No. 17-230 IN THE Supreme Court of the United …

1 No. 17-230 IN THE Supreme Court of the United states October Term, 2017 Alice IVERS, et al, Petitioner, v. WESTERLY PHARMACEUTICAL, INC., Respondent. On Writ of Certiorari to the Twelfth Circuit Federal Court of Appeals BRIEF FOR PETITIONER Attorneys for Petitioner Team 2624 i QUESTIONS PRESENTED I. Whether this Court s decisions in PLIVA v. Mensing, 564 604 (2011), and Mutual Pharmaceutical v. Bartlett, 133 S. Ct. 2466 (2013), pre-empt the Petitioner s claims in this case when neither decision addressed the changes made to the FDCA by the FDAAA of 2007 and when it is neither impossible nor an obstacle to adhere to both the FDCA and Illinoza Products Liability Law. II. Whether attorney s fees are considered awardable costs under Federal Rule of Civil Procedure 41(d) when neither Rule 41(d) nor the statute through which the claim arises overcome the default of not awarding attorney s fees as costs and when the Petitioner did not act in bad faith nor in a vexatious manner.

2 Ii 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 .. 5 ARGUMENT .. 9 I. STANDARD OF REVIEW .. 9 II. THE TWELFTH CIRCUIT ERRED WHEN IT HELD THAT COMPLIANCE WITH THE Supreme Court S DECISIONS IN MENSING AND BARTLETT PRE-EMPTED THE ABILITY OF IVERS TO BRING A SUIT AGAINST WESTERLY UNDER ILLINOZA PRODUCTS LIABILITY LAW.. 10 A. In This Case, The Court Is Not Bound By The Precedent Set In Any Case Prior To The Enactment Of The FDAAA Of 2007 Nor Is It Impossible For The Private Parties To Comply With Both Illinoza Products Liability Law And The FDCA As Amended.

3 11 i. The lower courts erred in ruling that they must follow precedent set in Mensing and Bartlett because neither decision addressed the changes made to the FDCA by the FDAAA of 2007.. 12 ii. Assuming arguendo that Mensing and Bartlett apply to the case at hand, it is not impossible to adhere to both the post-2007 FDCA as well as Illinoza Products Liability Law.. 14 B. Compliance With Illinoza Products Liability Law Does Not Impose An Obstacle To The Purposes And Objectives Congress Set Forth In The FDCA.. 16 i. The lower courts erred in ruling that Illinoza Products Liability Law imposed an obstacle to the purposes and objectives Congress set forth in the FDCA.. 17 III. THE LOWER COURTS ERRED IN CONCLUDING THAT ATTORNEY S FEES ARE CONSIDERED COSTS PURSUANT TO FRCP 41(D).

4 19 A. Attorney s Fees Are Not Costs Because Neither Rule 41(d) Nor The Statute Through Which The Claim Arises Overcome The Default Against Awarding iii Attorney s Fees As Costs In The American Rule Of Law.. 19 B. The Court May Maintain Attorney s Fees Despite Rule 41(d) Authorization When The Petitioner Acted In Bad Faith Or In A Vexatious Manner.. 23 CONCLUSION .. 25 APPENDIX A .. 26 APPENDIX B .. 27 APPENDIX C .. 28 APPENDIX D .. 33 APPENDIX E .. 42 iv TABLE OF AUTHORITIES Cases Aloha Airline, Inc. v. Mesa Air Group, Inc., 2007 Dist. WL 2320672 (West 2007).. 21 Anders v. FPA Corp., 1995 Dist. LEXIS 19592, 12 ( .1995) .. 21 Andrews v. America s Living Ctrs., LLC, 827 306, 309 (4th Cir. 2016).

5 Passim Costin v. Ally Bank Corp., No. 7:13-CV-113-BO, 2013 WL 5603230, at *1 ( Oct. 11, 2013).. 23 Esposito v. Piatrowski, 223 497, 500 (7th Cir. 2000).. 20, 21, 23 Rich Co., Inc. v. United states ex rel. Indus. Lumber Co., 417 116, 129 (1974).. 23 Florida Lime & Avocado Growers, Inc. v. Paul, 373 312, 142-43 (1963).. 11 Fulgenzi v. PLIVA, Inc., 711 578, 584 (2013).. 14, 15, 17, 18 Gade v. National Solid Wastes Mgmt. Ass n, 505 88, 110 (1992).. 16 Guise v. BWM Mortg., LLC, 377 795, 798 (7th Cir. 2004) .. 10 Guvenoz v. Target Corp., 391 Ill. Dec. 134, 147 (2015).. 12 Hassett v. Dafoe, 74 202, 206 (2013).. 13 Hensley v. Alcon Labs., Inc., 277 535, 543 (4th Cir. 2002).. 9, 23 Hillsborough County v.

