EMLEY v. WAL-MART STORES, INC.

UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF INDIANA

INDIANAPOLIS DIVISION

DONNA EMLEY, )

DENNIS EMLEY, )

)

Plaintiffs, )

)

v. ) No. 1:17-cv-02350-SEB-TAB

)

WAL-MART STORES, INC., )

L.N.K. INTERNATIONAL, INC., )

L. PERRIGO COMPANY, )

)

Defendants. )

ORDER DENYING DEFENDANTS’ PETITION FOR CERTIFICATION OF

INTERLOCUTORY APPEAL UNDER 28 U.S.C. § 1292(b)

This cause is before the Court on Defendants’ Petition to Certify Order for

Interlocutory Appeal1 [Dkt. 202; Dkt. 204], filed on July 26, 2019, pursuant to 28 U.S.C.

§ 1292(b) and Rule of App. Proc. 5(a)(3). Defendants seek certification for interlocutory

appeal of this Court’s Entry on Motions for Summary Judgment [Dkt. 199] with respect

to the single issue of whether Plaintiffs’ state law failure-to-warn claims are preempted

by federal law. For the reasons detailed in this entry, Defendants’ Motion is DENIED.2

1 Defendants L. Perrigo Company (“Perrigo”) and Wal-Mart Stores, Inc. (“Wal-Mart”) filed this

petition on July 26, 2019. Defendant L.N.K. International, Inc. (“L.N.K.”) moved to join the

petition as well as its co-defendants’ reply brief. [Dkt. 204, Dkt. 256]. L.N.K.’s Motions to Join

are granted.

2 On December 20, 2019, Plaintiffs filed a Notice of Supplemental Authority in support of its

opposition to Defendants’ Petition for Certification, which Defendant Perrigo sought to strike.

[Dkt. 319, Dkt. 321]. Because the Court has not relied on Plaintiffs’ newly submitted evidence in

ruling on Defendants’ petition, we deny as moot the Motion to Strike.

Background

The facts are largely undisputed and thus shall be reviewed only briefly here for

purposes of this ruling. On June 11, 2015, and again on June 12, 2015, Plaintiff Donna

Emley ingested two pills from a bottle of Equate-brand acetaminophen manufactured by

Defendant Perrigo, which she had purchased from a Wal-Mart near her home in Fort

Wayne, Indiana in 2013. On June 13, 2015, Ms. Emley noticed she had a mild rash that

worsened overnight, and her eyes became itchy and watery. Believing she was suffering

from an allergic reaction to something she had encountered during her recent travels to a

farm in Kentucky, she thought Benadryl would help. Her husband, Plaintiff Dennis

Emley, purchased Equate-brand Severe Allergy and Sinus Headache medicine from a

Wal-Mart in Tennessee. This product, manufactured by Defendant L.N.K., also contained

acetaminophen.

On June 14, 2015, after Ms. Emley’s symptoms had yet to improve, she sought

medical treatment at an urgent care center in Bowling Green, Kentucky. The attending

physician directed Ms. Emley to the Bowling Green Medical Center where she was

admitted for what turned into a five-day stay. On June 19, 2015, Ms. Emley was

transferred to the Vanderbilt University Medical Center where she was diagnosed with

Toxic Epidermal Necrolysis, a severe skin disorder associated with acetaminophen. She

remained hospitalized for nearly a month.

Ms. Emley has brought several state law claims against Defendants. Relevant here,

she has alleged that the Equate products were defective under the Indiana Products

Liability Act, Ind. Code. Ann. § 34-20-1-1, because their labels did not contain an

adequate warning regarding acetaminophen’s risk of severe skin reactions. Defendants

moved for summary judgment and invoked the affirmative defense of “impossibility

preemption,” arguing that compliance with federal regulations, specifically those relating

to the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 301 et seq, foreclosed their

liability for failure to add any such warning.

