IN THE Supreme Court of the United States. ALICE IVERS, Petitioner, v. WESTERLY PHARMACEUTICAL, INC., Respondent. BRIEF FOR PETITIONER

No. 17-230 IN THE Supreme Court of the United States ALICE IVERS, Petitioner, v. WESTERLY PHARMACEUTICAL, INC., Respondent. On Writ of Certiorari to the Twelfth Circuit Court of Appeals BRIEF FOR PETITIONER Brief for Petitioner Team 2616

QUESTIONS PRESENTED I. Whether a federal law that approves a generic drug on the condition that its labeling mirror the labeling of its brand-name counterpart preempts a state s product liability statute when the state s statute does not render it impossible for the generic manufacturer to follow both the federal and state law, nor does it burden the generic manufacturer, and in fact, the generic manufacturer failed to update its labeling within a reasonable amount of time. II. Whether Federal Rule of Civil Procedure 41(d) provides a mechanism for the court to award attorney s fees, thereby contradicting the American Rule, which requires each litigant to pay for his or her own attorney s fees, and overlooking Congress s wellestablished policy of explicitly permitting an award of attorney s fees in addition to costs in each instance where Congress intends to permit an award of attorney s fees. i

TABLE OF CONTENTS QUESTIONS PRESENTED... i TABLE OF CONTENTS... ii TABLE OF AUTHORITIES... iv OPINIONS BELOW...1 CONSTITUTIONAL AND STATUTORY PROVISIONS INVOLVED...1 STATEMENT OF THE CASE...1 SUMMARY OF THE ARGUMENT...4 ARGUMENT...5 I. STANDARD OF REVIEW...5 II. MS. IVERS S CLAIM IS NOT PREEMPTED BY FEDERAL LAW...5 A. Ms. Ivers s Claim is Not Preempted by Implied Conflict Preemption...7 1. Impossibility Preemption is Not Present Here Because Illinoza s Tort Law Complies with Federal Law...7 2. Illinoza Tort Law Does Not Create an Obstacle to Federal Law Requirements Because Congress Objectives are Not Further Burdened by Complying with Both State and Federal Requirements...10 3. The Pertinent Tort Law in Illinoza Differs from Tort Law in Other States Where Courts Have Found Preemption...11 B. Ms. Ivers is Entitled to Recovery Because Westerly Failed to Update the Label Within a Reasonable Amount of Time...14 1. Westerly s Failure to Update was Unreasonable and Westerly s Violation of Federal and State Law Injured Ms. Ivers...14 2. If This Court Does Not Find that Westerly s Failure to Update was Unreasonable, then Generic Manufacturers Will Have No Incentive to Update Their Labels...16 C. Westerly s Far-Reaching Interpretation of Preemption Purports to Expand Preemption to Unprecedented Realms...19 III. WESTERLY IS NOT ENTITLED TO ATTORNEY S FEES BECAUSE RULE 41(D) DOES NOT PERMIT RECOVERY OF SUCH FEES...21 ii

A. Awarding Westerly Attorney s Fees is Inconsistent with This Court s Precedent...22 B. When Read in the Context of the Federal Rules of Civil Procedure, the Text of Rule 41(d) Does Not Permit a Recovery of Attorney s Fees...24 CONCLUSION...30 APPENDIX A...1 APPENDIX B...1 APPENDIX C...1 iii

Cases TABLE OF AUTHORITIES Page(s) Alyeska Pipeline Serv. Co. v. Wilderness Soc y 421 U.S. 240 (1975)...23, 24, 28 29 Andrews v. America s Living Centers, L.L.C. 827 F.3d 206 (4th Cir. 2016)...24, 25, 29, 30 Arizona v. United States 567 U.S. 387 (2012)...10 Baker Botts L.L.P. v. ASARCO L.L.C. 135 S. Ct. 2158 (2015)...22, 23, 24 Behrle v. Olshansky 139 F.R.D. 370 (W.D. Ark. 1991)...24, 29 Buckman Co. v. Plaintiffs Legal Comm. 531 U.S. 341(2001)...7, 20 Cauley v. Wilson 754 F.2d 769 (7th Cir. 1985)...28 Celotex v. Calrett 477 U.S. 317 (1986)...5 Cleveland v. Caplaw Enters. 448 F.3d 518 (2d Cir. 2006)...5 Commissioner v. Jean 496 U.S. 154 (1990)...24 Couick v. Wyeth No. 3:09-CV-210-RJC-DSC, 2012 U.S. Dist. LEXIS 3699 (W.D.N.C. Jan. 11, 2012)...9 Crosby v. Nat l Foreign Trade Council 530 U.S. 363 (2000)...7 Duffy v. Duffy 218 F.3d 623 (6th Cir. 2000)...24 Duffy v. Ford Motor Co. 218 F.3d 623 (6th Cir. 2000)...28 iv

English v. General Elec. Co. 496 U.S. 72 (1990)...7 Esposito v. Piatrowski 223 F.3d 497 (7th Cir. 2000)...24, 25 Esquivel v. Arau 913 F. Supp. 1382 (C.D. Cal. 1996)...28 Fogerty v. Fantasy, Inc. 510 U.S. 517 (1994)...22 Freightliner Corp. v. Myrick 514 U.S. 280 (1995)...7 Fulgenzi v. PLIVA, Inc. 711 F.3d 578 (6th Cir. 2013)...8, 11, 20 Garza v. Wyeth No. 2:12-CV-00198, 2013 U.S. Dist. LEXIS 91029 (S.D. Tex. 2013)...8 Hardt v. Reliance Standard Life Ins. Co. 560 U.S. 242 (2010)...22 Hines v. Davidowitz 312 U.S. 52 (1941)...10 In re Fosamax Prods. Liab. Litig. 2013 U.S. Dist. LEXIS 115667 (S.D.N.Y. Aug. 14, 2013)...8 In re Hearn 376 F.3d 447 (5th Cir. 2004)...20 In re Reglan Litig. 226 N.J. 315 (2016)...8 In re Reglan Litig. A-2014-13T4, 2014 WL 5840281, at *6 (N.J. Super. Ct. App. Div. Nov. 12, 2014), aff'd, 226 N.J. 315, 142 A.3d 725 (2016)...20 Johnson v. Teva Pharm. USA, Inc. 758 F.3d 605 (5th Cir. 2014)...20 Key Tronic Corp. v. United States 511 U.S. 809 (1994)...21, 22, 23, 26, 28 v

