Supreme Court of the United States

Transcription

1 NO IN THE Supreme Court of the United States October Term 2017 ALICE IVERS, Petitioner, v. WESTERLY PHARMACEUTICAL, INC. Respondent. On Writ of Certiorari to the United States Court of Appeals for the Twelfth Circuit BRIEF FOR PETITIONER Team 2618 Attorneys for Petitioner

2 QUESTIONS PRESENTED I. Are Kimberly Ivers State law claims preempted by the Hatch-Waxman Act when they would, in fact, supplement the Act by requiring Respondent to comply with its Federal duty of sameness within a reasonable time under the Illinoiza Products Liability Act? II. Are attorney s fees available as part of costs under Federal Rule of Civil Procedure Rule 41(d) where the rule does not mention costs, where the underlying statute does not mention attorney s fees, and where the litigant did not act vexatiously or engage in forum shopping? i

3 TABLE OF CONTENTS QUESTIONS PRESENTED i TABLE OF CONTENTS ii TABLE OF AUTHORITIES v OPINIONS BELOW CONSTITUTIONAL AND STATUTORY PROVISIONS...1 STATEMENT OF THE CASE SUMMARY OF THE ARGUMENT ARGUMENT I. STANDARD OF REVIEW FOR QUESTION ONE II. IVERS CLAIMS UNDER THE ILLINOIZA PRODUCTS LIABILITY ACT SHOULD NOT BE DISMISSED ON THE PLEADINGS SINCE HER CLAIMS ARE NOT PREEMPTED BY FEDERAL LAW WHEN THEY POSE NO OBSTACLE TO AND ARE NOT INCONGRUENT WITH THE HATCH- WAXMAN ACT ii

4 A. Ivers claim is not preempted under a theory of obstacle preemption because her claim does not frustrate the purpose of the Hatch-Waxman Act...12 B. Ivers claims are not preempted by Federal law due to impossibility since it is not just possible, but required, under the Hatch-Waxman Act that Respondent update its label to mirror the brand name s warnings and its failure to do so is what Ivers is claiming caused her harm under Illinoiza state law..18 III. STANDARD OF REVIEW FOR QUESTION TWO.25 IV. ATTORNEY S FEES ARE NOT AVAILABLE UNDER RULE 41(D) WHERE THE UNDERLYING STATUTE DOS NOT PROVIDE FOR SUCH FEES, WHERE CONGRESS DID NOT SPECIFICALLY MENTION ATTORNEY S FEES AS PART OF COSTS, AND WHERE POLICY CONCERNS DO NOT JUSTIFY A DEVIATION FROM THE AMERICAN RULE...25 A. The plain meaning of Rule 41(d) does not allow for attorney s fees B. Attorney s fees should not be granted under Rule 41(d) where the underlying statute does not explicitly provide for such fees...28 C. Policy concerns regarding forum shopping and vexatious litigation do not justify a deviation from the plain meaning of the Federal Rules of Civil Procedure..31 CONCLUSION iii

5 APPENDIX A..I APPENDIX B.... II APPENDIX C.. III APPENDIX D.. IV APPENDIX E... V APPENDIX F... VII iv

6 TABLE OF AUTHORITIES Federal Cases: Page(s) Alyeska Pipeline Serv. Co. v. Wilderness Soc'y, 421 U.S. 240 (1975)..25 Andrews v. America s Living Centers, LLC, 827 F.3d 306 (4th Cir. 2016)...25, 29, 30, 31 Bell A. Corp. v. Twombly, 550 U.S. 544 (2007)..10 Crosby v. Natl. For. Trade Council, 530 U.S. 363 (2000).. 11 Esposito v. Piatrowski, 223 F.3d 497 (7th Cir. 2000) 25, 26, 29, 30, 31 Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013)... 11, 12, 20, 22 Guarino v. Wyeth, LLC, 719 F.3d 1245 (11th Cir. 2013)..21 Keeton v. Hustler Magazine, Inc., 456 U.S. 770, (1984)...31, 32 Lashley v. Pfizer, Inc., v

7 750 F.3d 470 (5th Cir. 2014)...20 Marek v. Chesny, 473 U.S. 1 (1985) 28, 29 Meredith v. Stovall, 216 F.3d 1087 (10th Cir. 2000).. 32 Moretti v. Wyeth, Inc., 579 Fed. Appx. 563, 566 (9th Cir. 2014) (unpublished)...21 Morris v. PLIVA, 713 F.3d 774 (5th Cir. 2013).4, 20, 21, 23 Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S. Ct (2013)..22 PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011). 10, 15, 21 Ramirez v. Dept. of Corrections, Colo., 222 F.3d 1238 (10th Cir. 2000)..10 Rogers v. Wal-Mart Stores, Inc., 230 F.3d 868 (6th Cir. 2000)...27 Starr v. Hill, No-2070-STA, 2010 WL , at *12 (W.D. Tenn. June 16, 2010) Strayhorn v. Wyeth Pharm., Inc., 737 F.3d 378 (6th Cir. 2013)...21 Wagner v. Teva Pharm. USA, Inc., 840 F.3d 355 (7th Cir. 2016)...21 Watson v. Mylan Pharm., Inc., , 2017 WL (10th Cir. July 13, 2017).21 Wyeth v. Levine, 555 U.S. 555 (2009)..11, 14, 16, 18 State Cases: vi

