No Alice IVERS, Petitioner, v. WESTERLY PHARMACEUTICAL, INC., Respondent

No. 17-230 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 Counsel for Respondent Team 2606 i

QUESTIONS PRESENTED I. Whether the Twelfth Circuit was correct in holding that decisions in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical v. Bartlett, 133 S. Ct. 2466 (2013), preempt Ivers' claims in this case, despite the fact that such claims are clearly distinguishable and fall neither under impossibility nor obstacle preemption. II. Whether a defendant is entitled to attorney s fees under Rule 41(d) of the Federal Rules of Civil Procedure when the rule makes no mention of attorney s fees and the longstanding American Rule is that each party to a litigation bears the cost of their own attorney s fees. ii

TABLE OF CONTENTS QUESTIONS PRESENTED... ii TABLE OF CONTENTS... iii OPINIONS BELOW... 1 STATEMENT OF THE CASE... 2 SUMMARY OF THE ARGUMENT... 5 I. The Twelfth Circuit was Incorrect in Holding that the Decisions in PLIVA V. Mensing, Inc. and Mutual Pharmaceutical v. Bartlett Preempt Ivers Claims in this Case.... 5 II. Rule 41(D) S Provision For Costs does not Include Attorney s Fees... 6 ARGUMENT... 7 I. STANDARD OF REVIEW... 7 II. THE TWELFTH CIRCUIT WAS INCORRECT IN HOLDING THAT THE DECISIONS IN PLIVA, INC. v. MENSING AND MUTUAL PHARMACEUTICAL v. BARTLETT, PREEMPT IVERS CLAIMS IN THIS CASE.... 8 A. Illinoza Tort Liability Law... 10 B. The Federal Food, Drug, and Cosmetic Act, as Amended by the Hatch- Waxman Act... 11 C. Impossibility Preemption Does Not Exist in This Case Because the Applicable Federal and State Laws at Issue Could Have Been Properly and Independently Followed.... 11 1. This Court s Decision In PLIVA, Inc. V. Mensing Does Not Preempt Ivers State Tort Law Claims Because the Generic Drug Manufacturer In PLIVA Was Required To Act Unilaterally Against The Federal Guidelines, While Westerly Was Not.... 12 2. This Court s Decision in Mutual Pharmaceutical v. Bartlett to Follow Its Decision in PLIVA Does Not Preempt the Clearly Distinguishable Facts in Ivers State Law Tort Claims.... 14 D. The Illinoza State Tort Law at Issue Creates No Obstacle in Carrying Out the Intention of Congress When They Passed the Federal Law Guidelines Required by the Hatch-Waxman Act and, Therefore, Are Not Preempted.... 17 III. THE TWELFTH CIRCUIT WAS INCORRECT IN HOLDING THAT AWARDABLE COSTS IN RULE 41(d) OF THE FEDERAL RULES OF CIVIL PROCEDURE ALLOWS FOR THE RECOVERY OF ATTORNEY S FEES.... 19 A. Ivers is Not Responsible for Westerly s Attorney s Fees Because Under the American Rule, United States Courts Do Not Award Attorney s Fees to Litigants Absent a Statutory Provision or Rule, And Rule 41(D) Does Not Provide For Attorney s Fees.... 21 iii

1. The Supreme Court has a Longstanding Policy of Adhering to the American Rule.... 21 2. There is No Express Provision Here Because the Text Of Rule 41(D) Does Not Provide for Attorney s Fees... 23 3. The explicit provisions of attorney s fees in other Federal Rules of Civil Procedure indicates that costs in Rule 41(d) was meant to have a distinct meaning from attorney s fees.... 24 4. Courts have analyzed Rule 41(d) s text and its relationship to the other Federal Rules of Civil Procedure to conclude that costs does not include attorney s fees.... 25 B. The assertion that it would be inconsistent for courts to award attorney s fees under Rule 41(a)(2) and not Rule 41(d) is incorrect because the rules apply to different points in the timeline of the case, and unjust outcomes would result if fees were awarded under Rule 41(d) that would not occur under Rule 41(a)(2). 27 C. Even if Rule 41(d) s provision of costs was interpreted to include attorney s fees, Ivers still does not have to pay for Westerly s attorney s fees because Ivers asserted the same facts and legal theories in both cases, and Rule 41(d) s provision of costs is only meant for recovery of costs that are unable to be used in a subsequent action.... 29 1. Costs should only be provided if the effort cannot be used in a subsequent litigation, which is not the case here.... 29 2. The costs incurred by Westerly in the initial litigation are still useful for the current litigation.... 31 3. The circuit court incorrectly stated the holding of Davis v. USX Corp., and its actual holding states that attorney s fees should not be awarded when the defendant will not be prejudiced because it can utilize the work from the initial litigation in the subsequent litigation.... 31 CONCLUSION... 33 APPENDIX A... 34 APPENDIX B... 35 iv

TABLE OF AUTHORITIES Page(s) Cases Alyeska Pipeline Serv. Co. v. Wilderness Society, 421 U.S. 240 (1975)..20, 21 Anders v. FPA Corp., 164 F.R.D. 383 (D.N.J.1995). 26 Andrews v. America's Living Ctrs, LLC, 827 F.3d 306 (4th Cir. 2016)... 16 Belkow v. Celotex Corp., 722 F. Supp. 1547 (N.D. Ill. 1989).. 31 Cauley v. Wilson, 754 F.2d 769 (7th Cir. 1985)...... 20, 30, 31 Chambers v. Nasco, Inc., 501 U.S. 32 (1991).. 21 Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992)... 10 Copeland v. Hussmann Corp., 462 F.Supp.2d 1012 (E.D. Mo. 2006). 30 Crosby v. National Foreign Trade Council, 530 U.S. 363 (2000). 17 Davis v. USX Corp., 819 F.2d 1270 (4th Cir. 1987)... 20, 32 Duffy v. Ford Motor Co, 218 F.3d 623 (6th Cir. 2000). 20, 27, 29 Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132 (1963)... 12 Fogarty v. Fantasy, Inc., 510 U.S. 517 (1994). 21 v

