No UNITED STATES SUPREME COURT ALICE IVERS, Petitioner, WESTERLY PHARMACEUTICAL, INC., Respondent

Transcription

1 No UNITED STATES SUPREME COURT ALICE IVERS, Petitioner, v. WESTERLY PHARMACEUTICAL, INC., Respondent On Writ of Certiorari to the United States Court of Appeals for the Twelfth Circuit BRIEF OF RESPONDENT Team #2620 Counsel for Respondent

2 STATEMENT OF ISSUES I. Whether this Court s decisions in PLIVA v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical v. Bartlett, 133 S. Ct (2013), preempt the Petitioner s claims in this case? II. Whether attorney s fees are considered awardable costs under Federal Rule of Civil Procedure 41(d)? i

3 TABLE OF CONTENTS STATEMENT OF ISSUES... i TABLE OF CONTENTS... ii TABLE OF AUTHORITIES... iii STATEMENT OF THE CASE... 1 SUMMARY OF THE ARGUMENT... 2 ARGUMENT... 4 I. MENSING AND BARTLETT PREEMPT PETITIONER S CLAIM BECAUSE COPMLIANCE WITH BOTH ILLINOZA PRODUCTS LIABILITY LAW AS WELL AS THE FDA S GUIDELINES IS NOT FEASIBLE, AND IN SUCH SITUATIONS STATE LAW MUST GIVE WAY TO FEDERAL LAW, WHICH WESTERLY WAS IN COMPLIANCE WITH THROUGH ITS INSTATING OF THE UPDATED LABEL II. THE TERM COSTS IN RULE 41(d) DOES INCLUDE ATTORNEY S FEES BECAUSE SUCH AN INTERPRETATION IS CONSISTENT WITH THE UNDERLYING PURPOSE OF RULE 41(d) AND THE ACCEPTED INTERPRETATION OF RULE 41(a)(2) A. Costs under Rule 41(d) include attorney s fees because the underlying purpose of the Rule is to deter forum shopping B. Because Rule 41(a)(2) has been found to include payment of attorney s fees, Rule 41(d) must also include attorney s fees in order to avoid inconsistent interpretations within the same Rule CONCLUSION ii

4 TABLE OF AUTHORITIES Federal Cases Alyeska Pipeline Service Co. v. Wilderness Society, 421 U.S. 240 (1975) Behrele v. Olshansky, 139 F.R.D. 370 (W.D. Ark. 1991) Bell v. Pfizer, Inc., 716 F.3d 1087 (8th Cir. 2013)... 6 Bell v. Wyeth, 117 F.Supp.3d 1555 (M.D. Ala. 2015)... 8 Caldwell v. Wells Fargo Bank, N.A., 2014 WL at *6 (N.D. Cal. 2014) Esposito v. Piatrowski, 223 F.3d 497 (7th Cir. 2000) , 14 Esquivel v. Arau, 913 F. Supp (C.D. Cal 1996)... 13, 15, Freightliner Corp. v. Myrick, 514 U.S Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013)... 8 Key Tronic Corp. v. United States, 511 U.S. 809 (1994)... 12, 14 LeCompte v. Mr. Chip, Inc., 528 F.2d 601 (5th Cir. 1976) Marek v. Chesny, 473 U.S. 1 (1985) Morris v. PLIVA, Inc., 713 F.3d 774 (5th Cir. 2013)... 2, 3 Mut. Pharm Co. v. Bartlett, 133 S.Ct (2013)... 5, 6, 7, 8 Ortega Trujillo v. Banco Central Del Ecuador, 379 F.3d 1298 (11th Cir. 2004) PLIVA, Inc. v. Mensing, iii

5 564 U.S. 604 (2011)... 5, 6 Rogers v. Wal-Mart Stores, Inc., 230 F.3d 868 (6th Cir. 2000) Simeone v. First Bank National Association, 971 F.2d 103 (8th Cir. 1992) Steinert v. Winn Group, Inc., 440 F.3d 1214 (10th Cir. 2006) Stevedoring Services of America v. Armilla Intern. B.V., 889 F.2d 919 (9th Cir. 1989) Wyeth v. Levine, 555 U.S. 555 (2009)... 6 Federal Statutes 21 U.S.C. 355 (2012)... v, 5 Rules Fed. R. Civ. P Fed. R. Civ. P Other 21 CFR , (C)... 6 Edward X. Clinton, Jr. Does Rule 41(d) Authorize an Award of Attorney s Fees?, 71 St. John s L. Rev. 81, 81 (1997) East Texas Code Annotated (a)... v Illz. Prod. Liability Act (1)...v, 5 U.S. Const., art. VI, cl v, 4 iv

