NO IN THE SUPREME COURT OF THE UNITE STATES. October Term, 2017 ALICE IVERS. Petitioner, WESTERLY PHARMACEUTICAL, INC. Respondent.

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1 NO IN THE SUPREME COURT OF THE UNITE STATES October Term, 2017 ALICE IVERS Petitioner, v. WESTERLY PHARMACEUTICAL, INC. Respondent. On Writ of Certiorari to the Twelfth Circuit Court of Appeals BRIEF FOR RESPONDENT Team 2626 Attorneys for Respondent

2 QUESTIONS PRESENTED 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 the Petitioner s claims in this case. 2. Whether attorney s fees are considered awardable costs under Federal Rule of Civil Procedure 41(d). ii

3 TABLE OF CONTENTS QUESTIONS PRESENTED... ii TABLE OF AUTHORITIES... v OPINIONS BELOW... 1 RELEVANT PROVISIONS... 1 STATEMENT OF THE CASE... 2 Statement of the Facts... 2 Procedural History... 3 SUMMARY OF THE ARGUMENT... 5 STANDARD OF REVIEW... 5 ARGUMENT... 6 I. Liability For Updating Labels is Governed by FDA Label Requirements, and State Labeling Requirements Should Be Preempted by Federal Law a. The history of FDA regulation and control of pharmaceutical drugs supports preemption of conflicting state statutes b. The case similarities between PLIVA v. Mensing, Mutual Pharmaceutical Co., Inc. v. Bartlett, and this case support preemption of the Illinoza product liability statute when discussing pharmaceutical drugs c. The FDA Drug Application and Change Request process requirements placed on generic drug manufacturers supports preemption of the Illinoza product liability statute d. Illinoza s product liability statute should be preempted when considering the Reasonable Timing standard for updating warning labels for generic pharmaceutical drugs II. This Court Should Hold That Attorneys Fees Are Permissible Under 41(d) iii

4 a. In Marek v. Chesney, 473 U.S. 1 (1985). this Court held that Fed. R. Civ P. 68 allowed for the recovery of attorneys fees within the scope of costs permitted. Fed. R. Civ. P. 41(d) presents the term costs in an analogous manner and should be interpreted the same as Rule 68, thereby allowing attorneys fees to be recovered b. The majority of courts addressing the issue allow attorneys fees to be recovered under Rule 41(d) c. The underlying statute in this case, the Federal Food, Drug, & Cosmetic Act, twice defines costs as including reasonable attorney fees. 21 USC 399d (b)(3)(c); 21 USC 399d (b)(7)(b). Applying the holding and rationale of Marek is appropriate here, and this Court should find attorneys fees are appropriate under Rule 41(d) CONCLUSION CERTIFICATE OF SERVICE APPENDIX A iv

5 TABLE OF AUTHORITIES CASES Alyeska Pipeline Serv. Co. v. Wilderness Soc'y, 421 U.S. 240, 245 (1975)... 21, 22 Andrews v. Am's Living Ctrs., LLC, 827 F.3d 306 (4th Cir. 2016) Esposito v. Piatrowski, 223 F.3d 497, 501 (7th Cir. 2000) Figueroa v. Foster, 864 F.3d 222, (2d Cir. 2017) Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 584 (6th Cir. 2013) Highmark Inc. v. Allcare Health Mgmt. Sys., Inc., 134 S. Ct. 1744, 1748 (2014) In re Darvocet, 756 F.3d 917 (6th Cir. 2014) Ivers v. Westerley Pharm., Inc., No (12th Cir. 2017) Kent v. Bank of Am., N.A., 518 Fed.Appx. 514 (8th Cir. 2013) Marek v. Chesney, 473 U.S. 1 (1985)... 22, 23, 26 Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466, 2477 (2013)... 14, 16 PLIVA, Inc. v. Mensing, 564 U.S. 604, 624 (2011)... passim Riegel v. Medtronic, Inc., 552 U.S. 312, 315 (2008) Rogers v Wal-Mart, 230 F.3d 868, 874 (6th Cir. 2000) Sanderson v. Spectrum Labs, Inc., 248 F.3d 1159 (7th Cir. 2000) Simeone v. First Bank Nat'l Ass'n, 971 F.2d 103 (8th Cir. 1992) Wyeth v. Levine, 555 U.S. 555, 587 (2009)... 13, 14, 15 STATUTES 21 C.F.R C.F.R v

