Moore v. Wyeth-Ayerst Laboratories, Inc. et al

Filing 37

MEMORANDUM OPINION & ORDER: 1. Zydus's Motion to Dismiss for failure to state a claim 30 is GRANTED in PART and DENIED in PART; 2. Zydus's Motion to Dismiss 30 is GRANTED as to Claims One through Six but DENIED as to the Seventh Cla im; 3. Moore's Motion for Leave to File an Amended Complaint [R. 32 at 17] is GRANTED. The Amended Complaint should be limited to the Seventh Claim only; and 4. Moore shall have thirty (30) days from the date of this Order by which to file an Amended Complaint in the record. Signed by Judge Gregory F. VanTatenhove on 9/29/2017.(CBD)cc: COR

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF KENTUCKY
CENTRAL DIVISION
FRANKFORT
CATHY MOORE,

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

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

MEMORANDUM OPINION
&
ORDER

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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, lifethreatening, recurrent ventricular arrhythmias when these arrhythmias have not responded to
other antiarrhythmic agents or when alternative agents have not been tolerated: Recurrent
1

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

1

<https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInf
ormationforHeathcareProfessionals/ucm084108.htm>
2
For a full list of side-effects, see ZyGenerics Medication Guide Amiodarone Hydrochloride Tables.
<http://www.zydususa.com/wp-content/plugins/products/MedicationGuide/Amiodarone%20HCl%20Tablets.pdf>

2

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

3

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

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(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, 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

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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).

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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.]
B
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, &

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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-towarn, 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

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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 medications when the agency determines that certain
circumstances are met:
(1) The drug product is one for which patient labeling could help prevent serious adverse
effects. (2) The drug product is one that has serious risk(s) (relative to benefits) of which
patients should be made aware because information concerning the risk(s) could affect
patients’ decision to use, or to continue to use, the product. (3) The drug product is
important to health and patient adherence to directions for use is crucial to drug’s
effectiveness.
21 C.F.R. § 208.1. In December 2004, the FDA determined that Cordarone must be
accompanied by a medication guide. Producers of generic bioequivalent drugs, such as Zydus,
have a duty of “sameness,” therefore Zydus must distribute the same medication guide. [R. 1 at
¶28; R. 30-1 at 7.]
Zydus, the manufacturer of such drugs, must either provide “Medication Guides in
sufficient numbers to distributors, packers, or authorized dispensers to permit the authorized
dispenser to provide a Medication Guide to each patient receiving a prescription for the drug
product” or provide “the means to produce Medication Guides in sufficient numbers to
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distributors, packers, or authorized dispensers to permit the authorized dispenser to provide a
Medication Guide to each patient receiving a prescription for the drug product.” 21 C.F.R. §
208.24. But, at the time a prescription drug is dispensed, it is the pharmacy (or authorized
dispenser) that must “provide a Medication Guide directly to each patient,” not the manufacturer
of the drug. 21 C.F.R. § 208.24(e).
Ms. Moore’s allegations state that she “was not provided the Medication Guide,” [R. 1 at
9], and that manufacturers have a “non-delegable” duty to ensure the consumer receives a
medication guide. [R. 1 at 11.] Importantly, in one numbered paragraph, Moore also asserted
that, “[a]ccording to the Pharmacies, no manufacturer is providing them or the patient’s [sic]
medication guides.” [R. 1 ¶ 115.] While this would be a violation of the manufacturer’s legal
duty, Zydus’ obligation to provide a medication guide arises solely from responsibility imposed
by the FDCA. See 21 C.F.R. § 208.24. Taken as true, Zydus may not have physically given
Medication Guides to the authorized dispensers but the complaint fails to address whether Zydus
provided pharmacies with “the means to produce Medication Guides” and Moore’s briefing
neglected to contemplate whether the online Medication Guide and resources, discussed supra
section “I,” satisfy Zydus’s lawful obligation. 21 C.F.R. § 208.24(c).
Even so, the Supreme Court made clear that it must be the Federal Government, not
private litigants, that bring suit for violation of the FDCA. See Buckman Co. v. Plaintiff’s Legal
Comm., 531 U.S. 341, at 349 n.4 (2011) (stating 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 also Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 586 (6th Cir. 2013) (finding
“[w]here the claim is based on traditional state-tort-law principles, the lack of a private cause of
action within a federal regulatory scheme will not preempt the claim for damages (even if state