Freightliner Corp. v. Myrick, 514 U.S. 280 (1995)... 12 Gade v. National Solid Wastes Management Ass n, 505 U.S. 88 (1992)... 9 Greenwood Grp., LLC v. Brooklands, Inc., 2016 U.S. Dist. LEXIS 90316, *7-9 (W.D.N.Y. July 12, 2016). 30 Gregory v. Dimock, 286 F.2d 717 (2d Cir.1961)... 27, 29 Grier v. Am. Honda Motor Co., Inc., 529 U.S. 861 (2000).. 8 Hines v. Davidowitz, 312 U.S. 52 (1941). 17 Key Tronic Corp. v. United States, 511 U.S. 809 (1994).. 21, 24, 26 Marek v. Chesny, 473 U.S. 1 (1985).. 22 Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)... 7, 8, 9, 10, 18 Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S.Ct. 2466 (U.S. 2013). 14, 15 PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011)... 5, 9, 10, 12, 17, 18, 19 Rogers v. Wal-Mart Stores, Inc., 230 F.3d 868 (6th Cir. 2000) 8, 20, 24, 25, 26 Siepel v. Bank of Am., N.A., 239 F.R.D. 558 (E.D. Mo. 2006).. 30 Simeone v. First Bank Nat'l. Ass'n, 125 F.R.D. 150, 155 (D.Minn. 1989).. 26 Tyco Laboratories Inc. v. Koppers Co., vi

627 F.2d 54 (7th Cir. 1980). 32 White v. Telelect, Inc., 109 F.R.D. 655 (S.D.Miss.1986). 28 Wyeth v. Levine, 555 U.S. 555 (2009)... 10, 12, 18, 19 Yoffe v. Keller Indus., Inc., 580 F.2d 126 (5th Cir. 1978)... 28 Zucker v. Katz, 708 F.Supp. 525 (S.D.N.Y. 1989)... 27 Statutes 21 C.F.R. 320.1... 11 21 U.S.C. 301 et seq. 11 21 U.S.C. 355 11, 14 21 U.S.C. 360.. 19 28 U.S.C. 1332. 4 28 U.S.C. 1441. 4 28 U.S.C. 1920.. 23, 24, 26 42 U.S.C. 1988 22 East Texas Code Annotated 12-12-12 23 Illz. Prod. Liability Act. 1998-4(1).. 11, 14 Rules Fed. R. Civ. P. 11. 24 Fed. R. Civ. P. 26. 24 Fed. R. Civ. P. 30.. 25, 26 vii

Fed. R. Civ. P. 37 25, 26 Fed. R. Civ. P. 41(d)... 4-8, 19-30, 33 Fed. R. Civ. P. 41(a)(2). 4, 27-32 Fed. R. Civ. P. 54 24, 26 Fed. R. Civ. P. 56 25, 26 Fed. R. Civ. P. 68.. 22 Constitution U.S. Const. Art. VI, Cl. 2.. 9 Restatements Restatement (Third) of Torts: Products Liability 1....10 viii

OPINIONS BELOW The unreported opinion of the United States Court of Appeals for the Twelfth Circuit appears on pages 9 22 of the record. The unreported opinion of the United States District Court for the District of Illinoza appears on pages 1 6 of the record. 1

STATEMENT OF THE CASE Petitioner Alice Ivers ( Ivers ) seeks to prevent pharmaceutical companies, such as Respondent Westerly Pharmaceuticals, Inc. ( Westerly ) from failing to warn about the disastrous side effects of their drugs. In February 2011, Ivers was diagnosed with Parkinson s disease. (R. at 1.) Ivers doctor prescribed her a daily dosage of ropidope hydrochloride ( ropidope ) as part of her treatment. (R. at 1.) The next month Ivers began taking the generic version of ropidope, manufactured by Westerly. (R. at 1.) In July 2011, Ivers began to develop compulsive spending and gambling behaviors. (R. at 3.) As a result, Ivers spent countless hours playing online poker and even transferred the majority of her retirement savings into an online poker service account. (R. at 3.) Ivers felt so much guilt from winning such a large amount of money that she was compelled to spend it on charitable gifts. (R. at 3.) By the end of 2012, she had entirely depleted her retirement savings and upon this realization her husband of thirty-five years filed for divorce. (R. at 3.) Ropidope is a chemical compound, which acts to inhibit the dopamine hormone reactions (i.e. tremors and motor impairment) associated with the symptoms of Parkinson s. (R. at 2.) Ropidope was approved to market as a new drug by the Federal Food and Drug Administration ( FDA ) in 1997. (R. at 2.) The prescription drug was originally patented by GlaxoCline, LLC, and is sold under the brand name Equip. (R. at 2.) GlaxoCline s patent expired in 2008 and Westerly submitted an Abbreviated New Drug Application ( ANDA ) to the FDA. (R. at 2.) The FDA approved Westerly s ANDA, and Westerly began selling its generic version 2

in 2009. (R. at 2.) Westerly then submitted labeling that mirrored the then-current label for Equip. (R. at 2.) GlaxoCline submitted a Supplemental New Drug Application ( snda ) in 2011, which requested prior approval of proposed changes to its package insert and labeling. The snda included a request to add a new paragraph under the Warnings and Precautions section that read: 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, and the inability to control these urges while taking one or more of the medications, including EQUIP, that increase central dopaminergic tone and that are generally used for the treatment of Parkinson s disease... In some cases, although not all, these urges were reported to have stopped when the dose was reduced or the medication was discontinued. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges while being treated with EQUIP. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking EQUIP. (R. at 2). The FDA approved this additive and in June 2011, GlaxoCline implemented it on Equip labels. (R. at 2.) In January, 2012, seven months later, Westerly submitted a Changes Being Effected (CBE) notification to the FDA, which stated that it would be updating ropidope s labels to match Equip s amended label. (R. at 2.) Ropidope s new label was finally effective on February 1, 2012. (R. at 2.) Procedural History Ivers initially filed her complaint against Westerly in the United States District Court for the Western District of East Texas under East Texas Products 3

