Supreme Court of the United States

Transcription

1 Team #2615 No In The Supreme Court of the United States Fall TERM, 2017 Alice Ivers, v. Petitioner, WESTERLY PHARMACEUTICAL, Inc. Respondent. On Writ of Certiorari to the United States Court of Appeals for the Twelfth Circuit Brief for Respondent COUNSEL FOR RESPONDENT September 21, 2017

2 QUESTIONS PRESENTED 1. Under this Court s holdings in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) and Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct (2013), does federal law preempt state claims of inadequate warning and defective design against a generic drug manufacturer when federal law prohibits the manufacturer from independently strengthening its label as state law would require? 2. Does a Federal Rule of Civil Procedure 41(d) award of costs properly include respondent s attorney s fees incurred in the first claim when petitioner voluntarily dismissed under Rule 41(a)(1)(A) and refiled a subsequent identical claim in another state? i

3 TABLE OF CONTENTS QUESTIONS PRESENTED... i TABLE OF AUTHORITIES... iii OPINIONS BELOW... vii CONSTITUTIONAL AND STATUTORY PROVISIONS INVOLVED... viii STATEMENT OF THE CASE... 1 SUMMARY OF THE ARGUMENT... 4 ARGUMENT... 6 I. THIS COURT S PRECEDENTS REQUIRE DISMISSAL OF PETITIONER S STATE CLAIMS OF INADEQUATE WARNING AND DEFECTIVE DESIGN ON FEDERAL PREEMPTION GROUNDS A. UNDER THIS COURT S PREVAILING PRECEDENT AND FEDERAL LAW, GENERIC DRUG MANUFACTURER, WESTERLY, CANNOT UNILATERALLY ALTER ITS WARNING LABEL IF THAT ALTERATION DEVIATES FROM THE BRAND NAME DRUG S LABEL B. WESTERLY CANNOT UNILATERALLY ALTER ITS DRUG DESIGN IF THAT ALTERATION DEVIATES FROM THE BRAND NAME DRUG S DESIGN II. ATTORNEY S FEES ARE COSTS AWARDABLE TO WESTERLY UNDER FEDERAL RULE OF CIVIL PROCEDURE 41(d) A. RULE 41(D) AUTHORIZES ATTORNEY S FEES BECAUSE THE EAST TEXAS PRODUCTS LIABILITY LAW UNDERLYING THE INITIAL CLAIM INCLUDES ATTORNEY S FEES AS COSTS B. THE PURPOSE AND INTENT OF RULE 41 ITSELF ALSO AUTHORIZES INCLUSION OF WESTERLY S ATTORNEY S FEES IN THE COSTS AWARDED UNDER RULE 41(D) CONCLUSION ii

4 Constitutional Provisions TABLE OF AUTHORITIES U.S. CONST. art. VI, cl Statutes 21 U.S.C. 355 (2016)... vi, 8, U.S.C (2011) U.S.C (1991) U.S.C (2011) Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No , 98 Stat Federal Food, Drug, and Cosmetic Act, ch. 675, 52 Stat (1938) (codified as amended at 21 U.S.C. 301 et seq.)... 7 Rules Fed. R. Civ. P , 18, 19, 20, 22, 23 Regulations 21 C.F.R vi, 8, 9, 10 Abbreviated New Drug Application Regulations, 57 Fed. Reg (proposed Apr. 28, 1992) (to be codified at 21 C.F.R. pts. 2, 5, 10, 310, 314, 320, & 433) United States Supreme Court Alyeska Pipeline Serv. Co. v. Wilderness Soc y, 421 U.S. 240 (1975);... 17, 18 Ashcroft v. Iqbal, 556 U.S. 662 (2009)... 6 Crosby v. Nat l Foreign Trade Council, 530 U.S. 363 (2000) Gade v. Nat l Solid Wastes Mgmt. Ass n, iii

5 505 U.S. 88 (1992)... 6 Gibbons v. Ogden, 22 U.S. 1 (1824)... 6 Hines v. Davidowitz, 312 U.S. 52 (1941)... 7 Key Tronic Corp. v. U.S., 511 U.S. 809 (1994) Marek v. Chesny, 473 U.S. 1 (1985)... 19, 20 Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)... 6 Mut. Pharm. Co. v. Bartlett, 133 S.Ct (2013)... i, 6, 7, 8, 13, 14, 15, 16, 21 PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011)... i, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 21 Singleton v. Wulff, 428 U.S. 106 (1976)... 7 Wyeth v. Levine, 555 U.S. 555 (2009)... 8, 9 Yates v. U.S., 135 S.Ct (2015) United States Court of Appeals Andrews v. Am. s Living Ctrs, LLC., 827 F.3d 306 (4th Cir. 2016)... 16, 17, 18, 20, 21, 22, 23 Aponte-Torres v. Univ. of P.R., 445 F.3d 50, 54 (1st Cir. 2006)... 6 Armstrong v. Frostie Co., 453 F.2d 914 (4th Cir. 1971) Davis v. USX Corp., 819 F.2d 1270 (4th Cir. 1987) iv

6 Drager v. PLIVA USA Inc., 741 F.3d 470 (4th Cir. 2014) Duffy v. Ford Motor Co., 218 F.3d 623 (6th Cir. 2000) Esposito v. Piatrowski, 223 F.3d 497 (7th Cir. 2000)... 17, 19, 20 Evans v. Safeway, 623 F.2d 121 (8th Cir. 1980) Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013)... 10, 12 LeBlang Motors, Ltd. v. Subaru of Am., Inc., 148 F.3d 680 (7th Cir. 1998) LeCompte v. Mr. Chip, Inc., 528 F.2d 601 (5th Cir. 1976) Meredith v. Stovall, 216 F.3d 1087 (10th Cir. 2000) (unpublished); Morris v. PLIVA, Inc., 713 F.3d 774 (5th Cir. 2013)... 10, 11, 12, 21 Painter v. Golden Rule Ins. Co., 121 F.3d 436 (8th Cir. 1997) Rogers v. Wal-Mart Stores, Inc., 230 F.3d 868 (6th Cir. 2000)... 19, 21 Simeone v. First Bank Nat l Ass n, 971 F.2d 103 (8th Cir. 1992) United States District Court Anders v. FPA Corp., 164 F.R.D. 383, 389 (D.N.J. 1995) Behrle v. Olshansky, 139 F.R.D. 370 (W.D. Ark. 1991) Copeland v. Hussmann Corp., v