6 U.S. Const., art. VI, cl. 2 providing that: CONSTITUTIONAL PROVISIONS This Constitution, and the Laws of the United States which shall be made in Pursuance thereof shall be the supreme Law of the Land any Thing in the Constitution or Laws of any State to the Contrary notwithstanding. STATUTORY PROVISIONS East Texas Code Annotated (a), providing: (a) In actions for personal injury, where plaintiff s claim for damages exceeds twentyfive thousand dollars ($25,000) and includes a written demand for fees, there shall be taxed and allowed to the plaintiff, as part of the costs of the action, a reasonable amount to be fixed by the court as attorney s fees. Illinoza Products Liability Act (1), providing that: [Relief may be provided] upon showing that a manufacturer s product was unreasonably dangerous due to (a) manufacturing defect (b) defective design (c) inadequate instructions or warnings, or (d) failure to conform to an express warranty. 21 U.S.C. 355(j)(2)(A)(v), providing: (j) Abbreviated new drug applications. (2) (A) An abbreviated application for a new drug shall contain (v) information to show that the labeling proposed for the new drug is the same as the labeling approved for the listed drug referred to in clause (i) except for changed required because of difference approved under a petition filed under subparagraph (C) or because the new drug and the listed drug are produced or distributed by different manufacturers; v

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

8 STATEMENT OF THE CASE The present appeal revolves around a generic drug manufactured by the Respondent, Westerly Pharmaceutical, Inc. ( Westerly ). Westerly produces generic ropidope hydrocholride ( ropidope ) in an attempt to provide low cost relief to persons who suffer from Parkinson s disease. (R. at 2.) GlaxoCline, LLC was the original producer of brand name ropidope, Equip, and began to market the new drug in 1997 after receiving approval from the Federal Drug Administration (FDA). (R. at 2.) Upon the expiration of GlaxoCline s patent, Westerly submitted an Abbreviated New Drug Application (ANDA) to the FDA and began selling its generic version in (R. at 2) In June of 2011, the FDA approved proposed changes to the Package Insert and labeling of Equip made by GlaxoCline. (R. at 2.) GlaxoCline proposed these changes, including a new paragraph under the Warnings and Precautions section in January of 2011, when they submitted a Supplemental New Drug Application (snda) to the FDA. (R. at 2.) This new paragraph included warnings regarding compulsive behaviors. (R. at 2.) Alice Ivers, ( Petitioner ), was prescribed ropidope in February, 2011 after being diagnosed with Parkinson s disease. (R. at 1.) She began taking Westerly s generic form of the drug in March of (R. at 1.) In July of the same year, Petitioner began to exhibit compulsive spending and gambling behaviors, including the continuous playing of online poker. (R. at 3.) She further proceeded to spend the funds she made and regrettably depleted her savings. (R. at 3.) Petitioner contends that the side effects of ropidope caused her to exhibit these compulsive behaviors. (R. at 3.) Prior to GlaxoCline requesting and receiving approval to change its label to add the warnings about compulsive behaviors, the labeling on Westerly s generic ropidope had been 1

9 identical to the approved brand-name drug. (R. at 2.) In January of 2012, after GlaxoCline s snda was approved, Westerly submitted a Changes Being Effected (CBE) notification to the FDA that it would be updating its labels to match the new label for Equip. (R. at 2-3.) Those changes came into effect in February of (R. at 3.) Petitioner originally filed suit against Westerly in the Western District of East Texas under East Texas Product Liability Law. (R. at 6.) However, after the Fifth Circuit s decision in Morris v. PLIVA, Inc., 713 F.3d 774, 777 (5th Cir. 2013), Petitioner promptly filed her Notice of Voluntary Dismissal pursuant to Federal Rule of Civil Procedure 41(a). (R. at 6.) Petitioner then filed this suit against Westerly in the state court of Illinoza on September 15, 2015, alleging that Westerly breached its duty under of care under the Illinoza Products Liability Act. (R. at 1.) Respondent removed the case to the United States District Court of Illinoza on October 14, (R. at 3.) The District Court dismissed the complaint as preempted by federal law, granting Westerly s Motion for Judgment on the Pleadings, and ordered Petitioner to pay Respondent s costs accrued in the course of the prior East Texas litigation with the exception of attorney s fees. (R. at 5, 7.) Petitioner timely appealed and the Twelfth Circuit Court of Appeals affirmed the District Court s decision in regards to the judgment on the pleadings and affirmed Westerly s award of costs. (R. at 9-10.) Additionally, the court reversed the order of the district court, finding that costs under Rule 41(d) should include attorney s fees. (R. at 10.) SUMMARY OF THE ARGUMENT The Twelfth Circuit s dismissal of the Complaint and award of costs and attorney s fees to Respondent should be affirmed because Petitioner s claim is preempted by federal law and an award of attorney s fees is consistent with the Federal Rules of Civil Procedure. 2

