Administrative Law Prof Blog

Fail: Commission attacks its own decision

A government can change its mind. But it must follow its rules about mind-changing. I like this case because of who is attacking the administrative decisions: The agency that made the decisions. From Dean Patty Salkin's Law of the Land blog, "CT Appeals Court Rules Planning and Zoning Commission May Not Reconsider Approval More than 15 Days After Decision".

The planning and zoning commission approved plaintiff's request to remove 200,000 cubic yards of earth material from his property to create hayfields and pastureland without requiring a special permit since the removal of earth material was incidental to agricultural operation as detailed in the plaintiff's engineer-designed site-plan. ...

The zoning commission later issued a cease and desist order concerning the removal of earth because it was "outside the scope of the original approval," which was for agricultural use, and not earth removal.

Plaintiff appealed the cease and desist order, and the [trial] court ruled that the [commission] did not have authority to reconsider the merits of its approval once the time for appealing had expired, and that affirmation of the cease and desist order was not supported by the facts. [The commission] appealed, maintaining that the court improperly concluded both that the underlying approval of the planning and zoning commission could not be collaterally attacked in a cease and desist order and that the agricultural operation of the plaintiff's land that was approved by the commission authorized the plaintiff to sell his gravel. The appellate court affirmed the judgment of the trial court because the time for appeal from the zoning commission [had] expired. The Court noted that the [commission] did not have the authority to execute a cease and desist order that collaterally challenged the unappealed decision and also, the record did not show the plaintiff exceeded the permits given ...

Under [Connecticut] General Statute §8-28, there must be publication of the zoning commission decision within 15 days ... then the zoning commission has 15 days to reconsider its decision. Defendants claim the zoning commission’s decision can be collaterally attacked because the decision was never published ... The court noted that the commission's failure to publish notice of its decision ... is a jurisdictional defect that makes the commission's decision void. However, ... [s]ince the record did not contain any allegation of the failure to publish, there is [no] jurisdictional defect and the decision [was] not void.

Alternatively, the [commissioners] claim they exceeded their statutory authority by granting the plaintiff's permit. The court stated, it is a general rule "that litigation about the merits of a cease and desist order does not permit a collateral attack on the validity of the zoning decision that was not challenged when it was made, even on jurisdictional grounds."  Since there was no challenge to the approval of the zoning decision within the appeal period, there can be no collateral attack on the decision in this cease and desist litigation. Because of this, the trial court rightly did not address the merits of the [commission's] claim.

The appellate court went on to examine the merits of the commission's claim that the plaintiff had exceeded the scope of his permit and found that he had not. Sounds like the planning and zoning commission figured out too late it had approved something it didn't really want to approve. EMM

Legislative and nonlegislative rulemaking

New on SSRN: "Legislative Rules, Nonlegislative Rules, and the Perils of the Short Cut" by David Franklin (DePaul). Abstract:    

Courts have long struggled to distinguish legislative rules, which are designed to have binding legal effect and must go through the rulemaking procedure known as notice and comment, from nonlegislative rules, which are not meant to have binding legal effect and are exempted from notice and comment. The distinction has been called “tenuous,” “baffling,” and “enshrouded in considerable smog.”

What is just as baffling is that prominent commentators such as John Manning, Peter Strauss, William Funk and Donald Elliot have proposed a simple solution to the problem—and courts have failed to take them up on it. Rather than inquiring into a rule’s nature or effects to decide whether it must undergo notice and comment, these commentators urge, courts should turn the question inside-out and ask whether the rule has undergone notice and comment in order to determine whether it can be made legally binding. This proposal, which I call the “short cut,” would economize on judicial decision costs. Moreover, its proponents say, it would not reduce oversight of the administrative process, because agencies would often opt to submit their rules to notice and comment ex ante in order to ensure that they are treated as legally binding ex post. Lately, proponents of the short cut such as Manning and Jacob Gersen have argued that their position is strengthened by the Supreme Court’s 2001 Mead decision, which presumptively disqualifies nonlegislative rules from Chevron deference.

This article explains—for the first time—not only why judges have resisted the short cut, but why they have been wise to do so. It argues that caution is warranted for three reasons: the short cut inadequately protects the interests of those persons, particularly regulatory beneficiaries, whose interests are affected by deregulatory or permissive agency pronouncements; it stands in tension with the longstanding principle that agencies may choose to announce new policy either through adjudication or rulemaking; and it ignores important differences between public scrutiny at the promulgation stage and heightened judicial scrutiny at the enforcement stage. Nor, I argue, does the Mead decision lend decisive force to the arguments in favor of the short cut, because nonlegislative rules are often accorded substantial deference in practice. These, in short, are the perils of the short cut.

