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Moore v. Zydus Pharmaceuticals (USA), Inc.

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

September 29, 2017

CATHY MOORE, Plaintiff,



         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.


         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.]


         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 (2009) (citing Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (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 (quoting Twombly, 550 U.S. at 557). 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). 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 (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.


         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, 131 S.Ct. 2567 (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 (2011). [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. § 355(j)(4)(G). Labeling includes “all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.” 21 U.S.C. § 321(m). This labeling must be “the same as the labeling approved for the [brand-name] drug.” 21 U.S.C. § 355 (j)(2)(A)(v).

         Drugs that have been approved through the NDA process are able to unilaterally strengthen drug warnings without prior approval by the FDA. PLIVA, Inc. v. Mensing, 131 S.Ct. 2567, 2575 (2011). But, ANDA drugs cannot disseminate additional information, update warnings, or directly correspond with healthcare providers concerning enhanced warnings as “[f]ederal law . . . demand[s] that generic drug labels be the same at all times as the corresponding brand-name drug labels.” Id. at 2578. Amiodarone is a generic drug, thus Zydus has a “duty of sameness” and must use identical ingredients and labelling (including warnings) utilized by the brand name drug that is emulated. Mensing, 131 S.Ct. at 2574. In the Mensing decision, the Supreme Court ruled that the plaintiff's state law claims based on liability under failure to warn were pre-empted by federal law when dealing with a generic brand drug manufacturer as the generic drug manufacturer could not change its labelling without violating FDA regulations. Id. at 2575. Preemption, or impossibility preemption, arises when there is a conflict between state and federal law and “it is impossible for a private party to comply with both state and federal requirements.” Mensing, 131 S.Ct. at 2570. The decision in Mensing was applied by the Sixth Circuit case In re Darvocet, Darvon, & Propoxyphene Prod. Liab. Litig., 756 F.3d 917, 925 (6th Cir. 2014).

         In addition to federal pre-emption, Zydus argues that Moore is not provided a private right of action to bring claims on the basis that Zydus allegedly failed in a duty that is solely established and enforced by the FDCA. [R. 30-1 at 13.] The FDCA does not specifically provide a legal avenue for a private party to enforce the provisions; instead, it calls for “all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.” 21 U.S.C. § 337(a). The Supreme Court has interpreted this clause of the statute and found that “[t]he FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance…” See Buckman Co. v. Plaintiff's Legal Comm., 531 U.S. 341, at 349 n.4 (2011).

         Despite the applicability of impossibility preemption in many similar actions, Moore argues that the instant action is not pre-empted by federal law and that the Mensing and Bartlett analysis is distinguishable. [R. 32 at 4.] Namely, Moore believes that the generic manufacturer was capable of “discharg[ing] its obligations under applicable state common law without violating federal law” therefore, impossibility “preemption is inapplicable.” [R. 32 at 4.] Zydus disagrees and argues that the claims brought for failure to warn, design defect, and manufacturing defect should be dismissed as those claims are preempted by federal law. [R. 30 at 8.]


         PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011) clarified that “[f]ederal law impliedly preempts state law when state and federal law “conflict”-i.e., when “it is impossible for a private party to comply with both state and federal law.” Id. at 2587. “[A]fter Mensing and Bartlett, Plaintiffs cannot sue a generic manufacturer on a failure to warn claim or a state law design defect claim that turns on the adequacy of a drug's warnings.” In re Darvocet, Darvon, & Propoxyphene Prod. Liab. Litig., 756 F.3d 917, 925 (6th Cir. 2014). This conclusion was reached, in part, due to the generic manufacturer's “duty of sameness” which does not allow for the generic manufacturer to modify the warnings or information provided to consumers.

         In Mensing, plaintiffs consumed a generic form of metoclopramide and alleged a number of state law claims, but, the Supreme Court determined that state-law tort claims brought against manufacturers of generic drugs are preempted by federal law. PLIVA, Inc. v. Mensing, 131 S.Ct. 2567, 2572 (2011). In addition to preemption of state law tort claims premised on failure-to-warn, the Supreme Court found that, due to the federal statutory scheme, generic manufacturers were not allowed to send letters (“Dear Doctor” letters) to providers concerning the risks associated with the drug or deviate from the FDA approved labeling. Id. at 2576-2581. The Court extended this holding in Mut. Pharm. Co. v. Bartlett, 133 S.Ct. 2466 (2013).

         In Bartlett, the Court “h[e]ld that state-law design-defect claims that turn on the adequacy of a drug's warnings are preempted by federal law under PLIVA.” Id. at 2470. The Bartlett Court explained that where “it was impossible for [the generic drug manufacturer] to comply with both its state-law duty to strengthen the warnings on [the drug]'s label and its federal-law duty not to alter [the drug]'s label . . . the state law is preempted.” Id. at 2473. “Thus, after Mensing and Bartlett, Plaintiffs cannot sue a generic manufacturer on a failure to warn claim or a state law design defect claim that turns on the adequacy of a drug's warnings.” In re Darvocet, Darvon, & Propoxyphene Prod. Liab. Litig., 756 F.3d 917, 925 (6th Cir. 2014).

         Nonetheless, Moore argues that the reasoning in Mensing and Bartlett's is inapplicable because “it would not violate federal law for Zydus to have provided a Medication Guide in conjunction with the prescription.” [R. 32 at 7.] Moore argues that the Medication Guide would have made clear that her use of the drug was “off-use” and that “Zydus failed to comply with federal law when it took no steps to ensure that the Medication Guide made it to her or to other consumers.” [R. 32 at 11.] More specifically, “the allegation is not one of an adequacy or ‘content' failure to warn . . . but an actual and physical negligent failure of Zydus to fulfill its federally-mandated responsibility to ensure that Medication Guides are available for distribution directly to patients with each prescription. [R. 32 at 11.] These accusations, in combination with Moore's resulting blindness, and over thirty pages of additional materials, support Moore's causes of action that allege negligence and gross negligence on behalf of both Defendants Wyeth-Ayerst Laboratories and Zydus Pharmaceuticals. [R. 1 at 30.]

         Ultimately, the claim against Zydus for failure to provide a medication guide is barred by 21 U.S.C. § 337(a). The FDA requires drug manufacturers to issue medication guides to accompany some prescription ...

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