10 Supreme Court precedent handling whether claims against generic drug manufacturers are preempted by federal law has held that such claims are preempted by FDA and FDCA regulations. These claims have been held to be preempted because it is impossible for the generic drug manufacturer to comply with its state law duty to strengthen its warnings and the federal law duty not to alter its label. In the case at issue, Petitioner alleges that Westerly negligently failed to warn of side effects and that this failure caused the alleged experienced harm. Westerly could not change the warning label until after GlaxcoCline changed theirs without being in breach of federal law. It is noteworthy that Westerly did issue a changes being effected (CBE) which put the public on notice of the impending label changes. Petitioner s situation differs from those situations where failure-to-update claims were deemed sufficiently narrow to escape preemption. Petitioner continued to take the drug for a year after being put on notice through Westerly s CBE, and thus it cannot be proved that Westerly s alleged failure-to-update ropidope s label was the proximate cause of Petitioner s symptoms. Additionally, existing case law relied on by Petitioner does not address the reasonableness standard in the realm of state law and preemption analysis, which is the basis of Petitioner s claim, but rather deals with violation of the duty of sameness. Ultimately, because Illinoza Products Liability Law conflicts with the Food and Drug Cosmetic Act, the decision of the lower court in granting Westerly s Motion for Judgment on the Pleadings should be affirmed. Additionally, the Court of Appeals correctly granted Respondents an award of attorney s fees pursuant to Federal Rule of Civil Procedure 41(d). The underlying purpose of the Rule is to prevent the practices of forum shopping and vexatious litigation and thus an award of attorney s fees is proper to avoid undue prejudice to defendants such as Westerly in this case. Petitioner engaged in blatant forum shopping when she voluntarily dismissed her complaint following the 3

11 decision in Morris v. PLIVA, Inc., 713 F.3d 774 (5th Cir. 2013), a decision which would have caused her case against the Respondents to be dead on arrival. An award of attorney s fees would further the goals of 41(d), which is to deter further instances of the type of forum shopping on display in the present case. Furthermore, authorizing awards of attorney s fees under Rule 41(d) would create consistency within Rule 41. It is generally agreed that Rule 41(a)(2) implicitly allows the award of attorney s fees despite a lack of explicit authorization in the Rule. This is because of the Rule s goal to reduce the prejudice to defendants when a plaintiff dismisses a case. Due to the exceptional variation within the Federal Rules as to the meaning of costs, this implicit authorization of an award of attorney s fees in Rule 41(a)(2) supports alignment with Rule 41(d). ARGUMENT I. MENSING AND BARTLETT PREEMPT PETITIONER S CLAIM BECAUSE COPMLIANCE WITH BOTH ILLINOZA PRODUCTS LIABILITY LAW AS WELL AS THE FDA S GUIDELINES IS NOT POSSIBLE AND IN SUCH SITUATIONS STATE LAW MUST GIVE WAY TO FEDERAL LAW, WHICH WESTERLY WAS IN COMPLIANCE WITH THROUGH ITS INSTATING OF THE UPDATED LABEL. Petitioner s claim that Westerly breached its duty under Illinoza products liability law by failing to warn about possible side effects of ropidope is preempted under federal law. Federal law prevented Westerly from updating ropidope s label until the original drug label was changed. After GlaxoCline changed Equip s labels, Westerly changed ropidope s within six months. Further, requiring generic drug manufacturers to stop production, marketing, and distribution efforts of generic drugs would frustrate the policy reasons for enacting the Hatch Waxman Act, primarily increasing access to drugs and encouraging pharmaceutical development of generic drugs. Therefore, the decision of the lower court in granting Westerly s Motion for Judgment on the Pleadings should be affirmed. 4

