MEMORANDUM OPINION & ORDER
Cathy Moore seeks to recover for alleged harm caused by her use of a generic
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.] Amiodar-one 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).
Cathy Moore alleges that in November of 2014, she began to experience symptoms of vision impairment following her Amio-darone 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 amio-darone 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 Amiodar-one. [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
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,
When reviewing a Rule 12(b)(6) motion, the Court “construe[s] the complaint in the light most favorable to the plaintiff, accepts] its allegations as true, and draw[s] all reasonable inferences in favor of the plaintiff.” DirecTV, Inc.,
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.,
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,
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,
In addition to federal pre-emption, Zy-dus 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. Plaintiffs Legal Comm.,
Despite the applicability of impossibility preemption in many similar actions, Moore argues that the instant action is not preempted by federal law and. that the Mens-ing 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.] Zy-dus 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,
In- Mensing, plaintiffs consumed a generic form .of metoclopramide and alleged a number of state law claims, but, the Supreme Court detérmined 'that state-law tort claims brought against manufacturers of generic drugs are preempted by federal law. PLIVA Inc. v. Mensing,
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 ge
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 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 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]ccord-
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.,
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.,
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 “actual injury or harm to the plaintiff and legal causation between the defendant’s breach
. 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, 1117.] “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. í, 1Í37.] “[Zydus] ..; had actual or constructive knowledge 'that [] Amiodarone cause[s] and contribute^] to severe and disabling medical conditions and deáth, 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.-l, ¶71.]
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, 1Í73.] “[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, 1178.] “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, 1Í82.] “[Zydus] ... also promoted Cordar-one®/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, 11109.] “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
Moore included allegations, as discussed supra section “B”, that neither she nor pharmacies received a medication guide. [Id. at 11115-16.] Many of the remaining allegations either accuse Wyeth of rampant misconduct or Zydus of failure to properly warn of 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,
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 amio-darone 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.,
The Kentucky Supreme Court’s holding in T & M Jewelry, Inc. v. Hicks ex rel. Hicks,
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 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,
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,
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 “[Zy-dus] knew or should have known of the
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.,
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 Amiodar-one 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 Amiodar-one, 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.,
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 Strayhom v. Wyeth Pharmaceuticals established that claims of breach of implied or express warranty, when dealing with the inadequacy of labels or warnings included with drugs approved by the FDA and governed by the FDCA, are pre-empt-ed by federal law in these circumstances. See Strayhorn v. Wyeth Pharmaceuticals,
In Strayhom, 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,
*886 Our conclusion is consistent with this court’s previous decision in Smith v. Wyeth, Inc.,657 F.3d 420 (6th Cir.2011), cert. denied,566 U.S. 974 ,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 implied-warranty 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.,
Express warranties are made in Kentucky, pursuant to Kentucky Revised Statute § 355.2-313, 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.,
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
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.,
Moore’s express warranty claim is essentially a preempted failure to warn claim that argues the warnings provided by Zy-dus with Amiodarone were inadequate. Zy-dus was not at liberty to provide altered warnings or warranties. írWhen 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.,
y
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 1114-20, 1Í27, U39-64.] 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 Amiodar-one, it follows that Zydus cannot promote or market their generic brand for off-label purposes.
Zydus makes two arguments in opposition. Fitfst, Zydus moves to dismiss the complaint as “[Moore] has failed to cite any Kentucky or. Sixth Circuit decisional law that would create á unique Kentucky substantive cause of action grounded in an
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 intent, and (4) the resulting injury.” United States v. Villaspring Health Care Ctr., Inc.,
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.,
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
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 apr plied. 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.,
Ill
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,
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.
Notes
. <https://www.fda.gov/Drugs/DrugSafety/ Posten arketDrugSafetylnformationfor Patients andProviders/DrugSafety InformationforHealthcareProfessionals/ucm 084108.htm>
. For a full list of side-effects, see ZyGenerics Medication Guide Amiodarone Hydrochloride Tables. <http://www.zydususa.com/wp-content/plugins/products/MedicationGuide/ Amiodarone% 20HC1% 20Tablets.pdf>
. 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 atfl 113.]