On June 27, 2019, we issued an order granting in part and denying in part

Defendants’ motions for summary judgment (“Summary Judgment Order”). We

specifically rejected Defendants’ contention that federal regulations preempted

Defendants’ addition of an allergy warning to the labels of their acetaminophen products.

Defendants now seek amendment of the Summary Judgment Order to include language,

pursuant to 28 U.S.C. § 1292(b), allowing the following question to be addressed on

immediate interlocutory appeal: Are Plaintiffs’ failure-to-warn claims against Defendants

preempted by federal law?

Analysis

District courts are empowered to certify an otherwise unappealable non-final order

for immediate appellate review if the order “involves a controlling question of law as to

which there is substantial ground for difference of opinion and that an immediate appeal

from the order may materially advance the ultimate termination of the litigation.” 28

U.S.C. § 1292(b). As the Seventh Circuit has explained, the statute contemplates that

certification for interlocutory appeal is appropriate only when certain criteria are present:

“there must be a question of law, it must be controlling, it must be contestable, and its

resolution must promise to speed up the litigation.” Ahrenholtz v. Bd. of Trs. of Univ. of

III., 219 F.3d 674, 675 (7th Cir. 2000) (emphasis in original). Additionally, the section

1292(b) petition “must be filed within a reasonable time after the order sought to be

appealed.” Ahrenholtz, 219 F.3d at 675-76 (emphasis in original). Unless all five criteria

are met, the district court is not authorized to certify its order for an immediate appeal. Id.

at 676.

The party moving for interlocutory appeal bears the heavy burden of persuading

the court “that exceptional circumstances justify a departure from the basic policy of

postponing appellate review until after the entry of a final judgment.” In re Bridgestone/

Firestone, Inc. Tires Prod. Liab. Litig., 212 F. Supp. 2d 903, 909 (S.D. Ind. 2002)

(emphasis in original). Interlocutory certification is the exception, not the rule, and thus

should only be granted “sparingly, and with discrimination,” Whitmore v. Symons Int'l

Grp., Inc., No. 1:09-CV-391-RLY-TAB, 2012 WL 3308990, at *1 (S.D. Ind. Aug. 13,

2012), and should not be invoked “merely to provide a review of difficult rulings in hard

cases.” Bridgestone/Firestone, Inc. 212 F. Supp. 2d at 909. We address each of these

prerequisites to certification below.

1. Whether the Preemption Question is One of Law

According to the Seventh Circuit’s guidance, “question of law’ as used in section

1292(b) refers to a question as to the meaning of a statutory or constitutional provision,

regulations, or common law doctrine. Ahrenholz, 219 F.3d at 676. Accordingly, an

interlocutory appeal is permissible only when the contested issue is “a ‘pure’ question of

law rather than merely an issue that might be free from factual contest.” Id. As the

Ahrenholz Court directed, “[D]istrict judges should . . . remember that ‘question of law’

means an abstract legal issue rather than an issue of whether summary judgment should

be granted.” Id.

Defendants here seek section 1292(b) certification of the question of whether

federal regulations preempted their compliance with Indiana’s products liability statute

with specific reference to the labeling requirements. They contend that this question,

which involves the interpretation of federal regulations, presents a pure question of law.

We agree. As such, the issue presented is of the type that readily qualifies as abstract and

wholly legal, as the Seventh Circuit has directed. Id. at 677 (citing United Airlines, Inc. v.

Mesa Airlines, Inc., 219 F. 2d. 605 (7th Cir. 2000)).

Plaintiffs disagree with this conclusion, arguing that “not all preemption

questions” are purely legal, particularly if they are of a “fact intensive nature.” Plaintiffs

cite the “scores of exhibits” Defendants have attached to their summary judgment briefs

as evidence of particular circumstances which would compel the appellate court to “hunt

through the record” to conduct a fact-sensitive inquiry in order to provide appellate

review of this Court’s decision.