7 462 F.Supp.2d 1012 (E.D. Mo. 2006) Esquivel v. Arau, 913 F.Supp (C.D. Cal. 1996) , 20, 22 Ivers v. Westerly Pharm. Co., No CV, 2 (D. Illz. 2015)... v, 1, 2, 3, 7, 10, 12, 21, 22, 23 Morris v. Wyeth, Inc., No , 2012 U.S. Dist. LEXIS (W.D. La. Feb. 21, 2012) Starr v. Hill, No STA, 2010 WL (W.D. Tenn. June 16, 2010) State Statutes East Texas Products Liability Law (a)... 16, 18 Illz. Prods Liability Act, (1)(c)... 10, 12, 15 Secondary Authorities BLACK S LAW DICTIONARY (10th ed. 2014)... 20, 21 DANIEL R. COQUILLETTE, ET. AL., 8-41 MOORE S FEDERAL PRACTICE CIVIL (2017) RESTATEMENT (THRID) OF TORTS: PRODS. LIAB. (AM. LAW INST. 1998)... 12, 15 ROBERT L. ROSSI, 2 ATTORNEY FEES AWARDS (3d ed. 2017) vi

8 OPINIONS BELOW This Court has granted petition for writ of certiorari to a case in the Twelfth Circuit Court of Appeals No No is petitioner s appeal of the appellate court s order affirming the district court s dismissal of the Complaint as preempted and reversing the district court s order to deny attorney s fees in an award of costs. The opinion of the court of appeals in that case is available at Ivers v. Westerly Pharm. Co., No , 10 (12th Cir. 2017). The district court s opinion is available at Ivers v. Westerly Pharm. Co., No CV, 2 (D. Illz. 2015). vii

9 CONSTITUTIONAL AND STATUTORY PROVISIONS INVOLVED The following constitutional and statutory provisions are relevant to this action s determination: United States Constitution Article VI, Clause 2 This Constitution, and the Laws of the United States which shall be made in Pursuance therof; 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. 21 U.S.C. 355 Federal Rule of Civil Procedure C.F.R. 314 viii

10 STATEMENT OF THE CASE A. Factual Background This case concerns a woman s attempt to hold a generic drug manufacturer liable under state law for allegedly inadequate warnings and defective design on its label and a company s attempt to recover attorney s fees after the petitioner voluntarily dismissed her first claim. The Federal Food and Drug Administration ( FDA ) approved ropidope in 1997, and GlaxoCline began selling it under the brand name, Equip. Ivers v. Westerly Pharm. Co., No CV, 2 (D. Illz. 2015) ( Ivers I ). In 2008, Westerly Pharmaceutical, Inc. ( Westerly ) submitted an Abbreviated New Drug Application ( ANDA ) to the FDA with the intention of marketing a generic version of Equip. Id. In 2009, after receiving FDA approval, Westerly began selling the generic form of the drug. Id. In January 2011, two years after Westerly began selling the generic drug, GlaxoCline submitted a Supplemental New Drug Application ( snda ) to the FDA. Id. GlaxoCline wanted to update its label to warn against impulse control/compulsive behaviors, including the urge to gamble. Id. Specifically, GlaxoCline wanted to add a new paragraph stating: 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. 1

11 Id. The FDA approved the proposed change in June 2011, and the Equip labels containing the new warning were on the market. Id. Petitioner, Alice Ivers, ( petitioner ) was diagnosed with Parkinson s disease in February 2011 and was prescribed the generic ropidope. Id. at 1. Petitioner began taking Westerly s generic ropidope on a daily basis, beginning in March Id. She began developing compulsive spending and gambling behaviors in July Id. From 2011 to 2012, petitioner invested most of her time and savings in an online poker account and won substantial sums of money, which she felt the urge to spend. Id. at 3. Her compulsive behaviors continued through the end of 2012 when she finally depleted her retirement savings. Id. Petitioner alleges she developed a compulsive gambling behavior while on the generic ropidope and those behaviors continued well after Westerly updated its label, damaging her finances and relationships. Ivers v. Westerly Pharm. Co., No , 10 (12th Cir. 2017) ( Ivers II ). In January 2012, Westerly submitted a Changes Being Effected ( CBE ) to notify the FDA that Westerly planned on updating its generic label to match Equip s new label. Ivers I, No CV at 2-3. Westerly s change adding the new warning to the label went into effect February 1, Id. at 3. B. Procedural History Petitioner filed a complaint in the United States District Court for the Western District of East Texas in January Id. at 5. That claim was based on East Texas products liability law. Id. Under Federal Rule of Civil Procedure 41(a)(1)(A), petitioner voluntarily and unilaterally dismissed her claim without prejudice after the Fifth Circuit issued a holding preempting similar claims to the petitioner s claims. Id. at

12 In 2015, Petitioner filed a products liability claim, alleging the same facts and legal theories as the case in 2013, in the state court of Illinoza against Westerly. Id. at 1. She claimed that Westerly owed her a duty under Illinoza products liability law. Id. at 3. Further, she claimed that this breach entitles her to relief, if she can show that Westerly was unreasonably dangerous due to defective design and inadequate instructions or warnings. Id. Thus, petitioner claims that Westerly breached its duty by having labels that were defectively designed with inadequate warnings of the side effects. Id. Westerly timely removed the action from Illinoza state court to the United States District Court for the District of Illinoza. Id. Westerly asserted diversity jurisdiction under 28 U.S.C (2011) and removal jurisdiction under 28 U.S.C (1991). Id. On November 2, 2015, Westerly filed a Motion for Judgment on the Pleadings, arguing that federal law preempted state law in this case. Id. at 3 4. Westerly also filed a Motion for an Award of Costs under Federal Rule of Civil Procedure 41(d) because this was petitioner s second litigation of the same claim. Id. at 3, 6. The District Court granted Westerly s Motion for Judgment on the Pleadings. Id. at 8. It also granted Westerly s Motion for an Award of Costs, but denied it in part, excluding an award of attorney s fees. Id. at 7 8. Petitioner was ordered to pay Westerly $ within 60 days of the order. Id. at 8. Petitioner appealed to the United States Court of Appeals for the Twelfth Circuit. Ivers II, No at 9. On appeal, the court affirmed the lower court s decision to grant the Motion for Judgment on the Pleadings and the decision concerning the Motion for an Award of Costs. Id. at 18. However, it reversed in part, ordering inclusion of attorney s fees as costs awarded under Rule 41(d). Id. at 18. This Court granted petitioner s writ of certiorari. Petition for Writ of Certiorari, No , 23 (July 17, 2017). 3

