United States District Court, D. South Carolina, Greenville Division
OPINION AND ORDER
Honorable A. Marvin Quattlebaum, Jr. United States District
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.
BACKGROUND AND PROCEDURAL POSTURE
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
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).
STANDARD OF REVIEW
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,
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).
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).
primary contention 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.
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. §
Mensing, Bartlett and
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 ...