6 21 U.S.C U.S.C. 360k U.S.C U.S.C. 399d... 25, U.S.C U.S.C RULES Federal Rules of Civil Procedure 41(d) CONSTITUTIONAL PROVISIONS U.S. Const. art. IV, cl vi

7 OPINIONS BELOW The decision and Order of the state court of Illinoza is unreported and referred to in the Record. (R. at 1.) The decision and Order of the District Court of Illinoza is unreported and provided to in the Record. (R. at 1-8.) The decision and Order of the Twelfth Circuit is unreported and provided to in the Record. (R. at 9-22.) RELEVANT PROVISIONS This case involves the U.S. Const. art. IV, cl. 2 and Federal Rules of Civil Procedure 41(d). The text for both of these provisions is reprinted in Appendix A. 1

8 STATEMENT OF THE CASE Statement of the Facts In February of 2011, the Plaintiff, Alice Ivers (Ivers), a resident of Cardozo, Illinoza, was diagnosed with Parkinson s disease. (R. at 1). As part of her treatment, Ivers physician prescribed ropidope hydrochloride (Drug). (R. at 1). Starting in March of 2011, Ivers began taking a generic form of the Drug manufactured by the Defendant and Texas Corporation with its headquarters located in Florham Park, New Jersey, Westerly Pharmaceutical, Inc. (Westerly). (R. at 1). The Drug is a chemical compound that acts as a non-ergoline dopamine agonist, meaning the Drug inhibits the dopamine hormone reactions that are associated with the symptoms suffered by Parkinson s patients. (R. at 2). The Drug was initially developed and patented by GlaxoCline, LLC (GlaxoCline), a competitor of Westerly. (R. at 2). GlaxoCline received the necessary Federal Food & Drug Administration (FDA) certification and was able to begin selling the Drug in (R. at 2). In 2008, the GlaxoCline patent for the Drug expired, allowing other pharmaceutical companies to submit an Abbreviated new Drug Application (ANDA) and seek FDA certification for generic versions of the Drug. (R. at 2). Westerly received FDA approval for its ANDA and began selling the Drug in (R. at 2). Westerly agreed to mirror GlaxoCline s warning label as a condition for FDA approval. (R. at 2). In January of 2011, GlaxoCline submitted a Supplemental New Drug Application (snda) to the FDA to request approval for a proposed addition to the 2

9 Warnings and Precautions section of their Drug product s package insert. (R. at 2). The addition reads as follows: 5.6 Impulse Control/Compulsive Behaviors Reports suggest that patients can experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge or compulsive eating, and/or other intense urges... while taking one or more of the [Drug].... In some cases, although not all, these urges were reported to have stopped when the dose was reduced or the medication was discontinued. (R. at 2). The FDA approved the changes described in GlaxoCline s snda and the changes to the packaging insert were made by June of (R. at 2). As a result of the changes, Westerly submitted a Changes Being Affected (CBA) in January of 2012 to notify the FDA that it would be updating its Drug labels to conform to the GlaxoCline Drug labels. (R. at 2-3). By July of 2011, Ivers claims to have developed a compulsive spending and gambling habit. (R. at 3). During the following months, this alleged addiction led Ivers to transfer a majority of her retirement savings into an online poker service account. (R. at 3). While Ivers won a substantial amount of money playing online poker, she had spent all her earnings on charitable gifts and antique auctions by the end of (R. at 3). Procedural History On January 15, 2013, Ivers filed a Complaint against Westerly in the Federal District Court of West Texas for violating the State s products liability law. (R. at 5). The Western Texas Court dismissed the case without prejudice. (R. at 5). Ivers then sued Westerly in Illinoza state court for alleging the same facts and legal theories 3