Koch v. Hankins 8 F.3d 650 (9th Cir. 1993)...28 Lashley v. Pfizer, Inc. 750 F.3d 470 (2014...20 Marek v. Chesny 427 U.S. 1 (1985)...22, 25 McLaughlin v. Chelshire 676 F.2d 855 (D.C. Cir. 1982)...29 Meredith v. Stovall 216 F.3d 1087 (10th Cir. 2000)...29 Morris v. PLIVA, Inc. 713 F.3d 774 (5th Cir. 2013)...19, 20 Mut. Pharm. Co. v. Bartlett 133 S. Ct. 2644 (2013)...8, 9, 12, 14 PLIVA, Inc. v. Kohles 137 S. Ct. 1434 (2017)...8 PLIVA, Inc. v. Mensing 564 U.S. 604 (2011)...6, 8, 9, 14, 17, 20 Riegel v. Medtronics, Inc. 552 U.S. 312 (2008)...10, 13 Rice v. Santa Fe Elevator Corp. 331 U.S. 218 (1947)...10 Robinson v. Bank of Am., N.A. 553 F. App x 648 (8th Cir. 2014)...29 Rogers v. Wal-Mart Stores, Inc. 230 F.3d 868 (6th Cir. 2000)...24, 25, 26, 27, 29 Runyon v. McCrary 427 U.S. 160 (1976)...22 Sanderson v. Spectrum Labs, Inc. 227 F. Supp. 2d 1001 (N.D. Ind. 2000)...28 vi

Silkwood v. Kerr-McGee Corp. 464 U.S. 238 (1984)...7 Valencia v. Affiliated Grp., Inc. 674 F. Supp. 2d 1300 (S.D. Fla. 2009)...28 Wyeth v. Levine 555 U.S. 555 (2009)...6, 7, 10, 11, 19, 21 Statutes 21 C.F.R. 201.57...14 21 C.F.R. 314.70...6, 16, 17, 18 21 C.F.R. 314.80...6, 14, 16, 17 21 C.F.R. 314.150...6, 7, 9, 15, 21 21 C.F.R. 320.1...8, 16 21 U.S.C.S. 355...6, 8, 14, 16, 17 21 U.S.C.S. 360k...10 28 U.S.C.S. 2412...24 42 U.S.C.S. 2000a-3...23 U.S. Const. art. VI, cl. 2...6 Rules Fed. R. Civ. P. 11...26 Fed. R. Civ. P. 26...26 vii

Fed. R. Civ. P. 30...26 Fed. R. Civ. P. 37...26 Fed. R. Civ. P. 41...22, 28, 29 Fed. R. Civ. P. 54(d)...27, 28 Fed. R. Civ. P. 56(g)...29 Secondary Sources Michael J. Wagner & Laura L. Peterson, The New Restatement (Third) of Torts Shelter from the Product Liabilty Storm for Pharmaceutical Companies and Device Manufactures?, 53 Food Drug L.J. 255, 232 (1998)... 12 OFFICE OF GENERIC DRUGS, GENERIC DRUG LABELING REVISIONS COVERED UNDER SECTION 505(J) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT (2013), available at http://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco /CDER/ManualofPoliciesProcedures/UCM339381.pdf2...15 Restatement (Third) of Torts: Products Liability 2...11, 12, 13 Restatement (Third) of Torts: Products Liability 6...12, 13 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 of Illinoza appears on pages 1 8 of the record. CONSTITUTIONAL AND STATUTORY PROVISIONS INVOLVED The constitutional provision at issue, the Supremacy Clause, is located at Appendix A. The statute at issue, Illinoza s products liability law, is located at Appendix B. The procedural rule at issue, Federal Rule of Civil Procedure 41(d), is located at Appendix C. STATEMENT OF THE CASE This case involves a dispute over whether the federal law that mandates a generic drug manufacturer to mirror its brand-name counterpart s label preempts a state law s duty-to-warn requirement, and whether Federal Rule of Civil Procedure 41(d) s provision for costs permits an award of attorney s fees, even though the statute does not explicitly provide for such fees. Westerly s Generic Ropidope Drug and its Label GlaxoCline first patented and received FDA approval from the Federal Food & Drug administration ( FDA ) in 1997 for the drug ropidope, sold under the brand name Equip, which eases the symptoms of Parkinson s Disease. R. at 2. GlaxoCline s patent expired in 2008, at which point Westerly Pharmaceuticals, Inc. ( Westerly ) submitted an Abbreviated New Drug Application ( ANDA ) to the FDA for approval to market and sell an equivalent generic version of the drug. The application was approved, and Westerly began to sell ropidope in 2009. R. at 2. 1

FDA granted Westerly approval with the necessary condition that it maintain a label that at all times mirrored Equip s most-current label. R. at 2. In January of 2011, GlaxoCline submitted a Supplemental New Drug Application (snda) to the FDA to request approval of proposed changes to its labeling. R. at 2. This proposed change included a warning regarding impulse control and compulsive behaviors in patients, and was implemented in June 2011. R. at 2. Notably, the warning specified that individuals may not notice the injurious side effects, thus, special warning was necessary. R. at 2. In July 2011, six months after GlaxoCline supplemented its new labeling, Alice Ivers ( Ms. Ivers ), who was taking Westerly s non-compliant drug, began to develop compulsive spending and gambling behaviors, indistinguishable from those behaviors described in GlaxoCline s new warning. R. at 2-3. Finally, in January 2012, seven months after GlaxoCline implemented its new labeling, Westerly submitted a Changes Being Effected (CBE) notification, telling the FDA that it would finally update its ropidope labeling to match Equip s label. R. at 2-3. Westerly s new label ultimately became effective on February 1, 2012, seven months after Ms. Ivers s injury. R. at 3. Detrimental Impact on Ms. Ivers Ms. Ivers developed severe spending and gambling behaviors while taking the generic ropidope. Her drug-induced conduct was exactly the kind of conduct Westerly s brand name counterpart which Westerly was charged with mirroring took affirmative actions to prevent. R. at 2-3. The behavior, beginning in July of 2011, ultimately culminated with the depletion of Ms. Ivers s entire retirement savings by the end of 2012. R. at 3. As a direct result, her husband of 35 years filed for divorce. R. at 3. 2

