Polt et al v. Sandoz, Inc.

MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM

E.D. Pa.October 25, 2016

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA CAROLINE POLT AND MONICA POLT, Individually and as Co-Executors of the Estate of JOANNE POLT, deceased, Plaintiffs, vs. SANDOZ INC., Defendant. Civil Action No. 16-2362 Hon. Eduardo Robreno ORDER AND NOW, this ____________ day of ______, 2016, upon consideration of Defendant Sandoz Inc.’s Motion to Dismiss the First Amended Complaint, and any response thereto, it is hereby ORDERED that said Motion is GRANTED, and this action is hereby dismissed with prejudice. BY THE COURT: _________________________ Hon. Eduardo Robreno, J. Case 2:16-cv-02362-ER Document 30 Filed 10/25/16 Page 1 of 24 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA CAROLINE POLT AND MONICA POLT, Individually and as Co-Executors of the Estate of JOANNE POLT, deceased, Plaintiffs, vs. SANDOZ INC., Defendant. Civil Action No. 16-2362 Hon. Eduardo Robreno MOTION TO DISMISS THE FIRST AMENDED COMPLAINT For the reasons set forth in the accompanying memorandum of law, which is incorporated herein by reference, Defendant Sandoz Inc. moves under Fed. R. Civ. P. 12(b)(6) to dismiss Plaintiffs’ First Amended Complaint for failure to state a claim upon which relief can be granted. WHEREFORE, Defendant Sandoz Inc. requests that this Court grant its Motion and dismiss this action with prejudice. Dated: October 25, 2016 Respectfully submitted, GREENBERG TRAURIG, LLP /s/ Gregory T. Sturges Gregory T. Sturges 2700 Two Commerce Sq., 2001 Market St. Philadelphia, PA 19103 (215) 988-7820 sturgesg@gtlaw.com Sara K. Thompson (admitted pro hac vice) Christiana Jacxsens (admitted pro hac vice) Terminus 200 3333 Piedmont Road, NE, Suite 2500 Atlanta, Georgia 30305 (678) 553-2100 thompsons@gtlaw.com jacxsensc@gtlaw.com Attorneys for Defendant Sandoz Inc. Case 2:16-cv-02362-ER Document 30 Filed 10/25/16 Page 2 of 24 1 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA CAROLINE POLT AND MONICA POLT, Individually and as Co-Executors of the Estate of JOANNE POLT, deceased, Plaintiffs, vs. SANDOZ INC., Defendant. Civil Action No. 16-2362 Hon. Eduardo Robreno SANDOZ INC.’S MEMORANDUM IN SUPPORT OF ITS MOTION TO DISMISS THE FIRST AMENDED COMPLAINT INTRODUCTION This is Plaintiffs’ second attempt to properly plead their claims in this case. As this Court made clear in granting Defendant Sandoz Inc.’s (“Sandoz”) first motion to dismiss Plaintiffs’ original complaint, Plaintiffs cannot state a claim for wrongful death unless they can allege sufficient facts to identify the product their decedent ingested, when they ingested it, and what Sandoz specifically did or failed to do that allegedly gives rise to each of their claims. The Court granted Plaintiffs 30 days to re-plead their claims with specific instructions not only to break down their claims into theories of liability but also to address noted failures to plead specific dates of ingestion, the basis for alleging their decedent ingested Sandoz’ amiodarone, and the particularized facts required by Fed. R. Civ. P. 9(b) to support their fraudulent off-label promotion claims. Despite the Court’s clear direction, Plaintiffs’ First Amended Complaint (the “FAC”) does little, if anything, to address these deficiencies. The FAC pleads no new facts to show why Plaintiffs believe the amiodarone ingested by the decedent was manufactured by Sandoz, does nothing to narrow the 10 year ingestion period pled in the original Complaint, and fails to include any new specific facts to bolster their fraud-based claims. Case 2:16-cv-02362-ER Document 30 Filed 10/25/16 Page 3 of 24 2 The FAC should be dismissed for three independent reasons. First, Plaintiffs have failed to plead any facts supporting their allegation that the amiodarone their decedent ingested was manufactured by Sandoz. At oral argument on Sandoz’ motion to dismiss the original complaint, this Court identified these “product identification” allegations as vital information omitted from Plaintiffs’ claim and requiring correction. In the Court’s words: Well, I think where we are is that we’ve got to walk before we run I guess. We have to get the complaint squared away, and so far we know that negligence per se should be flushed out, fraud allegations should be flushed out to satisfy 9(b), product identification, what I call product identification, should be flushed out as to the facts which connect this product to this plaintiff. The date or the approximate date at best of the ingestion needs to be flushed out […] Transcript of August 25, 2016 Oral Argument (“Tr.”), attached as Exhibit A, at 30:5-14 (emphasis added). The Court granted Sandoz’ motion and gave Plaintiffs 30 days (or more, if necessary) to gather specific product identification information and include it in an amended pleading. The FAC, however, includes no such information, and is nearly identical to the original complaint on this point. For this reason alone, the FAC should be dismissed. Second, all of Plaintiffs’ claims are still, at their root, failure-to-warn, design defect, or negligence claims that are preempted by federal law. Plaintiffs allege Sandoz “was required by the FDA to provide patients prescribed the drug with all FDA approved labels, warnings and Medication Guides[.]” (FAC ¶ 35). They also allege Sandoz “actively promoted their generic amiodarone in the stream of commerce for the ‘off-label’ uses openly promoted by [brand-name manufacturer] Wyeth.” (Id. ¶ 57). These claims seek to hold Sandoz, a generic drug maker, liable for purportedly inadequate warnings for amiodarone. However, because Sandoz manufactured and distributed amiodarone pursuant to Abbreviated New Drug Applications (“ANDAs”) approved by the U.S. Food and Drug Administration (“FDA”), which specified the content of the labeling, Plaintiffs’ failure to warn claims are preempted under PLIVA, Inc. v. Mensing, 131 S. Case 2:16-cv-02362-ER Document 30 Filed 10/25/16 Page 4 of 24 3 Ct. 2567 (2011), and Mutual Pharm. Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013). In Mensing, the Supreme Court held federal law preempts state law tort claims premised on alleged failure to warn of risks of generic drugs because such claims conflict with federal law requiring generic pharmaceutical manufacturers to conform their warnings to the equivalent brand name product. Mensing, 131 S. Ct. at 2577-78. The Court reinforced and expanded Mensing’s scope to include design defect claims and claims alleging a duty to withdraw from the market in Bartlett, 133 S. Ct. at 2480. The Third Circuit, other federal appellate courts, and this Court have all followed suit, affirming that tort suits against generic pharmaceutical manufacturers are preempted, whether pleaded under a negligence, failure to warn, or design defect theory. Further, Plaintiffs’ off-label promotion and failure to provide a Medication Guide claims are impliedly preempted as “fraud on the FDA” claims under the Supreme Court’s decision in Buckman v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001). Third, Plaintiffs’ claims are still insufficiently pled, even