Supreme Court of the United States

Transcription

1 No IN THE Supreme Court of the United States Alice IVERS, v. WESTERLY PHARMACEUTICAL, INC., Petitioner, Respondent. On Writ of Certiorari to the Twelfth Circuit Federal Court of Appeals BRIEF FOR RESPONDENT Attorneys for Respondent Team 2631

2 QUESTIONS PRESENTED I. Under this Court s federal preemption precedent including PLIVA, Inc. v. Mensing, is a failure-to-warn claim against a generic drug manufacturer preempted when this Court stipulated any claim around the adequacy of generic labels is preempted, and to not preempt could allow jury determinations of reasonableness contrary to FDA regulation requiring a duty of sameness? II. Under Federal Rule of Procedure 41(d), enacted to deter forum shopping and vexatious litigation, are attorney s fees awardable as costs when a duplicative claim is refiled after a voluntary dismissal in another jurisdiction? i

3 TABLE OF CONTENTS QUESTIONS PRESENTED... TABLE OF CONTENTS... TABLE OF AUTHORITIES... CONSTITUTIONAL AND STATUTORY PROVISIONS INVOLVED... ix OPINIONS BELOW... 1 STATEMENT OF THE CASE... 1 SUMMARY OF THE ARGUMENT... 5 ARGUMENT... 7 I. STANDARD OF REVIEW... 8 II. THIS COURT SHOULD AFFIRM THE LOWER COURT BECAUSE FEDERAL LAW PREEMPTS ANY ADDITIONAL STATE TORT DUTY A. This Claim Fails Under Impossibility Preemption Federal Law Preempts Claims of Inadequate Generic Labels This Claim Attempts to Backdoor in a Federal Cause of Action Where None Exists B. This Claim Fails Under Obstacle Preemption Imposing a Standard of Reasonableness onto Generic Manufacturers Hinders the Hatch-Waxman Act s Goal of Streamlining the ANDA Process Leaving Reasonableness to State Law and Factfinders Hinders the FDA s Role II. THE TWELFTH CIRCUIT CORRECTLY AWARDED ATTORNEY S FEES A. Rule 41(d) Costs Include Attorney s Fees Costs include attorney s fees unless otherwise noted ii i ii iv

4 2. The original claim s underlying statute does not prohibit the award of defendant s attorney s fees B. Excluding Attorney s Fees Contradicts Rule 41(d) s Intent Petitioner s conduct employs vexatious litigation and forum shopping in hopes to obtain a more favorable result Attorney s fees must be awardable costs to provide a viable deterrent to forum shopping and vexatious litigation C. Courts do and have effectively exercised discretion to award attorney s fees in cases involving Rule 41(d) CONCLUSION iii

5 Constitutions TABLE OF AUTHORITIES Page(s) U.S. Const. art. VI, cl ix, 8 9 Statutes 18 U.S.C (2006) U.S.C. 333 (2012) U.S.C. 334 (2012) U.S.C. 335(b), (c) (2012) U.S.C. 337(a) (2012)... 19, U.S.C. 355 (2012)... passim Fed. R. Civ. P. 41(d)... ix, 26 Fed. R. Civ. P.54(d)(1) Fed. R. Civ. P.68(d) Drug Price Competition and Patent Term Restoration Act of 1981, Pub. L. No , 98 Stat Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub. L , 117 Stat , 19 East Texas Code Annotated Illz. Prod. Liability Act (1)... ix, 11, 27 Administrative Regulations 21 C.F.R (2000) C.F.R (I)(2) (2017) iv

6 21 C.F.R (2017)... 9 Supreme Court Cases Ashcroft v. Iqbal, 556 U.S. 662 (2009)... 8 Baker Botts L.L.P. v. ASARCO LLC, 135 S. Ct (2015) Buckman Co. v. Plaintiff s Legal Committee, 531 U.S. 341 (2001)... 16, 17 Clinton v. Jones, 520 U.S. 681 (1997) Fid. Fed. Sav. & Loan Ass n v. de la Cuesta, 458 U.S. 141 (1982)... 9 Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132 (1963) Freightliner Corp. v. Myrick, 514 U.S. 280 (1995)... 12, 21 Gade v. National Solid Wastes Management Assn., 505 U.S. 88 (1992)... 8 Geier v. Am. Honda Motor Co., Inc., 529 U.S. 861 (2000)... 11, 23 Hines v. Davidowitz, 312 U.S. 52 (1941)... 11, 20 Kansas v. Colorado, 556 U.S. 98 (2009) Marek v. Chesny, 473 U.S. 1 (1985) Medtronic Inc. v. Lohr, 518 U.S. 470 (1996)... 9, 16, 24 v

7 Mut. Pharm. Co. v. Bartlett, 133 S. Ct (2013)... passim PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011)... passim Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) Sprietsma v. Mercury Marine, 537 U.S. 51 (2002) Wyeth v. Levine, 555 U.S. 555 (2009)... 10, 15, 22 Federal Circuit and District Court Cases Andrews v. America s Living Ctrs., LLC, 827 F.3d. 306 (4th Cir. 2016)... 30, 32 Behrle v. Olshansky, 139 F.R.D. 370 (W.D. Ark. 1991) Belkow v. Celotex Corp., 722 F. Supp (N.D. Ill. 1989) Cleveland v. Caplaw Enters., 448 F.3d 518 (2d Cir. 2006)... 8 Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006)... 18, 19 Esposito v. Piatrowski, 223 F.3d. 497 (7th Cir. 2000)... 26, 30 Evans v. Safeway Stores, Inc., 623 F.2d 121 (8th Cir. 1980) Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013)... 23, 24, 25 Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004)... 11, 18 vi