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regulations might be preempted)” but that “if the claims ‘exist solely by virtue of’ the regulatory
scheme, they are preempted.”). Since Ms. Moore’s claim concerning receipt of the medication
guide exists exclusively due to the federal regulatory scheme, her claim must fail as the cause of
action is merely based upon alleged violation of the FDCA and it is the FDA, not Ms. Moore,
that “has at its disposal a variety of enforcement options that allow it to make a measured
response to suspected fraud upon the Administration.” 3 Buckman Co. v. Plaintiffs' Legal Comm.,
531 U.S. 341, 349 (2001).
Further, concerning receipt of the medication guide by Moore, Kentucky has adopted the
Restatement (Third) of Torts: Products liability § 6(d), or “learned intermediary doctrine.” The
learned intermediary doctrine establishes an exception to the manufacturer’s duty to warn and
allows for that duty to be satisfied “if adequate warning [is] given to [the] patient’s health care
provider.” Larkin v. Pfizer, Inc., 153 S.W.3d 758, 770 (Ky. 2004). The briefing did not
extensively discuss this doctrine and Moore failed to respond to Zydus’s argument that this
exception would apply if the Court determined that the duty was not preempted. But, since the
Court’s ruling in favor of Zydus concerning provision of the Medication Guide rests on
preemption, the merits of Zydus’s argument concerning the learned intermediary doctrine need
not be addressed.
C
Besides distribution of a Medication Guide, Moore asserts negligence and gross
negligence against Zydus. [R. 1 at 30.] In Kentucky, to establish negligence, a plaintiff must
demonstrate the existence of a duty, breach thereof, and consequent injury, which includes

3

Moore’s complaint even recognizes that this claim is based upon FDA regulations. In the paragraph concerning the
cause of action accruing due to gross negligence the complaint states: “[d]espite the FDA requirements that the drug
companies provide the patients medication guide with FDA written material with their Amiodarone prescription, no
medication guide was provided to Cathy Moore…” [R. 1 at ¶ 113.]

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“actual injury or harm to the plaintiff and legal causation between the defendant’s breach and the
plaintiff’s injury.” Pathways, Inc. v. Hammons, 113 S.W.3d 85, 88 (Ky. 2003); Mullins v.
Commonwealth Life Insurance Company, 839 S.W.2d 245, 247 (Ky.1992). Establishing
gross negligence requires “something more than the failure to exercise slight care.” City of
Middlesboro v. Brown, 63 S.W.3d 179, 181 (Ky. 2001) (quoting Cooper v. Barth, Ky., 464
S.W.2d 233, 234 (Ky. 1971)). In fact, “there must be an element either of malice or
willfulness.” Id. More recently, the Kentucky Supreme Court has defined “gross negligence,” in
the context of punitive damages, as requiring a “finding of failure to exercise reasonable care,
and then an additional finding that this negligence was accompanied by wanton or reckless
disregard for the lives, safety or property of others.” City of Middlesboro, 63 S.W.3d at
181 (citing Horton v. Union Light, Heat & Power Co., 690 S.W.2d 382, 389-90 (Ky. 1985)).
Examining the complaint in its entirety, to the best of the Court’s understanding, Moore
alleges that Zydus was negligent in the following ways: “[Zydus] . . . [sought to] increase
Amiodarone sales as an initial, first-line anti-arrhythmic medication, for which Amiodarone has
never received FDA approval, i.e., an “off-label” use”. [R. 1, ¶14.] “[Zydus made a decision to]
actively conceal the illegal means that would be used to market the drug.” [R. 1, ¶17.] “Cathy
Moore was not provided the Medication Guide or the appropriate and up to date warning labels
that were required to be given to Cathy Moore…” [R. 1, ¶32.] “[Distribution of the Medication
Guide is a] “non-delegable” duty, and one that cannot be accomplished by other means.” [R. 1,
¶37.] “[Zydus] . . . had actual or constructive knowledge that [] Amiodarone cause[s] and
contribute[s] to severe and disabling medical conditions and death, such as those experienced by
Cathy Moore…” [R. 1, ¶65.] “[Zydus was] on notice of numerous instances of catastrophic
injuries caused by ingestion of Cordarone®/Amiodarone. [R. 1, ¶70; see also, R.1, ¶71.]

