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 U.S. 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.

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. ........................................................................................... 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). ...................... 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 U.S. Dist. WL 2320672 (West

2007). ......................................................................................................................... 21

Anders v. FPA Corp., 1995 U.S. Dist. LEXIS 19592, 12 (D.N.J .1995) ..................... 21

Andrews v. America’s Living Ctrs., LLC, 827 F.3d 306, 309 (4th Cir. 2016) .... passim

Costin v. Ally Bank Corp., No. 7:13-CV-113-BO, 2013 WL 5603230, at *1 (E.D.N.C.

Oct. 11, 2013). ........................................................................................................... 23

Esposito v. Piatrowski, 223 F.3d 497, 500 (7th Cir. 2000). ............................ 20, 21, 23

F.D. Rich Co., Inc. v. United States ex rel. Indus. Lumber Co., 417 U.S. 116, 129

(1974). ....................................................................................................................... 23

Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 312, 142-43 (1963). .......... 11

Fulgenzi v. PLIVA, Inc., 711 F.3d 578, 584 (2013). .................................. 14, 15, 17, 18

Gade v. National Solid Wastes Mgmt. Ass’n, 505 U.S. 88, 110 (1992). ..................... 16

Guise v. BWM Mortg., LLC, 377 F.3d 795, 798 (7th Cir. 2004) ................................ 10

Guvenoz v. Target Corp., 391 Ill. Dec. 134, 147 (2015). ............................................. 12

Hassett v. Dafoe, 74 A.3d 202, 206 (2013). ................................................................. 13

Hensley v. Alcon Labs., Inc., 277 F.3d 535, 543 (4th Cir. 2002). ........................... 9, 23

Hillsborough County v. Automated Med. Labs., Inc., 471 U.S. 707, 716 (1985). ...... 11

In re 1997 Grand Jury, 215 F.3d 430, 436 (4th Cir. 2000)......................................... 24

In re Reglan, 81 A.3d 80, 90 (2013). ...................................................................... 12, 13

In re Reglan, 81 A.3d 80, 90 (Pa. 2013). ..................................................................... 12

Key Tronic Corp. v. United States, 511 U.S. 809, 814 (1994). ....................... 18, 19, 20

Marek v. Chesny, 473 U.S. 1, 4 (1985). ................................................................. 19, 20

McCann v. Neilsen, 466 F.3d 619, 621 (7th Cir. 2006) .............................................. 10

Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996). ............................................... 11, 16

Mutual Pharmaceutical v. Bartlett, 133 S. Ct. 2466, 2472 (2013). ................... passim

v

PLIVA v. Mensing, 564 U.S. 604, 614 n.1 (2011). .............................................. passim

Runyon v. McCrary, 427 U.S. 160, 185 (1976) ..................................................... 18, 20

Sanderson v. Spectrum Labs, Inc., 248 F.3d 1159 (7th Cir. 2000) ............................ 23

Sprietsma v. Mercury Marine, 537 U.S. 51, 64 (2002). .............................................. 11

Wyeth v. Levine, 555 U.S. 555, 573 (2009). .............................................. 10, 11, 16, 17

Statutes

21 C.F.R. § 314.150(b)(10). .......................................................................................... 14

21 C.F.R. 314.150(b)(10). ............................................................................................. 11

21 U.S.C. § 355(o)(4) .............................................................................................. 12, 15

21 U.S.C. § 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

U.S. 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.

CONSTITUTIONAL AND STATUTORY PROVISIONS INVOLVED

The constitutional provision at issue, the Supremacy Clause of Article VI,

Clause two of the U.S. 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. (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), https://www.ninds.nih.gov/Disorders/All-Disorders/Parkinsons-Disease-

Information-Page.

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. (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. (R. at 2.) The FDA approved this change and GlaxoCline

implemented it on their drug labels in June 2011. (R. at 2.) Six months later,

Westerly decided to submit a Changes Being Effected (“CBE”) notification to the

FDA. (R. at 2-3.) The CBE was used to notify the agency that Westerly would be

making the same changes that GlaxoCline implemented on their label. (R. at 2-3.)

In February of 2012, one year and one month after GlaxoCline submitted an

3

application to change their label and 11 months after Ivers began taking this

medication daily, Westerly implemented the changes on their labels. (R. at 3.)

In July of 2011, five months after beginning daily ropidope ingestion, Ivers

began to develop one of the impulse control behaviors the sNDA from GlaxoCline

had proposed to the FDA seven months earlier and implemented one month earlier.

(R. at 3.) Ivers experienced a significant reduction in impulse control and began

gambling online, eventually spending all her and her now ex-husband’s money. (R.

at 3.) Due to her poor impulse control caused by ropidope, she spent all her

winnings on charitable gifts and antique auctions. (R.at 3.) Ivers’ lack of impulse

control and consequential loss of substantial sums of their shared money eventually

led to her husband of 35 years filing for divorce. (R. at 3.)

Procedural History

On January 15, 2013, Ivers filed a complaint against Westerly in the United

State District Court for the Western District of East Texas. (R. at 5.) In her

complaint, Ivers claimed that ropidope was unreasonably dangerous in accordance

with East Texas Products Liability Law. (R. at 5.) On February 14, 2013, the

opinion for Morris v. PLIVA, Inc. was issued by the Fifth Circuit which held that

the FDCA pre-empted a failure-to-update claim. (R. at 5.) On February 25, 2013,

before Westerly had filed an answer, Ivers filed a Notice for Voluntary Dismissal as

allowed by FRCP 41(a). (R. at 5.)

Following the voluntary dismissal of her case in the Western District of East

Texas, Ivers brought a suit under Illinoza Products Liability Law claiming that the

4

product by Westerly, ropidope, was unreasonably dangerous due to defective design

and inadequate instructions or warnings. (R. at 3.) Westerly removed the action

from the state court of Illinoza to United States District Court in the District of

Illinoza. (R. at 3.) On November 2, 2015, Westerly filed a Motion for Judgement on

the Pleadings and a Motion for an Award of Costs under FRCP 41(d) to cover costs

expended on defense in the initial East Texas case. (R. at 6.) Westerly sought

$4,318.52, the total amount of costs plus attorney’s fees accrued from the time the

complaint was filed, January 15, 2013, to the time it was voluntarily dismissed,

February 25, 2013. (R. at 3, 6.)

The District Court held, relying on PLIVA v. Mensing (“Mensing”) and

Mutual Pharmaceutical v. Bartlett (“Bartlett”), that Ivers’ claim for breach of a

state-law duty was pre-empted. (R. at 5.) They also held that Ivers, although

suffering financially due to her reduced impulse control, must reimburse Westerly

for the costs incurred in the original suit that was dismissed in the Western District

of East Texas. (R. at 7.) Westerly contended that the attorney’s fees incurred in the

previous suit should also be awarded to it, but the District Court held that

attorney’s fees were not a part of costs, relying on the plain language of Rule 41(d).

(R. at 7.)

Ivers appealed this decision in the United States Court of Appeals for the

Twelfth Circuit on January 14, 2016, contesting the District Court’s decision to

dismiss the case and to award costs to Westerly. (R. at 11.) Westerly filed a cross-

appeal on January 15, 2016, contesting the District Court’s decision to not award

5

attorney’s fees in addition to costs. (R. at 11.)

The Court of Appeals ruled that while the District Court was correct in the

outcome of the pre-emption claim, it was not as straightforward as the analysis set

forth in the court’s opinion. (R. at 12.) They also ruled that “costs contemplated by

Rule 41(d) include attorney’s fees.” (R. at 18.) Justice Motley filed a separate

opinion concurring in part and dissenting in part. (R. at 18.) Justice Motley

contended that Illinoza Products Liability Law is not pre-empted by the FDCA, and

that since pre-emption was not directly stated within the statute, the intent for pre-

emption can only be implied. (R. at 18-19.) Justice Motley agreed with the majority

that attorney’s fees should be awarded along with costs. (R. at 22.)

On July 17, 2017, a petition for writ of certiorari to the Twelfth Circuit Court

of Appeals before this Court was granted. (R. at 23.)