8 Teva Pharm. USA, Inc. v. Super. Ct., 158 Cal. Rptr. 3d 150 (Cal. App. 4th Dist. 2013) Constitutional Provisions: U.S. Const. art. VI, cl U.S. Const. amend. X...10 Federal Statutes: Fed. R. Civ. P. 41(d). 1, 2, 5, 6, 8, 9, Fed. R. Civ. P , 28, 30 Fed. R. Civ. P. 12(c)....10, 12, 18, 19, 25, 34 Hatch-Waxman Act. 21 U.S.C. 355(j)..1, 2, 6-8, 10-14, 17-24, 34 State Statutes: East Tx. Code Ann , 30 Illz. Prod. Liability Act (1).. 1, 2, 6, 8, 10, 24, 34 Secondary Sources: Edward X. Clinton, Jr., Does Rule 41(d) Authorize an Award of Attorney's Fees?, 71 St. John's L. Rev. 81 (1997)..27 Arthur L. Corbin, Legal Analysis and Terminology, 29 Yale L.J. 163, 169, 170 (1919). 14 Fed. R. Civ. P. 41(d), Notes of Advisory Committee on Rules Forum Shopping Reconsidered, 103 Harv. L. Rev (1990) vii

9 viii

10 TO THE HONORABLE SUPREME COURT OF THE UNITED STATES: Petitioner, Alice Ivers, appellant in the United States Court of Appeals for the Twelfth Circuit, and plaintiff in the United States District Court for the District of Illinoiza, submits this brief in support of her request that this Court find that Alice Ivers claims under the Illinoiza Products Liability Act are not preempted by the Hatch-Waxman Act and that Respondent is not entitled to attorney s fees under Federal Rule of Civil Procedure 41(d). OPINIONS BELOW The opinion and order for the United States Court of Appeals for the Twelfth Circuit is unpublished and unreported, but can be found at Alice Ivers v. Westerly Pharmaceutical, Inc., No (12 th Cir. February 2, 2017), and appears in the record at The opinion and order for the United States District Court for the District of Illinoiza is unpublished and unreported, but can be found at Alice Ivers v. Westerly Pharmaceutical, Inc., No CV (D. Illinoiza December 20, 2015), and appears in the record at 1-8. CONSTITUTIONAL AND STATUTORY PROVISIONS The Illinoiza state statute at issue, the Illinoiza Products Liability Act, is located at Appendix A. The constitutional provisions at issue, the Supremacy Clause of Article Six and the Tenth Amendment are found at Appendix B and C. Federal Civil Procedural Rule 41(d) is found at Appendix D. The Hatch-Waxman Act is found at Appendix E, and East Texas Code Annotated is found at Appendix F. 1

11 STATEMENT OF THE CASE This case involves a dispute over whether Alice Ivers claims under the Illinoiza Products Liability Act are preempted by the Drug Price Competition and Patent Term Restoration Act of 1984 ( Hatch-Waxman Act ). In addition, the parties are in dispute over whether an award of costs under Federal Civil Rule 41(d) ( 41(d) ) should be interpreted to include attorney s fees. The Drug In 1997, GlaxoCline, LLC patented a new drug to alleviate symptoms of Parkinson s disease and called it Equip. (R. 2.) After a strenuous and lengthy process to ensure patient safety, GlaxoCline, LLC was permitted by the Federal Drug Administration ( FDA ) to market Equip. (R. 2.) Equip is made from Ropidope Hydrochloride ( Ropidope ), which inhibits dopamine reactions associated with Parkinson s disease symptoms. (R. 1.) After GlaxoCline, LLC s patent expired in 2008, Respondent submitted an Abbreviated New Drug Application ( ANDA ) to the FDA in order to sell the generic version of Equip. (R. 2.) After ensuring that Respondent would be selling the exact same drug with the same warnings and labels as Equip, the FDA approved Respondent s request and they began selling it in (R. 2.) In January 2011, GlaxoCline submitted a supplemental New Drug Application to the FDA, seeking approval to change its package insert and labeling in order to reflect warnings that, among other things, use of Ropidope leads to intense urges toward compulsive behavior such as gambling and spending money. (R. 2.) The FDA approved these changes and GlaxoCline implemented them in 2

12 June (R. 2.) Respondent did not, at this time, take any action to change its labeling and warnings. (R. 2, 3.) Alice Ivers Alice Ivers, a resident of Cardozo, Illinoiza, was diagnosed with Parkinson s disease in February of (R. 1.) Within one month, her physician prescribed her Ropidope to treat the symptoms of her Parkinson s disease. (R. 1.) Starting in March 2011, Alice Ivers began taking the generic form of the drug, manufactured by Respondent, daily. (R. 1.) Within two months, in July of 2011, Alice Ivers developed compulsive spending and gambling habits. (R. 3.) Respondent, by this time, had still not taken any action to change its labeling and warnings, despite GlaxoCline already having implemented labels and warnings specifically regarding the compulsive behavior one month prior. (R. 2, 3.) Ivers played online poker continuously in her waking hours and, in the course of several months, had transferred the majority of her retirement savings into an online poker account. (R. 3.) It had been many months since GlaxoCline changed their label, but Respondent had still failed to take any action to do the same. (R. 2, 3.) While Ivers would often win substantial sums through her online poker habit, she felt compelled to spend it all on charitable gifts and antique auctions, steadily depleting her retirement savings. (R. 3.) Finally, in January 2012, Respondent submitted a Changes Being Effected notification to the FDA to let them know that, effective February 1, 2012, it would be updating its labels and warnings to match those of Equip. (R. 2, 3.) After less 3

13 than four weeks, the FDA approved the notification and Respondent changed its labels and warnings, effective February 1, (R. 2, 3.) It had been six months before Respondent took action to change its labels and warnings to match those of GlaxoCline s Equip. (R. 2, 3.) Between June, 2011 and February, 2012, Respondent s labels and warnings did not notify users about the possibility of compulsive behavior. (R. 2, 3.) By the time they did, it was too late for Alice Ivers. In November, 2012, her husband filed for divorce, having found out she completely depleted their retirement savings. (R. 3.) The Proceedings Alice Ivers originally brought this lawsuit in the fifth circuit, to the United States District Court of Texas, where Respondent has its headquarters. (R. 1, 5.) She filed on January 15, 2013 and, around the same time, Morris v. PLIVA, 713 F.3d 774 (5th Cir. 2013), was decided in the same circuit. (R. 5.) On February 25, 2013, Ivers voluntarily dismissed her claims under Federal Civil Procedure Rule 41(a)(1)(A). (R. 5, 6.) Respondent had not, by that time, filed their answer yet. (R. 6.) The rule allows for a one-time dismissal without prejudice when done before defendant has filed an answer. (R. 6.) While the rule also allows for a court to order that a plaintiff pay costs if plaintiff files the claim again, by the time she refiled her lawsuit, Ivers was without any retirement savings and likely divorced or separated from her husband. (R. 3, 6.) Alice Ivers filed this cause of action in her home state in the state court of Illinoiza on September 15, (R. 1.) Respondent, one month later, removed the 4