13 SUMMARY OF THE ARGUMENT The Twelfth Circuit correctly affirmed the district court s dismissal of the Complaint as preempted, and this Court should affirm. Petitioner attempts to carve out an exception from the Supreme Court s Mensing and Bartlett decisions. Congress carried out the legislative task of creating a tailored approval process for generic drugs. This approval process is entrenched on the idea of mirroring drugs that already underwent the onerous and costly FDA approval process. Although Congress could have easily declined to ease the approval burden on generic drugs by forcing generic drug manufacturers to go through the onerous approval process like any new drug, it did not. Federal law requires a generic drug manufacturer to mirror the brand name drug manufacturer s design or label. Further, it prohibits generic drug manufacturers from strengthening its warning or changing its design unless the brand name manufacturer has already done so. This case falls squarely under Mensing and Bartlett because petitioner roots her state claims of inadequate warning and defective design in Westerly s ongoing inadequate label. State law would force Westerly to act contrary to federal law and Supreme Court decisions by requiring generic drug label to possess a stronger label than that of the brand name drug. Therefore, this Court should uphold the strong precedent preempting state claims of inadequate warning and defective design and affirm the Twelfth Circuit s dismissal of petitioner s claims. Furthermore, the Twelfth Circuit properly included Westerly s attorney s fees as costs under Rule 41(d), even though fees are not individually listed in the language of the rule, because: (1) attorney s fees are authorized as costs under the East Texas products liability law governing the initial claim, and (2) an award of attorney s fees as costs is essential to the purpose and intent of Rule 41. 4

14 Even courts that consider the purposes of Rule 41 alone insufficient to include fees do include fees when the statute underlying the original claim authorizes attorney s fees in its description of costs. In this case, East Texas Products Liability Law explicitly states that as part of the costs of the action, a reasonable amount to be fixed by the court as attorney s fees is authorized. Since the first action was based on that provision, attorney s fees must be included in the Rule 41(d) award of costs. Moreover, the congressional purpose and intent of Rule 41 itself also authorizes inclusion of Westerly s attorney s fees in the costs awarded under Rule 41(d). The well-recognized purpose of Rule 41(d) is to deter forum shopping and vexatious litigation. Therefore, petitioner can only utilize a Rule 41 voluntary dismissal if it does not prejudice the respondent in subsequent litigation. Inclusion of fees is the only way to avoid prejudicing Westerly with the costs of petitioner s forum shopping. Thus, this Court should affirm the Twelfth Circuit s decision to include attorney s fees in costs awarded to the Westerly under Rule 41(d). This Court should affirm the Twelfth Circuit s holding in this case. Specifically, the Twelfth Circuit properly affirmed the dismissal of the Complaint as preempted. The Twelfth Circuit also properly reversed the lower court by ordering an inclusion of attorney s fees in the award of costs. 5

15 ARGUMENT I. THIS COURT S PRECEDENTS REQUIRE DISMISSAL OF PETITIONER S STATE CLAIMS OF INADEQUATE WARNING AND DEFECTIVE DESIGN ON FEDERAL PREEMPTION GROUNDS. This Court established a broad preemption defense against state tort claims of inadequate warning and defective design like petitioner s targeting generic drug manufacturers. See Mut. Pharm. Co. v. Bartlett, 133 S.Ct. 2466, 2475, 2479 (2013); PLIVA, Inc. v. Mensing, 564 U.S. 604, 625 (2011). Motions for judgment on the pleadings under Federal Rule of Civil Procedure 12(c) are held to the same standards as Rule 12(b)(6) motions. Aponte-Torres v. Univ. of P.R., 445 F.3d 50 (1st Cir. 2006). This Court reviews dismissal of a claim under Rule 12(b)(6) de novo, accepting all factual allegations in the complaint as true and viewing them in the light most favorable to the nonmoving party. Ashcroft v. Iqbal, 556 U.S. 662, 679 (2009). A motion for judgment on the pleadings implicates the pleadings as a whole. Aponte-Torres, 445 F.3d at 54. The Supremacy Clause preempts, thus invalidates, all state laws that conflict or interfere with an Act of Congress. U.S. CONST. art. VI, cl. 2; Gibbons v. Ogden, 22 U.S. 1, 211 (1824). Federal law may either expressly or implicitly preempt a state law. See Gade v. Nat l Solid Wastes Mgmt. Ass n, 505 U.S. 88, 98 (1992). The absence of an express preemption statement is not a basis for finding no conflict preemption. Mensing, 564 U.S. at 618 n.5. Rather, the purpose of Congress is the ultimate touchstone in every preemption analysis. Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996). To determine the congressional purpose, this Court must understand not only the statute s text, but also how Congress intended it to affect businesses, consumers, and the law. Id. at 486. Federal law preempts all state laws that create impossible conflicts with federal law. Crosby v. Nat l Foreign Trade Council, 530 U.S. 363, (2000). Impossible conflicts lead to the preemption of the state law when state law requires a private party s independent action 6