Plaintiffs’ argument ignores the fact that our Summary Judgment Order did not

turn on the factual circumstances underlying the issue of whether Defendants could have

provided the disputed warning. Instead, our preemption ruling relied entirely on a legal

interpretation of the relevant regulations, FDA guidance, and applicable case law.

Utilizing this same approach, the Seventh Circuit could resolve the preemption issue here

“quickly and cleanly” without reviewing any factual findings. This question presented is

thus precisely the type of abstract legal issue contemplated by section 1292(b). In re Text

Messaging Antitrust Litig., 630 F.3d 622, 626 (7th Cir. 2010).

2. Whether the Preemption Question is Controlling and Contestable

Plaintiffs have not advanced an argument as to whether the preemption question

before us is controlling. We have no difficulty concluding that a resolution of the issue

presented “is quite likely to affect the further course of the litigation.” Sokaogon Gaming

Enter. Corp. v. Tushie-Montgomery Assocs., Inc., 86 F.3d 656, 659 (7th Cir. 1996). We

thus concur with Defendants that the preemption question here is, indeed, controlling and

shall next address whether it is contestable pursuant to section 1292(b), that is, the

dominant dispute between the parties.

To resolve this issue, we begin with a brief review of our prior decision which

Defendants seek to certify.

A. This Court’s Rejection of Defendants’ Preemption Defense on Summary

Judgment

As observed at summary judgment, federal law provides several options to

manufacturers for marketing drugs. Each option has its own distinct regulatory

framework. Depending on the regulatory framework applicable to a specific drug, a

manufacturer may be authorized to add warnings to drug labels unilaterally without FDA

permission, or, conversely, may be barred from adding any such warnings.

Consequently, the question of whether a manufacturer is preempted from complying with

state law depends on how the drug may be marketed under its applicable regulatory

framework.

For example, in Wyeth v. Levine, the Supreme Court held that the manufacturer of

a drug being sold pursuant to an approved New Drug Application (“NDA”) was not

preempted by federal law from complying with duties to warn imposed by state law. 555

U.S. at 571 (holding that “absent clear evidence that the FDA would not have approved a

change to [the drug’s] label, [it would] not conclude that it was impossible for Wyeth to

comply with both federal and state requirements.”) In contrast, the Supreme Court in

PLVA Inc. v. Mensing reached the opposite result with regard to the manufacturers of

generic drugs marketed under an Abbreviated New Drug Application (“ANDA”). 564

U.S. 604 (2011) (holding that generic drugs have a “duty of sameness” to match their

labels “at all times [to] the corresponding brand-name drug labels.”) PLIVA, 564 U.S. at

618.

Acetaminophen was not approved pursuant to the NDA or ANDA processes,

which were the regulatory schemes under review by the Supreme Court in Wyeth and

PLIVA, respectively. Rather, it is manufactured and sold pursuant to the Over-the-

Counter (“OTC”) Drug Monograph Review Process. As explained in full in our

Summary Judgment Order, the monograph process is an entirely separate regulatory

system developed to allow marketing of particular OTC drugs generally recognized as

safe and effective. A final monograph “constitutes final agency action from which appeal

lies to the courts.” 21 C.F.R. § 330.10(a)(11).

To date, however, no final monograph for acetaminophen has been enacted. Thus,

acetaminophen is regulated by a tentative final monograph issued more than thirty years

ago.3 This tentative final monograph does not contain any warnings relating to severe

skin reactions such as the one allegedly suffered by Ms. Emley. However, the FDA has

issued Communications and Guidance regarding the need for such warnings. Most

relevant here, the FDA issued a document entitled “Guidance for Industry:

Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products

and Labeling Statements Regarding Serious Skin Reactions” (“The Guidance”) in

November 2014.4 This Guidance stated that the FDA “does not intend to object to the

marketing of products containing the following warning language:”

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may

include:

• Skin reddening

• Blisters

• Rash

If a skin reaction occurs, stop use and seek medical help right away.

The Guidance also contained the following disclaimer:

This guidance represents the current thinking of the Food and Drug

Administration (FDA or Agency) on this topic. It does not establish any rights for

any person and is not binding on the FDA or the public.

