Moore v. Zydus Pharm. (USA), Inc.

• Decision Date: 29 September 2017
• Docket Number: Civil No. 3:16-cv-00017-GFVT
• Citation: 277 F.Supp.3d 873
• Parties: Cathy MOORE, Plaintiff, v. ZYDUS PHARMACEUTICALS (USA), INC., Defendant.
• Court: U.S. District Court — Eastern District of Kentucky

277 F.Supp.3d 873

Cathy MOORE, Plaintiff,

v.ZYDUS PHARMACEUTICALS (USA), INC., Defendant.

Civil No. 3:16-cv-00017-GFVT

United States District Court, E.D. Kentucky, Central Division. Frankfort.

Signed September 29, 2017

Jacob E. Levy, Mark K. Gray, Gray & White, Paul J. Hershberg, Seiller Waterman, LLC, Louisville, KY, for Plaintiff.

Arthur J. Liederman, Nicole M. Battisti, Morrison Mahoney LLP, New York, NY, Quinn M. Hill, Palmer G. Vance, II, Stoll Keenon Ogden, PLLC, Lexington, KY, for Defendant.

MEMORANDUM OPINION & ORDER

Gregory F. Van Tatenhove, United States District Judge

Cathy Moore seeks to recover for alleged harm caused by her use of a generic drug. As explained below, in large measure Moore has no avenue of recovery. This is a function of federal preemption. Hence, the Defendant Zydus Pharmaceuticals' Motion to Dismiss [R. 30 ] is GRANTED in PART and DENIED in PART .

I

Plaintiff Cathy Moore suffered from a medical condition known as atrial fibrillation, for which she was prescribed a 90-day course of 200 milligram amiodarone hydrochloride tablets. [R. 1 at 8.] Amiodarone hydrochloride is a prescription medication created by Wyeth-Ayerst under the brand name Cordarone and distributed as a generic drug by Zydus under the label Amiodarone. [Id. at 6-8.] According to the Federal Drug Administration, amiodarone hydrochloride should be prescribed "for the treatment of only the following documented, life-threatening, recurrent ventricular arrhythmias when these arrhythmias have not responded to other antiarrhythmic agents or when alternative agents have not been tolerated: Recurrent ventricular fibrillation ; Recurrent hemodynamically unstable ventricular tachycardia" because there are "potentially life-threatening side-effects." Fed. Drug Admin., Information for Healthcare Professionals: Amiodarone (marketed as Cordarone ) (2013).¹ Those side-effects include "potentially fatal toxicities, including pulmonary toxicity, hepatic injury, and worsened arrhythmia" as well as nerve injuries and vision problems, amongst many others.² Id. ; [R. 1 at ¶ 33, R. 1 at 11-18.] The FDA requires that any manufacturer or distributer of amiodarone hydrochloride must provide approved labels, warnings, and medication guides to those prescribed the medication. [R. 1 at ¶27.]

Cathy Moore alleges that in November of 2014, she began to experience symptoms of vision impairment following her Amiodarone prescribed treatment. [R. at ¶ 38.] By September of 2012, Ms. Moore's vision troubles had escalated into blindness, with subsequent medical evaluations finding that the cause of her symptoms was amiodarone toxicity. [Id. ] She believes that Wyeth-Ayerst and Zydus, despite knowing of the inherent dangers posed to patients, engaged in an advertising campaign aimed at physicians that was designed to promote the use of Amiodarone for "off-label" treatments or treatments of diseases that were not of a "last resort" in nature. [R. 1 at 4-8.] Moore alleges that "[c]orrection of atrial fibrillation was never an FDA approved use of Cordarone or Amiodarone," thus, she believes that the "off-label" prescription of that drug is the cause of her symptoms. [Id. 8-9.] Moore further alleges that, at the time of her medical treatment, she had not yet received the required medication guide for her prescribed Amiodarone. [Id. at 9.] Had she received this medication guide, Ms. Moore claims she would have been more aware of the "off-label" use and the dangerous side-effects associated with the ingestion of Amiodarone. [Id. at 9-10.]

Moore filed the present diversity action against both Wyeth and Zydus on February 29, 2016. [R. 1.] None of the parties contest the Court's jurisdiction. The complaint contains seven causes of action directed at Zydus: (1) negligence; (2) gross negligence; (3) strict products liability—failure to warn; (4) negligent failure to warn; (5) breach of implied warranty; (6) breach of express warranty; and (7) fraud and deceit (in part, for off-label marketing). In May of 2016, Moore voluntarily dismissed Wyeth-Ayerst, leaving Zydus as the sole defendant. [R. 17.] Zydus filed a Motion to Dismiss [R. 30] and argues that Moore's claims are pre-empted by federal law, or, in the alternative, that her claims are insufficiently pled to satisfy the requirements of a complaint under Federal Rules of Civil Procedure 8 and 9. [R. 30-1.]