Ms. Ivers claims that Westerly breached its duty of care, as proscribed by Illinoza products liability law. R. at 3. Specifically, her Complaint alleges that Westerly s product was defectively designed as it contained inadequate warnings regarding the loss of impulse control and surge of compulsive behaviors, thus proximately causing the damage to her finances and relationships. R. at 3. Procedural History and Costs Ms. Ivers filed a complaint in the state court of Illinoza, to which Westerly responded by removing the proceeding to the United District Court for the District of Illinoza on October 14, 2015. R. at 1. The complaint alleged a products liability claim against Westerly under the Illinoza Products Liability Act. R. at 1. Westerly then filed a Motion for Judgment on the Pleadings and a Motion for an Award of Costs. R. at 3. In its Motion on the Pleadings, Westerly argued that the Federal Food, Drug & Cosmetic Act ( FDCA ), which required the duty-ofsameness, somehow preempted Illinoza products liability. R. at 4. In its Motion for an Award of Costs, Westerly contended that Ms. Ivers s previous suit against Westerly, in state court, which Ms. Ivers voluntarily dismissed, allowed the District Court to order her to pay for all or part of the costs of that previous litigation. R. at 6. The District Court granted Westerly s Motion on the Pleadings on the preemption claim. R. at 8. Additionally, the District Court granted Westerly s Award of Costs in part and denied it in part. R. at 8. The court granted the Award of Costs as to the $876.52 in court filing, delivery, research, and telecommunications costs, but denied Westerly s request for attorney s fees. R. at 7. The court explained attorney s fees are not authorized in costs. Id. On November 15, 2016, both parties appealed the District Court s decision to the Court of Appeals for the Twelfth Circuit. R. at 9. The Twelfth Circuit affirmed the District Court s 3

grant of Motion for Judgment on the Pleadings on the preemption claim, and reversed the portion of the District Court s order denying attorney s fees. R. at 10. This Court granted certiorari on July 17, 2017, limiting review to two questions: (1) whether this Court s decisions in PLIVA v. Mensing and Mutual Pharmaceutical v. Bartlett preempt Ms. Ivers s claims in this case; and (2) whether attorney s fees are considered awardable as costs under Federal Rule of Civil Procedure 41(d). R. at 23. SUMMARY OF THE ARGUMENT I. Ms. Ivers s Claim is Not Preempted by Federal Law. Westerly s argument that federal law preempts Ms. Ivers s claim violates the United States long-held assumption that a state s policing powers are not superseded by federal government unless Congressional intent to do so is made clear. The FDCA states that after approval to sell a generic prescription drug, the manufacturer is required to mirror the label of the brand-name drug, which Westerly failed to do. Westerly was obliged to comply with both federal and state law by mirroring its corresponding brand-name drug GlaxoCline, since Illinoza tort law complies with the federal law at issue. Impossibility preemption is therefore not present in the case at hand. Further, Illinoza law does not place an additional burden on federal law because Illinoza law complies with the federal requirements. Hence, the state tort law does not create an obstacle to comply with federal requirements. Further, Westerly did not update its ropidope label within a reasonable amount of time, which violated both federal and state law. Ultimately, this failure to update led to Ms. Ivers s avoidable injury. Westerly s unreliable interpretation of preemption purports to redefine preemption in an overly-expansive manner, which this Court has already rejected in the past. In 4

order to avoid this unfounded and unjustifiable expansion, this Court should find that Ms. Ivers s claim is not preempted. II. Rule 41(d) Does Not Permit the Court to Award Attorney s Fees to Westerly. Holding that the court may award attorney s fees under Rule 41(d) would be tantamount to allowing the Judiciary to invade the province of the legislature at its discretion and violate Legislative intent, thus crossing the boundaries set by separation of powers. This Court has clearly established precedent in favor of the American Rule, which requires that each litigant pays his or her own attorney s fees unless a statute provides otherwise. Further, statutes are to be read with the presumption that the American Rule should be followed. When reviewing the Federal Rules of Civil Procedure as a whole, it is clear that attorney s fees are not included in costs unless expressly provided by statute. Thus, to abide by Congressional intent and established precedent, Ms. Ivers should not be required to pay for Westerly s attorney s fees. ARGUMENT I. STANDARD OF REVIEW This Court is reviewing the Twelfth Circuit s affirmation of the district court s judgment on the pleadings on the federal preemption claim, and reversal of the holding that Federal Rule of Civil Procedure 41(d) permits an award of attorney s fees. Motions for judgment on the pleadings under Rule 12(c) are held to the same standards as motions to dismiss for failure to state a claim under Rule 12(b). Celotex v. Calrett, 477 U.S. 317, 322 (1986); Cleveland v. Caplaw Enters., 448 F.3d 518, 521 (2d Cir. 2006). Thus, this Court reviews an appeal for a district court s judgment is de novo, giving no deference to the lower court s judgment. Id. II. MS. IVERS S CLAIM IS NOT PREEMPTED BY FEDERAL LAW. 5