12 The Constitution s Supremacy Clause gives enacted federal law the preemptive position in regards to conflicting state laws. U.S. Const. art. VI, cl. 2. State laws that conflict with federal laws can be overridden both expressly and impliedly, and it has been held that state and federal laws conflict where it is impossible for a private party to comply with both federal and state requirements. See Freightliner Corp. v. Myrick, 514 U.S. 280, 287. The Food and Drug Cosmetic Act ( FDCA ) as amended by the Drug Price Competition and Patent Term Restoration Act, 98 Stat. 1585, commonly called the Hatch-Waxman Act, allows generic drugs to gain Food and Drug Administration ( FDA ) approval by showing equivalence to an already listed and approved drug. 21 U.S.C. 355(j)(2)(A)(2012). The FDCA allows generic drug manufactures to do this by completing an Abbreviated New Drug Application ( ANDA ) to market the generic drug after the patent expires, so long as it is the bioequivalent of the listed drug. 355(j)(2)(A)(iv). Additionally, federal law mandates that the labeling of the generic drug match that of the FDA approved label on the registered listed drug. Id. In the realm of state law tort suits, the Supreme Court has held that failure-to-warn claims against generic manufacturers are preempted by FDA and FDCA regulations. PLIVA, Inc. v. Mensing, 564 U.S. 604, 624 (2011). Under Illinoza products liability law, relief is provided upon showing that a manufacturer s product was unreasonably dangerous due to (a) manufacturing defect, (b) defective design, (c) inadequate instructions or warnings, or (d) failure to conform to an express warranty. Illz. Prod. Liability Act (1). State law claims which allege defects in the labeling of a generic drug have been held as preempted because it [is] impossible... to comply with both its state-law duty to strengthen the warnings... and its federal-law duty not to alter [its] label. Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466, 2473 (2013). 5

13 In Mensing, the Court rejected the argument that generic manufactures were liable under state law for failing to provide adequate warning labels. 564 U.S. at 624. The plaintiffs were given metoclopramide (generic Reglan), and, after taking the drug for several years, began to develop a severe neurological disorder that resembles Parkinson s disease. Id. at 610. The Court rejected their argument that the generic manufacturers were liable under state law for failing to provide adequate warning labels, and held both that the claims were preempted by federal law, given that only brand-name manufacturers can modify the information provided to physicians. Id. at 624. Additionally, in Bell v. Pfizer, Inc., the Eighth Circuit affirmed dismissal of a failureto-warn claim based on the generic manufacturer s alleged failure to incorporate a label change because the causal chain was broken. 716 F.3d 1087 (8th Cir. 2013). Similar claims against brand-name manufacturers may lead to a different result than those against generic manufacturers. In Wyeth v. Levine, the plaintiff was administered medicine for headaches through the IV-push method, as opposed to the IV-drip method. 555 U.S. 555 (2009). The plaintiff s claim alleged that the labeling was defective because it failed to warn and instruct medical personnel to use the IV-drip method, as opposed to the higher risk push method. Id. Her claim was premised on the theory that the brand-name drug manufacturer breached state law duty to provide an adequate warning label. Id. The Court held that the claim was not preempted, because it was possible for Wyeth, a brand name drug manufacturer, to unilaterally strengthen its warning without prior FDA approval through the Changes Being Effected ( CBE ) process. Id. at 573; see also 21 CFR (c)(6)(iii)(A), (C). The CBE process permitted the manufacturer to strengthen its warning, and FDA approval of the existing label does not conclusively establish that the FDA would not have approved the label change. 555 U.S. at

