The anti-deference pro-preemption paradox at the U.S. Supreme Court: the business community weighs in. (2024)

CONTENTSINTRODUCTIONI. THE ROBERTS COURT UNDER SCRUTINY A. Pro-Business Agenda: A Simple Story 1. Hostility to State Tort Law 2. Hostility to the Administrative State B. Deference to Federal Agencies: A Paradox EmergesII. BUSINESS COMMUNITY AGENDA A. Agency Deference 1. Vacillating Positions on Auer Deference a. Reliance on Auer Deference b. Rejection of Auer Deference 2. Steadfast Resistance B. Implications for Federal Preemption 1. Traditional Business Position: Deference to FDA Supports Pro Preemption View 2. Whither Steadfast Resistance to Auer? a. Auer Deference Wielded to Support Preemption b. Preemption ReconsideredCONCLUSION: WHAT THE FUTURE HOLDS

INTRODUCTION

Much has been written about the alleged pro-business bias of theRoberts Court. (1) According to various commentators, two indicia of theCourt's pro-business leanings are, first, its readiness to findstate tort law preempted by federal law and, second, its skepticismtoward Auer deference to federal agencies. (2)

Whether or not these discrete jurisprudential trends support apro-business agenda, there is an inherent tension between them. It isdifficult to reconcile individual Justices'--particularly thoseidentified as part of the "conservative core"--pro-preemptionpositions and anti-Auer positions, and this tension suggests that theoft-advanced pro-business narrative warrants a closer look.

The tension is on clearest display in drug preemption cases, whereeven the most anti-agency deference Justices readily defer to the Foodand Drug Administration (FDA), particularly when the agency'sinterpretation of its own regulations under Auer is at issue. (3) Whatexplains this seeming paradox? One plausible hypothesis is that theconservative core Justices' antipathy toward common law tortregulation runs even deeper than their hostility toward regulation byfederal agencies. (4) Indeed, various contemporary arguments for"taming the administrative beast have a distinctly deregulatorythrust" (5)--namely, the object of vilification is regulationitself, whether by agency or common law. But when forced to choose apoison, the Justices side with the agency (FDA) over common law tort.

How does unearthing this seeming paradox affect the conventionalnarrative of the pro-business Roberts Court? Perhaps the conservativecore Justices have indeed followed business interests, which resistregulation of all forms, but when forced to choose would prefer a singlefederal regulator over multiple forms of state regulation, includingcommon law tort. If this were so, then examination of the business groupbriefs before the U.S. Supreme Court should reflect the sameparadox--namely advocating in favor of more preemption, includingpreemption by agency action, while simultaneously pushing forreconsideration of Auer deference.

This Article examines the extent to which the business community isinvolved in, and is perhaps even playing a role in perpetuating, thisparadox. An examination of recent U.S. Supreme Court cases thatimplicate questions of Auer deference explodes the very notion of apredictable, uniform "business community" position. Dependingon the substantive issues at hand, business groups' amicus briefscan be found on either side of the Auer deference question: advocatingfor it in some instances, and vociferously opposing it in others. In andof itself, this lack of uniformity is not a surprise; the position takenwith respect to Auer deference tends to be the one that best advancesthe particular business group's interests at stake in thatparticular case.

There are, however, two stalwart outliers: The U.S. Chamber ofCommerce and the National Federation of Independent Businesses (the"Chamber" and "NFIB," respectively). No matter thecase, these groups steadfastly resist Auer deference. Indeed, theChamber has been consistent in its opposition to agency deference evenwhen the agency interpretation at issue ostensibly advances itsmembers' interests. (6)

Many business groups involved in cases where questions of Auerdeference rear their head tend not to be involved in FDA/federalpreemption cases. (7) On the flip side, there are a good number ofbusiness groups who intervene only in FDA/federal preemption cases yethave had rare, if any, involvement in cases concerning A uer deferenceoutside the preemption context. (8)

But two business groups have members with interests in both linesof cases: the Chamber and the Pharmaceutical Research and Manufacturersof America ("PhRMA"), which represents "thecountry's leading biopharmaceutical researchers and biotechnologycompanies." (9) It should come as no surprise that these groupsconsistently advocate for preemption, as do most or all business groupswho submit amicus briefs in drug preemption cases. What is of especiallygreat interest here, however, is the degree to which thesegroups'--particularly the Chamber's--passionate, consistentadvocacy against Auer deference is matched by their passionate,consistent advocacy in favor of preemption. As is explored in greaterdetail below, (10) these groups not only advocate for preemption, butoften explicitly ground their arguments on principles of agencydeference, even while railing against the notion of deference toagencies outside the preemption context.

These groups appear to be taking some steps to harmonize theirapproaches towards these lines of cases. The Chamber and PhRMA submitteda joint amicus brief in the most recent drug preemption case, (11) inwhich they advanced preemption arguments, but--strategically--did notground those arguments on agency deference principles. (12) It remainsto be seen whether they will continue to chip away at the paradox infuture briefs, and do so by advocating against agency deference acrossthe board.

It also remains to be seen how, if at all, this will affect theCourt going forward. Perhaps complicating this question most of all isthe totally unknown landscape that lies ahead in the era of PresidentTrump, who has enthusiastically voiced his own anti-regulatory views andhas stacked his agency appointments accordingly. Will the businesscommunity continue to feel the need to advocate against agency deferencewhen agencies may be mere regulatory shadows of their former selves?Alternatively, might the business community shift strategic gearsaltogether and adjust its focus away from litigation and towardslobbying Congress and agencies for clearer language, thus obviating theneed for courts to defer to any agency interpretation at all? Perhapsthis thorny paradox may vanish naturally, and relieve the Court of any(as-yet unacknowledged) burden to parse through it.

I. THE ROBERTS COURT UNDER SCRUTINY

The conventional narrative of the pro-business Roberts Court hasits limits. The Roberts Court has undoubtedly articulated pro-businesspositions firmly against onerous agency regulation and against manystate law claims. However, the Court's attack on agency deferenceand fear of a proliferating administrative state oddly vanishes when itcomes to federal preemption cases involving the FDA. Even the mostconservative Justices freely praise the FDA as the optimal regulator ofpublic health and safety. (13)

A. Pro-Business Agenda: A Simple Story

Two story lines have emerged in the pro-business narrative of theRoberts Court. First, the business community has rallied in favor offederal preemption of state tort law claims against manufacturers.Second, the business community has united in its opposition toburdensome federal regulation of business enterprises. And, in distinctlines of jurisprudence, the U.S. Supreme Court has seemed to followsuit.

1. Hostility to State Tort Law

Numerous commentators have fit the U.S. Supreme Court'sfederal preemption jurisprudence into a neat pro-business, anti-consumernarrative. (14) A spotlight has been shone on the recent spate ofpreemption cases involving prescription medical devices and drugs.

Riegel v. Medtronic, Inc. (15) was a watershed moment in federalpreemption jurisprudence, as the U.S. Supreme Court signaled that, goingforward, it would read "requirements" in a statutorypreemption provision to include state common law tort claims. (16)Charles Riegel sued Medtronic under state law for its alleged negligencein designing, manufacturing, and labeling a catheter. (17) The U.S.Supreme Court agreed with Medtronic--and the United States and variousbusiness groups as amici (18)--that these state law claims wereexpressly preempted by the Medical Device Amendments (MDA) to the FoodDrug & Cosmetic Act. (19)

Turning from medical devices to prescription drugs, in Wyeth v.Levine, (20) Diana Levine brought a state tort law failure-to-warn claimagainst brand-name drug manufacturer Wyeth for serious injuries thatoccurred after administration of an anti-nausea drug. (21) Wyeth arguedthat Ms. Levine's claim was preempted because the FDA had approvedthe warning label on the drug. (22) The U.S. Supreme Court rejectedWyeth's position, notwithstanding support by the United States andseveral business groups as amici. (23) But the Court then reversedcourse with respect to preemption of claims against generic drugmanufacturers. In PLIVA, Inc. v. Mensing, (24) Gladys Mensing and JulieDemahy filed state law failure-to-warn suits against the manufacturer oftheir generic digestion medication. (25) PLIVA argued that generic drugsare required by federal law to have the exact same labeling as theirbrandname equivalents, and thus the plaintiffs claims were preemptedbecause PLIVA, a generic drug manufacturer, could not have unilaterallyadded any additional warnings onto the drug's label. (26) The U.S.Supreme Court sided with PLIVA (27and various business groups as amici,but this time, against the United States's position). (28) And, inMutual Pharmaceutical Co. v. Bartlett, (28) Karen Bartlett, brought astate design defect liability claim against a generic drug manufacturer.(30) Once again, the U.S. Supreme Court held that the state law claimwas preempted by federal law regulating the manufacture of generic drugs(31)--a position backed by various business groups as amici, (32) aswell as the United States's position. (33)

The Constitutional Accountability Center ("CAC" (34))describes Wyeth, PLIVA, and Mutual Pharmaceutical as a "trio ofdecisions addressing prescription drug safety ... illustrating] thepractical importance and real-world effects of the Roberts Court'sbusiness cases, with Chief Justice Roberts voting with the businesscommunity in all three." (35)

Wyeth may seem an odd starting point given that the majority, perJustice Stevens, rejected all of the drug manufacturers' preemptionarguments. (36) But CAC characterizes Wyeth as "a powerful exampleof a case in which Chief Justice Roberts wanted to move the law in aprobusiness direction, but members of the conservative wing--in thiscase, Justices Kennedy and Thomas--balked." (37)

PLIVA and Mutual Pharmaceutical raise similar state tort claims,but against generic, as opposed to brand-name, prescription drugmanufacturers. In both of these cases, the U.S. Supreme Court majorityholds that the state law failure to warn and design defect claims,respectively, were preempted by federal law. (38) Once again, fittingthe compact narrative, CAC concludes that "[i]n the end, althoughthe legal issues in PLIVA and Mutual Pharmaceutical may be complicated,the bottom line is easy enough to understand: by siding with thebusiness community, Chief Justice Roberts and his conservativecolleagues closed the courthouse doors to certain patients who have beenseverely injured by generic drugs." (39)

2. Hostility to the Administrative State

A second pro-business narrative highlights efforts by the businesscommunity to unite in opposition to aggressive federal regulation.Industry groups commonly decry "executive overreach." (40)Free-market advocacy groups warn that "[millions of Americans aresuffering under the weight of burdensome regulation." (41)

Business group hostility towards federal regulation has translatedinto questioning or opposing judicial deference to agency decisions.According to the Chamber of Commerce, the "U.S. business communityhas become increasingly concerned in recent years about the consequencesof courts granting too much deference to regulatory decisions made byfederal agencies." (42) The Chamber has therefore voiced its"strong[] support[] [for] congressional efforts to restrainexcessive judicial deference to agency decision making." (43) Norare such concerns limited to groups representing big business. Indeed,small businesses complain that they are "disproportionately harmedby overreaching, costly federal regulations." (44)

The hostility towards Auer deference exhibited by the U.S. SupremeCourt's conservative core is seemingly in line with the thrust ofthe business community's position. Sixteen years after writing theAuer decision, the late Justice Scalia, in Decker, railed against thisdoctrine of deference to agency interpretations of their ownregulations, which he termed "a dangerous permission slip for theabrogation of power." (45) Elaborating further, Justice Scaliawarned: "[w]hen the legislative and executive powers are united inthe same person ... there can be no liberty; because apprehensions mayarise, lest the same monarch or senate should enact tyrannical laws, toexecute them in a tyrannical manner." (46)

Before Justice Scalia's untimely death, there was mountingsupport amongst the conservative core Justices for revisiting Auer. InPerez v. Mortgage Bankers Ass'n, (47) Justice Alito empathized withthe D.C. Circuit's creation of the Paralyzed Veterans doctrine,which required an agency seeking to amend a substantive interpretiverule to comply with notice-and-comment rulemaking procedures, suggestingit was:

 prompted by an understandable concern about the aggrandizement of the power of administrative agencies as a result of the combined effect of (1) the effective delegation to agencies by Congress of huge swaths of lawmaking authority, (2) the exploitation by agencies of the uncertain boundary between legislative and interpretive rules, and (3) this Court's cases holding that courts must ordinarily defer to an agency's interpretation of its own ambiguous regulations. (48)

Justice Thomas characterized Auer as "a transfer of thejudge's exercise of interpretive judgment to the agency." (49)Justice Scalia, perhaps emboldened by support from his conservativebrethren, made a pitch for altogether abandoning the doctrine:"[T]here are weighty reasons to deny a lawgiver the power to writeambiguous laws and then be the judge of what the ambiguity means. Iwould therefore restore the balance originally struck by the APA withrespect to any agency's interpretation of its own regulations ...by abandoning Auer...." (50)

B. Deference to Federal Agencies: A Paradox Emerges

Thus far, the pro-business Roberts Court story line seems fairlystraightforward--namely the Court has, by and large, acceded to thebusiness community's interests in resisting common law tort claimsagainst manufacturers and stemming the tide of administrativeregulations. But obscured from this conventional narrative isconsideration of a paradox that emerges when the Court'spro-preemption and anti-deference lines of jurisprudence seem tocollide. Namely, the conservative core Justices' attack on agencydeference and wider distaste for and distrust of the administrativestate is suspended in federal drug preemption cases, in which they giveenormous deference to the FDA. No doubt this reflects the Justices'hostility toward the common law of torts as a regulator. Indeed, theJustices repeatedly emphasize the institutional advantages of aregulatory scheme enforced by such an expert agency as the FDA. (51)They herald the FDA's broad perspective on larger public healthgoals over myopic juries that focus only on the injured plaintiff beforethem when deciding state tort law claims. (52) The Justices'reliance on Auer deference in this preemption line of jurisprudencestands in sharp contrast to the emerging line of cases calling forAuer's demise.

Consider Wyeth v. Levine, the case in which the majority rejectedpreemption of state law tort claims against a brand-name manufacturer.(53) In a vehement dissent, Justice Alito, joined by Chief JusticeRoberts and Justice Scalia, criticized the majority for "turning acommon-law tort suit into a 'frontal assault' on theFDA's regulatory regime for drug labeling," (54) embracing the"frontal assault " terminology from the United States'samicus brief in support of Wyeth. (55) The dissenting Justices showed nohesitation in giving the FDA far-reaching deference--in this case,relying on the agency's view as put forth in a preamble to aregulation. (56) This expansive view of deference to the underlyingfederal regulator is not easily reconciled with the conservativecore's attack on the administrative state. (57)

The starkest example to date is the puzzling persistence of Auerdeference as a pillar of preemption in the generic drug context. InPLIVA v. Mensing, in a majority opinion by Justice Thomas, the Courtdefers to the FDA: "[t]he FDA ... tells us that it interprets itsregulations to require that the warning labels of a brand-name drug andits generic copy must always be the same--thus generic drugmanufacturers have an ongoing federal duty of'sameness.'" (58) In so doing, the Justices invoke Auerdeference repeatedly (and with no hesitation): "The FDA'sviews are 'controlling unless plainly erroneous or inconsistentwith the regulation[s]' or there is any other reason to doubt thatthey reflect the FDA's fair and considered judgment." (59) Asa result, the Court "deferred] to the FDA's interpretation ofits CBE ['changes being effected' drug labeling regulation]and generic labeling regulations." (60)

II. BUSINESS COMMUNITY AGENDA

A closer look at the recent cases implicating A uer deferenceundercuts the very notion of a "business community" positionon the issue. Depending on the matter at hand, the particular businessgroup(s) whose members are affected, and the relevant agency'sinterpretive position on the regulation at issue, business groups mightjust as likely advocate in favor of deference as against it. The twooutliers are the Chamber of Commerce and the National Federation ofIndependent Businesses, who consistently oppose Auer deference.