SUMMARY OF THE ARGUMENT

I. 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.

The Supremacy Clause of the Constitution aims not to take away the police

power of the state, but rather to give the judicial branch a standpoint when

examining conflicts with state law. Pre-emption is a high bar because there is an

assumption that Congress intended the state and federal laws to coexist. To prove

pre-emption, it must be determined that it is either impossible for a private party to

comply with both state and federal law, or determined that state law stands as an

obstacle to accomplishing the purposes and objectives Congress had when passing

6

the legislation.

It is not impossible for Illinoza Products Liability Law to coexist with the

FDCA. Mensing and Bartlett, the cases the lower court relied on for the previous

analyses, are not applicable to this case as they did not address the changes that

were made to the FDCA with the addition of the FDAAA in 2007. As these cases did

not address the updated FDCA, they cannot be applied to the case at hand as each

pre-emption claim must be examined in a case-by-case basis with consideration of

differences in state laws. Even if Mensing and Bartlett apply, the impossibility

ruling put forth in both cases hinges on both generic companies needing to make

unilateral changes to their generic pharmaceutical in order to be compliant with

state law. This is not applicable to the case at hand.

In this case, the name-brand manufacturer, GlaxoCline, already updated

their label, meaning that no unilateral action would have needed to be taken. In

addition, the changes to the FDCA added by the FDAAA allow generic

manufacturers to submit changes to the FDA themselves and the FDA may order a

change in the label. Furthermore, all generic companies have a duty of “sameness.”

Guidance from the FDA details that if a change is approved for a label of a name-

brand drug it will notify the generic manufacturer and a CBE should be presented

to the FDA within 30 days of that notification. Illinoza Products Liability Law

requires that a product have an adequate warning which is what the FDCA

governs. Therefore, it is not impossible for a generic manufacturer to comply with

both Illinoza Products Liability Law and the FDCA.

7

Furthermore, Congress did not intend to pre-empt state remedies to protect

consumers, meaning Illinoza Products Liability Law is not an obstacle to the

enforcement of the FDCA. To ensure patient/consumer safety, the FDCA mandates

“sameness” between the generic and name-brand pharmaceuticals. This “sameness”

ensures that consumers, whether taking the name-brand or generic version of a

drug, are aware of any potential side effects. When the labels are not the same, it

appears they are different substances when in fact they must be proven to be

equivalent in every regard to be approved. Illinoza Products Liability Law, which is

based on the Third Restatement of Torts, is aimed at protecting consumers from

any unreasonable harm. In addition, in the seventy-plus years the FDCA has been

in effect it has never implemented an express pre-emption clause for

pharmaceuticals. While this is not the end of a pre-emption analysis, it is telling

that Congress has enacted express pre-emption provisions for medical devices but

not for pharmaceuticals. As Illinoza Products Liability Law is neither an obstacle to

the purposes of Congress that were outlined in the FDCA, nor is it impossible to

abide by both the FDCA and Illinoza Products Liability Law, this case cannot be

pre-empted.

II. The Lower Courts Erred in Concluding That Attorney’s Fees Are Considered

Costs Pursuant to FRCP 41(d).

Costs do not include Respondent’s attorney’s fees because American courts

typically have each party pay their own costs and fees. While Rule 41(d) empowers

the Court to order a plaintiff who previously dismissed an action based on the same

claim against the same defendant to pay the defendant’s costs if it chooses, the

8

lower court failed to establish why the Court should alter the default rule in this

case. The availability of attorneys' fees therefore, requires a determination that,

“Congress intended to set aside this longstanding American rule of law.” Key Tronic

Corp., 511 U.S. at 815. There is no language in the text of Rule 41(d) indicating that

Congress intended to alter the American rule of law as the rule does not refer to

attorney’s fees as an awardable cost.

Rule 41(d)’s plain language does not indicate whether costs are intended to

include attorney’s fees. The Supreme Court has interpreted the lack of specificity in

other rules to include attorney’s fees where the underlying statute defines ‘costs’ to

include attorney’s fees. Applying that same reasoning to our case, a party may only

recover attorney’s fees as part of its costs under Rule 41(d) where the underlying

statute defines costs to include attorney’s fees.

Ivers’ initial claim was brought in the Western District of East Texas, but her

claim following her voluntary dismissal was in Illinoza. If the governing underlying

statute is East Texas Products Liability Law (“ETPLL”), costs are not defined to

include attorney’s fees for the defendant, and therefore, Rule 41(d) would not

include attorney’s fees. The Illinoza Products Liability Law does not explicitly

define costs, but follows the Third Restatement of Torts. The Restatement indicates

that damages in a tort action do not ordinarily include compensation for attorney’s

fees, unless a claim or defense is oppressive or harassing. Since neither the rule, nor

the statutes which the cause of action arise out of permits the payment of the

respondent’s attorney’s fees, Ivers is not required to pay Westerly’s attorney’s fees

9

under FRCP Rule 41(d).

Rule 41(d) is designed so that plaintiffs have an efficient mechanism to

dismiss a complaint early in the arc of litigation before defendants have expended

much effort, and that the dismissal not be used as a tool for harassment or

abuse. Courts may only order attorney’s fees without the authorization of Rule 41(d)

when petitioners have acted in a vexatious manner or in bad faith. Courts look at

the conduct of the parties to determine if behavior is vexatious or in bad

faith. Petitioners who voluntarily dismiss their claims early in the arc of litigation

in an attempt to strengthen their case before facing federal scrutiny are often found

not to be vexatious.

Ivers did not voluntarily dismiss her case in bad faith or in a vexatious

manner. Ivers voluntarily dismissed her complaint following the issuance of an

opinion for a case that bore similarities to Ivers’ case. It was not without reason or

excuse. Ivers dismissed her claim to build a stronger case that could survive the

scrutiny of the courts. Concluding that Ivers’ voluntary dismissal was performed in

bad faith or in a vexatious manner at such an early point of litigation would

frustrate the purpose of Rule 41(d).

ARGUMENT

I. STANDARD OF REVIEW

This court is reviewing the Twelfth Circuit’s affirmation of Dismissal based

on Motion for Judgement on the Pleadings as well as their reversal of a Motion for

an Award of Costs not including attorney’s fees according to FRCP 41(d), both of

10

which were granted in favor of the Respondent. This Court reviews a decision to

grant a Motion for Judgement on the Pleadings pursuant to FRCP 12(c) de novo,

using the same standard applied to dismissals under FRCP 12(b)(6) for failure to

state a claim upon which relief can be granted. Guise v. BWM Mortg., LLC, 377

F.3d 795, 798 (7th Cir. 2004); McCann v. Neilsen, 466 F.3d 619, 621 (7th Cir. 2006).

The court accepts the facts put forth in the complaint in the light most favorable to

the non-moving party. McCann, 466 F.3d at 621. This Court reviews the

interpretation of the proper scope of a Federal Rule of Civil Procedure as a question

of law de novo. Andrews v. America’s Living Ctrs., LLC, 827 F.3d 306, 309 (4th Cir.

2016).

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.

Pre-emption began with the Constitution’s Supremacy Clause which gave

enacted federal law the supreme, or pre-emptive, standpoint when examining

conflicts with state law. U.S. Const. art. VI, cl. 2. Both Mensing and Bartlett rest on

the pre-emption analysis of state tort law against the FDCA therefore the analysis

of pre-emption in this case must also hinge on that issue. Mensing, 564 U.S. at 613;

Bartlett, 133 S. Ct. at 2473. Analysis must first begin with the two pillars of this

Court’s pre-emption jurisprudence. Wyeth v. Levine, 555 U.S. 555, 565 (2009). First,

“the purpose of Congress is the ultimate touchstone in every pre-emption case.”

Wyeth, 555 U.S. at 565. Second, the Court assumes that Congress did not go

against the historic idea of the police powers of the states unless this purpose is,

11

“clear and manifest.” Id.

There must be conflict between the precedent in Mensing and Bartlett, where

the FDCA pre-empts state tort law, and the case at hand, based on Illinoza

Products Liability Law that is so strong it overcomes the assumption that Congress

intended them to “coexist.” Hillsborough County v. Automated Med. Labs., Inc., 471

U.S. 707, 716 (1985). A conflict of proportions large enough to necessitate pre-

emption exists when, “it is impossible for a private party to comply with both state

and federal requirements, or where state law stands as an obstacle to the

accomplishment of the full purposes and objectives of Congress.” Sprietsma v.