Liability Law, but she filed a Notice of Voluntary Dismissal under Federal Rule of Civil Procedure 41(a) before Westerly filed an answer. (R. at 5.) Ivers alleged these same facts and legal theories against Westerly in the in the state court of Illinoza on September 15, 2015. (R. at 3.) In her complaint, Ivers argued that Westerly s failure to warn of ropidope s side effects proximately caused her compulsive gambling behavior and spending urges, which ultimately lead to irreversible damage to her finances and relationships. (R. at 3.) Ivers argued that Westerly breached the duty owed to her under Illinoza products liability law. (R. at 3.) Ivers bases her argument on sections (1)(b) and (c), alleging that ropidope s labels were defectively designed and contained inadequate warnings of their side effects. (R. at 3.) Westerly removed the proceeding to the United States District Court for the District of Illinoza, asserting diversity jurisdiction under 28 U.S.C. 1332 and removal jurisdiction under 28 U.S.C. 1441, on October 14, 2015. (R. at 1.) Westerly subsequently filed an answer along with a Motion for Judgement on the Pleadings and Motion for an Award of Costs under Federal Rule of Civil Procedure 41(d) on November 2, 2015. (R. at 3.) On December 20, 2015, the district court granted Westerly s motion for judgment on the pleadings and motion for an award of costs, with the stipulation that costs would not include attorney s fees. (R. at 7-8.) Both parties appealed the court s decision to the Court of Appeals for the Twelfth Circuit. (R. at 9.) The Twelfth Circuit affirmed the district court s dismissal of the complaint and affirmed its award of costs, but reversed a portion of the district court s order to hold that costs did include attorney s fees. (R. at 10.) 4

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. 2466 (2013), preempt Ivers claims in this case; and (3) whether attorney s fees are considered awardable costs under Federal Rule of Civil Procedure 41(d). (R. at 23.) SUMMARY OF THE ARGUMENT I. The Twelfth Circuit was Incorrect in Holding that the Decisions in PLIVA V. Mensing, Inc. and Mutual Pharmaceutical v. Bartlett Preempt Ivers Claims in this Case. Impossibility preemption does not exist in this case because Westerly had the opportunity to independently follow both federal and state requirements in administering its label for ropidope, the generic version of Equip. This Court s decision in PLIVA, Inc. v. Mensing and Mutual Pharmaceutical v. Bartlett do not preempt Ivers state tort law claims because they can be greatly distinguished. Unlike the generic drug manufacturers in PLIVA and Bartlett, GlaxoCline changed its label six months prior to Westerly s label change for ropidope. This change should have not only notified, but compelled Westerly to immediately make the change to ensure its consumers safety. Even more shocking is that GlaxoCline had notified the FDA of the dangerous side effects of Equip over a year before Westerly s label change was even implemented. Further, the circumstances in Bartlett created more notification to both the plaintiff and generic manufacturer. Unlike Bartlett, Ivers had virtually no idea what was causing 5

her compulsions due to Westerly s failure to warn. Westerly made no mention of the effects of its drug until its label change, six months after its RLD counterpart. Had Westerly properly updated their label, Ivers would have known that the medication was causing such behavior and took the necessary steps to control the compulsion. Ivers does not seek for Westerly to change its drugs composition, nor does she request that it stop selling it. However, she does seek remedy for the effects that Westerly s drug had on her. Holding Westerly liable under state law for the defective design of its label and failing to adequately warn of the drug s side effects within a reasonable time does not pose an obstacle to its responsibility under federal law to mirror the label of its brand name drug. This Court has consistently held that there is a presumption against federal preemption of state law. Congress was silent on their intention to preempt in their Hatch-Waxman Amendment to the FDCA, but eight years prior expressly preempted state law in a provision for medical devices. This furthers the fact that Congress s intent was to expedite generic drug manufacturers entry into the market, and not to preempt states from holding such manufacturers liable for their defective drug labels. Therefore, this court should reverse the decision of the Twelfth Circuit s holding that PLIVA, Inc. v. Mensing and Mutual Pharmaceutical v. Bartlett preempt Ivers state tort law claims. II. Rule 41(D) S Provision For Costs does not Include Attorney s Fees. 6

Rule 41(d) only provides for costs and does not allow for the recovery of attorney s fees. United States courts adhere to the American Rule, which states that each party to a litigation bears the costs of its own attorney s fees and courts only deviate from this longstanding rule when an express rule or statutory provision for attorney s fees exists. There is no express provision for attorney s fees in Rule 41(d), even though other Federal Rules of Civil Procedure do expressly provide for attorney s fees. Furthermore, Westerly is still not entitled to attorney s fees because Ivers is asserting the same facts and legal theories as the previous case and any work used in preparation for the initial case could have be used in the current case. Accordingly, this Court should reverse the Twelfth Circuit s decision that Rule 41(d) allows Westerly to recover attorney s fees. ARGUMENT I. STANDARD OF REVIEW This Court is reviewing the Twelfth Circuit s affirmation of judgment on the pleadings for the preemption claim, affirmation of the award of costs, and partial reversal of the of the denial of costs for attorney s fees, all granted in favor of Westerly. The Supreme Court s analysis of a preemption statute must begin with its text, but the interpretation of that language does not occur in contextual vacuum. Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996). Instead, two presumptions about the nature of preemption are followed. Id. The first presumption is that the state s assured police powers are not superseded by federal act unless that was [the] clear 7

