No ALICE IVERS, Petitioner, WESTERLY PHARMACEUTICAL, INC., Respondent. ON WRIT OF CERTIORARI TO THE SUPREME COURT OF THE UNITED STATES

Transcription

1 No ALICE IVERS, Petitioner, v. WESTERLY PHARMACEUTICAL, INC., Respondent. ON WRIT OF CERTIORARI TO THE SUPREME COURT OF THE UNITED STATES BRIEF FOR RESPONDENT Team 2605 Counsel for Respondent October Term, 2017

2 Questions Presented 1. Federal preemption. This Court has held that the Hatch-Waxman Act preempts state-tort claims against generic drug manufacturers. Ivers action against Westerly is based on the Illinoza Product Liability Act a state-tort law. Shouldn t her claim be preempted? 2. Attorney s fees. Most courts have held that attorney s fees are a permissible element of costs under Federal Rule of Civil Procedure 41(d) to deter forum shopping and vexatious litigation. Because Ivers forum-shopped by dismissing and refiling her action in a more-favorable forum, shouldn t this Court promote the Rule s purpose and award attorney s fees to Westerly? -ii-

3 Table of Contents Questions Presented... ii Table of Contents... iii Table of Authorities... v Constitutional and Statutory Provisions Involved... 1 Statement of the Case... 1 Facts... 1 A. Westerly manufactures an FDA-approved generic drug B. Westerly makes FDA-approved changes to the generic drug s labeling C. Ivers takes Westerly s generic drug and claims to develop gambling and money-spending urges Procedural History... 3 A. Ivers files and dismisses the initial action in East Texas state court B. Ivers refiles the same action in Illinoza state court Summary of Arguments The Hatch-Waxman Act preempts state-tort claims against generic drug manufacturers Attorney s fees are a permissible element of costs under Federal Rule of Civil Procedure 41(d) Arguments... 6 Standards of Review The Twelfth Circuit correctly held that the Hatch-Waxman Act preempts statetort claims against generic drug manufacturers A. The Hatch-Waxman Act s text supports preemption of Ivers claim based on the Illinoza Product Liability Act B. The Hatch-Waxman Act s history supports preemption of Ivers claim based on the Illinoza Product Liability Act (1) Statutory history supports preemption of Ivers claim (2) Legislative history supports preemption of Ivers claim C. The Hatch-Waxman Act s purpose supports preemption of Ivers claim based on the Illinoza Product Liability Act iii-

4 2. The Twelfth Circuit correctly held that attorney s fees are permissible costs under Rule 41(d) A. Allowing attorney s fees as permissible costs under Rule 41(d) directly promotes the Rule s underlying purpose: to deter forum shopping and vexatious litigation (1) The record supports the Twelfth Circuit s finding that Ivers was blatantly forum shopping when she dismissed and refiled her lawsuit.. 21 B. Allowing attorney s fees as permissible costs under Rule 41(d) provides interpretative consistency within Rule C. Under the hybrid approach, Westerly is still entitled to an award of fees because Ivers acted with vexatious intent Conclusion Appendix A Appendix B iv-

5 Table of Authorities United States Constitution U.S. Const. art. VI, cl United States Supreme Court Cases Alyeska Pipeline Service Co. v. Wilderness Society, 421 U.S. 240 (1975) Arlington Cent. Sch. Dist. Bd. v. Murphy, 548 U.S. 291 (2006)... 6 BedRoc Ltd., LLC v. United States, 541 U.S. 176 (2004)... 7 Dickerson v. United States, 530 U.S. 428 (2000) Hines v. Davidowitz, 312 U.S. 52 (1941) Holder v. Hall, 512 U.S. 874 (1994) Marek v. Chesny, 473 U.S. 1 (1985)... 23, 25 Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)... 7 Mutual Pharmaceutical v. Bartlett, 133 S. Ct (2013)... passim North Haven Bd. of Educ. v. Bell, 456 US. 512 (1982) Payne v. Tennessee, 501 U.S. 808 (1991) Pearson v. Callahan, 555 U.S. 223 (2009) v-

6 Planned Parenthood of Se. Pa. v. Casey, 505 U.S. 833 (1992) n.1 PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011)... passim Rice v. Santa Fe Elevator Corp., 331 U.S. 218 (1947)... 7 Runyon v. McCrary, 427 U.S. 160 (1976) Seminole Tribe of Florida v. Florida, 517 U.S. 44 (1996) United States v. Borden Co., 370 U.S. 460 (1962) United States v. Turkette, 452 U.S. 576 (1981)... 9 Wyeth v. Levine, 555 U.S. 555 (2009)... 9 United States District Court Cases Andrews v. America s Living Ctrs., LLC, 827 F.3d 306 (4th Cir. 2016)... 18, 19, 23, 24 Davis v. USX Corp., 819 F.2d 1270 (4th Cir. 1987) Esposito v. Piatrowski, 223 F.3d 497 (7th Cir. 2000)... 18, 23 Evans v. Safeway Stores, Inc., 623 F.2d 121 (8th Cir. 1980) Kent v. Bank of Am., N.A., 518 Fed. Appx. 514 (8th Cir. 2013) Meredith v. Stovall, 216 F.3d 1087 (10th Cir. 2000) vi-