Mercury Marine, 537 U.S. 51, 64 (2002). Neither of these issues exist in this case.

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.

“Impossibility pre-emption is a demanding defense.” Wyeth, 555 U.S. at 573.

It must be proven that compliance with both federal and state law is an absolute

impossibility. Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 312, 142-43

(1963). Due to concerns surrounding federalism, courts apply a presumption against

pre-emption, even more so in areas the states normally occupy like health and

safety. Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996).

Ivers’ claim is that Westerly breached the duty owed to her under Illinoza

Products Liability Law, sections (1)(b) and (c) which provide that the

manufacturer’s product was unreasonably dangerous due to (b) defective design,

12

and (c) inadequate instructions or warnings. Illz. Prod. Liability Act. 1998-4(1). The

FDA interprets the FDCA’s portion regarding generic drug labeling in the effect

that the generic drug’s labeling must, be “consistent with that for the listed [brand-

name] drug.” 21 C.F.R. 314.150(b)(10). The FDAAA of 2007 changed the

regulations for generic companies regarding labeling. Mensing, 564 U.S. at 614 n.1.

Mensing chose not to address the FDAAA changes. Id. A pre-emption analysis

under the FDAAA and Illinoza Products Liability Law is applicable for this case as

pre-emption issues are issues of state law not suited for a blanketed, federal

approach. In re Reglan, 81 A.3d 80, 90 (2013).

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.

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. After the 2007 amendments the FDAAA made to the

FDCA, generic manufacturers were required to propose stronger labeling to the

FDA when necessary, and the FDA could give permission to change their labeling

unilaterally. 21 U.S.C. § 355(o)(4); Guvenoz v Target Corp., 391 Ill. Dec. 134, 147

(2015). Mensing expressly left the issue of pre-emption based on the FDCA with the

addition of the FDAAA for another case. Mensing, 564 U.S. at 614 n.1.

In 2007, the FDAAA amended the FDCA allowing generic manufacturers to

propose changes to their labeling unilaterally. Guvenoz, 391 Ill. Dec. at 417. This

means that products liability claims through state law would not be pre-empted due

13

to a generic manufacturer’s inability to unilaterally change a label to include more

accurate side effects. Id. All Mensing claims pre-dated the FDAAA; therefore, the

court expressed “no view on the impact of that legislation.” Reglan A.3d at 83. As

all claims in the case at hand arose after the implementation of the FDAAA, an

examination of state and federal law is necessary to determine pre-emption. (R. at

1-3.); Reglan, 81 A.3d at 84; Hassett v. Dafoe, 74 A.3d 202, 206 (2013).

In both Reglan and Hassett, when the brand name manufacturer discovered

a neurological disorder side effect, it made changes to strengthen the warning, but

these changes were not communicated in the generic’s label. Reglan, 81 A.3d at 84;

Hassett, 74 A.3d at 206. The court held that post-2007 issues had not been

expressly pre-empted through the impossibility doctrine. Reglan, 81 A.3d at 91;

Hassett, 74 A.3d at 213. The court reasoned that because both Mensing and Bartlett

did not address the FDAAA and each pre-emption analysis is a nuanced balance

between specific state law and federal law, those decisions could not be held as

binding on any cases concerning the FDCA post-2007. Reglan, 81 A.3d at 85, 90;

Hassett, 74 A.3d at 213, 217. Ensuring pre-emption of claims such as the one at

hand is not applied in a blanket-fashion, but rather on a case-by-case basis after

careful consideration of each state’s law to protect consumers. Reglan 81 A.3d at 90.

Accordingly, this Court should not base dismissal on pre-emption grounds on

the cases of Mensing and Bartlett. Instead the Court should conduct an

independent pre-emption analysis against the FDCA with the FDAAA and Illinoza

Products Liability Law because all portions of Ivers’ claim occurred post-

14

implementation of the FDAAA.

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.

Assuming arguendo that Mensing and Bartlett apply to the case at hand, it is

not impossible to adhere to the FDCA following the FDAAA, as well as Illinoza

Products Liability Law. The failure of an approved brand-name drug to

appropriately update its label pre-empts the generic drug company’s liability

regarding label inadequacy in most cases. Bartlett, 133 S. Ct. at 2476-77; Mensing,

564 U.S. at 614. When the brand-name drug updates its label, the generic company

has a duty to update their label as soon as possible. Fulgenzi v. PLIVA, Inc., 711

F.3d 578, 584 (2013). With the addition of the FDAAA, it is not impossible to adhere

to these regulations as well as Illinoza Products Liability Law.

It is impossible for a generic drug manufacturer to unilaterally change their

label according to 21 C.F.R. § 314.150(b)(10). Mensing, 564 U.S. at 614. In Mensing,

both patients began using a generic drug for treatment. Id. at 613. While both

patients suffered from adverse side effects, the generic company was unable to

change their labels as the brand-name manufacturers had not updated their

product labels. Id. At the time of the Mensing decision, the FDA interpreted that a

brand-name drug and its generic copy must always be the same and therefore have

an “ongoing federal duty of sameness.” Id. at 613-14. This is different than the case

at hand because GlaxoCline had already updated its label. (R. at 2.) Westerly

directly violated its federal duty of sameness by not updating its label directly after

15

GlaxoCline updated the brand-name ropidope label in June of 2011. (R. at 2,).

Therefore, Westerly also violated Illinoza Products Liability Law, based on the

Third Restatement of Torts, that provides relief after showing a product was

unreasonably dangerous due to an inadequate warning.

Bartlett considers strict liability in addition to a failure-to-warn claim when

ruling on impossibility pre-emption. Bartlett, 133 S. Ct. at 2472. The court in

Bartlett held that the only way liability through state law could be avoided was by

the generic brand unilaterally updating its labels which was pre-empted by the

FDCA. Id. at 2478. The changes the FDAAA made to the FDCA significantly

impacts pre-emption analyses for post-2007 causes of action.

After the FDAAA was enacted, generic manufacturers were required to

propose stronger labeling if needed, and the FDA could order the changes be made

unilaterally per the FDCA. 21 U.S.C. § 355(o)(4). This Court has found the FDA’s

views controlling unless they are erroneous, inconsistent, or there is reason to doubt

they reflect a fair judgment by the FDA. Mensing, 564 U.S. at 614-15. Assuming

Westerly was unaware that impulse control and compulsive behaviors were side

effects and therefore did not report it to the FDA as is required under 21 C.F.R. §

314.80, 314.81, and 314.98, the FDA would have notified Westerly that it had

approved a change to GlaxoCline’s labeling and that Westerly should submit a CBE

supplement to its ANDA “within 30 days” of the notification. (R. at 2.); see also

16

Mensing, 564 U.S. at 614-15. 2

Furthermore, it is the ANDA holder’s responsibility to ensure they maintain

its duty of sameness. Fulgenzi, 711 F.3d at 584. FDA guidance suggests that the

CBE process allows generic companies to change their label to match an updated

brand-name label. Mensing, 564 U.S. at 615. Westerly needed to start the process of

changing its label as soon as the decision from the FDA on GlaxoCline’s changes

were released. Westerly was on notice, and had they been performing their duty of

sameness diligently, would have submitted their CBE in a timelier manner as

“approval may be withdrawn from a generic manufacturer if the generic drug’s label

‘is no longer consistent with that for [the brand name].’” Mensing, 564 U.S. at 615.

It was not impossible for Westerly to comply both with the FDCA’s duty of

sameness and Illinoza Products Liability Law. The “foreseeable risk of harm posed

by the product could have been reduced or avoided by the provision of reasonable

warnings by the seller” as the FDCA requires. See Restatement (Third) of Torts:

Prod. Liab. § 2(c) (1998).3

B. Compliance With Illinoza Products Liability Law Does Not Impose An

Obstacle To The Purposes And Objectives Congress Set Forth In The FDCA.

