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Greager v. McNEIL PPC, Inc.

United States District Court, N.D. Illinois, Eastern Division

October 28, 2019




         Plaintiff 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.


         Plaintiff 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.”[1] 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 wanton misconduct.

         Perrigo, 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.


         “A 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. 2004).

         “The 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).

         “Preemption 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 impossibility.” Id.

         “[I]n . . . 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. § 355(j)(2)(A)(v).

In re Testosterone Replacement Therapy Prod. Liab. Litig., 142 F.Supp.3d 747, 748 (N.D. Ill. 2015).

         Perrigo 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).

         The 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 ...

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