14 The Supreme Court further extended Mensing in Bartlett, where it held that federal pharmaceutical regulations also preempted state tort claims against generic manufacturers based upon design-defect theories. Bartlett, 133 S.Ct. at Contrary to failure-to-warn and designdefect claims against brand name drug manufacturers, which are not preempted because a manufacturer may alter its label without FDA approval, design-defect and failure-to-warn claims involving generic drugs have been held by the Court to be preempted because generic drugs are required to be identical in all respects to the brand name counterparts. Id. at In Bartlett, the Court held that state-law design-defect claims that turn on the adequacy of a drug s warnings are preempted by federal law under PLIVA. Id. at The plaintiff in Bartlett had been taking a drug whose label did not specifically refer to toxic epidermal necrolysis, but did warn about severe skin symptoms generally. Id at She suffered horrible effects from the drug through an acute case of toxic epidermal necrolysis, where more than half of the surface of her body was burned off or basically an open wound. Id. Despite the unfortunate outcome, the Court held that it was impossible for the manufacturer to comply with both its state-law duty to strengthen the warnings on [the drug s] label and its federal-law duty not to alter [the drug s] label. Id. at In determining whether the manufacturer could comply with both state-law duty and federal duty, the Court looked to New Hampshire tort law, which requires manufacturers to ensure that their products are not unreasonably dangerous. Id. at New Hampshire utilizes a risk-utility approach that evaluates whether a product is defective by weighing the magnitude of the danger against the utility of the product. Id. The court noted that increasing the usefulness of a product or reducing its risk of danger would require redesigning the drug[.] Id. at Redesign would be impossible here because the FDCA requires a generic drug to mirror the composition of the brand name counterpart. Id. Thus, federal law preempted the 7

15 manufacturer from taking the action required to avoid liability under New Hampshire law. Id. at Because federal law prevented an action that New Hampshire law required, the Court held that the state law was without effect. Id. (citing Maryland v. Louisiana, 451 U.S. 725 at 746). The Court additionally rejected plaintiff s argument that the manufacturer could avoid liability by choosing not to make the drug at all, deeming the stop-selling rationale in stark contrast with preemption doctrine because if the option of ceasing to act defeated a claim of impossibility, impossibility preemption would be all but meaningless. Id. at 2478 (citing Mensing, 564 U.S. at 621). In products liability cases, plaintiffs sometimes assert failure-to-update theories of liability. These failure-to-update theories may provide a way for claims to succeed if, under state tort law, the delay in updating the labels was unreasonable and was the proximate cause of injury. See, e.g., Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013). In Fulgenzi, the plaintiff had been taking metoclopramide, which is generic Reglan, starting in September 2004 and for over a year from to treat a reflux disease. Id. at 580. She alleged that the medicine led her to develop a neurological disorder that caused her to have involuntary facial movements. Id. In July 2004 and again in February 2009, the FDA approved labeling changes proposed by Schwarz Pharma, the manufacturer of Reglan, which the generic manufacturer PLIVA failed to incorporate. Id. The label changes were not instated the entire duration that the plaintiff was taking metoclopramide. Id. at 582. Because of the narrowness of the claim, the plaintiff succeeded in her theory that the delay in fulfilling the duty of sameness required by federal law was also unreasonable under state tort law, proximately caused her injuries, and was not preempted. Id. at 588. Crucial to the plaintiff s success was proving causation by showing that lack of adequate warnings contributed to her use of the product. Id. at 587. The court in Fulgenzi 8

16 said [a] plaintiff need not prove that the alternative warning would have been objectively reasonable, only that it would most likely have prevented the injury in this case. Id. at The narrowness of the holding of Fulgenzi is illustrated in Bell v. Wyeth, where the court refused to apply Fulgenzi, because Ms. Bell has not pled a failure-to-update claim sufficiently narrow to escape federal preemption. 117 F.Supp.3d 1555, 1363 (M.D. Ala. 2015). The issue at hand is similar to Mensing and Bartlett, and thus Petitioner s claim is preempted. Mensing and Bartlett show that failure-to-warn and design-defect claims against generic manufacturers are preempted by federal law. The claim in this case alleges that Westerly negligently failed to warn of side effects and that this failure proximately caused Petitioner to deplete her savings and engage in compulsive behavior. This is similar to the claims in Mensing and Bartlett, which allege that side effects were experienced that were not included on the drug s warning label. Because federal law prevents generic drug manufactures from changing their labels in conjunction with the holdings in Mensing and Bartlett, Petitioner s allegation that Westerly breached its state law duty by failing to alter its FDA label is preempted. It is important to note that while failing to alter the label is preempted, Westerly did take steps to issue warning to possible consumers about the pending label changes. Thus, this case is comparable to Wyeth v. Levine, where the plaintiff alleged that the brand-name manufacturer breached state law by failing to provide an adequate warning label. The Court held that because Wyeth had the option to strengthen its warning though the CBE process, that it was not impossible for Wyeth to comply with state and federal law. Here, although Westerly is a manufacturer of a generic drug, Westerly did issue a CBE, thus effectively taking a step to warn of the new pending label changes. 9

