayer acquired about Magnevist, her injuries were foreseeable (see

id. ).

By letter dated April 5, 2019, Bayer informed the Court that the parties had been unable to resolve their dispute. ("Bayer April 5 Letter," Dkt. No. 57.) Following a telephone conference (see "May 30 Conference," Dkt. Minute Entry for May 30, 2019), Sabol filed the Amended Complaint on July 15, 2019.

By letter dated July 29, 2019, Bayer reasserted two of the three arguments it first made in its February 25 Letter. ("Bayer July 29 Letter," Dkt. No. 65.) While Bayer no longer argues that it is not subject to personal jurisdiction in this Court, Bayer continues to assert that venue is not proper in the Southern District of New York (id. at 1), and further argues that the Amended Complaint fails to state a claim because Sabol's claims are preempted, she fails to show that her alleged injuries were foreseeable, and she acknowledges that gadolinium retention is not a cognizable injury. (Id. at 2-3.)

By letter dated July 31, 2019, Sabol responded to the Bayer July 29 Letter. ("July 31 Letter to Bayer," Dkt. No. 70.) Sabol first contends that because a substantial part of the events occurred in New York, the allegations in the Amended Complaint easily meet the test for venue set forth in Neufeld v. Neufeld, 910 F. Supp. 977, 986 (S.D.N.Y. 1996). Sabol also responds to Bayer's arguments that the Amended Complaint fails to state a claim. She maintains that her claims are not preempted because the Amended Complaint cites "a great deal" of newly acquired information that should have led Bayer to change its label. (Id. at 2.) Last, she states that fibrosis caused by gadolinium retention is a legally cognizable and foreseeable injury. (Id. at 3.)

By letter dated August 30, 2019, Bayer responded to Sabol's July 31 Letter. (See "Bayer August 30 Letter," Dkt. No. 81.) Bayer argues first that the Southern District of New York is not a proper venue because not all defendants are residents there, and because Sabol does not allege that the events or omissions giving rise to the claim occurred in the Southern District. Furthermore, Bayer notes that Sabol does not allege that there is no district in which the action could be brought, such that venue is proper in any district in which any defendant is subject to personal jurisdiction. (Bayer August 30 Letter at 1-2.) Bayer next states that Sabol's claims are preempted because she did not demonstrate any scientific development showing reasonable evidence of a causal connection between her claimed injuries and the use of Magnevist

in patients with normal kidney function. Similarly, Bayer disputes that Sabol's injuries were reasonably foreseeable or that gadolinium retention is a legally cognizable injury. (Id. at 3.)

By letter dated September 4, 2019, Sabol responded to the Bayer August 30 Letter. (See "September 4 Letter," Dkt. No. 82.) Sabol argues that venue is proper in the Southern District of New York because a substantial part of the events -- fourteen out of the twenty-three injections -- occurred at Mount Sinai Medical Center in Manhattan, within the Southern District of New York. Furthermore, Sabol argues, venue is proper in the Southern District because defendant GE Co. is a New York company. Second, Sabol argues that her claims are not preempted because the evidence cited in the Amended Complaint demonstrates that people with normal renal function suffer from gadolinium retention and that gadolinium retention causes physical injuries. She also argues that she has sufficiently alleged that her injuries were foreseeable, and that she has pled a legally cognizable injury. (Id. at 3 (citing Amended Complaint ¶¶ 4, 147).)

2. GE's Motion to Dismiss

By letter dated February 25, 2019, GE requested a pre-motion conference with regard to its anticipated motion to dismiss the complaint as to GE for failure to state a claim. (See "GE February 25 Letter," Dkt. No. 42.) GE advances two arguments why the Complaint should be dismissed for failure to state a claim. First, GE...