EMM

Electronic rulemaking

New on SSRN: "A Survey of Federal Agency Rulemakers’ Attitudes About E-Rulemaking" by Jeffrey Lubbers (American). Abstract:    

Drawing on a survey of U.S. civil servants engaged in developing regulations across a wide variety of agencies, this chapter analyzes how bureaucrats in key positions view the impact on their work of “electronic rulemaking” – that is, the creation of online opportunities for members of the public to comment on proposed administrative regulations. There is strong evidence that rulemakers appreciate the value of new technologies for public participation purposes and for internal administration and coordination functions, but less evidence that they see the utility of e-rulemaking for improving the quality of administrative rules.

EMM

Standing in environmental law

New on SSRN: "Standing and Environmental Law: An Overview" by Robin Craig (Florida State). Abstract:    

Standing has long been one of the most common constitutional challenges in federal environmental cases. While standing is technically a requirement in all federal cases in order to satisfy those courts’ constitutional restriction to hearing “Cases” and “Controversies,” standing rarely becomes a contested issue in “normal” litigation involving that plaintiff’s assertion that a defendant injured the plaintiff personally, as in most tort, property, and contract litigation. Instead, it is the “public interest” nature of many environmental lawsuits that has made environmental law a significant flashpoint for the U.S. Supreme Court’s standing jurisprudence. Specifically, because environmental plaintiffs often bring public interest claims, their connections to the legal problems challenged can appear attenuated, prompting defendants to assert that the plaintiffs lack standing to bring the legal challenge.

Environmental standing law has a long history in the Supreme Court, but new standing issues, such as the possibility of special standing rules for states, still arise. This chapter begins in Part I by tracing the early history of standing doctrine in the Court. Part II shifts focus to the Court’s specifically environmental standing decisions in the 20th century, emphasizing the importance of its 1992 decision in Lujan v. Defenders of Wildlife. Part III provides an overview of continuing and emerging issues in environmental standing, including, for example, the problem of increased risk (probabilistic) standing and the Supreme Court’s suggestion in Massachusetts v. EPA that states are entitled to “special solicitude” in the standing analysis.

EMM

Theory: Judicial deference to agency interpretation

New on SSRN: "The Hundred-Years War: The Ongoing Battle between Courts and Agencies over the Right to Interpret Federal Law" by Nancy Modesitt (Baltimore). Abstract:    

Since the Supreme Court’s 1984 Chevron decision, the primary responsibility for interpreting federal statutes has increasingly resided with federal agencies in the first instance rather than with the federal courts. In 2005, the Court reinforced this approach by deciding National Telecommunications Ass'n v. Brand X Internet Services, which legitimized the agency practice of interpreting federal statutes in a manner contrary to the federal courts' established interpretation, so long as the agency interpretation is entitled to deference under the well-established Chevron standard. In essence, agencies are free to disregard federal court precedent in these circumstances. This Article analyzes the question left unanswered by Brand X - specifically, whether agencies can also ignore federal court interpretations of federal statutes when the agency's interpretation is not entitled to Chevron deference - and argues, based on consideration of constitutional theory and practical repercussions, that agencies may only do so in extremely limited circumstances where there is substantial justification. This Article reviews the Equal Employment Opportunity Commission's policy of ignoring federal precedent in order to illustrate the damage caused by an unjustified policy.

EMM

Theory: Coordinating private sector regulation (torts) with government regulation

New on bepress: "Coordinating Sanctions in Torts" by Kyle D. Logue (Michigan). Abstract:

This Article begins with the canonical law-and-economics account of tort law as a regulatory tool, that is, as a means of giving regulated parties the optimal ex ante incentives to minimize the costs of accidents. Building on this regulatory picture of tort law, the Article asks the question how tort law should coordinate with already existing non-tort systems of regulation. Thus, for example, if a particular activity is already subject to extensive agency-based regulation, regulation that already addresses the negative externalities or other market failures associated with the activity, what regulatory role remains for tort law? Should tort law in such cases be displaced or preempted? The answer is: It depends. Sometimes, even in the presence of overlapping non-tort regulation, there is a regulatory role that tort law can play, sometimes not.