16 while federal law makes that action impossible. Mensing, 564 U.S. at 620. State law may also be preempted under obstacle preemption when state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress. Hines v. Davidowitz, 312 U.S (1941). This Court begins its preemption analysis by identifying the state tort duties and federal... requirements applicable to the parties. Mensing, 564 U.S. at 611. Petitioner makes state claims of inadequate warning and defective design. Ivers I, No CV at 3 ( alleging that ropidope s were defectively designed and contained inadequate warnings. ). Taking these claims as true, federal law preempts her state tort claims as it creates an impossible conflict with federal law. Although petitioner attempts to avoid this Court s holdings in PLIVA, Inc. v. Mensing and Mut. Pharm. Co. v. Bartlett, her state claims of inadequate warning and defective design do not escape preemption. See 133 S.Ct. at ; 564 U.S. at 618. This Court has stated that determining what questions may be taken up and resolved for the first time upon appeal is one left primarily to the discretion of the court of appeals to be exercised on the facts of individual cases. Singleton v. Wulff, 428 U.S. 106, 121 (1976). The Twelfth Circuit verifies that petitioner alleges inadequate warning. Ivers II, No at 9. Beyond an update to mirror the brand name drug, petitioner seeks a strengthened label on the generic drug because her side effects continued, inconsistent with even the updated warning. See id. at 10. Congress designed specific procedures tailored to approve generic drugs inexpensively, without duplicating the clinical trials already performed on the equivalent brand name drug. Mensing, 564 U.S. at 612. Congress amended the Federal Food, Drug, and Cosmetic Act ( FDCA ), ch. 675, 52 Stat (1938) (codified as amended at 21 U.S.C. 301 et seq.), by 7

17 passing the Drug Price Competition and Patent Term Restoration Act of 1984, commonly called the Hatch-Waxman Amendments. Pub. L. No , 98 Stat These amendments outline an ANDA for generic drugs, allowing for a quicker and cheaper approval process than the process for new drugs. 21 U.S.C. 355(j)(2) (2016); Bartlett, 133 S.Ct. at The ANDA process centers on a sameness requirement between a proposed generic drug and a brand name drug approved by the FDA. See 21 U.S.C. 355(j)(2)(A); 21 C.F.R (a)(7) (2016). Thus, a generic drug can gain FDA approval as long as the drug itself mirrors a reference-listed drug already approved by the FDA (typically a brand name drug) and is identical in active ingredients, safety, and efficacy. 21 U.S.C. 355(j)(2)(A); Mensing, 564 U.S at 612 n.2; 21 C.F.R (a). Moreover, the generic drug s labeling must be identical to the labeling approved by the FDA for the brand name drug. See, e.g., 355(j)(2)(A)(v); 355(j)(4)(G); 21 C.F.R (a)(8) (2016). If a generic drug strays away from the sameness requirement, the FDA may withdraw its approval of the generic drug. See 21 C.F.R (b) (2017). A FDA approved brand name drug may update its label one of two ways: through a supplemental new drug application ( snda ) or through a Changes Being Effected ( CBE ) supplement. 21 C.F.R (b) (2016). This Court recognizes that a brand name drug does not need FDA approval to unilaterally strengthen its label through the CBE process. See Wyeth v. Levine, 555 U.S. 555, (2009); 21 C.F.R (c). However, unlike a CBE supplement, the FDA must issue its approval of a snda before the brand name drug manufacturer officially implements any of the requested changes. 21 C.F.R (b)(3). Thus, a generic drug manufacturer may not unilaterally change its label even when a brand name drug manufacturer submits a snda to the FDA. See Mensing, 564 U.S. at 618. The generic drug manufacturer must wait to change its label until after the FDA approves the brand name drug 8

18 manufacturer s snda. See id.; 21 C.F.R (b). This Court should affirm the Twelfth Circuit s affirmation of the District Court s dismissal of petitioner s state claims of inadequate warning and defective design as preempted. A. UNDER THIS COURT S PREVAILING PRECEDENT AND FEDERAL LAW, GENERIC DRUG MANUFACTURER, WESTERLY, CANNOT UNILATERALLY ALTER ITS WARNING LABEL IF THAT ALTERATION DEVIATES FROM THE BRAND NAME DRUG S LABEL. Federal law prohibits Westerly from strengthening its label beyond that of the brand name drug s label as petitioner seeks to require under the preempted Illinoza product liability law. See Mensing, 564 U.S. at 623. Petitioner concedes Westerly updated its label to match its brand name drug, thus fulfilling its duty to include the same warning label as the brand name drug. See Ivers II, No at 10. Nevertheless, petitioner continues to allege that the updated warning is still inadequate. See id. In interpreting the labeling duties of drug manufacturers, this Court has held that it is the responsibility of a brand name manufacturer at all times for the accuracy and ensured adequacy of its label. Wyeth, 555 U.S. at A generic drug manufacturer is merely responsible for ensuring that its warning label is the same as the brand name drug s label. Mensing, 564 U.S. at 613. The FDA has long held that the [generic drug s] labeling must be the same as the listed drug product s labeling because the listed drug product is the basis for [generic drug] approval. Abbreviated New Drug Application Regulations, 57 Fed. Reg (proposed Apr. 28, 1992) (to be codified at 21 C.F.R. pts. 2, 5, 10, 310, 314, 320, & 433). Further, federal regulations prohibit a generic drug manufacturer unilaterally changing its label if that change would deviate from the brand name drug. See 21 C.F.R (a)(8)(iii). Illinoza state law would require Westerly to make an impossible unilateral change in order to present a label that is adequate in the eyes of the petitioner. Illz. Prod. Liability Act, 9