though the Court gave clear guidance at the hearing on the first motion to dismiss about what Plaintiffs needed to do to properly state their claims. Other federal district courts that have considered the very same allegations have found them lacking and have dismissed them on this basis. And Plaintiffs’ claim for failure to provide a Medication Guide is not a recognized cause of action under Pennsylvania law, despite their attempts to convert them into a negligence per se cause of action. This Court should grant Sandoz’ motion to dismiss the FAC and dismiss this action with prejudice. I. REGULATORY BACKGROUND A. The Federal Regulatory Framework for Generic Drugs. Pursuant to the Federal Food, Drug and Cosmetic Act (“FDCA”), the FDA regulates the approval of both brand name and generic drugs. See 21 C.F.R. §314.50(c)(2)(i) (brand name); 21 Case 2:16-cv-02362-ER Document 30 Filed 10/25/16 Page 5 of 24 4 C.F.R. §314.94(a)(8) (generic). A manufacturer seeking FDA approval to market a new drug must first demonstrate it is safe and effective and its proposed labeling is accurate and adequate, through the filing of a New Drug Application (“NDA”). Mensing, 131 S. Ct. at 2574. Generic drugs, by contrast, are “designed to be a copy of a Reference Listed Drug (“RLD”) (typically a brand name drug), and thus identical in active ingredients, safety and efficacy.” Id. Generic pharmaceutical manufacturers obtain FDA approval to manufacture and sell generic drug products under the regulatory framework set forth in what are commonly known as the Hatch-Waxman Amendments (“Hatch-Waxman”), 21 U.S.C. §355(j)(2)(A). Id. Hatch-Waxman changed the approval requirements for generic drugs to require only submission of an ANDA to show a generic drug is identical in all material respects to a previously-approved NDA, i.e., a brand name drug. 21 U.S.C. §355(j)(2)(A). Hatch-Waxman also requires that the “labeling proposed [for an ANDA] is the same as the labeling approved for the [brand name drug].” Mensing, 131 S. Ct. at 2574. To gain FDA approval, an ANDA applicant need only demonstrate that its “warning label is the same as the brand name’s.” Id. The only duty incumbent upon a generic pharmaceutical manufacturer under federal law with respect to its warnings is an ongoing duty of “sameness”-to ensure its generic drug’s labeling remains identical to the RLD to which it is required to remain equivalent. Id. at 2574- 75. Generic pharmaceutical manufacturers are prohibited from independently changing their labeling in any respect without prior FDA approval. Id. at 2577; see also 21 C.F.R. §314.150(b)(10) (authorizing FDA to revoke approval of a generic drug if its labeling “is no longer consistent with that for the [reference] listed drug”). For a generic pharmaceutical manufacturer to independently change its warning labeling, even to strengthen it, would violate federal law. Mensing, 131 S. Ct. at 2575. Case 2:16-cv-02362-ER Document 30 Filed 10/25/16 Page 6 of 24 5 This duty of sameness also extends to the drug’s design. Generic pharmaceutical manufacturers must show their products are bioequivalent to the brand name or RLD. See 21 U.S.C. §§ 355(j)(2)(A)(i)-(iii) (requiring generic drug to contain the same active ingredient(s); employ the same route of administration; present the same dosage form; and exhibit the same strength as its brand name counterpart). Federal law requires a generic to be “identical [to its brand equivalent] in active ingredients, safety, and efficacy,” just as each generic drug must “ensur[e] that its warning label is the same as the brand name’s.” Mensing, 131 S. Ct. at 2574 n.1. B. Regulatory History of Defendant’s Amiodarone. Amiodarone is a prescription pharmaceutical product indicated for treatment of life- threatening recurrent ventricular arrhythmias (recurrent ventricular fibrillation and recurrent hemodynamically unstable ventricular tachycardia) when other treatments are ineffective or have not been tolerated. Amiodarone was first manufactured and sold by Wyeth Pharmaceuticals, Inc. under the brand name Cordarone® in 1985, and later by other companies under names that included Pacerone® and generic amiodarone. Plaintiffs allege their decedent was prescribed a 200 mg course of amiodarone, purportedly manufactured by Sandoz, beginning approximately in 2004 and continuing through March 2014. (FAC ¶¶ 37, 38). Decedent “ingested the drug amiodarone according to the instructions.” (Id. ¶ 37). Eon Labs Manufacturing, Inc. (now known as Eon Labs, Inc. (“Eon”)) obtained ANDA approval to manufacture amiodarone 200 mg tablets on December 23, 1998.1 Eon was required 1 Information on ANDA #75315 may be found on the FDA website at https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Drug Details (last visited October 19, 2016). A true and correct copy of the FDA website is attached as Exhibit B. A true and correct copy of the FDA approval letter for ANDA #75315 is attached as Exhibit C. The Court may take judicial notice of public records in deciding a motion to dismiss Case 2:16-cv-02362-ER Document 30 Filed 10/25/16 Page 7 of 24 6 to submit an ANDA (#75315) to FDA, demonstrating bioequivalence to Cordarone® and proposed labeling materially identical to Cordarone® labeling. See 21 U.S.C. §355(j)(2)(A). FDA reviewed and approved the proposed labeling, determining it was materially identical to Cordarone®. Eon was acquired by Sandoz in 2005, and it transferred the ANDA to Sandoz. Federal law required Eon, and later Sandoz, to keep the labeling and design consistent with the approved labeling and design for Cordarone®. Mensing, 131 S. Ct. at 2575-77. This labeling requirement included a medication guide once FDA required one in December 2004 from NDA holder Wyeth, which later applied to ANDA holders such as Sandoz.2 II. PLAINTIFFS’ CLAIMS AGAINST SANDOZ Plaintiffs allege Ms. Polt’s death “was directly and proximately caused by the negligent actions of Defendant . . . for the failure to provide . . . up to date and required labeling and to provide Medication Guides to distributors[.]” (FAC ¶ 94). The FAC contains claims sounding in failure to warn, including that amiodarone “was and is unaccompanied by proper warnings” and “was defective due to inadequate post-marketing warning and instruction.” (Id. ¶¶ 60, 63). The FAC also includes allegations Sandoz “simultaneously engaged in a massive and fraudulent marketing and promotional scheme in which they aggressively and fraudulently promoted under Rule 12(b)(6). See Fed. R. Evid. 201(b)(2); In re Plastic Cutlery Antitrust Litig., No. 96- CV-728, 1998 WL 314655, at *3-*4 (E.D. Pa. June 15, 1998) (taking judicial of documents from Delaware Secretary of State proving that two defendants were separate corporate entities) (citing Redding v. Freeman Products, Inc., No. 94-398, 1995 WL 410922, at *2 (N.D. Ill. July 10, 1995); Pension Benefit Guar. Corp. v. White Consol. Indus., 998 F.2d 1192, 1197 (3d Cir. 1993)); Nikolouzakis v. Exinda Corp., No. 11-1261, 2012 WL 3239853, at *5 (D. Del. Aug. 7, 2012) (taking judicial notice of a “public document certified by Delaware’s Secretary of State”); Redding, 1995 WL 410922, at *2 (taking judicial notice of certificates of good standing showing defendants were separate corporate entities). 