For one example, if the non-tort regulatory standard is already “fully optimizing,” in the sense that the regulatory standard (a) sets both an efficient floor and an efficient ceiling of conduct and (b) is fully enforced by the regulatory authority, then tort law arguably should be fully displaced in the sense that no tort remedy should be available for harms caused by such an activity. If, however, the regulatory standard is only “partially optimizing” (for example, it is only an efficient minimum or efficient floor or it is only partially enforced), then tort law continues to have an important regulatory role to play.

This framework can be used to explain such tort doctrines as negligence per se and suggests circumstances in which there should be a corollary doctrine of non-negligence per se. It also helps to explain recent federal preemption cases involving overlapping tort and regulatory standards. Finally, the framework produces insights for how tort law might efficiently be adjusted to coordinate with overlapping social norms, which are also considered within the L&E tradition to be a form of regulation.

EMM

RegInfo.gov usability enhanced

From Penn's RegBlog, "White House Announces Enhancements To RegInfo.gov":

The Obama Administration’s OMB Director, Peter Orszag, recently announced upgrades to the RegInfo.gov website. In a February 16th posting on the White House website, Orszag stated that the administration was “debuting the OIRA Dashboard” – a website that “will allow people to track the progress of federal rules and regulations that have been submitted for interagency review and find other relevant information about the Office of Information and Regulatory Affairs (OIRA).”

RegInfo.gov is not new, nor is the availability of data on federal regulatory actions that users can find there. Although Orszag called it the “OIRA Dashboard,” it is also not solely a creation of OIRA, an office within the White House OMB; rather it is a joint undertaking between OIRA and the General Services Administration’s Regulatory Information Service Center.
 
But RegInfo.gov does now provide new, easy-to-read graphical displays of data on OIRA proceedings reviewing proposed agency regulations. Orszag’s announcement declares that “the Dashboard democratizes the data.”
 
The process by which OIRA reviews proposed regulations issued by federal agencies is governed by Executive Order 12,866, which requires agencies to submit significant regulatory actions to OIRA for review before they can be issued.  RegInfo.gov contains a useful and informative FAQ that explains this process.
 
Actions are considered significant under Executive Order 12,866 if they meet specific economic criteria (such as new rules that would impose annual costs greater than $100 million) or if they meet other general criteria (such as rules that would interfere with actions of other agencies or that would otherwise “raise novel legal or policy issues”). With the aid of the Dashboard's new graphical display, users can readily see that nearly 90% of the agency rules currently under OIRA review (81 out of 91) have been submitted to OIRA for reasons other than their effects on the economy.

EMM

New administrative law articles

From the University of Washington's Current Index to Legal Periodicals:

• Hungerford, Amanda. Note. Back to basics: courts' treatment of agency animal studies after Daubert. 110 Colum. L. Rev. 70-113 (2010). [H]|[L]|[W]

• Mazzone, Jason. Administering fair use. 51 Wm. & Mary L. Rev. 395-437 (2009). [H]|[L]|[W]

• Reiss, Dorit Rubinstein. Tailored participation: modernizing the APA rulemaking procedures. 12 N.Y.U. J. Legis. & Pub. Pol'y 321-377 (2008-2009). [H]|[L]|[W]

• Winn, Jane and Nicolas Jondet. A new deal for end users? Lessons from a French innovation in the regulation of interoperability. 51 Wm. & Mary L. Rev. 547-576 (2009). [H]|[L]|[W]

EMM

Mark M. Bell (J.D. candidate 2010) shared a recent piece he authored on how reviewing courts should treat guidance from administrative agencies.

A Pragmatic Approach to Judicial Review of Informal Guidance Documents

Abstract

The Supreme Court has increasingly allowed agencies to act by informal means. This change has caused intense confusion (1) respecting how these guidance documents fit within the administrative regime and (2) respecting the proper level of deference these informal documents should receive. This article details the Supreme Court’s current Chevron-deference jurisprudence and examines the Court’s treatment of informal guidance documents in several recent decisions.

This Article argues that the Court should abandon its current approach to guidance documents and analyze and defer to administrative action pragmatically. Under this pragmatic approach, the reviewing court should analyze the character of the agency action; that is to say, the court should determine whether the agency is initiating, modifying, or reversing policy. The character of the agency action should then dictate the types of procedures the agency can employ. The reviewing court can then ensure that the agency used the proper procedures depending on the character of the agency action. The level of deference will then formulaically flow from the type of procedure used.