19 1998-4(1)(c). This Court endorses the FDA s position that the CBE regulations allow changes to generic drug label only when a generic drug manufacturer changes its label to match an updated brand name label. Mensing, 564 U.S. at Even though the CBE process allows a drug manufacturer to add or strengthen a warning label, a generic drug manufacturer can only use this process if the brand name drug manufacturer adds or strengthens its own label first. See id.; 21 C.F.R (c)(6)(iii)(A). Although Westerly unilaterally submitted a CBE to update its warning label, it did this to mirror the updated warnings on the brand name drug s updated label. See Ivers I, No CV at 2-3. Petitioner concedes that Westerly updated its label to match the brand name drug. Ivers II, No at 10. Westerly properly used the CBE process in order to fulfill its requirement that its generic drug label be the same as the brand name drug s label after the FDA approved the brand name drug s snda. See Mensing, 564 at ; Ivers I, No CV at 2 3; 21 C.F.R (b)(3). Westerly fulfilled its duty of sameness, even if Illinoza state law still deemed the updated label as inadequate. See Ivers II, No at 10. Several courts, including this Court, have preempted inadequate warning claims when the desired label would be stronger and would deviate from the brand name drug s FDA-approved label. See Mensing, 564 U.S. at ; Fulgenzi v. PLIVA, Inc., 711 F.3d 578, (6th Cir. 2013); Morris v. PLIVA, Inc., 713 F.3d 774, (5th Cir. 2013). In PLIVA, Inc. v. Mensing, the plaintiffs were prescribed the generic drug of metoclopramide in 2001 and U.S. at In 2004 and 2009, the FDA approved progressively stronger label changes, which warned of the potential dangers associated with long-term use. Id. The first label change in 2004, at the request of the brand name drug manufacture, added [t]herapy should not exceed 12 weeks duration. Id. at 609. In 2009, the FDA ordered the brand name manufacturer to include its most aggressive warning a black box warning, stating [t]reatment with metoclopramide can cause 10

20 tardive dyskinesia, a serious movement disorder that is often irreversible.... Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases. Id. at 610. This Court determined that Minnesota and Louisiana state laws placed a duty directly on all drug manufacturers to adequately and safely label their products. Id. at 617 (emphasis added). The crux of the plaintiffs state claims was that the label changes of the drug s risks should have been made earlier than 2004 and 2009, as the manufacturers knew or should have known of the high risk of tardive dyskinesia in the long-term use of the drug and the manufacturers knew or should have known that their labels did not adequately warn of that risk. Id. at The state duties required all manufacturers both brand name and generic of this drug to to use a different, stronger label than the label actually used. Id. at 617. This Court concluded that, for generic drug manufacturers, it was impossible... to comply with both their state-law duty to change the label and their federal-law duty to keep the label the same. Id. at 618. Accordingly, this Court preempted the New Hampshire inadequate claim as preempted. Id. at 617. Similarly, a petitioner s state claim of inadequate warning was preempted when the she was prescribed metoclopramide from 2006 to 2008, and she alleged the inadequacy of all pre labeling. Morris v. Wyeth, Inc., No , 2012 U.S. Dist. LEXIS 23120, *10 (W.D. La. Feb. 21, 2012), aff d, 713 F.3d 774 (5th Cir. 2013). The court determined that tort liability does not arise for failure to attach an inadequate label. Morris, 713 F.3d at 777 (finding it logically incoherent to contend PLIVA had a duty to apply the 2004 warning label when Appellants also assert repeatedly that no labels pre-dating 2009 were adequate. ). Likewise, a plaintiff was preempted from claiming that the generic drug manufacturer should have included the 2009 black box warning for metoclopramide when: (1) the plaintiff was prescribed the drug from 2004 to 2007; (2) the weaker 2004 warning was required; and (3) the generic drug manufacturer never 11

21 updated its label to match the 2004 update. Fulgenzi, 711 F.3d at 582, 584 (holding any such allegations are preempted under Mensing. ). Claims are preempted when they seek a generic drug manufacturer to produce a stronger label than required. See Mensing, 564 U.S. at 617. Impossibility preemption is present here because it was unlawful under the FDCA for Westerly to do what Illinoza s product liability law required possess a stronger label than the brand name drug. See id. at 618. Just as the Minnesota and Louisiana laws scrutinized by this Court in Mensing, Illinoza s products liability law placed a duty on all drug manufacturers generic and brand name, alike to adequately label their products so that they are not unreasonably dangerous. See Illz. Prods. Liability Act, (1)(c); Mensing, 564 U.S. at 617; Ivers II, No at 15 n.7 (stating Illinoza follows the Restatement of the Law, Third, Torts: Product Liability. ). Illinoza s products liability law created a duty for the generic drug manufacturer to include an adequate warning so the drug is reasonably safe for foreseeable uses. See RESTATEMENT (THRID) OF TORTS: PRODS. LIAB. 6(d) (AM. LAW INST. 1998). It would be impossible to satisfy this state-law duty because making the generic drug safer would require a generic drug manufacturer, like Westerly, to use a different, stronger label than that of the brand name drug. See id.; Mensing, 564 U.S. at 617. Taking petitioner s allegations as true, petitioner continues to allege the inadequacy of the warning even after it was updated. See Ivers II, No at 10. The updated label included a warning that, in the event of compulsive behaviors, reducing or discontinuing use of the drug may stop those urges. Ivers I, No CV at 2 3. In alleging that her compulsive behaviors continued over ten months after the label update, petitioner seeks a stronger warning that compulsive behaviors will persist even if the dosage is reduced or discontinued. See id. at 2; Ivers II, No at 10; Morris, 713 F.3d at 777. Just as Minnesota and Louisiana product 12

22 liability laws were preempted under the FDCA, Illinoza s product liability law is also preempted, as it would require Westerly to unilaterally strengthen its label and deviate from the brand name drug s approved label. Mensing, 564 U.S. at 617. Because the Illinoza products liability law makes compliance with the FDCA impossible, impossibility preemption applies to petitioner s inadequate warning state claims. Id. B. WESTERLY CANNOT UNILATERALLY ALTER ITS DRUG DESIGN IF THAT ALTERATION DEVIATES FROM THE BRAND NAME DRUG S DESIGN. Petitioner s defective design claim is also preempted because it would require Westerly to either stop selling the drug altogether, or to impossibly change its chemical composition, bioequivalence, or labeling, all of which this Court has rejected for generic drug manufacturers. See Bartlett, 133 S.Ct. at 2477; Mensing, 564 U.S. at 617. This Court expressly and unambiguously rejects the stop-selling rationale where an alleged defective drug manufacturer could comply with state law by removing the drug from the market. Bartlett, 133 S.Ct. at 2477 ( Adopting the... stop-selling rationale would mean that not [Mensing], but also the vast majority if not all of the cases in which the Court has found impossibility preemption, were wrongly decided. ). State law is still subject to impossibility preemption even if it allows removal of an alleged defective drug from the market to satisfy a state duty. Id. ( Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility preemption would be all but meaningless. ). Further, the FDCA bars a generic drug manufacturer from altering its chemical or bioequivalent design under the abbreviated approval process. 21 U.S.C. 355(j)(2)(A)(ii) (v) and (8)(B); Bartlett, 133 S.Ct. at All drug manufacturers, generic or brand name, are prohibited from changing drug designs without prior FDA approval. Bartlett, 133 S.Ct. at If a generic drug manufacturer were to change the composition of the drug, it would need to go 13