A. Agency Deference

Business groups on the whole have deployed Auer deference argumentsstrategically, invoking Auer when the federal regulator's positionaligns with the business interest at stake while attempting to limit oreven disparage the doctrine when the federal regulator is at odds withthe relevant business interest. It would thus seem that there is not aconsistent or monolithic pro-business hostility to Auer deference.

Against this backdrop, however, the Chamber has consistentlyopposed Auer deference. (61) And the NFIB--representing 350,000 memberbusinesses as the nation's leading small business association--hasidentified Auer deference as the prime target of its attack. (62)

1. Vacillating Positions on Auer Deference

a. Reliance on Auer Deference

Several high-profile U.S. Supreme Court cases illustrate wheregroups representing business and industry interests urged the Court toratify, and even expand, Auer deference principles.

The American Bankers Association--representing small, regional, andlarge banks throughout the United States (63)--has made its endorsementof Auer deference plain, at least in cases in which deference to theposition espoused by the Federal Reserve Board supports its ownposition.

In Chase Bank USA, N.A. v. McCoy, (64) a plaintiff class of creditcard holders sued defendant Chase Bank, alleging that it had violatedthe Truth in Lending Act (TILA) by increasing interest ratesretroactively after credit accounts were closed. (65) The Ninth CircuitCourt of Appeals ruled in favor of the credit card holders,notwithstanding the fact that the Federal Reserve Board interpreted itsown "Regulation Z" of TILA as not requiring a creditor toprovide cardholders with a change-of-term notice. (66) On appeal to theU.S. Supreme Court, the Federal Reserve Board also filed an amicus briefin support of Chase. (67)

The American Bankers Association sharply criticized the NinthCircuit for failing to defer to the Federal Reserve Board'sinterpretation of its own regulation. (68) "In terms ofpolicy," the American Bankers Association argued, "the NinthCircuit's failure to defer to interpretive statements by the Boardundermines the banking industry's ability to rely on theBoard's expertise in a 'highly technical' area of the lawwhere 'creditors need sure guidance.'" (69) The AmericanBankers Association invoked the "long line of cases beginning with[Seminole Rock, the precursor to the Auer doctrine], [in which] theCourt has held that where an agency interprets its own regulations,'the ultimate criterion is the administrative interpretation, whichbecomes of controlling weight unless it is plainly erroneous orinconsistent with the regulation.'" (70) Quoting Auer, theAmerican Bankers Association insisted that "deference to anagency's interpretation of its own regulations is warranted so longas the interpretation 'reflect[s] the agency's fair andconsidered judgment on the matter in question."' (71)

The American Bankers Association was equally emphatic thatdeference was due even to informally issued agency interpretations. (72)It took the opportunity to remind the U.S. Supreme Court that the Courthad "been willing to defer to agency interpretations of regulationswhere they appear in a legal brief, or in an 'AdvisoryMemorandum' issued only to internal agency personnel and which theagency appeared to have written in response to pending litigation."(73) And it lamented that the Ninth Circuit's decision "callsinto question the continued ability of financial institutions toreasonably--and safely--rely on anything other than formal statements orguidance issued by the Board via notice and comment rulemaking."(74)

In Talk America, Inc. v. Michigan Bell Telephone Co., (76) SprintNextel and Comptel, two telecommunications corporations that benefitedfrom a Federal Communication Commission interpretation, likewise arguedfor Auer deference. (76) In that case, Michigan Bell, a subsidiary ofAT&T, challenged the Michigan Public Service Commission'sinterpretation of the Telecommunications Act as requiring incumbentlocal exchange carriers- like Michigan Bell--to give access to theirequipment and services to competitive local exchange carriers at cost.(77) The Sixth Circuit Court of Appeals held that " Auer deference[is] unavailing ... because the [Federal CommunicationCommission's] proffered interpretation is so plainly erroneous orinconsistent with the regulation ... that we can only conclude that theFCC has attempted to create a new de facto regulation under the guise ofinterpreting the regulation." (78)

Sprint Nextel and Comptel were competitive local exchange carriersadvantaged by the FCC's interpretation. In seeking Auer deference,Sprint Nextel stated plainly that "[a]n agency'sinterpretation of its own regulations is entitled to deference as longas it is not 'plainly erroneous or inconsistent with the regulation[s]' ... and such deference is amply warranted here." (79) Itargued that such deference was especially warranted given "thenotorious complexity both of the underlying technology and of theapplicable legal regime," making this "the archetypal case inwhich deference to the views of an expert agency is appropriate."(80) Comptel likewise complained that the Sixth Circuit improperlyfailed to defer to "the FCC's rules implementing the statuteand the agency's interpretation of those rules." (81) Itchastised the Sixth Circuit for "substituting its own judgment forthat of the expert agency not only with respect to the manner in whichtelephone networks are designed and operate but also with respect to themeaning of the expert agency's own regulations"notwithstanding the fact that "Congress has delegated to the FCCthe authority to resolve any ambiguities" and "[t]heFCC's interpretation of the term is therefore entitled toconsiderable weight." (82)

In Coeur Alaska, Inc. v. Southeast Alaska Conservation Council,(83) the Southeast Alaska Conservation Council sued the U.S. Army Corpsof Engineers for granting a permit to Coeur Alaska to dischargewastewater from its mining operations into an Alaskan lake. (84) TheNinth Circuit Court of Appeals agreed with the Conservation Council thatthe Army Corps did not have authority under the Clean Water Act to issuesuch a permit. (85) Before the U.S. Supreme Court, a number of businessgroups filed amicus briefs in support of Coeur Alaska and reliedexplicitly on agency deference doctrines. The Resource DevelopmentCouncil for Alaska (86) explicitly invoked Seminole Rock to criticizethe Ninth's Circuit's "failure to accord ... deference inthis case," which it argued was contrary to the U.S. SupremeCourt's "long-established principle of administrativelaw," thus "set[ting] a dangerous precedent against theextraordinary deference that must be afforded to an agency'sinterpretation of its own regulations." (87) The NationalAssociation of Home Builders agreed that the "case boils down toagency deference," (88) and asserted that "[d]eference is dueto the expert decisions by the [Army] Corps (and EPA)." (89) Insimilar fashion, the Council of Alaska Producers urged the U.S. SupremeCourt to "reverse the Ninth Circuit's ruling, and defer to theexpertise of the Corps and EPA, which have developed a regulatory regimethat addresses the relevant environmental concerns raised in thiscase." (90) And the National Mining Association concurred, statingthat "the Court should defer to the expert agencies'resolution of the issue--a resolution that is clear, that is of longstanding, and that reasonably balances [Congress's] concerns..." (91)

b. Rejection of Auer Deference

Business interest groups just as readily weigh in against deferenceto the underlying regulating agency's interpretation where theinterpretation at issue conflicts with their own agenda. Indeed, in theAuer case itself, the business community rallied behind the no-deferenceposition. The Chamber of Commerce submitted an amicus brief in supportof the police commissioners that argued that petitioners were exemptfrom overtime pay requirements under the Fair Labor Standards Act(FLSA). (92) The Chamber specifically argued that the Department ofLabor's interpretation of its regulations to the contrary "isentitled to little or no deference." (93) The Chamber focusedattention on the inconsistencies in the position taken by the Departmentof Labor over time and argued that, "[w]hile an agency'sinterpretation of its own regulations is generally to be followed unless'it is plainly erroneous or inconsistent with the regulation,'substantially less deference is due when an agency has put forthinconsistent interpretations, as the Department of Labor has done[here]." (94) The Labor Policy Association--"an organizationof the senior human resources officers of nearly 240 of thisnation's largest private sector employers" (95)--also filed anamicus brief in support of the police commissioners, and likewise arguedagainst deference to the agency. (96) The Labor Policy Associationcontended that "[legislative, or substantive, regulations are'issued pursuant to statutory authority and ... have the force andeffect of law,'" but "by way of contrast, a court is notrequired to give effect to an interpretive regulation. Varying degreesof deference are accorded to administrative interpretations based onsuch factors as the timing and consistency of the agency'sposition." (97) Thus, according to the Labor Policy Association,"although DOL's interpretations are entitled to someweight," they are "not 'entitled to the same deference asnorms that derive from the exercise of ... delegated lawmakingpower.'" (98)

The overtime provisions of the FLSA were once again before the U.S.Supreme Court in Christopher v. SmithKline Beecham Corp." In thatcase, pharmaceutical sales representatives, supported by the Secretaryof Labor as amicus, denied that they fell within the "outsidesalesmen" exception to the FLSA overtime requirements. (110) TheNinth Circuit had ruled against them. (101)

Various business groups filed amicus briefs in support ofSmithKline Beecham and against the sales representatives; all attemptedto limit the scope of Auer. The Chamber of Commerce argued "where,as here, an agency's regulations at most clarify only that certainsituations are included in the coverage of statutory provision, butoffer no guidance as to the outer limits of the statute, anagency's litigation position regarding those limits is not entitledto deference under Auer" given that "the agency has notengaged with the public or brought its expertise to bear on the relevantquestion of the contours of the statute." (102)

The Washington Legal Foundation ("WLF") echoed thistheme, arguing that "the law does not permit an agency to regulateby amicus brief," because "[w]hatever else Auer ... may besaid to require, it has never been understood to 'permit theagency, under the guise of interpreting a regulation, to create de factoa new regulation."' (103) WLF complained that the Departmentof Labor's "novel interpretation of the FLSA's outsidesales exemption ... abruptly contradicts the Department's ownregulatory and interpretative guidance to the contrary for over seventyyears." (104) This "abrupt and unexpected departure,"according to WLF, indicated that the interpretation "did notreflect the agency's 'fair and considered judgment' onthe matter in question," and instead suggested that the agency was"engaging in an after-the-fact effort to justify its new litigatingposition and policy preference." (105) WLF concludes that"allowing regulatory agencies to freely change theirinterpretations of regulations and statutes, without the formalprotections of notice-and-comment rulemaking, threatens to significantlyundercut the predictability that has long been a hallmark of our commonlaw system." (106)

The NFIB also advocated drawing clear lines on the limits of Auerdeference. And, as did the Chamber, it invoked the parroting exceptionto A uer deference: "DOL's position is not aimed atinterpreting an ambiguous regulation" because the ambiguity"instead lies in the statutory language, which is merely reiteratedby DOL's implementing regulations." (107)

PhRMA likewise aligned itself with the Chamber, WLF, and NFIB,arguing that "when an agency proffers a statutory interpretation inan amicus brief, without going through notice-and-comment rulemaking, itis not entitled to deference under either Chevron or A uer." (108)Moreover, deference would "upset [] settled expectations bydeparting abruptly and without explanation from the Department'slong-established flexible definition of sales." (109) Consistencyis key, according to PhRMA, because "an unexplained departure froman agency's longstanding interpretation of its regulation is'likely to reflect the agency's reassessment of wise policyrather than a reassessment of what the agency itself originallymeant.'" And "regulated entities structure their affairson the assumption that an agency will not suddenly and withoutexplanation abandon its long-held views." (110)

PhRMA also made vehement arguments against Auer deference in anamicus brief it submitted in support of a certiorari petition to theU.S. Supreme Court in In re Novartis Wage & Hour Litigation. (111)PhRMA took issue with the Second Circuit's ruling that a Departmentof Labor (DOL) amicus brief, in which the agency announced for the firsttime that pharmaceutical sales representatives are not exempt from theFLSA's overtime pay requirements, was entitled to"controlling" deference under Auer. (112) PhRMA characterizedthe Second Circuit's application of Auer in its decision as"extreme," because "[i]n focusing only on theDepartment's interpretations on this appeal, and turning a blindeye to the dramatic change in position that the interpretations reflect,the Second Circuit allowed the Department to undo regulationspromulgated through notice-and-comment rulemaking and engineer arevolution in FLSA jurisprudence via the expedient of an unsolicitedamicus brief." (113) But PhRMA went beyond the application of Auerdeference in this case to criticize the doctrine more generally. Itclaimed that "the Auer line of cases has generated confusion,"and that "[t]he proper scope of deference to an agency'sinterpretation of its regulations is an important question meritingcertiorari in its own right." (111) PhRMA advocated for lesser orno deference to be accorded in cases where an agency has issuedinconsistent interpretations of its regulations or where an agencyinvokes deference to attempt to circumvent the rulemaking process. (115)

2. Steadfast Resistance

What perhaps might be obscured amidst this backdrop of businessgroups' oscillating positions on agency deference is that theChamber of Commerce and NFIB have steadfastly resisted agency deference.Indeed, these groups have waged a consistent, sustained attack on Auerdeference, even when confronted with sympathetic agency views in aparticular case.