6 Automated Med. Labs., Inc., 471 707, 716 (1985).. 11 In re 1997 Grand Jury, 215 430, 436 (4th Cir. 2000).. 24 In re Reglan, 81 80, 90 (2013).. 12, 13 In re Reglan, 81 80, 90 (Pa. 2013).. 12 Key Tronic Corp. v. United states , 511 809, 814 (1994).. 18, 19, 20 Marek v. Chesny, 473 1, 4 (1985).. 19, 20 McCann v. Neilsen, 466 619, 621 (7th Cir. 2006) .. 10 Medtronic, Inc. v. Lohr, 518 470, 485 (1996).. 11, 16 Mutual Pharmaceutical v. Bartlett, 133 S. Ct. 2466, 2472 (2013).. passim v PLIVA v. Mensing, 564 604, 614 (2011).. passim Runyon v. McCrary, 427 160, 185 (1976) .. 18, 20 Sanderson v. Spectrum Labs, Inc., 248 1159 (7th Cir. 2000) .. 23 Sprietsma v. Mercury Marine, 537 51, 64 (2002).. 11 Wyeth v. Levine, 555 555, 573 (2009).

7 10, 11, 16, 17 Statutes 21 (b)(10).. 14 21 (b)(10).. 11 21 355(o)(4) .. 12, 15 21 355(o)(4); .. 12 Fed. R. Civ. P. 41(d)(1).. 20, 24 Fed. R. Civ. P. 54(d)(1) .. 18, 20 Illz. Prod. Liability Act. 1998-4(1).. 11 Rules Fed. R. Civ. P. 41(d).. 18, 20, 24 Fed. R. Civ. P. 54(d)(1).. 20 Fed. R. Civ. P. 68(d).. 20 Treatises Restatement (Second) of Torts 914 (1979).. 16, 19, 21, 22 Restatement (Third) of Torts: Prod. Liab. 2(c) (1998).. 16 Constitutional Provisions Const. art. VI, cl. 2.. 10 1 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 8 of the record.

8 CONSTITUTIONAL AND STATUTORY PROVISIONS INVOLVED The constitutional provision at issue, the Supremacy Clause of Article VI, Clause two of the Constitution, is located at Appendix A. The statutory provisions at issue, Illinoza Products Liability Act, the Federal Food Drug and Cosmetic Act ( FDCA ), the Food and Drug Administration Amendments Act ( FDAAA ) of 2007, and Federal Rule of Civil Procedure ( FRCP ) Rule 41, are at Appendices B, C, D, and E, respectively. STATEMENT OF THE CASE Background In 2011, Alice Ivers ( Ivers ), a resident of Cardozo, Illinoza, was diagnosed with Parkinson s. (R. at 1.) To treat this incurable disease1, Alice s doctor prescribed ropidope hydrochloride ( ropidope ) among other interventions.

9 (R. at 1.) Ivers did not receive the brand-name ropidope manufactured by GlaxoCline, LLC ( GlaxoCline ) but instead received the generic version of ropidope, manufactured by the respondent, Westerly Pharmaceuticals, Inc. ( Westerly ). (R. at 1.) Ivers took 1 Parkinson s Disease Information Page, NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS & STROKE (July 10, 2017), 2 the generic version of ropidope daily beginning in March of 2011. (R. at 1.) GlaxoCline was the initial patent holder for ropidope and received regulatory approval from the Federal Food and Drug Administration ( FDA ) to sell ropidope as a dopamine inhibitor for Parkinson s patients in 1997.

10 (R. at 2.) When GlaxoCline s patent expired in 2008, Westerly submitted an Abbreviated New Drug Application ( ANDA ) to the FDA to sell a generic version of the drug that is bioequivalent to that of the patent-holding company. (R. at 2.) The ANDA was approved and Westerly began selling generic ropidope in 2009. (R. at 3.) As a condition of FDA approval, Westerly s ropidope label matched that of the patent holding company. (R. at 2.) In January 2011, three months prior to Ivers taking Westerly s drug, GlaxoCline submitted a Supplemental New Drug Application ( sNDA ) to change the package insert and labeling of ropidope. (R. at 2.) This new insert and labeling detailed that there were possible impulse control and compulsive behavior side effects that could develop while the patient was taking the medication, and if such side effects developed, patients should consider a dose reduction or a stoppage of treatment with ropidope.