2 See also FDA, GUIDANCE FOR INDUSTRY: SAFETY LABELING CHANGES – IMPLEMENTATION OF SECTION

505(O)(4) OF THE FD&C ACT 11 (July 2013),

http://www.fda.gov/downloads/drugs/guidancecomplanceregulatoryinformation/guidance/ucm250783.

pdf. The Court in Mensing used FDA industry guidelines to inform their decisions regarding the

reasonableness of manufacturer actions. The guidelines indicate that the FDA notify generic

manufacturers in the event that a brand-name manufacturer changes its label. Generic

manufacturers are to submit a CBE to amend their ANDA within 30 days of notification. 3 See also Restatement of the Law, Third, Torts: Product Liability. While the record does not provide

the Illinoza Products Liability Law in full detail, it indicates that for areas in which the Law is

silent, the Illinoza legislature usually intended to follow the Third Restatement of Torts. (R. at 15,

n.7.)

17

Like impossibility pre-emption, obstacle pre-emption is also a high threshold

to overcome. Gade v. National Solid Wastes Mgmt. Ass’n, 505 U.S. 88, 110 (1992).

Obstacle pre-emption is an inquiry into “whether the ordinary meanings of state

and federal law conflict,” not just a consideration of whether there is friction

between the two. Wyeth, 555 U.S. at 588. “The purpose of Congress is the ultimate

touchstone,” to determine whether there is an obstacle between state and federal

action. Medtronic, 518 U.S. at 485-86.

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.

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. The non

obstante portion of the Supremacy Clause of the Constitution states that a court

does not need to go any further than “the ordinary meaning” of a federal law to

accommodate the provisions of a state law that may conflict with it. Mensing, 564

U.S. at 622. Congress did not intend to pre-empt state remedies to protect

consumers. Wyeth, 555 U.S. at 574-75. State laws that protect consumers for

violations of the duty of sameness found in the FDCA do not conflict with the

objectives and purposes of federal drug policy. Fulgenzi, 711 F.3d at 586.

This Court need not go further than “the ordinary meaning” of the FDCA to

accommodate provisions in Illinoza Products Liability Law. The FDCA requires a

duty of sameness. Mensing 564 U.S. at 614; Bartlett, 133 S. Ct. at 2476.

“Sameness,” as defined in the Merriam-Webster dictionary is the quality or state of

18

being the same; uniformity. “Sameness,” Merriam-Webster Dictionary, n.d. Web. 19 Sept.

2017. To achieve this “uniformity” Westerly needed to have the same label as

GlaxoCline to ensure patient/consumer safety for consumers like Ivers. The

sameness would have protected patients and consumers much like Illinoza Products

Liability Law is intended to. “When the ‘ordinary meaning’ of federal law blocks a

private party from independently accomplishing what state law requires, that party

has established pre-emption.” Mensing, 564 U.S. at 622. This blockage is not

present in the case at hand. The duty of sameness imposed by the FDCA aligns with

the duty owed to consumers through the Illinoza Products Liability Law. There is

nothing in the FDCA which would block a private party from seeking an

accomplishment of what Illinoza state law requires.

Furthermore, when the FDCA was passed, it did not have an express pre-

emption clause. Fulgenzi, 711 F.3d at 585. While this is not dispositive of a pre-

emption analysis, it should be noted that Congress has yet to enact an express pre-

emption provision for prescription drugs, but rather, has enacted one for medical

devices. Id. Nothing in the text of the FDAAA “evidences an intent to achieve such

savings [by making generic drugs more readily available] at the cost of safety,

effectiveness, or consumer protection." Id.

There is no obstacle in the FDCA or Congress’ language which would pre-

empt Illinoza law. The two laws do not come in conflict with one another, but rather

operate parallel from one another. To consider Illinoza Products Liability Law pre-

empted in this case would come at the cost of patient and consumer safety.

19

III. THE LOWER COURTS ERRED IN CONCLUDING THAT ATTORNEY’S

FEES ARE CONSIDERED COSTS PURSUANT TO FRCP 41(D).

FRCP 41(d) does not explicitly state if attorney’s fees are awardable as costs.

Fed. R. Civ. P. 41(d). Generally, United States courts follow the American rule of

law for awarding attorney’s fees as costs; that is, each party pays their own way.

Key Tronic Corp. v. United States, 511 U.S. 809, 814 (1994). Attorney’s fees are not

lightly imposed as awardable costs. Key Tronic Corp., 511 U.S. at 814; Runyon v.

McCrary, 427 U.S. 160, 185 (1976). An exception to the American rule of law must

be well-qualified by statute and demonstrative case law. Key Tronic Corp., 511 U.S.

at 815. When interpreting a statute as to the award of attorney’s fees with costs,

courts generally turn to the plain language of the statute. Marek v. Chesny, 473

U.S. 1, 4 (1985). Rule 41(d) does not explicitly define costs, but similarly situated

FRCP only include attorney’s fees for the prevailing party, or if the statute

underlying the cause of action includes attorney’s fees in costs. Andrews, 827 F.3d

at 311. The lower courts failed to establish that either the Illinoza or Texas

Products Liability statutes include Westerly’s attorney’s fees as awardable costs.

Further, interpretations of the Restatement of Torts have not reached the

conclusion that attorney’s fees are awardable as costs to a respondent. Absent

authorization by Rule 41(d) or the underlying statute, a court may only order

attorney’s fees when a party has acted in a vexatious manner or in bad faith.

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

Attorney’s Fees As Costs In The American Rule Of Law.

Costs do not include Respondent’s attorney’s fees because American courts

20

typically have each party pay their own costs and fees. While Rule 41(d) empowers

the Court to order a plaintiff who previously dismissed an action based on the same

claim against the same defendant to pay the defendant’s costs if it chooses, the

Appellate court failed to establish why the Court should alter the default rule in

this case.

Attorney's fees generally are not a recoverable cost of litigation. Key Tronic

Corp., 511 U.S. at 814. The traditional American rule of law stipulates that parties

pay their own legal costs. Id. at 814; Runyon, 427 U.S. at 185. The availability of

attorneys' fees therefore requires a determination that “Congress intended to set

aside this longstanding American rule of law.” Key Tronic Corp., 511 U.S. at 815.

There is no language in the text of Rule 41(d) indicating that Congress intended to

alter the American rule of law as the rule does not refer to attorney’s fees as an

awardable cost. Esposito v. Piatrowski, 223 F.3d 497, 500 (7th Cir. 2000).

Recognizing the American rule, the lower courts did not provide a reason as to why

America’s longstanding rule should be altered for this case.

In other places in the FRCP, rules are explicit about including or excluding

attorney’s fees. Marek, 473 U.S. at 4. Rule 54 explicitly excludes attorney’s fees

from recovery. Fed. R. Civ. P. 54(d)(1). Rule 54(d) says, “costs—other than

attorney's fees—should be allowed to the prevailing party.” Fed. R. Civ. P.

54(d)(1). Rule 41(d) does not provide such specificity. Rule 41(d)(1) says, “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 order the

21

plaintiff to pay all or part of the costs of that previous action.” Fed. R. Civ. P.

41(d)(1). Rule 41(d)’s plain language does not indicate whether costs are intended to

include attorney’s fees.

Other rules have similar, imprecise language. Marek, 473 U.S. at 9. Rule

68(d) says, “if the judgment that the offeree finally obtains is not more favorable

than the unaccepted offer, the offeree must pay the costs incurred after the offer

was made.” Fed. R. Civ. P. 68(d). The Supreme Court has interpreted the lack of

specificity in Rule 68(d) to include attorney’s fees “where the underlying statute

defines ‘costs’ to include attorney’s fees.” Marek, 473 U.S. at 9. Applying that same

reasoning to the case at hand, a party may only recover attorney’s fees as part of its

costs under Rule 41(d) where the underlying statute defines costs to include

attorney’s fees. Esposito, 223 F.3d at 501; Andrews, 827 F.3d at 311. Like Rule 68,

Courts have awarded attorney’s fees for Rule 41(d) if the underlying substantive

law allows for attorneys' fees. Anders v. FPA Corp., 1995 U.S. Dist. LEXIS 19592,

12 (D.N.J .1995); Aloha Airline, Inc. v. Mesa Air Group, Inc., 2007 U.S. Dist. WL

2320672 (West 2007). Even when a statute is unclear, damages in a tort action do

not ordinarily include compensation for attorney fees, except for when a claim or

defense is oppressive or harassing. Restatement (Second) of Torts § 914 (1979).