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Further, Moore’s complaint stated that: “Zydus . . . actively promoted their generic
Amiodarone in the stream of commerce for the “off-label” uses openly promoted by Defendant
Wyeth.” [R. 1, ¶73.] “[D]espite FDA warnings and thousands of adverse patient experiences,
[Zydus] continued their fraudulent marketing, promotional, and sales practices from 1999
through the present date.” [R. 1, ¶75.] “[Zydus] . . . concealed information about catastrophic
injuries and death, and thousands of serious adverse medical events.” [R. 1, ¶76.] “Amiodarone
manufactured and/or supplied by [Zydus] was and is unaccompanied by proper warnings” [R. 1,
¶77.] “[Zydus] failed to warn of material facts regarding the safety and efficacy of
Cordarone®/Amiodarone.” [R. 1, ¶78.] “Amiodarone manufactured, distributed, and/or supplied
by [Zydus] was defective due to inadequate post-marketing warning and instruction…” [R. 1,
¶81.] “[Zydus] . . . concealed this adverse event information, [and] simultaneously engaged in a
massive and fraudulent marketing and promotional scheme.” [R. 1, ¶82.] “[Zydus] . . . also
promoted Cordarone®/Amiodarone for heart conditions less severe than life-threatening
ventricular arrhythmia.” [R. 1, ¶83.] “[T]he warnings for []Amiodarone in effect during the
relevant time period were vague, incomplete, and/or otherwise wholly inadequate…” [R. 1, ¶88.]
“The injury of Cathy Moore was directly and proximately caused by the negligent actions of the
[Zydus]…” [R. 1, ¶109.] “Despite the FDA requirements that the drug companies provide the
patients medication . . . no medication guide was provided to Cathy Moore. [R. 1, ¶113.] Finally,
“[Zydus is] guilty of gross negligence for failure to provide the FDA required medication guide.”
[R. 1, ¶116.]
Moore included allegations, as discussed supra section “B”, that neither she nor
pharmacies received a medication guide. [Id. at ¶115-16.] Many of the remaining allegations
either accuse Wyeth of rampant misconduct or Zydus of failure to properly warn of

13

Amiodarone’s various side effects, but any cause of action brought against Zydus for negligence
grounded in failure to warn is preempted by federal law. PLIVA, Inc. v. Mensing, 131 S.Ct.
2567, 2575 (2011); [See R. 1, ¶¶32, 77, 78, 81, 88.]
It is difficult to determine which Defendant is accused of illicit behavior, as the
Complaint combines discussion of misconduct by “Defendants” rather than addressing the
singular conduct of Zydus or Wyeth. But, Moore supports her state law negligence claim by
drawing the Court’s attention to the allegation that Zydus improperly promoted off-label use of
amiodarone for atrial fibrillation and “the more general failure to provide any warning associated
within the placement of a hazardous product into commerce.” [R. 32 at 4.] Moore argues that
both Kentucky common law and the Kentucky Product Liability Act, Ky. Rev. Stat. 411.300 et
seq., provide viable state law claims. Id.
In response, Zydus argues that Moore’s negligence claims are solely premised on
violation of federal law and the standards established by the FDCA. [R. 30-1 at 16-17.] [R. 32
at 4 (citing Ky. Rev. Stat. 411.300 et seq.] Zydus cites to a fellow district court in the Western
District of Kentucky. [R. 30-1 at 16.] In discussing negligence per se, the District Court
determined that Kentucky law mandated that negligence per se claims be brought under KRS §
446.070, “which codified the common law negligence per se tort” and that “[t]he Kentucky
Supreme Court determined that the General Assembly did not intend KRS § 446.070 ‘to embrace
the whole of federal laws and the laws of other states and thereby confer a private civil remedy
for such a vast array of violations.” Sadler v. Advanced Bionics, Inc., 929 F. Supp. 2d 670, 681
(W.D. Ky. 2013) (citing T & M Jewelry, Inc. v. Hicks ex rel. Hicks, 189 S.W.3d 526, 530
(Ky.2006) (finding that “any statute in KRS 446.070 has been held to be limited to Kentucky
statutes and not to federal statutes or local ordinances.”). The district court concluded, and this