17 Illinoza s unreasonably dangerous state-law tort duty effectively prevents Westerly from taking measures to comply both with the statute and with federal law. Like the Court reasoned in Bartlett, application of the risk-utility approach to determine whether a product is defective would require redesigning the drug. Thus, compliance with the state tort duty while simultaneously adhering to federal law is not possible. In this instance, like Bartlett, the law requiring this action is without effect because compliance, only possible through redesign, would entail altering the composition of the drug. This would not be permissible because federal law mandates that the composition of generic drug be the bioequivalent of the name brand product. The Court in Bartlett also rejected the argument that the manufacturer could comply with federal and state law by choosing not to make the drug at all. This stop-selling rational is in stark contrast with preemption doctrine as well as the initiatives of the Hatch-Waxman Act, which sought to increase access to generic drugs and streamline the availability and production of such products. Here, under the risk-utility approach described in Bartlett, Westerly would have to halt production to comply. This is not the socially preferable course of action. Here, unlike the failure-to-update claim in Fulgenzi, Petitioner s claim is not sufficiently narrow to escape federal preemption. In Fulgenzi, the label changes were not instated the entire time that the plaintiff was taking the drug metoclopramide. In the present instance, the situation is very different. Petitioner continued to take ropidope for almost a year after Westerly submitted a CBE in January 2012 and consequently implemented label changes matching the newlyapproved label for Equip in February Additionally, the manufacturer in Fulgenzi failed to update its label to match the brand name drug. Here, it is not contested that Westerly did submit a CBE and a month later updated its label within six months of the FDA approving GlaxcoCline s ANDA. This poses problems in application of the test utilized in Fulgenzi. In 10

18 Fulgenzi, the plaintiff was able to prove that the delay in fulfilling the duty of sameness under federal law was unreasonable under state tort law, proximately caused her injuries, and was not preempted. In comparison to Petitioner s claim, many issues need to be addressed. First, state law reasonableness is not cohesive with federal law on label changes, and thus is not enforceable. Federal law prescribes a process for label changes that the generic manufacturer must follow. Fulgenzi does not address the reasonableness standard in the realm of state law and in context of preemption analysis, but rather deals with a failure-to-update claim and violation of the duty of sameness. The case at hand is distinguished on this basis, because Petitioner s claim contends that ropidope was unreasonably dangerous as a result of inadequate warnings. Also, even assuming that the analysis in Fulgenzi applies, it is not likely that six months is an unreasonable amount of time to issue a CBE and update drug labels to match GlaxcoCline s. As stated, Westerly complied with federal laws and thus obtained approval to sell ropidope with its given labels. In regards to proximate cause, because the CBE was issued in January 2012, after which petitioner continued to take ropidope, the causal chain is not clear. Because CBEs are issued for the purpose of notifying the public of changes that are in the process of being instated, it likely cannot be said that despite this public announcement, Petitioner is justified in asserting that her condition arises from her use of the drug. Such a conclusion would, in practice, provide remedies for ignorance of available information. Given the similarities between Mensing, Bartlett, and the case at issue, in conjunction with robust case law holding that state tort claims against generic drug manufacturers are preempted by federal law, Petitioner s claim is preempted. Here, it is impossible for Westerly to comply with federal and state law simultaneously. Additionally, state tort law conceptions of 11

19 reasonableness do not account for the federally mandated process. The cases relied on by Petitioner do not address the state-law reasonableness issue but rather deal with instances where generic manufacturers simply failed to update their warnings. Accordingly, the decision of the lower court in granting Westerly s Motion for Judgment on the Pleadings should be affirmed. II. THE TERM COSTS IN RULE 41(d) DOES INCLUDE ATTORNEY S FEES BECAUSE SUCH AN INTERPRETATION IS CONSISTENT WITH THE UNDERLYING PURPOSE OF RULE 41(d) AND THE ACCEPTED INTERPRETATION OF RULE 41(a)(2). Federal Rule of Civil Procedure 41 deals with the dismissal of actions from a court of law. Rule 41(d) provides that [i]f a plaintiff who previously dismissed an action in any court files an action based on or including the same claim against the same defendant, the court... may order the plaintiff to pay all or part of the costs of that previous action. Fed. R. Civ. P. 41(d). The Rule is completely silent as to the definition or scope of costs. Additionally, the Advisory Committee notes to Rule 41 do not comment on Rule 41(d), leaving the matter thoroughly unresolved. This has led to a split among the circuits as to whether Rule 41 allows for an award of attorney s fees as part of the costs mentioned in the Rule, with a majority of jurisdictions answering in the affirmative. Edward X. Clinton, Jr. Does Rule 41(d) Authorize an Award of Attorney s Fees?, 71 St. John s L. Rev. 81, 81 (1997). Here the term costs in Rule 41(d) should be found to include attorney s fees and the decision of the Court of Appeals should be affirmed. A. Costs under Rule 41(d) include attorney s fees because the underlying purpose of the Rule is to deter forum shopping. Awarding attorney s fees under the costs provision of Rule 41(d) conforms with the underlying purpose of the Rule, which is to prevent forum shopping and vexatious litigation. See Simeone v. First Bank National Association, 971 F.2d 103, 108 (8th Cir. 1992). Although the 12