We thus recognized in our Summary Judgment Order that the preemption issue

“hinge[d] on whether the Defendants had the ability to unilaterally add the warning at

issue to the labels of their products prior to the issuance of the Guidance without

violating federal law.”

3 Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human

Use; Tentative Final Monograph,” 53 Fed. Reg. 46204 (Nov. 16, 1988).

4 The Guidance can be found at https://www.fda.gov/media/90572/download.

Defendants, relying on 21 C.F.R. § 331.1(c)(2), argued that they were legally

bound to use only the “exact language” of the warnings established in the “applicable

monograph,” i.e., the tentative final monograph for acetaminophen, and to follow other

federal regulations related to monographs. Any failure to do so would result in their

products being deemed “misbranded,” and subject them to FDA enforcement actions,

fines, or criminal penalties. Plaintiffs rejected Defendants’ regulatory interpretation,

arguing that the term “applicable monograph” in section 331 was a reference to a final,

not tentative monograph. Accordingly, we addressed whether this provision demands

precise compliance when the monograph at issue had yet to be finalized.

After careful review of the applicable regulatory scheme, in light of the FDA’s

Guidance, we concluded that it does not, for the following reasons: the relevant

regulations do not authorize any enforcement actions based on non-compliance until after

a monograph is finalized, see 21 C.F.R. § 330.10(a)(9); 21 C.F.R. § 330.10(b);

Defendants had failed to identify any manufacturer or distributor operating under a

tentative final monograph that had ever faced regulatory consequences for deviating from

the “exact language” of a tentative final monograph;5 a tentative final monograph, by its

5 At summary judgment, Defendants asserted that “the FDA has, in fact, taken regulatory action

based upon the wording of drug warnings that it found to deviate from a tentative final

monograph,” citing to an FDA warning letter issued to Quadex Pharmaceuticals, LLC, in 2011

[Dkt. 86-20, Exh. 19]. We rejected this argument, finding that “the FDA’s position in that letter

was not that the product at issue was misbranded simply because its label was different from that

proposed in the applicable tentative final monograph; rather, the FDA found that the label

contained statements that were misleading.” In support of the present motion, Defendants

disagree with our interpretation of this letter, reasserting that the FDA has, in fact, taken such

regulatory action. We again reject Defendant’s contention; nothing in the letter indicates that the

FDA sought to take regulatory action simply because the product’s label deviated from its

very terms, has the legal status of a proposed rule and thus does not, as we have said,

wield the force and effect of federal law; acetaminophen was not subject to 21 C.F.R. §

330.13(b)(2), which authorizes regulatory action against manufacturers of certain drugs

that are not labeled in compliance with their corresponding tentative final monographs;

and, finally, draft guidance issued by the FDA in 2011 indicated that obligations to

comply with marketing requirements set out in a monograph do not attach until a final

monograph becomes effective.

Citing Wyeth, we concluded that we lacked any “clear evidence” that Defendants

would have faced adverse regulatory action by deviating from the exact language of the

tentative final monograph by adding an allergy warning to the acetaminophen products.

Accordingly, we held the doctrine of impossibility preemption did not shield Defendants’

from liability. This is the ruling which Defendants seek to have reviewed on a

preliminary basis by the Court of Appeals.

B. Contestability of the Issue

To justify an interlocutory appeal, section 1292(b) requires that there be a

“substantial ground for difference of opinion” as to the correct outcome. The parties’

disagreements reach this issue as well as to what this standard actually demands. They

are not alone in their disagreements; the district courts in our Circuit have reached

inconsistent conclusions as to what this standard entails, and the Seventh Circuit has not

yet expressly addressed the matter. Nat. Res. Def. Counsel v. Illinois Power Res., LLC,

tentative final monograph; the FDA issued the letter, with respect to the product’s labeling,

because the label conflated two forms of herpes, which rendered it misleading.