23 through the onerous and lengthy New Drug Application approval process, which would require clinical trials conducted over several years. Id. at 2471, Since the duty of sameness makes it impossible for a generic drug manufacturer to make its drug safer by changing its design, the only other remedy for an alleged defective design is a label change. Id. at ; Mensing, 564 U.S. at 617. However, this Court has determined this duty also prohibits independent alterations to the generic drug s label. Mensing, 564 U.S. at 617. The drug at issue in Bartlett was safe and effective for the vast majority of users and concerned only a very small number of patients who suffered an adverse and severe skin reaction to a nonsteroidal anti-inflammatory pain reliever. Bartlett, 133 S.Ct. at When the plaintiff began taking the generic drug, the label warned of severe skin reactions and the drug s package insert listed both toxic epidermal necrolysis and Steven-Johns syndrome as potential adverse reactions. Id. at Subsequently, the FDA recommended additional warnings of the toxic epidermal necrolysis to the drug s label. Id. The plaintiff could not remedy the alleged defective design claim under New Hampshire design defect law. Id. at New Hampshire law required all drug manufacturers to conduct a risk-utility approach in determining whether a drug design was unreasonably dangerous for foreseeable uses. Id. at 2472, This riskutility approach considered increasing the usefulness of a drug, decreasing the risk of danger, or strengthening the warning label. Bartlett, 133 S.Ct. at Increasing the usefulness of a drug or decreasing the risk of danger would require the drug s re-design, as both were the direct result of the drug s chemical composition and bioequivalence. Id. at Because the generic drug manufacturer was unable to change its design, the only other remedy to comply with state law would have been to change the drug s labeling, which this Court 14

24 preempted in Mensing. Id. at 2475; 564 U.S. at 617. Accordingly, this Court preempted New Hampshire s design defect law. Id. at Regardless of the tort theory used, petitioner cannot evade preemption if Illinoza products liability law is rooted in either strict liability or negligence. Drager v. PLIVA USA Inc., 741 F.3d 470, 478 (4th Cir. 2014) (finding Bartlett controlling even though New Hampshire in Bartlett used a risk-utility approach while Maryland used a consumer-expectation test to assess the unreasonable danger of a product); RESTATEMENT (THRID) OF TORTS: PRODS. LIAB. 6 cmt. f ( whether the case is brought under negligence or strict liability a plaintiff would be successful only if it could make out the elements set forth in 6(c). ). Likewise, Westerly is not required to stop selling its drug in order to avoid the impossible conflict between the FDCA and Illinoza products liability law. Bartlett, 133 S.Ct. at Like the New Hampshire design defect law, Illinoza s defective design law imposes substantial and conflicting duties on both generic and brand name drug manufacturers. See Illz. Prod. Liability Act, (1)(b); Bartlett, 133 S.Ct. at Petitioner would need to prove that the product was both defective and unreasonably dangerous to succeed in a design defect claim under Illinoza law. See Illz. Prod. Liability Act, (1)(b). Similar to New Hampshire, Illinoza employs a risk-utility approach to determine if a design is unreasonably dangerous. See RESTATEMENT (THRID) OF TORTS: PRODS. LIAB. 6(c). This would require Westerly to determine if the foreseeable risks of the drug s harm outweigh the foreseeable benefits of prescribing the drug for any class of patients. Id. Thus, liability will only attach if the drug design cannot be justified for any class of patients. Id. at 6 cmt. f. This state balancing test imposes greater duties on the generic drug manufacturer than the FDCA requires and is even more burdensome than the preempted New Hampshire law. See Bartlett, 133 S.Ct. at 15

25 Under Illinoza state law, Westerly would have the impossible task of changing its drug s chemical composition, bioequivalence, or labeling. Bartlett, 133 S.Ct. at ; Mensing, 564 U.S. at 617. Therefore, federal law would preempt petitioner s defective design claim under Illinoza state law. Bartlett, 133 S.Ct. at II. ATTORNEY S FEES ARE COSTS AWARDABLE TO WESTERLY UNDER FEDERAL RULE OF CIVIL PROCEDURE 41(D). This Court should affirm the Twelfth Circuit s inclusion of Westerly s attorney s fees as costs under Fed. R. Civ. P. 41(d), even when not individually listed in the language of the rule, because (1) attorney s fees are authorized as costs under the East Texas products liability law governing the initial claim and (2) an award of attorney s fees as costs is essential to the purpose and intent of Rule 41. Rule 41(d) is triggered when, as in this case, petitioner voluntarily dismisses her first action and brings a second action based on or including the same claim against the same party under Rule 41(a)(1). Rule 41(d)(1) empowers courts to require petitioner to pay the costs a responding party incurs defending the first of the duplicitous claims. In this case, the lower courts agree that costs were properly awarded to Westerly. Ivers II, No at 17. Thus, the only issue on appeal is whether the attorney s fees Westerly incurred in the first action are properly included in the awarded costs. Petition for Writ of Certiorari, No at 23. The scope of costs under Rule 41 is a question of law this Court reviews de novo. Andrews v. Am. s Living Ctrs, LLC., 827 F.3d 306, 309 (4th Cir. 2016). A. RULE 41(D) AUTHORIZES ATTORNEY S FEES BECAUSE THE EAST TEXAS PRODUCTS LIABILITY LAW UNDERLYING THE INITIAL CLAIM INCLUDES ATTORNEY S FEES AS COSTS. Westerly s attorney s fees from the first action are awardable as Rule 41(d) costs because they are authorized as such by of the East Texas Code, which governs the first claim. 16