II

Federal Rule of Civil Procedure 12(b)(6) allows a defendant to seek dismissal of a complaint which fails to state a claim upon which relief can be granted. Fed. R. Civ. P. 12(b)(6). In making such a motion, "[t]he defendant has the burden of showing that the plaintiff has failed to state a claim for relief." DirecTV, Inc. v. Treesh , 487 F.3d 471, 476 (6th Cir. 2007) (citing Carver v. Bunch , 946 F.2d 451, 454-55 (6th Cir. 1991) ). Federal Rule of Civil Procedure 8 requires only "a short and plain statement of the claim showing that the pleader is entitled to relief." Fed. R. Civ. P. 8(a)(2). However, to survive a motion to dismiss, the complaint "must contain either direct or inferential allegations" establishing each material element required for recovery under some actionable legal theory. Bishop v. Lucent Technologies, Inc. , 520 F.3d 516, 519 (6th Cir. 2008) (internal citation and quotation marks omitted).

When reviewing a Rule 12(b)(6) motion, the Court "construe[s] the complaint in the light most favorable to the plaintiff, accept[s] its allegations as true, and draw[s] all reasonable inferences in favor of the plaintiff." DirecTV, Inc. , 487 F.3d at 476 (citation omitted). The Court, however, "need not accept as true legal conclusions or unwarranted factual inferences." Id. (citation omitted). Moreover, as is now well known, "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, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (citing Bell Atlantic Corp. v. Twombly , 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007) ). In other words, the facts that are pled must rise to the level of plausibility, not just possibility—"facts that are merely consistent with a defendant's liability ... stop[ ] short of the line between possibility and plausibility." Iqbal , 556 U.S. at 678, 129 S.Ct. 1937 (quoting Twombly , 550 U.S. at 557, 127 S.Ct. 1955 ). According to the Sixth Circuit, "[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." DirecTV, Inc. , 487 F.3d at 476 (citing Twombly , 550 U.S. at 556, 127 S.Ct. 1955 ). Thus, the plaintiff must at least "provide the grounds of his entitlement to relief, [which] requires more than labels and conclusions...." Twombly , 550 U.S. at 555, 127 S.Ct. 1955 (internal citations and quotation marks omitted).

When ruling on a Rule 12(b)(6) motion, a district court generally may not consider matters presented outside the pleadings unless it converts the motion into one for summary judgment under Rule 56. Fed. R. Civ. P. 12(d) ; Heinrich v. Waiting Angels Adoption Servs., Inc. , 668 F.3d 393, 405 (6th Cir. 2012). The district court, however, also has the discretion to ignore such evidence and resolve the motion solely on the basis of the pleadings. Heinrich , 668 F.3d at 405 ; Max Arnold & Sons, LLC v. W.L. Hailey & Co., Inc. , 452 F.3d 494, 502-03 (6th Cir. 2006) (collecting cases). Certain matters beyond the allegations in the complaint such as "matters of public record, orders, items appearing in the record of the case, and exhibits attached to the complaint, also may be taken into account." Amini v. Oberlin College , 259 F.3d 493, 502 (6th Cir. 2001) (citations and internal quotation marks omitted). Additionally, the Sixth Circuit has held that when a defendant attaches undisputed documents to a motion to dismiss, they "are considered part of the pleadings if they are referred to in the plaintiff's complaint and are central to her claim." Id. (citations and internal quotation marks omitted). In the instant action, all documents considered by the court were either matters of public record, orders, or items appearing in the record of the case, therefore the court will not convert the motion into one for summary judgment.

A

Zydus argues that "[Moore's] causes of action based on the adequacy of the product warnings under state law is preempted by federal law," based upon their reading of the decision in PLIVA, Inc. v. Mensing , 564 U.S. 604, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011). [R. 30-1 at 1-2.] Zydus further argues that Moore is not afforded a private right of action by the Food, Drug, and Cosmetics Act (FDCA) or Food and Drug Administration (FDA) regulations, citing to the decision in Buckman Co. v. Plaintiff's Legal Comm. , 531 U.S. 341, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). [ Id. ] To understand the arguments presented by Zydus, a brief explanation of the framework established by the FDCA and FDA regulations will be helpful.

Under the FDCA, the FDA provides approval and makes regulations regarding the manufacture and prescription of drugs by brand name and generic producers. See 21 C.F.R. § 314.50(c)(2)(i) ; 21 C.F.R. § 314.94(a)(8). Drug companies that bring a new product to market are required to file a New Drug Application ("NDA") with the Food and Drug Administration to market their drug. See 21 U.S.C. § 355(j)(2)(A). New Drug Applications require costly and time intensive clinical trials. In contrast, generic drugs receive accelerated approval by the FDA through the submission of an Abbreviated New Drug Application ("ANDA") that only requires the generic manufacturers to provide proof that their product is identical in both composition and labelling to a previously approved brand name drug and to maintain the labelling pursuant to the requirements imposed on the brand name drug by the FDA. 21 U.S.C. § 355(j)(2)(A) ; 21 U.S.C....