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Court agrees, “violations of federal law do not support negligence per se claims under Kentucky
law.” Sadler, 929 F. Supp. 2d at 681 (citing St. Luke Hosp. Inc., v. Straub, 354 S.W.3d 529, 534
(Ky. 2011) (holding that “[v]iolations of federal laws and regulations and the laws of other states
do not create cause of action based on KRS 446.070.”); Cf. Fulgenzi v. PLIVA, Inc., 711 F.3d
578, 588 (6th Cir. 2013) (recognizing that “courts have found that, as long as authorized by
state law, negligence per se suits premised on violation of federal law could go forward”)
(emphasis added)).
The Kentucky Supreme Court’s holding in T & M Jewelry, Inc. v. Hicks ex rel. Hicks,
189 S.W.3d 526, 530 (Ky.2006) offers binding and unequivocal precedent concerning the scope
of KRS 446.070 and demonstrates that Moore does not have a state based right to sue for
negligence in this matter. Other authority also requires dismissal, pursuant to Federal Rule of
Civil Procedure 12(b)(6), of the first and second cause of action for negligence and gross
negligence. Ms. Moore alleges that she was harmed by Zydus’s “manufacture, marketing,
distribution[,] and sale of” Amiodarone. [R. 1 at 30.] But, importantly, the “duty of sameness”
prevents Zydus, the generic producer of Amiodarone, from altering any warnings, labeling, or
the composition of the generic drug from that of the listed drug. Mut. Pharm. Co. v. Bartlett, 133
S. Ct. 2466, 2475 (2013) (stating that “the FDCA requires a generic drug to have the same active
ingredients, route of administration, dosage form, strength, and labeling as the brand-name drug
on which it is based”).
Moore cites to a number of unpublished district court cases to suggest that Moore’s
various causes of action are not preempted and that she has presented a claim for relief that
satisfies the burdens imposed by the federal pleading standard. Most of the cases are merely
persuasive authority and distinguishable. For instance, to support Moore’s claim for negligence

15

per se for failure to provide the Medication Guide, Moore cites to Marvin v. Zydus
Pharmaceuticals, Inc., WDWI-15-cv-748-bbc, a case from the Western District of Wisconsin.
[R. 32 at 16-17.] The district court determined that § 337(a) did not prohibit the plaintiff from
bringing a claim for negligence per se (for failing to provide a medication guide) because the
claim was not preempted under Buckman and the allegation “meets the requirements for
negligence per se claims under Wisconsin law.” [R. 32-8 at 4-5.] In Kentucky this matter is
distinguishable. Under Kentucky law and the Kentucky Supreme Court’s analysis of KRS
446.070, which codifies the doctrine of negligence per se, the Court found that the statute “did
not intend for KRS 446.070 to . .. confer a private civil remedy for” violations of federal law. T
& M Jewelry, Inc. v. Hicks ex rel. Hicks, 189 S.W.3d 526, 530 (Ky.2006).
Significantly, Moore has not alleged that the generic drug was defectively manufactured
or that Zydus failed to adhere to the formula that was previously approved by the FDA. Rather,
the complaint primarily addresses the effectiveness of warnings, various side-effects, and
Moore’s use of the generic drug itself. Accordingly, Moore fails to “state a claim to relief that is
plausible on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). The facts that are pled
failed to rise to the level of plausibility, as Moore’s claims are preempted and cannot succeed as
a matter of law. See, e.g., Strayhorn v. Wyeth Pharmaceuticals, Inc., 737 F.3d 378, 391 (6th Cir.
2013) (recognizing that the Courts of Appeals “have interpreted Mensing to broadly preempt
claims that are, at their core, claims that the generic manufacturer failed to provide additional
warnings beyond that which was required by federal law of the brand-name manufacturers”);
Bell v. Pfizer, 716 F.3d 1087 (8th Cir. 2013) (remanding a case for further consideration of
design-defect and breach of implied warranty but determining that the “vast majority” of
Plaintiff’s allegations were “preempted failure to warn claims”); Gaeta v. Perrigo Pharm. Co.,

