Case 1:19-cv-13432-NLH-AMD Document 110 Filed 06/29/20 Page 1 of 36 PageID: 1911
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`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
`
`
`
`1:19-cv-13432-NLH-AMD
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`
`OPINION
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`
`
`
`
`
`
`
`
`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.
`
`
`APPEARANCES:
`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.
`
`

`

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`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
`
`
`
`
`2
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`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,
`
`
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`3
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`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.
`
`
`1 According to Plaintiff’s amended complaint, Defendant
`Mallinckrodt Inc. developed, invented, manufactured, tested,
`marketed, advertised, and sold a linear GBCA named OptiMARK
`before it sold its contrast media portfolio, including OptiMARK,
`to Guerbert LLC in 2015. Defendant Guerbert LLC manufactured,
`tested, marketed, advertised and sold OptiMARK before it removed
`OptiMARK from the United States market in 2018. In August 2016,
`OptiMARK’s product label indicated that it was manufactured and
`distributed by Defendant Liebel-Flarsheim Company LLC.
`Defendant AmerisourceBergen has been engaged in the
`distribution, supply, marketing, and sale of OptiMARK in the
`State of New Jersey.
` Defendants moved to dismiss Plaintiff’s original complaint. In
`response, Plaintiff filed an amended complaint. The motions to
`dismiss Plaintiff’s original complaint are therefore moot.
`Pending are Defendants’ motions to dismiss Plaintiff’s amended
`complaint.
`
` 2
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`4
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`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 (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
`
`
`3 For example, Plaintiff pleads: “Upon information and belief,
`the Defendants have or may have failed to comply with all
`federal standards and requirements applicable to the sale of
`GBCAs including, but not limited to, violations of various
`sections and subsections of the United States Code and the Code
`of Federal Regulations.” (Pl. Compl., Docket No. 1 at 38, ¶
`126.) Plaintiff further claims that “notwithstanding the
`overwhelming evidence of causal association between GBCAs and
`NSF [renal impairment called nephrogenic systemic fibrosis], the
`FDA [Food and Drug Administration] and the GBCA industry have
`cast the issue of retention as separate from the medical
`community’s experience with NSF, coming short of acknowledging
`any untoward health effects from gadolinium retention in non-
`renal patients,” and “to date, the FDA and the GBCA industry
`have refused to acknowledge that GBCAs can cause NSF in renal
`patients but also can cause, in non-renal patients, a variety of
`NSF-like injuries and symptoms along a continuum, ranging from
`minor to severe.” (Id. at 36, ¶¶ 120-21.)
`
`
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`5
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`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
`
`
`4 Separate from the well-pleaded complaint rule, another basis
`for federal jurisdiction is be complete pre-emption. See Ben.
`Nat’l Bank v. Anderson, 539 U.S. 1, 8 (2003) (explaining that
`there is an exception to the well-pleaded complaint rule “when a
`federal statute wholly displaces the state-law cause of action
`through complete pre-emption,” and this exception exists because
`“[w]hen the federal statute completely pre-empts the state-law
`cause of action, a claim which comes within the scope of that
`cause of action, even if pleaded in terms of state law, is in
`reality based on federal law”). However, in contrast to
`complete pre-emption, the defenses of impossibility pre-emption
`and other pre-emption defenses may not serve as the basis for
`federal jurisdiction at the time of removal. See Caterpillar
`Inc. v. Williams, 482 U.S. 386, 393 (1987) (explaining that a
`case may not be removed to federal court on the basis of a
`federal defense, including the defense of pre-emption, even if
`the defense is anticipated in the plaintiff's complaint, and
`even if both parties concede that the federal defense is the
`only question truly at issue). Regardless of which type of pre-
`emption doctrine may possibly apply to Plaintiff’s claims, as
`discussed below, the Court cannot determine at this stage in the
`case whether Plaintiff’s PLA claims are pre-empted by federal
`law - either completely or through a pre-emption defense - and
`therefore federal pre-emption has not been established to
`support subject matter jurisdiction under that principle at this
`time.
`
`
`
`6
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`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 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 (2007) (alteration in original)
`(citations omitted) (first citing Conley v. Gibson, 355 U.S. 41,
`47 (1957); Sanjuan v. Am. Bd. of Psychiatry & Neurology, Inc.,
`
`
`5 Because there is no diversity of citizenship between Plaintiff
`and Defendants, subject matter jurisdiction under 28 U.S.C. §
`1332(a) is unavailable.