10 under Illinoza state law. (R. at 3). Westerly timely removed the action to the Federal District Court of Illinoza, asserting jurisdiction under 28 U.S.C and (R. at 3). The District Court found the Illinoza state law preempted by Federal Law and Granted Westerly s Rule 12(c) motion. (R. at 4-5). Westerly filed a Motion to Award Costs, seeking a court order for Ivers to pay the Attorney s Fees Westerly incurred defending itself in the Texas District Court. (R. at 5). The District Court Granted in part and Denied in part Westerly s Motion. (R. at 5-7). Ivers next appealed the District Court s decision the United States Court of Appeals for the Twelfth Circuit on January 13, (R. at 9). Westerly filed a cross-appeal on January 15, 2016, contesting the District Courts denial of attorney s fees. (R. at 11). The Appellate Court affirmed the District Court s finding that Illinoza state law is preempted but held that attorney s fees should be awarded to Westerly. (R. at 12-18). Ivers appealed the case to the United States Supreme Court, which chose to hear the case. (R. at 23). 4

11 SUMMARY OF THE ARGUMENT This case must be pre-empted by the holdings in PLIVA v. Mensing and Mutual Pharmaceutical v. Bartlett. After reviewing the basis behind pre-emption, the historical changes in the FDA, and discussing possible actions resulting from a view of the reasonableness standard, we request that this Court follow its prior holdings and pre-empt this product liability statute. The majority of Circuits that have addressed the issue agree that the Federal Rules of Civil Procedure 41(d) does allow for recovery of attorneys fees, either as a right, or when the underlying statute specifically provides for attorneys fees to be included in costs. Here, the underlying statutory interpretation should mirror the way that this Court handled an identical ambiguity regarding costs in Federal Rules of Civil Procedure 68, in Marek v. Chesney. Additionally, here, the underlying statute defines costs as including reasonable attorneys fees in two chapters. For the foregoing reasons, we respectfully request that this Court affirm the Circuit Court s decision below, awarding attorneys fees to the Respondent. STANDARD OF REVIEW Questions of law are reviewed de novo. Highmark Inc. v. Allcare Health Mgmt. Sys., Inc., 134 S. Ct. 1744, 1748 (2014). 5

12 ARGUMENT I. Liability For Updating Labels is Governed by FDA Label Requirements, and State Labeling Requirements Should Be Preempted by Federal Law. Introduction The initial question placed upon this court is whether PLIVA v. Mensing and Mutual Pharmaceutical v. Bartlett pre-empt the petitioner s product liability claim against Westerly Pharmaceutical under the Illinoza Products Liability Act. This is a question of first impression on the Court, but remains a question directly in line with three major recent cases regarding prescription drugs and conflict preemption. A determination of pre-emption for generic drug product liability regulations would be consistent with the definition and use of conflict pre-emption, the evolution of federal regulation control over prescription drugs, this Court s past holdings, and policy arguments regarding reasonableness in changing a generic label. Pre-emption Pre-emption of federal laws over conflicting state laws is based in the Supremacy Clause of the United States Constitution. That clause declares: This Constitution, and the laws of the United States which shall be made in pursuance thereof... shall be the supreme law of the land; and the judges in every state shall be bound thereby, anything in the Constitution or laws of any State to the contrary notwithstanding. U.S. Const. art. IV, cl. 2. In general, three types of pre-emption exist: express pre-emption, where Congress has expressly pre-empted local law; field pre-emption, where Congress has 6

13 legislated so comprehensively that federal law occupies an entire field of regulation and leaves no room for state law; and conflict pre-emption, where local law conflicts with federal law such that it is impossible for a party to comply with both or the local law is an obstacle to the achievement of federal objectives. Figueroa v. Foster, 864 F.3d 222, (2d Cir. 2017). The Court has pre-empted state law based on its interpretation of broad federal policy objectives, legislative history, or generalized notions of congressional purposes that are not contained within the text of federal law. Wyeth v. Levine, 555 U.S. 555, 587 (2009) (THOMAS, J., concurring in judgment). Congress has not created any express pre-emption statements concerning product liability regulations for generic drugs. However, the discussion of preemption and federal drug regulations is not novel to this court nor to the FDA. First, this Court held that the need for FDA approval of brand name drug labeling changes does not provide a manufacturer with a complete defense to tort claims. Id. at (2009). This tort action against a brand-name manufacturer for failure to provide adequate warnings is not pre-empted because it is possible for a manufacturer to comply with both state and federal law under the FDA s changesbeing-effected (CBE) process. Id. This Court also stated that tort claims against generic drug manufacturers for a failure to provide adequate warning labels is preempted when the only action a manufacturer could independently take is not a matter of state-law concern. PLIVA, Inc. v. Mensing, 564 U.S. 604, 624 (2011). This Court has also stated because it is impossible for Mutual and other similarly 7

