Gremo v. Bayer Corp., 1:19-cv-13432-NLH-AMD

Decision Date29 June 2020
Docket Number1:19-cv-13432-NLH-AMD
Citation469 F.Supp.3d 240
Parties Kimberly GREMO, Plaintiff, v. BAYER CORPORATION, Bayer Healthcare LLC, Bayer Healthcare Pharmaceuticals, Inc., GE Healthcare, Inc., General Electric Company, Mallinckrodt, Inc., Mallinckrodt LLC, Guerbert LLC, Liebel-Flarsheim Company LLC, Amerisource Bergen Corporation, Amerisource Bergen Drug Corporation, Defendants.
CourtU.S. District Court — District of New Jersey


JENNIFER GREENBLATT, pro hac vice, EDWARD DUMOULIN, pro hac vice, GOLDMAN ISMAIL TOMASELLI BRENNAN & BAUM LLP, 564 W. RANDOLPH ST., STE. 400, CHICAGO, IL 60661, WILFRED P. CORONATO, MCCARTER & ENGLISH LLP, FOUR GATEWAY CENTER 100 MULBERRY ST., NEWARK, NJ 07102, On behalf of Defendants Bayer Corporation, Bayer HealthCare LLC, and Bayer HealthCare Pharmaceuticals Inc.

STEPHEN G. TRAFLET, DEBRA M. ALBANESE, TRAFLET & FABIAN, 264 SOUTH STREET, MORRISTOWN, NJ 07960, MICHAEL L. O'DONNELL, pro hac vice, JEREMY A. MOSELEY, pro hac vice, WHEELER TRIGG O'DONNELL LLP, 370 SEVENTEENTH STREET, #4500, DENVER, COLORADO 80202, On behalf of Defendants GE Healthcare Inc. and General Electric Company.

ERIN (LOUCKS) LEFFLER, SHOOK, HARDY & BACON L.L.P., TWO COMMERCE SQUARE, 2001 MARKET STREET, SUITE 3000, PHILADELPHIA, PA 19103, DEVIN K. ROSS, pro hac vice, ROBERT T. ADAMS, pro hac vice, SHOOK, HARDY & BACON L.L.P., 2555 GRAND BOULEVARD, KANSAS CITY, MO 64108, On behalf of Defendants Mallinckrodt, Inc., Mallinckrodt LLC, Amerisource Bergen Corporation, and Amerisource Bergen Drug Corporation


HILLMAN, District Judge

This matter concerns FDA-approved gadolinium-based contrast agents ("GBCAs") administered intravenously by medical professionals to enhance the quality of magnetic resonance imaging

("MRI"). The MRIs are used to diagnose serious conditions, such as cancer, strokes and aneurysms. Plaintiff, Kimberly Gremo, claims that Defendants’ GBCAs caused her "gadolinium toxicity, or Gadolinium Deposition Disease (GDD), as characterized by a multitude of symptoms," including "skin issues including rashes," "teeth issues including darkened teeth and spots," "brain fog and memory loss," and "loss of smell."

Plaintiff has filed suit against Defendants Bayer Corporation, Bayer HealthCare LLC, Bayer HealthCare Pharmaceuticals, Inc. (collectively "Bayer"), GE Healthcare, Inc., General Electric Company (collectively "GE"), Mallinckrodt, Inc., Mallinckrodt LLC (collectively "Mallinckrodt"), Guerbert LLC ("Guerbert"), Liebel-Flarsheim Company LLC ("Liebel-Flarsheim"), Amerisource Bergen Corporation, and Amerisource Bergen Drug Corporation (collectively "AmerisourceBergen"), as "manufacturers" or "sellers" of the GBCAs to which Plaintiff was exposed: Magnevist

(manufactured and sold by Bayer), Omniscan (manufactured and sold by GE), and OptiMARK (manufactured and sold by Guerbet, Mallinckrodt, Liebel-Flarsheim, and AmerisourceBergen1 ).

In her amended complaint,2 Plaintiff has asserted two counts for Defendants’ alleged violations of New Jersey's Product Liability Act (PLA), N.J.S.A. 2A:58C-2 : failure to warn (Count I) and defective design (Count II). Plaintiff has also asserted a breach of express warranty claim against Defendants pursuant to N.J.S.A. 12A:2-313 (Count III).

Defendants have moved to dismiss all of Plaintiff's claims against them for numerous reasons. Plaintiff has opposed Defendants’ motions. For the reasons expressed below, Defendants’ motions will be denied.


Defendants removed Plaintiff's complaint from state court to this Court pursuant to 28 U.S.C. § 1331.