7 Morris v. PLIVA, Inc., 713 F.3d 774 (5th Cir. 2013)... 17, 21 Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., 601 F.3d 1359 (Fed. Cir. 2010) Rogers v. Wal-Mart Stores, Inc., 230 F.3d 868 (6th Cir. 2000) Sanderson v. Spectrum Labs, Inc., 248 F.3d 1159 (7th Cir. 2000) Simeone v. First Bank Nat. Ass n, 971 F.2d 103 (8th Cir. 1992) Thatcher v. Hanover Ins. Grp., 659 F.3d 1212 (8th Cir. 2011) United States v. Linney, 134 F.3d 274 (4th Cir. 1998)... 6 United States v. Presley, 52 F.3d 64 (4th Cir. 1995)... 6 State Court Cases Behrle v. Olshansky, 139 F.R.D. 370 (W.D. Ark. 1991)... 20, 21, 22 Copeland v. Hussmann Corp., 462 F. Supp. 2d 1012 (E.D. Mo. 2006) Esquivel v. Arau, 913 F. Supp (C.D. Cal. 1996) Progressive N. Ins. Co. v. Romanshek, 697 N.W.2d 417 (Wis. 2005) n.1 Robinson v. Nelson, No MLW, 1999 WL (D. Mass. 1999) Simeone v. First Bank Nat. Ass n, 125 F.R.D. 150 (D. Minn. 1989) vii-

8 Rules Fed. R. Civ. P Fed. R. Civ. P passim Fed. R. Civ. P. 54(d) Statutes and Regulations 21 U.S.C. 355(j)(2)(A) Abbreviated New Drug Application Regulations, 57 Fed. Reg (Apr. 28, 1992) E. Tex. Code Ann Other Authorities Aaron S. Kesselheim et al., Risk, Responsibility, and Generic Drugs, 367 New Eng. J. Med (2012) Antonin Scalia & Bryan A. Garner, Reading Law: The Interpretation of Legal Texts (2012)... 8 Bryan Garner et al., The Law of Judicial Precedent (2016) Caleb Nelson, Preemption, 86 Va. L. Rev. 225 (2000)... 7, 8 Christian E. Mammen, Using Legislative History in American Statutory Interpretation (2002)... 11, 15 David A. Strauss, Why Plain Meaning?, 72 Notre Dame L. Rev (1997)... 9 Ellen J. Flannery & Peter Barton Hutt, Balancing Competition and Patent Protection in the Drug Industry, 40 Food Drug Cosm. L.J. 269 (1985) The Federalist No. 78 (Alexander Hamilton) viii-

9 Frank E. Horack, Jr., Congressional Silence: A Tool of Judicial Supremacy, 25 Tex. L. Rev. 247 (1947). 13 H.R. 2430, 115th Cong. (as passed by Senate, Aug. 18, 2017) H.R. Rep. No , pt. 1 (1984) James W. Moore et al., 5 Moore's Federal Practice (2d ed. 1992) John W. MacDonald, The Position of Statutory Construction in Present Day Law Practice, 3 Vand. L. Rev. 369 (1950)... 7 Karen M. Gebbia-Pinetti, Statutory Interpretation, Democratic Legitimacy and Legal-System Values, 21 Seton Hall Legis. J. 233 (1997)... 8 Press Release, Orrin Hatch, Senator, U.S. Congress (Sept. 24, 2014) Randy J. Kozel, Precedent and Reliance, 62 Emory L.J (2013) n.1 Richard Ekins, The Nature of Legislative Intent (2012) Steven S. Gensler, 1 Federal Rules of Civil Procedure, Rules and Commentary Rule 41 (Feb. 2017).. 18 Thomas G. Hansford & James F. Spriggs III, The Politics of Precedent on the U.S. Supreme Court (2006) Viet D. Dinh, Reassessing the Law of Preemption, 88 Geo. L.J (2000)... 7 William D. Popkin, The Judicial Role (2013)... 9 William N. Eskridge, Jr., Interpreting Law (2016) ix-

10 Opinions Below The unreported opinion of the Court of Appeals for the Twelfth Circuit appears on pages 9 22 of the record. The unreported opinion of the District Court of Illinoza appears on pages 1 8 of the record. Constitutional and Statutory Provisions Involved The constitutional provision at issue, the Supremacy Clause, is located at Appendix A. The rule at issue, Federal Rule of Civil Procedure 41(d), is located at Appendix B. Statement of the Case This case involves a dispute over whether the Hatch-Waxman Act preempts state-tort claims and whether attorney s fees may be considered awardable costs under Federal Rule of Civil Procedure 41(d). Facts A. Westerly manufactures an FDA-approved generic drug. In 2009, Westerly Pharmaceutical began to sell its FDA-approved generic version of the drug ropidope hydrochloride. (R. at 2.) Another company, GlaxoCline, patented and sold the drug for 12 years, but Westerly could produce a generic version after their patent expired. Id. Because of FDA requirements, the labeling of Westerly s generic drug mirrored the labeling of GlaxoCline s drug. Id. -1-

11 B. Westerly makes FDA-approved changes to the generic drug s labeling. GlaxoCline requested FDA approval to change its drug s labeling to include a new warning in early Id. The new warning advised consumers that the drug could cause intense urges to gamble... [and] spend money among other similar urges and that the drug s prescribers should monitor any urges and consider dose reduction or stopping the medication. Id. The FDA approved the request in June Id. Then, in early 2012, Westerly requested FDA approval to update the labeling of the generic drug to parallel the new labeling of GlaxoCline s drug. Id. The FDA approved, and Westerly instituted the updated labeling by February (R. at 3.) C. Ivers takes Westerly s generic drug and claims to develop gambling and money-spending urges. In February 2011, a physician diagnosed Alice Ivers with Parkinson s disease and prescribed to her ropidope hydrochloride to treat the illness. (R. at 1.) Within one month, she was taking Westerly s generic drug daily. Id. Four months after initially taking the drug, she claims to have developed gambling and moneyspending urges. (R. at 3.) She also claims the urges led to the depletion of her retirement savings and the divorce from her husband all by the end of Id. -2-