26 Ivers II, No at 22 (Motley, J., dissenting). The statute underlying the claim is commonly used to justify inclusion of attorney s fees when it includes attorney s fees in its description of costs. See Alyeska Pipeline Serv. Co. v. Wilderness Soc y, 421 U.S. 240, 246, (1975); Andrews, 827 F.3d at 312; Esposito v. Piatrowski, 223 F.3d 497, 501 (7th Cir. 2000). When a statute explicitly includes attorney s fees in its description of costs, a court is authorized to award those fees as costs. See Alyeska, 421 U.S. at 250. Accordingly, this Court clarified that the underlying statute does not itself authorize inclusion of fees when it explicitly excludes fees from the description of costs. See id. at In Alyeska, the District of Columbia Circuit awarded the respondent attorney s fees as costs under the private attorney general exception to the American rule against such an award because the respondent was acting for the common benefit of the citizens. Id. at 246. This Court reversed, holding a general common benefit policy interest inadequate for statutory authorization of fees where the statute underlying the claim explicitly excluded fees and expenses of attorneys from costs which could be awarded to respondents. Id. at (citing 28 U.S.C (2011), Except as otherwise specifically provided by statute, a judgment for costs, as enumerated in section 1920 of this title, but not including the fees and expenses of attorneys, may be awarded. ). Moreover, the Fourth Circuit applied the same statutory authorization test. Andrews, 827 F.3d at 312. The statute underlying the original suit, however, was silent regarding attorney s fees, and therefore did not justify inclusion of fees. Id. Most importantly, the Seventh Circuit found sufficient statutory authorization of fees. Esposito, 223 F.3d at 501. Those fees were awardable because Section 1983 stated that prevailing [respondents] in such actions may recover [attorney s] fees when certain factual conditions are met. Id. 17

27 In this case, petitioner s first claim is based on East Texas Products Liability Law (a), which states that there shall be taxed and allowed as part of the costs of the action, a reasonable amount to be fixed by the court as attorney s fees. Ivers II, No at 22 (Motley, J., dissenting). In stark contrast to both the statutory provision in Alyeska, which explicitly excluded attorney s fees from costs, and to the provision in Andrews, which was silent on the matter, East Texas Products Liability Law unambiguously lists reasonable attorney s fees as part of the costs. 421 U.S. at ; 827 F.3d at 312; Ivers II, No at 22 (Motley, J., dissenting). The underlying statute governing the initial claim authorizes this Court to award Westerly s attorney s fees as Rule 41(d) costs. B. THE PURPOSE AND INTENT OF RULE 41 ITSELF ALSO AUTHORIZES INCLUSION OF WESTERLY S ATTORNEY S FEES IN THE COSTS AWARDED UNDER RULE 41(D). Attorney s fees incurred must also be included in awards of costs under Rule 41(d) based on two purposes underlying the Rule. First, inclusion of fees prevents petitioners from using Rule 41(a) voluntary dismissals as a vehicle for forum shopping and vexatious litigation. See Andrews, 827 F.3d at 309. Second, it ensures respondents are not prejudiced by Rule 41(a) dismissals. The American rule is generally that attorney s fees are not among a prevailing party s recoverable costs. Alyeska, 421 U.S. at 247. However, the American rule should not preclude an award of fees under Rule 41(d) because a respondent is clearly not a prevailing party when forced to re-litigate after petitioner voluntarily dismisses without prejudice and then refiles under different laws. See ROBERT L. ROSSI, 2 ATTORNEY FEES AWARDS 3:8 (3d ed. 2017) (respondents were not considered the prevailing party where the claim was dismissed without prejudice). This Court has established a clear exception to the American rule, even if it applies, where Congress authorizes the award of fees, either in its language or its intent. See Key Tronic 18

28 Corp. v. U.S., 511 U.S. 809 (1994). This congressional authorization to award attorney s fees as costs is found in the purpose and intent of Rule 41(d). See Esposito, 223 F.3d at 500. This Court recognizes 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, 511 U.S. at 815. Nonetheless, courts excluding attorney s fees disregard intent, arguing merely that the plain language of the Rule does not constitute a congressional authorization of awarding fees. See Rogers v. Wal-Mart Stores, Inc., 230 F.3d 868, (6th Cir. 2000); Duffy v. Ford Motor Co., 218 F.3d 623, (6th Cir. 2000). These courts overlook the critical point that [t]he Rules themselves do not define costs one way or the other. Ivers II, No at 17. The textual ambiguity of costs requires analysis beyond the plain language. See Yates v. U.S., 135 S.Ct. 1074, (2015). It is a fundamental principle of statutory construction that the meaning of a word cannot be determined in isolation, but must be drawn from the context in which it is used. Id. Notably, rather than creating a narrow rule, Congress grants broad discretion to a court in exercising its power in Rule 41(d) to avoid prejudice after a voluntary dismissal. Esquivel v. Arau, 913 F.Supp. 1382, 1386 (C.D. Cal. 1996). If the Rule were intended for limited, specific application, it would be written to require such; that is not the case here. See id. That is not the case here. Rule 41(d) is intentionally broad, and its award of costs necessarily includes attorney s fees. Ivers II, No at 10. In a case involving ambiguity of the scope of costs in a Federal Rule of Civil Procedure, this Court adopted the construction of the Rule [which] best furthers the objective of the Rule. Marek v. Chesny, 473 U.S. 1, 5(1985). In this setting, given the importance of costs to the Rule, it is very unlikely that this omission was mere oversight; on the contrary, the most reasonable inference is that the term costs was intended to refer to all costs properly awardable under the relevant substantive statute or other authority. 19

