Category: Administrative Law

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UCLA Law Review Vol. 63, Issue 5

Volume 63, Issue 5 (June 2016)
Articles

How Governments Pay: Lawsuits, Budgets, and Police Reform Joanna C. Schwartz 1144
Second-Order Participation in Administrative Law Miriam Seifter 1300
The Freedom of Speech and Bad Purposes Eugene Volokh 1366

 

Comments

Evolving Jurisdiction Under the Federal Power Act: Promoting Clean Energy Policy Giovanni S. Saarman González 1422
Election Speech and Collateral Censorship at the Slightest Whiff of Legal Trouble Samuel S. Sadeghi 1472
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UCLA Law Review Vol. 63, Issue 1

Volume 63, Issue 1 (January 2016)
Articles

Navigating Paroline‘s Wake Isra Bhatty 2
Regional Federal Administration Dave Owen 58
Exhausting Patents Wentong Zheng 122

 

Comments

Post-Deportation Remedy and Windsor‘s Promise Kate Shoemaker 168
Forget Congress: Reforming Campaign Finance Through Mutually Assured Destruction Nick Warshaw 208
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FOIA Requests for Tax Returns

Donald Trump’s refusal thus far to release his tax returns raises an interesting issue.  Tax returns are not subject to the Freedom of Information Act (FOIA). I can’t just ask the IRS to give me his returns and get them. While this makes sense as a general matter given the privacy concerns involved, I wonder whether the custom of having high public officials release their returns should be codified by making their returns subject to FOIA.

For an ordinary citizen, tax returns should be private unless they are required for a criminal investigation or are subject to a valid subpoena in a civil case.  Presidential candidates (at least the two major party nominees) have voluntarily released their returns for a long time, though I don’t know for how long.  It seems to me that the public’s right to know in this instance overrides a candidate’s privacy interest. We might find out, for instance, that Trump did not pay any federal income tax last year.  I’d like to know if he did, and I think that I have a right to know.  Political pressure may compel him to act, but should that be the only way of obtaining that information?

FTC Boston Pub Library Washington News Co 1930-45 postcard 03
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The 5 Things Every Privacy Lawyer Needs to Know about the FTC: An Interview with Chris Hoofnagle

The Federal Trade Commission (FTC) has become the leading federal agency to regulate privacy and data security. The scope of its power is vast – it covers the majority of commercial activity – and it has been enforcing these issues for decades. An FTC civil investigative demand (CID) will send shivers down the spine of even the largest of companies, as the FTC requires a 20-year period of assessments to settle the score.

To many, the FTC remains opaque and somewhat enigmatic. The reason, ironically, might not be because there is too little information about the FTC but because there is so much. The FTC has been around for 100 years!

In a landmark new book, Professor Chris Hoofnagle of Berkeley Law School synthesizes an enormous volume of information about the FTC and sheds tremendous light on the FTC’s privacy activities. His book is called Federal Trade Commission Privacy Law and Policy (Cambridge University Press, Feb. 2016).

This is a book that all privacy and cybersecurity lawyers should have on their shelves. The book is the most comprehensive scholarly discussion of the FTC’s activities in these areas, and it also delves deep in the FTC’s history and activities in other areas to provide much-needed context to understand how it functions and reasons in privacy and security cases.

Read More

Green Bag Article 02
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The Ultimate Unifying Approach to Complying with All Laws and Regulations

Professor Woodrow Hartzog and I have just published our new article, The Ultimate Unifying Approach to Complying with All Laws and Regulations19 Green Bag 2d 223 (2016)  Our article took years of research and analysis, intensive writing, countless drafts, and endless laboring over every word. But we hope we achieved a monumental breakthrough in the law.  Here’s the abstract:

There are countless laws and regulations that must be complied with, and the task of figuring out what to do to satisfy all of them seems nearly impossible. In this article, Professors Daniel Solove and Woodrow Hartzog develop a unified approach to doing so. This approach (patent pending) was developed over the course of several decades of extensive analysis of every relevant law and regulation.

 

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University of Toronto Law Journal – Volume 66, Number 1, Winter 2016

utlj-logo

University of Toronto Law Journal – Volume 66, Number 1, Winter 2016
Public Law for the Twenty-First Century – special symposium issue

ARTICLES
Introduction: Public law for the twenty-first century
David Dyzenhaus

Polycentricity and queue jumping in public law remedies: A two-track response
Kent Roach

Public law and ordinary legal method: Revisiting Dicey’s approach to droit administratif
Mark D Walters

The lure and the limits of dialogue
Aileen Kavanagh

Adjudicating constitutional rights in administrative law
Tom Hickman

Full text of the University of Toronto Law Journal is available online at UTLJ Online, Project Muse, JSTOR, HeinOnline, Westlaw, Westlaw-CARSWELL, LexisNexis and Quicklaw.