12 Procedural History A. Ivers files and dismisses the initial action in East Texas state court. In January 2013, Ivers filed an East Texas Products Liability Law action in East Texas state court, alleging Westerly breached its duty to her by marketing a generic drug with insufficient warnings. (R. at 5.) A month later, the Fifth Circuit issued an unrelated opinion holding that federal law preempted a similar state-tort claim regarding a different FDA-approved generic drug. (R. at 5.) Eleven days after that, Ivers filed a Notice of Voluntary Dismissal under Federal Rule of Civil Procedure 41(a). Id. B. Ivers refiles the same action in Illinoza state court. Over two years later, in September 2015, Ivers refiled her action alleging the same facts and legal theories in Illinoza state court. (R. at 1.) Westerly then removed the action to federal district court and filed a motion for judgment on the pleading and a motion for an award of costs. (R. at 1, 3.) The district court ruled in Westerly s favor, holding federal law preempted Ivers state-tort claim. (R. at 8.) Additionally, the court ordered Ivers to pay certain costs Westerly incurred defending the suit filed and dismissed in East Texas, but denied the award of attorney s fees. Id. Both Ivers and Westerly appealed the decision to the Court of Appeals for the Twelfth Circuit. (R. at 8) The Twelfth Circuit affirmed both the district court s -3-

13 dismissal of Ivers state-tort claim and the court s order to pay certain costs, but reversed the district court s dismissal of the award of attorney s fees under Federal Rule of Civil Procedure 41(d). (R. at 18.) This Court granted certiorari on July 17, 2017 and limited the review to two issues: (1) whether this Court s decisions in PLIVA v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical v. Bartlett, 133 S. Ct (2013), preempt Ivers claims in this case; and (2) whether attorney s fees are considered awardable costs under Federal Rule of Civil Procedure 41(d). (R. at 23.) Summary of Arguments 1. The Hatch-Waxman Act preempts state-tort claims against generic drug manufacturers. This Court s decisions in Mensing and Bartlett indicate the Hatch-Waxman Act preempts state-tort claims against generic drug manufacturers. Ivers claim which is nearly analogous to the facts in Mensing and Bartlett is based on state-tort law. Therefore, this Court should hold Ivers claim preempted. Putting precedent aside, statutory interpretation also indicates that the Hatch- Waxman Act should preempt state-tort claims against generic drug manufacturers. The Act s text, history both statutory and legislative and purpose all indicate federal preemption. In the interest of justice, this Court should hold Ivers claim preempted as well. -4-

14 2. Attorney s fees are a permissible element of costs under Federal Rule of Civil Procedure 41(d). It is no coincidence that Ivers dismissed her original complaint just eleven days after the Fifth Circuit held that federal law preempted a similar claim against a different generic drug manufacturer. This Court can infer from the record that Ivers knew the East Texas state court would follow Fifth Circuit precedent and rule in Westerly s favor. So, she dismissed her action and over two years later found a more favorable forum outside of the Fifth Circuit: the Illinoza state court. Westerly seeks redress under Federal Rule of Civil Procedure 41(d) for the unnecessary expenditures defending against Ivers action in the East Texas state court. Most courts hold that attorney s fees are permissible costs under Rule 41(d). If attorney s fees are not allowed under 41(d), then plaintiffs like Ivers can abuse Rule 41 to forum shop and bring vexatious litigation. This is the exact type of conduct the Rule is supposed to deter. Also, substantial case law permits attorney s fees under Rule 41(a)(2). It would be inconsistent to award fees under that provision but prohibit fees under Rule 41(d). Ultimately, this Court should allow the award of attorney s fees under 41(d) to avoid interpretative inconsistencies within the Rule and to avoid creating a gaping loophole that would encourage forum shopping and vexatious litigation at the defendant s expense. -5-

15 Arguments Standards of Review This Court is reviewing the Twelfth Circuit s dismissal of Ivers complaint and Westerly s award of costs and attorney s fees. Both questions presented are questions of constitutional, statutory, and regulatory interpretation, which are reviewed de novo. United States v. Presley, 52 F.3d 64, 67 (4th Cir. 1995) ( We review the constitutionality of a statute de novo.... ); United States v. Linney, 134 F.3d 274, 282 (4th Cir. 1998) (stating that issues of statutory construction are reviewed de novo). 1. The Twelfth Circuit correctly held that the Hatch-Waxman Act preempts state-tort claims against generic drug manufacturers. This Court has already addressed claims like Ivers and held that the Hatch- Waxman Act preempts state-tort claims against generic drug manufacturers. See PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011); Mutual Pharmaceutical v. Bartlett, 133 S. Ct (2013). Additionally, statutory interpretation indicates that Ivers claims should be preempted. The traditional interpretative rules based on text, history, and purpose all show the Twelfth Circuit properly dismissed Ivers complaint. See Arlington Cent. Sch. Dist. Bd. v. Murphy, 548 U.S. 291, 324 (2006) (Breyer, J., dissenting) ( [W]e must retain all traditional interpretative tools.... ). -6-

16 A. The Hatch-Waxman Act s text supports preemption of Ivers claim based on the Illinoza Product Liability Act. Statutory interpretation begins with the words of the text. See BedRoc Ltd., LLC v. United States, 541 U.S. 176, 183 (2004) ( [O]ur inquiry begins with the statutory text, and ends there as well if the text is unambiguous. ). The texts of the Hatch- Waxman Act and the Illinoza Product Liability Act contradict the possible enforcement of both. Therefore, this Court should uphold the supremacy of federal law and rule Ivers claim preempted. Ivers may claim a presumption against preemption and that preemption analysis should focus on congressional intent. See Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947) (noting an assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress. ); see Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996) ( [T]he purpose of Congress is the ultimate touchstone in every preemption case. (quoting Retail Clerks Int l Ass n v. Schermerhorn, 375 U.S. 96, 103 (1963))). But many dispute this presumption and analysis of congressional intent remains controversial. See Viet D. Dinh, Reassessing the Law of Preemption, 88 Geo. L.J. 2085, 2086 ( The actual strength of the presumption is a matter of considerable doubt.... ); see, e.g., John W. MacDonald, The Position of Statutory Construction in Present Day Law Practice, 3 Vand. L. Rev. 369, 371 (1950) ( [A]nyone who has ever dealt with the legislative process knows how conspicuously absent is a collective legislative intention. ). In fact, preemption jurisprudence lies in complete disarray; its overly convoluted and complicated rules approach incomprehension. E.g., Caleb -7-