As discussed above, the Chamber resisted deference to theDepartment of Labor in Auer. But it did so by attempting to carve out aninconsistency exception to agency deference; namely, where the agencyhas put forth varying interpretations, none should be entitled todeference. (116) In Christopher v. SmithKline Beecham Corp., the Chambermounted the beginnings of a broad-scale attack on Auer deference. TheChamber raised a normative objection to such deference, arguing that"granting controlling deference on issues not remotely addressedduring a rulemaking would perversely invite agencies to avoid clear andcomprehensive regulations accompanied by notice and comment and insteadadopt major policy changes via amicus brief." (117) The Chamberdrew a direct parallel to the Mead doctrine, which limits Chevrondeference to situations where the agency has interpreted a statute after"engaging] in the sort of procedural formalities that indicate theagency was exercising the authority 'to make rules carrying theforce of law."' (118) And the Chamber argued that Auer toomust be limited lest agencies circumvent Mead by "simply pass[ing]a regulation parroting the statute, and then invoking] controllingdeference under Auer to its interpretation of its own regulation."(119)

At the time of Christopher, the NFIB was also seeking to curtail orlimit Auer deference. The NFIB argued that "[w]hile deference to anagency's interpretations may be appropriate in some circumstances,clear bounds need to be set to ensure that critical regulatory changesare not permitted to occur absent notice-and-comment procedures."(120) At that time, the NFIB was starting to build an edifice of policyjustifications for a wider-scale attack on Auer. Significantly, the NFIBclaimed that " [permitting agencies such as DOL to announce newpolicies through obscure methods, such as amicus filings, would have adevastating impact on industries," including "massiveretroactive liability." (121) NFIB further claimed that allowingagencies to "informally interpret statutory language" createsthe risk that the "agency's new position will have adetrimental sweeping effect across any entire industry." (122) NFIBalso foreshadowed what would become its paramount concern regardingnotice to the regulated community: "APA procedures guarantee thatthe regulated community is put on notice of proposed new regulations andchanges to existing regulations" and that "the regulatedcommunity is given the opportunity to provide the agency with thebenefit of its hands-on knowledge regarding how the regulatory changeswill impact them." (123)

But of course, in both Auer and Christopher, the DOL'sposition was adverse to that of the relevant business communities. Inthis respect, Decker v. Northwest Environmental Defense Center, (124)wherein the agency position favored business interests, is a pivotalcase that tests the nature of principled opposition to Auer deference.In Decker, the Northwest Environmental Defense Center sued the OregonState Forester and several logging companies, alleging that theyviolated the Clean Water Act by using ditches and channels to funnelstorm water runoff into nearby rivers without a permit. (125) The EPAfiled an amicus brief in support of the Oregon State Forester andlogging companies, interpreting its regulations as not requiring permitsfor the runoff discharges at issue. (126) The Ninth Circuit Court ofAppeals, however, ruled against the EPA and in favor of the NorthwestEnvironmental Defense Center. (127) In its amicus brief before the U.S.Supreme Court, the EPA argued that, in the face of an ambiguous Rule,"the court of appeals should have deferred under Auer to EPA'sinterpretation of its own Rule provided in the government's amicusbrief." (128)

Before the U.S. Supreme Court, several business groups--includingthe American Forest Resource Council, the National Alliance of ForestOwners, and the Chamber of Commerce--submitted amicus briefs. As mightbe expected, two of the business groups advocated deference to the EPA,which supported the relevant business community's position. TheAmerican Forest Resource Council, a "nonprofit corporation thatrepresents the forest products industry," argued that the NinthCircuit decision should be reversed because it "failed to givedeference to the [EPA's] long-standing interpretation" of itsRule. (129) And the National Alliance of Forest Owners, a "tradeassociation representing owners and managers of over 79 million acres ofprivate forests in 47 states," likewise criticized the NinthCircuit for "fail[ing] to afford Auer deference to EPA'slongstanding construction of its Rule." (130)

Here, significantly, the Chamber took a different tack.Notwithstanding the fact that the EPA's interpretation supportedthe Chamber's position, the Chamber explicitly disavowed theagency's claim to deference and based its arguments on independentlegal grounds. The Chamber argued that the rule unambiguously exemptslogging ditches and channels from the permit requirement and thusclaimed that the Ninth Circuit's interpretation to the contrary waserroneous. (131) The Chamber went out of its way to disavow theEPA's reasoning, stating that "[w]hile the United Statesultimately reaches the correct outcome ... its analysis is plainlywrong." (132) According to the Chamber, Auer deference had no roleto play in the analysis and it warned that to "defer to theagency's position [here] would be to permit the agency, under theguise of interpreting a regulation, to create de facto a newregulation." (133)

The Chamber transitioned into a full-scale attack on Auer,emphasizing the "perverse incentives propelling [agencies] towardcrafting ambiguous rules when they are asked ... to implement statutesthrough regulations" and the "related danger" whereby"[e]ven where a regulation itself is not ambiguous, an agency mightwell strain to manufacture a false, post hoc ambiguity and therebycreate administrative flexibility that allows the agency to dispensewith notice and comment before effecting regulatory changes." (134)

The Chamber continued its concerted assault on Auer in Perez v.Mortgage Bankers Ass'n. (135) Perez was yet another case addressingthe scope of an exception to the FLSA overtime rule. The Department ofLabor issued an opinion letter in 2006 stating that mortgage loanofficers fell within the "administrative employee" exceptionto the overtime rule, then subsequently reversed its position in asecond interpretation in 2010. (136) The Mortgage Bankers Associationsued the DOL for changing its interpretation without going throughnotice and comment rulemaking, and the D.C. Circuit Court of Appealsruled in favor of Mortgage Bankers Association. (137) Business groupsfiled six briefs in support of Mortgage Bankers. (138)

Among those groups was the Chamber, which remained steadfast in itsincreasingly vociferous opposition to Auer. (139) The Chamber arguedthat "[u]nder Auer, agencies can thwart meaningful feedback bypromulgating vague legislative regulations and then interpreting thoseregulations as they see fit, knowing that courts must accept thoseinterpretations as long as they are not patently incompatible with thestatutory or regulatory text." (140) The Chamber's brief isreplete with a parade of horribles, or at least "seriousconcerns" raised by Auer. the threat to separation of powers; (141)the concern that "[ajgencies may not have special insight into whattheir regulations say, and their policy expertise is arguably irrelevantto the purely interpretive task of figuring out what the law is";and the concern that "Auer deference 'creates a risk thatagencies will promulgate vague and open-ended regulations that they canlater interpret as they see fit, thereby frustrating the notice andpredictability purposes of rulemaking.'" (142) The Chamberraises an issue of particular concern to businesses, namely that givingdeference to agencies' interpretive about-faces "wouldthreaten the reliance interests of those who, because of theagency's ambiguous legislative regulations, must structure theiraffairs around interpretive rules." (143)

As might be expected, several other business groups, including theNFIB, (144) endorsed the D.C. Circuit's Paralyzed Veteransdoctrine, framing the doctrine as a way to prevent agencies fromsignificantly changing interpretations to the detriment ofbusinesses' reliance interests and then receiving Auer deferencefor those interpretations. (145) The National Mining Association("NMA") urged the Court to adopt a rule whereby "[a]nagency that wants to reverse itself and dispense with notice and commentmust also abandon any claim to deference, justify its departure from theprior interpretation, and refrain from applying the new interpretationretroactively." (146) Recall that NMA was one of the groups thaturged deference to the expertise of the Corps and the EPA in CoeurAlaska. Granted, Coeur Alaska did not entail an agency's change inposition. Even so, in Perez, the NMA expressed more general distaste forAuer. "[T]he same federal government that today tells the Courtthat agency interpretations are harmlessly non-binding will tomorrowdemand that the courts treat such interpretations as binding. And undercurrent doctrine, the courts will generally agree, as long as the agencystays within the 'considerable legal leeway' that Auerdeference extends." (147)

B. Implications for Federal Preemption

In the federal preemption context, business groups tout theinstitutional advantages that the FDA has over the state tort law systemas a regulatory mechanism. The Product Liability Advisory Council("PLAC") summarizes the mainstream position, namely that the"judge, the jury, and the plaintiff in an individual case focusonly on the particular matter before the court" and that "[i]nlitigation, each lawyer's obligation is solely to represent his orher client zealously." (148) Accordingly, the "FDA, notlawyers for individual litigants, has the job of protecting the publichealth." (149)

In making pro-preemption arguments, amici repeatedly urge the Courtto afford substantial weight to the views of an agency that stateregulation interferes with the federal regulatory scheme that the agencyhas been charged with administering. Business groups have tended toinvoke Auer (and Chevron) deference to support preemption, particularlyin the FDA context.

The Chamber of Commerce has weighed in on a large number ofpreemption cases in the federal courts of appeals and U.S. SupremeCourt. (150) Neither the Chamber nor PhRMA has wavered from its propreemption view. But with respect to reliance on Auer deference, theremay be some trace evidence of a shifting away. The Chamber did not weighin on PLIVA, but it did intervene (in a joint amicus brief with PhRMA)in Mutual Pharmaceutical where it argued for preemption with nary amention of Auer.

1. Traditional Business Position: Deference to FDA SupportsPro-Preemption View

The traditional pro-preemption business position is consistentlyput forth by PLAC, a "nonprofit association with more than 120corporate members representing a broad cross-section of American andinternational product manufacturers." (151) Time and again, PLAChas invoked deference to the FDA in advocating preemption of state tortclaims against medical device and drug manufacturers.

In Riegel v. Medtronic, Inc., PLAC cites various FDA statements tobolster its claim that "[i]n enacting the express preemptionprovision in the MDA, Congress determined that imposition of staterequirements in addition to or different from federal regulation wouldundermine public health." (152) PLAC draws attention to the factthat the "FDA has stated in [the U.S. Supreme Court], in Courts ofAppeals, and in the preamble to regulations, [that] allowing statejudges and juries to second-guess the FDA's approval of [medicaldevices], or to dictate different requirements than FDA has imposed,impedes FDA's ability to fulfill its mandate in furtherance ofpublic health." (153) PLAC points to the FDA's preemptionpreamble to its drug labeling regulation, which states that'"[s]tate-law attempts to impose additional warnings lead tolabeling that does not accurately portray a product's risks'and threaten [the] 'FDA's statutorily prescribed role as theexpert Federal agency responsible for evaluating and regulatingdrugs.'" (154)

PLAC has likewise been a staunch advocate for federal preemption inthe prescription drug context. In Wyeth, PLAC explicitly calls for theCourt to accord deference to FDA determinations that state law couldthreaten to upset a federal regulatory scheme that the agency lias beentasked with implementing. (155) PLAC claims the "FDA'sinterpretation of the FDCA is clear" that FDA approval of labelingpreempts contrary state law, and that in "reaching the oppositeconclusion ... [t]he Vermont Supreme Court's failure to defer tothe FDA's interpretation of the FDCA is contrary to [U.S. SupremeCourt] precedent." (156) PLAC is emphatic that the FDA'sposition is "reasonable and entitled to full deference." (157)Nor, PLAC argues, should "[t]he fact that the FDA has articulatedits preemption determination in a regulatory preamble and a series ofamicus briefs ... diminish the deference owed that determination"because an "agency's conclusion that federal law preemptsstate law may properly be communicated in 'regulations, preambles,interpretive statements and responses to comments.'" (158)Moreover, citing Auer, PLAC argues that the fact that the'"agency's fair and considered judgment on the matter inquestion' is conveyed 'in the form of a legal brief' doesnot make the agency's view 'unworthy of deference.'"(159)

Other affected industry groups have also weighed in on federalpreemption before the U.S. Supreme Court. In Riegel, the AdvancedMedical Technology Association and Medical Device ManufacturersAssociation, whose members consist of medical device manufacturers,characterize the FDA as "an expert federal agency," which"Congress has charged ... with striking a careful balance of publichealth objectives." (160) It claims that the FDA has a "uniquevantage point" since it "'holds the only broad,cross-cutting knowledge' and 'experience with the totality ofother applications,' and also utilizes its knowledge of 'thelatest science.'" (161) In contrast, "lay juries are notinstitutionally well-equipped to make the kinds of nuanced risk-benefitcalculations and scientific judgments Congress has charged FDA--as theexpert federal agency--with making." (162) In making this argument,the Association drew from an FDA amicus brief in which the FDA"cautioned that state common-law tort actions which'encourage, and in fact require, lay judges and juries to"second-guess" FDA's balancing of the benefits and risksof a specific device, create pressures for "defensivelabeling" ... [and] result [] in scientifically unsubstantiatedwarnings and underutilization of beneficial treatments.'"(163)

Picking up this same theme of contrasting federal agency regulationwith state tort liability, CropLife America, the American ChemistryCouncil, and Consumer Specialty Products Association, whose membersconsist of pesticide manufacturers, claim that "[conflicting ordiffering jury verdicts, which indisputably have a regulatory effect ona product's manufacturer, can impede, impair, or destroy thenational uniformity that Congress seeks to achieve under the auspices ofexpert and experienced federal agencies such as FDA and EPA." (164)And they likewise extol regulation by agency experts, urging that"consumer protection is enhanced when highly experienced federalagencies, staffed by dedicated scientific experts, regulate productssuch as medical devices, drugs, and pesticides in a nationally uniformmanner." (165) In sum, the pesticide manufacturers conclude thatthe "substantial health, safety, environmental, and productperformance benefits that nationally uniform, EPA-regulated productlabeling affords to consumers, farmers, and professional pesticideapplicators cannot be over-stated" and that the "sameundoubtedly is true for nationally uniform medical device and druglabeling." (166)

Groups such as PLAC do not have much interest in the Auer line ofcases, so there is no way to gauge whether their pro-agency advocacywould hold up outside of the preemption context. But, significantly,groups such as PhRMA and the Chamber of Commerce do.

2. Whither Steadfast Resistance to Auer?

The Chamber and PhRMA have never wavered in their pro-preemptionpositions. But the enthusiasm with which they wield Auer deference insupport may be wavering.

a. Auer Deference Wielded to Support Preemption

In Wyeth, PhRMA, along with the Biotechnology Industry Organization("BIO")--whose "members are involved in research anddevelopment of innovative healthcare technologies"--submitted abrief advocating for Auer deference. (167) Both groups insisted that theVermont Supreme Court misinterpreted the FDA's drug labelingregulation as "granting] manufacturers general permission to'add and strengthen warnings' without prior FDAapproval," whereas "FDA has long interpreted its regulation ascreating a limited exception that applies only to 'concerns aboutnewly discovered risks' and 'important new information aboutthe safe use of a drug.'" (168) According to PhRMA and BIO,this FDA "interpretation of the substantive meaning of its ownregulation is entitled to substantial judicial deference" underAuer. (169)

Likewise, in Fussman v. Novartis Pharmaceuticals Corp., (170) PhRMAsquarely relied on Auer deference in an amicus brief urging the U.S.Supreme Court to grant certiorari to overturn a Fourth Circuit decisionfinding that state law failure to warn liability is not preempted by theFDA's authority. (171) After describing the FDA's labelapproval process, PhRMA argued that the "FDA's view that itsCBE regulation permits a unilateral label change only when justified bynew and significant information easily satisfies" the "plainlyerroneous or inconsistent with the regulations" test for receivingAuer deference. (172)

Recall, however, that only three years later, PhRMA intervened asamicus in Christopher, joining forces with the Chamber and NFIB inresisting Auer deference. (173) Specifically, it argued that "whenan agency proffers a statutory interpretation in an amicus brief,without going through notice-and-comment rulemaking, it is not entitledto deference under either Chevron or Auer." (174) Perhaps toreconcile this reliance on Auer with its prior position in In reNovartis Wage & Hour Litigation, PhRMA noted specifically in Fussmanthat the interpretation in this case "is the agency'slongstanding and consistent view, dating back to the 1982 promulgationof the regulation." (175)

