United States District Court, N.D. Illinois, Eastern Division
MEMORANDUM OPINION AND ORDER
JORGE ALONSO UNITED STATES DISTRICT JUDGE
Allison Greager brings this product liability action against
numerous manufacturers and sellers of ibuprofen, asserting
claims of defective design, failure to warn of inherent
risks, and numerous other, related state-law claims.
Defendants L. Perrigo Company (“Perrigo”) and
Walmart Inc. (“Walmart”) move to dismiss. For the
following reasons, the motions are granted.
alleges, as relevant here, that on June 15, 2012, suffering
from a fever, she ingested Motrin IB and a generic equivalent
sold by Walmart under the store-brand name
“Equate.” The active ingredient in both products is
ibuprofen, a nonsteroidal anti-inflammatory drug available
over the counter to reduce swelling, pain, or fever. As a
result of her ingestion of these ibuprofen products,
plaintiff claims, she developed a severe skin disorder,
either Stevens-Johnson Syndrome or its more severe cousin,
toxic epidermal necrolysis, and suffered serious injuries to
her skin and other bodily organs, causing permanent damage
that will require lifelong medical care. Plaintiff
subsequently filed this action, asserting claims of defective
design, failure to warn, negligence, consumer fraud, breach
of implied warranty of merchantability, and willful and
which manufactures the Equate-branded ibuprofen product, and
Walmart move to dismiss, arguing that plaintiff's claims
are preempted as to the Equate product by the Federal Food,
Drug and Cosmetic Act (“FDCA”), 21 U.S.C. §
301 et seq., and regulations promulgated thereunder.
Additionally, the moving defendants argue that plaintiff
fails to state a claim against them based on her ingestion of
Motrin IB. In her combined response brief, plaintiff
apparently concedes that she does not state a claim against
Perrigo or Walmart based on her ingestion of Motrin IB,
instead focusing on her claims based on the Equate product,
which she argues are not preempted.
motion under Federal Rule of Civil Procedure 12(b)(6) tests
whether the complaint states a claim on which relief may be
granted.” Richards v. Mitcheff, 696 F.3d 635,
637 (7th Cir. 2012). Under Rule 8(a)(2), a complaint must
include “a short and plain statement of the claim
showing that the pleader is entitled to relief.”
Fed.R.Civ.P. 8(a)(2). The short and plain statement under
Rule 8(a)(2) must “‘give the defendant fair
notice of what . . . the claim is and the grounds upon which
it rests.'” Bell Atl. Corp. v. Twombly,
550 U.S. 544, 555 (2007) (quoting Conley v. Gibson,
355 U.S. 41, 47 (1957)). Under federal notice-pleading
standards, a plaintiff's “[f]actual allegations
must be enough to raise a right to relief above the
speculative level.” Id. Stated differently,
“a complaint must contain sufficient factual matter,
accepted as true, to ‘state a claim to relief that is
plausible on its face.'” Ashcroft v.
Iqbal, 556 U.S. 662, 678 (2009) (quoting
Twombly, 550 U.S. at 570). “A claim has facial
plausibility when the plaintiff pleads factual content that
allows the court to draw the reasonable inference that the
defendant is liable for the misconduct alleged.”
Id. (citing Twombly, 550 U.S. at 556).
“Only when the plaintiff pleads itself out of
court-that is, admits all the ingredients of an impenetrable
defense-may a complaint that otherwise states a claim be
dismissed under Rule 12(b)(6).” Xechem, Inc. v.
Bristol-Myers Squibb Co., 372 F.3d 899, 901 (7th Cir.
preemption doctrine is grounded in the Constitution's
Supremacy Clause.” Wis. Cent., Ltd. V.
Shannon, 539 F.3d 751, 762 (7th Cir. 2008). The
Supremacy Clause declares that federal law “shall be
the supreme Law of the Land . . . any Thing in the
Constitution or Law of any State to the Contrary
notwithstanding.” U.S. Const. Art. VI., cl. 2.