17 Nelson, Preemption, 86 Va. L. Rev. 225, (2000) ( Most commentators who write about preemption agree on at least one thing: Modern preemption jurisprudence is a muddle. ). Fortunately, this Court has provided a constitutionally-based solution: merely look to the text. Preemption jurisprudence s roots are in the Supremacy Clause of the United States Constitution, but over the past century, courts have distorted its meaning to an abysmal degree. U.S. Const. art. VI, cl. 2; see, e.g., Antonin Scalia & Bryan A. Garner, Reading Law: The Interpretation of Legal Texts 3 (2012) ( Ours is a common-law tradition in which judicial improvisation has abounded. ). Here, too, the lower courts juggled various preemption possibilities to determine the validity of Ivers claim. The Twelfth Circuit considered both impossibility preemption and obstacle preemption, admitting the Supreme Court has developed a complex taxonomy of preemptions. (R. at 12.) But embracing the plurality s non obstante solution in Mensing and looking to ordinary meaning of the text greatly simplifies preemption jurisprudence and returns American law to democratic legitimacy. See generally Karen M. Gebbia-Pinetti, Statutory Interpretation, Democratic Legitimacy and Legal-System Values, 21 Seton Hall Legis. J. 233, (1997). This is because the non obstante provision of the Supremacy Clause impliedly repeal[s] conflicting state law. PLIVA, Inc. v. Mensing, 564 U.S. 604, 622 (2011). But Ivers like some judicial voices may argue usage of plain meaning in federal preemption cases is unprecedented. E.g., Id. at 642 (Sotomayor, J., -8-

18 dissenting) ( That the plurality finds it necessary to resort to this novel theory of the Supremacy Clause a theory advocated by no party or amici in these cases is telling. ). Professor Nelson s point should be well-taken: [W]hen the application of a doctrine produces such poor results in area after area, it is time to take a fresh look at the doctrine itself. Nelson, Preemption, supra, at 233. Still, the Court might conclude the use of this ordinary meaning still allows for pragmatic judicial partnering. William D. Popkin, The Judicial Role 92 (2013). But this conclusion would be unwarranted because a concrete test exists within the Supremacy Clause, fully embraced by the Founders: It requires courts to ignore state law if (but only if) state law contradicts a valid rule established by federal law, so that applying the state law would entail disregarding the valid federal rule. Nelson, Preemption, supra, at 234. The Court, therefore, only needs to look to the law s ordinary or plain meaning to determine there is a logical contradiction in the enforcement of both federal and state law. United States v. Turkette, 452 U.S. 576, 580 (1981) ( In determining the scope of a statute, we look first to its language. ); see generally David A. Strauss, Why Plain Meaning?, 72 Notre Dame L. Rev (1997); Wyeth v. Levine, 555 U.S. 555, 590 (2009) (Thomas, J., concurring) (quoting Nelson, Preemption, supra, at ). Thus, the ordinary meanings of both the Illinoza Product Liability Act and the Hatch-Waxman Act must be compared. Mensing, 564 U.S. at 611. To establish ordinary meaning the most fundamental semantic rule of interpretation the Court only needs to consider that every word employed -9-

19 ... is to be expounded in its plain, obvious, and common sense.... Scalia & Garner, supra, at 69; Id. (quoting Joseph Story, Commentaries on the Constitution of the United States 157 (1833)). Ivers contends Westerly s product caused unreasonabl[e] danger[] due to... defective design, [and] inadequate instructions or warnings.... (R. at 3.) (citing Illz. Prod. Liability Act (1)). The codified Hatch-Waxman Act, however, indicates Westerly and other generic drug manufacturers can only gain approval when their generic drugs are equivalent to an FDA-approved drug and must show that the labeling proposed for the new [generic] drug is the same as the labeling approved for the listed drug referred. 21 U.S.C. 355(j)(2)(A); 21 U.S.C. 355(j)(2)(A)(v). After approval, Westerly cannot change labeling. Abbreviated New Drug Application Regulations, 57 Fed. Reg (Apr. 28, 1992) ( [The generic] product s labeling must be the same as the listed drug product s labeling.... ). State law clearly burdens Westerly with a duty in tension with federal law. Cf. Mensing, 564 U.S. at 623 ( Here, state law imposed a duty on the Manufacturers to take a certain action, and federal law barred them from taking that action. The only action the Manufacturers could independently take asking for the FDA's help is not a matter of state-law concern. Mensing and Demahy s tort claims are preempted. ). Therefore, federal law preempts Ivers state-tort claim. -10-