Another group to have struggled to reconcile its generalanti-agency inclination with its reliance on agency deference argumentsin preemption litigation is the Washington Legal Foundation("WLF"). In 2006, the WLF issued a press release calling fordeference to be given to an FDA statement of policy outlining theagency's pro-preemption position. (170) WLF "praised the [FDA]for issuing a policy statement indicating that manufacturers who labeltheir drugs in accordance with FDA policy cannot be sued under state lawfor failure to include additional safety warnings in their productlabeling." (177) According to thenWLF Chief Counsel Richard Samp,"[t]he policy statement does not represent a shift in FDA'sviews; FDA has taken the same position in litigation for several years.Nonetheless, issuing the policy statement is an important step, becauseit significantly increases the likelihood that courts will heedFDA's views." (178) WLF noted that "because viewsexpressed in the course of litigation are not deemed official positionsof a federal agency courts [had not been] required to defer toFDA's views." (179) But "WLF argued that because thoseviews have been incorporated into an official policy statement, courtsare now required to give deference to FDA's interpretation offederal law." (180) Accordingly, in its amicus brief in Wyeth, WLFtook the position that the "FDA's view that the imposition ofliability under state law for defendant's alleged failure to warnwould interfere with FDA's accomplishment of regulatory objectivesis in our view entitled to at least as much deference, if not more, asthe FDA's view of its preemption authority." (181)

WLF's position here contradicts its emphaticendorsement--three years later in Christopher--of the Wyeth Court'sultimate refusal to give deference to the FDA's interpretation ofthe scope of its own preemption authority. Indeed, its amicus briefcited with approval the Court's refusal in Wyeth to give deferenceto the FDA's interpretation of the scope of its own preemptionauthority in light of the FDA's "procedural failure" infailing to give an opportunity for notice and comment, and advocatedthat "[t]he same result should obtain here." (182) It alsoechoed Justice Scalia's warning in Talk America that "allowingan agency to both promulgate its own rules as well as interpret them'frustrates the notice and predictability purposes of rulemaking,and promotes arbitrary government.'" (183)

Even the Chamber of Commerce, otherwise so scrupulously consistentin opposing Auer deference, has wavered in this line of cases. InRiegel, the Chamber argued that the MDA preempted requirements imposedby state tort law. For support, it cited the brief submitted by theSolicitor General at the petition stage, noting that "the FDAinterprets Section 360k(a) as expressly preempting state tort claimsthat seek to impose different or additional requirements on devices thathave won premarket approval." (184) The Chamber also citesadditional statements made by the FDA as amicus in another devicepreemption case, noting that the "FDA recognizes that theMDA's express preemption clause furthers not only Congress'sgoal of protecting innovation and reducing regulatory burdens but alsoits goal of protecting and promoting the public health." (185)

In Wyeth, the Chamber criticized the Vermont Supreme Court, whichhad ruled against Wyeth below, for "declining] to give any weightto certain statements made by the FDA relating to preemption and theadverse and disruptive effects of certain state-law product liabilitylawsuits on the federal regulatory scheme." (186) In doing so, theChamber explicitly invoked Auer deference. According to the Chamber, thelower court's interpretation of a key FDA regulation ran counter tothe FDA's own interpretation of the provision. (187) Moreover, theChamber, citing Auer, asserted that the "FDA's longstandinginterpretation of the CBE regulation is entitled to deference undersettled principles of administrative law." (188)

b. Preemption Reconsidered

We return to the puzzle in PLIVA; namely, Justice Thomas'curious invocation of Auer deference to sustain the pro-preemptionholding. The Chamber did not participate as an amicus in PLIVA, (189) soin this case, the Court did not seem to be following the Chamber'surging.

Petitioners PLIVA and Actavis each addressed Auer deference. PLIVAreminded the Court that the FDA "interpreted the CBE provision to... preclude deviations between the branded and generic productlabeling." (190) And, PLIVA contended, the "FDA's settledinterpretation of its own regulations is entitled to substantialdeference[,] ... the virtually conclusive deference to which it isdue" under Auer.m The Actavis brief echoed the deference argumentsmade by PLIVA. It also argued that the FDA's "regulationspreempt state failure-to-warn claims which would require a genericmanufacturer to unilaterally change its label" and even if"there were any ambiguity in the Agency's regulations, ...then the Agency's consistent and longstanding interpretation ofthose regulations would be entitled to deference" under A uer.(192)

Nonetheless, as PLIVA pointed out in its brief, the FDA regulationat 21 C.F.R. [section] 314.3(b) explicitly stated that the duty ofsameness applied not only to the manufacturer's initial labelapplication to the FDA but also to "all amendments andsupplements." (193) Justice Thomas could have opted to hold thatthis regulation was unambiguous on its face, thereby reaching the sameconclusion without resorting to Auer.

In Mutual Pharmaceutical, there was nary a mention of Auer, nor didany of the parties or other amici briefs invoke Auer. A joint amicusbrief submitted by the Chamber and PhRMA, consistent with their prioramicus briefs in preemption cases, emphasized the comparative advantageof drug labeling regulation by the expert FDA over lay jurors. Thus,they argued that "FDA's risk-benefit analyses should befavored because they are objectively better in promoting public healththan equivalent determinations by votes of lay jurors" and becausethe "FDA relies on its experienced staff and panels of trainedmedical and pharmacological experts[, whereas] there is no suggestionthat the lay jury in New Hampshire had the benefit of suchexpertise." (194) Moreover, they argued, "FDA review of a[][New Drug Application] typically includes a year or more of closeanalysis; a jury trial may take a few days or weeks" and the"FDA must balance the benefits of the proposed drug to the entiretreatable population against the potential incidence of its knownrisks" whereas "however instructed, a jury's attentioncannot help but be focused on a single, grievously injuredindividual." (195)

CONCLUSION: WHAT THE FUTURE HOLDS

The business community's uniting in opposition to Auerdeference is proceeding apace. In a recent case, Bible v. United StudentAid Funds, Inc., (196) business groups joined forces in an all-outassault on Auer deference. The National Association of Manufacturers("NAM") urged the U.S. Supreme Court to take the case giventhat "[t]his case presents an ideal opportunity to overrule thedeferential perspectives mandated by Auer ... and ... SeminoleRock." (197) It noted the "[sjerious concerns regarding Auerand Seminole Rock deference [that] have been voiced by the Chief Justiceand other members of this Court" and raised the specter of"the danger posed by the growing power of the administrativestate." (198) WLF joined groups like NAM (199) in calling for Auerdeference to be "reject[ed] ... once and for all." (200) WLFwarned ominously that "if the Court allows the rule of deferenceannounced in Auer ... [and] Seminole Rock ... to stand, it will sanctiona profound and ongoing injustice that damages its reputation."(201)

But the Bible case was litigated and decided in the era ofPresident Obama. Will the business community need to rally forAuer's demise in what promises to be an era of minimal regulationunder the Trump Administration? In the wake of President Trump'searly initiatives signaling regulatory rollback, the NFIB has predictedthat " [f]or small businesses, 2017 may end up being the year theregulatory tide turn[s]." (202) More specifically, the NFIBcharacterized Executive Order 13771, (203) in conjunction with theregulatory freeze ordered by White House Chief of Staff Reince Priebuson January 20, 2017, as "a very lethal weapon against regulatoryoverreach." (204) In a similar vein, the Chamber has pronouncedthat "[a]fter years of talk, Washington is actually starting totame the regulatory leviathan." (205) If the President himself hasexpressed wariness of "a system that no longer imposes anymeaningful checks on executive action," (206) and has nominatedagency heads who enthusiastically share his views, need the businesscommunity fear overzealous agency action or expansive interpretations ofagency power?

Alternatively, should the steadfast resistance to Auer deferencehold, what would that mean in the preemption context? If Auer deferenceis no longer a reliable pillar of preemption in the generic drugpreemption context (and beyond), business groups might switch gears withan increased emphasis on lobbying affected agencies for preemptiverulemaking as well as increased efforts lobbying Congress for expresspreemption provisions. (207)

(1.) I would be remiss if the first and foremost citation here werenot: Business and the Roberts Court (Jonathan H. Adler ed., 2016), whichcontains a wealth of references to the relevant literature.

(2.) See infra Part I.A.

(3.) See, e.g., PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (rulingby way of the five more-conservative leaning justices, over a dissentjoined by the four more-liberal leaning justices, that state tort lawwas preempted based in part on Auer deference to the FDA).

(4.) See Catherine M. Sharkey, The Administrative State and theCommon Law: Regulatory Substitutes or Complements? 65 Emory L.J. 1705,1733 (2016) ("[I]t would appear that these Justices' hostilitytoward the common law of torts trumps even their caustic criticism ofthe ever-inflating administrative state.").

(5.) Id. at 1708.

(6.) See infra Part II.A.2.

(7.) The NFIB, for example, is heavily invested in stemming thetide of regulatory overreach by intervening in cases challenging Auerdeference, whereas it has not tended to be involved in FDA/federalpreemption cases. See infra Part II.A.2.

(8.) The Product Liability Advisory Council (PLAC) provides aparadigmatic example here. See infra Part II.B.l.

(9.) PhRMA, http://www.plirma.org [https://perma.cc/55M8-MEF5](last visited Feb. 18, 2017).

(10.) See infra Part II.B.

(11.) Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013).

(12.) See Brief of the Chamber of Commerce of the U.S. & Pharm.Research & Mfrs. of Am. as Amici Curiae in Support of Petitioner at4-11, Mut. Pharm,. Co., 133 S. Ct. 2466 (No. 12-142) (outlining theChamber's and PhRMA's arguments in favor of preemption).

(13.) See infra Part II.B.

(14.) See, e.g., Erwin Chemerinsky, The Roberts Court, at AgeThree, 54 Wayne L. Rev. 947, 962 (2008) ("[T]he Roberts Court isthe most pro-business Court of any since the mid-1980s."); LeeEpstein, William M. Landes & Richard A. Posner, How Business Faresin the Supreme Court, 97 Minn. L. Rev. 1431, 1472 (2013) ("[T]heRoberts Court is much friendlier to business than either the Burger orR.ehnquist Courts, which preceded it, were.").

(15.) 552 U.S. 312 (2008).

(16.) Id. at 324 ("Congress is entitled to know what meaningthis Court will assign to terms regularly used in its enactments. Absentother indication, reference to a State's 'requirements'includes its common-law duties.").

(17.) Id. at 320.

(18.) Brief for the United States as Amicus Curiae SupportingRespondent at 27-28, Riegel, 552 U.S. 312 (No. 06-179); see, e.g., Briefof the Chamber of Commerce of the U.S. as Amicus Curiae in Support ofRespondent at 2, Riegel, 552 U.S. 312 (No. 06-179) (arguing that statetort law claims are preempted under prior decisions of the U.S. SupremeCourt); Brief of Prod. Liab. Advisory Council, Inc. as Amicus Curiae inSupport of Respondent at 19, Riegel, 552 U.S. 312 (No. 06-179) (arguingthat congressional intent and prior decisions of the U.S. Supreme Courtdemonstrate that MDA preempts state tort law claims).

(19.) Riegel, 552 U.S. at 328-29 (citing Brief for the UnitedStates as Amicus Curiae Supporting Respondent, supra note 18, at 27-28).

(20.) 555 U.S. 555 (2009).

(21.) Id. at 559-60.

(22.) Id. at 560-61.

(23.) Id. at 580-81. But see, e.g., Brief for the United States asAmicus Curiae Supporting Petitioner at 10, Wyeth, 555 U.S. 555 (No.06-1249) (arguing that the FDCA preempts state tort law claims relatedto labeling that the FDA has approved); Brief for PhRMA & BIO asAmici Curiae Supporting Petitioner at 5, Wyeth, 555 U.S. 555 (No.06-1249) (arguing that state tort law claims related to labelingundermine the FDA and should be preempted under preemption principles);Brief of the Generic Pharm. Ass'n as Amicus Curiae in Support ofPetitioner at 7-13, Wyeth, 555 U.S. 555 (No. 06-1249) (arguing thatpreemption applies in FDA-approved labeling cases).

(24.) 564 U.S. 604 (2011).

(25.) Id. at 610.

(26.) Id.

(27.) Id. at 624 ("Here, state law imposed a duty on theManufacturers to take a certain action, and federal law barred them fromtaking that action.... Mensing and Demahy's tort claims arepre-empted.").

(28.) Brief for the United States as Amicus Curiae SupportingRespondents, PLIVA, 564 U.S. 604 (Nos. 09-993, 09-1039, 09-1501). Thegovernment took the position that "FDA regulations require[brand-name drug manufacturers] and [generic drug manufacturers] aliketo act upon new safety information that warrants added or strengthenedwarnings" so that the agency can "determine whether thelabeling for the generic and listed drugs should be revised." Id.at 12 (quoting 57 Fed. Reg. 17,961 (Apr. 28, 1992)). But see Brief ofApotex, Inc. as Amicus Curiae in Support of Petitioners at 10-14, PLIVA,564 U.S. 604 (Nos. 09-993, 09-1039, 09-1501) (arguing that both impliedand obstacle preemption apply to Mensing's and Demahy'sclaims); Brief of Generic Pharm. Ass'n as Amicus Curiae in Supportof Petitioners at 2-3, PLIVA, 564 U.S. 604 (Nos. 09-993, 09-1039,09-1501) (arguing the Congressional policy reasons backing preemptionand why they apply in this case).

(29.) 133 S. Ct. 2466 (2013).

(30.) Id. at 2470.

(31.) Id. at 2477, 2480 ("Because it is impossible for Mutualand other similarly situated manufacturers to comply with both state andfederal law, New Hampshire's warning-based design-defect cause ofaction is pre-empted....").

(32.) See, e.g., Brief of the Chamber of Commerce of the U.S. &Pharm. Research & Mfrs. of Am. as Amici Curiae in Support ofPetitioner at 4, Mut. Pharm.., 133 S. Ct. 2466 (No. 12-142) (arguingthat Mutual's conflicting federal and state law responsibilitiesmilitate in favor of preemption); Brief of the Prod. Liab. AdvisoryCouncil, Inc. as Amicus Curiae in Support of Petitioner at 12, Mut.Pharm., 133 S. Ct. 2466 (No. 12-142) (arguing that the FDCA forbadeMutual from complying with state law, and thus preemption applied).

(33.) See Brief for the United States as Amicus Curiae SupportingPetitioner at 14, Mut. Pharm., 133 S. Ct. 2466 (No. 12-142) (arguingthat "[PLIVA 's[ holding that the FDCA preempts state failureto warn claims against generic drug manufacturers controls thiscase.").

(34.) The CAC's website describes its mission as "a thinktank, law firm, and action center dedicated to fulfilling theprogressive promise of our Constitution's text and history."About Us, Constitutional Accountability Ctr.,http://www.theusconstitution.org/about [https://perma.cc/DLV3-8ZWL](last visited Feb. 16, 2017).

(35.) Tom Donnelly, Constitutional Accountability Ctr., Roberts at10: Chief Justice Roberts and Big Business 13-14 (2015) http://theusconstitution.org/sites/default/files/briefs/Roberts-at-10-Business.pdf [https://perma.cc/U3WU-T9GS].

(36.) Wyeth v. Levine, 555 U.S. 555, 579-81 (2008).

(37.) Donnelly, supra note 35, at 15.