14 situated manufacturers to comply with both state and federal law, New Hampshire's warning-based design-defect cause of action is pre-empted with respect to FDA-approved drugs sold in interstate commerce. Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466, 2477 (2013). a. The history of FDA regulation and control of pharmaceutical drugs supports preemption of conflicting state statutes. In order to best understand possible pre-emption for product liability cases, it is pertinent to review the well-documented history of the federal government overseeing and controlling prescription medications through the Food and Drug Administration (FDA). The FDA began its regulatory function through the 1906 Federal Food and Drugs Act, which prohibited interstate commerce in adulterated and misbranded food, drugs, medicines and liquors. The act also began the agency s regulatory overview of packaging and labels of drugs. Fed. Food and Drugs Act of 1906, (last visited September 21, 2017). In the 1930s, Congress became increasingly concerned about unsafe drugs and enacted the Federal Food, Drug, and Cosmetic Act (FDCA) in 1936, requiring premarket approval of new drugs. 21 U.S.C As it enlarged the FDA's powers to protect the public health and assure the safety, effectiveness, and reliability of drugs, Congress took care to preserve state law. The 1962 amendments added a saving clause, indicating that a provision of state law would only be invalidated upon a direct and positive conflict with the FDCA. Wyeth, 555 U.S. at 567. In 1976, Congress enacted an express pre-emption over any 8

15 state provision for requirements relating to the safety or effectiveness of medical devices. 21 U.S.C. 360k (West). Following the pre-emption of medical devices, Congress began issuing additional duties to the FDA in regards to generic medication. Specifically, in 1984, Congress passed the Hatch-Waxman Amendments, which allows a generic drug manufacturer to gain FDA approval simply by showing that its drug is equivalent to an already-approved brand-name drug, and that the safety and efficacy labeling proposed for its drug is the same as that approved for the brand-name drug. PLIVA, 131 S. Ct. at Years later in 2006, the FDA released a regulation preamble declaring that state-law failure-to-warn claims threaten the FDA s statutorily prescribed role governing the content and format of prescription drug labels. Wyeth, 555 U.S. at 574. In 2007, Congress amended the FDCA, and granted the FDA statutory authority to require a manufacturer to change its drug label based on safety information that becomes available after a drug s initial approval. Id. at 567. b. The case similarities between PLIVA v. Mensing, Mutual Pharmaceutical Co., Inc. v. Bartlett, and this case support preemption of the Illinoza product liability statute when discussing pharmaceutical drugs. There are stark similarities between the fact patters of PLIVA v. Mensing, Mutual Pharmaceutical Co., Inc. v. Bartlett, and this case. The plaintiffs in PLIVA took prescribed generic medications and claimed to develop adverse conditions as a result. The plaintiffs brought claims against the manufacturers alleging liability under state tort law for failing to provide adequate warning labels. PLIVA at 610. In PLIVA, both statutes require a drug manufacturer that is or should be aware of 9