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B Corps for Bankers

Claire Hill and Richard Painter’s new Better Bankers, Better Banks aims to find a way forward by looking backward – and by casting a few sidelong glances as well. It is valuable for what it has to say about the view in all directions.

Begin from where we are – the point from which Hill and Painter would like to see forward movement. Where we are now is a world in which, even seven years out from the crash of ’08, banking scandal is near boring in its ubiquity. From Libor in 2012 to Euribor, forex, commodity and precious metal cornering thereafter, the story of financial markets of late seems an unending parade of horribles.

How do we get out of this seeming cesspool? Here is where Hill and Painter look backward and sideways.

First let’s look back. Time was when ‘bankers’ – Hill and Painter employ the term broadly to cover all folk who hold ‘other folks’ money’ – invested not only our money, but their money too. By organizing as general partnerships whose partners were jointly and severally liable for losses, they kept, as the current idiom has it, ‘skin in the game.’ This of course aligned their interests with client and institutional interests – to some extent, anyway. (Names like ‘Jay Gould’ should remind us that ‘some extent’ wasn’t the ‘full extent.’) And so there were limits on how much by way of other folks’ money the bankers were likely to fritter away.

Now let’s look sideways. There appears to be growing consensus, in the face of such scandals as those just rehearsed, that our regulatory and law enforcement regimes’ penchant for penalizing banks rather than bankers just isn’t cutting it. Compared to the gains to be had from wrongful behavior unlikely to be caught, even five or twelve billion dollar settlements between banks and their regulators are chump change. Oughtn’t we, then, focus our efforts upon the human agents through whom the banks act? After all, five billion – or five years in jail – are more likely to pinch if you’re human.

Hill and Painter like what they see in both directions. They find limitations, however, in how effective the enforcement of finance-regulatory provisions can be. These, they believe, are just too easy to game – a fact that might partly account for regulators’ going after the banks rather than the bankers in the first place. Why not, then, take yet another sidelong glance in another direction – that of contemporary moves to simulate better regulation through private ordering? Are there not means, for example, of appealing to socially responsible investors by committing to operate as a socially responsible business – e.g., as a ‘B Corp’ or ‘Benefit Corp’?

Indeed there are, and though they do not discuss these new business forms, Hill and Painter valuably adapt, in effect, the idea behind them to financial firms. Herewith the authors’ novel suggestion to introduce a practice of what they call ‘Covenant Banking.’ The idea is for financial firms whose owners or managers are comfortable with the idea to undertake ‘skin in the game’ commitments on the part of their managers. Managers would voluntarily assume some liability for losses, thereby partly replicating the ancien regime of pre-corporate partnership banking. Investors could then choose between what kinds of institutions through which they invest – the more risk-averse perhaps working through covenant banks, the more risk-cavalier working through today’s more familiar casinoish firms.

It would be hard not to like this proposal. What’s not to like? Like recent proposals for Wall Street voluntarily to maintain ‘naughty lists‘ of bankers who have gotten themselves into trouble, it imposes nothing, yet offers something – the prospect of ‘better bankers,’ hence ‘better banks,’ for at least some investors. It simply expands the field of choice, and who in these times doesn’t like choice?

If I have any reservations about Hill and Painter’s proposal or their brief in its favor, they have to do with the prospect of some people’s possibly taking the authors to claim or to promise more than they actually intend.

To begin with, we should note that wrongs such as those alleged in connection with Libor, Euribor, forex, and commodity and precious metal cornering are not wrongs of excessive risk-taking. They are wrongs of sheer fraud and manipulation. It isn’t the case that ‘skin in the game’ on the part of the relevant fraudsters in these cases ‘would’ have helped; the ‘skin’ seems to have been at the core of the ‘game’ from the start, and was indeed part of the problem – the fraudsters profited precisely by illicitly betting their own money on what they controlled. Hill and Painter, then, should not be taken to be targeting this form of market abuse through their proposal.

A distinct but related point has to do with the lead-up, not to 2012 and after, but to 2008. It is still common to hear that year’s cataclysm blamed upon venal behavior or ‘excessive risk-taking’ by ‘bankers.’ And such behavior clearly occurred – it always does. But a very strong case can be made – I think I and others have made it – that the principal causes of 2008 were more radical than mere vice or recklessness on the part of some bankers. They are endemic to capitalism itself absent serious and sustained effort on the part of the polity to distribute capital’s returns – or capital itself – far more equitably than we’d managed before 1929 or between 1970 and 2008. ‘Better bankers’ would certainly be better than worse bankers; better still would be better distributions of that with which bankers bank.