(38.) PLIVA, Inc. v. Mensing, 564 U.S. 604, 625 (2011); Mut. Pharm.Co. v. Bartlett, 133 S. Ct. 2466, 2480 (2013).

(39.) Donnelly, supra note 35 at 17-18.

(40.) The Danger of Deferring to the Bureaucrats, Am. Energy All.:Energy Townhall (May 17, 2016),http://americanenergyalliance.org/2016/05/17/ 10592/[https://perma.cc/9DCQ-ZRTW] (expressing need to "halt[] thecontinuous onslaught of executive overreach in all policy areas,including the energy and environment sector").

(41.) Letter from Competitive Enterprise Inst., et al., to Membersof the U.S. Congress (June 7, 2016),https://cei.org/sites/default/files/2016%20Chevron%20SOPRA%20coalition%201etter%20-%20Updated%206222015%20%282% 29%20.pdf[https://perma.cc/8KZC-JB3Z]. The Competitive Enterprise Instituteargues: " Auer provides a perverse incentive for an agency to issuedeliberately vague regulations that it can reinterpret as it chooses,avoiding the notice-and-comment requirements of the AdministrativeProcedure Act for a change in regulation." Id.

(42.) Letter from R. Bruce Josten, Exec. Vice President ofGov't Affairs, Chamber of Commerce of the U.S., to Members of theU.S. Congress (Mar. 18, 2016),https://www.uschamber.com/sites/default/files/documents/files/3.18.16_hill_letter_to_congress_supporting_h.r.-4768_and_s._2724_the_separation_of_powers_restoration_act.pdf [https://perma.cc/FY8J-U7DD].

(43.) Id.

(44.) Karen Kerrigan, Letter to U.S. House: "Separation ofPowers Restoration Act," SBE Council (June 27, 2016, 1:48 PM),http://sbecouncil.org/2016/06/27/letter-to-u-s-house-separation-of-powers-restoration-act/[https:// perma.cc/EM63-B67Z]; see Letter from TechFreedom, et al., toMembers of the U.S. Congress (July 11, 2016),http://docs.techfreedom.org/SOPRALetter .pdf[https://perma.cc/ALT9-F647] ("Chevron means Internet regulationwill now be a game of political ping-pong--with the courts resigned tositting on the sidelines, watching the ball bounce back and forth[,creating] ongoing uncertainty [that] is particularly damaging to smallbusinesses, who often lack the resources needed to comply with shiftingregulatory burdens and litigate against unfavorable regulatorychanges."). TechFreedom's letter was cited by a sponsor of thebill during the House debate. 162 Cong. Rec. H4615, H4617 (daily ed.July 11, 2016).

(45.) Decker v. Nw. Envtl. Def. Ctr., 133 S. Ct. 1326, 1341 (2013)(Scalia, J., concurring in part and dissenting in part).

(46.) Id. (quoting Baron de Montesquieu, The Spirit of Laws 151-52(Thomas Nugent trans., O. Piest ed. 1949) (1748)).

(47.) 135 S. Ct. 1199 (2015).

(48.) Id. at 1210 (Alito, J., concurring in part and concurring inthe judgment).

(49.) Id. at 1219 (Thomas, J., concurring in the judgment).

(50.) Id. at 1212-13 (Scalia, J., concurring in the judgment)(citations omitted). Justice Scalia reiterated the concerns he hadoutlined previously in Decker. "Because the agency (not Congress)drafts the substantive rules that are the object of thoseinterpretations, giving them deference allows the agency to control theextent of its notice-and-comment-free domain. To expand this domain, theagency need only write substantive rules more broadly and vaguely,leaving plenty of gaps to be filled in later, using interpretive rulesunchecked by notice and comment." Id. at 1212.

(51.) See, e.g., Wyeth v. Levine, 555 U.S. 555, 604-06 (2009)(Alito, J., dissenting) (framing the preemption question as partly achoice between the agency's expertise and the expertise of theparties' witnesses at trial).

(52.) See, e.g., id. at 626 ("[JJuries are ill equipped toperform the FDA's cost-benefit-balancing function.... [JJuries tendto focus on the risk of a particular product's design or warninglabel that arguably contributed to a particular plaintiff's injury,not on the overall benefits of that design or label.... In contrast, theFDA has the benefit of the long view.") (citations omitted).

(53.) Id. at 579-81 (majority opinion).

(54.) Id. at 606 (Alito, J., dissenting).

(55.) Brief for the United States as Amicus Curiae SupportingPetitioner, supra note 23, at 21.

(56.) See Wyeth, 555 U.S. at 622-23 (Alito, J., dissenting)("[P]re-emption is arguably more appropriate here than in Geierbecause the FDA (unlike the DOT) declared its pre-emptive intent in theFederal Register.") (citing 71 Fed. Reg. 3933-3936); see also id.at 623 (citing Justice Breyer's concurring opinion in Medtronic,Inc. v. Lohr, 518 U.S. 470, 506 (1996) for the proposition that thepreamble to the regulation should carry greater weight because the FDAincludes its understanding of state and federal requirements in thepreamble).

(57.) It is striking that Justice Thomas (writing a separateconcurrence in Wyeth) stands alone in eschewing any reliance on agencycomments, regulatory history, and agency litigating positions in impliedpreemption analysis. Id. at 60001 (Thomas, J., concurring) ("[N]oagency ... can preempt a State's judgment by merely musing aboutgoals or intentions not found within or authorized by the statutorytext."). For further elaboration, see Catherine M. Sharkey, AgainstFreewheeling, Extratextual Obstacle Preemption: Is Justice ClarenceThomas the Lone Principled Federalist?, 5 N.Y.U. J.L. & Liberty 63(2010).

(58.) PLIVA, Inc. v. Mensing, 564 U.S. 604, 613 (2011) (citingBrief for the United States as Amicus Curiae Supporting Respondents,supra note 28, at 16).

(59.) Id. at 613 (quoting Auer v. Robbins, 519 U.S. 452, 461(1997)).

(60.) Id. at 614. Note too that, in Mutual Pharmaceutical, themajority per Justice Alito relied on federal drug regulations "asinterpreted by the FDA" in deeming state law preempted. Mut. Pharm.Co. v. Bartlett, 133 S. Ct. 2466, 2476 (2013).

(61.) See infra Part II.A.2.

(62.) See Five Things NFIB Is Doing to Cabin Agency Discretion,Nat'l Fed'n of indep. Bus. (Nov. 8, 2016),http://www.nfib.coin/content/legal-blog/legal/five-things-nfib-is-doing-to-cabin-agency-discretion-75891/[https:// perma.cc/8M2S-24SZ] ("[I]n United States v. Texas, and inFlytenow v. FA A, we argued that it was time for the Court [to] overturnAuer v. Robbins ...."); Kerrigan, supra note 44 ("[Making surethat] 'agencies' interpretations of law would no longerreceive deference [is] exactly the remedy small businesses need to get afair shake in courts."). The letter praises the introduction of the"Separation of Powers Restoration Act" legislation as "agood start to rein in a bureaucracy that is stifling growth, innovation,competitiveness, and new business startups." Id. The Chevrondoctrine is another key target; this doctrine of judicial deference toagency statutory interpretation is described as "a dangerousjudicial abdication that has fueled overregulation and the growth of theadministrative [state] for decades." Id.

(63.) According to the American Bankers Association website:"The American Bankers Association is the united voice ofAmerica's hometown bankers[-]small, regional and large banks thattogether employ more than 2 million women and men, hold nearly $17trillion in assets, safeguard $12.8 trillion in deposits and extend morethan $9 trillion in loans." About the American Bankers Association,Am. bankers Ass'N, http://www.aba.com/About/Pages/ default.aspx[https://perma.cc/LG2F-T7LG] (last visited Feb. 19, 2017).

(64.) 562 U.S. 195 (2011).

(65.) Id. at 201-02.

(66.) Id. The U.S. Supreme Court reversed with a unanimous decisionthat applied Auer deference to the Board's interpretation thatRegulation Z does not require a creditor to provide cardholders with achange-of-term notice. Id. at 208 ("Under Auer ... we defer to anagency's interpretation of its own regulation, advanced in a legalbrief, unless that interpretation is plainly erroneous or inconsistentwith the regulation.") (citations omitted).

(67.) Brief for the United States as Amicus Curiae, Chase Bank, 562U.S. 195 (No. 09-329).

(68.) Brief of the Am. Bankers Ass'n as Amicus Curiae insupport of Petitioner at 4, Chase Bank, 562 U.S. 195 (No. 09-329)(criticizing the Ninth Circuit for failing to defer to the"interpretation of Regulation Z by the Board, which has recentlymade its position crystal clear via amicus filings in this and otherproceedings").

(69.) Id. at 5. (quoting Ford Motor Credit Co. v. Milhollin, 444U.S. 555, 566 (1980)). The American Bankers Association elaborated:"The [Ninth Circuit] panel failed to account for the value to theindustry of being allowed to rely on official agency statements orinterpretations (albeit less formal than a final regulation) forguidance with respect to TIL A or other regulatory issues." Id.

(70.) Id. at 17. (quoting Bowles v. Seminole Rock & Sand Co.,325 U.S. 410, 414 (1945)).

(71.) Id. at 18 (omission in original) (quoting Auer v. Robbins,519 U.S. 452, 462 (1997)); see also id. at 19-20. ("TheBoard's plain and repeated statements--whether they are offered inan amicus brief submitted by the agency or contained in regulatorydocuments such as the preamble to a proposed rule that is published inthe Federal Register--plainly 'reflect the agency's fair andconsidered judgment on the matter in question.'" (quotingAuer, 519 U.S. at 462)).

(72.) Id. at 17-18. Note the sharp contrast between the AmericanBankers Association's position here in favor of deference toinformally issued interpretations and the vehement opposition to suchdeference voiced by business groups in other cases. See infra PartII.A.1.b.

(73.) Brief of the Am. Bankers Ass'n as Amicus Curiae inSupport of Petitioner, supra note 68, at 18; see also id. at 19("Courts regularly defer to agency interpretations of their ownregulations that are embodied in considerably less formal statementsthan those at issue in the present litigation.").

(74.) Id. at 19.

(75.) 564 U.S. 50 (2011).

(76.) Brief for Sprint Nextel Corp. as Amicus Curiae SupportingPetitioners at 19, Talk Am., Inc., 564 U.S. 50 (Nos. 10-313, 10-329);Brief for Amicus Curiae Comptel in Support of Petitioners at 2-3, TalkAm., Inc., 564 U.S. 50 (Nos. 10-313, 10-329).

(77.) Talk Am., Inc., 564 U.S. at 55.

(78.) Mich. Bell Tel. Co. v. Covad Commc'ns Co., 597 F.3d 370,375 n.6 (6th Cir. 2010). The U.S. Supreme Court reversed. The majoritylooked to the FCC's interpretation of its regulations to resolvethe ambiguities in the statutory scheme, and deferred to thatinterpretation after finding it "reasonable." Talk Am., Inc.,564 U.S. at 59-67. "[W]e defer to an agency's interpretationof its regulations, even in a legal brief, unless the interpretation is'plainly erroneous or inconsistent with the regulation[s]' orthere is any other 'reason to suspect that the interpretation doesnot reflect the agency's fair and considered judgment on the matterin question.'" Id. at 59 (quoting Auer v. Robbins, 519 U.S.452, 461-62 (1997)).

(79.) Brief for Sprint Nextel Corp. as Amicus Curiae SupportingPetitioners, supra note 76, at 19 (quoting Auer, 519 U.S. at 461).Sprint Nextel elaborates: "[T]he most that can be said about theregulations and orders at issue is that they 'do not give adefinitive answer' to the question presented.... [Accordingly,] itcertainly cannot be said that the FCC's regulations and ordersunambiguously compel a contrary interpretation ... [so] [d]eference tothe FCC's interpretation is therefore appropriate." Id. at19-20. Moreover, Sprint Nextel argued that there "is no other validbasis for refusing to defer to the FCC's interpretation"because this is neither a situation in which the regulation falls withinthe "parroting" exception to A uer deference articulated inGonzales v. Oregon, 546 U.S. 243, 257 (2006), nor one in which "theagency's position is simply 'a "post hoc"rationalization' advanced ... to defend past agency action againstattack." Id. at 20 (omissions in original) (quoting Auer, 519 U.S.at 462).

(80.) Brief for Sprint Nextel Corp. as Amicus Curiae SupportingPetitioners, supra note 76, at 21.

(81.) Brief for Comptel as Amicus Curiae in Support of Petitioners,supra note 76, at 3; see also id. at 17-18 ("The Sixth Circuitfound the FCC's interpretation ... to be 'so plainly erroneousor inconsistent with the regulation' as to warrant no deference.But the FCC's interpretation is neither erroneous nor inconsistentwith any regulation." (citation omitted)). Comptel urged the U.S.Supreme Court to grant Chevron deference to the FCC's rulesimplementing the Telecommunications Act. Id. at 18-19.

(82.) Id. at 9-11.

(83.) 557 U.S. 261 (2009).

(84.) Id. at 266.

(85.) Coeur Alaska, Inc. v. U.S. Army Corps of Eng'rs, 486F.3d 638, 655 (9th Cir. 2007) (ruling that the Army Corps improperlyinterpreted the Clean Water Act when granting permits). Reversing theNinth Circuit, the U.S. Supreme Court accorded Auer deference to aninternal memorandum of the EPA. Coeur Alaska, 557 U.S. at 283-84 (notingthat the memorandum "is entitled to a measure of deference becauseit interprets the agencies' own regulatory scheme" (citingAuer v. Robbins, 519 U.S. 452, 461 (1997))); see also id. at 278("accepting] it as correct" (citing Auer, 519 U.S. at 461));id. At 284-86 (detailing the five factors that led the Court to concludethat "the Memorandum presents a reasonable interpretation of theregulatory regime").

(86.) The Resource Development Council for Alaska is a "tradeorganization comprised of businesses and individuals from all resourcesectors." Brief of the Res. Dev. Council for Alaska, Inc. as AmicusCuriae in Support of Petitioners at 1, Coeur Alaska, 557 U.S. 261 (Nos.07-984, 07-990).

(87.) Id. at 29 (citing Bowles v. Seminole Rock & Sand Co., 325U.S. 410, 414 (1945)). The Council argued further that "the NinthCircuit's holding ... runs counter to the plain language of theAct, and overturns the EPA's and the Corps' carefullyconsidered permitting program for the regulation of mine tailings."Id.