Petitioner’s initial 2013 cause of action was brought in Texas pursuant to the

East Texas Products Liability Law (“ETPLL”). (R. at 22.) ETPLL allows attorney’s

fees as part of costs, but only indicates this provision for the petitioner. Id.;

Andrews, 827 F.3d at 311. The statute does not say anything about awarding

22

attorney’s fees to a respondent. Andrews, 827 F.3d at 311. If the governing

underlying statute is ETPLL, costs do not include attorney’s fees for the defendant,

and therefore, Rule 41(d) would not include attorney’s fees.

Petitioner’s claim following her voluntary dismissal was brought in the

District Court of Illinoza under the Illinoza Products Liability Law. (R. at 1). The

Illinoza Products Liability Law’s definition of costs is not included in the record, but

the Twelfth Circuit Opinion indicates that Illinoza closely follows the Restatement

of Torts for areas it does not explicitly discuss. (R. at 15, n. 7.) Restatement of Torts

discusses expenses of litigation. The Restatement indicates that damages in a tort

action do not ordinarily include compensation for attorney fees, unless a claim or

defense is oppressive or harassing. Restatement (Second) of Torts § 914.4 While the

Illinoza Products Liability Law is silent on the inclusion of attorney’s fees, it is

likely that they are not included in costs. Westerly has not included any evidence or

argument in support of this claim being oppressive or harassing, nor has either

lower court in their decisions.

Rule 41(d) permits the court to order the payment of the opposing party’s

costs if the petitioner voluntarily dismissed a similar claim with the same

defendant. The rule does not explicitly include attorney’s fees. The American rule of

law’s default is to have each party pay its own way. Since neither the rule, nor the

statutes which the cause of action arise out of permits the payment of the

respondent’s attorney’s fees, Ivers is not required to pay Westerly’s attorney’s fees

4 The Restatement (Third) of Torts does not discuss attorney’s fees or expenses of litigation, so the

Restatement (Second) remains the most current treatise on the matter.

23

under FRCP Rule 41(d).

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.

Rule 41(d) is designed so that plaintiffs have an efficient mechanism to

dismiss a complaint early in the arc of litigation before defendants have expended

much effort, and that the dismissal not be used as a tool for harassment or

abuse. Courts may only order attorney’s fees without the authorization of Rule 41(d)

when petitioners have acted in a vexatious manner or in bad faith. Respondent

failed to evidence that level of misconduct by the petitioner, and the lower courts

failed to indicate any such conduct.

Rule 41(d) creates a mechanism to dismiss a complaint early before

defendants have expended much effort. Andrews, 827 F.3d at 311. Generally, a

party may recover reasonable attorney’s fees as part of its costs under Rule 41(d)

only where the underlying statute defines costs to include attorney’s fees. Esposito,

223 F.3d at 501. When Rule 41(d) does not authorize attorney’s fees, a court may

award fees in addition to costs when the petitioner has ‘‘acted in bad faith,

vexatiously, wantonly, or for oppressive reasons.’’ Sanderson v. Spectrum Labs, Inc.,

248 F.3d 1159 (7th Cir. 2000); F.D. Rich Co., Inc. v. United States ex rel. Indus.

Lumber Co., 417 U.S. 116, 129 (1974). Courts have the authority to shift attorney’s

fees, but only in the extraordinary circumstances where bad faith or abuse can form

a basis for doing so. Hensley v. Alcon Labs., Inc., 277 F.3d 535, 543 (4th Cir. 2002).

The conduct of the parties determines if behavior is vexatious or in bad faith.

Andrews, 827 F.3d at 311. Courts look to the plain meaning of vexatious when

24

evaluating a situation. Andrews, 827 F.3d at 313. Petitioners who voluntarily

dismiss their claims early in the arc of litigation to strengthen their case before

facing federal scrutiny are often found not to be vexatious. Andrews, 827 F.3d at

313; Costin v. Ally Bank Corp., No. 7:13-CV-113-BO, 2013 WL 5603230, at *1

(E.D.N.C. Oct. 11, 2013).

The Court could still compel Ivers to pay Westerly’s costs if it found that

Ivers’ voluntary dismissal was vexatious or in bad faith. See Hensley, 277 F.3d at

543. Ivers did not voluntarily dismiss her case in bad faith or in a vexatious

manner. Courts look to the plain meaning of vexatious when evaluating a situation.

Andrews, 827 F.3d at 313. Black's Law definition of vexatious is “without

reasonable or probable cause or excuse.” In re 1997 Grand Jury, 215 F.3d 430, 436

(4th Cir. 2000). Ivers’ actions were not vexatious or in bad faith. Ivers voluntarily

dismissed her complaint before Westerly filed an answer following the issuance of

an opinion for a case that bore similarities to Ivers’ case. This is not without reason

or excuse. Ivers dismissed her claim to build a stronger case considering recent legal

developments that could survive the scrutiny of the court.

Concluding that Ivers’ voluntary dismissal was performed in bad faith or in a

vexatious manner at such an early point of litigation would frustrate the purpose of

Rule 41(d). Rule 41(d) creates a mechanism to dismiss a complaint early before

defendants have expended much effort, just as Ivers used it. Andrews, 827 F.3d at

311; Fed. R. Civ. P. 41(d). Ivers was operating within her ability in Rule 41(d). If the

Court concludes that Ivers’ voluntary dismissal was vexatious or in bad faith, it will

25

make the protections of Rule 41(d) moot for future plaintiffs and diminish the

strength of potential complaints that could have been improved through voluntary

dismissal.

Rule 41(d) is designed to protect both plaintiffs and defendants from

expending effort on a claim that will likely fail. To ensure this protection, Courts

may only order attorney’s fees when petitioners have acted in bad faith or in a

vexatious manner. Westerly never evidenced this level of misconduct by Ivers, and

the appellate court erred in deciding otherwise. Ivers was within the guidelines of

rule 41(d) when she voluntarily dismissed her complaint before Westerly filed its

answer. She should not be punished for utilizing rights granted to her through the

FRCP.

CONCLUSION

For the forgoing reasons, Petitioner respectfully requests that this Court 1)

reverse the Twelfth Circuit Court of Appeals and find that neither Mensing,

Bartlett, nor the FDCA pre-empt Illinoza Products Liability Law in this case, and 2)

reverse the Twelfth Circuit Court of Appeals, and find costs awarded under FRCP

41(d) do not include attorney’s fees.

Respectfully Submitted,

Team 2624

Attorneys for Petitioner

26

APPENDIX A

U.S.C.A. Const. Art. VI cl. 2

Clause 2. Supreme Law of Land

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 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.

27

APPENDIX B

Illz. Prod. Liability Act. 1998-4(1)

“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.”

28

APPENDIX C

Federal Food, Drug, and Cosmetic Act

21 U.S.C.A. § 355

§ 355. New drugs

(o) Postmarket studies and clinical trials; labeling

(1) In general

A responsible person may not introduce or deliver for introduction into interstate

commerce the new drug involved if the person is in violation of a requirement

established under paragraph (3) or (4) with respect to the drug.

(2) Definitions

For purposes of this subsection:

(A) Responsible person

The term “responsible person” means a person who--

(i) has submitted to the Secretary a covered application that is pending; or

(ii) is the holder of an approved covered application.

(B) Covered application

The term “covered application” means-

(i) an application under subsection (b) for a drug that is subject to section

353(b) of this title; and

(ii) an application under section 262 of Title 42.

(B) New safety information; serious risk

The terms “new safety information”, “serious risk”, and “signal of a serious risk”

have the meanings given such terms in section 355-1(b) of this title.