2 FDA approved Wyeth’s Medication Guide for Cordarone® on December 3, 2004. See http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18972s030ltr.pdf, a true and correct copy of which is attached hereto as Exhibit D. Subsequently, all ANDA holders incorporated medication guides into the labeling for their amiodarone products, in January 2005. Case 2:16-cv-02362-ER Document 30 Filed 10/25/16 Page 8 of 24 7 amiodarone for uses never authorized by the FDA” and “actively promoted their generic amiodarone in the stream of commerce for the ‘off-label’ uses openly promoted by Wyeth.” (Id. ¶¶ 64, 57). Finally, Plaintiffs allege their decedent did not receive a Medication Guide, claiming Sandoz was “responsible by federal regulation for ensuring that the appropriate warning labels and Medication Guides were provided to [decedent].” (Id. ¶ 40). Sandoz denies these allegations and denies that it can be held liable to Plaintiffs. Notably, these claims are identical to other amiodarone product liability claims dismissed on the grounds of federal preemption. See Rusk v. Sandoz Inc., No. A-14-cv-549-LY, 2015 U.S. Dist. LEXIS 179113 (W.D. Tex. Oct. 26, 2015) (granting dismissal in part); Stephens v. Teva Pharm. Inc., et al., 70 F. Supp. 3d 1246 (N.D. Ala. 2014) (dismissing without leave to amend); Perdue v. Wyeth Pharm., Inc., No. 4:15-cv-208-FL, 2016 U.S. Dist. LEXIS 94636 (E.D. N.C. July 20, 2016) (dismissing all claims against generic pharmaceutical manufacturers of amiodarone with prejudice), Elliott v. Sandoz, Inc., No. 2:16-CV-00861-RDP, 2016 WL 4398407, at *9 (N.D. Ala. Aug. 18, 2016) (dismissing plaintiff’s failure-to-warn claims with prejudice). ARGUMENT I. THE FIRST AMENDED COMPLAINT FAILS TO ALLEGE SPECIFIC FACTS SUPPORTING THE CONCLUSORY ALLEGATION THAT DECEDENT INGESTED SANDOZ AMIODARONE. During oral argument on Sandoz’ motion to dismiss Plaintiffs’ original complaint, this Court raised the “threshold issue” of “production identification”, i.e., the facts supporting the allegation “that the plaintiff took [] the defendant’s drug[.]” Tr. at 23:15-19. Counsel for plaintiffs agreed that the allegations in the original complaint were “not as good as we have been able to produce in other complaints.” Id. at 23:20-22. He continued that plaintiffs in this type of litigation are “usually able to ascertain the NDC number” (the National Drug Code, a unique product identifier used for drugs intended for human use), id. at 23:22-23, and explained that the Case 2:16-cv-02362-ER Document 30 Filed 10/25/16 Page 9 of 24 8 original complaint’s vague product identification allegations were the result of having filed the original complaint in a “hurry” to meet the statute of limitations. Id. at 24:1-3. At the time of filing, Plaintiffs had not yet collected “the prescription records where you really get into the detail[.]” Id. at 24:3-5. The Court asked if Plaintiffs could amend their complaint to “include that information”-the NDC numbers and decedent’s alleged dates of ingestion of a Sandoz drug. Id. at 24:6-7; 24:19-23; 25:4-5 (“We would want to give you [the Court] a pretty good accurate date of [ingestion]”). Plaintiffs’ counsel responded: We clearly would, Your Honor, and we have in other cases and we clearly would. And as Ms. Thompson knows, if we determine it’s not her drug, of course we admittedly, you know, back off. Id. at 24:8-11. The Court granted Plaintiffs 30 days (or more if needed) to amend their complaint to include the NDC code or other specific product identification information. Id. at 25:6-10 (“The Court: How long would it take[,] do you think[,] to get the product identification and date of ingestion data? Mr. Wood: Clearly no more than 30 days, sometimes faster […]”). Ultimately, the Court granted the motion without prejudice and with leave to amend, expressly stating that leave was granted so that Plaintiffs could bolster their product identification allegations. Id. at 30:5-14; 37:1-7 (“The plaintiff will have 30 days to file the amended complaint, and if there is a need for additional time, I’ll be flexible about that. The points at the very least should be addressed in the amended complaint those that were discussed here.”). Despite this exchange and the clear instructions of the Court, Plaintiffs did not include product identification information in their FAC nor asked for more time to obtain it. As in their original Complaint, Plaintiffs have only made broad accusations that decedent “was prescribed, purchased, and ingested the drug amiodarone . . . manufactured, promoted and/or sold or distributed by Defendant,” and that “[p]rescription, medical records and the NDC Number of the tablets prescribed and ingested by [decedent] all confirm [she] consumed amiodarone; more Case 2:16-cv-02362-ER Document 30 Filed 10/25/16 Page 10 of 24 9 particularly the amiodarone manufactured by Sandoz Inc.” (Compare FAC ¶¶ 1, 4, with Compl. ¶¶ 1, 4) (making identical allegations). Again, just as they did in the original complaint, Plaintiffs generally reference the existence of an NDC number, but do not plead any specific NDC number attributable to Sandoz (or any other manufacturer of amiodarone), nor do they provide any other basis for their belief decedent ingested a Sandoz product. (Compare FAC ¶¶ 5, 38, with Compl. ¶¶ 5, 38) (making identical allegations). Although the FAC includes a few “new” paragraphs alleging treating physician Dr. Bradley Bacik prescribed decedent a course of 200 mg amiodarone tablets once daily from 2004 through 2014 (FAC ¶ 91), these same allegations appear in the original complaint. (Compl. ¶ 37). Moreover, these allegations add nothing as to whether decent ingested Sandoz’ amiodarone. In fact, this same 10 year ingestion period was in the original Complaint and was raised at the prior hearing as another point on which amendment should make the complaint more specific so that Sandoz and the Court could judge whether a statute of limitations issue exists in this case. (Compare FAC ¶ 37, with Compl. ¶ 37) (both alleging ingestion period from “approximately 2004 and continuing on through March 2014”). The FAC makes no effort to narrow either the time period during which Plaintiffs claim their decedent was taking amiodarone, or to make clear when during this 10 year period the decedent allegedly ingested Sandoz’ amiodarone as opposed to other manufacturers, even though it is extremely unlikely that decedent received only Sandoz amiodarone for the entire ingestion period. In short, Plaintiffs were instructed to provide some new allegations to support their assertion that their decedent ingested a Sandoz product and to provide specific dates of ingestion, yet they have completely failed to do so. Decedent’s history of drug ingestion and product identification from the prescription records are both information uniquely available to Plaintiffs. If they had a good faith basis for Case 2:16-cv-02362-ER Document 30 Filed 10/25/16 Page 11 of 24 10 their claims, they should have made that plain in the FAC, as the Court directed. That they have not done