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

CourtU.S. District Court — District of New Jersey
Writing for the CourtHILLMAN, District Judge
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.
Decision Date29 June 2020
Docket Number1:19-cv-13432-NLH-AMD

469 F.Supp.3d 240

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.

1:19-cv-13432-NLH-AMD

United States District Court, D. New Jersey.

Signed June 29, 2020


469 F.Supp.3d 246

DEREK BRASLOW, KETTERER BROWNE & ANDERSON, 11130 SUNRISE VALLEY DRIVE, SUITE 140, RESTON, VA 20190, T. MATTHEW LECKMAN, pro hac vice, LITTLEPAGE BOOTH LECKMAN, 1912 W. MAIN ST., HOUSTON, TX 77098, On behalf of Plaintiff.

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

JAMIE L. KENDALL, BRAD M. WELSH, ALEXANDRA H. SCHULZ, KENDALL LAW PC, 308 E. LANCASTER AVENUE, SUITE 315, WYNNEWOOD, PENNSYLVANIA 19096, BRIAN W. SHAFFER, MORGAN LEWIS & BOCKIUS LLP, 1701 MARKET STREET, PHILADELPHIA, PENNSYLVANIA 19103-2921, On behalf of Defendants Guerbet LLC and Liebel-Flarsheim Company, LLC.

HILLMAN, District Judge

469 F.Supp.3d 247

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.

I. JURISDICTION

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

469 F.Supp.3d 248

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

II. DISCUSSION

A. Standard for Motion to Dismiss

When considering a motion to dismiss a complaint for failure to state a claim upon

469 F.Supp.3d 249

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...

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  • In re Valsartan, Losartan, & Irbesartan Prods. Liab. Litig., MDL No. 2875 (RBK/KW)
    • United States
    • United States District Courts. 3th Circuit. United States District Courts. 3th Circuit. District of New Jersey
    • January 29, 2021
    ...plaintiffs re-plead their allegations under the NJPLA, they will likely make out a viable design defect claim. Gremo v. Bayer Corp., 469 F. Supp. 3d 240, 255 (D.N.J. 2020). In Gremo, an individual brought a design defect claim against numerous companies alleging that their gadolinium-based ......
  • Silver v. Bayer Healthcare Pharm., C/A 2:19-cv-3495-DCN-MHC
    • United States
    • United States District Courts. 4th Circuit. United States District Court of South Carolina
    • June 10, 2021
    ...the drug manufacturer that the FDA would not approve a change to the drug's label to include that warning.” Gremo v. Bayer Corp., 469 F.Supp.3d 240, 254 (D.N.J. 2020) (quoting Albrecht, 139 S.Ct. at 1672). However, the production or consideration of evidence outside of the complaint is gene......
  • Lara v. Cool Clouds Distribution, Inc., Civil Action No. 20-8030 (SDW) (LDW)
    • United States
    • United States District Courts. 3th Circuit. United States District Courts. 3th Circuit. District of New Jersey
    • February 16, 2021
    ...however, "the issue upon which most claims will turn is [] proof . . . of a reasonable alternative design[.]" Gremo v. Bayer Corp., 469 F. Supp. 3d 240, 255 (D.N.J. 2020). Puff Bar argues that it cannot be liable under the NJPLA's "consumer expectation" affirmative defense because (i) "[t]h......
  • Silver v. Bayer Healthcare Pharm., 2:19-cv-3495-DCN-MHC
    • United States
    • United States District Courts. 4th Circuit. United States District Court of South Carolina
    • September 30, 2021
    ...there is nothing that suggests courts must analyze whether the manufacturer should “alter” the composition. See Gremo v. Bayer Corp., 469 F.Supp.3d 240, 256-57 (D.N.J. June 29, 2020) (distinguishing “state-law design-defect claims like New Hampshire's that place a duty on manufacturers to r......
  • Request a trial to view additional results
10 cases
  • In re Valsartan, Losartan, & Irbesartan Prods. Liab. Litig., MDL No. 2875 (RBK/KW)
    • United States
    • United States District Courts. 3th Circuit. United States District Courts. 3th Circuit. District of New Jersey
    • January 29, 2021
    ...plaintiffs re-plead their allegations under the NJPLA, they will likely make out a viable design defect claim. Gremo v. Bayer Corp., 469 F. Supp. 3d 240, 255 (D.N.J. 2020). In Gremo, an individual brought a design defect claim against numerous companies alleging that their gadolinium-based ......
  • Martin v. DHL Express (USA), Inc., Civil Action No. 3:21-cv-13363
    • United States
    • United States District Courts. 3th Circuit. United States District Courts. 3th Circuit. District of New Jersey
    • January 20, 2022
    ...to dismiss Plaintiff's original putative class action complaint. (ECF No. 6). That motion is denied as moot. Gremo v. Bayer Corp. , 469 F. Supp. 3d 240, 247 n.2 (D.N.J. 2020).2 A duty is "[a] tax levied on an imported or exported commodity; esp[ecially] the federal tax levied on goods shipp......
  • Silver v. Bayer Healthcare Pharm., C/A 2:19-cv-3495-DCN-MHC
    • United States
    • United States District Courts. 4th Circuit. United States District Court of South Carolina
    • June 10, 2021
    ...the drug manufacturer that the FDA would not approve a change to the drug's label to include that warning.” Gremo v. Bayer Corp., 469 F.Supp.3d 240, 254 (D.N.J. 2020) (quoting Albrecht, 139 S.Ct. at 1672). However, the production or consideration of evidence outside of the complaint is gene......
  • Lara v. Cool Clouds Distribution, Inc., Civil Action No. 20-8030 (SDW) (LDW)
    • United States
    • United States District Courts. 3th Circuit. United States District Courts. 3th Circuit. District of New Jersey
    • February 16, 2021
    ...however, "the issue upon which most claims will turn is [] proof . . . of a reasonable alternative design[.]" Gremo v. Bayer Corp., 469 F. Supp. 3d 240, 255 (D.N.J. 2020). Puff Bar argues that it cannot be liable under the NJPLA's "consumer expectation" affirmative defense because (i) "[t]h......
  • Request a trial to view additional results

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