20 B. The Hatch-Waxman Act s history supports preemption of Ivers claim based on the Illinoza Product Liability Act. If this Court cannot decipher the Hatch-Waxman Act s preemption with the mere use of text, then it can look to the Act s history. See generally Christian E. Mammen, Using Legislative History in American Statutory Interpretation 26 9 (2002). When courts look to history, they look to both statutory history and legislative history. See, e.g., William N. Eskridge, Jr., Interpreting Law (2016). Both the statutory history and legislative history of the Hatch-Waxman Act indicate Ivers claim based on the Illinoza Product Liability Act should be preempted. (1) Statutory history supports preemption of Ivers claim. To determine statutory history, courts look the legislature s formal changes in the law, enactment of new laws, and other amendments over time. After this Court s decisions in Mensing and Bartlett, the legislature was silent. This Court, therefore, should consider Mensing and Bartlett as controlling precedent and find Ivers claim preempted. While use of legislative history is controversial, use of statutory history is not. See, e.g., Eskridge, supra, at 204 (2016) ( No one in the academy and no federal or state judge maintains that statutory history is not admissible and potentially relevant when judges are interpreting those laws. ). Statutory history of the Hatch- Waxman Act indicates this Court s holdings in Mensing and Bartlett were correct. Therefore, because Ivers state-tort claim is practically analogous to the claims in -11-

21 those cases, this Court should adhere to its precedent and find the claim preempted. (R. at 13.) ( She argues that her claim can be distinguished from the claims preempted in the Supreme Court cases. We cannot agree. ). Adherence to horizontal precedent is good jurisprudence. See, e.g., The Federalist No. 78 (Alexander Hamilton) (asserting that judges should be bound down by strict rules and precedents, which serve to define and point out their duty in every particular case that comes before them.... ). In fact, this Court has said that it is the preferred course because it promotes the evenhanded, predictable, and consistent development of legal principles, fosters reliance on judicial decisions, and contributes to the actual and perceived integrity of the judicial process. Payne v. Tennessee, 501 U.S. 808, 827 (1991); see also Thomas G. Hansford & James F. Spriggs III, The Politics of Precedent on the U.S. Supreme Court 20 (2006) ( Nearly eighty-five percent of respondents... indicated that precedent should have some or a large impact on the justices decisions. ). This Court should uphold its own precedent set in Mensing and Bartlett and preempt Ivers claim. Any argument that departure from horizontal precedent must be supported by some special justification, ignores a fundamental principle of the doctrine of precedent. Dickerson v. United States, 530 U.S. 428, 443 (2000). In evaluating the factors that weigh against overruling this horizontal precedent, the Court should note prior decisions involving statutory interpretation and that -12-

22 statutory history indicates acceptance of decisions. See Bryan Garner et al., The Law of Judicial Precedent (2016). 1 Because Congress can change judicial interpretation of legislation, this Court has been hesitant to overrule precedent interpreting a statute. Pearson v. Callahan, 555 U.S. 223, 233 (2009). Congressional failure to amend a statute speaks to the legislative silence doctrine. Frank E. Horack, Jr., Congressional Silence: A Tool of Judicial Supremacy, 25 Tex. L. Rev. 247, 253 (1947) ( So long as policy determination is [congressional] responsibility, it is their privilege to act wisely or unwisely or not to act at all. ). Since Mensing and Bartlett, there has been no change in FDA legislation regarding generic drug manufacturers and their responsibility in generic drug labeling whatsoever. See, e.g., H.R. 2430, 115th Cong. (as passed by Senate, Aug. 18, 2017); but see Aaron S. Kesselheim et al., Risk, Responsibility, and Generic Drugs, 367 New Eng. J. Med (2012) ( In response, a bipartisan group of lawmakers introduced legislation seeking to make generics manufacturers responsible for updating their labels just as brand-name drug companies are. The legislation remains under consideration in both the House and the Senate. ). The Court, therefore, should consider Congress silence as acquiescence to that interpretation. Notably, Justice Thomas asserts that Congress and the FDA retain 1 This Court has also noted that reliance is an influential reason to uphold horizontal precedent. Randy J. Kozel, Precedent and Reliance, 62 Emory L.J. 1459, 1466 (2013); Planned Parenthood of Se. Pa. v. Casey, 505 U.S. 833, 855 (1992) ( The inquiry into reliance counts the cost of a rule s repudiation as it would fall on those who have relied reasonably on the rule s continued application. ). Additionally, the Court accounts for the value of reliance in commercial law. Lower courts note that precedent is a particularly strong factor that militates against overruling where the legal rule impacts contractual relationships and has been relied upon by industry. Progressive N. Ins. Co. v. Romanshek, 697 N.W.2d 417, 429 (Wis. 2005). -13-

23 the authority to change the law and regulations if they so desire, indicating that legislative action is always possible. Mensing, 564 U.S. at 626; cf. Seminole Tribe of Florida v. Florida, 517 U.S. 44, 63 (1996) ( [B]ecause in such cases correction through legislative action is practically impossible. ). (2) Legislative history supports preemption of Ivers claim. When statutory language produces absurd results, courts look to legislative history. See, e.g., Holder v. Hall, 512 U.S. 874, 932 n.28 (1994) ( The Court, however, carefully repeated Justice Jackson s admonition that [r]esort to legislative history is only justified where the face of the [statute] is inescapably ambiguous. (quoting Garcia v. United States, 469 U.S. 70, 76 n.3 (1984))). Some opine that holdings in Mensing and Bartlett are absurd and that legislative history must be consulted. E.g., Mensing, 564 U.S. at 643 (Sotomayor, J., dissenting) ( Today s decision leads to so many absurd consequences that I cannot fathom that Congress would have intended to pre-empt state law in these cases. ). But this Court should also note that even if an act s meaning is plain regardless of the alleged absurdity then use of legislative history can confirm and support that meaning. E.g., United States v. Borden Co., 370 U.S. 460, 467 (1962) (noting both [the] express wording and legislative history of an act supported the government s interpretation). Ultimately, consultation of the legislative history of the Hatch- Waxman Act supports the preemption of Ivers state-tort claim. -14-