14 case to the United States District Court of Illinoiza and filed their answer and a motion to dismiss on the pleadings as well as a motion for costs, including attorney s fees. (R. 1.) While the court granted Respondent s motion to dismiss on the pleadings and their motion for costs from the first case, the court did not agree with Respondent that attorney s fees should be interpreted into the plain meaning of Federal Civil Procedure Rule 41(d). (R. 7.) Both Ivers and Respondent appealed the decision to the twelfth circuit, but that circuit affirmed the lower court s ruling on the motion to dismiss on the pleadings and the award of costs. (R. 10, 11.) The twelfth circuit also reversed the lower court s ruling on attorney s fees and granted them to Respondent. (R. 10.) Alice Ivers then timely filed her petition for a writ of certiorari and this Court granted the questions at issue. (R. 23.) 5

15 SUMMARY OF THE ARGUMENT Alice Ivers, an Illinoiza resident suffering from Parkinson s disease and left destitute and without her spouse, seeks relief from this Court from the twelfth circuit s ruling that her claims under the Illinoiza Products Liability Act are preempted by the Federal law known as the Hatch-Waxman Act. She also seeks relief from this Court from the twelfth circuit s salt in the wound ruling that she must pay attorney s fees to Respondent for her initial lawsuit filed in the fifth circuit. We ask that this Court vacate the twelfth circuit s ruling and find that her failure to update claims are not preempted by Federal law. We further ask that this Court find that attorney s fees are not available as part of costs under Federal Rule of Civil Procedure 41(d). Preemption While this Court has a complicated taxonomy of types of preemption under the Supremacy Clause, the only one at issue in this case is conflict preemption. The Hatch-Waxman Act contains no express preemption clause. Rather, Respondent argues, and the twelfth circuit agreed, that Ivers state law claims were preempted both because they created an obstacle to the purposes of Congress in creating the Hatch-Waxman Act and because it would not be possible for Respondent to comply with both its state duties to Ivers and its Federal duties under the Hatch-Waxman Act. Alice Ivers state law claims do not create an obstacle to the purposes of Congress in enacting the Hatch-Waxman Act. First, while the purpose of the 6

16 Hatch-Waxman Act was to speed FDA approval of generic drugs, it is equally important to the act that such generic drugs be safe to the public. The Hatch- Waxman Act requires generic drugs do be identical to the corollary brand name drug, and all brand name drugs must go through extensive testing to demonstrate safety. Thus, by requiring generic drugs to be identical to the branded drug, Congress made clear that they did not intend to sacrifice safety in the name of getting the drug more quickly approved. Alice Ivers claim would help to ensure the safety of generic drugs, and thus is not contrary to the purpose of the Hatch- Waxman Act. Not only is Alice Ivers claim not an obstacle to the implementation of the Hatch-Waxman Act it actually supplements it. While the Hatch-Waxman Act requires generic drug manufacturers to certify the aforementioned sameness to the branded drug, the act provides no remedy to an individual injured by a company that failed to update its safety information to comply with that duty of sameness. Thus, a consumer could potentially have the right to a safe drug as required by the duty of sameness yet no remedy for a violation of that right by a generic drug manufacturer. As such, imposing a duty to comply with sameness pairs a remedy with that right, and serves to supplement the Hatch-Waxman Act. Alice Ivers claims do not create a state law duty that would make it impossible for Respondent to comply with while complying with the Federal duties created by the Hatch-Waxman Act. This Court, in its earlier rulings regarding the Hatch-Waxman Act and generic drugs, focused on contexts in which the state law 7

17 duties required by plaintiff s claims would have required defendant generic drug manufacturers to change their warnings and labels when the brand name drug manufacturer had not done so. This directly conflicted with the Hatch-Waxman Act. The Hatch-Waxman Act required a Federal duty of sameness (in chemistry, labeling, inserts and warnings) between the generic and brand name drugs. Thus, it was not possible to perform the two duties. Ivers claims are different. Alice Ivers claims that Respondent failed to update its labeling and warnings in a reasonable time, specifically during the time that the brand name drug had the sufficient labeling and warnings. Quite simply, this makes the duty arising from state law, to update labeling and warnings in a reasonable amount of time, consistent with the Federal duty of sameness since, during that reasonable amount of time, Respondent was required under Federal law to update its labeling and warnings to match those of the brand name drugs. For this reason, we ask this Court to find that Ivers claims are not preempted by Federal law due to any alleged impossibility of Respondent s ability to comply with both state and Federal duties. This Court should vacate the twelfth circuit s ruling and find that Alice Ivers claims under the Illinoiza Products Liability Act are not preempted by the Hatch- Waxman Act. Costs Attorney s fees should not be given to respondent as part of costs under Federal Rule of Civil Procedure Rule 41(d). Readings the word costs in Rule 41(d) 8