Finally, there is a danger in underselling what proper law enforcement, adequately funded and staffed, can do where finance-regulation is concerned. When Wall Street contributes more to political campaigns than most other industries, when DOJ officials openly admit to having feared to prosecute bankers for fear of rattling markets, and when regulators like the CFTC and the SEC are chronically understaffed and underfunded, we should be skeptical of suggestions that ‘gameability’ of the rules is the sole – or even principal – reason for old fashioned law enforcement’s not having eradicated rulebreaking by financiers. Indeed, as Hill and Painter themselves note, a rule change at the NYSE in 1970 played a critical role in the move from partnership to incorporated form among Wall Street investment banks. If that is so, could a legal re-imposition of some variant of the old rule not itself make for ‘better bankers’?

None of these caveats should be taken as more than what they are – mere caveats. There is much, much to be learned from a reading of Hill and Painter, and much is quite plausibly promised by their Covenant Banking. And since, as before noted, their proposal is made in effect to the banks rather than the polity, it seems to be all upside, no down. Let, then, those bankers intrigued by the Hill/Painter proposal give it a go. One might even imagine some funds offering their services in A and B flavors, so to speak – in Covenant and Noncovenant forms. In such case consistently better performance by one kind over the other might in future foment a stampede to the winning kind, and with it a privately worked transformation.

From Territorial to Functional Governance

Susan Crawford is one of the leading global thinkers on digital infrastructure. Her brilliant book Captive Audience spearheaded a national debate on net neutrality. She helped convince the Federal Communications Commission to better regulate big internet service providers. And her latest intervention–on Uber–is a must-read. Crawford worries that Uber will rapidly monopolize urban ride services. It’s repeatedly tried to avoid regulation and taxes. And while it may offer a good deal to drivers and riders now, there is no guarantee it will in the future.

A noted critic of the sharing economy, Tom Slee, has backed up Crawford’s concerns, from an international perspective. “For a smallish city in Canada, what happens to accountability when faced with a massive American company with little interest in Canadian employment law or Canadian traditions?”, Slee asks, raising a very deep point about the nature of governance. What happens to a city when its government’s responsibilities are slowly disaggregated, functionally? Some citizens may want to see the effective governance of paid rides via Uber, of spare rooms via AirBnB, and so on. A full privatization of city governance awaits, from water to sidewalks.

If you’re concerned about that, you may find my recent piece on the sharing economy of interest. We’ll also be discussing this and similar issues at Northeastern’s conference “Tackling the Urban Core Puzzle.” Transitions from territorial to functional governance will be critical topics of legal scholarship in the coming decade.

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FAN 71.2 (First Amendment News) Floyd Abrams prevails in off-label drug case — Court grants preliminary injunction

[Today a] U.S. judge . . . barred the U.S. Food and Drug Administration from stopping Irish drugmaker Amarin Corp from promoting its fish oil drug for off-label uses, saying the company is protected by the First Amendment.The preliminary order by U.S. District Judge Paul Engelmayer in Manhattan means Amarin can promote its Vascepa pill to doctors for off-label use as long as it does so truthfully. Friday’s decision is a preliminary injunction, not a final order. However, Engelmayer said in granting the injunction that Amarin was likely to prevail. –Reuters, Aug. 7, 2015

Four days ago I wrote a post titled “Amarin v. FDA –Important Commercial Speech Case May be Decided Soon.”

Well, that case was decided today. In a detailed and nuanced 71-page opinion, U.S. District Judge Paul A. Engelmayer ruled in the Plaintiffs’ favor and granted a preliminary injunction. Floyd Abrams was the lead counsel for Amarin.

Recall the respective claims made by the parties:

→ Plaintiff’s Claim: “Amarin Pharma wants to provide healthcare professionals with truthful, non-misleading information about its prescription drug Vascepa®, and four doctors who want to receive that information, as they determine when and whether to prescribe that drug. If Amarin provides that information, however, it is at high risk of criminal and civil sanctions being sought against it by the United States.”

→ Government’s Claim: “Plaintiffs seek a court order that would allow Amarin to distribute its drug Vascepa under circumstances which could establish that Amarin intends an unapproved new use for Vascepa, i.e., a use for which FDA has not determined that the drug is safe and effective. But Plaintiffs’ legal arguments strike at the very heart of the new drug approval process, and a court decision in Plaintiffs’ favor has the potential to establish precedent that would return the country to the pre-1962 era when companies were not required to prove that their drugs were safe and effective for each of their intended uses.”

→ District Court Holding

The Court has held that Amarin’s proposed communications, as modified herein, are presently truthful and non-misleading. But the dynamic nature of science and medicine is that knowledge is ever-advancing. A statement that is fair and balanced today may become incomplete or otherwise misleading in the future as new studies are done and new data is acquired. The Court’s approval today of these communications is based on the present record. Amarin bears the responsibility, going forward, of assuring that its communications to doctors regarding off-label use of Vascepa remain truthful and non-misleading.