16

469 Fed. Appx. 556 (9th Cir. 2012), aff’g 562 F.Supp.2d 1091 (N.D. Cal. 2008). Moore’s
allegations of negligence and gross negligence are mere “labels and conclusions” and do not
provide the grounds for Ms. Moore’s entitlement to relief on these claims. Twombly, 550 U.S. at
556. For these reasons, the first two counts of Moore’s Complaint will be dismissed.
D
Moore also brings claims under strict products liability for failure to warn and negligent
failure to warn. [R. 1 at 31-35.] The traditional failure to warn claim under products liability
involves a dereliction of duty in which a manufacturer or producer knows, or has reason to know,
that their product presents unreasonable risks of injury to a user but fails to warn said users of the
inherent dangers. See Restatement (Third) of Torts: Proc. Liab. § 2 (1998); 13 Ky. Prac. Tort
Law § 13:8 (2016 ed.). Specifically, Moore alleges “[Zydus] knew or should have known of the
defective condition, characteristics, and risks associated with” Amiodarone and that “[Zydus]
consciously disregarded this increased risk of harm by failing to warn of such risks…” [R. 1 at
32.]
In Moore’s Response, she argues that her claims are viable under Kentucky common law
“and consistent with Kentucky’s Product Liability Act, Ky. Rev. Stat. 411.300 et seq.” [R. 32 at
4.] However, the Sixth Circuit held in Smith v. Wyeth, Inc., 657 F.3d 420, 423 (6th Cir. 2011),
that following PLIVA v. Mensing, 131 S.Ct. 2567 (2011), “federal law preempts state law that
imposes on generic-drug manufacturers the duty to change a drug’s label, thus barring the
plaintiffs’ state-law tort claims.” Smith v. Wyeth, Inc., 657 F.3d 420, 423 (6th Cir. 2011). While
“[t]he [Products Liability Act] applies to all damage claims arising from the use of products,
regardless of the legal theory advanced,” Monsanto Co. v. Reed, 950 S.W.2d 811, 814
(Ky.1997), the Moore’s cause of action is, at its core, attacking the adequacy of the warnings

17

provided by Zydus.
For example, in the complaint’s discussion of strict products liability for failure to warn,
Moore claims that “[t]he warnings and directions provided with Amiodarone by [Zydus] failed
adequately to warn of the potential risks and side effects of Amiodarone and the dangerous
propensities of said medication,” and “Wyeth, as the brand-name manufacturer, designer and
marketer of Amiodarone, owed a duty of care to Moore and other consumers of Amiodarone, to
ensure they receive proper warnings.” [R. 1 at ¶¶ 122-123.]
Consistent with Supreme Court and Sixth Circuit precedent, Moore’s claims for failure to
warn pursuant to strict products liability and negligent failure to warn are preempted. See
Strayhorn v. Wyeth Pharmaceuticals, Inc., 737 F.3d 378, 391 (6th Cir. 2013) (recognizing that
the Courts of Appeals “have interpreted Mensing to broadly preempt claims that are, at their
core, claims that the generic manufacturer failed to provide additional warnings beyond that
which was required by federal law of the brand-name manufacturers”); Schrock v. Wyeth Inc.,
727 F.3d 1273, 1287-90 (10th Cir. 2013).
E
Moore alleges that the Zydus breached both an implied and express warranty, as Zydus
impliedly and expressly warranted that the generic medication was safe for its intended use. [R.
1 at 35-36.] More specifically, Moore claims that Zydus “impliedly warranted that Amiodarone .
. . was fit for the particular purposes for which it was intended and was sold” and that “[Zydus]
breached their written warranties applicable to Amiodarone by continuing their sales and
marketing campaigns . . . while they knew of the defects and risks associates with the off label
use of such products…” Id. The Sixth Circuit case Strayhorn v. Wyeth Pharmaceuticals
established that claims of breach of implied or express warranty, when dealing with the