8 Guarino v. Wyeth, LLC, 719 F.3d 1245 (11th Cir. 2013) Lofton v. McNeil Consumer & Specialty Pharms., 672 F.3d 372 (5th Cir. 2012)... 16, 17, 18 Lozano v. Am. Express Travel Related Servs., Inc., No HA, 2002 WL (D. Or. Dec. 6, 2002) Meredith v. Stovall, No , 2000 U.S. App. LEXIS (10th Cir. June 23, 2000) Simeone v. First Bank Nat l Assn, 971 F.2d 103 (8th Cir. 1992)... 28, 30, 32 Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir. 2011) St. Jude Med. S.C., Inc. v. Cormier, 745 F.3d 325 (8th Cir. 2014)... 8 Starr v. Hill, No STA, 2010 WL (W.D. Tenn. June 16, 2010) Secondary Sources Black's Law Dictionary 655 (6th ed. 1990) Christine A. Gaddis, Buckman Extended: Federal Preemption of State Fraud-on-the-FDA Statutes, 69 Food Drug L.J. 113 (2014)... 18, 19 Catherine M. Sharkey, Tort-Agency Partnerships in an Age of Preemption, 15 Theoretical Inq. L. 359 (2014) , 21 H.R. Rep , pt. 1, at 16 (1984) vii

9 Transp. & Indus. Analysis Section: Res., Sci., & Indus. Div., Cong. Research Serv., RL 30373, The Cost of Prescription Drugs for the Uninsured Elderly & Legislative Approaches (2001) viii

10 CONSTITUTIONAL AND STATUTORY PROVISIONS INVOLVED The Supremacy Clause of the United States Constitution provides in relevant part: This Constitution, and the Laws of the United States...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... U.S. Const. art. VI, cl. 2. Illinoza law provides in relevant part: 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). The Hatch-Waxman Amendments provide in relevant part: An abbreviated application for a new drug shall contain information to show that the conditions of use prescribed, recommended, or suggested in the labeling proposed for the new drug have been previously approved for a drug listed U.S.C. 355(j)(2)(A). Federal Rule of Civil Procedure 41(d) provides: If a plaintiff who previously dismissed an action in any court files an action based on or including the same claim against the same defendant, the court: (1) may order the plaintiff to pay all or part of the costs of that previous action; and (2) may stay the proceedings until the plaintiff has complied. Fed. R. Civ. P. 41(d). ix

11 OPINIONS BELOW The unreported opinion of the United States Court of Appeals for the Twelfth Circuit appears on pages 9 22 of the record. The unreported opinion of the United States District Court for the District of Illinoza appears on pages 1 7 of the record. STATEMENT OF THE CASE This case involves a dispute over whether federal law preempts state law regarding the design and warnings for generic pharmaceuticals subject to FDA requirements prohibiting unilateral alteration, and whether attorney s fees should be awarded as costs after a claim was voluntarily dismissed and refiled elsewhere following a contrary finding on a similar claim. New Drug Development and Revision In 1997, the Federal Food & Drug Administration (FDA) approved an application from pharmaceutical company GlaxoCline, LLC to market the new chemical compound ropidope hydrochloride ( ropidope ) under the brand name Equip. (R. at 2.) GlaxoCline patented ropidope and developed it to mitigate symptoms of Parkinson s disease. (R. at 2.) GlaxoCline s ropidope patent expired in 2008, allowing other pharmaceutical companies to manufacture, distribute, and sell generic forms of ropidope. (R. at 2.) GlaxoCline continued to sell its Equip brand; and in 2011, proposed changes to the Package Insert and labeling by submitting a Supplemental New Drug Application (snda) to the FDA. (R. at 2.) This snda sought approval for new content in Equip s 1

12 Warnings and Precautions section. (R. at 2.) The new section, titled 5.6 Impulse Control/Compulsive Behaviors, stated: Reports suggest that patients can experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge or compulsive eating, and/or other intense urges, and the inability to control these urges while taking one or more of the medications, including EQUIP, that increase central dopaminergic tone and that are generally used for the treatment of Parkinson s disease. In some cases, although not all, these urges were reported to have stopped when the dose was reduced or the medication was discontinued. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges while being treated with EQUIP. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking EQUIP. (R. at 2.) The FDA approved this addition, and GlaxoCline changed the Equip labels in June (R. at 2.) Westerly Pharmaceutical Westerly Pharmaceutical Inc., a Texas corporation, has headquarters in Florham Park, New Jersey. (R. at 1.) The FDA approved Westerly s Abbreviated New Drug Application (ANDA) for ropidope with the standard condition that Westerly s labeling mirror that of Equip. Westerly complied and began selling its generic version of ropidope in (R. at 2.) In January 2012, Westerly, as required, submitted a Changes Being Effected (CBE) notification to the FDA detailing its plan to update its generic ropidope labels to match Equip s revised labels. (R. at 3.) Westerly executed its label change on February 1, (R. at 3.) 2