KP

Agency v. agency and Ex Parte Young

New on SSRN: "Closing the Gap: The Fourth Circuit's Narrowing of the Ex Parte Young Exception in Virginia v. Reinhard and the Implications for Administrative Law" by Harrison Mann Gates (Richmond). Abstract:    

The legal debate over state sovereign immunity has persisted practically since the founding. Under the sovereign immunity doctrine, states cannot be sued without their consent even for violations of the Constitution or federal law. Sovereign immunity, thus, kindles the lasting tension between the supposed supremacy of federal law and the separate sovereignty of the states. Since its initial recognition of state sovereign immunity in Hans v. Louisiana, the Supreme Court has recognized several exceptions to the doctrine designed to secure state compliance with federal law. One such exception is the Ex Parte Young doctrine. In Ex Parte Young, the Court announced that individual state citizens could bring suit against state officers in federal court for an ongoing violation of federal law. In recent decades, however, the Supreme Court has vastly expanded the bar of sovereign immunity as an integral part of the “federalist revival” begun by the Rehnquist Court. The Court recently has incorporated the “anti-commandeering” principles from parallel federalism cases into its sovereign immunity jurisprudence, resulting in a significant narrowing of federal judicial power to hear claims against the states. In Virginia v. Reinhard, the Fourth Circuit confronted a question of first impression about the applicability of the Ex Parte Young exception. That case presented the issue of whether a state administrative agency could bring suit in federal court against another state agency to secure its compliance with federal law. In holding that the agency could not bring suit under Ex Parte Young, the Court of Appeals issued a decision with major implications for administrative law and how state agencies may enforce state compliance with federal regulatory schemes. This paper ultimately concludes that Reinhard merely constitutes a natural extension of the sound theoretical principles announced in the Supreme Court’s most recent sovereign immunity cases. Moreover, the practical consequences for state agency enforcement of federal regulatory schemes will be minimal because of the remaining avenues available for enforcing federal rights.

EMM

Minnesota ultra vires decision

When Judge E.L. Lippman describes "The Land Use Case that Every Minnesota Rule Writer Should Read" on his Within the Scope blog, I have to disagree. This is a case that every local, state, and federal rule writer should read.

The opinion arises out of a challenge to the Department of Natual Resources' refusal to certify a local variance in favor of a landowner who wished to build a home along the Saint Croix River. The City of Lakeland granted the variance, but the DNR refused to certify this action - a matter that under the state's scenic river rules purportedly deprived the variance of its legal effect. ...

[T]he Minnesota Court of Appeals reversed the agency's determination ... because the denial of the certification was not rendered within 60 days of the ALJ's decision.

Disagreeing, the agency sought further review with the Minnesota Supreme Court.

A unanimous Supreme Court affirmed the lower court decision; albeit on very different grounds. The Supreme Court reasoned that the Legislature's delegation to the DNR to "manage and administer" the scenic river system was not broad enough to authorize the state rules which required the DNR's approval of locally-granted variances. In the view of the Court, if such a review power was intended, the grant of authority to the DNR would be both differently-worded and more explicit. Without the lawful authority to set-aside locally-granted variances, the lack of an approval from the DNR did not imperil the landowner's variance. ...

We have an ultra vires finding contradicting the agency's interpretation of its establishing statute by a unanimous state supreme court.

For a more detailed study of the two appellate court decisions - which each of administrative lawyer should be doing these days - the Court of Appeals' unpublished decision is accessible here; and the Supreme Court's affirmance is accessible here.

See footnote 4 of the Supreme Court opinion. EMM

New administrative law articles

From the University of Washington's Current Index to Legal Periodicals:

• Hungerford, Amanda. Note. Back to basics: courts' treatment of agency animal studies after Daubert. 110 Colum. L. Rev. 70-113 (2010). [H]|[L]|[W]

• Mazzone, Jason. Administering fair use. 51 Wm. & Mary L. Rev. 395-437 (2009). [H]|[L]|[W]

• Reiss, Dorit Rubinstein. Tailored participation: modernizing the APA rulemaking procedures. 12 N.Y.U. J. Legis. & Pub. Pol'y 321-377 (2008-2009). [H]|[L]|[W]

• Winn, Jane and Nicolas Jondet. A new deal for end users? Lessons from a French innovation in the regulation of interoperability. 51 Wm. & Mary L. Rev. 547-576 (2009). [H]|[L]|[W]

EMM

Retrospective: "Review of Agency Rules in the D.C. Circuit: Back to the Future?"