(88.) Supplemental Brief of Amicus Curiae Nat'l Ass'n ofHome Builders Supporting Petitioners at 3, Coeur Alaska, 557 U.S. 261(Nos. 07-984, 07-990). The National Association of Home Builders--alongwith the Council of Alaska Producers and the National MiningAssociation--exhorted the Court to accord Chevron deference to the ArmyCorps' interpretation of the Clean Water Act. See Brief of theCouncil of Alaska Producers as Amicus Curiae in Support of Petitionersat 3, Couer Alaska, 557 U.S. 261 (Nos. 07-984, 07-990) (arguing that theArmy Corps appropriately balanced the environmental and economicimplications of the Clean Water Act); see also Brief Amici Curiae of theNat'l Mining Ass'n, et al. in Support of Petitioners at 14,Coeur Alaska, 557 U.S. 261 (Nos. 07-984, 07-990) (arguing the conflictshould be resolved by expert agencies); Supplemental Brief of AmicusCuriae Nat'l Ass'n of Home Builders Supporting Petitioners,supra, at 3 ("]T]he question for the court is whether theagency's answer is based on a permissible construction of thestatute." (quoting Chevron U.S.A., Inc. v. Nat. Res. Def. Council,Inc., 467 U.S. 837, 842-43 (1984))).

(89.) Supplemental Brief of Amicus Curiae Nat'l Ass'n ofHome Builders Supporting Petitioners, supra note 88, at 3. Here, theNational Association of Home Builders relied on Chevron (as opposed toAuer) deference, but the thrust of its support for deference to theagency based upon its expertise is clear. See Brief of Amicus CuriaeNat'l Ass'n of Home Builders Supporting Petitioners at 10,Coeur Alaska, 557 U.S. 261 (Nos. 07-984, 07-990) ("Whether adischarge of sediment is more likely to move downstream ... 'is aclassic example of a factual dispute the resolution of which implicatessubstantial agency expertise.'" (citing Marsh v. Or. Nat. Res.Council, 490 U.S. 360, 376 (1989)).

(90.) Brief of the Council of Alaska Producers as Amicus Curiae inSupport of Petitioners, supra note 88, at 3 ("The facts of thiscase demonstrate the need for deference to a reasonable interpretationof statutory terms--such as that provided by the Corps and EPA in thiscase.").

(91.) Brief Amici Curiae of the Nat'l Mining Ass'n, etal. in Support of Petitioners, supra note 88, at 14-15. As an initialmatter, the National Mining Association argued that the "CleanWater Act's plain language is dispositive" in favor of CoeurAlaska, but that if the Court found the statute ambiguous, "theagencies entrusted to fulfill Congress's commands would be left toreconcile conflicting statutory mandates." Id. at 14. Indeed,according to the National Mining Association, the conflicting statutorymandates were "precisely the sort of statutory ambiguity that maybe resolved by expert agencies--and whose resolution thereby is entitledto judicial deference." Id. at 15. Here, too, the National MiningAssociation invoked Chevron (as opposed to Auer) deference: "thisprinciple--that an agency's resolution of warring statutorymandates is analyzed under Chevron--is not open to seriousdispute." Id. at 16.

(92.) Brief Amici Curiae of the Chamber of Commerce of the U.S.& the Fair Labor Standards Act Reform Coal, in Support ofRespondents, Auer v. Robbins, 519 U.S. 452 (1997) (No. 95-897), 1996 WL585673 at *3.

(93.) Id. at *16 n.7.

(94.) Id. (quoting Bowles v. Seminole Rock & Sand Co., 325 U.S.410, 414 (1945) and citing Thomas Jefferson Univ. v. Shalala, 512 U.S.504, 510-12, 514-16 (1994)). The Chamber argued, in the alternative,that "[i]n any event, the Department's latest interpretationis plainly erroneous and inconsistent with the regulations." Id.

(95.) Brief of the Labor Policy Ass'n as Amicus Curiae inSupport of Respondents, Auer, 519 U.S. 452 (1997) (No. 95-897), 1996 WL585671 at *1.

(96.) See id. at *7-16 (arguing that the Department of Labor'ssalary basis test is an outdated interpretation that is not entitled todeference).

(97.) Id. at *7 (omission in original) (quoting Batterton v.Francis, 432 U.S. 416, 425 n.9 (1977)).

(98.) Id. at *8 (quoting Martin v. Occupational Safety & HealthReview Comm'n, 499 U.S. 144, 157 (1991)).

(99.) 132 S. Ct. 2156 (2012).

(100.) Id. at 2159.

(101.) Christopher v. SmithKline Beecham Corp., 635 F.3d 383, 401(9th Cir. 2011).

(102.) Brief of Chamber of Commerce of the U.S. as Amicus Curiae inSupport of Respondent at 5, SmithKline Beecham, 132 S. Ct. 2156 (No.11-204). The Chamber argued that the "parroting exception" toAuer deference applied to DOL's regulation implementing the FLSA.Id. at 19 ("An agency does not acquire special authority tointerpret its own words when, instead of using its expertise andexperience to formulate a regulation, it has elected merely toparaphrase the statutory language.") (quoting Gonzales v. Oregon,546 U.S. 243, 257 (2006)).

(103.) Brief of Wash. Legal Found, et al. as Amici Curiae inSupport of Respondent at 10, SmithKline Beecham, 132 S. Ct. 2156 (No.11-204) (quoting Christensen v. Harris Cty., 529 U.S. 576, 588 (2000)).WLF has not been steadfast in its resistance to Auer deference.Consider, for example, its amicus intervention in Allegheny TeledyneInc. v. United States, 316 F.3d 1366 (Fed. Cir. 2003), cert, denied subnom., Gen. Motors Corp. v. United States, 540 U.S. 1068 (2003). WLFargued that the Federal Circuit improperly "dismissed the views ofthe promulgating and implementing agencies," and condemned in nouncertain terms the court's "contempt for basic principles ofagency deference." Brief for Amicus Curiae Wash. Legal Found, inSupport of the Petition for Certiorari at 2, Gen. Motors Corp., 540 U.S.1068 (No. 03-165). WLF attacked each of the three reasons the FederalCircuit gave for affording no weight to the Cost Accounting StandardsBoard (CASB) staff documents: that the documents were written byCASB's associate director and were not representative of the viewsof the agency at large; that the documents "were not [formalinterpretations] published by the Board to aid the interpretation of CAS413"; and that the documents were written nine months after theissuance of CAS 413. Id. at 5-7. Especially relevant here, WLF arguedthat the informality of the documents did not affect their weight underAuer, because "while this Court has recently refused to afford fullChevron deference to an agency interpretation of a statute on the groundthat the interpretation is insufficiently formal ... it has neverafforded anything less than full Seminole Rock deference to an informalagency interpretation of its own regulations." Id. at 6 (citingAuer v. Robbins, 519 U.S. 452, 461-63 (1997)); see also id. at 7("[I]n Auer, the agency's interpretation came only in anamicus brief filed at the Court's request, long after thepromulgation of the relevant regulation."). WLF's contentionhere that the informality of agency interpretations does not lessen theamount of deference they are owed is at odds with its later insistencein Christopher that no deference should be accorded to any agencyinterpretation that was not issued through the formal process ofnotice-and-comment rulemaking.

(104.) Brief of Wash. Legal Found, et al. as Amici Curiae inSupport of Respondent, supra note 103, at 3.

(105.) Id. at 9.

(106.) Id. at 2.

(107.) Brief of Nat'l Fed'n of Indep. Bus. Small Bus.Legal Ctr. as Amicus Curiae in Support of the Respondent at 22,SmithKline Beecham, 132 S. Ct. 2156 (No. 11-204).

(108.) Brief of Pharm. Research & Mfrs. of Am. as Amicus Curiaein Support of Respondent at 4, SmithKline Beecham Corp., 132 S. Ct. 2156(No. 11-204). According to PhRMA, Chevron deference was not warrantedbecause an interpretation announced in an amicus brief does not gothrough notice and comment rulemaking. And Auer deference was notwarranted because the regulation merely parrots the statute. Id.

(109.) Id.

(110.) Id. at 31 (quoting Dismas Charities, Inc. v. U.S. Dep'tof Justice, 401 F.3d 666, 682 (6th Cir. 2005).

(111.) 611 F.3d 141 (2d Cir. 2010), abrogated by SmithKlineBeecham, 132 S. Ct. 2156.

(112.) See Brief of Pharm. Research & Mfrs. of Am. (PhRMA) asAmicus Curiae in Support of Petitioner at 3, In re Novartis Wage &Hour Litig., 611 F.3d 141 (No. 10-460) (criticizing the SecondCircuit's application of Auer deference to an amicus brief thatdramatically changed Department of Labor policy).

(113.) Id. (internal quotation marks omitted).

(114.) Id. at 3-4.

(115.) Id. at 5-12.

(116.) Brief Amici Curiae of the Chamber of Commerce of the U.S.& the Fair Labor Standards Act Reform Coal, in Support ofRespondents, supra note 92, at *16 n.7.

(117.) Brief of Chamber of Commerce of the U.S. as Amicus Curiae at5-6, Christopher v. SmithKline Beecham Corp., 132 S. Ct. 2156 (2012)(No. 11204).

(118.) Id. at 20-21, (quoting United States v. Mead Corp., 533 U.S.218, 226-27).

(119.) Id. at 21.

(120.) Brief of Nat'l Fed'n of Indep. Bus. Small Bus.Legal Ctr. as Amicus Curiae in Support of the Respondent, supra note107, at 23, SmithKline Beecham, 132 S. Ct. 2156 (No. 11-204).

(121.) Id. at 25-26.

(122.) Id. at 24 (emphasis omitted).

(123.) Id.

(124.) 133 S. Ct. 1326 (2013).

(125.) Id. at 1328-29.

(126.) Brief for the United States as Amicus Curiae SupportingPetitioners at 3, Decker, 133 S. Ct. 1326 (Nos. 11-338, 11-347).

(127.) Nw. Envtl. Def. Ctr. v. Brown, 640 F.3d 1063, 1087 (9th Cir.2011).

(128.) Brief for the United States as Amicus Curiae at 12, Decker,133 S. Ct. 1326 (Nos. 11-338, 11-347).

(129.) Brief of Am. Forest Res. Council, Pub. Lands Council,Nat'l Cattlemen's Beef Ass'n, Mont. Wood Prods.Ass'n Inc., Ark. Forestry Ass'n, Fed. Forest Res. Coal., Inc.& Intermountain Forest Ass'n as Amici Curiae in Support ofPetitioners at 1, 7, Decker, 133 S. Ct. 1326 (Nos. 11-338, 11-347).

(130.) Brief for Nat'l All. of Forest Owners et al. as AmiciCuriae in Support of Petitioners at 1, 27, Decker, 133 S. Ct. 1326 (Nos.11-338, 11-347). The National Alliance of Forest Owners conceded that"[s]uch deference is to be denied in certain circumstances,"but concluded that "there was no reason to deny it here." Id.(citing SmithKline Beecham, 132 S. Ct. at 2166). And, in a footnote, theNational Alliance also pointed out that the Ninth Circuit had failed to"articulate why EPA's interpretation of ambiguous terms suchas 'nonpoint source' did not warrant deference underChevron." Id. at 13 n.5. The NFIB brief did not address Auer, butargued that the Court should accord Chevron deference to the EPA'sinterpretation of the Clean Water Act. Brief of Amicus Curiae of TheNat'l Fed'n of Indep. Bus. Small Bus. Legal Ctr. at 3, Decker,133 S. Ct. 1326 (Nos. 11-338, 11-347) ("[T]he EPA'sSilviculture Rule deserves Chevron deference because the agency provideda reasoned explanation for exempting timber harvesting operations fromNPDES permitting requirements consistent with the principles offederalism entailed in the Ninth and Tenth Amendments."). NFIB didcaution that Chevron "does not vest [an agency] with unbridleddiscretion to resolve ambiguities in any conceivable manner. Theagency's interpretation must be reasonable, and must comport withthe background principles of our constitutional system." Id. It didstate unequivocally, however, that " Chevron deference is notparamount to ... judicial abdication." Id. at 5.

(131.) Brief of Amicus Curiae Chamber of Commerce of the U.S. inSupport of Petitioners at 14-18, Decker, 133 S. Ct. 1326 (Nos. 11-338,11-347).

(132.) Id. at 19.

(133.) Id. (quoting Christensen v. Harris Cty., 529 U.S. 576, 588(2000)). See also id. (arguing that because "Auer deference iswarranted only when the language of the regulation is ambiguous,"even the "EPA has no discretion to read the [Rule] as the NinthCircuit did" (quoting Christensen, 529 U.S. at 588)). Moreover, theChamber argued that the EPA's "shifting positions in thislitigation undermine any agency deference that [it] might otherwise beentitled to claim." Id. at 20 (citing SmithKline Beecham, 132 S.Ct. at 2167-68).

(134.) Id. at 21-22 (citing SmithKline Beecham, 132 S. Ct. at2168).

(135.) 135 S. Ct. 1199 (2015). The Chamber and NFIB have, moreover,waged this frontal assault on Auer in the lower courts. For example, inRivera v. Peri & Sons Farms Inc., 755 F. 3d 892 (9th Cir. 2013),cert denied, 134 S. Ct. 2819 (2014), the Chamber joined a coalitionbrief urging the U.S. Supreme Court to grant certiorari to overturn theNinth Circuit's decision giving deference to the DOL'sinterpretation of the FLSA as requiring employers to reimburse foreignworkers' pre-employment travel and immigration expenses. See Briefof the Chamber of Commerce of the U.S. & Nat'l MiningAss'n as Amici Curiae in Support of Petitioner at 3-6, Rivera, 134S. Ct. 2819 (No. 13-950) (asking the U.S. Supreme Court to grantcertiorari specifically to reconsider Auer). The Chamber characterizedAuer deference as a "doctrine [that] arose from a single sentencein the 1945 Seminole Rock decision, which was then cited and applied insubsequent cases without any examination of the rule's underlyingmerits." Id. at 3. It asked the Court to "grant certiorari tosquarely address the ongoing validity of the Auer doctrine," notingthat several Justices had recently "called for a reconsideration ofAuer in an 'appropriate case'" and deeming this to bethat appropriate case. Id. at 3-4. It explained that "[t]he scopeof such deference is tremendously important to the business community,as administrative agencies have increasingly attempted to make policythrough informal guidance rather than notice-and-commentrulemaking." Id. at 4. NFIB likewise seized the opportunity toattack Auer. To NFIB, the case "squarely presents the issue ofwhether the judiciary is required to cede its power to interpretadministrative regulations to administrative agencies." Brief ofAmici Curiae Ctr. for Constitutional Jurisprudence, Cato Inst. &Nat'l Fed'n of Indep. Bus. Small Bus. Legal Ctr. in Support ofPetitioner at 2, Rivera, 134 S. Ct. 2819 (No. 13-950). NFIB's briefrevisits familiar anti-Auer arguments: the doctrine is "contrary to[the] fundamental principles of separation of powers" andrepresents "an abdication of [the judiciary's] duty." Id.at 2-3 (quoting Talk Am., Inc. v. Mich. Bell Tel. Co.. 131 S. Ct. 2254,2266 (2011) (Scalia, J., concurring). It rejects the premise that"the agency, the drafter of the regulation, has some specialinsight into its intent when enacting the regulation" as irrelevantfor the purposes of the deference debate because "courts are boundby the language of the laws, not by 'the unexpressed intention ofthose who made' it." Id. at 10 (citing Decker, 133 S. Ct. at1339-40 (Scalia, J., dissenting in relevant part)). It argues that"[a]ctive judicial review incentivizes agencies to promulgateunambiguous regulations that give fair notice to the regulatedcommunity." Id. at 11. The brief concludes with a sectionsummarizing all of the opinions in which the Justices have voiced doubtsabout Auer. Id. at 13-15. See also Brief of Amici Curiae Se. LegalFound., Nat'l Fed'n of Indep. Bus. Small Bus. Legal Ctr., TheBuckeye Inst., The Beacon Ctr. of Tenn. & Thomas P. Gross in Supportof Petitioner at 5, Flytenow, Inc. v. Fed. Aviation Admin., 137 S. Ct.618 (2017) (No. 16-14) (urging the Court to grant certiorari not only toresolve the circuit split on the specific question of the deference owedto agency interpretations of common law terms, but also because"this case also provides an opportunity to address the doubtsraised by several members of this Court as to the continued validity ofAuer").