As the Court found in denying Plaintiff's motion to remand under the well-pleaded complaint rule (see Docket No. 108), even though the three counts in Plaintiff's complaint assert claims based on state law, on the face of Plaintiff's complaint, over which she is the "master," she has also raised claims arising under the laws of the United States, as well as claims that necessarily depend on resolution of a substantial question of federal law, to both of which § 1331 applies.3 See Franchise Tax Bd. of Cal. v. Constr. Laborers Vacation Trust for S. Cal., 463 U.S. 1, 22, 28, 103 S.Ct. 2841, 77 L.Ed.2d 420 (1983) ("[T]he party who brings the suit is master to decide what law he will rely upon," but "it is an independent corollary of the well-pleaded complaint rule that a plaintiff may not defeat removal by omitting to plead necessary federal questions in a complaint." "Congress has given the lower federal courts jurisdiction to hear, originally or by removal from a state court, only those cases in which a well-pleaded complaint establishes either that federal law creates the cause of action or that the plaintiff's right to relief necessarily depends on resolution of a substantial question of federal law.").4 Thus, this Court may properly exercise subject matter jurisdiction over Plaintiff's complaint pursuant to 28 U.S.C. § 1331 and supplemental jurisdiction over Plaintiff's other state law claims under 28 U.S.C. § 1367.5

A. Standard for Motion to Dismiss

When considering a motion to dismiss a complaint for failure to state a claim upon which relief can be granted pursuant to Federal Rule of Civil Procedure 12(b)(6), a court must accept all well-pleaded allegations in the complaint as true and view them in the light most favorable to the plaintiff. Evancho v. Fisher, 423 F.3d 347, 351 (3d Cir. 2005). It is well settled that a pleading is sufficient if it contains "a short and plain statement of the claim showing that the pleader is entitled to relief." Fed. R. Civ. P. 8(a)(2).

"While a complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations, a plaintiff's obligation to provide the ‘grounds’ of his ‘entitle[ment] to relief’ requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do...." Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) (alteration in original) (citations omitted) (first citing Conley v. Gibson, 355 U.S. 41, 47, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957) ; Sanjuan v. Am. Bd. of Psychiatry & Neurology, Inc., 40 F.3d 247, 251 (7th Cir. 1994) ; and then citing Papasan v. Allain, 478 U.S. 265, 286, 106 S.Ct. 2932, 92 L.Ed.2d 209 (1986) ).

To determine the sufficiency of a complaint, a court must take three steps: (1) the court must take note of the elements a plaintiff must plead to state a claim; (2) the court should identify allegations that, because they are no more than conclusions, are not entitled to the assumption of truth; and (3) when there are well-pleaded factual allegations, a court should assume their veracity and then determine whether they plausibly give rise to an entitlement for relief. Malleus v. George, 641 F.3d 560, 563 (3d Cir. 2011) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 664, 675, 679, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (alterations, quotations, and other citations omitted).

A district court, in weighing a motion to dismiss, asks "not whether a plaintiff will ultimately prevail but whether the claimant is entitled to offer evidence to support the claim." Twombly, 550 U.S. at 563 n.8, 127 S.Ct. 1955 (quoting Scheuer v. Rhodes, 416 U.S. 232, 236, 94 S.Ct. 1683, 40 L.Ed.2d 90 (1974) ); see also Iqbal, 556 U.S. at 684, 129 S.Ct. 1937 ("Our decision in Twombly expounded the pleading standard for ‘all civil actions’ ...."); Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir. 2009) (" Iqbal ... provides the final nail in the coffin for the ‘no set of facts’ standard that applied to federal complaints before Twombly."). "A motion to dismiss should be granted if the plaintiff is unable to plead ‘enough facts to state a claim to relief that is plausible on its face.’ " Malleus, 641 F.3d at 563 (quoting Twombly, 550 U.S. at 570, 127 S.Ct. 1955 ).

A court in reviewing a Rule 12(b)(6) motion must only consider the facts alleged in the pleadings, the documents attached thereto as exhibits, and matters of judicial notice. S. Cross Overseas Agencies, Inc. v. Kwong Shipping Grp. Ltd., 181 F.3d 410, 426 (3d Cir. 1999). A court may consider, however, "an undisputedly authentic document that a defendant attaches as an exhibit to a motion to dismiss if the plaintiff's claims are based on the document." Pension Benefit Guar. Corp. v. White Consol. Indus., Inc., 998 F.2d 1192, 1196 (3d Cir. 1993). If any other matters outside the pleadings are presented to the court, and the court does not exclude those matters, a Rule 12(b)(6) motion will be treated as a summary judgment motion pursuant to Rule 56. Fed. R. Civ. P. 12(b).

B. Summary of Plaintiff's allegations

Plaintiff's amended complaint contains almost 20 pages of explanatory background concerning the development of GBCAs, their effects on the human body, the interaction of the FDA with the GBCA industry for the approval, labeling, marketing, and sale of GBCAs, and Plaintiff's experience with Defendants’ GBCAs. (Docket No. 62 at 12-31.) In Plaintiff's oppositions to Defendantsmotions to dismiss, Plaintiff presents a two-page summary of the information and allegations contained in her amended complaint:

Gadolinium is a chemical element that does not occur naturally in the body and is toxic in its free, cationic state. See Amended Complaint, Doc. No. 62, at ¶¶ 90-92, 100. Because gadolinium is highly paramagnetic, it is particularly effective for use in Magnetic Resonance (MR) imaging, and gadolinium-based

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