From Dan Ernst at the Legal History Blog: "Judicial Review of Agency Rulemaking in the DC Circuit: A Retrospective".

The Historical Society of the District of Columbia Circuit has announced a retrospective panel, "Review of Agency Rules in the D.C. Circuit: Back to the Future?" on Wednesday, March 31, 2010 at 4:30 p.m. in the Ceremonial Courtroom of the E. Barrett Prettyman U.S. Courthouse, Washington, D.C. Admission is free. A reception will follow the program.

For more information, see Dan's post. EMM

Theory: Weiser on agency organizational design problems

Recently posted to SSRN: "Institutional Design, FCC Reform, and the Hidden Side of the Administrative State" by Phil Weiser (Colorado). Abstract:    

Legal scholars have long recognized the importance of the modern administrative state, focusing intently both on the substance of regulatory law and the process of administrative law. Neither focus, however, recognizes the importance of institutional design and institutional processes as determinants of the nature and shape of administrative regulation. The era of neglect towards institutional analysis by both scholars and policymakers may well be on its last legs, as it is increasingly clear that the institutional processes used by regulatory agencies - including when to act by rulemaking as opposed to by adjudication, how to engage the public, and how to collect and share data relevant to policymaking - greatly shape the substantive outcomes of important regulatory proceedings. The emerging question will be how best to study institutional process and create a new direction for administrative law scholarship.

The Federal Communications Commission (FCC) represents an ideal case study to underscore the importance of institutional analysis. Over the last fifty years, the agency has confronted a regular set of criticisms about its reliance on ex parte communications, its lack of data-driven decision-making, and its tendency to act in an ad hoc manner. Nonetheless, the importance of reforming the agency has not risen to the top of the scholarly or public agenda - until recently. In the wake of a series of high-profile criticisms of how the agency operates, the question is now finally shifting to how - and not whether - to reform that agency's institutional processes. This Article highlights the importance of asking that question, explaining how the FCC operates in dysfunctional ways, how it can be reformed, and why this case study highlights an important new frontier for administrative law scholarship.

See the Jotwell review of this article by Lisa Bressman (Vanderbilt), "Everything but the Agency". EMM

What law applies

In her Law of the Land blog, Patty Salkin (Albany) reviews a recent Maryland case in "Burden of Proof Remains with Subdivision Applicant Before the Board of Appeals".

Frizz-King Enterprises ... initiated the process to build a subdivision .... Grasslands Plantation, Inc, the owner of the adjacent property, continued to oppose the subdivision in a series of hearings before the Board of Appeals and Planning Commission. ... The Commission approved the proposed subdivision and in doing so, ignoring the insistence of both parties, failed to make any findings of fact. ... Grasslands appealed the determination, arguing that the board improperly placed the burden of proof on it as the appellant and that the newly enacted provisions should have been applied in the proceedings.

The Court of Appeals first determined that the Board’s de novo proceedings were an “entirely new hearing at which time all aspects of the case should be heard anew, as if no decision has been previously rendered.”  The court went on to hold that in light of the purely de novo nature of the proceedings, the burden of proof should have remained on Frizz-King to establish that its proposed subdivision satisfied the requirements of the Queen Anne’s County Code.  

[Shortly before oral argument on appeal to the Court of Special Appeals, the County enacted two ordinances, the “Conformity Act” and the “Emergency Service Ordinance,” both of which imposed on the Commission a stricter standard of compliance with the County’s Comprehensive Plan when approving a subdivision.] ... [T]he ­­­court determined that the ordinances should [be] retrospectively applied to the development’s approval determination. The Court held that since the Emergency Service Ordinance was substantive law it should be applied at the new hearing because it is the law in effect at the time of the hearing and does not impair vested rights. In addition, it held that the Conformity Act, an arguable procedural law change, shall also apply ... as the Commission’s or Board’s process of making its decision will “begin anew” for an independent reason, namely, the [application of the correct] burden of proof. The court reasoned that the proper analysis for determining the retroactive application of a procedural law change turns on “what aspect of the administrative/adjudication process is changed, at what point in the administrative/adjudication process the change is made, and the question presented to the reviewing court.”