18 to mean attorney s fees would be reading into the rule language that is not there, and going against the plain meaning of the rule. Furthermore, the absence of the words attorney s fees from Rule 41(d) are evidence that Congress did not intend for Rule 41(d) to include attorney s fees, since other rules of civil procedure specifically name attorney s fees as part of costs. This Court has reviewed another rule in the past, Federal Rule of Civil Procedure Rule 68, and held that absent an underlying statute that allows for attorney s fees, such fees are not to be awarded. Here, the underlying statute in question does not allow for attorney s fees. Lastly, policy concerns that govern vexatious litigation and forum shopping as a justification for awarding attorneys fees and costs do not apply in this case. Ivers was not engaging in vexatious litigation, and she was not engaging in statefederal forum shopping that has been traditionally disfavored by this court. Furthermore, the District court may have abused its discretion when it did not properly analyze if any costs were appropriate given Ivers lack of money due to her charitable donations. Therefore, this court should reverse the Circuit court s judgment granting attorney s fees to respondent, and find that an award of attorney s fees is not available under Rule 41(d). 9

19 ARGUMENT I. STANDARD OF REVIEW FOR QUESTION ONE 12(c) motions to dismiss on the pleadings share the same standard as 12(b)6 motions to dismiss. Ramirez v. Dept. of Corrections, Colo., 222 F.3d 1238, 1240 (10th Cir. 2000). This Court reviews 12(b)6 motions to dismiss de novo. PLIVA, Inc. v. Mensing, 564 U.S. 604, 617 (2011). To prevail against a motion to dismiss, a Plaintiff need only have pleaded sufficient facts, taken as true, to state a claim to relief that is plausible on its face. Bell A. Corp. v. Twombly, 550 U.S. 544, 570 (2007). II. IVERS CLAIMS UNDER THE ILLINOIZA PRODUCTS LIABILITY ACT SHOULD NOT BE DISMISSED ON THE PLEADINGS SINCE HER CLAIMS ARE NOT PREEMPTED BY FEDERAL LAW WHEN THEY POSE NO OBSTACLE TO AND ARE NOT INCONGRUENT WITH THE HATCH-WAXMAN ACT. Ivers pleadings under state law are not in conflict with the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch- Waxman Act. They neither create an obstacle for the purposes of Congress in the passing of the Act, nor do they present an impossibility for Respondent to overcome in following both their state and Federal duties. The Constitution is the supreme law of the land and it grants Congress the power to preempt state law. U.S. Const. art. VI, cl. 2. Notwithstanding this, the tenth amendment grants to the states or to the people all powers not granted to the federal government or prohibited to the states. U.S. Const. amend. X. Flowing from these parameters, any preemption analysis starts with the assumption that 10

20 the historic police powers of the States, e.g. health and safety, are not to be superseded by any Federal Act unless that was the clear and manifest purpose of Congress. Wyeth v. Levine, 555 U.S. 555, 565 (2009). The central question in preemption analysis is whether sufficient evidence has been provided, overcoming the presumption against preemption, that Congress intended to preempt state law. Id. This Court has developed a three-part overarching taxonomy of preemption. Crosby v. Natl. For. Trade Council, 530 U.S. 363, (2000). Claims under state law may be preempted by an express provision of Congress when enacting a Federal law. Id. Without an express provision for preemption, this Court finds preemption implied in two instances: When the movant either proves that Congress intended to take over the field from the states or there is a clear conflict between the two laws. Id. Conflict preemption is found in one of two ways: 1) When it is found that the state law creates an obstacle to the purpose and objectives of Congress in creating the Federal law; or, 2) When it is found to be impossible to perform both what state law and Federal law require. Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 584 (6th Cir. 2013). The Hatch-Waxman Act contains no express provision preempting state law and no argument has been made that Congress intended to take over the health law field from the states. Respondent, instead, has focused on an illusory conflict between the two laws. (R. 4.) Thus, what is at issue here is conflict preemption; however, no such conflict exists. There is simply no way to ignore the overarching 11

21 purpose of Congress that drugs, even generic ones, must be safe for people using them. This is totally consistent with the state duty to warn consumers of foreseeable dangers as they arise. In addition, Ivers claims that Respondent acted negligently only during the period that Respondent failed to update its label to mirror the brand name label. (R. 15.) The Hatch-Waxman Act is not just consistent with this state duty, but requires it. (R ) Therefore, we ask that this Court find that Ivers claims are not preempted by the Hatch-Waxman Act and deny Respondent s 12(c) motion to dismiss on the pleadings. A. Ivers claim is not preempted under a theory of obstacle preemption because her claim does not frustrate the purpose of the Hatch-Waxman-Waxman Act. Obstacle preemption occurs when a state law frustrates the purpose or implementation of legislation passed by congress. Hines v. Davidowitz, 312 U.S. 52, 67 (1941). The imposition of a state law duty to update the warning and safety label of a generic drug to match the warning and safety label of its brand name corollary does not frustrate the purposes of the Drug Price Competition and Patent Term Restoration Act of 1984 otherwise known as the Hatch-Waxman Act. Moreover, such a state law duty serves to supplement and strengthen the Hatch- Waxman Act. The Hatch-Waxman Act was passed by congress as an amendment to the Food, Drug, and Cosmetic Act (the FDCA) for the purpose of facilitating the entry of generic drugs onto the market in order to help relieve the financial of brand name drugs on the healthcare field. Caraco Pharmaceuticals Laboratories Ltd. v. Novo 12

22 Nordisk A/S, 566 U.S. 399, 405 (2012). Congress employed a variety of devices in the Hatch-Waxman Act to facilitate entry of generic drug alternatives into the market, but of specific importance was a provision permitting generic manufacturers to submit an abbreviated application to the FDA for the approval of the drug. Eli Lilly and Co. v. Medtronic, 496 U.S. 661, 676. This abbreviated application (abbreviated new drug application, or ANDA) speeds the approval of generic drugs by not requiring the extensive studies, multiple phases of clinical trials, and testing required for FDA approval of brand name drugs. Fulgenzi v. PLIVA, 711 F.3d at 581. Rather, a generic drug manufacturer need only certify that its generic drug has the same active ingredients and is biologically equivalent. This duty is known as sameness. Id. at 582. Congress did not intend to compromise drug safety at the expense of bringing generic drugs more quickly to market. Fulgenzi, 711 F.3d at 585. While the Hatch- Waxman Act aimed to facilitate the process of getting generics to the market, the FDCA, and specifically the Kefauvor Harris Act, requires brand name drugs to demonstrate safety in order to receive FDA approval. Id Because the Hatch- Waxman Act requires sameness of a generic to its corollary brand name drug, and because the Kefauvor Harris Act requires brand name drugs to demonstrate safety before approval, the sameness requirement of the Hatch-Waxman Act functions to ensure the safety of generic drugs. Id It is this combination of allowing generic drugs to be approved via an abbreviated process, while also requiring sameness to the branded drug, that allows the Hatch-Waxman Act to speed generic 13