`
`
`
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`40 F.3d 247, 251 (7th Cir. 1994); and then citing Papasan v.
`Allain, 478 U.S. 265, 286 (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 (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 (quoting Scheuer v. Rhoades, 416
`U.S. 232, 236 (1974)); see also Iqbal, 556 U.S. at 684 (“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
`
`
`
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`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).
`
`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
`Defendants’ motions to dismiss, Plaintiff presents a two-page
`
`
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`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 contrast agents (GBCAs) have
`been developed as means to introduce gadolinium into the
`body and enhance diagnostic imaging. See id. at ¶¶ 93-99.
`Because naturally occurring gadolinium is toxic, GBCAs are
`“chelated” constructs, meaning the gadolinium is bound in
`either a “linear” or “macrocyclic” compound. See id. at ¶¶
`101-110. Linear GBCAs are less stable and more prone to
`separation of the gadolinium from its compound (or “de-
`chelation”). See id. Once de-chelated, free gadolinium will
`bind to tissue or cells in a biological structure. See id.
`In other words, if the chelation separates or falls away
`from the gadolinium, the patient would become exposed to
`raw and highly toxic gadolinium. So chelation is designed
`to protect the human body from direct exposure to a toxic
`heavy metal. The kidneys play a central role in the
`clearance of GBCAs from the body, so predictably, patients
`with compromised kidney function are at risk for slower or
`reduced clearance of GBCAs, which in turn increases the
`risk of de-chelation and retention of free gadolinium in
`the body. See id. at ¶ 111. The undisputed public record
`shows that, in patients with compromised kidney function,
`GBCAs can cause the rare and often fatal disease,
`Nephrogenic Systemic Fibrosis (NSF), see, e.g., id. at ¶¶
`112-116, and the class labeling for GBCAs has warned
`physicians about that risk since 2007. See id. at ¶¶ 115-
`116.
`
`
`
`Plaintiff Kimberly Gremo contends that NSF is the end-
`stage of a broader condition that runs on a continuum, with
`pre-cursor symptoms and ailments, such as those she has
`suffered, on one end and full-blown NSF on the other. See,
`e.g., id. at ¶¶ 124, 147-48, 156-59. She contends that the
`risk for NSF and NSF-like injuries is not limited to those
`with compromised kidney function but instead extends to all
`patients exposed to GBCAs. See id. Furthermore, she
`contends that macrocyclic GBCAs, which have long been FDA-
`approved and available as alternatives to their linear
`counterparts in the United States, are more stable, less
`
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`prone to de-chelation, and consequently safer alternatives.
`See id. at ¶¶ 105-110. Her suit alleges that Defendants
`knew or should have known about this safety information and
`yet failed to warn the medical community and failed to
`alter the design of their linear products to comport with
`that of their macrocyclics. See id. at ¶¶ 168-205.
`
`
`
`From 2007 to 2016, Plaintiff was exposed to the linear
`GBCAs manufactured by Defendants on at least ten separate
`occasions. See id. at ¶ 164. She was exposed to
`Mallinckrodt / Guerbet’s OptiMARK on at least six occasions
`[; Bayer’s Magnevist on at least one occasion; and GE’s
`Omniscan on at least three occasions]. See id. She alleges
`that, as a direct and proximate result of her linear GBCA
`exposure, she developed gadolinium toxicity, evidenced by a
`multitude of symptoms, ailments, injuries and adverse
`health effects that she now suffers, to wit: skin issues,
`including rashes, dermatitis, burning, hyperpigmentation,
`rough patches, loss of elasticity, peeling and callus-like
`buildup; teeth issues, including darkened teeth and spots,
`cracking, and sensitivity; neurological issues, including
`brain fog and memory loss; pain in her hips, back, bones
`and joints; neuropathy; fatigue; muscle aches and
`fasciculation; and loss of smell. See id. at ¶¶ 165-67.
`
`(See Docket No. 82 at 4-5; 83 at 5-6; 85 at 6-7.)
`
`C.
`Plaintiff’s claims under the PLA
`
`
`
`
`Under the New Jersey Product Liability Act (PLA),
`A manufacturer or seller of a product shall be liable
`in a product liability action only if the claimant
`proves by a preponderance of the evidence that the
`product causing the harm was not reasonably fit,
`suitable or safe for its intended purpose because it:
`a. deviated from the design specifications, formulae,
`or performance standards of the manufacturer or from
`otherwise identical units manufactured to the same
`manufacturing specifications or formulae, or b.