13 Alice Ivers Alice Ivers is a Cardozo, Illinoza resident diagnosed with Parkinson s disease in February (R. at 1.) Ivers physician employed a variety of treatments, including a prescription for ropidope. (R. at 1.) Ivers began taking daily doses of Westerly s generic form of ropidope in March 2011, three months after GlaxoCline revised its Equip labeling. (R. at 1.) Ivers claims she acquired compulsive spending and gambling habits in July 2011, constantly playing poker and transferring most of her retirement savings into an online poker account. (R. at 3.) She won large sums of money in 2011 and 2012 from playing poker but allegedly spent her winnings on charitable gifts and antique auctions. (R. at 3.) Ivers depleted her retirement savings by the end of 2012 and contends the unadvised side-effects of the generic ropidope caused her behavior and ensuing financial losses. (R. at 3.) Procedural Background Ivers originally filed a products liability claim against Westerly in the United States Court for the Western District of East Texas on January 15, 2013, alleging Westerly provided defective design and inadequate warnings under the East Texas Products Liability Law (ETPLL). (R. at 5.) On February 25, 2013, Ivers submitted a Notice of Voluntary Dismissal under Rule 41(a) ten days after the Fifth Circuit issued its opinion in Morris v. PLIVA, Inc., holding the Federal Drug and Cosmetic Act (FDCA) preempted a similar generic label claim. (R. at 5.) 3

14 Then on September 15, 2015, Ivers filed another complaint seeking $500,000 in damages against Westerly in the state court of Illinoza, claiming Westerly breached its duty under Illinoza products liability law sections (1)(b) and (c) by distributing an unreasonably dangerous product due to defective design and inadequate instructions or warnings. (R. at 1, 3.) Westerly successfully removed the case to federal court on diversity grounds and presented a Rule 12(c) motion for judgment on the pleadings. (R. at 1.) On December 20, 2015, the district court granted Westerly s 12(c) motion and dismissed Ivers complaint, ruling that FDA regulations for generic labeling preempted the state law tort liability for defective design and failure-to-warn claims. (R. at 11.) In response to Westerly s motion for an award of costs, the district court ordered Ivers to partially pay Westerly s costs from the previously dismissed Texas claim. The court ordered Ivers to pay $876.52, a sum excluding attorney s fees of $3,442. (R. at 11.) On January 14, 2016, Ivers appealed both decisions to dismiss her claim and award costs to Westerly. (R. at 11.) The appellate court affirmed the dismissal due to preemption and ordered Ivers to pay all Westerly s costs, including $3,442 in attorney s fees. (R. at 18.) 4

15 SUMMARY OF THE ARGUMENT I. Federal law preempts this state law claim which attempts to impose contrary obligations onto a generic manufacturer. The Supremacy Clause allows a federal law or regulation to preempt state law and render at least a part of that law invalid. This precedent allows Congress or a federal agency to dictate rules where they prefer uniformity. The Federal Drug Administration is one such agency. Congress enacted differing standards for brandname manufacturers and generic manufacturers because of different goals for each. Ilinoza attempts to impose an additional state law tort duty onto Westerly, clashing directly with the Hatch-Waxman Act. Even with no express preemption provision, conflict preemption - both impossibility and obstacle - applies. First, Westerly cannot comply with this additional state law tort duty without violating federal law. In recent years, this Court has preempted state law design defect or failure-to-warn claims based on the warning labels. Also, allowing any of these claims to continue enables a plaintiff to pursue a federal cause of action Congress did not create. The FDA regulates whether Westerly complied with its duty of sameness quickly enough - not a private citizen. Second, imposing this additional state law tort duty frustrates the purposes of the FDCA and the Hatch-Waxman Act. Federal law imposes a duty of sameness onto generic manufacturers. Generic drug labels need to mirror the brand-name drug labels. Allowing a fact-finder to determine whether a generic drug manufacturer acted reasonably could lead to hundreds of different definitions of 5

16 reasonableness within one state. This inconsistency would lead a generic manufacturer to be unsure of how to proceed and avoid litigation, chilling and frustrating one of the major purposes of the Hatch-Waxman Act. By passing the Hatch-Waxman Act, Congress intended for generic drugs to have different federal duties enabling lower costs. Therefore, Respondent respectfully requests this Court affirm the judgment of the Twelfth Circuit Court of Appeals and find this state claim preempted. II. Attorney s fees are awardable as costs under Rule 41(d). Rule 41(d) allows defendants to recoup litigation costs as a means to deter forum shopping and vexatious litigation. The rule applies to voluntary claim dismissal, and subsection (d) denotes a plaintiff s refiling of a similar claim after a prior dismissal. Ivers invoked the rule by voluntarily dismissing her original action in East Texas and refiling a similar action in Illinoza. Ivers brazen conduct in carrying out these actions warrants full enforcement of the rule to satisfy its intent and fair proceedings. Ivers dismissed the initial filing after a similar case met an unsuccessful outcome in her chosen jurisdiction. She refiled in a different forum under a different statute despite clear indications that preemption invalidated her claim. Rule 41(d) seeks to shield the defendant from incurring the hassling costs of chasing such frivolous filings and researching a solid defense. Furthermore, if Congress intended to exclude attorney s fees from the awardable costs, it would have drafted express language doing so, as it has for other 6