EMM

New administrative law articles

From the University of Washington's Current Index to Legal Periodicals:

• Bhargava, Nikhil. Recent development. Broker-dealers and investment advisers: the Administration's plans for the future of regulation. 61 Admin. L. Rev. 907-918 (2009). [H]|[L]|[W]

• duPont, James C. Comment. A second chance at legal certainty: AIG collapse provides impetus to regulate credit default swaps. 61 Admin. L. Rev. 843-869 (2009). [H]|[L]|[W]

• Healy, Thomas P. Comment. Clearing the air: pursuing a course to define the federal government's role in the voluntary carbon offset market. 61 Admin. L. Rev. 871-891 (2009). [H]|[L]|[W]

• Leiderman, Aaron Greene. Agency polymorphism. 61 Admin. L. Rev. 781-811 (2009). [H]|[L]|[W]

• McGuire, Nicholas. Recent development. RESPA update: how homebuilders blocked HUD's recent effort to reform RESPA and regulate affiliated business arrangements. 61 Admin. L. Rev. 893-906 (2009). [H]|[L]|[W]

• Virelli, Louis J. III. Scientific peer review and administrative legitimacy. 61 Admin. L. Rev. 723-780 (2009). [H]|[L]|[W]

• Waxman, Matthew C. Administrative detention of terrorists: why detain, and detain whom? 3 J. Nat'l Sec. L. & Pol'y 1-37 (2009). [H]|[L]|[W]

• Weiser, Philip J. Institutional design, FCC reform, and the hidden side of the administrative state. 61 Admin. L. Rev. 675-721 (2009). [H]|[L]|[W]

EMM

Virelli on Evolutionary Due Process

Newly published on Colloquy : Northwestern University Law Review, "Evolutionary Due Process" by Louis J. Virelli III (Stetson). Introduction:

The issue of evolution instruction in American public schools is becoming increasingly complex, both legally and politically. Until recently, the controversy over whether and how to teach evolution in public school science classes has been singularly focused on the constitutional limits of government support for religion under the First Amendment’s Establishment Clause. Current measures in Louisiana and Texas, however, represent a shift toward a new “adjudicative model” for addressing questions of evolution instruction. This adjudicative model permits individual educators to treat evolution issues on a case-by-case basis, which, in turn, implicates a new constitutional issue in the evolution education debate: procedural due process. By creating powerful disincentives for anti-evolutionist policymakers, procedural due process concerns could affect the future of evolution education even more profoundly than does the Establishment Clause. This Essay explores the relationship between evolution education policy and procedural due process by first identifying and defining the adjudicative model. It then considers the model’s constitutional ramifications for evolution instruction, concluding that this new approach to policymaking introduces procedural due process concerns that radically alter the legal and political calculus of the debate over evolution education.

Thanks to Jamie Fox (Stetson) for the pointer. EMM

New: Veterans Law Review

A new forum for administrative law scholarship:

Veterans Law Review (Copies & Submissions)

VETERANS LAW REVIEW - Vol, 2009 (online version) 

MAILING LIST

Information regarding inclusion on the mailing list for future editions of the VETERANS LAW REVIEW may be obtained by writing to the Managing Editor, Veterans Law Review, Room 841 (mail code 01A), Lafayette Bldg., 810 Vermont Ave., N.W., Washington, D.C. 20420.

INDIVIDUAL COPIES

Individual copies of the VETERANS LAW REVIEW may be obtained by writing to the Managing Editor.

SUBMISSIONS FOR THE 2010 VETERANS LAW REVIEW

Each manuscript should be typed, double–spaced and preferably in Times New Roman 12. Submissions are accepted January 1 to June 1 of each year for consideration of publication in the next edition. We actively encourage veterans’ service organizations, veterans and people who work on veterans’ issues to submit original legal writings for consideration for publication. The editors review each manuscript for scholarly merit, clarity, and accuracy only. The editors will notify the author of any substantive changes. Submissions should conform to the current edition of the Blue Book: A Uniform System of Citation. Authors are invited to discuss potential submissions with the current VETERANS LAW REVIEW Managing Editor by email at BVAVeteransLawReviewEditor@va.gov.

Unless otherwise indicated all editors are lawyers or Veterans Law Judges working at the Board of Veterans’ Appeals.