Ms. Ivers s cause of action against Westerly is not preempted by federal law because her injury arose from Westerly s failure to abide by federal law. Although the Supremacy Clause of the United States Constitution states that federal law shall be the supreme Law of the Land, this clause does not support Westerly s assertion that the Illinoza state law conflicts with federal requirements. In fact, Westerly violated the Federal Food, Drug & Cosmetic Act ( FDCA ), which plainly states that after approval to sell a generic prescription drug, the manufacturer is required to mirror the label of the brand-name drug. 21 C.F.R. 314.150(b)(10); PLIVA, Inc. v. Mensing, 564 U.S. 604, 618 (2011) (stating, Federal law demanded that generic drug labels be the same at all times as the corresponding brand-name drug labels ). A brand-name drug manufacturer may unilaterally strengthen its warning without prior FDA approval. Wyeth v. Levine, 555 U.S. 555, 573 (2009); 21 C.F.R. 314.70(c)(6)(iii) (dictating that no prior approval is needed for [c]hanges in the labeling to reflect newly acquired information ). In Levine, this Court held that a lawsuit was not preempted because the drug manufacturer could update its label, and at the same time comply with both state and federal law. 555 U.S. at 573. Additionally, this Court explained that newly acquired information is not limited to new data, but also encompasses new analyses of previously submitted data. Levine, 555 U.S. at 569 (internal citations omitted). In their respective roles, a brand-name manufacturer who seeks a New Drug Approval ( NDA ) is ultimately responsible for the accuracy and adequacy of the label, 21 U.S.C. 355(b)(1), while the generic manufacturer, as a condition for approval to sell the generic drug, is equally responsible to ensure that its label is the same as that of the brand name. Id at 314.150(b)(10). Additionally, federal law requires generic manufacturers to review all reports of adverse drug experiences received from any source. 21 C.F.R. 314.80(b). In the case at hand, 6

Westerly did not meet its duty to ensure that its label mirrored GlaxoCline s label. Since Illinoza law does not create a different or an additional requirement from the pertinent federal requirements, Ms. Ivers s claim is not preempted. A. Ms. Ivers s Claim is Not Preempted by Implied Conflict Preemption. A state law is preempted only when it is impossible for a private party to comply with both state and federal law (referred to as impossibility preemption), or when the law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress. Crosby v. Nat l Foreign Trade Council, 530 U.S. 363, 372 (2000). While it is true that regulations implemented by federal agencies may preempt state law, preemption does not occur when state law comports with federal law. Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 353 (2001) (stating that state-law causes of actions that parallel federal safety requirements may be permitted). 1. Impossibility Preemption is Not Present Here Because Illinoza s Tort Law Complies with Federal Law. Illinoza law is not preempted by federal law because Westerly could and was, in fact, required to comply with both federal and state law. Implied conflict preemption exists only 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) (quoting English v. General Elec. Co., 496 U.S. 72, 79 (1990)). This Court has previously dictated that impossibility preemption is a demanding defense, Levine, 555 U.S. at 573, to which a defendant bears the burden to demonstrate the impossibility. See Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 255 (1984). Congressional intent for strict compliance by the generic manufacturer could not be more obvious. Congress passed federal legislation that expressly requires a manufacturer of a generic prescription drug to at all times mirror its corresponding brand-name label, or risk facing 7

withdrawal of its Abbreviated New Drug Application ( ANDA ). 21 C.F.R. 314.150(b)(10). The approval of an ANDA is predicated on the requirements that the generic drug be the bioequivalent to the name-brand or Referenced-Listed Drug ( RLD ). Furthermore, the generic drug is also required to use the same labeling as the RLD. 21 U.S.C. 355(j)(2)(A)(iv) (v); 21 C.F.R. 320.1(c). See also Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466, 2475 (2013). As this Court stated in Mensing, Federal law does not dictate the text of each generic drug's label, but rather ties those labels to their brand-name counterparts. 564 U.S. at 620. Thus, no impossibility preemption arises when a state law merely requires compliance with federal law. See id. This fact is even more evident when considering that the FDA and the brand-name manufacturer s revised label complied with Illinoza s requirements. Id; R. at 2 3. No impossibility preemption exists in the present case because Westerly s failure to follow the mandated federal law consequently gave rise to noncompliance with Illinoza law. If Westerly had complied with the required federal law, Westerly also would have been in compliance with Illinoza law. As the Sixth Circuit succinctly stated, [a generic drug manufacturer s] violation of its federal duty of sameness defeats its impossibility-preemption arguments. Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 586 (6th Cir. 2013). Courts find no preemption, even after Mensing, when the name-brand manufacturer changes its label and the generic manufacturer fails to update its corresponding label. See In re Reglan Litig., 226 N.J. 315, 331 332 (2016), cert. denied sub nom. PLIVA, Inc. v. Kohles, 137 S. Ct. 1434 (2017) (holding that a generic manufacturer is required to mirror the brand-name manufacturer labeling when the label is changed to provide information about adverse reactions); In re Fosamax Prods. Liab. Litig., 2013 U.S. Dist. LEXIS 115667, at *8 *12 (S.D.N.Y. Aug. 14, 2013) (finding no preemption when generic manufacturer failed to revise its label to match the 8

label changes made by the name-brand manufacturer). Garza v. Wyeth LLC, No. 2:12-CV- 00198, 2013 U.S. Dist. LEXIS 91029, at *8-9 (S.D. Tex. 2013) (rejecting defendant s argument that state law was preempted because generic manufacturer failed to update its label despite their actual or constructive knowledge [the drug s risk], and despite FDA-approved labeling changes to the brand-name drug ). In Couick v. Wyeth, the court similarly held there was no impossibility preemption when the generic manufacturer failed to update its label to match the name-brand manufacturer s updated label. No. 3:09-cv-210-RJC-DSC, 2012 U.S. Dist. LEXIS 3699, at *9-10 (W.D.N.C. Jan. 11, 2012). Factually similar to the present case, the plaintiff in Couick was harmed during the time period that the generic manufacturer failed to update its label to include the RLD s additional warnings. Id. The impossibility preemption issues found in Mensing and Bartlett do not exist in the present case. See generally Mensing, 564 U.S. 604; Bartlett, 133 S. Ct. 2466. In Mensing, this Court found preemption barred the claim only because the name-brand drug made no alterations to their drug s label, and yet state law required the generic manufacturer to change its label and deviate from its RLD. See generally Mensing, 564 U.S. 604. In Bartlett, this Court found preemption because in order to comply with the state requirements, the generic manufacturer was mandated to redesign its label to include information that was not present in its RLD. See Bartlett, 133 S. Ct. 2466. Unlike in Mensing and Bartlett, GlaxoCline submitted its CBE in January 2011 to reflect the very risks of harm that Ms. Ivers ultimately suffered. R at 2 3. Once GlaxoCline updated its label, Westerly was mandated by federal law to reflect those changes in its own label. 21 C.F.R. 314.150(b)(10). In contrast to those cases, Illinoza law does not require the generic manufacturer to include additional warnings absent in the RLD. Thus, in the present case, state 9