and manifest purpose of Congress. Id. The second presumption is that any understanding of scope of preemption statute must rest primarily on fair understanding of congressional purpose. Id. Under Rule 41(d), the district court has the discretion to grant or deny costs to a defending party. See Fed. R. Civ. P. 41(d); Rogers v. Wal-Mart Stores, Inc., 230 F.3d 868, 873 74 (6th Cir. 2000). To the extent, however, that the district court s order also concerns interpretation of the proper scope of a Federal Rule of Civil Procedure, that question of law is reviewed de novo. Andrews v. America's Living Ctrs., LLC, 827 F.3d 306, 309 (4th Cir. 2016). II. THE TWELFTH CIRCUIT WAS INCORRECT IN HOLDING THAT THE DECISIONS IN PLIVA, INC. v. MENSING AND MUTUAL PHARMACEUTICAL v. BARTLETT, PREEMPT IVERS CLAIMS IN THIS CASE. The Twelfth Circuit was incorrect in holding that the decisions in PLIVA, Inc. v. Mensing and Mutual Pharmaceutical v. Bartlett, preempt Ivers claims in this case. However, Ivers claim is greatly distinguished from that of both cases. Further, other federal requirements call for unilateral action of the generic drug manufacturers that could have aided in the prevention of Ivers injuries. Congress s intent to preempt state laws is the ultimate touchstone for a preemption analysis. E.g. Medtronic, 518 U.S. at 485. Congress may explicitly state its intent to preempt, but in the absence of an explicit statement from Congress, federal law preempts state law if Congress s intent to do so may fairly be implied. Grier v. Am. Honda Motor Co., Inc., 529 U.S. 861, 883-86 (2000). Congress's intent, of course, primarily is discerned from the language of the pre-emption statute and 8

the statutory framework surrounding it. Medtronic, 518 U.S. at 485 86 (citing Gade v. National Solid Wastes Management Ass n, 505 U.S. 88, 111 (1992) (Kennedy, J., concurring in part and concurring in judgment). Also relevant however, is the structure and purpose of the statute as a whole, as revealed not only in the text, but through the reviewing court's reasoned understanding of the way in which Congress intended the statute and its surrounding regulatory scheme to affect business, consumers, and the law. Id., at 98, 112 S.Ct., at 2383 (opinion of O Connor, J.), Medtronic, Inc. v. Lohr, 116 S.Ct. 2240, 2250 51, 518 U.S. 470, 485 86 (U.S.Fla.,1996). Because Congress did not expressly state its intention in the FDCA to preempt Illinoza Tort Liability Law, the Twelfth Circuit relied on an implied preemption analysis. (R. at 12-16.) Federal law impliedly pre-empts state law when state and federal law conflict. PLIVA, Inc. v. Mensing, 564 U.S. 604, 634 (2011) (Sotomayor, S. dissenting) (internal quotation marks omitted). Conflict preemption falls under two categories: impossibility and obstacle. Id. The Twelfth Circuit held that Ivers state tort law claim fell under both impossibility and obstacle conflict preemption. Id. However, the application of Ivers state tort law claim does not make the execution of the FDCA s mirroring guidelines impossible, nor does it create an obstacle to Congress s intention of expediting generic drug manufacturers entry into the pharmaceutical market. The Constitution s Supremacy Cause gives federally-enacted laws the preemptive position when state law conflicts. U.S. Const. Art. VI, Cl. 2. A 9

preemption analysis requires a comparison between federal and state law. PLIVA, 564 U.S. at 604. The state and federal laws concerned here involve the labeling and warning duties for manufacturers of generic prescription drugs. In making a determination of preemption it is assumed that State law is not superseded by federal unless there is a clear and manifest purpose of Congress. Wyeth v. Levine, 555 U.S. 555, 565 (2009) (noting that Congress s purpose is the ultimate touchstone in every preemption case). This Court has long used a presumption against the pre-emption of state police power regulations to support a narrow interpretation of such an express command. Medtronic, Inc. v. Lohr, 518 U.S. 470, 484 85 (1996) (quoting Cipollone v. Liggett Group, Inc., 505 U.S. 504, 505 (1992)). Such an approach is consistent with both federalism concerns and the historic primacy of state regulation of matters of health and safety. Medtronic, 518 U.S. at 484 85. A. Illinoza Tort Liability Law Ivers brought her original complaint under Illinoza Tort Liability law. (R. at 3.) Although Illinoza has not addressed the specific parameters of unreasonable warnings regarding prescription drugs, it generally follows the Restatement of the Law, Third, Torts: Products Liability. (R. at 15.) Under such, a commercial seller or distributor is held liable for any harm caused by defective products. Restatement (Third) of Torts: Products Liability 1. The Plaintiff holds the burden to prove that the manufacturer s product was unreasonably dangerous due to (a) manufacturing defect, (b) defective design, (c) inadequate instructions or warnings, or (d) failure to 10