so despite being given an opportunity and time to do so speaks volumes about the weakness of their claims against Sandoz. Because the FAC contains no new information “connect[ing] this product to this plaintiff,” and is still insufficiently pled, the FAC should be dismissed, this time with prejudice. II. PLAINTIFFS’ CLAIMS ARE ALL PREEMPTED BY FEDERAL LAW. Even if Plaintiffs had adequately pled both product identification and a specific ingestion period, their claims are all still preempted by federal law. Each of Plaintiffs’ claims against Sandoz is premised on failure-to-warn allegations and is therefore preempted under Bartlett and Mensing. And Plaintiffs’ off-label promotion and Medication Guide claims are impliedly preempted as “fraud on the FDA” claims under Buckman. Because the preemption challenge here presents a purely legal issue, it is appropriate for the Court to decide the issue at the pleading stage. See Mensing, 131 S. Ct. 2567. A. Plaintiffs’ Failure-to-Warn Claims Are Preempted. Plaintiffs allege that Sandoz’ amiodarone was “defective due to inadequate post- marketing warning and instruction.” (FAC ¶ 59). Thus, Plaintiffs openly contend that Sandoz’ labeling should have contained different or additional warnings-precisely the type of claim preempted by Mensing, which held that all state law tort claims attacking the sufficiency of warnings provided by generic pharmaceutical manufacturers about ANDA-approved drugs are preempted by federal law. 131 S. Ct. at 2577-81. The consolidated lawsuits at issue in Mensing “involve[d] state tort law claims based on certain drug manufacturers’ alleged failure to provide adequate warning labels for generic metoclopramide.” Id. at 2572. Faced with the question of “whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, these state-law claims,” the Supreme Court held that they do. Id. The majority Case 2:16-cv-02362-ER Document 30 Filed 10/25/16 Page 12 of 24 11 recognized the dispositive impact on all product liability suits against generic pharmaceutical manufacturers, holding “because pharmacists, acting in full accord with state law, substituted generic metoclopramide [for the branded product] . . . federal law pre-empts these lawsuits.” Id. at 2581 (emphasis added). The dissenting justices also emphasized the impact on suits against generic pharmaceutical manufacturers, stating “[i]f [a consumer] takes a generic drug, as occurs 75 percent of the time, she now has no right to sue.” Id. at 2592 (Sotomayor, J., dissenting.) (emphasis added). The overwhelming majority of state and federal courts, including the Third Circuit, have recognized the plain impact of Mensing: no state law tort claims attacking a generic drug’s warnings, representations, or disclosures can survive federal preemption. See, e.g., In re Fosamax (Alendronate Sodium) Products Liab. Litig. (No. II), 751 F.3d 150, 165 (3d Cir. 2014), (holding strict-liability design-defect claims are preempted); Sikkelee v. Precision Airmotive Corp., --- F.3d ---, 2016 WL 1567236, at *18-*19 (3d Cir. Apr. 19, 2016) (citing Mensing and Bartlett for proposition that “where manufacturers are unable to simultaneously comply with both federal and state requirements, state law design defect claims are conflict preempted”); Wolfe v. McNeil-PPC, Inc., 773 F. Supp. 2d 561 (E.D. Pa. 2011) (holding state-law failure-to- warn claims are preempted where a defendant adduces clear evidence that the FDA would not have approved the change to a drug label that was necessary to comply with state law).3 The 3 See also, e.g., Guarino v. Wyeth, 719 F.3d 1245 (11th Cir. 2013) (all state law warning claims are preempted); Johnson v. Teva Pharm. USA, Inc., 758 F.3d 605 (5th Cir. 2014) (affirming dismissal of all claims including failure to warn, design defect, and stop-selling as preempted); In re Darvocet, Darvon & Propoxyphene Products Liab. Litig., 756 F.3d 917 (6th Cir. 2014) (affirming dismissal of all claims against generic pharmaceutical manufacturer defendants); Eckhardt v. Qualitest Pharm., Inc., 751 F.3d 674 (5th Cir. 2014) (same); Lashley & Del Valle v. Pfizer, Inc., 750 F.3d 470 (5th Cir. 2014) (affirming all claims dismissed as preempted); Drager v. PLIVA USA, Inc., 741 F.3d 470 (4th Cir. 2014) (same); Moretti v. Mutual Pharm. Co., 518 Fed. Appx. 486 (8th Cir. 2013) (affirming dismissal of warning claims as preempted). Case 2:16-cv-02362-ER Document 30 Filed 10/25/16 Page 13 of 24 12 Supreme Court reaffirmed and expanded Mensing in Bartlett, recognizing preemption applies to design defect claims or claims alleging a duty to withdraw a product from the market. 133 S. Ct. at 2480. Since Bartlett, more than 100 federal and state courts have dismissed virtually all products liability and tort claims against generic pharmaceutical manufacturers as preempted. Indeed, numerous district courts have granted motions to dismiss failure-to-warn claims in cases involving the exact same product at issue in this case-amiodarone-and virtually identical allegations about off-label promotion and failure to provide a medication guide. See, e.g., Rusk, 2015 U.S. Dist. LEXIS 179113; Stephens, 70 F. Supp. 3d at 1254; Perdue, 2016 WL 3951091 at *6; Elliott, 2016 WL 4398407, at *9. In Rusk, the court addressed nearly identical claims regarding amiodarone and found all of the plaintiff’s failure-to-warn claims preempted as a matter of law. Likewise, in Stephens, the court held under Mensing that failure-to-warn claims are “wholly preempted by federal law,” and plaintiffs could not “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.” 70 F. Supp. 3d at 1250. In Perdue, the court found that both the off-label promotion and failure to provide a medication guide claims were preempted. 2016 WL 3951091 at *6. Most recently, in Elliott, the court cited Mensing to dismiss the same failure-to-warn claims asserted here relating to amiodarone. 2016 WL 4398407, at *5-*6. B. Plaintiff’s Negligence Per Se Claims Premised upon Off-Label Promotion and Failure to Provide a Medication Guide Are Also Impliedly Preempted. Claims premised upon violations of federal duties are also impliedly preempted under Buckman, in which the Supreme Court held “[t]he FDCA leaves no doubt that it is the Federal Government rather than private litigants who [is] authorized to file suit for noncompliance with the [law].” 