No. 1:13-CV-01181-JBM-TSH, 2016 WL 9650981, at *5 (C.D. Ill. Nov. 2, 2016)

(“Courts have differed in their interpretations of contestable . . .[It] is the most difficult of

the four requirements to determine.”); Van Straaten v. Shell Oil Prod. Co., LLC, 813 F.

Supp. 2d 1005, 1020 (N.D. Ill. 2011), rev’d and remanded on other grounds, 678 F.3d

486 (7th Cir. 2012) (“Courts have adopted different definitions of ‘contestable.’”).

“Ironically,” wrote one of our sister courts, “there may be substantial grounds of

difference of opinion regarding the standard which governs whether an issue of law is

‘contestable.’” In re Archdiocese of Milwaukee, 496 B.R. 905, 912 (E.D. Wis.

2013), rev’d and remanded on other grounds; Listecki v. Official Comm. of Unsecured

Creditors, 780 F.3d 731 (7th Cir. 2015). However, the prevailing approach adopted by

district courts, including ours, is to impose a rigid standard for “contestability” which can

be satisfied only in rare circumstances, such as when there is a “substantial likelihood”

that the district court’s order would be reversed on appeal. See Van Straaten, 813 F.

Supp. 2d at 1021; Novelty, Inc. v. Mountain View Mktg., Inc., No. 1:07-CV-01229-SEB-

JMS, 2010 WL 11561280, at *7 (S.D. Ind. Jan. 29, 2010); City of Joliet v. Mid-City Nat.

Bank, No. 05-C-6746, 2008 WL 4889038, at *2 (N.D. Ill. June 13, 2008). We share this

view that an issue is not contestable merely because reasonable judicial minds could

differ, nor is an issue contestable when the court is unguided by binding precedent. As we

previously ruled:

[T]he mere lack of judicial precedent on the issues does not establish substantial

ground for difference of opinion. Indeed, if interlocutory appeals were permissible

whenever there is merely the lack of judicial precedent, the effect would be no

more than to obtain an appellate stamp of approval on the ruling(s) by the trial

court. Instead, we examine the strength of the arguments in opposition to the

challenged ruling. This analysis includes examining whether other courts have

adopted conflicting positions regarding the issue of law proposed for certification.

BridgeStone/Firestone, 212 F. Supp. 2d at 910.

While Defendants’ request for permission to take an interlocutory appeal outlines

the basis for their disagreement with our Summary Judgment Order, it does not support a

finding that there are substantial grounds for differences among judicial opinions as to the

merits of these arguments.

Defendants rely on the lack of Seventh Circuit or Supreme Court precedent on the

precise question before us in arguing that the issues are contestable. This does not suffice,

however, since district courts, without contrary direction from the Seventh Circuit, have

routinely held that a party seeking to establish the element of “contestability” must show

more than the mere lack of precedent.6 Id. See also MetLife Inv’rs USA Ins. Co. v. Estate

of Lindsey, No. 2:16-CV-00097, 2018 WL 925252, at *2 (N.D. Ind. Feb. 15, 2018);

6 Defendants rely on Boim v. Quranic Literacy Inst. & Holy Land Found. For Relief And Dev.,

291 F.3d 1000, 1001 (7th Cir. 2002) to argue that an issue is contestable if it has not been settled

by controlling authority. There, the Seventh Circuit accepted an interlocutory appeal for

“questions of first impression” regarding the interpretation of a federal statute. The Boim court

did not address whether purely legal questions of first impression are always contestable.

However, we do not believe that the Seventh Circuit intended to create such a per se rule.