18

inadequacy of labels or warnings included with drugs approved by the FDA and governed by the
FDCA, are pre-empted by federal law in these circumstances. See Strayhorn v. Wyeth
Pharmaceuticals, 737 F.3d 378, 395-96 (6th Cir. 2013).
In Strayhorn, the Defendant producer of a generic metoclopramide argued that the
Plaintiffs’ claims were preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), 21
U.S.C. §§ 301 et seq., and the United States Supreme Court decision PLIVA, Inc. v. Mensing,
131 S.Ct. 2567 (2011). Strayhorn, 737 F.3d at 383-86. The Sixth Circuit Court of Appeals
agreed and, in considering claims that arose under Tennessee law, noted that:
Our conclusion is consistent with this court's previous decision in Smith v. Wyeth, Inc.,
657 F.3d 420 (6th Cir.2011), cert. denied, ––– U.S. ––––, 132 S.Ct. 2103, 182 L.Ed.2d
868 (2012), which affirmed the district court's determination that the plaintiffs' state-law
claims—centering on a failure to warn under Kentucky law that included claims for
breach of implied warranty—were preempted. We further note that Kentucky's impliedwarranty regime is substantially the same as that of Tennessee. Compare Ky.Rev.Stat. §
355.2–314 with Tenn.Code Ann. § 47–2–314. To not find preemption in the present case
would require us to disregard this court's binding precedent.
Strayhorn v. Wyeth Pharm., Inc., 737 F.3d 378, 396 (6th Cir. 2013). As in Strayhorn, Ms.
Moore’s cause of action based upon breach of implied warranty essentially “boil[s] down to the
failure to give additional warnings.” Id. at 395 (holding that “[t]he plaintiffs' implied-warranty
claims under Tenn.Code Ann. § 47–2–314 fare no better because they are entirely premised on a
failure-to-warn theory”). Consistent with the Sixth Circuit’s holding, Ms. Moore’s impliedwarranty claim fails as preempted and must be dismissed. “In particular, the plaintiff[] do[es]
not allege that the generic [Aniodarone she] took was ineffective for treating the [heart
condition] for which it was prescribed; only that it was unsafe when used long-term [and offlabel] because of the drug’s dangerous side effects,” but “such implied-warranty claims are
preempted by both Mensing and Bartlett.” Strayhorn v. Wyeth Pharm., Inc., 737 F.3d 378, 396
(6th Cir. 2013)
19

Express warranties are made in Kentucky, pursuant to Kentucky Revised Statute § 355.2313, by:
(a) Any affirmation of fact or promise made by the seller to the buyer which relates to the
goods and becomes part of the basis of the bargain creates an express warranty that the
goods shall conform to the affirmation or promise.
(b) Any description of the goods which is made part of the basis of the bargain creates an
express warranty that the goods shall conform to the description.
(c) Any sample or model which is made part of the basis of the bargain creates an express
warranty that the whole of the goods shall conform to the sample or model.
(2) It is not necessary to the creation of an express warranty that the seller use formal
words such as “warrant” or “guarantee” or that he have a specific intention to make a
warranty, but an affirmation merely of the value of the goods or a statement purporting to
be merely the seller's opinion or commendation of the goods does not create a warranty.
Ky. Rev. Stat. Ann. § 355.2-313. In the context of reviewing the appropriateness of jury
instructions that were provided by a district court, the Sixth Circuit contemplated this Kentucky
statute and the process by which an express warranty may be created. Overstreet v. Norden
Labs., Inc., 669 F.2d 1286, 1290 (6th Cir. 1982). The Court of Appeals held that “[t]he mere
existence of a warranty is insufficient to sustain an action for breach of an express warranty. The
warranty must be ‘part of the basis of the bargain’ between the parties.” Id. at 1291 (citing Ky.
Rev. Stat. Ann. § 355-2313(1) (a), Comment 1(C)).
Ms. Moore bases her express warranty cause of action on statements made “[by]
authorized agents or sales representatives, in publications, package inserts, the internet, and other
communications intended for physicians, patients, [Ms. Moore], and the general public. [R. 1 at
35-36.] The Complaint does not provide specific examples of any warranties made by Zydus.
Presumably, Moore relied upon statements contained in the Medication Guide itself. Yet, seeing
that Moore repeatedly states that she did not receive a Medication Guide, the statements
contained therein cannot be considered an express warranty by Zydus. Ms. Moore could not
contemplate information she had not received as the “basis of the bargain” that was made
20