EMM

Agencies must follow their own rules

On his Drug and Device Law blog, Jim Beck (Dechert, Philadelphia) reviews a District Court slapdown of the FDA in "Smoke 'Em If You Got 'Em (The FDA May Try To Take Them Away)".

What does a smokeless “electronic cigarette” have to do with drugs and medical devices?  Well, according to the FDA, an electronic cigarette is a "drug-device combination."  Lately, however, it seems that the Agency’s position has become a strategic misstep. It gave rise to this a recent opinion by Judge Richard Leon, Smoking Everywhere, Inc. v. FDA, ___ F.Supp.2d ___, 2010 WL 129667 (D.D.C. Jan. 14, 2010). ...
 
What caught our eye about the opinion was the discussion about whether the manufacturers were making “therapeutic” claims about their electronic cigarettes.  The argument the court rejected was classic FDA-speak: We have already concluded that electronic cigarettes appear to be “intended…to prevent, mitigate, or treat the withdrawal symptoms of nicotine addiction.” Id. at *8. Therefore, electronic cigarettes aren’t “tobacco products” but are instead drug-device combinations that are being marketed for unapproved uses in violation of the FDCA. And don’t you dare second-guess us, because we’re the FDA and our opinions are entitled to “Chevron deference.”  ...

Not so fast, said Judge Leon. “Intended use” doesn’t turn on FDA diktat – rather, “[t]he ‘intended use’ of a product is determined by ‘the objective intent of the persons legally responsible’ for labeling the product.” 2010 WL 129667, at *8 (quoting 21 C.F.R. §201.128). Oops. The court took the FDA to task for advancing a position that was “unsupported by substantial evidence,” id., where the best the FDA could do (other than relying on its own prior conclusion that electronic cigarettes are intended to prevent nicotine withdrawal) was point to a couple of advertisements suggesting electronic cigarettes as “an alternative – albeit a healthier alternative – to traditional cigarettes.” Id. at *9. Ouch. ...
 
So what should [a] court look to as evidence of “objective intent” when determining the intended use of a drug or device?

    * “‘Labeling claims, advertising matter, or oral or written statements’ by the labeler;” id. at *8; or
    * “‘by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised.’” Id.

What’s not on that list? FDA conclusions about the “intended use” of the product. Of course, even these indicia of “objective intent” are subject to criticism because of their vagueness ... But at a minimum, the FDA’s own conclusions shouldn’t be considered probative, let alone conclusive, of the “intended use” of a product. ...

EMM

Vagueness

Deborah Fox & Dawn McIntosh of Meyers Nave (California) review an interesting new opinion in "8,000 Adult Items in One Store Found 'Substantial' by 2nd Circuit".

In VIP of Berlin, LLC v. Town of Berlin, __ F.3d __, 2010 WL 252292 (2nd Cir. Jan. 2010), the Second Circuit Court of Appeals overturned a district court ruling and rejected an as-applied vagueness challenge to a Town of Berlin's ordinance and in so doing, presented an excellent discussion of the vagueness doctrine and its application to the construction of the term "substantial".

The Town of Berlin defines an Adult Oriented Store as "any establishment having 'a substantial or significant portion of its stock in trade in Adult Books, Adult Videos or Adult Novelties or any combination thereof.'" (Id. at p. 1.) The plaintiff argued that the definition of "substantial or significant" was impossibly vague because it did not provide him with sufficient guidance to determine exactly how much adult inventory he could stock without being considered an Adult Oriented Store. In rejecting this claim, the Court of Appeal looked to the ordinary meaning of the words "substantial" and "significant" and explained that VIP would fall within the definition of an Adult Oriented Store if "part" of its stock in trade devoted to adult merchandise is of "considerable quantity" and "of a noticeably or measurably large amount." (Id. at p. 5.)

Over 8,000 items of the store's inventory of 67,237 items, or 12%, were determined by the Town manager to be "adult" in nature. The court held that 8,000 adult items is clearly a considerable quantity, and therefore "substantial," because the plain meaning of the ordinance encompasses both the absolute number of adult items and the percentage of adult items in the total inventory. Thus, 8,000 adult items is "substantial" whether these items constitute 100% of the store's inventory or only 12% as in this instance.

Now, I was taught (and my experience has confirmed) that whenever a lawyer uses the word 'clearly' whatever is being described probably isn't clear. Is a 'portion' measured by dollar value, shelf space, line items, or inventory count? 'Considerable' to whom? I'm still looking for a standard here. EMM