Indeed, later that same year, the Seventh Circuit rejected a party’s plea that this Court abused its

discretion in Firestone/Bridgestone when it denied certification of an order for interlocutory

appeal. In re Ford Motor Co., Bridgestone/Firestone N. Am. Tire, LLC, 344 F.3d 648, 654-55

(7th Cir. 2003). The standard established by Firestone/Bridgestone—that the lack of judicial

precedent does not render an issue contestable—has been regularly applied by district courts in

this Circuit when evaluating petitions for interlocutory appeal. Defendants also cite In re Text

Messaging Antitrust Litig. 630 F.3d 622, 626 (7th Cir. 2010). That case, however, is clearly

distinguishable. There, the Seventh Circuit observed that federal litigation was in such “ferment”

after pleading standards were altered by the Supreme Court’s decisions in Ashcroft v. Iqbal, 556

U.S. 662, 129 S. Ct. 1937, 173 L.Ed.2d 868 (2009) and Bell Atlantic Corp. v. Twombly, 550 U.S.

544, 127 S. Ct. 1955, 167 L.Ed.2d 929 (2007) that an interlocutory appeal could provide

necessary guidance. Here, no such “ferment” exists.

Webster v. Ctr. for Diagnostic Imaging, Inc., No. 1:16-CV-02677-JMS-DML, 2017 WL

5598286, at *3 (S.D. Ind. Nov. 21, 2017); Patrick v. Pyod, 2014 WL 5343284, at *1

(S.D. Ind. Oct. 20, 2014); Anderson v. Foster, No. 13-CV-256-JPS, 2013 WL 4523228,

at *3 (E.D. Wis. Aug. 27, 2013); Olympia Exp., Inc. v. Linee Aeree Italiane S.P.A., 437 F.

Supp. 2d 780, 791 (N.D. Ill. 2006), rev’d on other grounds, 509 F.3d 347 (7th Cir. 2007);

Bzdawka v. Milwaukee Cty., No. 04-C-0193, 2006 WL 8444975, at *1 (E.D. Wis. Apr. 6,

2006); United States v. NL Indus., Inc., No. 91-CV-578-JLF, 2005 WL 8173717, at *1

(S.D. Ill. July 12, 2005).

While questions left unanswered by controlling authorities may suffice in

exceptional circumstances to warrant an interlocutory appeal, we are not relieved by that

void from determining if such uncertainty warrants an exception to the normal, preferred

course of litigation that culminates in a final appeal. Section 1292(b) requests are not to

be granted merely to resolve difficult questions of law. See Pugh v. Nat’l Collegiate

Athletic Ass’n, No. 1:15-CV-01747-TWP-DKL, 2016 WL 7100606, at *6 (S.D. Ind. Dec.

6, 2016); Olympia Exp., Inc., 437 F. Supp. 2d at 791; Bzdawka, 2006 WL 8444975, at *1

(E.D. Wis. Apr. 6, 2006); BridgeStone/Firestone, 212 F. Supp. 2d at 910.

Regarding the strength of Defendants’ arguments against our holding, we examine

whether other courts have reached conclusions on the merits that are contrary to our own.

MetLife Inv’rs USA Ins. Co., 2018 WL 925252, at *2; Thompson v. Burnett, No. 1:15-

CV-01712-TWP-DML, 2017 WL 6606536, at *2 (S.D. Ind. Dec. 27, 2017); Collier v.

Caraway, No. 2:14-CV-00365-JMS-MJD, 2017 WL 2774493, at *2 (S.D. Ind. June 26,

2017); Anderson v. Foster, 2013 WL 4523228, at *3; Olympia Exp., Inc., 437 F. Supp. 2d

at 791; United States v. NL Indus., Inc., 2005 WL 8173717, at *1; BridgeStone/Firestone,

212 F. Supp. 2d at 910. Our review discloses that they have not.

Apparently, only one case, In re Tylenol (Acetaminophen) Mktg., Sales Practices

& Prod. Liab. Litig., 144 F. Supp. 3d 699 (E.D. Pa. 2015), addresses whether a tentative

final monograph possesses the force of federal law sufficient to preempt state law. In