conform to an express warranty. Illz. Prod. Liability Act. 1998-4(1). Ivers brought this suit under sections (b) and (c). (R. at 3.) B. The Federal Food, Drug, and Cosmetic Act, as Amended by the Hatch-Waxman Act The federal law at issue is the Federal Food, Drug, and Cosmetic Act ( FDCA ), which gives oversight authority to the FDA to the safety of food, drugs, and cosmetics. See generally 21 U.S.C. 301 et seq. In 2012, Congress amended the FDCA when it passed the Drug Price Competition and Patent Term Restoration Act, otherwise known as Hatch-Waxman Act, promoting the entry of generic drugs into the market. 21 U.S.C. 355(j)(2)(A)(2012). Under this Act, once the patent expires on a previously FDA-approved drug, manufacturers may sell generic versions of the drug after receiving an Abbreviated New Drug Application ( ANDA ) review by the FDA. Id. at 355(j). To receive abbreviated approval, the manufacturer of the generic version must get FDA certification that it is equivalent in ingredients, dosage, strength, and labeling to the brand-name, or referencelisted drug ( RLD ), it imitates. Id.; see also 21 C.F.R. 320.1(c) (2015). The generic manufacturer must mirror the same labeling as the FDA approved label of the RLD. 21 U.S.C. 355(j)(2)(A)(v). C. Impossibility Preemption Does Not Exist in This Case Because the Applicable Federal and State Laws at Issue Could Have Been Properly and Independently Followed. Impossibility preemption does not exist in this case because Westerly had the opportunity to independently follow both federal and state requirements in administering its label for ropidope, the generic version of Equip. An impossibility 11

preemption exists when it is impossible for a private party to comply with both state and federal requirements. Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995). The question for impossibility is whether the private party could independently do under federal law what the state law requires of it PLIVA, 564 U.S. at 638; see also Wyeth, 555 U.S. at 573. Impossibility preemption is a demanding defense that gives the defense the burden of proving that compliance with both federal and state law is a physical impossibility. PLIVA, 564 U.S. at 634 (Sotomayor, S. dissenting) (emphasis added) (quoting Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-143 (1963)); see also Wyeth, 555 U.S. at 573. This high burden rejects the mere possibility of the inability to comply with both state and federal laws and seeks that the party utilizing this defense show an inevitable collision. Florida Lime & Avocado Growers, 373 U.S. at 143. Westerly failed to meet the burden of showing that such an inevitable collision exists. Further, the Twelfth Circuit incorrectly found that Westerly had met this burden through its utilization of distinguishable cases, namely PLIVA, Inc. v. Mensing and Mutual Pharmaceutical v. Bartlett. 1. This Court s Decision In PLIVA, Inc. V. Mensing Does Not Preempt Ivers State Tort Law Claims Because the Generic Drug Manufacturer In PLIVA Was Required To Act Unilaterally Against The Federal Guidelines, While Westerly Was Not. This Court in PLIVA, Inc. v. Mensing, found impossibility when a generic drug manufacturer failed to unilaterally change its label to warn consumers about its drug s side effects. 564 U.S. 604. In PLIVA, the original patent owner of the 12

brand name drug had not updated its label to notify of its dangerous side effects, therefore the generic brand manufacturer was neither notified nor able to change its label. Id. Our case can be greatly distinguished from that of PLIVA because unlike the generic manufacturer in PLIVA, Westerly s brand name counterpart, Equip, implemented a new label. (R. at 2.) Equip s manufacturers, GlaxoCline, submitted a Supplemental New Drug Application (snda) to add a new paragraph under their Warnings and Precautions section in January of 2011. Id. At the very least, this date should have been the first warning sign to Westerly that a change to its label was necessary. The second time that Westerly should have been aware that it needed to change its label was when Equip s updated label was actually approved and implemented in June of 2011. (R. at 2.) However, Westerly failed to mirror its brand name counterpart for another nine months, until it finally submitted a Changes Being Effected (CBE) notification to the FDA in January 2012, notifying the agency that it would be updating its ropidope labels to match the new Equip labels. (R. at 2-3.) It wasn t until February 1, 2012, over a year after Westerly s initial notification that its label needed to be updated, that ropidope s labels properly warned its consumers about the side effects of the drug. (R. at 3.) Ivers began experiencing the side effects of ropidope in July of 2011, just one month after Equip s new label was implemented. (R. at 3.) Had Westerly acted promptly in amending its label, Ivers would have known that her compulsive gambling and spending habits were being caused by her medication and either ceased medication or spoken with her doctor about controlling it. 13

2. This Court s Decision in Mutual Pharmaceutical v. Bartlett to Follow Its Decision in PLIVA Does Not Preempt the Clearly Distinguishable Facts in Ivers State Law Tort Claims. This Court in Mutual Pharmaceutical Co., Inc. v. Bartlett, reversed the First Circuit court of appeals decision, finding the decision in PLIVA, Inc. v. Mensing controlling and that the FDCA preempted the relevant state tort law. 133 S.Ct. 2466, 2470 (2013). The Court further determined that the only way both state and federal law could be applied is if the generic drug manufacturer redesigned its label or chemical composition, going directly against the FDCA mirroring policy. Id. at 2475. Ivers original complaint argued that Westerly s drug label for ropidope was defectively designed. (R. at 3.) State tort law imposes liability on manufacturers of defectively designed drugs, and the Hatch Waxman Act requires generic manufacturers to mirror its RDL s composition. See Illz. Prod. Liability Act. 1998-4(1); see also 21 U.S.C. 355(j)(2)(A)(iv) (2012). While the facts of Bartlett are nearly consistent with that of PLIVA, Ivers cases is distinguishable. Further, the circumstances in Bartlett created more notification to both the plaintiff and generic manufacturer. In Bartlett, in 2004, plaintiff was prescribed a generic version of a nonsteroidal anti-inflammatory drug (NSAID), for shoulder pain. 133 S.Ct. at 2481. As a result, plaintiff developed toxic epidermal necrolysis, which caused her to become severally disfigured, have physical disabilities, and is nearly blind. Id. While the generic drug s label did not specifically refer to Stevens Johnson Syndrome or toxic epidermal necrolysis, they were listed as potential adverse 14