17 rules. Costs outside of attorney s fees represent a relatively nominal sum and provide no disincentive for refiling. Excluding attorney s fees would violate the intent of the rule, and serve as a weak deterrent to the very type of litigation it seeks to prevent. Therefore, this Court should affirm the Twelfth Circuit s holding that Ivers pay all requested costs, including attorney s fees. ARGUMENT When determining if federal law preempts state law when the federal law does not contain an express preemption, courts apply conflict preemption principles. Both the district court and the Twelfth Circuit held federal law preempted the state law claim under both impossibility and obstacle preemption. (R. at 5, 16.) Both lower courts determined it would be impossible for Westerly to comply with both the federal law duty and the state law duty; and even if it could comply, compliance with state law would frustrate the purpose of the FDA regulations. (R. at 5, 16.) Ivers dodged established statutes and shopped forums to avoid the inevitability of preemption nullifying her claim. Rule 41(d) seeks to stem the tide of such vexatious litigation by allowing courts to order the plaintiff to pay for the defendant s litigation costs. For the rule to be effective, awardable costs must include attorney s fees, as auxiliary costs alone do not provide a viable deterrent. Therefore, the Twelfth Circuit properly held FDA regulations preempted Ivers design defect and failure-to-warn claims, and that the costs in Rule 41(d) include attorney s fees. 7

18 I. STANDARD OF REVIEW This Court reviews the Twelfth Circuit s decision to affirm the district court s finding from the pleadings that federal law preempts Ivers state law claims for design defect and failure-to-warn, and to affirm the award of court costs while reversing the denial of attorney s fees. This Court reviews a judgment on the pleadings de novo. St. Jude Med. S.C., Inc. v. Cormier, 745 F.3d 325, 327 (8th Cir. 2014). The standard for rule 12(c) motions for judgment on the pleadings is equivalent to the standard for motions to dismiss for failure to state a claim under 12(b). Cleveland v. Caplaw Enters., 448 F.3d 518, 521 (2d Cir. 2006). The pleadings must contain sufficient facts that, when presumed to be true, state a claim that is plausible on its face. Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). II. THIS COURT SHOULD AFFIRM THE LOWER COURT BECAUSE FEDERAL LAW PREEMPTS ANY ADDITIONAL STATE LAW TORT DUTY. The Supremacy Clause of the U.S. Constitution establishes that state law conflicting with federal law has no effect. Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466, 2473 (2013); Gade v. National Solid Wastes Management Assn., 505 U.S. 88, 108 (1992) ( [U]nder the Supremacy Clause, from which our pre-emption doctrine is derived, any state law, however clearly within a State s acknowledged power, which interferes with or is contrary to federal law, must yield (internal quotations omitted)). When a state law regulation requires an action that violates or creates an obstacle to federal law, the state law fails. Id. The Supremacy Clause provides: This Constitution, and the Laws of the United States which shall be made in Pursuance thereof; and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme 8

19 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. U.S. Const. art. VI, cl. 2. Both federal laws and federal regulations can preempt state laws. Fid. Fed. Sav. & Loan Ass n v. de la Cuesta, 458 U.S. 141, 153 (1982). The federal government takes center stage in regulating this field: the safety and labeling accuracy of food, drugs, and cosmetics. Medtronic Inc. v. Lohr, 518 U.S. 470, 475 (1996). Since the Food and Drug Act of 1906, the federal government began expanding its role in health and safety regulations. Lohr, 518 U.S. at 475. In 1938, Congress passed the Food Drug and Cosmetic Act (FDCA). In 1962, the FDCA required a manufacturer seeking to market a new drug to prove it safe and effective and its label accurate and adequate. PLIVA, Inc. v. Mensing, 564 U.S. 604, 612 (2011). This procedure was costly and involved lengthy clinical testing, so Congress passed the Hatch-Waxman Act to revise the procedures for Abbreviated New Drug Applications (ANDA). Drug Price Competition and Patent Term Restoration Act of 1981, Pub. L. No , 98 Stat. 1585; 21 U.S.C. 355(j) (2012). Under these new amendments, generic drugs could gain FDA approval by showing equivalence to a brand-name drug or listed drug the FDA had already approved. Mensing, 564 U.S. at 612; 21 U.S.C. 355(j)(2)(A) (2012). If the brand-name manufacturer changed its labeling, the generic drug manufacturer could submit a Changes Being Effected (CBE) to the FDA to notify the agency that it would be updating its labels to mirror those of the brand-name drug. 21 C.F.R (2017). 9

20 This change in the law created different federal drug labeling duties for brand-name and generic drug manufacturers. Mensing, 564 U.S. at 613. These differing duties created a different outcome when a private citizen sued a brandname versus a generic drug manufacturer on product liability failure-to-warn claims. See Wyeth v. Levine, 555 U.S. 555, 573 (2009) (holding the brand-name manufacturer could act unilaterally to strengthen its labeling); see Mensing, 564 U.S. at 624 (holding failure-to-warn claims preempted because state law imposed a duty on generic drug manufacturers that federal law barred them from complying with the state-law tort duty). A brand-name drug manufacturer may unilaterally change or strengthen its warning without prior FDA approval. Mensing, 564 U.S. at 624. Conversely, generic drug manufacturers have a federal duty of sameness forcing them not to change drug labels without action from the brand-name manufacturers or the FDA. Id. Thus, the only avenue available to generic drug manufacturers is to comply with the regulations laid out for them they have no other option. See Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142 (1963). Westerly Pharmaceutical, Inc. sells ropidope, the generic version of Equip. (R. at 2.) When it began selling ropidope in 2009, the labeling mirrored Equip s 2009 labeling. (R. at 2.) Then in 2011, ropidope s brand-name manufacturer, GlaxoCline, announced a change to its labeling slated for June (R. at 2.) Then, complying with federal regulations, Westerly submitted a CBE in January 2012 to notify the FDA it would be mirroring the newly-approved label for Equip beginning in 10