(3) Studies and clinical trials

(A) In general

29

For any or all of the purposes specified in subparagraph (B), the Secretary may,

subject to subparagraph (D), require a responsible person for a drug to conduct a

postapproval study or studies of the drug, or a postapproval clinical trial or

trials of the drug, on the basis of scientific data deemed appropriate by the

Secretary, including information regarding chemically-related or

pharmacologically-related drugs.

(B) Purposes of study or clinical trial

The purposes referred to in this subparagraph with respect to a postapproval

study or postapproval clinical trial are the following:

(i) To assess a known serious risk related to the use of the drug involved.

(ii) To assess signals of serious risk related to the use of the drug.

(iii) To identify an unexpected serious risk when available data indicates the

potential for a serious risk.

(C) Establishment of requirement after approval of covered application

The Secretary may require a postapproval study or studies or postapproval

clinical trial or trials for a drug for which an approved covered application is in

effect as of the date on which the Secretary seeks to establish such requirement

only if the Secretary becomes aware of new safety information.

(D) Determination by Secretary

(i) Postapproval studies

The Secretary may not require the responsible person to conduct a study

under this paragraph, unless the Secretary makes a determination that the

reports under subsection (k)(1) and the active postmarket risk identification

and analysis system as available under subsection (k)(3) will not be sufficient

to meet the purposes set forth in subparagraph (B).

(ii) Postapproval clinical trials

The Secretary may not require the responsible person to conduct a clinical

trial under this paragraph, unless the Secretary makes a determination that a

postapproval study or studies will not be sufficient to meet the purposes set

forth in subparagraph (B).

(E) Notification; timetables; periodic reports

(i) Notification

30

The Secretary shall notify the responsible person regarding a requirement

under this paragraph to conduct a postapproval study or clinical trial by the

target dates for communication of feedback from the review team to the

responsible person regarding proposed labeling and postmarketing study

commitments as set forth in the letters described in section 101(c) of the Food

and Drug Administration Amendments Act of 2007.

(ii) Timetable; periodic reports

For each study or clinical trial required to be conducted under this paragraph,

the Secretary shall require that the responsible person submit a timetable for

completion of the study or clinical trial. With respect to each study required to

be conducted under this paragraph or otherwise undertaken by the

responsible person to investigate a safety issue, the Secretary shall require the

responsible person to periodically report to the Secretary on the status of such

study including whether any difficulties in completing the study have been

encountered. With respect to each clinical trial required to be conducted under

this paragraph or otherwise undertaken by the responsible person to

investigate a safety issue, the Secretary shall require the responsible person to

periodically report to the Secretary on the status of such clinical trial

including whether enrollment has begun, the number of participants enrolled,

the expected completion date, whether any difficulties completing the clinical

trial have been encountered, and registration information with respect to the

requirements under section 282(j) of Title 42. If the responsible person fails to

comply with such timetable or violates any other requirement of this

subparagraph, the responsible person shall be considered in violation of this

subsection, unless the responsible person demonstrates good cause for such

noncompliance or such other violation. The Secretary shall determine what

constitutes good cause under the preceding sentence.

(F) Dispute resolution

The responsible person may appeal a requirement to conduct a study or clinical

trial under this paragraph using dispute resolution procedures established by

the Secretary in regulation and guidance.

(4) Safety labeling changes requested by Secretary

(A) New safety information

If the Secretary becomes aware of new safety information that the Secretary

believes should be included in the labeling of the drug, the Secretary shall

promptly notify the responsible person or, if the same drug approved under

subsection (b) is not currently marketed, the holder of an approved application

under subsection (j).

31

(B) Response to notification

Following notification pursuant to subparagraph (A), the responsible person or

the holder of the approved application under subsection (j) shall within 30 days--

(i) submit a supplement proposing changes to the approved labeling to reflect

the new safety information, including changes to boxed warnings,

contraindications, warnings, precautions, or adverse reactions; or

(ii) notify the Secretary that the responsible person or the holder of the

approved application under subsection (j) does not believe a labeling change is

warranted and submit a statement detailing the reasons why such a change is

not warranted.

(C) Review

Upon receipt of such supplement, the Secretary shall promptly review and act

upon such supplement. If the Secretary disagrees with the proposed changes in

the supplement or with the statement setting forth the reasons why no labeling

change is necessary, the Secretary shall initiate discussions to reach agreement

on whether the labeling for the drug should be modified to reflect the new safety

information, and if so, the contents of such labeling changes.

(D) Discussions

Such discussions shall not extend for more than 30 days after the response to

the notification under subparagraph (B), unless the Secretary determines an

extension of such discussion period is warranted.

(E) Order

Within 15 days of the conclusion of the discussions under subparagraph (D), the

Secretary may issue an order directing the responsible person or the holder of

the approved application under subsection (j) to make such a labeling change as

the Secretary deems appropriate to address the new safety information. Within

15 days of such an order, the responsible person or the holder of the approved

application under subsection (j) shall submit a supplement containing the

labeling change.

(F) Dispute resolution

Within 5 days of receiving an order under subparagraph (E), the responsible

person or the holder of the approved application under subsection (j) may appeal

using dispute resolution procedures established by the Secretary in regulation

and guidance.

(G) Violation

32

If the responsible person or the holder of the approved application under

subsection (j) has not submitted a supplement within 15 days of the date of such

order under subparagraph (E), and there is no appeal or dispute resolution

proceeding pending, the responsible person or holder shall be considered to be in

violation of this subsection. If at the conclusion of any dispute resolution

procedures the Secretary determines that a supplement must be submitted and

such a supplement is not submitted within 15 days of the date of that

determination, the responsible person or holder shall be in violation of this

subsection.

(H) Public health threat

Notwithstanding subparagraphs (A) through (F), if the Secretary concludes that

such a labeling change is necessary to protect the public health, the Secretary

may accelerate the timelines in such subparagraphs.

(I) Rule of construction

This paragraph shall not be construed to affect the responsibility of the

responsible person or the holder of the approved application under subsection (j)

to maintain its label in accordance with existing requirements, including

subpart B of part 201 and sections 314.70 and 601.12 of title 21, Code of Federal

Regulations (or any successor regulations).

(5) Non-delegation

Determinations by the Secretary under this subsection for a drug shall be made

by individuals at or above the level of individuals empowered to approve a drug

(such as division directors within the Center for Drug Evaluation and Research).

33

APPENDIX D

Food and Drug Administration Amendments Act of 2007

21 C.F.R. § 314.80

§ 314.80 Postmarketing reporting of adverse drug experiences.

(a) Definitions. The following definitions of terms apply to this section:

Adverse drug experience. Any adverse event associated with the use of a drug in

humans, whether or not considered drug related, including the following: An

adverse event occurring in the course of the use of a drug product in professional

practice; an adverse event occurring from drug overdose whether accidental or

intentional; an adverse event occurring from drug abuse; an adverse event occurring

from drug withdrawal; and any failure of expected pharmacological action.

Disability. A substantial disruption of a person’s ability to conduct normal life

functions.

Life-threatening adverse drug experience. Any adverse drug experience that places

the patient, in the view of the initial reporter, at immediate risk of death from the

adverse drug experience as it occurred, i.e., it does not include an adverse drug

experience that, had it occurred in a more severe form, might have caused death.

Serious adverse drug experience. Any adverse drug experience occurring at any

dose that results in any of the following outcomes: Death, a life-threatening adverse

drug experience, inpatient hospitalization or prolongation of existing

hospitalization, a persistent or significant disability/incapacity, or a congenital

anomaly/birth defect. Important medical events that may not result in death, be

life-threatening, or require hospitalization may be considered a serious adverse

drug experience when, based upon appropriate medical judgment, they may

jeopardize the patient or subject and may require medical or surgical intervention

to prevent one of the outcomes listed in this definition. Examples of such medical

events include allergic bronchospasm requiring intensive treatment in an

emergency room or at home, blood dyscrasias or convulsions that do not result in

inpatient hospitalization, or the development of drug dependency or drug abuse.

Unexpected adverse drug experience. Any adverse drug experience that is not listed

in the current labeling for the drug product. This includes events that may be

symptomatically and pathophysiologically related to an event listed in the labeling,

but differ from the event because of greater severity or specificity. For example,

34

under this definition, hepatic necrosis would be unexpected (by virtue of greater

severity) if the labeling only referred to elevated hepatic enzymes or hepatitis.