16 its product s danger to label that product in a way that renders its reasonably safe. Id. at 611. This court determined these failure-to-warn statutes were pre-empted by federal law. In the case of Mutual Pharmaceutical, the respondent took medication that lead to adverse medical conditions. The adverse conditions were listed as potential reactions on the package insert rather than the drug s label, and the respondent s doctor admitted to not reading the box label. Mutual, 133 S. Ct. at The respondent sued Mutual for failure-to-warn and design-defect claims. The design defect claims were the only claims to be brought before this Court and were preempted, as the state statute imposes affirmative duties on manufacturers by subjecting them to strict liability for physical harm caused by selling a product even though the manufacturer has exercised all possible care in the preparation and sale of the product. Id. at In this case, the petitioner began taking a generic prescription drug and began to develop adverse behaviors. (R. at 3). The petitioner claimed a breach of the Illinoza products liability law, which provides relief upon showing that the product was unreasonably dangerous due to a defective design and inadequate instructions or warnings. (R at 3). This case includes both of the claims determined by this Court to be pre-empted from PLIVA v. Mensing and Mutual Pharmaceutical Co. Inc, v. Bartlett, with only changes in the statutory language. c. The FDA Drug Application and Change Request process requirements placed on generic drug manufacturers supports preemption of the Illinoza product liability statute. 10

17 When comparing the state statutes for Minnesota, Louisiana, New Jersey, and Illinoza regarding prescription drug labeling, the lack of complexity and specificity is immediately identifiable. While states have blanket liability if a drug is unreasonably dangerous or includes inadequate instructions or warnings, the FDA s involvement is much more complex. Prior to approval of a new drug application, the FDA must approve of the exact text in a proposed label and receive full reports of investigations which have been made to show whether or not such drug is safe and effective. 21 U.S.C. 355(b)(1). On the other hand, generic drugs can gain FDA approval simply by showing equivalence to a reference listed drug that has already been approved by the FDA, which allows manufacturers to develop generic drugs inexpensively, without duplicating the clinical trials already performed on the equivalent brand-name drug. PLIVA, 564 U.S. at Any generic drug going through the Abbreviated new drug application (ANDA) process must include information showing that the drug is bioequivalent to the namebrand, has the same labeling as the name-brand, and has information showing that the administration, dosage form, and strength of the drug are the same as the name-brand. 21 U.S.C In order to market Ropidope, Westerly was required to submit an ANDA to the FDA with mirrored information to that of Equip. (R at 2). Change applications to name-brand and generic drugs may be just as intensive as the original application. For name-brand drugs, major changes require supplemental submission and approval prior to distribution of the product, including some changes in labeling. 21 C.F.R. 314(b). However, the FDA may allow 11

18 for certain changes to occur upon receipt by the agency rather than after agency approval for name-brand drugs, including adding or strengthening a warning for which evidence of a causal association satisfies the standard for inclusion, a statement about drug abuse, or an instruction about dosage and administration that is intended to increase the safe use of the product. 21 C.F.R. 314(c)(6). This type of change would be considered a change being effected. GlaxoCline, the holder of Equip s NDA, submitted a Supplemental New Drug Application to add additional warnings in January 2011 in accordance with the FDA process. (R. at 2). Generic drugs must always have the same warning labels as the brand-name drug, equalizing to an ongoing federal duty of sameness. PLIVA, 564 U.S. at 613. Due to this requirement, a generic manufacturer is prohibited from making any unilateral changes to a drug s label and the approval for a generic drug may be withdrawn if the generic drug s label is no longer consistent with that for the brand-name drug. Mut. Pharm., 133 S. Ct. at Should a state law require a generic manufacturer make any changes with labeling to be in compliance, federal law would only permit changes if the FDA and the brand-name manufacturer changed the brand-name label to do so. PLIVA, 564 U.S. at 620. In this case, until the FDA approved GlaxoCline s requested label change in June 2011, Westerly would not be able to begin the process of making any alterations to the generic drug s label and desired changes would be pre-empted through PLIVA v. Mensing and Mutual Pharmaceutical Co., Inc. v. Bartlett. 12