23 entry into the market without sacrificing drug safety. Id. The sameness requirement plainly demonstrates that congress had no intention to sacrifice drug safety in order to achieve approval of generic drugs more quickly. Id. Thus, both speed and safety are essential purposes of the Hatch-Waxman Act. A duty to update safety information within a reasonable time strengthens the Hatch-Waxman Act by providing a remedy to those individuals injured when a manufacturer violates their duty of sameness. Wyeth v. Levine, 555. U.S. 555, 574 (2009). Where a duty is imposed, there must logically be a corresponding right conferred. Arthur L. Corbin, Legal Analysis and Terminology, 29 Yale L.J. 163, 169, 170 (1919). Further, where an individual has a right, there must by absolute necessity be a corresponding remedy. Marbury v. Madison, 5 U.S. 137 (1803). In Wyeth v. Levine, the Supreme Court addressed the issue of availability of a state tort remedy against manufacturers of brand name drugs for failure to provide adequate safety information. Wyeth, 555 U.S. at In Wyeth, plaintiff brought suit against the manufacturer of Phenergan, alleging injury as a result of failure to provide risk information associated with intravenous administration of Phenergan. Id. The Court recognized the duty of brand drug manufacturers to provide adequate safety information pursuant to the FDCA. Id. at 574. Further, by recognizing such a duty, the Court implicitly recognized the corresponding right of a consumer to have adequate safety information about a drug. Id. The Court held that a state tort remedy for failure to provide adequate safety information should be available. Id. at 579. In support of its holding, the Court specifically cited the fact 14

24 that the FDCA provided no remedy for an individual injured by a company which violated its duty to provide safety information. Id. at 574. Thus, where a Federal statute creates a duty, but provides no specific remedy, a state cause of action can serve to supplement the Federal statute by providing a remedy. The duty of sameness required for approval of generic drugs via an Abbreviated New Drug Application ( ANDA ) is an ongoing duty. PLIVA v. Mensing. 564 U.S. 604, 613 (2011). Sameness is required for approval of a generic drug, but there are also situations in which the duty of sameness becomes relevant even after the approval of a generic drug. Id. at 614. This situation arises when a generic drug has been approved, and the brand name drug has a change to its safety information. Id. The duty of sameness of a generic manufacturer arises in this scenario, as a requirement of its availability on the market is that its safety label match that of the brand drug. Id. Thus, where a brand name drug changes its label, generic drug manufacturers have a duty to update the generic form of the drug to match the changes made to the brand name label. Ivers claim based on the failure of Respondent to timely update the warning label does not frustrate the purpose of speedy approval of generic drugs. As discussed above, the mechanism used by congress to speed approval of generic drugs was the implementation of an Abbreviated New Drug Application, or ANDA. However, congress clearly demonstrated that it was not their intent to sacrifice safety in the name of efficiency by imposing a duty of sameness on the generic manufacturer. Just as the ANDA was the mechanism by which congress sped the 15

25 approval of generic drugs, the duty of sameness is mechanism by which congress ensured the safety of generic drugs. Ivers merely seeks to impose a duty for Respondent to do that which is already a prerequisite for Respondent to have Ropidope on the market. Ivers proposed duty to update safety information within a reasonable time therefore does not frustrate the purpose of the act, as safety is equally important to speed when approving a generic drug. A duty to update safety information to match that of the brand name within a reasonable time strengthens and supplements the Hatch-Waxman Act because it creates a remedy for those injured as a result of violations of the Act. The reasoning of the Wyeth Court is directly applicable to this case. Both Wyeth and this case involve a duty imposed on drug manufacturers by federal legislation, but in both cases, no remedy is provided for those who are injured by violation of that duty. In Wyeth, the FDCA required a duty for brand drug makers to provide adequate safety information, thus creating a corresponding right for consumers to have access to that information before taking the drug. Similarly, the Hatch-Waxman Act imposes the duty of sameness on generic manufacturers, creating a corresponding right for consumers taking a generic drug to have the same safety information as the corollary brand name drug. Just as the Wyeth court grounded its recognition of a state tort for violation of the FDCA on the reasoning that the FDCA provided no remedy to an injured party, the Court here should recognize a state tort because the Hatch-Waxman Act provides no remedy to an individual injured by a manufacturer violating its duty of sameness. To deny Ivers proposed duty to update safety 16

26 information within a reasonable time would to be deny petitioner a remedy where she has a clearly articulated right. Thus, imposition of such a duty supplements and strengthens the Hatch-Waxman Act by providing a remedy Petitioner who claims injury as a result of violation of the act. Finally, Ivers claim does not center on any action taken by Respondent at any time before the FDA approved Respondent s ANDA for Ropidope. There is no claim that Respondent violated its duty of sameness prior to its approval by the FDA. Such a claim would be nonsensical as sameness is a prerequisite for approval, and Ropidope would not be on the market if it had not met its duty of sameness when it applied for approval. The duty of sameness relevant here is that which arose when the brand name corollary of Ropidope updated its safety information. When this occurred, Respondent had a duty to update the safety information on Ropidope. Moreover, Ivers does not even base her claim on the fact that Respondent failed to meet its duty of sameness, but rather that it failed to do so within a reasonable time. She seeks to impose a duty that when a generic drug is on the market, and its brand name corollary changes its safety information, the generic manufacturer must update its safety information within a reasonable time. The duty of sameness implicated here is not that which is required for initial approval. Rather, her claim focuses on the action by Respondent after Ropidope had been approved and was available on the market. Ivers claim is not that Respondent violated its duty of sameness. Rather, her claim is that once on the market, after the brand name corollary of Ropidope changed its safety information, Respondent 17