law did not require Westerly to include additional warnings outside of the RLD, but instead required compliance with the same federal laws that Westerly clearly violated when Ms. Ivers suffered harm. Thus, Ms. Ivers s cause of action is not preempted. 2. Illinoza Tort Law Does Not Create an Obstacle to Federal Law Requirements Because Congress Objectives are Not Further Burdened by Complying with Both State and Federal Requirements. Illinoza tort law requires compliance with federal law, but does not create an obstacle to the federal law requirements. As this Court has consistently held, a state law may be preempted if it stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress. Hines v. Davidowitz, 312 U.S. 52, 67 (1941). This Court has long held that there is an inherent assumption that the historic police powers of the States are not superseded unless that was the clear and manifest purpose of Congress. Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947). See also Arizona v. United States, 567 U.S. 387, 400, 132 S. Ct. 2492, 2501 (2012). In Levine, this Court rejected a drug manufacturer s argument that compliance with a state law duty would interfere with Congress purpose of entrusting an expert agency with drug labeling decisions. 555 U.S. at 556. Further rejecting the manufacturer s argument, this Court stated that if Congress believed state laws would create an obstacle to its objectives, Congress would have enacted an express preemption provision. Id. at 567. Therefore, this Court found that state common-law suits continued unabated despite FDA regulation. Id (citing Riegel v. Medtronic, Inc., 552 U.S. 312, 340 (2008) (Ginsburg, J., dissenting). This is of paramount importance when considering that Congress did in fact create an express preemption for medical devices. See 21 U.S.C.S. 360k. Furthermore, this Court found that the FDA traditionally regarded state law as a 10

complementary form of drug regulation, which parallels Congress decision to not expressly preempt state tort suits. Levine, 555 U.S. at 578. No obstacle preemption exists in the present case because enforcing both state and federal law does not place an extra burden on FDA or FDCA s requirements, as the laws are in compliance with one another. In Levine, this Court noted that it was unpersuaded by a drug manufacturer s argument that failure-to-warn claims like [plaintiff s] obstruct the federal regulation of drug labeling. 555 U.S. at 573-75, 581. Similarly, in Fulgenzi, the Sixth Circuit stated that [i]t is hard to see how permitting state tort suits to go forward against samenessviolating generic defendants frustrates federal policies where permitting suits against FDAcompliant branded defendants does not. 711 F.3d at 586 (citing Levine, 555 U.S. at 573-75). 3. The Pertinent Tort Law in Illinoza Differs from Tort Law in Other States Where Courts Have Found Preemption. As the Twelfth Circuit noted, Illinoza has not addressed the parameters of unreasonable warnings, but instead follows the Restatement of the Law, Third: Products Liability ( Third Restatement ). R. at 15, n.7. The Third Restatement contends that to establish a design defect, the plaintiff must demonstrate that a reasonable alternative design existed, which the manufacturer could have used, but failed to do so. Restatement (Third) of Torts: Products Liability, 2(b). Specifically, a product: (b) is defective in design when the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design and the omission of the alternative design renders the product not reasonably safe; (c) is defective because of inadequate instructions or warnings when the foreseeable risks of harm posed by the product could have been reduced or avoided by the provision of reasonable instructions or warnings and the omission of the instructions or warnings renders the product not reasonably safe. 11

Id. at 2(b) (c) (emphasis added). Furthermore, unlike the Restatement of the Law, Second: Products Liability s ( Second Restatement ), the Third Restatement makes a specific provision for prescription drugs. Id. at 6(c). In that section, the drafters of the Third Restatement addressed preemption regarding prescription drugs. Id 6 cmt. b. The drafters carefully stated, [L]iability cannot attach if the manufacturer has complied with the applicable federal standard. Id. Meaning, if a generic manufacturer complied with federal law, state tort liability would not be available to plaintiffs. See id. Thus, taking the Third Restatement s approach into consideration, the state s duty to warn exists separately from that of federal law. In contrast, this Court found preemption in Bartlett because New Hampshire used the Second Restatement s risk/utility analysis for design defects. 133 S. Ct. at 2472. See, Michael J. Wagner & Laura L. Peterson, The New Restatement (Third) of Torts - Shelter from the Product Liability Storm for Pharmaceutical Companies and Medical Device Manufacturers?, 53 Food Drug L.J. 225, 232 (1998) (discussing that a majority of courts use the case-by-case risk/benefit analysis, which asks, if the risk in using a drug outweighs the benefit it brings to the user, then the drug is defective, and the manufacturer is strictly liable for any injury to the user ). The Second Restatement s test requires balancing the drug s usefulness, the feasibility of an alternative design, and the presence and efficacy of a warning to find whether a manufacturer is liable under state law. Bartlett, 133 S. Ct. at 2472. The generic manufacturer in Bartlett correctly claimed that federal law prohibited them from unilaterally changing their label. Id. As such, that manufacturer argued that New Hampshire law was preempted because it was unable to take the necessary remedial action to not subject itself to New Hampshire s product liability laws. Id at 2470. Namely, to revise its label to include warnings not provided in the name-brand manufacturer s label. Id. This Court agreed with the defendant only because New Hampshire 12