19 d. Illinoza s product liability statute should be preempted when considering the Reasonable Timing standard for updating warning labels for generic pharmaceutical drugs. Although Westerly s change to warning labels would require action by both the name-brand manufacturer and the FDA and would likely be pre-empted, it is important to mention the reasonableness discussion brought up by the Court of Appeals. Should there be a required change to a drug s warning label through the FDA, as there was in this case, all labels shall be revised to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug. 21 C.F.R (c). The petitioner in this case claims that Waverly s 6- month window before submitting its Change Being Effected notification did not occur within a reasonable amount of time. (R. at 15). The Court should take into consideration the time it may take for FDA approval through the Drug Application process. Westerly initially submitted and Abbreviated New Drug Application to the FDA in 2009 and did not receive approval until (R. at 2). GlaxoCline submitted a Supplemental New Drug Application for package insert changes in January 2011 and the FDA approved those changes in June Six months later in January 2012, Westerly submitted a CBE to notify the FDA of expected changes to the label effective on February 12th. The issues of reasonableness appeared in a number of other courts with varying holdings. The Sixth Circuit held in Fulgenzi v. PLIVA that there is no impossibility as long as the approval comes after the independent action of the private party and that independently updating labels of a generic to match that of 13

20 the branded manufacturer through the CBE process is a federal and state requirement. 711 F.3d 578, 584 (6th Cir. 2013). The court stated that the information for the drug was not updated the entire time the plaintiff was prescribed a drug, up to three years. Id. at 582. The Northern Division of Kentucky held and the Sixth Circuit affirmed that a failure to timely update drug labeling could have occurred is nothing more than a sheer possibility and is not sufficient to state a claim for relief even when disregarding a pre-emption concern. In re Darvocet, Darvon, & Propoxyphene Prod. Liab. Litig., 756 F.3d 917 (6th Cir. 2014). The court also stated that plaintiff claims are pre-empted to the extent they allege failure to comply with FDCA or FDA regulations. Id. As a final example, the Southern District of New York held that the lack of updating a label for a year after issuance by the brand-name manufacturer is preempted in accordance with Filgenzi v. PLIVA. The district emphasized that the duty of generic defendants extends only to their alleged failure to update the label within a reasonable time. In re Fosamax Prod. Liab. Litig., 965 F. Supp. 2d 413, 418 (S.D.N.Y. 2013). Although these cases do not include concrete timelines regarding reasonableness in having generic brands change labels, the courts offer additional information regarding the need to comply with FDA or FDCA regulations prior to any state actions. The FDA is an expert body, and better placed to set drug policy than state legislatures, much less state juries in after-the-fact verdicts. Riegel v. 14

21 Medtronic, Inc., 552 U.S. 312, 315 (2008). Should states be pre-empted from most claims concerning generic drugs except for occurrences of inadequate delays that meet both state and federal guidelines, a determination of timeliness and reasonableness would lie in the hands of a lay jury instead of with a federal agency that understands timelines for all drug applications. Conclusion This case must be pre-empted by the holdings in PLIVA v. Mensing and Mutual Pharmaceutical v. Bartlett. After reviewing the basis behind pre-emption, the historical changes in the FDA, and discussing possible actions resulting from a view of the reasonableness standard, we request that this Court follow its prior holdings and pre-empt this product liability statute. II. This Court Should Hold That Attorneys Fees Are Permissible Under 41(d). This Court should affirm the Circuit Court s decision below, awarding attorneys fees to the Respondent for three reasons. First, this Court has previous held, in an analogous case, interpreting another Rule that attorneys fees were recoverable under the term costs. Second, the majority of Circuit Courts that have addressed the issue have held that attorneys fees were recoverable under Rule 41(d). Finally, the underlying statute in the case at bar, specifically defines costs to include attorneys fees. 15

22 a. In Marek v. Chesney, 473 U.S. 1 (1985). this Court held that Fed. R. Civ P. 68 allowed for the recovery of attorneys fees within the scope of costs permitted. Fed. R. Civ. P. 41(d) presents the term costs in an analogous manner and should be interpreted the same as Rule 68, thereby allowing attorneys fees to be recovered. In the American legal system, the standard rule is that each party pays its own attorneys fees. The American Rule, as it has come to be known, holds that the prevailing party may not recover attorneys' fees as costs or otherwise. Alyeska Pipeline Serv. Co. v. Wilderness Soc y, 421 U.S. 240, 245 (1975). However, by the time the Federal Rules of Civil Procedure (FRCP) were adopted in the late 1930s, there were already established exceptions to the American Rule. Marek v. Chesney, 473 U.S. 1 (1985). Even under the general rule, a court may assess attorneys fees for the willful disobedience of a Court order... as part of the fine to be levied on the defendant; or when the losing party has acted in bad faith, vexatiously, wantonly, or for oppressive reasons..... These exceptions are unquestionably assertions of inherent power in the courts to allow attorneys' fees in particular situations.... Alyeska, 421 U.S. at 259. However, most of the exceptions were found in federal statutes that specifically directed courts to award attorney's fees as part of costs in particular cases. Id. at This Court highlighted the fact that the authors of the FRCP were aware of the exceptions to the American Rule when they drafted the rules. Marek, 473 U.S. at 8. Accordingly, this Court held that attorneys fees were included as costs under Rule 68 when Congress defined costs in the underlying statute to include attorneys fees. Id. at 8-9. This Court reasoned that the drafters of the FRCP were 16