24 The primary documents to determine legislative history are official committee reports. Mammen, supra, at 26. And while committee reports on the Act are relatively sparse, available reports indicate one applicable and pertinent congressional goal: that the Act should save American consumers, state governments, and the federal government a significant amount of money. Ellen J. Flannery & Peter Barton Hutt, Balancing Competition and Patent Protection in the Drug Industry, 40 Food Drug Cosm. L.J. 269, 271 (1985). The House Committee on Energy and Commerce issued a Report noting that the FDA considers [forcing generic drug manufacturers to retest their generic drugs] to be unnecessary and wasteful because the drug has already been determined to be safe and effective. H.R. Rep. No , pt. 1, at 16 (1984). Because Congress wanted to encourage generic drug production, it intended liability to fall not on the generic drug manufacturers, but on FDA-approved drug manufacturers. Generic drug manufacturers bound by the labeling requirements of the FDA-approved drugs would save money, passing those savings onto consumers. By allowing Ivers claim, this Court would severely undermine this history. C. The Hatch-Waxman Act s purpose supports preemption of Ivers claim based on the Illinoza Product Liability Act. Professor Ekins notes that [t]he legislature does not aim to make fully known to promulgate to the community the reasons for each particular [legislative] choice.... The Nature of Legislative Intent 250 (2012). So, to look for purpose obstacle -15-

25 preemption s fundamental basis courts consider statements by those most familiar with the legislation. E.g., North Haven Bd. of Educ. v. Bell, 456 US. 512, (1982) (considering a statement by Title IX-sponsor Senator Birch Bayh). Because those statements show that state-tort laws would frustrate the Hatch-Waxman Act s purpose, this Court should hold that Ivers claim is preempted. This Court has noted that obstacle preemption displaces state law when it stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress. Hines v. Davidowitz, 312 U.S. 52, 67 (1941). Allowing statetort claims under the Illinoza Product Liability Act and other state legislation would obstruct congressional intent. On the 30th anniversary of the Hatch-Waxman Act, Senator Orrin Hatch the Act s sponsor stated: When President Reagan signed Hatch-Waxman into law, he said it provided regulatory relief, increased competition, economy on government, and best of all, the American people will save money, and yet receive the best medicine that pharmaceutical science can provide. The past 30 have proven President Reagan's statement to be true. Press Release, Orrin Hatch, Senator, U.S. Congress (Sept. 24, 2014). This perspective mirrors other courts interpretations of Hatch s intent. E.g., Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., 601 F.3d 1359, 1360 (Fed. Cir. 2010) (noting that with the Act, Hatch intended to strike[] a balance between two potentially competing policy interests inducing pioneering development of pharmaceutical formulations and methods and facilitating efficient transition to a market with low-cost, generic versions of those pioneering inventions -16-

26 at the close of a patent term (citing Andrx Pharms., Inc. v. Biovail Corp., 276 F.3d 1368, 1371 (Fed. Cir. 2002))), rev d on other grounds, 566 U.S. 399 (2012). Any Hatch-Waxman Act interpretation that allows for state-tort claims imposes additional duties and creates additional burdens for generic drug manufacturers, thereby inherently increasing regulation, decreasing competition, and ultimately harming American consumers. 2. The Twelfth Circuit correctly held that attorney s fees are permissible costs under Rule 41(d). Ivers originally filed her claim against Westerly in state court within the Fifth Circuit. (R. at 5.) But eleven days after the Fifth Circuit held in Morris v. PLIVA, Inc. that federal law preempted a similar failure-to-update claim, Ivers voluntarily dismissed her action under Federal Rule 41(a). Id.; 713 F.3d 774, 778 (5th Cir. 2013). She then refiled the exact same claim against Westerly in the more-favorable Twelfth Circuit. Id. Under Rule 41(d), the Twelfth Circuit properly awarded Westerly the costs including attorney s fees expended defending the previous suit. (R. at 18). Under Rule 41(d), when a plaintiff, like Ivers, dismisses an action and commences another action on the same claim against the same defendant, the court may require the payment of costs in the prior action before preceding to the second. Fed. R. Civ. P. 41(d). The Rule provides as follows: (d) If a plaintiff who previously dismissed an action in any court files an action based on or including the same claim against the same defendant, the court: -17-

27 (1) may order the plaintiff to pay all or part of the costs of that previous action; and (2) may stay the proceedings until the plaintiff has complied. Id. Neither the rule itself nor the Advisory Committee Notes define costs, so courts are split over whether an award of costs under Rule 41(d) may include attorney s fees. See Copeland v. Hussmann Corp., 462 F. Supp. 2d 1012, (E.D. Mo. 2006) (discussing split). There are three positions taken by the courts. See Steven S. Gensler, 1 Federal Rules of Civil Procedure, Rules and Commentary Rule 41 (Feb. 2017). The Twelfth Circuit followed the majority, which hold that an award of attorney s fees is properly included in Rule 41(d) costs because it promotes the Rule s fundamental purpose: to deter forum shopping and vexatious litigation. See Evans v. Safeway Stores, Inc., 623 F.2d 121, 122 (8th Cir. 1980); see also Meredith v. Stovall, 216 F.3d 1087 (10th Cir. 2000). The Sixth Circuit disagrees and holds that fees are not available because the rule does not explicitly provide for them. Rogers v. Wal-Mart Stores, Inc., 230 F.3d 868, 874 (6th Cir. 2000). Lastly, the Fourth and Seventh Circuits take a hybrid approach that allows attorney s fees only to the extent that: (1) the underlying substantive law would allow for recovery of attorney s fees as costs; or (2) the court makes a specific finding that the plaintiff acted vexatiously, wantonly, or in bad faith. See Andrews v. America s Living Ctrs., LLC, 827 F.3d 306, 311 (4th Cir. 2016); see also Esposito v. Piatrowski, 223 F.3d 497, 501 (7th Cir. 2000). -18-