531 U.S. at 349 n.4 (citing 21 U.S.C. § 337(a)). Plaintiffs’ off-label promotion claim alleges Sandoz violated FDA regulations making it “unlawful for a manufacturer to promote any Case 2:16-cv-02362-ER Document 30 Filed 10/25/16 Page 14 of 24 13 drug for a use not described in the approved labeling of the drug,” 21 U.S.C. §§ 331(d), 352(f), and 355. Pennsylvania law does not recognize any similar restrictions. See § III.B, infra. Thus, because Plaintiffs’ off-label promotion claims are based solely on violations of federal law, they are impliedly preempted under Buckman. See, e.g., Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166, 1177 (C.D. Cal. 2013) (“any negligence claim based solely on illegal off-label promotion is impliedly preempted under Buckman and § 337(a)”). Similarly, a manufacturer’s duty to provide or to make a Medication Guide available is created by federal law, and no private right of action exists to permit Plaintiffs to pursue violations of this exclusively federal duty. See § III.C, infra. See also 21 C.F.R. §208.24(b); 21 U.S.C. §337(a). “The duty of the Defendant to provide Medication Guides to pharmacies (i.e., “distributors, packers or authorized dispensers”) arises solely under federal law.” Elliott, 2016 WL 4398407, at *6 (emphasis in original). Thus, Plaintiffs’ claims alleging Sandoz failed to provide Medication Guides are impliedly preempted. Buckman, 531 U.S. at 349. In Perdue, a nearly identical case, the Eastern District of North Carolina dismissed off- label promotion and failure to provide Medication Guide claims involving amiodarone, finding both impliedly preempted under Buckman and 21 U.S.C. §337(a). Perdue, 2016 WL 3951091 at *3-*6. Perdue first recognized traditional products liability claims-similar to those alleged in the FAC-against generic pharmaceutical manufacturers are preempted by Mensing and Bartlett, and also opined that off-label promotion and Medication Guide claims are premised upon federal duties only the federal government has the right to enforce. Id. at *3. Applying Buckman, the Perdue Court recognized this lack of a private right of action is fatal to both claims, because they allege violations of federal duties. Id. at *5-*6. As such, the Perdue Court dismissed both claims as preempted. Id.; see also Elliott, 2016 WL 4398407, at *10 (“Plaintiff’s claim that Defendant Case 2:16-cv-02362-ER Document 30 Filed 10/25/16 Page 15 of 24 14 was negligent for failing to provide Medication Guides to Decedent is preempted by section 337(a).”). The claims in this case are virtually identical, and should meet the same fate. III. PLAINTIFFS’ CLAIMS ARE STILL INSUFFICIENTLY PLED. Even if they were not clearly preempted, Plaintiffs’ claims would also be subject to dismissal for failure to state a claim under Fed. R. Civ. P. 12(b)(6), 8(a)(2), and 9(b). A complaint must contain sufficient factual matter, if accepted as true, to state a claim that is plausible on its face. Id. The Court need not accept legal conclusions as true, even if stated as factual allegations. Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). A Complaint must contain a “plain statement of the claim showing that the pleader is entitled to relief, in order to give the defendant fair notice of what the claim is and the grounds upon which it rests.” Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 554 (2007). Dismissal is warranted if a complaint merely contains “naked assertions devoid of further factual enhancement,” Iqbal, 556 U.S. at 678, or “a formulaic recitation of the elements of a cause of action.” Twombly, 550 U.S. at 555. Factual allegations “must be enough to raise a right to relief above the speculative level.” Id. “Where a complaint pleads facts that are merely consistent with a defendant’s liability, it stops short of the line between possibility and plausibility of entitlement to relief.” Id. at 570. The Supreme Court has articulated a two-pronged approach to decide whether a complaint’s factual allegations are sufficient to survive a motion to dismiss. See Iqbal, 556 U.S. at 678-80. First the Court must identify and set aside any conclusory allegations, because it is not required to accept these as true, even if disguised as factual allegations. Id. at 1949-50. Next, the Court must determine whether the complaint pleads a claim to relief that is plausible on its face once the conclusory allegations are stripped away. Id. at 679. This analysis requires more than the sheer possibility that a defendant acted unlawfully. Id. at 680. Here, the FAC contains only Case 2:16-cv-02362-ER Document 30 Filed 10/25/16 Page 16 of 24 15 conclusory allegations and legal recitations, devoid of any factual support, which do not rise to the level of plausibility. “Where the well-pleaded facts do not permit the court to infer more than the mere possibility of misconduct, the complaint has alleged-but it has not ‘show[n]’-that the ‘pleader is entitled to relief.’” Gelman, 583 F.3d at 187 (quoting Iqbal and Fed. R. Civ. P. 8(a)(2)). Dismissal is required where a plaintiff pleads facts showing that it is not entitled to relief. Schmidt v. Skolas, 770 F.3d 241, 251 (3d Cir. 2014) (citing cases holding, inter alia, dismissal is “appropriate when ‘the plaintiff effectively pleads herself out of court’ by alleging facts that establish [a] defense”). Plaintiffs have simply not met their pleading obligations. A. Plaintiffs’ Fraudulent Off-Label Promotion Claims Fail. At the outset, like the original complaint, the FAC alleges conduct subject to the heightened pleading requirements of Fed. R. Civ. P. 9(b) for fraud-based claims. For example, Plaintiffs allege “while Defendant concealed this adverse event information, they simultaneously engaged in a massive and fraudulent marketing and promotional scheme in which they aggressively and fraudulently promoted amiodarone for uses never authorized by the FDA”; “Defendant continued their [sic] fraudulent marketing, promotional, and sales practices through the present date”; and “Defendant’s deception, concealment, and fraudulent marketing and promotion has been so pervasive throughout the United States[.]” (FAC ¶¶ 58, 64. 70). As with the product identification issue, at the hearing on the first motion to dismiss the Court flagged these allegations as insufficient under Rule 9(b). Tr., at 30:9-10 (the “fraud allegations should be flushed out to satisfy 9(b)”). But Plaintiffs have not cured this problem at all; the FAC includes no new allegations with respect to Sandoz’ alleged participation in the supposed fraud. The allegations on these points are identical to the original complaint, and thus the FAC remains inadequate for the same reasons as the original complaint. Case 2:16-cv-02362-ER Document 30 Filed 10/25/16 Page 17 of 24 16 Complaints alleging fraud must satisfy not only the fundamental requirements of Rule 8(a), but also the heightened pleading requirements of Rule 9(b). A complaint “must state with particularity the circumstances constituting fraud.” Fed. R. Civ. P. 9(b). Plaintiffs’ fraud-based claims fall woefully short of these requirements. “The purpose of Rule 9(b) is ‘to place the defendants on notice of the precise misconduct with which they are charged, and to safeguard defendants against spurious charges of immoral and fraudulent behavior.’” U.S. ex rel. Gohil v. Sanofi-Aventis U.S. Inc., 96 F. Supp. 3d 504, 517 (E.D. Pa. 2015) (quoting Seville Indus. Mach. Corp. v. Southmost Mach. Corp., 742 F.2d 786, 791 (3d Cir.1984)). In order to comply with the particularity requirement of a fraud claim, the following elements must be pled: (1) A specific false representation of material facts; (2) knowledge by the person who made it of its falsity; (3) ignorance of its falsity by the person to whom it was made; (4) the intention that it should be acted upon; and (5) the plaintiff acted upon it to his damage. Fulton Fin. Advisors, Nat. Ass’n v. NatCity Investments, Inc., No. CIV.A. 09-4855, 2013 WL 5635977, at *4 (E.D. Pa. Oct. 15, 2013) (citing Christidis v. First Pa. Mortgage Trust, 717 F.2d 96, 99 (3d Cir. 1983)). The FAC’s vague blanket assertion of a “massive and fraudulent marketing and promotional scheme,” with no reference to what misrepresentations were made, who made them, when, or to whom, adds nothing to the original complaint’s failure to specify any purported fraudulent conduct by Sandoz (as opposed to the innovator of brand-name Cordarone®, Wyeth, who is not a defendant here). Plaintiffs also do not even attempt to identify the declarant, time, place or context of any alleged fraudulent representations, acts or omissions. Plaintiffs’ fraud- based allegations are conclusory statements, unsupported by facts, and entirely devoid of the requisite “particularity [of] the circumstances constituting fraud.” Fed. R. Civ. P. 9(b). Case 2:16-cv-02362-ER Document 30 Filed 10/25/16 Page 18 of 24 17 B. Plaintiffs’ Off-Label Promotion Claims Are Baseless and Conclusory. The FAC likewise fails to state a claim against Sandoz because it is premised almost entirely on allegations of allegedly wrongful off-label promotion conduct undertaken by brand manufacturer Wyeth (who, again, is not a named defendant here), coupled with conclusory assertions that Sandoz was a supposed beneficiary of Wyeth’s purportedly wrongful conduct. For example, Plaintiffs allege, “Sandoz . . . actively promoted their generic amiodarone in the stream of commerce for the ‘off-label’ uses openly promoted by Wyeth.” (FAC ¶ 57). Plaintiffs do not identify any specific allegedly fraudulent representations or off-label promotion representations or activities actually undertaken by Sandoz, and thus has not sufficiently pled this claim. Moreover, while the FAC names the physician who prescribed amiodarone to decedent, Plaintiffs do not allege he was misled by Sandoz specifically about either amiodarone’s intended use or the risks of off-label use. In Pennsylvania, “in the case of prescription drugs . . . a manufacturer’s duty to warn is governed by the ‘learned intermediary doctrine.’” Terrell v. Davo, Inc., CIV.A. 13-5074, 2014 WL 3746532, at *9 (E. D. Pa. July 30, 2014) (citing Baldino v. Castagna, 478 A.2d 807, 812 (Pa. 1984)). “A prescription drug manufacturer has no duty to provide direct warnings to the ultimate consumer of its prescription drug products if the manufacturer has given proper warnings concerning the drug to the prescribing physician.” Cahill v. Miles, Inc., No. CIV. A. 91-1966, 1992 WL 110537, at *3 (E.D. Pa. May 13, 1992). “When a drug is ‘available only upon prescription of a duly licensed physician, the warning required is not to the general public or to the patient, but to the prescribing doctor,’ who is thought to be best situated to evaluate the information and explain it to the patient in the context of his or her individual medical circumstances.” Hricik v. Stryker Biotech, LLC, 89 F. Supp. 3d 694, 703 (E.D. Pa. 2015) (internal citations omitted). Because Plaintiffs have not alleged that Case 2:16-cv-02362-ER Document 30 Filed 10/25/16 Page 19 of 24 18 Sandoz misled decedent’s physician in some fashion or that the physician relied upon some misrepresentation by Sandoz, prior to his prescribing amiodarone to the decedent, their claims must fail. Plaintiffs’ off-label promotion allegations allege, at most, that Sandoz was an unwitting beneficiary of wrongful conduct by other non-parties, which is not sufficient to state an off-label promotion claim against Sandoz, and the FAC does not cure this fatal defect. C. Plaintiffs’ Medication Guide Claims Fail as a Matter of Law. Plaintiffs also cannot state a claim against Sandoz based on the FAC’s allegation that the decedent “was not provided the Medication Guide . . . from Defendant that were [sic] required to be given,” and that, if she had received one, she “would have been aware of the serious lung related side effects that would lead to her physical condition, injuries and ultimately her death as well as other issues.” (FAC ¶ 40). These allegations are premised on a failure to warn, and are thus preempted as previously explained. Moreover, Sandoz had no duty under federal or state law to provide a Medication Guide directly to decedent. Under Pennsylvania law, a manufacturer discharges its sole duty to warn by warning a consumer’s physician. Moore v. Watson Pharm. Labs., No. CIV.A. 01-4260, 2002 WL 63592, at *1 (E.D. Pa. Jan. 16, 2002). Plaintiffs therefore have no cause of action for failure to provide a Medication Guide under Pennsylvania law. Nor did Sandoz have any duty under federal law to ensure its Medication Guides were delivered to consumers. Contrary to Plaintiffs’ assertions, federal law requires manufacturers to make Medication Guides available to “authorized dispensers.” The regulation states: (b) Each manufacturer who ships a container of drug product for which a Medication Guide is required under this part is responsible for ensuring that Medication Guides are available for distribution to patients by either: Providing 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 (2) Providing the means to produce Medication Guides in sufficient numbers to distributors, packers, or authorized dispensers to permit the authorized dispenser to provide a Case 2:16-cv-02362-ER Document 30 Filed 10/25/16 Page 20 of 24 19 Medication Guide to each patient receiving a prescription for the drug product… (e) Each authorized dispenser of a prescription drug product for which a Medication Guide is required under this part shall, when the product is dispensed to a patient (or to a patient’s agent), provide a Medication Guide directly to each patient (or to the patient’s agent) unless an exemption applies under §208.26. 21 C.F.R. §208.24(b),(e). An “authorized dispenser” is “an individual licensed, registered, or otherwise permitted by the jurisdiction in which he or she practices to provide drug products on prescription in the course of professional practice.” Id. §208.3(a). Sandoz is thus not an authorized dispenser and was not required to provide Medication Guides directly to patients. Plaintiffs’ bare allegation that Defendant did not provide Medication Guides includes reference to an unidentified pharmacy, but otherwise does not identify the “pharmacy.” (FAC ¶ 39). Plaintiffs’ allegations also do not account for the possibility that a wholesaler or distributor failed to deliver Medication Guides that Sandoz did properly ship with the medication, rather than Sandoz having failing to include Medication Guides with its shipment.4 Finally, the regulation imposing a duty on manufacturers to provide a Medication Guide is created by federal law and no private right of action exists under state law. See 21 C.P.R. § 208.24(b); see also 21 U.S.C. §337(a); Comella v. Smith & Nephew, Inc., No. 13 C 1850, 2013 WL 6504427, at *2 (N.D. Ill. Dec. 11, 2013). Thus, Plaintiffs have no right to enforce the regulation requiring distribution of a Medication Guide, and their claims should be dismissed, as was the case in Perdue and Elliott for nearly identical allegations. 