Similarly, cerebral thromboembolism and cerebral vasculitis would be unexpected

(by virtue of greater specificity) if the labeling only listed cerebral vascular

accidents. “Unexpected,” as used in this definition, refers to an adverse drug

experience that has not been previously observed (i.e., included in the labeling)

rather than from the perspective of such experience not being anticipated from the

pharmacological properties of the pharmaceutical product.

(b) Review of adverse drug experiences. Each applicant having an approved

application under § 314.50 or, in the case of a 505(b)(2) application, an effective

approved application, shall promptly review all adverse drug experience

information obtained or otherwise received by the applicant from any source,

foreign or domestic, including information derived from commercial marketing

experience, postmarketing clinical investigations, postmarketing

epidemiological/surveillance studies, reports in the scientific literature, and

unpublished scientific papers. Applicants are not required to resubmit to FDA

adverse drug experience reports forwarded to the applicant by FDA; however,

applicants must submit all followup information on such reports to FDA. Any

person subject to the reporting requirements under paragraph (c) of this section

shall also develop written procedures for the surveillance, receipt, evaluation, and

reporting of postmarketing adverse drug experiences to FDA.

(c) Reporting requirements. The applicant shall report to FDA adverse drug

experience information, as described in this section. The applicant shall submit two

copies of each report described in this section to the Central Document Room, 5901–

B Ammendale Rd., Beltsville, MD 20705–1266. FDA may waive the requirement for

the second copy in appropriate instances.

(1)(i) Postmarketing 15–day “Alert reports”. The applicant shall report each

adverse drug experience that is both serious and unexpected, whether foreign or

domestic, as soon as possible but in no case later than 15 calendar days of initial

receipt of the information by the applicant.

(ii) Postmarketing 15–day “Alert reports”—followup. The applicant shall

promptly investigate all adverse drug experiences that are the subject of these

postmarketing 15–day Alert reports and shall submit followup reports within 15

calendar days of receipt of new information or as requested by FDA. If

additional information is not obtainable, records should be maintained of the

unsuccessful steps taken to seek additional information. Postmarketing 15–day

Alert reports and followups to them shall be submitted under separate cover.

(iii) Submission of reports. The requirements of paragraphs (c)(1)(i) and (c)(1)(ii)

35

of this section, concerning the submission of postmarketing 15–day Alert

reports, shall also apply to any person other than the applicant (nonapplicant)

whose name appears on the label of an approved drug product as a

manufacturer, packer, or distributor. To avoid unnecessary duplication in the

submission to FDA of reports required by paragraphs (c)(1)(i) and (c)(1)(ii) of

this section, obligations of a nonapplicant may be met by submission of all

reports of serious adverse drug experiences to the applicant. If a nonapplicant

elects to submit adverse drug experience reports to the applicant rather than to

FDA, the nonapplicant shall submit each report to the applicant within 5

calendar days of receipt of the report by the nonapplicant, and the applicant

shall then comply with the requirements of this section. Under this

circumstance, the nonapplicant shall maintain a record of this action which

shall include:

(A) A copy of each adverse drug experience report;

(B) The date the report was received by the nonapplicant;

(C) The date the report was submitted to the applicant; and

(D) The name and address of the applicant.

(iv) Report identification. Each report submitted under this paragraph shall

bear prominent identification as to its contents, i.e., “15–day Alert report,” or

“15–day Alert report-followup.”

(2) Periodic adverse drug experience reports.

(i) The applicant shall report each adverse drug experience not reported under

paragraph (c)(1)(i) of this section at quarterly intervals, for 3 years from the

date of approval of the application, and then at annual intervals. The applicant

shall submit each quarterly report within 30 days of the close of the quarter (the

first quarter beginning on the date of approval of the application) and each

annual report within 60 days of the anniversary date of approval of the

application. Upon written notice, FDA may extend or reestablish the

requirement that an applicant submit quarterly reports, or require that the

applicant submit reports under this section at different times than those stated.

For example, the agency may reestablish a quarterly reporting requirement

following the approval of a major supplement. Followup information to adverse

drug experiences submitted in a periodic report may be submitted in the next

periodic report.

(ii) Each periodic report is required to contain: (a) a narrative summary and

analysis of the information in the report and an analysis of the 15–day Alert

reports submitted during the reporting interval (all 15–day Alert reports being

36

appropriately referenced by the applicant’s patient identification number,

adverse reaction term(s), and date of submission to FDA); (b) a FDA Form

3500A (Adverse Reaction Report) for each adverse drug experience not reported

under paragraph (c)(1)(i) of this section (with an index consisting of a line listing

of the applicant’s patient identification number and adverse reaction term(s));

and (c) a history of actions taken since the last report because of adverse drug

experiences (for example, labeling changes or studies initiated).

(iii) Periodic reporting, except for information regarding 15–day Alert reports,

does not apply to adverse drug experience information obtained from

postmarketing studies (whether or not conducted under an investigational new

drug application), from reports in the scientific literature, and from foreign

marketing experience.

(d) Scientific literature.

(1) A 15–day Alert report based on information from the scientific literature is

required to be accompanied by a copy of the published article. The 15–day

reporting requirements in paragraph (c)(1)(i) of this section (i.e., serious,

unexpected adverse drug experiences) apply only to reports found in scientific

and medical journals either as case reports or as the result of a formal clinical

trial.

(2) As with all reports submitted under paragraph (c)(1)(i) of this section,

reports based on the scientific literature shall be submitted on FDA Form 3500A

or comparable format as prescribed by paragraph (f) of this section. In cases

where the applicant believes that preparing the FDA Form 3500A constitutes an

undue hardship, the applicant may arrange with the Division of

Pharmacovigilance and Epidemiology for an acceptable alternative reporting

format.

(e) Postmarketing studies.

(1) An applicant is not required to submit a 15–day Alert report under

paragraph (c) of this section for an adverse drug experience obtained from a

postmarketing study (whether or not conducted under an investigational new

drug application) unless the applicant concludes that there is a reasonable

possibility that the drug caused the adverse experience.

(2) The applicant shall separate and clearly mark reports of adverse drug

experiences that occur during a postmarketing study as being distinct from

those experiences that are being reported spontaneously to the applicant.

(f) Reporting FDA Form 3500A.

(1) Except as provided in paragraph (f)(3) of this section, the applicant shall

complete FDA Form 3500A for each report of an adverse drug experience

37

(foreign events may be submitted either on an FDA Form 3500A or, if preferred,

on a CIOMS I form).

(2) Each completed FDA Form 3500A should refer only to an individual patient

or a single attached publication.

(3) Instead of using FDA Form 3500A, an applicant may use a computer-

generated FDA Form 3500A or other alternative format (e.g., a computer-

generated tape or tabular listing) provided that:

(i) The content of the alternative format is equivalent in all elements of

information to those specified in FDA Form 3500A; and

(ii) The format is agreed to in advance by MedWatch: The FDA Medical

Products Reporting Program.

(4) Ten copies or fewer of FDA Form 3500A and/or a copy of the instructions for

completing the form may be obtained from the Division of Pharmacovigilance

and Epidemiology (HFD–730), Center for Drug Evaluation and Research, Food

and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. More than

10 copies of the form may be obtained by writing to the Consolidated Forms and

Publications Distribution Center, Washington Commerce Center, 3222 Hubbard

Rd., Landover, MD 20785.

(g) Multiple reports. An applicant should not include in reports under this section

any adverse drug experiences that occurred in clinical trials if they were previously

submitted as part of the approved application. If a report applies to a drug for which

an applicant holds more than one approved application, the applicant should submit

the report to the application that was first approved. If a report refers to more than

one drug marketed by an applicant, the applicant should submit the report to the

application for the drug listed first in the report.

(h) Patient privacy. An applicant should not include in reports under this section

the names and addresses of individual patients; instead, the applicant should

assign a unique code number to each report, preferably not more than eight

characters in length. The applicant should include the name of the reporter from

whom the information was received. Names of patients, health care professionals,

hospitals, and geographical identifiers in adverse drug experience reports are not

releasable to the public under FDA’s public information regulations in part 20.