21 February (R. at 2.) Petitioner then brought this product liability claim under Illinoza state law which provides relief 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). Petitioner alleges that complying with federal regulations was not enough. (R. at 3.) However, this state law claim cannot be sustained. The two main categories of preemption are express preemption and implied preemption. Express preemption requires Congress to explicitly state its intention to preempt state law. In the absence of an express preemption, federal law preempts state law if one can imply Congress intended to preempt state law. Geier v. Am. Honda Motor Co., Inc., 529 U.S. 861, (2000). The FDA regulations here do not contain an express preemption provision or expressly preserve state tort claims. Mensing, 564 U.S. at 617 n.5. Even without an express preemption provision, federal law preempts this claim under implied preemption. When analyzing implied preemption, a court begins with the assumption that a state law is valid and should be reluctant to resort to the Supremacy Clause. Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961, 965 (6th Cir. 2004). There are two types of implied preemption: impossibility and obstacle. See Mensing, 564 U.S. at 617 (holding state law preempted using impossibility preemption); see Hines v. Davidowitz, 312 U.S. 52, 73 (1941) (holding state law preempted using obstacle 11

22 preemption). Respondent requests this Court affirm the lower court s opinion because of both impossibility preemption and obstacle preemption. A. This Claim Fails Under Impossibility Preemption. [S]tate and federal law conflict where it is impossible for a private party to comply with both state and federal requirements. Mensing, 564 U.S. at 617 (quoting Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995) (internal quotations omitted)). Allowing this products liability claim to move forward to trial pushes Westerly into a jury verdict that could require it to violate federal law. The FDCA preempts this claim under impossibility preemption for two reasons: (1) claims that generic labels are inadequate are preempted; and (2) this claim attempts to backdoor in a federal cause of action where none exists. 1. Federal Law Preempts Claims of Inadequate Generic Labels. This Court in Mensing held federal law demands generic drug labels be the same at all times as the corresponding brand-name labels. Mensing, 564 U.S. at 614. Under federal law, generic drug manufacturers cannot change their labels on their own. Bartlett, 133 S. Ct. at 2476 (2013). The generic manufacturers cannot even notify consumers, doctors, or pharmacists of FDA-approved label changes without taking on liability. Guarino v. Wyeth, LLC, 719 F.3d 1245, 1249 (11th Cir. 2013). Here, federal law preempts the claim that generic labels are inadequate because the claim is not sufficiently narrow and could allow a jury verdict on failure-to-warn or design defects in the warning labels that directly conflicted with 12

23 federal law. Ivers claims Westerly did not act reasonably, not merely that it did not update its labels in a reasonable time. This claim could imply a need to send out other notifications and force them to violate their duty of sameness. Many measures that juries consider reasonable fall in direct conflict with federal law. The Sixth Circuit, in interpreting this Court s precedent explained [t]he Supreme Court held, unequivocally, however, that federal law preempts state laws that impose on generic-drug manufacturers the duty to change a drug s label, thus barring the plaintiffs state-law tort claims. Smith v. Wyeth, Inc., 657 F.3d 420, 423 (6th Cir. 2011). A plaintiff might request that, for a drug company to act reasonably, manufacturers could send Dear Doctor letters to send additional warnings to prescribing physicians and other healthcare professionals. Mensing, 564 U.S. at 615. The plaintiffs in Mensing suggested to this Court that PLIVA could have acted reasonably by sending out these Dear Doctor letters. Id. The Dear Doctor letters are labeling and thus, the generic drug manufacturers may not use these letters unilaterally. Id.; 21 C.F.R (I)(2) (2017). Westerly complied with the law and updated its label to match that of GlaxoCline, the brand-name manufacturer. In Mensing, this Court discussed the different federal labeling duties for brand-name and generic drug manufacturers. Mensing, 564 U.S. at 613. The FDA requires a brand-name drug manufacturer seeking approval for a new drug to show the label is both accurate and adequate. Id. However, a generic drug manufacturer is responsible for ensuring that its warning 13

24 label is the same as the brand name s. Id. As the manufacturer could not take action without permission and assistance from the FDA, it could not independently satisfy the state law tort duties. Id. at 623. Thus, federal law barred the generic manufacturer from satisfying the state law tort duty. Id. Similar to PLIVA, Inc., Westerly can only act with permission and assistance from the FDA. Thereby, Westerly complied with the federal duty holding it responsible for a duty of sameness. By allowing this claim to proceed on the merits, a jury could determine that not only did Westerly perhaps not comply soon enough, but that Westerly should have complied far earlier than GlaxoCline. The jury could also require Westerly to use a different, stronger label than that used by the brand-name. Westerly may not change the labels unilaterally since the only option for a generic drug manufacturer is to ask for FDA assistance in convincing the brand-name manufacturer to adopt a stronger label so that all corresponding generic drug manufacturers could do so as well. Mensing, 564 U.S. at 617. In Mensing, the brand-name manufacturer had not yet updated its labeling to allow PLIVA to update as well. Here, GlaxoCline had changed the label. Nevertheless, this distinction is immaterial. Allowing a jury to determine reasonableness within the parameters of state law comes into direct conflict with the FDA regulations for generic drugs. Even for the design defect claim, the federal duty of sameness applies. Bartlett, 133 S. Ct. at The FDCA requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, and labeling as 14