between herself and Zydus. Overstreet, 669 F.2d at 1291.
Moore’s use of Amiodarone for atrial fibrillation was “off-label.” [R. 1 at 8-9.] Despite
her alleged reliance, the “express-warranty claims are without merit because the labels never
explicitly warranted that [Amiodarone] was safe for” the treatment of atrial fibrillation.
Strayhorn v. Wyeth Pharm., Inc., 737 F.3d 378, 395 (6th Cir. 2013); [R. 30-1 at 13.] Just as in
Strayhorn, Ms. Moore has not alleged that Zydus warranted that Amiodarone was safe for her
off-label use of the drug. Instead, she claims that Zydus expressly warranted that the drug was
“safe, effective, fit[,] and proper for its intended use.” [R. 1 at 36.] Further, healthcare
professionals relied on the express warranties of Zydus in prescribing this medicine to Moore.
Id. But, Zydus is unable to unilaterally change, modify, alter, or enhance any warnings or
warranties provided with the generic drug due to the continual federal “duty of sameness.” Mut.
Pharm. Co. v. Bartlett, 133 S. Ct. 2466, 2475 (2013) (stating that “the FDCA requires a generic
drug to have the same active ingredients, route of administration, dosage form, strength, and
labeling as the brand-name drug on which it is based”).
Moore’s express warranty claim is essentially a preempted failure to warn claim that
argues the warnings provided by Zydus with Amiodarone were inadequate. Zydus was not at
liberty to provide altered warnings or warranties. “When a generic manufacturer cannot obey
federal law without being held liable under a state-law warranty action, the state action is
preempted.” Strayhorn v. Wyeth Pharm., Inc., 737 F.3d 378, 396 (6th Cir. 2013) (citing PLIVA,
Inc. v. Mensing, 131 S.Ct. 2567, 2577 (2011)). Once again, Moore’s causes of action based
upon the breach of express and implied warranty will be dismissed for failure to state a claim.
Fed. R. Civ. P. 12(b)(6).

21

F
Now, the Court must turn to the Moore’s seventh cause of action for fraud, deceit, and
off-label marketing. Moore believes that Zydus engaged in or benefitted from marketing
schemes designed to promote off-label uses of Amiodarone and that the Defendants, collectively,
engaged in this aggressive campaign to promote the use of Amiodarone for unapproved purposes
in order to realize larger profits. [R. 1 at ¶14-20, ¶27, ¶39-64.] Beyond marketing the generic
drug, Moore asserts that both Zydus and Wyeth actively deceived medical professionals and
patients by concealing material facts concerning the drug’s dangerous side effects. In 21 U.S.C.
§ 331(d), the FDCA prohibits drug manufacturers from either directly or indirectly promoting or
marketing their products for uses other than those that have received approval from the FDA.
Since Wyeth received FDA approval for specific uses of Cordarone and Zydus cannot deviate in
any way in the manufacturing of Amiodarone, it follows that Zydus cannot promote or market
their generic brand for off-label purposes.
Zydus makes two arguments in opposition. First, Zydus moves to dismiss the complaint
as “[Moore] has failed to cite any Kentucky or Sixth Circuit decisional law that would create a
unique Kentucky substantive cause of action grounded in an allegation of off-label promotion...”
[R. 36 at 5.] Second, Zydus argues that the complaint has inadequately pled a cause of action
pursuant to Federal Rule of Civil Procedure 9(b).
Federal Rule of Civil Procedure 9(b) requires, “[i]n alleging fraud or mistake, a party
must state with particularity the circumstances constituting fraud or mistake. Malice, intent,
knowledge, and other conditions of a person's mind may be alleged generally.” Fed. R. Civ. P.
9. Courts have read Rule 9(b) to require the complaint to convey “(1) the time, place, and
content of the alleged misrepresentation, (2) the fraudulent scheme, (3) the defendants' fraudulent

22

intent, and (4) the resulting injury.” United States v. Villaspring Health Care Ctr., Inc., 2011
WL 6337455 (E.D. KY. Dec. 19, 2011) (citing Chesbrough v. VPA, P. C., 655 F.3d 461, 467
(6th Cir. 2011) (internal quotation marks omitted); Sanderson v. HCA-The Healthcare Co., 447
F.3d 873, 877 (6th Cir. 2006) (“[A]t a minimum, Rule 9(b) requires that the plaintiff specify the
‘who, what, when, where, and how’ of the alleged fraud.”) (quoting United States ex rel.
Thompson v. Columbia/HCA Healthcare Corp., 125 F.3d 899, 903 (5th Cir. 1997)). “When
deciding a motion to dismiss under Rule 9(b) for failure to plead fraud with particularity, a court
must also consider the policy favoring simplicity in pleading, codified in the ‘short and plain
statement of the claim’ requirement of Federal Rule of Civil Procedure 8.” Sanderson v. HCA–
The Healthcare Co., 447 F.3d 873, 876 (6th Cir.2006). At the same time, “a district court need
not accept claims that consist of no more than mere assertions and unsupported or unsupportable
conclusions.” Sanderson, 447 F.3d at 876 (citing Kottmyer v. Maas, 436 F.3d 684, 688 (6th
Cir.2006)).
The majority of the complaint fails to specify actions undertaken by Zydus and instead
conflates accusations of wrongdoing against the two originally named “Defendants.” Instead of
providing specific details concerning when the wrongful conduct took place, the Complaint
alleges that the “Defendants’ scheme in the past involved and continues to involve a calculated
and deceitful sales campaign…” [R. 1, ¶9.] Some specific accusations were made in the
Complaint (for example, R. 1, ¶59 states that Wyeth’s “pharmaceutical sales and marketing
directors encouraged their respective sales representatives to visit physicians’ offices” to
promote off-label use), but the complaint unsuccessfully provides a foundation for the “who,
what, when, where, and how” of the alleged fraud as to Zydus. See Sanderson v. HCA-The
Healthcare Co., 447 F.3d 873, 877 (6th Cir. 2006); [see also R. 30-1 at 24 (“[P]laintiff has failed