Tylenol, the plaintiff alleged that the manufacturer of Tylenol (which contains

acetaminophen) failed to warn users of the risk of liver damage associated with

consuming acetaminophen. That court’s holding, unlike ours, turned on an examination

of the particular facts: the manufacturer had, in fact, changed its product’s label, thus

undermining the claim that it was “impossible” to do so. Although the court’s discussion

could likely have ended there, it noted: “Furthermore, Extra Strength Tylenol was and

still is regulated by the Tentative Final Monograph (TFM) which is only a proposed

rule.” As explained by the FDA in a letter to the manufacturer regarding the alterations of

dosage information on a label: “Under a TFM, manufacturers market products at their

own risk and are able to make voluntary adjustments taking into context the information

presented in the proposed TFM.” Thus, the court concluded, “the onus [is] on them[.]”

Id. at 730.

While Plaintiffs rely on these excerpts of the Tylenol decision to argue that the

Eastern District of Pennsylvania’s analysis aligns with our own, Defendants attempt to

distinguish the Tylenol case while concurrently asserting that a close reading of that

decision actually undercuts our holding. Defendants transmute the FDA’s statement in its

letter that voluntarily adjustments to products’ labels should “tak[e] into context the

information presented in the proposed TFM” into an indication that the FDA mandates

precise compliance with tentative final monographs. Thus, argue Defendants, the

evidence cited by the Tylenol court contradicts our holding. We disagree with this

approach. Nothing in the letter establishes that the FDA unequivocally mandates that

manufacturers match the “exact language” of tentative final monographs, nor did the

Tylenol court infer as much from the letter. The letter also does not undermine the

conclusions we reached as did the Eastern District of Pennsylvania that the legal effect of

a tentative final monograph is that simply of a proposed rule. We agree that there are

some aspects of the decision in Tylenol that make it distinguishable from our case, but

those distinctions do no undermine our case.

In any event, this single holding does not compel a decision to grant Defendants’

petition for interlocutory appeal. Defendants’ challenges to our regulatory interpretation

holding that “applicable monograph” means “final monograph” is unpersuasive.

Defendants fault us for failing to give the undefined term “applicable monograph” its

plain and unambiguous meaning, per the definition of “applicable” in Black’s Law

Dictionary, which they argue is broad enough to encompass the tentative final

monograph without disrupting the regulatory framework.7

We concede that questions of statutory interpretation can make an issue ripe for

contestability, but certification of an appeal is not available merely because reasonable

7 Black’s Law Dictionary (11th ed. 2019) defines the term “applicable” as: “1. Capable of being

applied; fit and right to be applied. 2. (Of a rule, regulation, law, etc.) affecting or relating to a

particular person, group, or situation; having direct relevance.”

minds might differ as to issues of statutory construction. See Pugh v. Nat’l Collegiate

Athletic Ass’n, 2016 WL 7100606, at *6; Bridgestone/Firestone, 212 F. Supp. 2d at 909

(rejecting Defendants’ argument that the contestability prong is satisfied whenever a

“reasonable appellate judge could vote for reversal” because “for any difficult question of

law, there are at least two supportable positions”). Here, Defendants’ argument as to why

“applicable monograph” should include “tentative monograph” does not foreclose

alternate reasonable inferences to the effect that “applicable monograph” does not include

tentative final monographs. We have held: Based on the plain language of the relevant

regulations, the “exact language” requirement and the consequences for non-compliance

do not attach until the effective date of the monograph, which does not exist until a

monograph is finalized. This interpretation reflects reading the regulations “as a whole,”

not “a series of unrelated and isolated provisions.” Arreola-Castillo v. United States, 889

F.3d 378, 386 (7th Cir. 2018). Defendants have not quarreled with this reasoning.

Our interpretation further is consistent with the obvious fact that the tentative final

monograph, as a proposed rule, does not have the force and effect of federal law and

consequently the power of preemption. This highlights the flaw in Defendants’ legal

theory. If the tentative final monograph did have the force and effect of a final regulation,

then Defendants would not have been permitted to deviate from its “exact language” by

virtue of the non-binding guidance from the FDA—which would not supersede codified

federal regulations such as the “exact language” provision. This approach would

effectively undermine the entire regulatory rule-making process.