required to be on the positive side of the balancing inquiry was preempted by federal law, since a generic s manufacturer was disallowed from making independent changes to its design and label. Id. at 2470, 2473. In other words, New Hampshire s legal test required a very subjective balancing of a drug s benefits to its detriments. Id. Specifically, New Hampshire found that the drug in that case possessed more negative attributes than benefits, hence, the manufacturers were required to update its label to reflect this danger. Id. This court found preemption because a general manufacturer is disallowed from making independent changes to its design and label, and that was exactly what the state of New Hampshire purported to do. Id. Illinoza does not use such a balancing test. Instead, a plaintiff must show that a reasonable alternative design was available to the manufacturer, and that the manufacturer then failed to implement it. Restatement, 2, 6. Additionally, the fact that Westerly violated federal law is neither necessary nor sufficient to establish liability under Illinoza s product liability statute. Instead, Illinoza law requires a showing of a reasonable alternative design, which in this case, Ms. Ivers simply contends is the label adopted by the RLD. See Restatement, 2(b) (c); R. at 2 3, 14 15. Hence, Illinoza law is not different from federal law because the reasonable alternative design is the same design approved by the FDA. R. at 2 3. Moreover, Illinoza law does not create an additional requirement to the federal requirements, because an alternative design is first needed to make a cause of action viable. See Riegel, 128. S. Ct. at 1011 (stating that state tort lawsuits are only preempted to the extent that they are different from, or in addition to federal requirements). In the present case, the alternative design was introduced into the marketplace by the name-brand manufacturer that Westerly was mandated to mirror. R. at 2 3. Therefore, because it was not impossible for Westerly to comply with both federal and state law, nor was Illinoza law an obstacle to federal law, Ms. Ivers s claim is not preempted by federal law. 13

B. Ms. Ivers is Entitled to Recovery Because Westerly Failed to Update the Label Within a Reasonable Amount of Time. This court should reverse the trial court s finding and hold that Westerly s failure to update was unreasonable for two key reasons: first, Westerly had one-year s notice of the drug s risk, yet it failed to update the label, which is a violation of both federal and state law; and, second, to hold otherwise would allow manufacturers to freely act negligently at the cost of society s well-being. 1. Westerly s Failure to Update was Unreasonable and Westerly s Violation of Federal and State Law Injured Ms. Ivers. A generic manufacturer is not allowed to unilaterally change their label. However, the general manufacturer is nonetheless required to update their label to match the RLD if the namebrand manufacturer makes any changes to the label. Bartlett, 133 S. Ct at 2476; Mensing, 131 S. Ct. at 2575. The generic manufacturer is responsible for the accuracy and adequacy of its label. 21 U.S.C. 355(b)(1). In order to comply with its duty of sameness, the FDCA imposes the duty on a manufacturer to review all reports of adverse drug experiences received from any source. 21 C.F.R. 314.80(b). The FDCA gives this duty paramount importance, amending the statute in 2007 to require updated safety information, even after the NDA has been approved. See 21 U.S.C. 355. This revision also allows the FDA to require manufacturers to change their labels. Id. Regarding new safety risks and when the label should be updated, the FDA mandates that labeling shall be revised to include a warning as soon as there is reasonable evidence of an 14

association of a serious hazard with a drug. 21 C.F.R. 201.57(c)(6)(i) (emphasis added). As the record states, on January 2011 one whole year before Westerly submitted its CBE GlaxoCline requested to add an additional warning which stated in part that 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. R. at 2 3. Thus, since January 2011, reasonable evidence indicated a serious hazard with rodipope. The FDA agreed and approved GlaxoCline s updated label. Id. Yet, Westerly inexplicably failed to update its own label, six months after the FDA approved the new warning. Id. As the court below noted, the relevant federal statutes do not give a bright-line rule for when a label should be updated. R. at 15. However, to illustrate the unreasonableness in the delay, it is informative to review the FDA s Manual of Policy and Procedures, where it does prescribe a deadline for updating. 1 In situations when a name-brand manufacturer is in the process of updating its label, a generic manufacturer may still obtain an ANDA (with that namebrand manufacturer as the RLD). Id. However, the generic manufacturer must update its label within two months from when the RLD updates its label. Id (stating that the ANDA holder must submit a Supplement Changes Being Effected containing the revised labeling no later than 60 days ). In the present case, Westerly failed to update by a time period more than three times from what is allowed in similar situations. R. at 2 3. Westerly s ANDA approval was predicated on its duty of sameness. 21 C.F.R. 314.150(b)(10). Therefore, if the approval of a new ANDA requires it to be updated within two months, when the name-brand manufacturer is in the process 1 OFFICE OF GENERIC DRUGS, GENERIC DRUG LABELING REVISIONS COVERED UNDER SECTION 505(J) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT (2013), available at http://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco /CDER/ManualofPoliciesProcedures/UCM339381.pdf 15

of revising the label, the failure to update six months after the updated RLD is approved, is unequivocally unreasonable. 2. If this Court does not find that Westerly s failure to update was unreasonable, then generic manufacturer s will have no incentive to update their labels. As established above, the harmful side effects that harmed Ms. Ivers s were known, by the most conservative of estimates, to GlaxoCline for at least one whole year before Westerly even attempted to update its label. R. at 2-3. Furthermore, federal law is equally clear regarding the manufacturer s duty of sameness in relation to the RLD, 21 U.S.C. 355(j); 21 C.F.R. 320.1(c), and the duty to review all reports of adverse effects the drug may have on individuals. 21 C.F.R. 314.80(b). Therefore, this Court should not excuse Westerly s failure to follow its necessary federal duties, which are the basis for its permission to manufacture ropidope in the first place. The Twelfth Circuit briefly described the statutory process by which a drugs label may be updated. (See R. at 12-15.) However, some important information failed to be considered by both the trial and appellate court. The trial court refers to the process that GlaxoCline used to update its label as a Supplemental New Drug Application ( snda ). R. at 2. It refers to Westerly s process, in contrast, as going through a Changes Being Effected ( CBE ). R. at 2-3. However, the process that both GlaxoCline and Westerly, specifically, used was the CBE. The relevant statute, titled Supplements and Other Changes to an Approved Application, creates an exception for certain changes that normally require prior approval before distribution. 21 C.F.R. 314.70(b)(2)(v)(A). One such exception is for labeling changes 16