reactions on the drug s package insert. Id. at 2472. In 2005, the FDA completed a comprehensive review of the risks and benefits, [including the risk of toxic epidermal necrolysis], of all approved NSAID products. Id. As a result, the FDA recommended changes to the labeling of all NSAIDs, including the generic drug manufacturer, to more explicitly warn against toxic epidermal necrolysis. Id. Plaintiff brought claims against the generic manufacturer under state tort law claiming defective designed of its label. Id. A jury found the generic manufacturer liable and awarded her over $21 million. Id. The First Circuit affirmed this decision, and found that neither the FDCA nor the FDA s regulations pre-empted plaintiff s design defect claim, distinguishing its fact from that of PLIVA, Inc. v. Mensing by holding that generic manufacturers facing design-defect claims could comply with both state and federal law by simply choosing not to make the drug at all. Id. This Court held that federal law preempted the relevant state law because it would call for a redesign of the generic drug manufacturer s label or the drug itself, both of which, the Court opined, would be impossible. Id. at 2475. First and foremost, this Twelfth Circuit has failed to recognize that the RLD in Ivers case changed their label six months prior to Westerly s label change for ropidope. (R. at 2-3). This was not the case for the generic manufacturer in Bartlett. Also unlike Bartlett, Ivers had virtually no idea what was causing her compulsions due to Westerly s failure to warn. Westerly made no mention of the effects of its drug until its label change, six months after its RLD counterpart. In July 2011, Ivers began to develop compulsive spending and gambling behaviors. (R. at 3.) As a 15

result, Ivers spent countless hours playing online poker and even transferred the majority of her retirement savings into an online poker service account. (R. at 3.) By the end of 2012, she had entirely depleted her retirement savings and upon this realization her husband of 35 years filed for divorce. (R. at 3.) The plaintiff in Bartlett had notification of issues with NSAIDs had she read the drug packet insert. Further, the FDA conducted a study specifically regarding the generic manufacturers drug and recommended a label update. This is an example of the FDA directly suggesting labels should be updated when a product is deemed to have serious adverse effects despite its RLD s failure to do so. Had Westerly properly updated their label, Ivers would have known that the medication was causing such behavior and took the necessary steps to control the compulsion. Ivers does not seek for Westerly to change its drugs composition, nor does she request that it stop selling it. However, she does seek remedy for the effects that Westerly s drug had on her. Unlike the plaintiffs in both PLIVA and Bartlett, Ivers complaint did not ask Westerly to act unilaterally. In fact, Ivers simply asked that Westerly properly follow its brand name counterpart and act promptly in matching their label change. Impossibility conflict does not exist in this case. Westerly had the opportunity to follow both federal and state requirements in administering its label for the generic version of Equip, ropidope. Under state law Westerly had the duty to manufacture a drug that was not defective and adequately warned its consumers of its uses, abuses, and side effects. Under federal law, Westerly had the duty to mirror the 16

label of its brand name counterpart. For a period of over a year, Westerly failed to do both. It was not impossible for Westerly to both adequately warn about ropidope s side effects and mirror the label of its brand name counterpart. Instead, Westerly failed to properly maintain its reports and information on ropidope, ignored its brand name counterparts actions, and failed to take action on its defective drug for a year. Further, had Ivers known of the negative effects of ropidope s composition, she would have reconsidered the medication, and potentially discontinued use. D. The Illinoza State Tort Law at Issue Creates No Obstacle in Carrying Out the Intention of Congress When They Passed the Federal Law Guidelines Required by the Hatch-Waxman Act and, Therefore, Are Not Preempted. Holding Westerly liable under state law for the defective design of its label and failing to adequately warn of the drug s side effects within a reasonable time does not pose an obstacle to its responsibility under federal law to mirror the label of its brand name drug. Obstacle preemption exists when state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress. PLIVA, 564 U.S. at 2587 (quoting Crosby v. National Foreign Trade Council, 530 U.S. 363, (2000)). Whether an obstacle exists is determined on a caseby-case basis. Hines v. Davidowitz, 312 U.S. 52, 67 (U.S. 1941). The Twelfth Circuit held that this case presented an obstacle preemption by imposing two standards on manufacturers: (1) state tort law s reasonableness deadline and (2) the federally required procedures for updating labels. (R. at 15). The court held that these two standards placed a fact-specific and state-by-state 17

basis analysis that would frustrate the objectives of the Hatch-Waxman Act. Id. More specifically, the court held that determining a reasonable time standard required by Illinoza tort law for Westerly to have updated its label would create an obstacle for the Hatch-Waxman Act s objective of expediting the compliance burdens on generic manufactures that contravene its streamlined process. (R. at 15-16.) Further, the court held that leaving reasonableness up to state law and juries would contravene the FDA s role as administrator of national drug-safety policy. (R. at 16.) The states have traditionally held the power to regulate health and safety matters within their jurisdiction. PLIVA, 564 U.S. at 633 (citing Medtronic, 518 U.S. at 485). While Congress has had some oversight in certain matters of state tort litigation against drug manufacturers, they have "never expressly preempted state law tort action against neither generic nor brand name drug manufacturers. PLIVA, 564 U.S. at 633; see also Wyeth, 555 U.S. at 575. In fact, when Congress amended FDCA in 1962 to expand the FDA s powers to enlarg[e] the protect the public health and assure the safety, effectiveness, and reliability of drugs, [it] took care to preserve state law. Wyeth, 555 U.S. at 575 (quoting 76 Stat. 780). Congress stated that nothing in the amendments made by this Act to the [FDCA] shall be construed as invalidating any provision of State law which would be valid in the absence of such amendments unless there is a direct and positive conflict between such amendments and such provision of State law. Pub.L. 87 781, 202, 76 Stat. 793. In 1976, Congress did, however, enact an express preemption provision for 18