28 The Court should hold attorney s fees are a permissible element of costs under 41(d). Permitting fees will directly promote the Rule s underlying purpose and provide interpretative consistency within Rule 41. Although every case may not warrant an award of fees under 41(d), courts should have the discretion to use the provision to deter behavior similar to Ivers. A. Allowing attorney s fees as permissible costs under Rule 41(d) directly promotes the Rule s underlying purpose: to deter forum shopping and vexatious litigation. Granted, the general rule is that attorney s fees are not a recoverable cost of litigation absent explicit congressional authorization. Runyon v. McCrary, 427 U.S. 160, 185 (1976) (citing Alyeska Pipeline Service Co. v. Wilderness Society, 421 U.S. 240, 247 (1975)). But the Supreme Court has also stated that [t]he absence of specific reference to attorney s fees is not dispositive if the statute otherwise evinces an intent to provide for such fees. Key Tronic Corp. v. United States, 551 U.S. 809, 815 (1994). Thus, judicial interpretation is appropriate to determine whether Congress has implicitly authorized an award of attorney s fees under Rule 41(d). Id. It is well settled that the purpose of Rule 41(d) is to serve as a deterrent to forum shopping and vexatious litigation. Simeone v. First Bank Nat. Ass n, 971 F.2d 103, 108 (8th Cir. 1992) (citing James W. Moore et al., 5 Moore's Federal Practice (2d ed. 1992)). This includes attempts to gain any tactical advantage by dismissing and refiling the suit. Andrews, 827 F.3d at 309 (citation omitted); see also Robinson v. Nelson, No MLW, 1999 WL at 2 (D. Mass. 1999) -19-

29 ( Rule 41(d) is intended to prevent plaintiffs from gaining an advantage through forum shopping, especially by plaintiffs who have suffered setbacks in one court and dismiss to try their luck somewhere else. ); Thatcher v. Hanover Ins. Grp., 659 F.3d 1212, 1214 (8th Cir. 2011) ( [I]t is inappropriate for a plaintiff to use voluntary dismissal as an avenue for seeking a more favorable forum. ). The very first Federal Rule of Civil Procedure requires that the Rules be interpreted and administered so as to secure the just determination of every action. Fed. R. Civ. P. 1. With this Rule in mind, this Court can see how Behrle v. Olshansky illustrates why disallowing attorney s fees under Rule 41(d) would produce outcomes that clearly contradict the drafters intent. 139 F.R.D. 370 (W.D. Ark. 1991). In Behrle, the plaintiff was not satisfied with his initial case after three full days of trial, so he nonsuited it under Rule 41, and the very next day, filed the same claim in federal court. Id. at 371. Under Rule 41(d), the federal court awarded the defendant all costs and attorney s fees that resulted from defending the initial claim in state court. Id. The court reasoned that, [s]urely Congress intended [Rule 41(d)] have some teeth. Id. at 374. If the court may impose only costs which a winning party would be entitled to recover under Rule 54(d),... then the provision is useless. Id. at 373. The court went on to say that, disallowing fees would only entitle the defendant to a measly $ in costs, while expecting him to pay thousands of dollars in attorney s fees for the fruitless litigation that was caused by the plaintiff. Id. The court refused to accept an outcome that left the defendant -20-

30 bearing such an expense. Id. ( Assuming that there is some fairness in the law, that simply can t be the law. ). Admittedly, Westerly s time spent defending the previous action is less than the defendant endured in Behrle. Nevertheless, simply because Ivers behavior may be less egregious, does not mean the court should encourage such behavior. Like in Behrle, if the Court denies an award of fees under 41(d), Westerly would be expected to pay over $3,000 in attorney s fees because Ivers was not satisfied with how the ruling in Morris would have negatively impacted her case in the Fifth Circuit. Obviously, attorney s fees will always constitute the major portion of costs expended in defending a lawsuit. Therefore, stripping courts of the discretion to award attorney s fees under 41(d) would severely limit the Rule s role as an antidote to forum shopping and vexatious litigation. (1) The record supports the Twelfth Circuit s finding that Ivers was blatantly forum shopping when she dismissed and refiled her lawsuit. On February 14, 2013, the Fifth Circuit held in Morris that state law failure to warn claims against generic manufacturers are preempted by federal law. 713 F.3d 774. After Morris, Ivers state-tort claim under the East Texas Products Liability Law would have been dismissed in the Fifth Circuit. So, in response, Ivers filed for Voluntary Dismissal under Rule 41(a) and refiled the same suit against Westerly in the more favorable Twelfth Circuit. (R. at 5.) Meanwhile, Westerly continued to incur legal fees while Ivers forum shopped to gain a tactical advantage. -21-

31 Although an award of costs and fees under Rule 41(d) may not be appropriate in every case, courts have held that blatant forum shopping is the exact type of conduct that warrants such an award. See Simeone v. First Bank Nat. Ass n, 125 F.R.D. 150, (D. Minn. 1989) (awarding costs and fees under Rule 41(d) where plaintiff s dismissal and refiling in federal court were part of an effort by plaintiff to secure a more favorable forum); see also Behrle, 139 F.R.D. at 372 (awarding costs and fees under Rule 41(d) where there [could] be no explanation for plaintiff s actions other than he was forum shopping ). Similarly, this Court should find that an award of costs, including fees, is an appropriate remedy for Ivers conduct. B. Allowing attorney s fees as permissible costs under Rule 41(d) provides interpretative consistency within Rule 41. The award of attorney s fees under Rule 41(d) is also supported by the substantial case law permitting attorney s fees under other provisions of Rule 41. Under Rule 41(a)(2), attorney s fees may be awarded as a term or condition of voluntary dismissal, even though that provision makes no explicit reference to fees. See, e.g., Davis v. USX Corp., 819 F.2d 1270, 1276 (4th Cir. 1987) (ordering the plaintiff pay costs including attorney s fees under 41(a)(2)). Given the purpose of Rule 41(d) is to discourage vexatious litigation and unnecessary expenditures by defending parties, many courts agree that it would be inconsistent to award attorneys fees as a condition of voluntary dismissal under Rule 41(a)(2), but completely prohibit the awarding of such fees when a case that is -22-