to show newly acquired information. 21 C.F.R. 314.70(b)(2)(v)(A), (c)(6)(iii). Under that exception, once GlaxoCline submitted its CBE to the FDA on January 2011, GlaxoCline needed to wait only thirty (30) days before it was allowed to start distribution using the new label. 21 C.F.R. 314.70(b)(2)(v)(A); 21 C.F.R. 314.70(c)(6)(iii). It is important to note that GlaxoCline could have started distribution even though FDA approval was not official until June 2011. See id. R. at 2. Based on the record GlaxoCline could have started production as early as February 2011, and yet, Westerly failed to implement the revised label until February 2012. R. at 2-3.; 21 C.F.R. 314.70(b)(2)(v)(A); 21 C.F.R. 314.70(c)(6)(iii). Such a situation is exactly why Congress implemented the manufacturer s duties to stay informed and mirror the name-brand drug at all times. 21 U.S.C. 355(b)(1); 21 U.S.C. 355(j); 21 C.F.R. 314.80(b). Such provisions were adopted to avoid situations where the name-brand manufacturer took affirmative steps to make the RLD safer, however, the generic manufacturer disregards the changes, to the detriment of society. It is important to note that the process to update a label is the same for the name-brand manufacturer and the generic manufacturer. Under Supplements and other changes to an approved ANDA, the statute clearly states that an applicant must comply with the requirements of 314.70 and 314.71 regarding the submission of supplemental ANDAs and other changes to an approved ANDA. 21 C.F.R. 314.97(a). Because the same process of 21 C.F.R. 314.70 applies to the generic manufacturer, the exception for prior approval for revised labeling is available to them as well. See id. Obviously, the CBE becomes available to the generic manufacturer only once the name-brand manufacturer implements the updated label. See Mensing, 564 U.S. at 624. Similarly, the revisions that the generic manufacturer can make are 17

only those that the name-brand manufacturer has already made. 21 U.S.C. 355(j)(2)(A)(v) and 21 C.F.R. 314.94(a)(8). Therefore, a generic manufacturer who wishes to abide by federal regulations, should submit its own CBE once a name-brand manufacturer has revised its label. Then, after the CBE is submitted to the FDA, the manufacturer must wait the allotted thirty (30) days of notice pass, at which point the manufacturer may begin distribution of the drug with the revised label. 21 U.S.C. 314.70, 314.97. It is evident from the record that Westerly possessed the same interpretation of the previously stated information. The record states that in January 2012, Westerly submitted a Changes Being Effected (CBE) notification to the FDA notifying the agency that it would be updating its ropidope labels effective as of February 1, 2012. R. at 2-3. (Emphasis added). Unlike the name-brand manufacturer who from the record appears to have waited to start distribution until after FDA approval Westerly demonstrated it possessed the knowledge that once GlaxoCline s label was updated, Westerly could use a CBE to revise it label to match. R. at 2-3. Westerly also appears to possess the knowledge that it could update its own label without the explicit approval of the FDA. See id. In other words, Westerly knew that by sending the notification to the FDA, Westerly was free to update the label after thirty days passed (unless it received an express rejection from the FDA). R. at 2-3.; 21 C.F.R. 314.70(b)(2)(v)(A), (b)(c)(6)(iii). Therefore, this Court should hold that Westerly unreasonably failed to update its label. Had Westerly submitted its CBE once GlaxoCline began distribution of the updated label on June 2011, Westerly would have been able to start distribution by July 2011. R. at 2-3. See 21 C.F.R. 314.70(b)(2)(v)(A); 21 C.F.R. 314.70(b)(c)(6)(iii). As the record shows Ms. Ivers 18

began developing the harmful side-effects beginning in July 2011. R. at 3. If Westerly had simply followed the law, Ms. Ivers s would not have been injured. Id. Thus, for this Court to hold otherwise would allow manufacturers to harm society by eroding the manufacturer s duty to update beyond recognition. If this Court does not find Westerly s failure to update unreasonable, it will be sanctioning generic manufacturers who fail to update their label for one year even though the dangers of their drug are known to them while also deeming an inexplicable failure to update as reasonable. C. Westerly s Far-Reaching Interpretation of Preemption Purports to Expand Preemption to Unprecedented Realms. If Westerly s expansive interpretation of preemption is accepted, federal preemption will infringe upon realms that have never before been preempted, such as this Court s duty-to-warn decision in Levine. Specifically, Westerly claims that because federal law prevents generic manufacturers from unilaterally changing their labels, state tort claims are thus preempted. R. at 5. However, Defendant s argument mischaracterizes established law since a complaint alleging a violation of a federal statute as an element of a state cause of action is nonetheless a state law, and not a federal law claim. Merrell Dow Pharm. Inc. v. Thompson, 478 U.S. 804, 817 (1986). In other words, just because a state law claim may implement the fact that the Defendant was also in violation of federal law, does not make the claim a federal cause of action. See id. In concocting their argument, Westerly relies on Morris v. PLIVA, Inc. to reason that Ms. Ivers s claim is preempted. See Morris, 713 F.3d 774, 775 (5th Cir. 2013). R. at 14 15. That case, however, is inapposite to the present case. The Morris plaintiff alleged that even if the generic manufacturer had properly updated its label, the updated name-brand s label was also inadequate. 713 F.3d at 777. Therefore, the court held that that there could be no tort liability for failure to attach an inadequate label. Id. In the present case, however, Ms. Ivers does not 19