29 Id. at 9. The same reasonable inference to further the objective of the Rule should be drawn regarding Rule 41(d), as costs are central to the objective of Rule 41(d). See Esposito, 223 F.3d at 501. The totality of Rule 41 provides the context for Rule 41(d). See Andrews, 827 F.3d at ; see also Davis v. USX Corp., 819 F.2d 1270, 1276 (4th Cir. 1987); LeBlang Motors, Ltd. v. Subaru of Am., Inc., 148 F.3d 680, (7th Cir. 1998); Painter v. Golden Rule Ins. Co., 121 F.3d 436, (8th Cir. 1997). Courts use Rule 41(a)(2) to impose payment of respondent s attorney s fees as a condition of petitioner s right to voluntary dismissal under Rule 41. Esposito, 223 F.3d at 501. If the court can require a petitioner s payment of respondent s attorney s fees as a condition of a voluntary dismissal, the court must also necessarily be able to award those attorney s fees under Rule 41(d). See Andrews, 827 F.3d at Therefore, attorney s fees are clearly includable as respondent s costs awarded under Rule 41(d) in the event of a 41(a) voluntary dismissal. See id. A majority of courts award attorney s fees as Rule 41(d) costs. 1 And, many of that majority emphasize the intent underlying the Rule in their reasoning. 2 The well-recognized purpose of Rule 41(d) is to serve as a deterrent to forum shopping and vexatious litigation. Andrews, 827 F.3d at 312 (citing Simeone v. First Bank Nat l Ass n, 971 F.2d (8th Cir. 1992)). A petitioner s suit is vexatious when it is meant to create trouble and expense for the respondent. Vexatious Suit, BLACK S LAW DICTIONARY (10th ed. 2014). However, the Rule does not require bad faith in the petitioner s dismissal and refiling to justify award of costs and, 1 Andrews, 827 F.3d at (4th Cir. 2016); Esposito, 223 F.3d at 501 (7th Cir. 2000); Meredith v. Stovall, 216 F.3d 1087 (10th Cir. 2000) (unpublished); Evans v. Safeway, 623 F.2d 121, 122 (8th Cir. 1980); Esquivel, 913 F.Supp. at 1390; Anders v. FPA Corp., 164 F.R.D. 383 (D.N.J. 1995). 2 Andrews, 827 F.3d at (4th Cir. 2016); Esposito, 223 F.3d at 501 (7th Cir. 2000); Esquivel, 913 F.Supp. at 1390; Anders, 164 F.R.D. at 389 (D.N.J. 1995). 20

30 therefore, attorney s fees. See Rogers, 230 F.3d at 874. Even honest attempts to gain any tactical advantage by dismissing and refiling th[e] suit are sufficient to justify costs. Andrews, 827 F.3d at 309 (citing Rogers, 230 F.3d at 874). In this case, the petitioner sought a tactical advantage by forum shopping when she voluntarily dismissed her case within the Fifth Circuit after it adopted this Court s preemption holding in Mensing. Morris, 713 F.3d at 778 (citing Mensing, 564 U.S. at 617); Ivers I, No CV at 5. Petitioner s first action was based entirely on the defective design and inadequate warning claims in East Texas products liability law. Ivers I, No CV at 5. Since the FDCA preempts state inadequate warning and defective design claims against generic drug manufacturers, Westerly s responsive efforts regarding the state litigation went to waste. See Bartlett, 133 S.Ct at 2479; Mensing, 564 U.S. at 617; Ivers I, No CV at 5. Dismissal of the Texas claim, followed by refiling of the same claims under Illinoza law naturally creates trouble and expense for the respondent. Ivers II, No (Motley, J., dissenting); Vexatious Suit, BLACK S LAW DICTIONARY. The petitioner s dismissal and refiling is a clear example of the forum shopping this Rule was designed to prevent. See Andrews, 827 F.3d at 312. Although Rule 41(a) allows petitioners leave to voluntarily dismiss an action without prejudice, it does so only so long as no other party will be prejudiced. LeCompte v. Mr. Chip, Inc., 528 F.2d 601, 604 (5th Cir. 1976). In addressing important judicial efficiency considerations of forum shopping and vexatious litigation, Congress intended that the provision of the federal rules have some teeth. Andrews, 827 F.3d at 309 (citing Behrle v. Olshansky, 139 F.R.D. 370 (W.D. Ark. 1991)). To that end, Congress provides courts the responsive power to prevent unfair effects on respondents that may result from such dismissals. Id. The no prejudice condition is essential to the proper function of a Rule 41 voluntary dismissal. See Id. 21

31 Furthermore, awarding fees as Rule 41(d) costs does not deter petitioners from utilizing Rule 41(a) for voluntary dismissal because the award is still limited to legal work from the previously dismissed case that cannot be used in the recommenced case. DANIEL R. COQUILLETTE, ET. AL., 8-41 MOORE S FEDERAL PRACTICE CIVIL 41.70(6) (2017). Petitioner is not necessarily required to pay the full amount of respondent s attorney s fees from the first action. See id. Rather, she is only responsible for the work that became useless when she chose to change forums. Id. Limiting the award to include only what is now useless prevents unnecessary legal fees from prejudicing the respondent. See id. Courts use this limitation to ensure the petitioner does not essentially fund the respondent s defense, but that she still pays what is equitable under the circumstances of voluntary dismissal. See Copeland v. Hussmann Corp., 462 F.Supp.2d 1012, 1024 (E.D. Mo. 2006); Esquivel, 913 F.Supp. at Clearly, exclusion of fees would take the teeth out of the rule and leave the respondent prejudiced, paying the price for the petitioner s voluntary dismissal in the form of unnecessary attorney s fees. See Andrews, 827 F.3d at 309. A respondent s attorney s fees are an integral part of defending the initial action. Esquivel, 913 F.Supp. at Rule 41(a) limits dismissal to relatively early in the proceedings, which could theoretically limit respondents expenditures. See Armstrong v. Frostie Co., 453 F.2d 914 (4th Cir. 1971). However, denial of incurred fees effectively punishes the diligent respondent for promptly preparing for the initial suit. See id. In considering the award s efficacy in avoiding prejudice, the amount of Westerly s attorney s fees incurred compared to other costs is worth noting. See Starr v. Hill, No STA, 2010 WL , *13 (W.D. Tenn. June 16, 2010); Ivers I, No CV at 7. Direct court costs ($876.52) only constitute 20.2 percent of the total award from the initial, dismissed action ($4,318.52), while attorney s fees constitute 79.8 percent. Ivers I, No CV at 7. Thus, 22