23

to identify one specific instance of Zydus’ alleged off-label promotion of amiodarone. In
contrast, Moore notably provided over half a dozen specific examples of Wyeth’s alleged
wrongful and fraudulent marketing (Compl. ¶¶ 27, 41, 45, 48, 54, 59, 62)”.)]
Moore argues, generally, that state common law provides a cause of action that has not
been preempted by federal law. [R. 32 at 4.] Also, Moore brings an alternative argument and
requests the Court’s leave to amend her pleadings so that she may provide adequate specificity.
Id. Amendments to pleadings are governed by Federal Rule of Civil Procedure 15, which
provides that even if the party does not seek the amendment within the of-right period, the court
may give leave to permit such an amendment and should “freely give leave when justice so
requires.” Fed. R. Civ. P. 15(a)(2). The United States Supreme Court has read this provision
broadly and the Sixth Circuit has recognized that “where the underlying facts would support, a
motion for leave to amend should be granted, except in cases of undue delay, undue prejudice to
the opposing party, bad faith, dilatory motive, repeated failure to cure deficiencies by
amendments previously allowed, or futility.” Duggins v. Steak’n Shake, Inc., 195 F.3d 828 (6th
Cir. 1999) (citing Foman v. Davis, 371 U.S. 178 (1962)).
At this stage, it is unclear whether providing Moore with an opportunity to amend her
complaint would be futile. Adequate specificity concerning fraud, deceit, or off-label marketing
as to Zydus may provide Moore with a cognizable right to recovery if her claims are supported
by state law and not solely premised on private enforcement of the FDCA. Alternatively, it is
also possible new allegations of off-label marketing will make evident that impossibility
preemption must again be applied. Accordingly, Moore will be allowed to amend her complaint
as to the seventh cause of action. See Fed. R. Civ. P. 15(a); Marks v. Shell Oil Co., 830 F.2d 68,
69 (6th Cir. 1987) (“Though the decision to grant leave to amend is committed to the trial court's

24

discretion, that discretion is limited by Fed.R.Civ.P. 15(a)'s liberal policy of permitting
amendments to ensure the determination of claims on their merits.”).
III
The Supreme Court has discussed this unique area of law and recognized, from the
perspective of many plaintiffs, “finding pre-emption here but not in [other cases] makes little
sense.” PLIVA, Inc. v. Mensing, 564 U.S. 604, 625 (2011). Were Moore to have continued her
suit against the brand-name drug, federal law would not have preempted that lawsuit but the
Court “acknowledge[s] the unfortunate hand that federal regulation has dealt” those that are
injured by the consumption of generic drugs. This Court, like the Surpreme Court, is not given
the “task to decide whether the statutory scheme established by Congress is unusual or even
bizarre.” Id. While true that “different federal statutes and regulations may, as here, lead to
different pre-emption results” the laws passed by Congress and enforcement of the Supremacy
Clause demand this result. Accordingly, and the Court being otherwise sufficiently advised, it is
hereby ORDERED as follows:
1.

Zydus’s Motion to Dismiss for failure to state a claim [R. 30] is GRANTED in

PART and DENIED in PART;
2.

Zydus’s Motion to Dismiss [R. 30] is GRANTED as to Claims One through Six

but DENIED as to the Seventh Claim;
3.

Moore’s Motion for Leave to File an Amended Complaint [R. 32 at 17] is

GRANTED. The Amended Complaint should be limited to the Seventh Claim only; and
4.

Moore shall have thirty (30) days from the date of this Order by which to file an

Amended Complaint in the record.

25

This the 29th day of September, 2017.

26