contest that the RLD s label was adequate. R. at 13. Even assuming arguendo that the facts are similar, Westerly s reliance on that case is questioned by the fact that the Morris plaintiff did not even plead the issue that the general manufacturer failed to update its label. Id. The Fifth Circuit addressed the issue only in dicta. Id. (stating no such claim appears in Appellants' live pleading. ). Even still, the persuasiveness of that opinion should be questioned, considering the court gave no explanation in its opinion as to why the claims where preempted. 713 F.3d at 777. The Fifth Circuit has twice repeated its position in Morris, and twice failed to substantiate its reasoning. See Johnson v. Teva Pharm. USA, Inc., 758 F.3d 605, 612 (2014); Lashley v. Pfizer, Inc., 750 F.3d 470, 475 (2014) (per curiam). Even if the court had properly stated its reasoning, the court also found additional deficiencies with the statements the plaintiffs requested from the updated label. Id. The Fourth District Court of Appeals in California specifically addressed the Morris court and stated: We respectfully believe Morris v. Pliva, Inc. was incorrectly decided. The Supreme Court in Mensing, 131 S.Ct. at 2576, held that a generic drug manufacturer's Dear Doctor letter contain[ing] substantial new warning information would not be consistent with the drug's approved labeling, and would therefore violate the duty of sameness. Mensing does not preempt a claim that a generic drug manufacturer failed to send a Dear Doctor letter containing the same information that is on the RLD s approved label. The contrary conclusion of Morris v. Pliva, Inc. is supported by neither the language nor the rationale of Mensing. Teva Pharm. USA, Inc. v. Superior Court, 217 Cal. App. 4th 96, 114-15, 158 Cal. Rptr. 3d 150, 163-64 (2013) (internal citation omitted) (emphasis added). See also In re Reglan Litig., A-2014-13T4, 2014 WL 5840281, at *6 (N.J. Super. Ct. App. Div. Nov. 12, 2014), aff'd, 226 N.J. 315, 142 A.3d 725 (2016) ( We are convinced, however, that the reasoning in Fulgenzi is more persuasive than that in Morris). Also of importance to note, the Fifth Circuit opinion that Westerly relies on did not even adopt its own rationale. See In re Hearn, 376 F.3d 447, 453 n.5 20

(5th Cir. 2004) (Fifth Circuit decisions should not be read as adopting alternative rationales or holdings unless they are clearly expressed. ). Instead, the more persuasive interpretation of this Court s precedent is that a claim based on traditional state-tort-law principles that parallels federal safety requirements but does not exist solely by virtue of federal law is not preempted. Fulgenzi, 711 F.3d at 586 (quoting Buckman, 531 U.S. at 353) (internal citations omitted). This corresponds with the FDCA, since generic manufacturers who do not promptly update their labels risk losing their ANDA. 21 C.F.R. 314.150(b)(10). To preempt such causes of action would entirely contradict the FDA s priorities. This Court has already expressed its agreement with this position when it held that the FDA has limited resources to monitor the 11,000 drugs on the market and failure to warn actions like the ones at hand lend force to the FDCA's premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times. Levine, 555 U.S. at 578 579. Therefore, to adopt Westerly s proposed preemption doctrine would allow the authority of generic manufacturers to remain unchecked. Even further, it would free the manufacturers of any sort of repercussions for their failure to follow simple requirements, such as the requirement to mirror the name-brand manufacturer s label. To hold otherwise would deteriorate the purpose of both the FDA and the FDCA, especially since Westerly was only permitted to sell its product on the condition that it mirror its brand-name equivalent. To avoid expanding preemption to unprecedented and unjustifiable lengths, this Court should reverse and remand, and find Ms. Ivers s claim to not be preempted. III. WESTERLY IS NOT ENTITLED TO ATTORNEY S FEES BECAUSE RULE 41(D) DOES NOT PERMIT RECOVERY OF SUCH FEES. Ms. Ivers is not obligated to pay Westerly s attorney s fees under Federal Rule of Civil Procedure 41(d). The plain language of the Rule only permits an award of the costs, not 21

attorney s fees, of a prior action where a plaintiff who previously dismissed an action in any court files an action based on or including the same claim against the same defendant. Federal Rule of Civil Procedure 41. Additionally, this Court s precedent strongly indicates the same. See Key Tronic Corp. v. United States, 511 U.S. 809, 814 (1994). Therefore, under both this Court s established law and the text of Federal Rules of Civil Procedure and Rule 41(d), the decision to extract attorney s fees from Ms. Ivers s already depleted savings should be reversed attorney s fees should not be granted under Rule 41(d). A. Awarding Westerly Attorney s Fees is Inconsistent with This Court s Precedent. This Court s precedent establishes that attorney s fees are not awarded under the circumstances presented in this case. A bedrock principle of the United States legal system is the American Rule, reaffirmed by this Court in Hardt v. Reliance, holding that each litigant pay[] his own attorney s fees, win or lose, unless a statute or contract provides otherwise. Baker Botts L.L.P. v. ASARCO LLC, 135 S. Ct. 2158, 2164 (2015) (quoting Hardt v. Reliance Standard Life Ins. Co., 560 U.S. 242, 252-253 (2010)). When a statute potentially invades the common law American Rule, the statute is to be read with a presumption favoring the retention of long-established and familiar legal principles. See Baker Botts, 135 S. Ct. at 2164 (citing Fogerty v. Fantasy, Inc., 510 U.S. 517, 534 (1994)). Thus, straying from the American Rule without strong evidence that Rule 41(d) includes an award attorney s fees would be improper. Further, this Court s precedent firmly establishes attorney s fees generally are not a recoverable cost of litigation absent explicit congressional authorization. Key Tronic, 511 U.S. at 814 (citing Runyon v. McCrary, 427 U.S. 160, 185 (1976)). Rule 41(d) omits a provision providing for an award of attorney s fees, which is required to award such fees unless the underlying substantive statute provides otherwise. Marek v. Chesny, 473 U.S. 1, 8 9 (1985); see 22