“Where state and federal law directly conflict, state
law must give way.” PLIVA, Inc. v. Mensing,
564 U.S. 604, 617 (2011) (internal quotation marks omitted).
can take on three different forms: express preemption, field
preemption, and conflict preemption.” Aux Sable
Liquid Prod. v. Murphy, 526 F.3d 1028, 1033 (7th Cir.
2008). Express preemption is when Congress “define[s]
explicitly the extent to which its enactments preempt state
law.” English v. Gen. Elec. Co., 496 U.S. 72,
78 (1990). Field preemption is when “the federal
regulatory scheme is so pervasive or the federal interest so
dominant that it may be inferred that Congress intended to
occupy the entire legislative field.” Planned
Parenthood of Ind., Inc. v. Comm'r of Ind. State
Dep't Health, 699 F.3d 962, 984 (7th Cir. 2012)
(citing Arizona v. United States, 567 U.S.
387, 399 (2012)). Conflict preemption is when “state
law conflicts with federal law to the extent that compliance
with both federal and state regulations is a physical
. . . disputes over drug labels, conflict preemption takes
center stage.” Guilbeau v. Pfizer Inc., 880
F.3d 304, 310 (7th Cir. 2018). The FDCA prescribes a
two-tiered application process drug manufacturers must follow
before they can put their products on the market:
[D]rug manufacturers [must] gain approval from the United
States Food and Drug Administration (FDA) before introducing
a drug into interstate commerce. 21 U.S.C. § 355(a). To
obtain FDA approval for a new drug, a manufacturer must
submit a New Drug Application (NDA), a comprehensive
submission that must include, for example, detailed
information about the drug's composition and full reports
of investigations into the drug's safety and
effectiveness. See Id. § 355(b)(1). In
addition, NDA applicants must submit “the labeling
proposed to be used for [the] drug, ” §
355(b)(1)(F), and they are “responsible for the
accuracy and adequacy of [the] label” they submit.
[Mensing, 564 U.S. at 613] (citing 21 U.S.C.
§§ 355(b)(1), (d)). Manufacturers of generic drugs,
however, need not submit such comprehensive applications.
Rather, the FDA will approve a generic drug pursuant to an
abbreviated new drug application (ANDA) upon a showing that
the generic drug is equivalent to a previously approved
“reference listed drug” (RLD). See 21
U.S.C. § 355(j)(2)(A). The labeling proposed in the ANDA
must also be “the same as the labeling approved”
for the generic drug's RLD. Id. §
In re Testosterone Replacement Therapy Prod. Liab.
Litig., 142 F.Supp.3d 747, 748 (N.D. Ill. 2015).
manufactures and markets the Equate-branded ibuprofen under
an ANDA. The moving defendants argue that, given that federal
law imposes a “duty of sameness, ”
Mensing, 564 U.S. at 616, on generic drug
manufacturers-i.e., their products and their product
labeling must be identical to those approved for a
corresponding brand-name equivalent, or “reference
listed drug”-it was impossible for them to comply with
any duty under state tort law to redesign the product or to
amend or add to the warnings on its label. See Id.
at 618-19, 624-26; Mut. Pharm. Co. v. Bartlett, 570
U.S. 472, 475-76, 486-88 (2013).
Court agrees. The Supreme Court's decisions in
Mensing and Bartlett control this case, and
they establish that it would be impossible for defendants to
comply with state tort law as well as the FDCA and applicable
regulations, which prohibited them from altering the product
or its label in any way. See Houston v. United
States, No. 14 C 1042, 2015 WL 1840685, at *1 (N.D. Ill.
Apr. 20, 2015) (citing Mensing and
Bartlett) (“Qualitest can only abide by these
state-law duties [to design a reasonably safe product and
warn of its dangerous propensities] if it changes the design
or labeling of [its generic drug] Allopurinol, steps that
federal law prohibits it from taking.”),
aff'd, 638 Fed.Appx. 508 (7th Cir. 2016);
see also Gaeta v. Perrigo Pharm. Co., 562 F.Supp.2d
1091, 1097-98 (N.D. Cal. 2008) (reaching similar outcome
prior to Mensing, reasoning in part that federal law
imposes a strict duty of sameness because