25 the brand-name drug on which it is based. Id. (citing 21 U.S.C. 355(j)(2)(A)(ii) (v) and (8)(B) (2012)). The Court of Appeals held the claim was not preempted because Mutual could have taken the drug completely off the shelf. Id. at This Court rejected this rationale as incompatible with our pre-emption jurisprudence because if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be all but meaningless. Id. (quotations omitted). This Court held state law claims which place a duty on manufacturers to render a drug safer.... are in conflict with federal laws that prohibit manufacturers from unilaterally altering drug composition or labeling. Id. at As this conflicts with state law and complying with such remedial measures makes it impossible to also comply with federal law, the claim is preempted. Id. Applying Bartlett s rationale, federal law preempts Petitioner s design defect claim because Westerly cannot change its design and comply with federal law at the same time. Also, Westerly does not need to pull ropidope off the shelf in order to comply with the state law tort duty because this would render this Court s impossibility preemption meaningless. Id. at The question for impossibility preemption is whether the private party could independently do under federal law what state law requires of it. Levine, 555 U.S. at 573. State law demands a safer label or a more reasonable warning but it does not consider the implications it could have by forcing a generic drug manufacturer such as Westerly to violate federal law. This Court has not held that generic drug manufacturers must comply with heavier state law duties when this state law duty 15

26 conflicts with FDA regulations. See Bartlett, 133 S. Ct. at 2477 (holding the patient s state-law tort claim preempted because it was impossible for the manufacturer to comply with both the state-law requirements and federal law); Lohr, 518 U.S. at 503 (holding patient s claim is not preempted because it applied a statutory scheme under 360k which required little federal oversight). Westerly asks this Court to uphold precedent and continue to prevent state courts from forcing them to violate federal law. 2. This Claim Attempts to Backdoor in a Federal Cause of Action Where None Exists. If Congress intended for a person to sue a drug manufacturer for failure to comply with federal regulations, it would have created an independent federal cause of action to pursue. Congress created no such avenue. Among the traditional police powers, [this] Court has also occasionally recognized the historic primacy of state regulation on matters of health and safety. Lofton v. McNeil Consumer & Specialty Pharms., 672 F.3d 372, 378 (5th Cir. 2012) (citing Lohr, 518 U.S. at 485) (internal quotations omitted). In Buckman, this Court held federal statute preempted a fraud-on-the-fda claim. Buckman Co. v. Plaintiff s Legal Committee, 531 U.S. 341, 350 (2001). The plaintiffs in Buckman alleged a violation of state tort law because the manufacturer made fraudulent representations to the FDA. Id. at 343. The relationship between the FDA and the manufacturers it regulates are inherently federal in character because the relationship originates from, is governed by, and terminates according to federal law. Id. at 347. Congress enacted a federal 16

27 statutory scheme empowering the FDA to punish manufacturers committing fraudon-the-fda. Id. Plaintiff s state law claim conflicts with the FDA s responsibility to police fraud consistently with the Agency s judgment and objectives and is impliedly preempted. Id. at 350. Congress enacted laws allowing the FDA to enforce 21 U.S.C Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub. L , 117 Stat In 115, this Act enforces a civil penalty under (a) for: Any brand name drug company or generic drug applicant which fails to comply with any provision of this subtitle shall be liable for a civil penalty of not for than $11,000, for each day during which such entity is in violation of this subtitle. Such penalty may be recovered in a civil action brought by the United States, or brought by the Commission in accordance with the procedures established in section 16(a)(1) of the Federal Trade Commission Act (15 U.S.C. 56(a)) and a provision for compliance and equitable relief under (b) for: If any brand name drug company or generic drug applicant fails to comply with any provision of this subtitle, this United States district court may order compliance, and may grant such other equitable relief as the court in its discretion determines necessary or appropriate, upon application of the Assistant Attorney General or the Commission. Id. at 115. This section establishes a way for the FDA to punish or deter manufacturers from violating the regulations in 21 U.S.C Id.; 21 U.S.C. 355 (2012). In interpreting this Court s precedent, the Fifth Circuit extended Buckman. Lofton, 672 F.3d at 380. In Lofton, a Texas failure-to-warn statute imposed a rebuttable presumption that a drug manufacturer is not liable for failure to warn if the FDA has approved the warnings or information accompanying the product 17

28 alleged to have harmed the plaintiff. Id. at 374. Texas allowed a plaintiff to rebut this presumption by proving the manufacturer had committed fraud on the FDA. Id. In interpreting Buckman, the Fifth Circuit held federal law preempts this avenue of rebutting the presumption. See id. at 380. The Fifth Circuit then noted, while analyzing Levine, this Court preserved common law state tort law claims that parallel or reinforce the.... [FDA s].... efforts but do not involve the relationship between the federal regulator and the regulated entity. Christine A. Gaddis, Buckman Extended: Federal Preemption of State Fraud-on-the-FDA Statutes, 69 Food Drug L.J. 113, (2014) (citing Lofton, 672 F.3d at 377). This claim is not parallel and involves a relationship between the federal regulator, the FDA, and the regulated entity, Westerly. Coming to the same conclusion as the Fifth Circuit in Lofton, the Sixth Circuit held federal law preempted a similar statute in Michigan and that there is no meaningful difference between fraud-on-the-fda claims struck down in Buckman and Appellants claims under Michigan tort law. Desiano v. Warner- Lambert & Co., 467 F.3d 85, 93 (2d Cir. 2006) (citing Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961, 966 (6th Cir. 2004)). Petitioner s claim here has no meaningful difference between the claims this Court struck down in Buckman. Petitioner alleges Westerly s ropidope labels were unreasonably dangerous because of defective design and contained inadequate warnings of side effects. (R. at 3.) She based her allegation on the idea that Westerly unreasonably failed to update its label to include warnings soon enough. (R. at 11.) This position runs contrary to 18