(136.) Dep't of Labor, Wage & Hour Div., FLSA2006-11,Opinion Letter on Mortgage Loan Officers Under the FLSA (Mar. 31, 2006);Dep't of Labor, Wage & Hour Div., Administrator'sInterpretation No. 2010-1 (Mar. 24, 2010).

(137.) Mortg. Bankers Ass'n v. Harris, 720 F.3d 966, 968 (D.C.Cir. 2013).

(138.) Brief of the Nat'l Mining Ass'n as Amicus CuriaeSupporting Respondent, Perez, 135 S. Ct. 1199 (Nos. 13-1041, 13-1052);Brief for the Am. Hosp. Ass'n, Ass'n of Am. Med. Colls. &Healthcare Fin. Mgmt. Ass'n as Amici Curiae Supporting Respondent,Perez, 135 S. Ct. 1199 (Nos. 13-1041, 13-1052); Brief of Amici CuriaeUtil. Air Reg. Grp. & American Forest & Paper Ass'n inSupport of Respondent, Perez, 135 S. Ct. 1199 (Nos. 13-1041, 13-1052);Brief of Amici Curiae Chamber of Commerce of the U.S., Am. Fuel &Petrochemical Mfrs., Am. Health Care Ass'n, Bus. Roundtable,Nat'l Ass'n of Mfrs. & Sees. Indus. & Fin. Mkts.Ass'n in Support of Respondents, Perez, 135 S. Ct. 1199 (Nos.13-1041, 13-1052); Brief for Nat'l Fed'n of Indep. Bus., Am.Farm Bureau Fed'n, Am. Petroleum Inst., Nat'l Ass'n ofHome Builders & Retail Litig. Ctr. as Amicus Curiae SupportingRespondents, Perez v. Mortg. Bankers Ass'n, 135 S. Ct. 1199 (2015)(Nos. 13-1041, 13-1052); Brief of Amicus Curiae Quicken Loans, Inc. inSupport of Respondent Mortg. Bankers Ass'ns, Perez v. Mortg.Bankers Ass'n, 135 S. Ct. 1199 (2015) (Nos. 13-1041, 13-1052).

(139.) The Chamber and NFIB were joined in their efforts tooverrule Auer by several additional business groups filing amicusbriefs. See, e.g., Brief of Amici Curiae Util. Air Reg. Grp. &American Forest & Paper Ass'n in Support of Respondent, supranote 138, at 13-15 (urging the Court to overrule Auer/Seminole Rock andthus hold that if an agency interprets its rules outside thenotice-and-comment process, that interpretation is entitled to onlySkidmore respect in accordance with its "power to persuade").

(140.) Brief of Amici Curiae Chamber of Commerce of the U.S. et al.in Support of Respondents, supra note 138, at 6, 13-14.

(141.) Id. at 14-15 (citing John F. Manning, ConstitutionalStructure and Judicial Deference to Agency Interpretations of AgencyRules, 96 Colum. L. Rev. 612, 638-54 (1996)).

(142.) Id. (quoting Christopher v. SmithKline Beecham Corp., 132 S.Ct. 2156, 2168 (2012)).

(143.) Id. at 21. The Chamber elaborated: "Although the DueProcess Clause and administrative law protections such as arbitrary andcapricious review would guard against the most egregious threats toreliance interests, the high barriers posed by some of these doctrinesmight not shield reliance interests in the ordinary case where an agencychanges its mind to the detriment of the regulated parties." Id. at21-22.

(144.) Brief for Nat'l Fed'n of Indep. Bus., Am. FarmBureau Fed'n, Am. Petroleum Inst., Nat'l Ass'n of HomeBuilders & Retail Litig. Ctr. as Amicus Curiae SupportingRespondents, supra note 138, at 21-22.

(145.) See, e.g., Brief of Amicus Curiae Quicken Loans Inc. inSupport of Respondent Mortg. Bankers Ass'n, supra note 138, at 16(praising Paralyzed Veterans as "protecting] interests of regulatedentities by requiring administrative agencies ... to comply with the APAbefore substantively changing a prior definitive interpretation");Brief for the Am. Hosp. Ass'n, Ass'n of Am. Med. Colls. &Healthcare Fin. Mgmt. Ass'n as Amici Curiae Supporting Respondent,supra note 138, at 4 (similarly advocating for the Paralyzed Veteransdoctrine).

The Washington Legal Foundation's amicus brief primarilyfocused on persuading the Court to uphold the D.C. Circuit'sParalyzed Veterans rule, which WLF characterized as "an effectivetool for distinguishing those rule revisions that are purelyinterpretative and do not have the force of law (and are thus exemptfrom the APA's notice-and-comment requirements) from substantiverule revisions that are subject to those requirements." Brief ofWash. Legal Found. & Allied Educ. Found, as Amici Curiae in Supportof Respondent at 2, Perez, 135 S. Ct. 1199 (Nos. 13-1041, 12-1052). WLFexpressed concern that, if it were overturned, "some federalagencies will seek to evade that procedural requirement by adopting defacto amendments to substantive rules under the guise of merely're-interpreting' those rules." Id. WLF invoked Auer inan interesting way to bolster its contention that the Department ofLabor's challenged position--that mortgage loan officers are notexempt from the FLSA's overtime provisions--was a substantive rulethat was subject to notice-and-comment requirements. WLF pointed outthat in other recent FLSA litigation, the Department had filed amicusbriefs arguing that its position was entitled to Auer deference. Id. at21-22. But because "this Court has made clear that interpretiverules are not entitled to Auer deference," WLF reasoned, theDepartment's "assertion that [its rule] is entitled to Auerdeference is a strong indication that [it] deems [the rule to be] asubstantive rule, not an interpretive rule." Id. at 22. Thus,instead of criticizing the Auer doctrine, WLF assumed its legitimacy inusing it to prove a corollary point.

(146.) Brief of the Nat'l Mining Ass'n as Amicus CuriaeSupporting Respondent, supra note 138, at 26. According to the NMA, the"Court has already laid the groundwork for such a rule." Id.at 27-28 (citing Thomas Jefferson Univ. v. Shalala, 512 U.S. 504, 512(1994); United States v. Mead Corp., 533 U.S. 218, 234-35 (2001)).

(147.) Id. at 11 (emphasis omitted).

(148.) Brief of Prod. Liab. Advisory Council, Inc. as Amicus Curiaein Support of Respondent, supra note 18, at 22.

(149.) Id.

(150.) The Chamber of Commerce has been involved in a large numberof federal preemption cases, taking the following positions in thesecases: Metro. Milwaukee Ass'n of Commerce v. Milwaukee Cty., 431F.3d 277 (7th Cir. 2005) (urging the court to find that the NationalLabor Relations Act preempted a county ordinance that required certaincounty-paid patient transport and patient care contractors to enter intolabor peace agreements); Chamber of Commerce of the U.S. v. Brown, 554U.S. 60 (2008) (arguing that a California law prohibiting employers whoreceive more than $10,000 in state funds annually from using those funds"to assist, promote, or deter union organizing" was preemptedby the National Labor Relations Act); Rowe v. N.H. Motor Transp.Ass'n, 552 U.S. 364 (2008) (urging the court to affirm the districtcourt's judgment that Maine's effort to regulate motor carriertraffic where it involved the transport of tobacco products is preemptedby the Motor Carrier Act and the Federal Aviation AdministrationAuthorization Act); Mason v. SmithKline Beecham Corp., 596 F.3d 387 (7thCir. 2010) (urging the Seventh Circuit to hold that a state law failureto warn claim is conflict-preempted by the FDA's rejection ofadditional warnings for a class of anti-depressant drugs); Kurns v. R.R.Friction Prods. Corp., 132 S. Ct. 1261 (2012) (arguing that the FederalRailroad Safety Acts preempted state-law-based tort claims relating toinjury sustained during the manufacture of locomotive equipment); Am.Trucking Ass'ns, Inc. v. City of Los Angeles, 133 S. Ct. 2096(2013) (arguing that the Federal Aviation Administration AuthorizationAct preempted a municipal government program barring federally licensedmotor carriers from access to a port); Entergy Nuclear Vt. Yankee, LLCv. Shumlin, 733 F.3d 393 (2d Cir. 2013) (asking the court to find thatthe Atomic Energy Act preempted conflicting Vermont state regulations);Am. Tort Reform Ass'n v. Occupational Safety & Health Admin.,738 F.3d 387 (D.C. Cir. 2013) (urging the court, to vacate OSHA'samendments to the Hazard Communication Standard announcing that statetort claims were no longer preempted); Arn.'s Health Ins. Plans v.Hudgens, 742 F.3d 1319 (11th Cir. 2014) (urging the court to hold that aGeorgia law imposing additional reporting requirements on self-fundedinsurance plans was preempted by the Employee Retirement Income SecurityAct); Nw., Inc. v. Ginsberg, 134 S. Ct. 1422 (2014) (arguing that statelaw claims for breach of implied-by-law covenants are preempted by theAirline Deregulation Act); Armstrong v. Exceptional Child Ctr., Inc.,135 S. Ct. 1378 (2015) (arguing that the Supremacy Clause confers aprivate right of action to enjoin states from enforcing preempted statelaw); Penske Logistics, LLC v. Dilts, 135 S. Ct. 2049 (2015) (urging theU.S. Supreme Court to grant a petition for certiorari to clarify thatthe Federal Aviation Administration Authorization Act preemptedCalifornia's meal and rest break laws as applied to motorcarriers); Little v. Louisville Gas & Elec. Co., 805 F.3d 695 (6thCir. 2015) (asking the court to hold that the Clean Air Act preemptedstate common law nuisance claims); Gobeille v. Liberty Mut. Ins. Co.,136 S. Ct. 936 (2016) (urging the U.S. Supreme Court to hold that aVermont law that imposed record keeping and reporting obligations onself-employed plans beyond those required by the Employee RetirementIncome Security Act was preempted); Cook v. Dow Chem. Co., 136 S. Ct.2055 (2016) (asking the Supreme Court to grant a petition for certiorariand find that the Price-Anderson Act preempted state law claims by aplaintiff who suffered a nuclear-related injury); Johnson & Johnsonv. Reckis, 136 S. Ct. 896 (2016) (asking the U.S. Supreme Court to granta petition for certiorari and hold that the FDA's rejection ofwarning language proposed in a Citizen Petition is "clearevidence" sufficient to preempt state tort failure to warn claims);Puerto Rico v. Franklin Ca. Tax-Free Trust, 136 S. Ct. 1938 (2016)(arguing that the federal Bankruptcy Code preempted a Puerto Ricostatute creating a mechanism for Puerto Rico's struggling publicutilities to restructure their debts).

(151.) Brief of Prod. Liab. Advisory Council, Inc. as Amicus Curiaein Support of Respondent, supra note 18, at 1.

(152.) Id. at 4.

(153.) Id.

(154.) Id. at 22 (quoting Requirements on Content and Format ofLabeling for Human Prescription Drug and Biological Products, 71 Fed.Reg. 3922, 3935 (Jan. 24, 2006)).

(155.) See Brief of Amicus Curiae Prod. Liab. Advisory Council,Inc. in Support of Petitioner at 4, Wyeth v. Levine, 555 U.S. 555 (2009)(No. 06-1249).

(156.) Id. at 30. PLAC cites Hillsborough Cty. v. Automated Med.Labs., Inc., 471 U.S. 707, 714-15 (1985), for the proposition that when,"as in the case of the FDA, Congress has delegated authority to anexpert federal agency to implement and enforce a federal regulatoiyscheme, the agency's determination that state law threatens toupset federal objectives 'is dispositive ... unless either theagency's position is inconsistent with clearly expressedcongressional intent, or subsequent developments reveal a change in thatposition.'" Id. at 31 (omission in original).

(157.) Id. at 32.

(158.) Id. (quoting Hillsborough Cty., 471 U.S. at 718).

(159.) Id. (quoting Auer v. Robbins, 519 U.S. 452, 462 (1997)).PLAC also disputed the lower court's rejection of Chevrondeference. The Vermont Supreme Court disregarded the FDA'sinterpretation of the FDCA in part because it believed that"Congress, in a savings clause, expressly limited impliedpreemption in the drug context to situations in which compliance withfederal and state law is a physical impossibility," and"[Chevron] deference to an agency's interpretation isappropriate only when a statute is silent or ambiguous with respect tothe specific issue the agency has considered." Id. at 33 (internalquotation marks omitted). PLAC argued that the Vermont SupremeCourt's belief was wrong because it was rooted in amisinterpretation of the U.S. Supreme Court's implied preemptiondoctrine, but did not otherwise contest the lower court'sexplanation of the Chevron doctrine's applicability. Id.

(160.) Brief of the Advanced Med. Tech. Ass'n (ADVAMED), DRI,MedMarc & the Med. Device Mfrs. Ass'n (MDMA) as Amici Curiae inSupport of Respondent at 1, Riegel v. Medtronic, Inc., 552 U.S. 312(2008) (No. 06-179).

(161.) Id. at 9-10 (quoting Food & Drug Admin., Innovation orStagnation: Challenge and Opportunity on the Critical Path to NewMedical Products 13 (2004),https://www.fda.gov/downloads/ScienceResearch/SpecialTopics/CriticalPathlnitiative/CriticalPathOpportunitiesReports/UCM113411.pdf [https://perma.cc/Q86P-2V38]).

(162.) Id. at 15-16.

(163.) Id. at 27 (quoting Letter-Brief of the United States asAmicus Curiae at 25-26, Horn v. Thoratec Corp., 376 F.3d 163 (3d Cir.2004) (No. 02-4597)).

(164.) Brief of CropLife Am., Am. Chem. Council & ConsumerSpecialty Prods. Ass'n as Amici Curiae in Support of Respondent at4, Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (No. 06-179).

(165.) Id. at 13.