`failed to contain adequate warnings or instructions,
`or c. was designed in a defective manner.
`
`N.J.S.A. 2A:58C-2.
`
`The cited statutory text establishes three causes of action
`
`
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`under the PLA: (1) design defect, (2) manufacturing defect, or
`(3) warnings defect. Mendez v. Shah, 28 F. Supp. 3d 282, 296
`(D.N.J. 2014) (citing Roberts v. Rich Foods, Inc., 139 N.J.
`365, 375, 654 A.2d 1365 (N.J. 1995); Dziewiecki v. Bakula, 361
`N.J. Super. 90, 97-98, 824 A.2d 241 (App. Div. 2003)). The
`standard of liability is that the product “was not reasonably
`fit, suitable or safe for its intended purpose.” Id. (citing
`Cornett v. Johnson & Johnson, 414 N.J. Super. 365, 998 A.2d 543
`(App. Div. 2010)). The “mere occurrence of an accident and the
`mere fact that someone was injured are not sufficient to
`demonstrate the existence of a defect.” Id. (citation omitted).
`
`Plaintiff has asserted a warnings defect claim and a design
`defect claim.
`1.
`Count I - Failure-to-Warn
`
`
`To prove a failure-to-warn claim, a plaintiff must show:
`(1) the product was defective; (2) the defect existed when the
`product left the defendant's control; and (3) the defect caused
`injury to a reasonably foreseeable user. Lopez v. Borough of
`Sayreville, 2008 WL 2663423, at *15–16 (N.J. Super. Ct. App.
`Div. 2008) (citing Coffman v. Keene Corp., 133 N.J. 581, 593,
`628 A.2d 710 (1993)). In a failure-to-warn case, “the duty to
`warn is premised on the notion that a product is defective
`absent an adequate warning for foreseeable users that the
`product can potentially cause injury.” Id. (citing Clark v.
`
`
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`Safety–Kleen Corp., 179 N.J. 318, 336, 845 A.2d 587 (2004))
`(other citation omitted). The failure to provide necessary
`warnings constitutes a breach of duty. Id. (citation omitted).
`
`Initially, the plaintiff must establish that the defendant
`had a duty to warn. Id. (citing James v. Bessemer Processing
`Co., 155 N.J. 279, 297–98, 714 A.2d 898 (1998)). The
`manufacturer of a product has a duty to warn about any risk
`relating to the product that it knows or ought to know, unless
`the risk and the way to avoid it are obvious. Id. (citing
`Feldman v. Lederle Labs., 97 N.J. 429, 434, 479 A.2d 374 (1984))
`(other citation omitted). Once plaintiff establishes a duty to
`warn, she must then establish that an adequate warning was not
`provided. Id. (citation omitted). A manufacturer “shall not be
`liable for harm caused by a failure to warn if the product
`contains an adequate warning or instruction.” N.J.S.A. 2A:58C-
`4.
`
`
`An “adequate warning” is defined as:
`[O]ne that a reasonably prudent person in the same or
`similar circumstances would have provided with respect to
`the danger and that communicates adequate information on
`the dangers and safe use of the product, taking into
`account the characteristics of, and the ordinary knowledge
`common to, the persons by whom the product is intended to
`be used....
`
`N.J.S.A. 2A:58C-4.
`
`
`“Causation is a fundamental requisite for establishing any
`product-liability action,” and a “plaintiff must demonstrate . .
`
`
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`. the defect in the product was a proximate cause of the
`injury.” Lopez, 2008 WL 2663423 at *15–16 (citation omitted).
`“Ordinarily, the jury considers issues of proximate cause.” Id.
`(citing Shelcusky v. Garjulio, 172 N.J. 185, 206, 797 A.2d 138
`(2002)).
`
`In the context of products regulated by the FDA, such as
`GBCAs, issues of federal pre-emption arise. See Merck Sharp &
`Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1672 (U.S. 2019)
`(explaining that federal pre-emption “takes place when it is
`impossible for a private party to comply with both state and
`federal requirements”) (quoting Mutual Pharmaceutical Co. v.