medical devices. PLIVA, 564 U.S. at 633; 21 U.S.C. 360k(a), Pub.L. 94 295, 521, 90 Stat. 574. No such provision was included in the Hatch-Waxman amendments to the FDCA, which is powerful evidence that [it] did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness. PLIVA, 564 U.S. 604, 633 34 (U.S.,2011) (quoting Wyeth, 555 U.S. at 575). Allowing a state or jury to determine whether a drug s label was updated in a reasonable time, would not get in the way of Congress s intention to expand the generic drug market. It is contrary to Congress s silence on preemption in the FDCA amendments to not allow the state to litigate Ivers claim. Congress s intent in implementing the Hatch-Waxman Act was to expedite the compliance burdens on generic manufactures that contravene its streamlined process, not to preempt states from holding drug manufacturers liable for the injuries incurred by state citizens because of the manufacturers defective labels. Such a decision would leave an innumerable amount of injured consumers without the justified recourse against the wrongdoer. III. THE TWELFTH CIRCUIT WAS INCORRECT IN HOLDING THAT AWARDABLE COSTS IN RULE 41(d) OF THE FEDERAL RULES OF CIVIL PROCEDURE ALLOWS FOR THE RECOVERY OF ATTORNEY S FEES. The Twelfth Circuit was incorrect in holding that awardable costs in Rule 41(d) of the Federal Rules of Civil Procedure allows for the recovery of attorney s fees. United States courts adhere to the American Rule, which states that each party to a litigation should bear the costs of its own attorney s fees. Alyeska Pipeline 19

Serv. Co. v. Wilderness Soc'y, 421 U.S. 240, 254-55 (1975). Courts only deviate from the American Rule when an express rule or statutory provision for attorney s fees exists, and Rule 41(d) makes no such provision. Id. Rule 41(d) only provides: 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. Fed. R. Civ. P. 41. There is no express provision for attorney s fees in Rule 41(d), even though other Federal Rules of Civil Procedure do expressly provide for attorney s fees. See, e.g., Fed. R. Civ. P. 11(c)(2); Fed. R. Civ. P. 30(g). Furthermore, even if the Court chooses to interpret Rule 41(d) s provision of costs to include attorney s fees, Westerly is still not entitled to attorney s fees because Ivers is asserting the same facts and legal theories as the previous case and any work used in preparation for the initial case could have be used in the current case. Cauley v. Wilson, 754 F.2d 769, 772 (7th Cir. 1985) (noting that the purpose of the rule is to reimburse a defendant for recovery of costs that are unable to be used in a subsequent action). Several United States circuit courts have held that Rule 41(d) does not include attorney s fees. Rogers, 230 F.3d at 873 76; Duffy v. Ford Motor Co, 218 F.3d 623, 632 (6th Cir. 2000); see also Davis v. USX Corp., 819 F.2d 1270, 1276 (4th Cir. 1987). Accordingly, this Court should side with those circuit courts and hold that Westerly is not entitled to attorney s fees under Rule 41(d). 20

A. Ivers is Not Responsible for Westerly s Attorney s Fees Because Under the American Rule, United States Courts Do Not Award Attorney s Fees to Litigants Absent a Statutory Provision or Rule, And Rule 41(D) Does Not Provide For Attorney s Fees. The American Rule is the long-prevailing common law presumption that each party to a litigation should bear the cost of its own attorney s fees. Alyeska Pipeline, 421 U.S. at 254-55. Unlike the British Rule, in which the losing party pays the winning party s attorney s fees, the American Rule only allows an award of attorney s fees in rare circumstances, such as when a statute or rule provides for them. See Fogarty v. Fantasy, Inc., 510 U.S. 517, 533 (1994); Chambers v. Nasco, Inc., 501 U.S. 32, 45-46 (1991) (noting that a court may award attorney's fees when a party acts in bad faith to delay or disrupt litigation). Rule 41(d) makes no such provision and only states that a court may order for the payment of costs of the action previously dismissed as it deems proper. Fed. R. Civ. P. 41(d). 1. The Supreme Court has a Longstanding Policy of Adhering to the American Rule. The Supreme Court has maintained its policy of following the American Rule by not granting attorney s fees in a variety of cases. See Alyeska Pipeline, 421 U.S. at 254-55; Key Tronic Corp. v. United States, 511 U.S. 809, 815-816 (1994). In Alyeska Pipeline Serv. Co. v. Wilderness Society, the Court held that the prevailing party in a lawsuit is never entitled attorney s fees unless Congress has passed a statute explicitly authorizing the award. 421 U.S. at 254-55. Since Alyeska Pipeline, Congress has done just that and has explicitly authorized attorney s fees 21

in a variety of circumstances, none of which involve the authorization of attorney s fees under Rule 41(d). See 42 U.S.C. 1988 (providing for the award of attorney s fees in civil rights actions); Fed. R. Civ. P. 11(c)(2) (stating that the prevailing party may be awarded reasonable expenses, including attorney s fees ); Fed. R. Civ. P. 30(g) (providing for reasonable attorney s fee award where deponent fails to appear for deposition). In the few cases where the Supreme Court has allowed a recovery of attorney s fees, an express statutory provision existed that is not present in this case. In Marek v. Chesny, the Supreme Court held that the term costs in Rule 68 of the Federal Rules of Civil Procedure authorized an award of attorney s fees to a plaintiff in a civil rights case only because the underlying statute allowed a recovery of attorney s fees. 473 U.S. 1, 9 (1985). The plaintiff in Marek brought a civil rights claim, and under Section 1988, a plaintiff who prevails in a civil rights suit is entitled to recover attorney s fees and costs. Id.; see also 42 U.S.C. 1988(b). The defendants argued that Rule 68 barred plaintiff s recovery of attorney s fees, but the Court held that because Congress expressly included attorney's fees as costs available to a plaintiff in the underlying substantive civil rights statute, the plaintiff is entitled to attorney s fees under Rule 68. Marek, 473 U.S. at 9. Like the issue in Marek where Rule 68 of the Federal Rules of Civil Procedure provided for costs without defining the term, Rule 41(d) provides for costs without defining the term. But unlike the case in Marek, where the substantive statute in the litigation provided for the award of attorney s fees, the 22