(166.) Id. at 18.

(167.) Brief for PhRMA & BIO as Amici Curiae SupportingPetitioner, supra note 23, at 2.

(168.) Id. at 29-30 (citing New Drug and Antibiotic Regulations, 47Fed. Reg. 46,622, 46,623, 46,635 (Oct. 19, 1982)).

(169.) Id. at 30. PhRMA and BIO also argue that "anagency's determination that a state law poses an obstacle toachieving the purposes and objectives of federal law is also entitled toa degree of judicial deference." Id. at 30 n.14 (citing Medtronic,Inc. v. Lohr, 518 U.S. 470, 496 (1996) and Geier v. Am. Honda Motor Co.,529 U.S. 861, 883 (2000)).

(170.) 509 F. App'x 215 (4th Cir. 2013), cert, denied 134 S.Ct. 88 (2013).

(171.) See Brief for Pharm. Research & Mfrs. of Am. as AmicusCuriae in Support of Petitioner, Fussman, 134 S. Ct. 88 (No. 12-1339).

(172.) Id. at 8 (quoting PLIVA, Inc. v. Mensing, 564 U.S. 604, 615(2011)).

(173.) See supra Part II.A.l.b.

(174.) Brief of Pharm. Research & Mfrs. of Am. (PhRMA) asAmicus Curiae in Support of Respondent, supra note 108, at 4. Accordingto PhRMA, Chevron deference was not warranted because an interpretationannounced in an amicus brief does not go through notice and commentrulemaking. And Auer deference was not warranted because the regulationmerely parrots the statute. Id. at 28.

(175.) Brief for Pharm. Research & Mfrs. of Am. as AmicusCuriae in Support of Petitioner, supra note 171, at 9.

(176.) Press Release, Wash. Legal Found., WLF Hails FDA PolicyStatement on Preemption of Failure-to-Warn Suits (Jan. 25, 2006),http://www.wlf.org/ upload/012506RS.pdf [https://perma.cc/V7X7-B7DY].

(177.) Id. at 1.

(178.) Id.

(179.) Id. at 2.

(180.) Id.

(181.) Brief of Wash. Legal Found. & Am. Coll. of EmergencyPhysicians as Amici Curiae in Support of Petitioner at 13, Wyeth v.Levine, 555 U.S. 555 (2008) (No. 06-1249) (quoting Colacicco v. Apotex,Inc., 521 F.3d 253, 275 (3d Cir. 2008), vacated, 129 S. Ct. 1578(2009)).

(182.) Brief of Wash. Legal Found, et al. as Amici Curiae inSupport of Respondent, supra note 103, at 16 (quoting Wyeth, 555 U.S. at577).

(183.) Id. at 10-11 (quoting Talk Am., Inc. v. Mich. Bell Tel. Co.,564 U.S. 50, 69 (2011) (Scalia, J., concurring)). To be sure, WLF didnot take a categorically anti-Auer position in Christopher. Itacknowledged that "[u]nder Auer, an agency's interpretation ofan ambiguous regulation is sometimes entitled to deference because it ispresumed that the agency is best situated to interpret its ownwords." Id. at 18. But it made clear that "an agency cannotproperly claim to be 'interpreting' a regulation when it is ineffect changing that regu lation." Id.

(184.) Brief of the Chamber of Commerce of the U.S. as AmicusCuriae in Support of Respondent, supra note 18, at 6.

(185.) Id. at 7.

(186.) Brief of the Chamber of Commerce of the U.S. as AmicusCuriae in Support of Petitioner at 7-8, Wyeth v. Levine, 555 U.S. 555(2009) (No. 06-1249). The Chamber also took the lower court to task forits reliance on the "presumption against preemption." Id. at7.

(187.) Id. at 10-11 (explaining that the lower court"incorrectly thought that Section 314.70 [the "Changes BeingEffected" provision of the FDA's labeling regulations] allowedWyeth to make unilateral changes to [Phenergan's] drug label[]without obtaining prior FDA approval whenever [Wyeth] believes it willmake the product safer," when "[i]n fact, the FDA has longinterpreted the CBE regulation as permitting changes to labeling onlywhere the changes reflect newly discovered information about thedrug's safety--information that the FDA has not previouslyconsidered." (internal quotation marks omitted)).

(188.) Id. at 11 (citing Auer v. Robbins, 519 U.S. 452, 461(1997)). The Chamber also implicitly endorsed Chevron deference byurging that "courts should apply the ordinary rules relating todeference to administrative agencies' interpretations of thestatutes and regulations they administer at this first step of the[conflict preemption] analysis," in which the court interprets therelevant federal and state laws. Id. at 30. Specifically, with respectto implied preemption analysis, the Chamber argued that when a courtevaluates "the extent of the conflict between state and federallaws and ... determines] whether the inconsistency rises to the level ofa violation of the Supremacy Clause," it is "entirelyappropriate to afford substantial weight to the views of anadministrative agency charged with implementing a comprehensiveregulatory scheme in a technical area where, as here, the agencyconcludes, for persuasive reasons, that state regulation interferes withits regulatory regime or presents an obstacle to the achievement offederal objectives." Id. at 30-31 (citing Medtronic, Inc. v. Lohr,518 U.S. 470, 496 (1996); Geier v. Am. Honda Motor Co., Inc., 529 U.S.861, 883 (2000)). According to the Chamber, this "approach makeseminent sense" because "[t]he determination whether state lawstands as an obstacle to a complex federal regulatory scheme often ...involve[s] technical or policy-based judgments about the practicaleffect of state law on the efficient and effective operation of acomplex statutory and regulatory scheme--judgments that anadministrative agency such as the FDA is uniquely well suited tomake." Id. at 31-32. Thus, the Chamber argues, "the Courtshould also give substantial weight to the FDA's 2006 statements[in the preamble to its drug labeling rule] relating to preemption andthe adverse and disruptive effects of certain state-law productliability lawsuits on the federal regulatory scheme," which are"persuasive and thus deserving of substantial weight in thisCourt." Id. at 11.

(189.) A likely explanation is that its members were divided on theissue--namely whether generic drug manufacturers should be shielded fromliability by preemption whereas brand name manufacturers were not (inlight of Wyeth).

(190.) Brief of Petitioners PLIVA, Inc.; TEVA Pharm. USA Inc. &UDL Labs, Inc. at 43, PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (Nos.09-993, 09-1039, 09-1501).

(191.) Id.

(192.) Brief of Petitioners Actavis Inc. & Actavis ElizabethLLC at 22, Mensing, 564 U.S. 604 (Nos. 09-993, 09-1039, 09-1501).

(193.) Brief of Petitioners PLIVA, Inc.; TEVA Pharms. USA Inc.& UDL Labs, Inc., supra note 190, at 33.

(194.) Brief of the Chamber of Commerce of the U.S. of Am. &Pharm. Research & Mfrs. of Am. as Amici Curiae in Support ofPetitioner, supra note 12, at 20.

(195.) Id.

(196.) 799 F.3d 633 (7th Cir. 2015), cert, denied, 136 S. Ct. 1607(2016). The Bible case involved the question whether a borrower'sstate-law breach of contract claim against a guaranty agency for herstudent loans is preempted by the Higher Education Act (HEA). TheSeventh Circuit Court of Appeals held that the claim was not preemptedby the HEA because it did not conflict with federal law and opined thatthe contract at issue "simply incorporate[d] applicable federalregulations as the standard for compliance." Id. at 639. In soholding, the court deferred to the Secretary of Education'sinterpretations of the applicable statutes and regulations as providingthat "a guaranty agency may not impose collection costs on aborrower who is in default for the first time but who has timely enteredinto and complied with an alternative repayment agreement." Id.

(197.) Brief of Nat'l Ass'n of Mfrs. & the Nat'lShooting Sports Found., Inc. as Amici Curiae in Support of Petitionersat 2, Bible, 799 F.3d 633 (No. 15-861).

(198.) Id. at 3 (quoting City of Arlington v. Fed. Commc'nsComm'n, 133 S. Ct. 1863, 1879 (2013) (Roberts, C.J., dissenting)).The brief cited all of the Justices' opinions expressingreservations about Auer from City of Arlington, Decker, and Perez. NAMexplained that "Amici are concerned that such deference mayactually provide disincentives for regulatory clarity, therebysacrificing notice and predictability in rulemaking," and suggestedthat Auer "might be understood as an end-run around rulemaking inthe extreme." Id. at 4-5 (quoting Lisa Schultz Bressman, BeyondAccountability: Arbitrariness and Legitimacy in the AdministrativeState, 78 N.Y.U. L. Rev. 461, 552 (2003)). NAM insisted that Auerconflicts with the APA, which "allocates interpretive authority tothe judiciary," and threatens separation of powers. Id. at 8-13.NAM took particular issue with agency interpretations announced in anamicus brief during litigation, outside of the context of rulemaking, aswas true in the case at hand. Id. at 13-14.

(199.) Nor has NAM been steadfast in its resistance to Auer.Consider, for example, its amicus brief in In re Polar Bear EndangeredSpecies Act Listing & 4(d) Rule Litig., 794 F. Supp. 2d 65 (D.D.C.2011). NAM argued that the Fish and Wildlife Service's"preambles and documents interpreting]" the Endangered SpeciesAct rules "are entitled to deference" under Auer. Memorandumof the Nat'l Trade Ass'ns in Opposition to Plaintiffs'Motion for Summary Judgment on the 4(d) Rule & in Support of Fed.Defendants' Cross-Motion for Summary Judgment on the 4(d) Rule at14, In re Polar Bear Endangered Species Act Listing & 4(d) RuleLitig, 794 F. Supp. 2d 65 (Nos. l:08-cv-2113, 1:09-cv-0159). Moregenerally, NAM argued that on "science issues, judicial review mustgenerally be at its most deferential" because "a federalagency must have discretion to rely on the reasonable opinions of itsown qualified experts even if the court might find contrary views morepersuasive." Id. (internal citations and quotation marks omitted).

(200.) Brief of Professor Philip Hamburger & Wash. Legal Found,as Amici Curiae in Support of Petitioner at 2, Bible, 799 F.3d 633 (No.15-861).

(201.) Id. The brief articulated two primary arguments forrenouncing Auer. First, it argued that Auer deference "requiresArticle III judges to abandon their office and duty of independentjudgment" under the Constitution. Id. at 3. Second, it argued thatbecause "Auer precommits judges to favor one party overanother" where one of those parties is a federal agency, it"requires judges to adopt a systematic bias in favor of thegovernment" that violates the Fifth Amendment's guarantee ofdue process of law. Id. at 4.

(202.) President Trump Is Pushing Regulations out the Door,Nat'l Fed'n of Indep. Bus. (Feb. 1, 2017),http://www.nfib.com/content/analysis/national/donald-trump-is-pushing-regulations-out-the-door/[https://perma.cc/K3NWDRWR].

(203.) Exec. Order No. 13771, 82 Fed. Reg. 9339 (Feb. 3, 2017).

(204.) Id. On the day that President Trump announced ExecutiveOrder 13771, the NFIB issued a press release: "[t]hePresident's order is a good first step on the long road towardeliminating bail-and-chain regulations so small businesses can createjobs and expand the economy." NFIB Welcomes Trump's Actions onRegulations, Nat'l Fed'n of Indep. Bus. (Jan. 30, 2017),http:// www.nfib.com/content/press-release/economy/nfib-welcomes-trumps-actionson-regulations/ [https://perma.cc/7GM6-W2X4]. The statement urgedregulatory agencies and the Office of Management and Budget to"keep ... in mind" that "the extraordinary costs andcomplexity of regulations falls hardest on America's small andindependent businesses." Id.

(205.) Sean Hackbarth, How Congress and Trump Are Taming theRegulatory Leviathan, U.S. chamber of Commerce (Feb. 14, 2017, 5:15 PM),https:// www.uschamber.com/above-the-fold/how-congress-and-trump-are-tamingthe-regulatory-leviathan [https://perma.cc/5LTB-HMJY]. Unlike NFIB,the Chamber did not immediately issue a statement regarding ExecutiveOrder 13771, but two weeks later, its senior vice president and chiefpolicy officer said in an interview that it is not the two-for-oneprovision, but rather the provision requiring the net cost of all newregulations to be zero that "really can have a profound impact. Itgives you a new target for when you're writing regulations."Juliet Eilperin, Why Trump's Order to Cut Government Regulation IsEven Bolder Than It Seems, Wash. Post. (Feb. 13, 2017), https://www.washingtonpost.com/news/powerpost/wp/2017/02/13/why-trumpsorder-to-cut-government-regulation-is-even-bolder-than-it-seems/[https:// perma.cc/6ZZN-4799].

(206.) Brief of Amici Curiae Se. Legal Found, Nat'l Fed'nof Indep. Bus. Small Bus. Legal Ctr, The Buckeye Inst, The Beacon Ctr.of Tenn. & Thomas P. Gross in Support of Petitioner, supra note 135at 5.

(207.) Business groups have already turned their attention toCongress with respect to reining in the regulatory state. TheChamber's website notes that "now is the time to seriouslythink about how federal regulations get made," insisting that"[w]hile the Constitution requires a lot of effort to write a newlaw, over the decades it's become relatively easy for federalagencies to write regulations that have the full weight of law," towhich "federal courts have given ... tremendous deference."Hackbarth, supra note 205. As a solution, the Chamber proposes theRegulatory Accountability Act, which recently passed the House vote andwill soon be before the Senate. Id.; Letter from 616 Bus. Grps. &Ass'ns to Mitch McConnell and Charles Schumer, Senate MajorityLeader and Democratic Leader (Feb. 6, 2017), https://www.uschamber.com/sites / default/files/documents/files/2.6.17-_multi-association_Jetter__to_ senate_supporting__the_regulatory_accountability__act.pdf[https://perma .cc/F557-KESBj. Significantly, the RegulatoryAccountability Act bill--which includes the Separation of PowersRestoration Act--amends 5 U.S.C. [section] 706 to eliminate judicialdeference to an agency's determination of the costs and benefits orother economic or risk assessment if the agency failed to conform toguidelines established by OIRA, determinations made in the adoption ofan interim rule, or guidance. See Regulatory Accountability Act of 2017,H.R. 5, 115th Cong. sec. 107, [section] 706. It is thus not a stretch toimagine such groups urging Congress to intervene in the federalpreemption context as well. And this approach, moreover, would obviatethe need to rely on deference to federal agencies in that context.

Catherine M. Sharkey, Crystal Eastman Professor of Law, New YorkUniversity School of Law. This Article was prepared for a symposium on"Business in the Roberts Court" at Case Western ReserveUniversity School of Law held on September 23, 2016. I am grateful toLarry Ebner, Robert Gasaway, Karen Harned, Bert Rein, Rich Samp, AlanUntereiner, and Luke Wake for sharing their realworld perspectives aboutvarious issues raised in this Article. Terry Ding (NYU 2018) providedspectacular research assistance.