4 Even if Plaintiffs intended to allege Sandoz failed to supply Medication Guides with amiodarone dispensed to decedent, this claim would be wildly speculative. Plaintiffs would be guessing that if Defendant had provided a Medication Guide, it would have been given to decedent, she would have reviewed and appreciated it and would have elected not to take a drug prescribed by her doctor. A speculative and conclusory allegation that Defendant failed to provide a Medication Guide to the “pharmacy” and that this may have somehow changed the outcome does not satisfy Twombly and Iqbal pleading standards and should be dismissed. Case 2:16-cv-02362-ER Document 30 Filed 10/25/16 Page 21 of 24 20 D. Plaintiff’s Accusations of Indirect Benefit to Sandoz Fail as a Matter of Law. In addition to Plaintiffs’ conclusory and unsubstantiated allegations of off-label promotion of amiodarone by Sandoz, the FAC also levies conclusory accusations against Sandoz for allegedly benefiting from Wyeth’s alleged off-label promotion of Cordarone®. (FAC ¶¶ 11- 16; 32-35; 56 (“Defendant took advantage of the pervasive brand innovator promotional activities of Wyeth and Defendant’s version of the drug directly benefited from the decades of marketing of the drug for ‘off-label’ uses by Wyeth.”). Because such tenuous accusations are nothing more than a repackaging of otherwise preempted claims, Plaintiffs’ allegations of wrongful and indirect benefit fail under Pennsylvania law for the reasons already described. The FAC acknowledges the federal requirement for sameness between brand name and generic drug labeling, which prohibits generic pharmaceutical manufacturers like Sandoz from unilaterally altering product labeling or warnings. (FAC ¶¶ 29-30; 34). Upon this foundation, just like the original complaint, the FAC alleges specific facts concerning off-label promotion on the part of brand manufacturer Wyeth. (Id. at 31-32 (“Wyeth aggressively and successfully marketed Cordarone® for inappropriate ‘off-label’ uses as a ‘first line anti-arrhythmic therapy.”)). In stark contrast to the allegations levied directly against Wyeth, as to Sandoz, the FAC contains only bare recitations devoid of any statements of circumstances, occurrences, or events. Essentially, Plaintiffs allege that Sandoz must have benefitted from Wyeth’s alleged conduct. However, this leaves the FAC insufficiently pled as to the sole defendant in this case, Sandoz, as it lacks any allegation of actionable conduct on the part of Sandoz beyond fulfilling its federally-prescribed duty to preserve the sameness of its product and labeling. See Gelman, 583 F.3d at 187. At most, Plaintiffs allege Sandoz was the unwitting beneficiary of promotion and representation by Wyeth, which does not state a claim against Sandoz that can survive Case 2:16-cv-02362-ER Document 30 Filed 10/25/16 Page 22 of 24 21 dismissal. CONCLUSION For all of the foregoing reasons, Sandoz respectfully requests that this Court dismiss Plaintiffs’ Complaint against it with prejudice pursuant to Fed. R. Civ. P. 12(b)(6) and other relief that the Court deems just and proper. Dated: October 25, 2016 Respectfully submitted, GREENBERG TRAURIG, LLP /s/ Gregory T. Sturges Gregory T. Sturges 2700 Two Commerce Sq., 2001 Market St. Philadelphia, PA 19103 (215) 988-7820 sturgesg@gtlaw.com Sara K. Thompson (admitted pro hac vice) Christiana Jacxsens (admitted pro hac vice) Terminus 200 3333 Piedmont Road, NE, Suite 2500 Atlanta, Georgia 30305 (678) 553-2100 thompsons@gtlaw.com jacxsensc@gtlaw.com Attorneys for Defendant Sandoz Inc. Case 2:16-cv-02362-ER Document 30 Filed 10/25/16 Page 23 of 24 1 IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA CAROLINE POLT AND MONICA POLT, Individually and as Co-Executors of the Estate of JOANNE POLT, deceased, Plaintiffs, vs. SANDOZ INC., Defendant. Civil Action No. 16-2362 Hon. Eduardo Robreno CERTIFICATE OF SERVICE I certify that on October 25, 2016, a copy of the foregoing Motion to Dismiss the First Amended Complaint, Memorandum in Support, and supporting Exhibits were filed electronically and served on all counsel of record via the Court’s ECF System. /s/ Gregory T. Sturges Gregory T. Sturges Case 2:16-cv-02362-ER Document 30 Filed 10/25/16 Page 24 of 24 EXHIBIT A Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 1 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 2 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 3 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 4 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 5 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 6 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 7 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 8 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 9 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 10 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 11 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 12 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 13 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 14 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 15 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 16 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 17 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 18 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 19 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 20 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 21 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 22 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 23 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 24 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 25 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 26 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 27 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 28 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 29 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 30 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 31 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 32 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 33 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 34 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 35 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 36 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 37 of 38 Case 2:16-cv-02362-ER Document 30-1 Filed 10/25/16 Page 38 of 38 EXHIBIT B Case 2:16-cv-02362-ER Document 30-2 Filed 10/25/16 Page 1 of 3 Disclaimer11 1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain 2. http://www.addthis.com/bookmark.php 3. http://www.fda.gov/default.htm 4. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm 5. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm 6. http://www.fda.gov/Drugs/InformationOnDrugs/ucm075234.htm 7. http://www.fda.gov/Drugs/InformationOnDrugs/UCM079874 8. http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm 9. http://www.accessdata.fda.gov/scripts/email/cder/commentdrugcat.cfm 10. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm 11. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/default.htm#web Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Site Map Transparency Website Policies U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA FAQ6 | Instructions7 | Glossary8 | Contact Us9 Email Link Drug Details Drug Name(s) AMIODARONE HYDROCHLORIDE FDA Application No. (ANDA) 075315 Active Ingredient(s) AMIODARONE HYDROCHLORIDE Company SANDOZ Original Approval or Tentative Approval Date December 23, 1998 Therapeutic Equivalents Labels are not available Approval History, Letters, Reviews, and Related Documents Other Important Information from FDA 10 Products on Application (ANDA) #075315 Click on a column header to re-sort the table: Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLDTE Code AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 200MG TABLET;ORAL Prescription No AB AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 400MG TABLET;ORAL Prescription No AB Back to Top | Back to Previous Page | Back to Drugs@FDA Home FDA/Center for Drug Evaluation and Research Office of Communications Division of Online Communications Update Frequency: Daily Links on this page: FDA Home3 Drug Databases4 Drugs@FDA5 Page 1 of 2Drugs@FDA: FDA Approved Drug Products 10/25/2016https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseacti... Case 2:16-cv-02362-ER Document 30-2 Filed 10/25/16 Page 2 of 3 For Government For Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive Links on this page: Page 2 of 2Drugs@FDA: FDA Approved Drug Products 10/25/2016https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseacti... Case 2:16-cv-02362-ER Document 30-2 Filed 10/25/16 Page 3 of 3 EXHIBIT C Case 2:16-cv-02362-ER Document 30-3 Filed 10/25/16 Page 1 of 3 ANDA 75-315 December 23, 1998 Eon Labs Manufacturing, Inc. Attention: Sadie M. Ciganek 227-15 N. Conduit Avenue Laurelton, NY 11413 Dear Madam: This is in reference to your abbreviated new drug application dated January 6, 1998, submitted pursuant to Section 505(j) of the Federal Food, Drug, and Cosmetic Act, for Amiodarone Hydrochloride Tablets, 200 mg. Reference is also made to your amendments dated June 19, August 26, September 16, October 9, and November 13, 1998. We have completed the review of this abbreviated application and have concluded that the drug is safe and effective for use as recommended in the submitted labeling. Accordingly, the application is approved. The Division of Bioequivalence has determined your Amiodarone Hydrochloride Tablets, 200 mg to be bioequivalent and, therefore, therapeutically equivalent to the listed drug (Cordarone® brand of Amiodarone Hydrochloride Tablets, 200 mg of Wyeth Ayerst Laboratories, Inc.). Your dissolution testing should be incorporated into the stability and quality control program using the same method proposed in your application. Under 21 CFR 314.70, certain changes in the conditions described in this abbreviated application require an approved supplemental application before the change may be made. Post-marketing reporting requirements for this abbreviated application are set forth in 21 CFR 314.80-81 and 314.98. The Office of Generic Drugs should be advised of any change in the marketing status of this drug. We request that you submit, in duplicate, any proposed advertising or promotional copy which you intend to use in your initial advertising or promotional campaigns. Please submit all proposed materials in draft or mock-up form, not final print. Submit both copies together with a copy of the proposed or final printed labeling to the Division of Drug Marketing, Advertising, Case 2:16-cv-02362-ER Document 30-3 Filed 10/25/16 Page 2 of 3 and Communications (HFD-40). Please do not use Form FD-2253 (Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use) for this initial submission. We call your attention to 21 CFR 314.81(b)(3) which requires that materials for any subsequent advertising or promotional campaign be submitted to our Division of Drug Marketing, Advertising, and Communications (HFD-40) with a completed Form FD-2253 at the time of their initial use. Validation of the regulatory methods has not been completed. It is the policy of the Office not to withhold approval until the validation is complete. We acknowledge your commitment to satisfactorily resolve any deficiencies which may be identified. Sincerely yours, Douglas L. Sporn Director Office of Generic Drugs Center for Drug Evaluation and Research Case 2:16-cv-02362-ER Document 30-3 Filed 10/25/16 Page 3 of 3 EXHIBIT D Case 2:16-cv-02362-ER Document 30-4 Filed 10/25/16 Page 1 of 4 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 18-972/S-030 Wyeth Pharmaceuticals, Inc. Attention: Caroline Henesey, Ph.D. P.O. Box 8299 Philadelphia, PA 19101-8299 Dear Dr. Henesey: Please refer to your supplemental new drug application dated August 20, 2004, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Cordarone (amiodarone HCl) 200 mg Tablets. We acknowledge receipt of your submission dated October 25, 2004. This supplemental new drug application provides for the addition of a medication guide to the approved labeling. In addition, a reference to the medication guide has been added to the PRECAUTIONS section of the package insert labeling, and to the carton and container labels. We have completed our review of this application. This application is approved, effective on the date of this letter, for use as recommended in the agreed-upon labeling text. The final printed labeling (FPL) must be identical to the enclosed labeling (text for the package insert, text for the medication guide) and submitted labeling (immediate container and carton labels submitted October 25, 2004). Please submit the FPL electronically according to the guidance for industry titled Providing Regulatory Submissions in Electronic Format - NDA. Alternatively, you may submit 20 paper copies of the FPL as soon as it is available, in no case more than 30 days after it is printed. Please individually mount 15 of the copies on heavy-weight paper or similar material. For administrative purposes, this submission should be designated "FPL for approved supplement NDA 18-972/S-030.” Approval of this submission by FDA is not required before the labeling is used. If you issue a letter communicating important information about this drug product (i.e., a “Dear Health Care Professional” letter), we request that you submit a copy of the letter to this NDA and a copy to the following address: MEDWATCH, HFD-410 FDA 5600 Fishers Lane Rockville, MD 20857 We remind you that you must comply with reporting requirements for an approved NDA (21 CFR 314.80 and 314.81). If you have any questions, please contact: Mr. Russell Fortney Case 2:16-cv-02362-ER Document 30-4 Filed 10/25/16 Page 2 of 4 NDA 18-972/S-030 Page 2 Regulatory Health Project Manager (301) 594-5311 Sincerely, {See appended electronic signature page} Norman Stockbridge, M.D., Ph.D. Acting Director Division of Cardio-Renal Drug Products Office of Drug Evaluation I Center for Drug Evaluation and Research Enclosure Case 2:16-cv-02362-ER Document 30-4 Filed 10/25/16 Page 3 of 4 --------------------------------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------------------- /s/ --------------------- Norman Stockbridge 12/3/04 11:28:26 AM Case 2:16-cv-02362-ER Document 30-4 Filed 10/25/16 Page 4 of 4