27 failed to follow suit in a reasonable time. Because the duty of reasonableness she seeks to impose on Respondent is one that arises after Ropidope had already been approved by the FDA, such a duty would pose little, if any, barrier to generic drugs making it to the market. Implementation of a state duty of reasonableness does not frustrate the purpose of the Hatch-Waxman act because safety is an important part of the purpose of the act. Moreover, such a duty supplements the act in that it provides a remedy for the right of safety conferred in the act. As such, obstacle preemption should not apply to Ivers claim. B. Ivers claims are not preempted by Federal law due to impossibility since it is not just possible, but required, under the Hatch-Waxman Act that Respondent update its label to mirror the brand name s warnings and its failure to do so is what Ivers is claiming caused her harm under Illinoiza state law. Respondent does not prevail on their claim that the Hatch-Waxman Act preempts Ivers state law claims because it is, in fact, not just consistent with, but a requirement under Federal law that Respondent comply with the state duties raised by Ivers claims. In order to prevail on a claim that a federal law preempts a state law through impossibility, the 12(c) movant must demonstrate that it is impossible to comply with both federal and state requirements. Wyeth v. Levine, 555 U.S. at 573. Impossibility preemption is a demanding defense. Id. The presumption against preemption requires more than just a showing that it is possible that the two duties could conflict, but that they actually do. Id. 18

28 Ivers claims that Respondent violated its duty under Illinoiza state law to have an updated label within a reasonable amount of time that warned of the harm she could suffer by taking Ropidope. (R. 15.) The claim, at its core, utilizes as evidence Respondent s Federal duty to keep its label updated with the brand name drug it was based on. For, Ivers alleges, the brand name drug label was adequate. Effectively, Ivers claim is that, had Respondent met its Federal duty of sameness within a reasonable time, it would have met its state duty to adequately warn. That it did not do so is evidence that it failed to meet its Illinoiza state law duty to warn. As Ivers state law claim does not trade on Respondent meeting a duty that would violate its Federal duty of sameness, Respondent s state law duty and Federal duty of sameness are not incongruent. This puts Ivers claims squarely outside the realm of this Court s Mensing and Mutual line of cases. In fact, the Federal duty of sameness effectively requires Respondent to meet the state law duty under Illinoiza law that Ivers alleges Respondent failed to meet. Furthermore, Ivers claims of harm do not also trade on the brand name drug label being inadequate. Her claims, therefore, in no way involve a requirement for Respondent to violate the Federal duty of sameness; they rest on the narrow ledge set by a number of circuits in order to avoid preemption by Federal law in cases like these. We ask this Court to find that Ivers claims are not preempted by Federal law and to deny Respondent s 12(c) motion to dismiss on the pleadings. 19

29 State law claims that the generic manufacturer failed to update its label to mirror brand name warnings are not preempted by the Hatch-Waxman Act. Fulgenzi v. PLIVA, Inc., 711 F.3d at 584. Fulgenzi brought failure to warn claims against PLIVA, a generic drug manufacturer, specifically alleging that PLIVA failed to update their label to match the brand name drug label. Id. at The court noted that PLIVA had a Federal duty of sameness under the Hatch-Waxman Act to update its label to match the brand name drug s warning label. Id. at 584. As Fulgenzi had alleged that it was PLIVA s failure to meet this sameness duty under Federal law that violated the state law, the court reasoned that there was no conflict between the state and Federal duties. Id. As there was no conflict between the state and Federal duties, the court concluded that the Hatch-Waxman Act did not preempt the state law. Failure to update claims are not preempted by the Hatch-Waxman Act when the harm alleged arises only from the period of time that the generic drug manufacturer failed to update their warnings to match the brand name drug. Morris v. PLIVA, 713 F.3d 774, 777 (5 th Cir. 2013). The fifth circuit in Morris further refined the finding in Fulgenzi. See Id. Morris had pleaded that PLIVA had violated the sameness duty, but had also pleaded that once the labels were the same, they were still inadequate. Id. Underlying this legal posture is the claim that the generic manufacturer s label was inadequate, even when it matched the brand name s label. Lashley v. Pfizer, Inc., 750 F.3d 470, 475 (5th Cir. 2014). Thus, under these specific types of pleadings, to meet its state duty, the generic 20

30 manufacturer would have had to change its label from the brand name drug s label. Id. This would violate its Federal duty of sameness under the Hatch-Waxman Act and would thus make the state law preempted by Federal law. Teva Pharm. USA, Inc. v. Super. Ct., 158 Cal. Rptr. 3d 150, 160 (Cal. App. 4th Dist. 2013). Therefore, where the pleadings are that the generic manufacturer s warning label was only inadequate during the time that it was not the same as the brand name manufacturer s, state law is not preempted by Federal law and the pleadings are sufficient. Strayhorn v. Wyeth Pharm., Inc., 737 F.3d 378, 399 (6th Cir. 2013). A number of courts since have followed either the Fulgenzi or Morris line of reasoning. See Wagner v. Teva Pharm. USA, Inc., 840 F.3d 355, 359 (7th Cir. 2016); Moretti v. Wyeth, Inc., 579 Fed. Appx. 563, 566 (9th Cir. 2014)(unpublished); Watson v. Mylan Pharm., Inc., , 2017 WL , at *2 (10th Cir. July 13, 2017); Guarino v. Wyeth, LLC, 719 F.3d 1245, 1249 (11th Cir. 2013). On the other hand, when state law duties require generic drug manufacturers to violate their Federal duty of sameness in labeling, then those state law duties are preempted by the Hatch-Waxman Act. PLIVA v. Mensing, 564 U.S. at Mensing was a consolidation of two cases with nearly identical facts. Id. at 610. This Court confronted whether Federal law preempts state law when the claims pleaded under the state law would require generic drug manufacturers to change their warning labels to differ from the warnings on the brand name drugs they are a copy of. Id. This Court took note in its reasoning that Federal law requires that generic drug labels must be the same as their brand name 21