20 traditional American Rule requires each party to a law suit to bear the cost of its own attorney s fees, the Supreme Court in Alyeska Pipeline Service Co. v. Wilderness Society, 421 U.S. 240 (1975) outlined three exceptions. Those exceptions were express statutory authority for the award of attorney s fees, bad faith, or willful disobedience of a court order. Id. at More recently, the Supreme Court has confirmed that the authorization for the award can be implicit. Key Tronic Corp. v. United States, 511 U.S. 809, 815 (1994). The underlying purpose of Rule 41 is often cited by courts which allow the award of attorney s fees under Rule 41(d) as a primary reason for their decision. See Esposito v. Piatrowski, 223 F.3d 497, 501 (7th Cir. 2000) (holding that recovery of attorney s fees under Rule 41(d) is allowed when the underlying statute defines costs to include such fees); Esquivel v. Arau, 913 F. Supp. 1382, 1391 (C.D. Cal 1996). In Esquivel, the plaintiff originally filed suit in the Southern District of New York, but then subsequently filed another action in the Central District of California. The New York suit was voluntarily dismissed under Rule 41(a)(1) and the defendants moved for an award of costs including attorney s fees. The court found that the defendants were entitled to both expenses and attorney s fees. In reaching their opinion, the court noted that a possible explanation for awards of attorney s fees under Rule 41(d) was that courts addressing the issue have implicitly recognized that Rule 41(d)... in cases where voluntary dismissal is sought in order to commence a subsequent action, are simply codifications of the bad faith or abusive litigation exception to the Alyeska rule. Esquivel, 913 F. Supp. at 1391 (citing Rocelle Dreyfuss, Promoting the Vindication of Civil Rights Through the Attorney s Fees Award Act, 80 Colum. L. Rev. 346, 349 n.22 (1980)). Additionally, in Esposito, the Seventh 13

21 Circuit noted that awarding attorney s fees as part of costs would advance the purpose of Rule 41(d). 1 Here, the Petitioner has engaged in exactly the sort of practice which Rule 41 was designed to prevent. Much like the plaintiff in Esquivel, the Petitioner voluntarily dismissed her action in order to bring an almost precisely similar case in a different jurisdiction. However, even more damning for the petitioner in the current case is the chronology of events leading up to the dismissal of the original action. The Fifth Circuit opinion Morris v. PLIVA, Inc., 713 F.3d 774 (5th Cir. 2013) was released on February 14, 2013, a mere eleven days before Petitioner filed her Notice of Voluntary Dismissal. 2 Morris held that the FDCA preempted a claim that was similar to Petitioner s, thus making it all but certain that Petitioner would not be able to succeed on her claim in that jurisdiction. Id. at 778. Even if Rule 41(d) and Rule 41(a)(2) were not implicitly recognized as exceptions to Alyeska as Esquivel suggests, Petitioner s conduct is a prime example of bad faith and forum shopping. As soon as it became apparent that she would be unable to win her suit in her original choice of venue, Petitioner abandoned ship, searching for greener pastures. Without the option of awarding attorney s fees to aggrieved parties in similar situations to Westerly under Rule 41(d), plaintiffs will be free to switch jurisdictions unilaterally in order to find the best fit, causing great financial harm to defendants along the way. Rule 41(d) would essentially be rendered ineffective as to its primary purpose. As the Western District of Arkansas eloquently stated, [s]urely, Congress intended that that provision of the federal rules have some teeth. Behrele v. Olshansky, 139 F.R.D. 370, 374 (W.D. Ark. 1991). 1 The Seventh Circuit differs, however, from the Central District of California as it follows the rule laid out in Marek v. Chesny, 473 U.S. 1, 9 (1985), that attorney s fees will only be awarded when the underlying statute defines costs to include such fees. 2 Petitioner filed her Notice of Voluntary Dismissal on February 25,