Like the Wyeth court, we struggle to validate Defendants’ fear of regulatory action

when no such action, following the issuance of the tentative final monograph in 1988, has

ever been charged against a manufacturer who, absent some independent basis, merely

added a warning to a drug marketed under a tentative final monograph. Wyeth, 555, U.S.

at 570 (“And the very idea that the FDA would bring an enforcement action against a

manufacturer for strengthening a warning pursuant to the CBE regulation is difficult to

accept—neither Wyeth nor the United States has identified a case in which the FDA has

done so.”). We reject Defendants’ attempts to invoke such fear that our Court’s ruling

will prevent the FDA from taking any regulatory action against manufacturers operating

under tentative final monographs; as explained in our Summary Judgment Order, the

FDA maintains the ability to take enforcement actions against such manufacturers if it

believed labels are improper or misleading in some way.

Defendants stress the “novelty” of the issues presented here but fail to establish

how novelty alone warrants a departure from the preferred course of litigation

culminating in an appeal. While the relevant regulations do leave ample room for

reasonable disagreement as to the meaning of the term “applicable monograph,” this

disagreement, unsupported by conflicting authorities, does not indicate a substantial

likelihood that our Summary Judgment Order would be reversed on appeal. Accordingly,

we hold that the issue of whether Plaintiffs’ failure-to-warn claims are preempted by

federal law is not “contestable.”

CONCLUSION

Because the criteria for interlocutory appeal are conjunctive, not disjunctive, and

Defendants have failed to satisfy all of those requirements, their request for immediate

interlocutory appeal must be denied. Ahrenholz, 219 F.3d at 676. Defendants’ Petition for

Certification of Interlocutory Appeal [Dkt. 202] is accordingly DENIED.

Defendant L.N.K.’s Motions to Join [Dkt. 204, Dkt. 256] are GRANTED.

Defendant Perrigo’s Motion to Strike [Dkt. 321] is DENIED AS MOOT.

IT IS SO ORDERED.

Date:___ 1/8/2020 Fuh Gaus Barker

SARAH EVANS BARKER, JUDGE

United States District Court

Southern District of Indiana

Distribution:

Richard M. Barnes

GOODELL, DEVRIES, LEECH & DANN, LLP

rmb@ gdldlaw.com

Bonnie J. Beavan

GOODELL DEVRIES LEECH & DANN LLP

bjb @ gdldlaw.com

Nicholas Gene Brunette

REMINGER CO. LPA (Indianapolis)

nbrunette @reminger.com

Charles Andrew Childers

CHILDERS, SCHLUETER & SMITH, LLC

achilders @cssfirm.com

18

Brett T. Clayton

REMINGER CO. LPA (Indianapolis)

bclayton@reminger.com

Neil Edwards

CHILDERS, SCHLUETER & SMITH, LLC

nedwards@cssfirm.com

Jeff S. Gibson

WAGNER REESE, LLP

jgibson@wagnerreese.com

Sean L. Gugerty

GOODELL DEVRIES LEECH & DANN LLP

sgugerty@gdldlaw.com

Katherine M. Haire

REMINGER CO. LPA (Indianapolis)

khaire@reminger.com

Logan C. Hughes

REMINGER CO., LPA - College Park

lhughes@reminger.com

Haley Johnston

FROST BROWN TODD LLC (Indianapolis)

hjohnston@fbtlaw.com

Jonathan Andrew Knoll

COHEN & MALAD LLP

jknoll@cohenandmalad.com

Gregory L. Laker

COHEN & MALAD LLP

glaker@cohenandmalad.com

Mary Nold Larimore

ICE MILLER LLP (Indianapolis)

larimore@icemiller.com

Kevin C. Schiferl

FROST BROWN TODD LLC (Indianapolis)

kschiferl@fbtlaw.com