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Galloway v. Aurobindo Pharma Limited Inc.

United States District Court, D. South Carolina, Greenville Division

May 31, 2018

Jennifer Galloway, Plaintiff,
v.
Aurobindo Pharma Limited Inc. and Aurobindo Pharma U.S.A. Inc., Defendants.

          OPINION AND ORDER

          The Honorable A. Marvin Quattlebaum, Jr. United States District Court Judge

         This matter comes before the Court on Defendants' Aurobindo Pharma Limited Inc. and Aurobindo Pharma U.S.A. Inc. (“Defendants”) Motion to Dismiss Plaintiff Jennifer Galloway's (“Plaintiff”) Complaint pursuant to Federal Rule of Civil Procedure 12(b)(6). Specifically, Defendants contend that all of Plaintiff's state law claims are preempted by federal law. The matter has been fully briefed, and the Court heard arguments on May 3, 2018. For the following reasons, the Court hereby grants Defendants' Motion to Dismiss.

         I. BACKGROUND AND PROCEDURAL POSTURE

         Plaintiff Jennifer Galloway (“Plaintiff”) alleges that she suffered a myocardial infarction on December 13, 2013, as a result of using the generic drug Sumatriptan, an FDA-approved, migraine headache prescription medication manufactured by Defendants. (Compl. ¶¶ Intro., 22-26). Sumatriptan is the generic version of the name brand IMITREX®.

         The Complaint was filed on February 20, 2017 in the Court of Common Pleas in Greenville County, South Carolina against Aurobindo and Bi-Lo, LLC. Plaintiff's claims sound in strict liability, negligence, breach of express and implied warranty, fraud and negligent misrepresentation. Plaintiff voluntarily dismissed Bi-Lo, LLC. (ECF No. 1.1). Defendants then removed the case pursuant to 28 U.S.C. §§ 1332 and 1441, et seq. (ECF No. 1) and filed an Answer (ECF No. 5), specifically asserting the affirmative defense of failure to state a claim pursuant to Fed.R.Civ.P. 12(b)(6) (Ans. ¶¶ 100, 112-115, 132).

         II. STANDARD OF REVIEW

         A court may dismiss a complaint under Fed.R.Civ.P. 12(b)(6) for failure to state a claim if the plaintiff fails to set forth “enough facts to state a claim to relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007); Ashcroft v. Iqbal, 556 U.S. 662, 697 (2009). Unless the complaint pleads sufficient facts to cross the line “from conceivable to plausible, ” it must be dismissed. Twombly, 550 U.S. at 570. The federal pleading standard “demands more than an unadorned, the-defendant-unlawfully-harmed-me accusation.” Iqbal, 556 U.S. at 678. “[L]egal conclusions, elements of a cause of action, and bare assertions devoid of further factual enhancement fail to constitute well-pled facts for Rule 12(b)(6) purposes, ” as do “unwarranted inferences, unreasonable conclusions, or arguments.” Nemet Chevrolet, Ltd. v. Consumeraffairs.com, Inc., 591 F.3d 250, 255 (4th Cir. 2009) (citations omitted).

         Even when a complaint does state a claim for relief, it should be dismissed for failure to state a claim if the allegations in the complaint establish an affirmative defense. Federal preemption is a “pure question of law” and thus may be determined by this Court on a Rule 12(b)(6) motion to dismiss. See Kendall v. Hyundai Motor Co., 2000 WL 34013265, at *2 (D.S.C. Nov. 20, 2000) (quoting Pokorny v. Ford Motor Co., 902 F.2d 1116, 1122 (3d Cir. 1990)); Drager v. PLIVA USA, Inc., 741 F.3d 470, 475-79 (4th Cir. 2014) (affirming judgment on the pleadings on preemption grounds); see also Hensley Mfg., Inc. v. ProPride, Inc., 579 F.3d 603, 613 (6th Cir. 2009) (“[T]here is no reason not to grant a motion to dismiss where the undisputed facts conclusively establish an affirmative defense as a matter of law.”). Dismissal on preemption grounds should be without leave to amend, because amendment would be futile. See GE Investment Private Placement Partners II v. Parker, 247 F.3d 543, 548 (4th Cir. 2001); In re Darvocet, Darvon and Propoxyphene Prods. Liab. Litig., 2012 WL 718618, at *6 (E.D. Ky. Mar. 5, 2012), aff'd, 756 F.3d 917 (6th Cir. 2014) (preemption finding rendered any amendment futile).

         III. DISCUSSION

         Defendant's primary contention[1] is that all of Plaintiff's state law claims for both design and warning defects in a generic drug are preempted by the requirements of the Federal Food, Drug and Cosmetics Act, 21 U.S.C. §§ 301 et seq., (“FDCA”). The argument is twofold. First, Defendants argue state law claims as to warning defects in generic drugs are preempted under PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011). Second, Defendants argue state law claims as to design defects in generic drugs are preempted under Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013). Moreover, Defendants contend the Fourth Circuit has squarely addressed this issue in Drager v. PLIVA USA, Inc., 741 F.3d 470 (4th Cir. 2014). This Court agrees.

         A. Hatch-Waxman

         The Hatch-Waxman amendments of the FDCA, codified at 21 U.S.C. § 355(j), control the production of generic drugs. Drager, 741 F.3d at 475. For a variety of reasons, the FDCA imposes substantially different requirements on the producers of name brand drugs and the producers of their generic counterparts. Id. Generally, producers of generic drugs gain authorization to market their products by demonstrating equivalence to the previously authorized name brand versions in several important ways, including specifically, formulation and labeling. Id. Moreover, generics must maintain equivalence to maintain authorization. Id. (citing 21 U.S.C. § 355(j)).

         B. Mensing, Bartlett and Drager

         The United States Supreme Court has addressed the applicability of Hatch-Waxman to both claims of defective warning and to claims of defective design. First, in Mensing, Justice Thomas, writing for the majority, held that because generic drug producers are not entitled to unilaterally change their labeling, any state law tort premised on such a failure is preempted. 564 U.S. at 618. Similarly, in Bartlett, Justice Alito, writing for the majority, held that because generic drug producers are also barred ...


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