31 counterparts. Id. at 613. Thus, this Court reasoned, if the generic manufacturers had changed their labels to accommodate the state duty, they would violate their sameness duty under the Hatch-Waxman Act. Id. at 618. No amount of wiggling could suffice; as long as state law requires a violation of sameness, Federal law, the Court held, preempts state law. Id. at 624. Two years later, this Court reaffirmed this decision when it found that design defect claims in this context are preempted for the same reasons. Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S. Ct. 2466, (2013) (holding that design defect claims in this context also violate the Federal duty of sameness.) At their core, Ivers state liability claims are premised on the theory that Respondent failed to update their labels to give adequate warning, when, Ivers alleges, the brand name drug label was already in place and sufficient. Just like Fulgenzi, Ivers brings claims alleging that Respondent failed to update their labels to mirror the brand name drug manufacturer as soon as they could have. (R. 11.) Here, just like in Fulgenzi, Respondent has a Federal duty under the Hatch- Waxman Act to update its label. (R ) Ivers, similar to Fulgenzi, alleged that it was this violation of their sameness duty that made the label inadequate. (R. 15.) Thus, as the court in Fulgenzi reasoned, this Court should find that Respondent could have complied with both its Federal and state duties. We ask that this Court follow the sixth circuit in Fulgenzi, finding that failure to update claims under state law do not present an impossible conflict between Federal and state duties, 22

32 specifically, as in Ivers claims, when the brand name drug label was already in place and sufficient. Ivers state law claims only concern harm caused by Respondent s labels during the time that Respondent was not in compliance with their sameness duty. (R. 15.) Ivers, like Morris, pleaded that Respondent was liable for failing to update its label to match the brand name manufacturers. (R. 11.) However, unlike in Morris, Ivers did not go on to claim that those updated labels were also inadequate warnings. (R. 15.) Reasoning from this converse fact, this Court should find that Ivers claim, unlike Morris, is not based on an inconsistent legal theory that ultimately requires Respondent to violate its Federal duty to comply with its state duty or vice versa. Therefore, this Court, in holding with a number of circuits, should find that Ivers claim is not preempted by the Hatch-Waxman Act. The failure to update claim that Ivers brings under state law does not require Respondent to violate its duty of sameness under the Hatch-Waxman Act. Unlike Mensing and Bartlett, the key issue in this case is whether Federal law preempts state law when the state duty would require the generic manufacturer to update its label to meet the Federal duty of sameness. (R. 15.) The Court here too should take note that Federal law requires generic manufacturers to follow the duty of sameness. (R ) However, in this case it cuts the opposite way. In contrast to Mensing and Bartlett, the state law duty in this case would force the generic manufacturers to meet their sameness duty. (R. 15.) The state duty actually supplements the Hatch-Waxman Act. As this Court reasoned in Mensing and 23

33 Bartlett that the Federal duty of sameness was the salient factor in determining preemption, so too here. Indeed, the fact that Ivers state claims force Respondent to adhere to their Federal duty of sameness, this Court should conclude that Ivers claims, unlike in Mensing and Bartlett, are in fact not preempted by Federal law. Indeed, not only do they not conflict in this instance, but the state duty here nicely supplements Respondent s Federal duty. We ask, therefore, that this Court rule that the Hatch-Waxman Act does not make it impossible for Respondent to comply with their state law duties as alleged by Ivers under the Illinoiza Products Liability Act. Ivers state law claim does not frustrate the purpose and objective of the Hatch-Waxman Act. While the purpose of the Hatch-Waxman Act was to increase the speed at which generic drugs are approved, Congress did not intend to do so at the cost of safety. Her claims do not prevent a barrier for entry to generic drug manufacturers to get their products on the market. Moreover, her state law claim serves to supplement the Hatch-Waxman Act by providing an enforcement mechanism for the duty of sameness mandated by the Act. In addition, Ivers state law claims are not in conflict with the Hatch-Waxman Act. In fact, Ivers state law claims are based on the harm caused to Ivers when Respondent failed to update their warning labels to mirror the brand name manufacturer labels. Respondent s ability to do so is not just a possibility, but a requirement under the Hatch-Waxman Act. In addition, Ivers does not go on to claim that all the labels, including those that came after, are inadequate as well. Hence, Ivers claims do not present a state 24

34 law duty for Respondent that would have been impossible to meet without violating its Federal duty. Therefore, we ask that this Court vacate the lower court s ruling and deny Respondent s 12(c) motion to dismiss on the pleadings. III. STANDARD OF REVIEW FOR QUESTION TWO The proper scope of a rule of procedure is a question of law subject to de novo review. Andrews v. America s Living Centers, LLC, 827 F.3d 306, 309 (4th Cir. 2016). IV. ATTORNEY S FEES ARE NOT AVAILABLE UNDER RULE 41(D) WHERE THE UNDERLYING STATUTE DOES NOT PROVIDE FOR SUCH FEES, WHERE CONGRESS DID NOT SPECIFICALLY MENTION ATTORNEY S FEES AS PART OF COSTS, AND WHERE POLICY CONCERNS DO NOT JUSTIFY A DEVIATION FROM THE AMERICAN RULE. If a plaintiff who has once dismissed an action in any court commences an action based upon or including the same claim against the same defendant, the court may make such order for the payment of costs of the action previously dismissed as it may deem proper and may stay the proceedings in the action until the plaintiff has complied with the order. Fed. R. Civ. P. 41(d). Federal courts adhere to the American Rule, which recognizes that attorneys' fees are not generally a recoverable cost of litigation (unless specifically ordered by the court or provided by contract). Esposito v. Piatrowski, 223 F.3d 497, 500 (7th Cir. 2000) (citing Alyeska Pipeline Serv. Co. v. Wilderness Soc'y, 421 U.S. 240, 247 (1975)). 25