32 voluntarily dismissed is refiled under Rule 41(d). Esposito, 223 F.3d at 501(citing Esquivel v. Arau, 913 F. Supp. 1382, 1391). In either situation, the plaintiff caused the defendant to incur unnecessary expenditures, and it would be anomalous to require the plaintiff to internalize the full costs of its conduct in one context but not the other. Esquivel, 913 F. Supp. at Thus, the inclusion of attorney s fees under Rule 41(d) provides interpretive consistency and allows the subsections of Rule 41 to work in tandem. C. Under the hybrid approach, Westerly is still entitled to an award of fees because Ivers acted with vexatious intent. In Marek v. Chesny, this Court examined whether attorney s fees may be awarded under Federal Rule of Civil Procedure U.S. 1 (1985). Like Rule 41(d), Rule 68 refers to the payment of costs without defining the term. See Fed. R. Civ. P. 68. The Court concluded that Rule 68 was intended to refer to all costs properly awardable under the relevant substantive statute. Marek, 473 U.S. at 9. In other words, courts must look to the underlying statute that is the basis of the plaintiff s claim, and if that statute allows for an award of fees, then fees may be awarded under Rule 68. Id. The Fourth and Seventh Circuits extended Marek s logic to Rule 41(d), while also recognizing that lower courts should be given discretion to award fees if it deems proper. See Andrews, 827 F.3d at 311; Esposito, 223 F.3d at 500. The Fourth Circuit stated: -23-

33 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. A court may also, within its discretion, award attorneys fees where it makes a specific finding that the plaintiff has acted in bad faith, vexatiously, wantonly, or for oppressive reasons, a well-established exception to the American Rule. Andrews, 827 F.3d at 311. In applying this hybrid approach, this Court must first consider whether the underlying statute supporting Ivers tort claim allows attorneys fees. Id. at 312. Ivers initially sued under the East Texas Products Liability Law, which states: (a) In 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. E. Tex. Code Ann As is apparent from the text, the statute is silent as to attorney s fees in suits where the defendant prevails. So, this Court must turn next to whether Ivers acted vexatiously to warrant an award of attorney s fees. Andrews, 827 F.3d at 312. Ivers prior dismissal and refiling of the same claim against the same defendant delayed the resolution this case, increased the costs of defending this case, and wasted judicial resources. Courts consider this type of repeated litigation as vexatious behavior that warrants an award of fees under 41(d). See Robinson v. Bank of Am., N.A., 553 Fed. Appx. 648, 652 (8th Cir. 2014) (affirming fee award where plaintiff dismissed complaint in federal court and brought the same action in state court); Kent v. Bank of Am., N.A., 518 Fed. Appx. 514, 517 (8th Cir. 2013) (affirming fee award based on vexatious behavior where no explanation for -24-

34 refiling was provided and the only changes were incidental ); Sanderson v. Spectrum Labs, Inc., 248 F.3d 1159, at 6 (7th Cir. 2000) (affirming fee award where allegations in first complaint were repeated almost verbatim in his second complaint ). Thus, even if this Court follows the precedent set forth in Marek, Ivers vexatious behavior still warrants an award of fees. Conclusion For the reasons set forth above, Westerly respectfully requests that this Court: (1) affirm the Twelfth Circuit s dismissal of Ivers complaint as preempted; and (2) affirm the Twelfth Circuit s order awarding Westerly $ in costs and $3,442 in attorney s fees. Respectfully submitted, /s/ Team 2605 Counsel for Respondent Westerly Pharmaceutical, Inc. -25-

35 U.S. Const. art. VI, cl. 2. Appendix A Relevant Constitutional Provisions This Constitution, and the Laws of the United States which shall be made in Pursuance thereof; and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding. -26-

36 Appendix B Relevant Rules Fed. R. Civ. P. 41(a). (a) Voluntary Dismissal. (1) By the Plaintiff. (A) Without a Court Order. Subject to Rules 23(e), 23.1(c), 23.2, and 66 and any applicable federal statute, the plaintiff may dismiss an action without a court order by filing: (B) (i) (ii) a notice of dismissal before the opposing party serves either an answer or a motion for summary judgment; or a stipulation of dismissal signed by all parties who have appeared. Effect. Unless the notice or stipulation states otherwise, the dismissed any federal- or state-court action based on or including the same claim, a notice of dismissal operates as an adjudication on the merits. (2) By Court Order; Effect. Except as provided in Rule 41(a)(1), an action may be dismissed at the plaintiff's request only by court order, on terms that the court considers proper. If a defendant has pleaded a counterclaim before being served with the plaintiff's motion to dismiss, the action may be dismissed over the defendant's objection only if the counterclaim can remain pending for independent adjudication. Unless the order states otherwise, a dismissal under this paragraph (2) is without prejudice. Fed. R. Civ. P. 41(d). (d) Costs of a Previously Dismissed Action. If a plaintiff who previously dismissed an action in any court files an action based on or including the same claim against the same defendant, the court: (1) may order the plaintiff to pay all or part of the costs of that previous action; and (2) may stay the proceedings until the plaintiff has complied. -27-