(i) Recordkeeping. The applicant shall maintain for a period of 10 years records of

all adverse drug experiences known to the applicant, including raw data and any

correspondence relating to adverse drug experiences.

(j) Withdrawal of approval. If an applicant fails to establish and maintain records

and make reports required under this section, FDA may withdraw approval of the

application and, thus, prohibit continued marketing of the drug product that is the

38

subject of the application.

(k) Disclaimer. A report or information submitted by an applicant under this section

(and any release by FDA of that report or information) does not necessarily reflect a

conclusion by the applicant or FDA that the report or information constitutes an

admission that the drug caused or contributed to an adverse effect. An applicant

need not admit, and may deny, that the report or information submitted under this

section constitutes an admission that the drug caused or contributed to an adverse

effect. For purposes of this provision, the term “applicant” also includes any person

reporting under paragraph (c)(1)(iii) of this section.

21 C.F.R. § 314.150

§ 314.150 Withdrawal of approval of an application or abbreviated application.

(a) The Food and Drug Administration will notify the applicant, and, if appropriate,

all other persons who manufacture or distribute identical, related, or similar drug

products as defined in §§ 310.6 and 314.151(a) of this chapter and for a new drug

afford an opportunity for a hearing on a proposal to withdraw approval of the

application or abbreviated new drug application under section 505(e) of the act and

under the procedure in § 314.200, if any of the following apply:

(1) The Secretary of Health and Human Services has suspended the approval of

the application or abbreviated application for a new drug on a finding that there

is an imminent hazard to the public health. FDA will promptly afford the

applicant an expedited hearing following summary suspension on a finding of

imminent hazard to health.

(2) FDA finds:

(i) That clinical or other experience, tests, or other scientific data show that the

drug is unsafe for use under the conditions of use upon the basis of which the

application or abbreviated application was approved; or

(ii) That new evidence of clinical experience, not contained in the application or

not available to FDA until after the application or abbreviated application was

approved, or tests by new methods, or tests by methods not deemed reasonably

applicable when the application or abbreviated application was approved,

evaluated together with the evidence available when the application or

abbreviated application was approved, reveal that the drug is not shown to be

safe for use under the conditions of use upon the basis of which the application

or abbreviated application was approved; or

(iii) Upon the basis of new information before FDA with respect to the drug,

39

evaluated together with the evidence available when the application or

abbreviated application was approved, that there is a lack of substantial

evidence from adequate and well-controlled investigations as defined in §

314.126, that the drug will have the effect it is purported or represented to have

under the conditions of use prescribed, recommended, or suggested in its

labeling; or

(iv) That the application or abbreviated application contains any untrue

statement of a material fact; or

(v) That the patent information prescribed by section 505(c) of the act was not

submitted within 30 days after the receipt of written notice from FDA specifying

the failure to submit such information; or

(b) FDA may notify the applicant, and, if appropriate, all other persons who

manufacture or distribute identical, related, or similar drug products as defined in §

310.6, and for a new drug afford an opportunity for a hearing on a proposal to

withdraw approval of the application or abbreviated new drug application under

section 505(e) of the act and under the procedure in § 314.200, if the agency finds:

(1) That the applicant has failed to establish a system for maintaining required

records, or has repeatedly or deliberately failed to maintain required records or

to make required reports under section 505(k) or 507(g) of the act and § 314.80,

§ 314.81, or § 314.98, or that the applicant has refused to permit access to, or

copying or verification of, its records.

(2) That on the basis of new information before FDA, evaluated together with

the evidence available when the application or abbreviated application was

approved, the methods used in, or the facilities and controls used for, the

manufacture, processing, and packing of the drug are inadequate to ensure and

preserve its identity, strength, quality, and purity and were not made adequate

within a reasonable time after receipt of written notice from the agency.

(3) That on the basis of new information before FDA, evaluated together with

the evidence available when the application or abbreviated application was

approved, the labeling of the drug, based on a fair evaluation of all material

facts, is false or misleading in any particular, and the labeling was not corrected

by the applicant within a reasonable time after receipt of written notice from the

agency.

(4) That the applicant has failed to comply with the notice requirements of

section 510(j)(2) of the act.

(5) That the applicant has failed to submit bioavailability or bioequivalence data

required under part 320 of this chapter.

(6) The application or abbreviated application does not contain an explanation of

40

the omission of a report of any investigation of the drug product sponsored by

the applicant, or an explanation of the omission of other information about the

drug pertinent to an evaluation of the application or abbreviated application

that is received or otherwise obtained by the applicant from any source.

(7) That any nonclinical laboratory study that is described in the application or

abbreviated application and that is essential to show that the drug is safe for

use under the conditions prescribed, recommended, or suggested in its labeling

was not conducted in compliance with the good laboratory practice regulations

in part 58 of this chapter and no reason for the noncompliance was provided or,

if it was, the differences between the practices used in conducting the study and

the good laboratory practice regulations do not support the validity of the study.

(8) Any clinical investigation involving human subjects described in the

application or abbreviated application, subject to the institutional review board

regulations in part 56 of this chapter or informed consent regulations in part 50

of this chapter, was not conducted in compliance with those regulations such

that the rights or safety of human subjects were not adequately protected.

(9) That the applicant or contract research organization that conducted a

bioavailability or bioequivalence study described in § 320.38 or § 320.63 of this

chapter that is contained in the application or abbreviated application refuses to

permit an inspection of facilities or records relevant to the study by a properly

authorized officer or employee of the Department of Health and Human Services

or refuses to submit reserve samples of the drug products used in the study

when requested by FDA.

(10) That the labeling for the drug product that is the subject of the abbreviated

new drug application is no longer consistent with that for the listed drug

referred to in the abbreviated new drug application, except for differences

approved in the abbreviated new drug application or those differences resulting

from:

(i) A patent on the listed drug issued after approval of the abbreviated new drug

application; or

(ii) Exclusivity accorded to the listed drug after approval of the abbreviated new

drug application that do not render the drug product less safe or effective than

the listed drug for any remaining, nonprotected condition(s) of use.

(c) FDA will withdraw approval of an application or abbreviated application if the

applicant requests its withdrawal because the drug subject to the application or

abbreviated application is no longer being marketed, provided none of the

conditions listed in paragraphs (a) and (b) of this section applies to the drug. FDA

will consider a written request for a withdrawal under this paragraph to be a

waiver of an opportunity for hearing otherwise provided for in this section.

Withdrawal of approval of an application or abbreviated application under this

41

paragraph is without prejudice to refiling.

(d) FDA may notify an applicant that it believes a potential problem associated with

a drug is sufficiently serious that the drug should be removed from the market and

may ask the applicant to waive the opportunity for hearing otherwise provided for

under this section, to permit FDA to withdraw approval of the application or

abbreviated application for the product, and to remove voluntarily the product from

the market. If the applicant agrees, the agency will not make a finding under

paragraph (b) of this section, but will withdraw approval of the application or

abbreviated application in a notice published in the Federal Register that contains a

brief summary of the agency’s and the applicant’s views of the reasons for

withdrawal.

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APPENDIX E

Federal Rules of Civil Procedure Rule 41

Rule 41. Dismissal of Actions

(a) 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 federal- or 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.

(b) Involuntary Dismissal; Effect. If the plaintiff fails to prosecute or to comply with

these rules or a court order, a defendant may move to dismiss the action or any

claim against it. Unless the dismissal order states otherwise, a dismissal under this

subdivision (b) and any dismissal not under this rule--except one for lack of

jurisdiction, improper venue, or failure to join a party under Rule 19--operates as an

adjudication on the merits.

43

(c) Dismissing a Counterclaim, Crossclaim, or Third-Party Claim. This rule applies

to a dismissal of any counterclaim, crossclaim, or third-party claim. A claimant’s

voluntary dismissal under Rule 41(a)(1)(A)(i) must be made:

(1) before a responsive pleading is served; or

(2) if there is no responsive pleading, before evidence is introduced at a hearing or

trial.

(d) 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 or part of the costs of that previous action;

and

(2) may stay the proceedings until the plaintiff has complied.