35 There is no language in the text of Rule 41(d) indicating that Congress intended to alter the American Rule as the rule does not refer to attorneys' fees as an awardable cost. Esposito, 223 F.3d at 500. A party may recover reasonable attorneys' fees as part of its costs under Rule 41(d) only where the underlying statute defines costs to include attorneys' fees. Id. at 501. East Texas Code Annotated states that [i]n actions for personal injury, where plaintiff's claim for damages exceeds twenty-five thousand dollars ($25,000) and includes a written demand for fees, there shall be taxed and allowed to the plaintiff, as part of the costs of the action, a reasonable amount to be fixed by the court as attorney's fees. East Tx. Code Ann The Circuit Court erred in awarding respondent attorney s fees under Rule 41(d). First, where the underlying statute in question, East Texas Code Annotated does not provide for attorney s fees to a defending party, second, where Congress did not specifically mention attorney s fees in Rule 41(d), and third, where Ivers did not remove her case for vexatious reasons or engage in state-federal forum shopping. Consequently, the Circuit Court s granting of attorney s fees to respondent should be reversed. A. The plain meaning of Rule 41(d) does not allow for attorney s fees. The Circuit court erred when it interpreted Rule 41(d) to allow for attorney s fees where such an interpretation went against the plain meaning of the rule. 26

36 Where Congress has intended to provide for an award of attorney fees, it has usually stated as much and not left the courts guessing. Rogers v. Wal-Mart Stores, Inc., 230 F.3d 868, 874 (6th Cir. 2000). Further, the law generally recognizes a difference between the terms costs and attorney fees and we have no desire to conflate the two terms. Id. Rather, we must assume that Congress was aware of the distinction and was careful with its words when it approved Rule 41(d). Id. In Rogers, the Sixth Circuit overturned a District Court decision that had awarded attorney s fees to a respondent under Rule 41(d). Id. at 876. The Court reasoned that although some rules of Civil Procedure leave a level of ambiguity, it is improper for the court to essentially re-draft the rule themselves by reading into it language that is not there. Id. at Thus, the court held that attorney s fees are not available under Rule 41(d) simply because the rule does not explicitly provide for them. Id. at 874. Here, Rule 41(d) does not provide for an award of attorney s fees as part of costs. Like the reasoning in Rogers, where the court held that defining attorney s fees as part of costs in Rule 41(d) would be reading into language absent from the rule, this court should not re-draft a rule of Congress, and instead follow the textual language that Congress has explicitly provided and find that attorney s fees are not available to Respondent. The text of other federal rules further suggests that Rule 41(d) does not authorize an award of attorney s fees. Edward X. Clinton, Jr., Does Rule 41(d) Authorize an Award of Attorney's Fees?, 71 St. John's L. Rev. 81, 90 (1997). For 27

37 example, Rule 37(c)(1) provides for sanctions when a party fails to disclose information required to be disclosed by Rule 26 and allows for a party to recover reasonable expenses, including attorney s fees. Id. The text of these rules allowing recovery of attorney s fees suggests that their drafters understood the difference between costs and attorney s fees and intended to distinguish between the two forms of relief. Id. Thus, given the plain meaning of Rule 41(d), along with the text of other federal rules which specifically name attorney s fees when available, this Court should find that the Circuit court erred when it awarded attorney s fees to Respondent under Rule 41(d). B. Attorney s fees should not be granted under Rule 41(d) where the underlying statute does not explicitly provide for attorney s fees. Beyond the plain meaning of Rule 41(d), the Circuit court should not have awarded attorney s fees as part of costs where the underlying statute did not specifically provide for them. Absent congressional expressions to the contrary, where the underlying statute defines costs to include attorney's fees, only then may such fees be included as costs for purposes of Rule 68. Marek v. Chesny, 473 U.S. 1, 9, (1985). In Marek, this Court refused to interpret the term costs in Federal Rule of Civil Procedure 68 to include attorney s fees where the underlying statute in the initial lawsuit did not specifically allow for them. Id. at The Court reasoned that given the importance of costs to the Rule, it is very unlikely that the omission of 28

38 attorney s fees was a mere oversight, rather, the most reasonable inference is that the term costs in the Rule was intended to refer to all costs properly awardable under the relevant substantive statute or other authority. Id. at 9. Rule 41(d) does not provide for an award of attorneys' fees as a matter of right; instead, a district court may award attorneys' fees under this rule only where the underlying statute provides for attorneys' fees. Andrews, 827 F.3d at 311. In Andrews, the court held that attorney s fees were not available to defendants under Rule 41(d) where the statute that Plaintiff originally brought the suit under, 29 U.S.C. 216(b), stated that when plaintiff prevails a court shall allow a reasonable attorney s fee to be paid by the defendant. Id. at 312. Reasoning that the statue was silent as to attorney s fees in suits where the defendant prevails, the court held that an award of attorney s fees on a statutory basis would be improper. Id. Similarly, in Esposito, the court held that attorney s fees may only be awarded under rule 41(d) where the underlying statute which formed the basis of the original suit allows for recovery of such fees and costs, or unless such fees are specifically ordered by the court. 223 F.3d 497 at 501. Although the court failed to rule that an award of fees was improper since defendant refused to pay the fees during litigation, the court nevertheless reasoned that Esposito s suit, brought under U.S.C. 1983, would only have allowed an award for attorney s fees if the statute had allowed it. Id. Since 1983 only allows for recovery of attorney s fees to respondents in the case of a suit being frivolous, and since that condition was not met, the court held that such an award under 1983 would have been improper. Id. 29