29 the FDA s regulatory scheme designed to police the drug manufacturers who fail to comply with 21 U.S.C By alleging Westerly unreasonably failed to update its label, Ivers claims that Westerly violated FDA regulations with a false label for the months before update. Petitioner does not have the authority to police Westerly for not complying with a regulation that Westerly allegedly violated. Congress created a means for the FDA to police the drug manufacturers and intentionally did not create such a cause of action for individuals. Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Pub. L , 117 Stat Allowing an individual to polic[e] fraud on the FDA through a tort action could interfere with how the FDA might wish to police that kind of fraud itself. Desiano, 467 F.3d at 93. If Westerly was de-frauding the FDA by not keeping up with its duty of sameness soon enough, then that should be for the FDA to determine, not petitioner or a factfinder. The FDA has the exclusive authority to initiate enforcement proceedings for failure to comply, can make criminal allegations after a finding of fraud, impose criminal or civil penalties, issue an injunction, and withdraw ANDA. See Christine A. Gaddis, supra 18, at 133; 21 U.S.C. 337(a) (2012); 18 U.S.C (2006); 21 U.S.C. 333 (2012); 21 U.S.C. 334 (2012); 21 U.S.C. 335(b), (c) (2012). Congress even established a way for a private individual to file a petition with the FDA, requesting the agency take administrative action against a regulated entity. 21 C.F.R (2000). 19

30 There is no federal, private cause of action under the FDA. See Catherine M. Sharkey, Tort-Agency Partnerships in an Age of Preemption, 15 Theoretical Inq. L. 359, 370 (2014) (citing 21 U.S.C. 337(a) (2012)) ( [A]ll such proceedings for enforcement, or to restrain violations of [the FDCA] shall be by and in the name of the United States. ). Therefore, because Congress has established a thorough regulation scheme through the FDA and its regulations, Petitioner cannot lawfully bring a federal cause of action when none exists. B. This Claim Fails Under Obstacle Preemption. Imposing both state tort law and federally required procedures on Westerly frustrates the objectives of the Hatch-Waxman Act and necessitates preemption. This Court applied obstacle preemption for the first time in Hines. See Hines v. Davidowitz, 312 U.S. 52, 73 (1941) (applying obstacle preemption in the foreign relations context by comparing the federal government s power versus the State s power to legislate in the foreign relations area). In Hines, the federal government had passed regulations completely exercising its authority in the registration of aliens. Id. at 66. Pennsylvania s law, then, stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress. Id. at 67. For Congress, uniformity in the rules allowing aliens to come into the country might validly be desirable. Id. at 73. Important questions to consider when determining whether obstacle preemption applies are the nature of the power exerted by Congress, the object sought to be attained, and the character of the obligations imposed by the law. Id. 20

31 at 70. When Congress has occupied an entire field, any attempt of a State to enact legislation in that field could frustrate Congress purpose in enacting this legislation. In the generic drug arena, Congress has provided a broad and comprehensive plan for generic drug manufacturers to put their products on the market. See 21 U.S.C. 355 (2012). Through the ANDA process, generic drug manufacturers must demonstrate their proposed label is equivalent to the corresponding brand-name drug s label. 21 U.S.C. 355(j) (2012). The purpose of the Hatch-Waxman Act then allows generic drug manufacturers to eliminat[e] the need.... to prove their drugs safety and efficacy independently, thereby lowering the cost to obtain approval for generic drugs. Christine A. Gaddis, supra 18, at 116 (citing Mensing, 564 U.S. at 611). The objectives of Congress enable generic drug manufacturers to reduce their prices and requiring these manufacturers to comply with a state law requiring reasonableness frustrates this objective. Congress has fully occupied the field of drug safety and efficiency. In Myrick, this Court held the National Highway Traffic Safety Administration (NHTSA) did not fully occupy the field because it had not regulated in the area the state was regulating. See Freightliner Corp. v. Myrick, 514 U.S. 280, (1995). This Court came to a similar finding in Sprietsma, where the field was not fully occupied in that area because the Federal Boat Safety Act did not convey clear intent to completely occupy the field. See Sprietsma v. Mercury Marine, 537 U.S. 51, 69 (2002). Unlike Myrick, where there was no federal standard addressing the requirement of ABS devices, the FDA has issued regulations regarding how generic 21

32 manufacturers are to warn their consumers. Myrick, 514 U.S. at Also unlike Sprietsma, the FDA intends to regulate how brand-name and generic drug manufacturers label their products and warn their customers. The FDA even indicates what actions generic drug manufacturers may undertake to remain within their duty of sameness. Unlike in Levine, obstacle preemption applies in this case. See Levine, 555 U.S. at 581. Wyeth, a brand-name drug manufacturer, claimed that because the CBE regulation required FDA approval, the FDA bore primary responsibility for drug labeling and not the brand-name drug manufacturer. Id. at 570. This Court held [f]ailure-to-warn actions, in particular, lend force to the FDCA s premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling and state law complements FDA regulation. Id. at 579. In Levine, the drug manufacturer at issue is a brand-name drug manufacturer. Here, Westerly is a generic drug manufacturer which creates an important distinction. Congress purposes for FDA regulation of generic drugs include speeding up the regulatory process to allow for a lowered cost of drugs. 21 U.S.C. 355 (2012); See generally Transp. & Indus. Analysis Section: Res., Sci., & Indus. Div., Cong. Research Serv., RL 30373, The Cost of Prescription Drugs for the Uninsured Elderly and Legislative Approaches (2001). Congress purposes for generic drugs do contain a need for expediency. Thus obstacle preemption applies here. Federal law preempts this failure-to-warn claim under Illinoza state tort law under obstacle preemption because: (1) imposing a state tort standard of 22