→ District Court’s order:

The Court grants Amarin’s application for preliminary relief. Specifically, the Court declares that:

(1.)  Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa, i.e., to treat patients with persistently high triglycerides, and under Coronia, such speech may not form the basis of a prosecution for misbranding; and

(2) Based on the information presently known, the combination of statements and disclosures that Amarin proposes to make to doctors relating to the use of Vascepa to treat persons with persistently high triglycerides, as such communications have been modified herein,* is truthful and non-misleading.

See alsoCourt Approves Amarin (AMRN) to Tell Doctors About Off-Label Vascepa Usage,” StreetInsider.com, Aug. 7, 2015 (listing approved statements).

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FAN 70.1 (First Amendment News) Amarin v. FDA –Important Commercial Speech Case May be Decided Soon

The FDA has long sought to ban manufacturers from promoting off-label uses of approved drugs and medical devices.  In taking the position that manufacturers and their agents cannot promote off-label uses, the FDA suggests they are safeguarding the public from misbranded medical products and ensuring that manufacturers do not circumvent the drug and device approval processes. Critics, however, have long contended that the FDA’s position violates the First Amendment to the extent it prohibits truthful speech. — Evelien Verpeet, ReedSmith, June 18, 2015

Should pharmaceutical companies be able to advertise drugs for uses not  approved by the FDA? It seems like a no brainer — of course not! But as with so many other things in life and law, the answer (especially the First Amendment answer) is not so obvious.

→ The caseAmarin Pharma, Inc. v. United States Food & Drug Administration (Dist. Ct., S. Dist. NY).

→ Judge: The matter was argued before U.S. District Judge Paul A. Engelmayer on July 7, 2015. A ruling is expected soon.

Unknown5→ Plaintiff’s Claim: “Amarin Pharma wants to provide healthcare professionals with truthful, non-misleading information about its prescription drug Vascepa®, and four doctors who want to receive that information, as they determine when and whether to prescribe that drug. If Amarin provides that information, however, it is at high risk of criminal and civil sanctions being sought against it by the United States.”

U.S. Atty. Preet Bharara

U.S. Atty. Preet Bharara

→ Government’s Claim: “Plaintiffs seek a court order that would allow Amarin to distribute its drug Vascepa under circumstances which could establish that Amarin intends an unapproved new use for Vascepa, i.e., a use for which FDA has not determined that the drug is safe and effective. But Plaintiffs’ legal arguments strike at the very heart of the new drug approval process, and a court decision in Plaintiffs’ favor has the potential to establish precedent that would return the country to the pre-1962 era when companies were not required to prove that their drugs were safe and effective for each of their intended uses.”

The FDA has long banned promotion of drugs for uses other than those it has approved. Yet so-called off-label uses are legal and account for about 20% of all prescriptions. Some off-label uses of drugs have even become the standard of care for particular conditions. But the drug’s manufacturer and its agents—and only them—cannot legally talk about this. Patients can—and do—discuss off-label uses of drugs endlessly in online forums. Doctors certainly exchange information about these uses. — David B. Rivkin Jr. &  Andrew Grossman, WSJ, May 21, 2015

 P’s Counsel: Floyd Abrams is the lead counsel for the Plaintiff with Joel Kurtzberg and Michael B. Weiss (see here re P’s complaint)

→ Gov.’s CounselPreet Bharara is the attorney for the Defendant along with Ellen London and Benjamin Mizer

→ Amicus Briefs: Pharmaceutical Research and Manufacturers of America and Washington Legal Foundation — both in support of the Plaintiff / Public Citizen in support of the United States

→ FDA Letter to Judge Engelmayer, June 8, 2015 (see here for a discussion of the mootness issue raised by this letter)

Excerpts from United States v. Caronia (2nd Cir. 2012) re off-label promotions 

The government’s construction of the FDCA asprohibiting off-label promotion does not, by itself, withstand scrutiny under Central Hudson’s third prong [that the regulation directly advance the government’s interests] . . . . The last prong of Central Hudson requires thegovernment’s regulation to be narrowly drawn to further the interests served. . . Here, the government’s construction of the FDCA to impose a complete and criminal ban on off-label promotion by pharmaceutical manufacturers is more extensive than necessary to achieve the government’s substantial interests. . . . We conclude simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug. Judge Denny Chin for the majority.

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[T]he majority calls into question the very foundations of our century-old system of drug regulation. I do not believe that the Supreme Court’s precedents compel such a result. . . . If drug manufacturers were allowed to promote FDA-approved drugs for non-approved uses, they would have little incentive to seek FDA approval for those uses. — Judge Debra Ann Livingston dissenting

Summary of Amarin’s First Amendment Arguments Read More