`Bartlett, 570 U. S. 472, 480 (2013) and citing U. S. Const.,
`Art. VI, cl. 2). Applicable here, “[t]he state law that we
`consider is state common law or state statutes that require drug
`manufacturers to warn drug consumers of the risks associated
`with drugs. The federal law that we consider is the statutory
`and regulatory scheme through which the FDA regulates the
`information that appears on brand-name prescription drug labels.
`The alleged conflict between state and federal law in this case
`has to do with a drug that was manufactured by [Defendants] and
`was administered to [Plaintiff] without a warning of certain
`associated risks.” Id.
`
`“[S]tate law failure-to-warn claims are pre-empted by the
`Federal Food, Drug, and Cosmetic Act and related labeling
`
`
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`regulations when there is ‘clear evidence’ that the FDA would
`not have approved the warning that state law requires.” Id. at
`1676 (discussing Wyeth v. Levine, 555 U.S. 555, 571 (2009)).
`This “impossibility pre-emption” - i.e., federal law makes it
`impossible for a defendant to also comply with state law - is a
`“a demanding defense.” Id. (discussing Wyeth, 555 U.S. at 573,
`555, finding that “absent clear evidence that the FDA would not
`have approved a change to [the drug’s] label, we will not
`conclude that it was impossible for Wyeth to comply with both
`federal and state requirements”). Despite the FDA’s oversight
`of drug labeling,6 “a central premise of federal drug regulation
`[is] that the manufacturer bears responsibility for the content
`of its label at all times.” Id. at 1677 (citing Wyeth, 555 U.S.
`at 570-71).
`
`“[F]ederal law - the FDA’s CBE [“changes being effected”]
`
`
`6 Prospective drug manufacturers work with the FDA to develop an
`appropriate label when they apply for FDA approval of a new
`drug. 21 U.S.C. §§ 355(a), 355(b), 355(d)(7); 21 C.F.R. §
`314.125(b)(6). But FDA regulations also acknowledge that
`information about drug safety may change over time, and that new
`information may require changes to the drug label. Id. §§
`314.80(c), 314.81(b)(2)(i). Drug manufacturers generally seek
`advance permission from the FDA to make substantive changes to
`their drug labels. However, an FDA regulation called the
`“changes being effected” or “CBE” regulation permits drug
`manufacturers to change a label without prior FDA approval if
`the change is designed to “add or strengthen a ... warning”
`where there is “newly acquired information” about the “evidence
`of a causal association” between the drug and a risk of harm.
`21 C.F.R. § 314.70(c)(6)(iii)(A).
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`regulation - permits drug manufacturers to change a label to
`reflect newly acquired information if the changes add or
`strengthen a . . . warning for which there is evidence of a
`causal association, without prior approval from the FDA.” Merk,
`139 S. Ct. at 1679 (quoting 21 C.F.R. § 314.70(c)(6)(iii)(A))
`(quotations omitted). “Of course, the FDA reviews CBE
`submissions and can reject label changes even after the
`manufacturer has made them,” and “manufacturers cannot propose a
`change that is not based on reasonable evidence.” Id. (citing
`§§ 314.70(c)(6), (7). 314.70(c)(6)(iii)(A)). “But in the
`interim, the CBE regulation permits changes, so a drug
`manufacturer will not ordinarily be able to show that there is
`an actual conflict between state and federal law such that it
`was impossible to comply with both.” Id.
`
`Defendants in this case argue that the impossibility pre-
`emption doctrine requires the dismissal of Plaintiff’s failure-
`to-warn claims under the New Jersey PLA.7 At this pleading
`
`
`7 Several Defendants also argue that Plaintiff’s claims against
`them fail to satisfy the pleading standards of Fed. R. Civ. P. 8
`and Twombly/Iqbal, particularly because she often refers to
`“Defendants” collectively. Although it is often the case that
`pleading claims against defendants as a group without
`identifying who did what is fatal to the viability of those
`claims, see, e.g., Twombly, 550 U.S. at 558 (insisting “upon
`some specificity in pleading before allowing a potentially
`massive factual controversy to proceed” to an “inevitably costly
`and protracted discovery phase”), Plaintiff’s amended complaint
`does not meet that fate. Plaintiff’s amended complaint
`specifies which Defendant is responsible for which GBCA and when
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`stage, the Court disagrees.
`
`As a primary matter, Plaintiff has properly pleaded her
`failure-to-warn claims under the PLA. Plaintiff alleges
`Defendants’ GBCA product labels were defective (Amend. Compl.