22 B. Because Rule 41(a)(2) has been found to include payment of attorney s fees, Rule 41(d) must also include attorney s fees in order to avoid inconsistent interpretations within the same Rule. Attorney s fees are also awardable as costs under Rule 41(d) because holding otherwise would create inconsistency within Rule 41. It would be inconsistent to award attorney s fees as a condition of voluntary dismissal under Rule 41(a)(2), but completely prohibit the awarding of such fees when a case that is voluntarily dismissed is refiled under Rule 41(d). Esposito, 223 F.3d at 501. The main argument against the inclusion of attorney s fees under Rule 41(d) is that the text of the Rule does not explicitly provide for those fees. See Rogers v. Wal-Mart Stores, Inc., 230 F.3d 868, 874 (6th Cir. 2000); Caldwell v. Wells Fargo Bank, N.A., 2014 WL at *6 (N.D. Cal. 2014) (quoting Banga v. First United States, N.A., 2010 U.S. Dist. LEXIS , at *14 (N.D. Cal. 2010). However, [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. The Federal Rules are incredibly inconsistent when assigning meaning to the term costs in different contexts. Esquivel, 913 F.Supp. at 1390 (discussing Rule 54(d)(1), Marek, and Rule 41(a)(2)). For example, many courts have interpreted the language of Rule 41(a)(2) 3 to allow district courts to impose the payment of attorney s fees as a condition of voluntary dismissal despite the absence of explicit authorization in the Rule. See Steinert v. Winn Group, Inc., 440 F.3d 1214, 1222 (10th Cir. 2006) (citing 9 Charles A. Wright & Arthur R. Miller, Federal Practice and Procedure 2366, at 309 (2d ed. 1995)); Ortega Trujillo v. Banco Central Del Ecuador, 379 F.3d 1298, 1302 (11th Cir. 2004); Stevedoring Services of America v. Armilla Intern. B.V., 889 F.2d 919 (9th Cir. 1989). An award of attorney s fees is considered permissible 3 Rule 41(a)(2) states in relevant part that an action may be dismissed at the plaintiff s request only by court order, on terms that the court considers proper. 15

23 under Rule 41(a)(2) because the Rule is designed to reduce the prejudice to defendants after a plaintiff has dismissed a case. LeCompte v. Mr. Chip, Inc., 528 F.2d 601, 603 (5th Cir. 1976). Another example of the Federal Rule s inconsistencies with the meaning of costs is Rule 54(d)(1), which states that taxable costs include Costs Other than Attorneys Fees. Fed. R. Civ. P. 54(d)(1). This construction would suggest that attorney s fees are typically included in the definition of costs. Here, because of the textual ambiguity plaguing the meaning of costs in the Federal Rules, a textual approach to the interpretation of Rule 41(d) is unhelpful. In both Rule 41(d) and Rule 41(a)(2) a defendant will accumulate potentially considerable expenses in paying to fight a litigation that will eventually be dismissed and moved to a separate jurisdiction. [I]t would be inconsistent to conclude that a court has discretion to condition Rule 41(a)(2) voluntary dismissal without prejudice on payment of attorney s fees, but that a court does not have discretion to exact the same payment from a plaintiff who has noticed... dismissal in a previous case. Esquivel, 913 F. Supp at 1391 (emphasis in original). Denying awards of attorney s fees under Rule 41(d) would thus deprive a wide swath of defendants of economic relief. By forcing defendants to pay the costs forced upon them by plaintiffs who decide to pursue a new venue for their cases, a textualist approach would create inordinate prejudice towards these defendants as they try to move forward and fight the case in the updated venue. It should be noted that by allowing awards of attorney s fees under Rule 41(d), district courts will still have the discretion as to when to grant such awards. By aligning the interpretation of Rule 41(d) with the widely accepted interpretation of Rule 41(a)(2), courts will have more options to ease the burden placed on defendants by plaintiffs who reinstitute dismissed cases. CONCLUSION 16

24 For the foregoing reasons, we respectfully request that this Court affirm the decision of the Court of Appeals dismissing the Petitioners complaint and awarding costs to the Respondents including attorney s fees. Respectfully Submitted, //s// Team #