23 well aware of distinctions between statutes defining costs as including attorneys fees and those that left attorneys fees out of the definition of costs. Id. Against this background of varying definitions of "costs," the drafters of Rule 68 chose not to define the term and gave no explanation as to its intended meaning in the history of the Rule. Given this historical background and in light of the importance of the term "costs" to the Rule, it is unlikely that this omission was merely an oversight. Rather, the most reasonable inference is that the drafters intended for the term "costs" in Rule 68 to include to all costs properly awardable under the relevant substantive statute or other authority. In other words, all costs properly awardable in an action are to be considered within the scope of Rule 68 "costs." Absent congressional expressions to the contrary, where the underlying statute defines "costs" to include attorney's fees, we are satisfied such fees are to be included as costs for purposes of Rule 68. Id. The same logic the Court applied to Rule 68 should be applied to Rule 41(d), as both rules use similar terms, and were devised by the same people. b. The majority of Circuits addressing the issue allow attorneys fees to be recovered under Rule 41(d). The majority of courts addressing the issue have found that attorneys fees may be recovered under Rule 41(d), either as a right, or where the underlying statute supporting the litigation defines costs to including attorneys fees. The Eighth Circuit, in Kent v. Bank of America, N.A., 518 Fed.Appx. 514 (8th Cir. 2013), held that attorneys fees are generally allowable, at the discretion of the district courts. It reasoned that allowing an award of attorneys fees under Rule 41(d) is " 17

24 intended to serve as a deterrent to forum shopping and vexatious litigation." Id. at 516 (citing Simeone v. First Bank Nat'l Ass'n, 971 F.2d 103 (8th Cir. 1992)). Other courts that have addressed this question have applied this Court s Marek rationale to Rule 41(d), allowing attorneys fees only when the underlying statutes define costs to include them. The Seventh Circuit, in Sanderson v. Spectrum Labs, Inc., 248 F.3d 1159 (7th Cir. 2000), held that attorneys fees were permissible, in that case, it was because the Lanham Act specifically provided they are included in costs. The court later explained that, " the substantive statute which formed the basis of the original suit allow[ed] for the recovery of such fees as costs." Esposito v. Piatrowski, 223 F.3d 497, 501 (7th Cir. 2000). It further noted that where fees are specifically ordered by the court they are allowable. Id. The Fourth Circuit, in Andrews v. Am. s Living Ctrs., LLC, 827 F.3d 306 (4th Cir. 2016), adopted the Seventh Circuit s Esposito rationale, holding: Id. at 311. We find the Seventh Circuit's reasoning persuasive and thus adopt it here. 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. Only one circuit court, the Sixth Circuit, holds that attorneys fees are not recoverable under Rule 41(d). Rogers v Wal-Mart, 230 F.3d 868, 874 (6th Cir. 2000). It reasoned that where the rule did not explicitly provide for attorneys fees, there could be no award made. The court clarified: 18