`Docket No. 62 ¶¶ 170-174), the defect existed when the products
`left Defendants’ control (id. ¶ 170), and the defect caused
`injury to Plaintiff, a reasonably foreseeable user (id. ¶¶ 181-
`182). Plaintiff has also pleaded how Defendants’ failure to
`provide necessary warnings constitutes a breach of their duty to
`warn Plaintiff of the risks related to their GBCAs of which
`Defendants knew or should have known. (Id. ¶¶ 174-179.)
`
`To determine whether Plaintiff’s properly pleaded failure-
`to-warn claims are pre-empted by the Federal Food, Drug, and
`Cosmetic Act and related labeling regulations, Defendants must
`show by clear evidence that the FDA would not have approved the
`warning that Plaintiff contends state law requires. Merk, 139
`S. Ct. at 1676 (citing Wyeth, 555 U.S. at 571). For Defendants
`
`
`Plaintiff was administered each GBCA. Because the product
`labeling (and thus allegations regarding Defendants’ failure to
`warn of the risks of their GBCAs), the product design (and thus
`allegations concerning design defects), and the express
`warranties are all the same for each GBCA, Plaintiff’s
`collective reference to “Defendants” is permissible, and indeed
`preferable, so that she avoids veering into Rule 12(f) territory
`if she were to restate every collective allegation specific to
`each Defendant. See Fed. R. Civ. P. 12(f) (providing that the
`court on its own or on the motion of defendant the court may
`strike redundant matter). Plaintiff’s amended complaint does
`not run afoul of proper pleading standards.
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`to do this at the motion to dismiss stage, Defendants are
`constrained to point to the contents of Plaintiff’s complaint,
`or “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, 998 F.2d at 1196.
`Defendants, however, have not so constrained themselves.
`
`Defendants assert various arguments for why the
`impossibility pre-emption doctrine bars Plaintiff’s state law
`failure-to-warn claims, but as the Supreme Court has reiterated,
`impossibility pre-emption is “a demanding defense” rather than a
`pleading requirement. Moreover, the impossibility pre-emption
`defense places the burden on Defendants - and not Plaintiff - to
`support that defense with “clear evidence,” which is evidence
`provided by Defendants that “shows the court that the drug
`manufacturer fully informed the FDA of the justifications for
`the warning required by state law and that the FDA, in turn,
`informed the drug manufacturer that the FDA would not approve a
`change to the drug’s label to include that warning.” Merk, 139
`S. Ct. at 1672.
`
`Even though “a judge, not the jury, must decide the pre-
`emption question,” id. at 1676, that question is not properly
`before the Court to answer at this time. See, e.g., Wyeth, 555
`U.S. at 572-73 (finding that after the completion of discovery
`and at the trial-ready stage of the case Wyeth’s evidence for
`
`
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`its pre-emption defense failed for who reasons: (1) the record
`did not show that Wyeth supplied the FDA with an evaluation or
`analysis concerning the specific dangers that would have merited
`the warning, and (2) the record did not show that Wyeth
`attempted to give the kind of warning required by state law but
`was prohibited from doing so by the FDA) (quotations and
`alterations omitted).
`Plaintiff’s failure-to-warn claims against all Defendants8
`
`
`
`8 In addition to joining in on the arguments made by
`Mallinckrodt, AmerisourceBergen argues that it is entitled to
`dismissal of Plaintiff’s product liability claims because it is
`a “product seller” within the meaning of N.J.S.A. 2A:58C-8 and
`it meets the requirements for immunity enumerated by N.J.S.A.
`2A:58C-9. “While those in the wholesale and retail chain of
`distribution may potentially be liable for the foreseeable
`injuries proximately caused by defective products intended for
`ultimate sale to the public, they may be relieved from liability
`where they comply with the exculpatory provisions of the
`Products Liability Act, N.J.S.A. 2A:58C–9.” D.J.L. v. Armour
`Pharmaceutical Co., 704 A.2d 104, 117 n.25 (N.J. Super. L. Div.
`1997). To that end, AmerisourceBergen provides an affidavit to
`demonstrate the exculpatory provisions by “certifying the
`correct identity of the manufacturer of the product” at issue,
`demonstrate that it has not “exercised some significant control
`over the design, manufacture, packaging or labeling of the
`product relative to the alleged defect in the product which
`caused the in