substantive statute at hand makes no such provision. Only an ambiguous reference is made to attorney s fees in the statute governing Ivers original claim in East Texas under East Texas Code Annotated 12-12-12, 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. (R. at 22.) This statute may seem like it is Westerly s glimmer of hope for recovery, but it states that the prevailing plaintiff in a claim is entitled to attorney s fees and does not indicate that the award of attorney s fees is to be made to the defendant. Therefore, the underlying statute does not indicate that Westerly is entitled to attorney s fees. 2. There is No Express Provision Here Because the Text Of Rule 41(D) Does Not Provide for Attorney s Fees. The text of Rule 41(d), which Westerly attempts to utilize here, provides for costs, but does not provide for attorney s fees. Fed. R. Civ. P. 41(d). The Rule provides: 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. Id. The term costs is not defined, and the Rule itself makes no reference to attorney s fees. See Fed. R. Civ. P. 41. Costs may not be defined in Rule 41(d), but some insight as to its meaning may be provided by Section 1920 of the United States Code, which describes the 23

kinds of costs a court may award under Federal Rule of Civil Procedure 54(d). Rogers, 230 F.3d at 873 76. Section 1920 grants a court the ability to assign costs for all of the following items: (1) fees of the clerk and marshal; (2) fees for printed or electronically recorded transcripts; (3) fees and disbursements for printing and witnesses; (4) fees for exemplification and the costs of making copies of any materials used in the case; (5) docket fees; and (6) compensation of court appointed experts, compensation of interpreters, and salaries, fees, expenses, and costs of special interpretation services. 28 U.S.C. 1920 (2008). Costs has a rather expansive reach in this section of the Code, but even that reach does not extend to attorney s fees. Similarly, Rule 41(d) s reference to costs should not include the award of attorney s fees. 3. The explicit provisions of attorney s fees in other Federal Rules of Civil Procedure indicates that costs in Rule 41(d) was meant to have a distinct meaning from attorney s fees. Although the Supreme Court has indicated that a Rule s lack of a specific reference to attorney s fees is not necessarily dispositive, Key Tronic Corp., 511 U.S. at 815, this absence in conjunction with the text of the other federal rules strongly suggests that Rule 41(d) does not authorize an award of attorney s fees. Numerous federal rules expressly provide for the recovery of attorney s fees while Rule 41(d) does not. See Fed. R. Civ. P. 11(c)(2) (allowing recovery of some or all of the reasonable attorneys' fees and other expenses incurred as a direct result of the violation of Rule 11); Fed. R. Civ. P. 26(g)(3) (allowing recovery of reasonable expenses incurred because of the violation [of Rule 26], including a reasonable 24

attorney's fee ); Fed. R. Civ. P. 30(g)(2) (allowing court to award reasonable expenses... including reasonable attorney's fees for failure to attend or serve subpoena); Fed. R. Civ. P. 37(a)(4)(A) & (B) (allowing court to award reasonable expenses, including attorney's fees, incurred in making or opposing motion to compel discovery); Fed. R. Civ. P. 37(c)(1) (allowing recovery of reasonable expenses, including attorney's fees for failure to disclose information required by Rule 26(a)); Fed. R. Civ. P. 37(c)(2) (allowing recovery of reasonable expenses... including attorney's fees for failure to comply with Rule 36 request); Fed. R. Civ. P. 37(d) (allowing recovery of reasonable expenses, including attorney's fees for failure to respond to request for inspection); Fed. R. Civ. P. 56(g) (allowing recovery of reasonable expenses... including reasonable attorney's fees for presenting affidavit made in bad faith). The fact that other federal rules explicitly provide for the recovery of attorney's fees suggests that the drafters understood the difference between costs and attorney's fees and intended to distinguish between the two forms of relief. See Rogers, 230 F.3d at 873 76. Based on this distinction, it is logical to conclude that if the drafters intended Rule 41(d) to include attorney s fees, they would have explicitly provided for such relief. 4. Courts have analyzed Rule 41(d) s text and its relationship to the other Federal Rules of Civil Procedure to conclude that costs does not include attorney s fees. Courts have analyzed of Rule 41(d) s text and its relationship to other Federal Rules of Civil Procedure to conclude that costs is not intended to 25

encompass attorney s fees. In Rogers v. Wal-Mart Stores, Inc. the court held that the ambiguity of the Federal Rules of Civil Procedure with respect to attorney s fees suggests that they should not be award unless explicitly provided for. 230 F.3d at 873 76. The court noted that Rule 41(d) only speaks of costs and does not mention attorney s fees, while several other provisions in the Federal Rules of Civil Procedure explicitly provide for recovery of attorney s fees. Id. See Simeone v. First Bank Nat'l. Ass'n, 125 F.R.D. 150, 155 (D.Minn. 1989) (listing Fed. R. Civ. P. 30(g)(2), 37(a)(4), 37(c), 37(d) & 56(g)). The court further illustrated the fact that Congress does not consider attorney s fees to be part of costs by pointing out that 28 U.S.C. 1920 lists the items a court may tax as costs to a prevailing party under Rule 54(d) but does not include attorney fees. Id.; see also Anders v. FPA Corp., 164 F.R.D. 383, 390 (D.N.J.1995) (denying attorney fees in part because of lack of express authorization). In Key Tronic Corp. v. U.S., the court used similar logic to determine that a statute that allowed for the award of necessary costs of response did not include attorney s fees. 511 U.S. at 815-816. The Court based its decision on several reasons, one of which was that Congress had expressly provided for attorney s fees in other sections of the statute and therefore its omission from the section at issue strongly suggest[s] a deliberate decision not to authorize such awards. Id. at 818-19. Just as both courts in Rogers and Key Tronic Corp., concluded that costs does not include attorney s fees because there are express provisions for such fees in 26