25 Where Congress has intended to provide for an award of attorney fees, it has usually stated as much and not left the courts guessing. Further, the law generally recognizes a difference between the terms "costs" and "attorney fees" and we have no desire to conflate the two terms. Rather, we must assume that Congress was aware of the distinction and was careful with its words when it approved Rule 41(d). Id. Interestingly, the Sixth Circuit s rationale can be used to support the same conclusion that the Seventh and Fourth Circuits reached. Where the argument is that Congress explicitly states when it intends to provide for an award of attorney fees, then when an underlying statute provides for costs that include attorneys fees. Congress intended to codify the awarding of attorneys fees in litigation costs for cases arising from substantive statutes that carry such a provision, as evidenced by the fact that Congress drafts and passes its own legislation, while the FRCP is drafted by appointees of the Supreme Court, and merely confirmed by Congress. In other words, statutes are a direct statement by Congress of its intent and the FRCP, which is a direct statement of this Court. c. The underlying statute in this case, the Federal Food, Drug, & Cosmetic Act, twice defines costs as including reasonable attorney fees. 21 USC 399d (b)(3)(c); 21 USC 399d (b)(7)(b). Applying the holding and rationale of Marek is appropriate here, and this Court should find attorneys fees are appropriate under Rule 41(d). According to the record below, the present case was brought under the provisions of the Federal Food, Drug, & Cosmetic Act. Ivers v. Westerley Pharm., Inc., No (12th Cir. 2017). The Federal Food, Drug, & Cosmetic Act defines costs as including reasonable attorney fees in two separate provisions. See 21 USC 399d (b)(3)(c); 21 USC 399d (b)(7)(b). 19

26 First, in 21 USC 399d (b)(3)(c), the drafters of the statute said that in cases where an order finds that a violation of the statute has occurred, the Secretary may assess against the person against whom the order is issued a sum equal to the aggregate amount of all costs and expenses (including attorneys and expert witness fees) reasonably incurred. 21 USC 399d (b)(3)(c). Second, in 21 USC 399d (b)(7)(b), Congress again defined costs to include attorney fees. There, Congress specified that the court, in issuing any final order under this paragraph, may award costs of litigation (including reasonable attorneys and expert witness fees) to any party whenever the court determines such award is appropriate. 21 USC 399d (b)(7)(b). This Court held, with regard to similar ambiguity about costs in Rule 68, that where the underlying statute defines "costs" to include attorney's fees, we are satisfied such fees are to be included as costs for purposes of Rule 68. Marek, 473 U.S. at 9. Here, Congress defined costs to include attorneys fees in the statute underlying this case, and they should be included as costs for the purposes of Rule 41(d). The majority of Circuits that have addressed the issue agree that 41(d) does allow for recovery of attorneys fees, either generally, or when the underlying statute provides for attorneys fees to be included in costs. Here, the underlying statutory interpretation should mirror the way that this Court handled an identical ambiguity regarding costs in Rule 68, in Marek. Additionally, the underlying statute here twice defines costs as including reasonable attorneys fees. For the 20

27 foregoing reasons, we respectfully request that this Court affirm the Circuit Court s decision below, awarding attorneys fees to the Respondent. CONCLUSION This case must be pre-empted by the holdings in PLIVA v. Mensing and Mutual Pharmaceutical v. Bartlett. After reviewing the basis behind pre-emption, the historical changes in the FDA, and discussing possible actions resulting from a view of the reasonableness standard, we request that this Court follow its prior holdings and pre-empt this product liability statute. The majority of Circuits that have addressed the question agree that 41(d) does allow for recovery of attorneys fees, either generally, or when the underlying statute provides for attorneys fees to be included in costs. Here, the underlying statutory interpretation should mirror the way that this Court handled an identical ambiguity regarding costs in Rule 68, in Marek. Additionally, the underlying statute here twice defines costs as including reasonable attorneys fees. For the foregoing reasons, we respectfully request that this Court affirm the Circuit Court s decision below, awarding attorneys fees to the Respondent. 21

28 CERTIFICATE OF SERVICE We certify that a copy of Petitioner s brief was served upon Respondent, Ruben C. Mason, through the counsel of record by certified U.S. mail return receipt requested, on this, the 22nd day of September, Team 2626 Attorneys for Respondent 22

29 APPENDIX A Constitutional Provisions U.S. Const. art. IV, cl. 2. 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, anything in the Constitution or laws of any State to the contrary notwithstanding. Statutory Provisions Fed. R. Civ. P. 41(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. 23