33 reasonableness onto generic drug manufacturers would hinder the Hatch-Waxman Act s purpose of streamlining the ANDA process; and (2) allowing factfinders to determine reasonableness undermines the FDA s role in regulating generic drug manufacturers. 1. Imposing a Standard of Reasonableness onto Generic Manufacturers Hinders the Hatch-Waxman Act s Goal of Streamlining the ANDA Process. Imposing a standard of reasonableness onto generic drug manufacturers imposes conflicting tort duties which result in more liability for lawsuits. Westerly complied with federal law and federal regulations requiring a duty of sameness. A different standard would chill the generic drug manufacturers by requiring them to second-guess the FDA s regulations to make sure they are also complying with each state s view on what is reasonable. Obstacle preemption is not measured by the size of the obstacle, but on whether the obstacle frustrates the purpose of an agency regulation. See Geier v. Am. Honda Motor Co., 529 U.S. 861, 882, 885 (2000). The state law failure-to-warn claim aims to establish a different standard for safety and effectiveness than the one established by Congress under the Hatch-Waxman Act. In Fulgenzi, the Sixth Circuit argues that the Hatch-Waxman Act recognized new clinical trials for generic drugs were unnecessary and demonstrated sameness was enough to show the drug to be safe and effective. Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 586 (6th Cir. 2013) (citing H.R. Rep , pt. 1, at 16 (1984)) (internal quotations omitted). Before the Hatch-Waxman Act, the FDCA required drug 23

34 manufacturers to prove the safety and effectiveness of all new drugs. Id. at 585. The Sixth Circuit contends this requirement has not changed, but acknowledges the Hatch-Waxman Act changes what procedures generic drug manufacturers need to follow to prove the safety and effectiveness of their drugs. Id. at Congress determined proving sameness was enough to show the drug was safe and effective. Id. Westerly complied with this duty of sameness when it changed ropidope s label. By updating its label to be the same as GlaxoCline s, Westerly satisfied the requirement to prove the drug was safe and effective. Requiring yet another standard to prove this generic drug was safe and effective runs contrary to the Hatch-Waxman Act. Therefore, under obstacle preemption, federal law preempts this state law claim alleging Westerly unreasonably failed to warn. 2. Leaving Reasonableness to State Law and Factfinders Hinders the FDA s Role. The FDA is an expert body, and better placed to set drug policy than state legislatures, much less state juries in after-the-fact verdicts. Fulgenzi, 711 F.3d at 585 (citing Riegel v. Medtronic, Inc., 552 U.S. 312, 315 (2008)). A case-by-case inquiry into whether a generic drug manufacturer complied with the federal regulation in a way a jury could consider reasonable exposes drug manufacturers to uncertainty. This uncertainty could chill the generic drug market by creating, even within only one state, many different definitions of what the manufacturer should have done. This variance leads to confusion and would slow down the ANDA process when the purpose of the Hatch-Waxman Act was to streamline the ANDA process. 24

35 The dissent in Lohr determined federal requirements specific to medical devices preempted state law requirements. Id. (citing Lohr, 518 U.S. at 512). Imposing liability for breaching state law causes of action allows the state to govern and control conduct and policy. Id. at 324. This Court makes the point in Riegel, that state tort law that requires a manufacturer s catheters to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme no less than state regulatory law to the same effect. Id. A federal regulation adopted by an agency requires a cost-benefit analysis where the agency determines whether this new regulation making an item more effective but leading to a greater risk is worthwhile because of the many more lives the new or amended regulation could save. Id. at 325. A jury, on the other hand, is likely unconcerned with the benefits of the effectiveness and instead will care more about the costs that impacted the injured party. Id. A federal agency then is in a better position to determine reasonableness. A jury might consider the Hatch-Waxman Act s purpose of ultimately lowering generic drug prices and the generic drug manufacturer s duty of sameness to be unreasonable. Allowing a jury to make this call would frustrate the purposes of the Hatch-Waxman Act and allow a case-by-case analysis of a generic drug manufacturer s actions. A case-by-case analysis of each generic drug manufacturer who complied with their federal duty of sameness leaves uncertainty as to what is actually required of a manufacturer. 25

36 Leaving a generic drug manufacturer in a state of stasis where they are unsure of what to do to comply with even one state s standard of reasonableness when the answer depends on a factfinder frustrates the purposes of the FDA. Instead of leaving drug manufacturers in a state of confusion and allowing factfinders to determine what reasonableness means to the FDA, Congress should be the one to define the regulation. Anything else in this matter frustrates the purposes of the FDA and Congress. Therefore, federal law, under obstacle preemption, should preempt this state law claim which attempts to impose a different requirement onto Westerly. III. THE TWELFTH CIRCUIT CORRECTLY AWARDED ATTORNEY S FEES. Rule 41(d) of the Federal Rules of Civil Procedure refers to the costs of a previously dismissed action. Fed. R. Civ. P. 41(d). The rule states that 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 may: (1) order the plaintiff to pay all or part of the costs of that previous action; and (2) stay the proceedings until the plaintiff has complied. Id. The intent of the law is also paramount in its interpretation and application. Ordering payment of defendant s costs should effectively deter forum shopping and vexatious litigation. Esposito v. Piatrowski, 223 F.3d. 497, 501 (7th Cir. 2000). Imposing nominal awards by excluding attorney s fees offers little deterrent and may even provide an incentive to initiate more unwarranted litigation. 26