Category Archives: Christopher Robertson

Live Blogging from FDA in the 21st Century Conference, Panel 3: Protecting the Public within Constitutional Limits

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[Posted on behalf of W. Nicholson Price II, Academic Fellow, The Petrie-Flom Center (with the disclaimer re: live blogging - see posts below)]

The third panel at the conference covered commercial speech protection and off-label drug promotion, in reaction to the Second Circuit’s December 12 case, United States v. Caronia.  Caronia was promoting Xyrem, approved for narcolepsy, for off-label uses, which is prohibited by FDA.  He was criminally charged and convicted, but the Second Circuit held this prohibition constitutionally suspect.

Leading off was Aaron Kesselheim.  Aaron started off describing the FDA’s prohibition on off-label promotion.  Off-label promotion prohibition is based on the requirement of substantial evidence for efficacy.  There are some safe-harbors, like distributing papers, but generally off-label promotion is prohibited because promotion drives prescription patterns, and off-label promotion for unapproved uses can have significant negative consequences.  FDA has negotiated many major settlements, totaling billions of dollars in recent years.  In this context, the Caronia decision is troubling from a public health point of view, even if not particularly surprising given the history of commercial free speech doctrine.

Aaron described four ways forward for the FDA after Caronia.  First, the government could rely more heavily on written materials as evidence, arguing that it is part of the label.  Second, the government could change the prosecutorial language, using speech as evidence of an attempt to misbrand, rather than prosecuting for speech; this might not be enough to fix the problem.  Third, the government could prosecute off-label promotion as false and misleading speech, but that requires hard case-by-case evaluations.  Fourth, the government could better argue that the Central Hudson test for commercial free speech is met.

Next, Chris Robertson also took Caronia as a jumping-off point, noting that Caronia was actually convicted of conspiracy to introduce a misbranded drug into interstate commerce – though the Second Circuit held he was actually convicted for his speech.  Caronia comes in the wake of robust First Amendment jurisprudence from the Supreme Court, including Citizens United, Sorrell, Stevens, Alvarez, and Fox v. FCC, and thus might be a harbinger of this reasoning spreading across the country.  In addition, the reasoning of Caronia could potentially apply equally to drugs with no approved use, and thus undermine the entire FDCA (since what is defined as a drug is determined by label claims).

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Experiential Training in Health Law?

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Many law schools are thinking about experiential education, and health law would seem to be a great opportunity.  There is a bewildering range of ways to implement experiential training, from simulation-based courses, to in-house clinics, along with placement clinics and hybrid clinics, and externships too.  Many of these seem to blur together on the margins.

The Center for the Study of Applied Legal Education’s 2010-11 Survey of Applied Legal Education (available on SSRN) found that of the 156 law schools responding, 17 had clinics whose “single predominate substantive focus” was defined as “health law,” which amounts to 1.5% of all clinics in the study.  (See p7.)  Also listed were 24 “elder law” clinics and 20 “disability law” clinics, which I suspect may overlap.  The report also shows 29 field placement programs (out of 145 schools responding), which focus on health law.  (See p8.)  In particular, I am aware of Harvard’s Health Law and Policy Clinic.   And SLU’s excellent health law program places clinic students in hospital settings.  I have come across other programs at Pitt, Suffolk, GW, and Northeastern.

We do not have a health law clinic at University of Arizona, but I have helped place my JD students in unofficial externships with the Tucson Family Advocacy Program, a medical-legal partnership that addresses some of the social determinants of health (e.g., a letter to a landlord to stop a roach infestation, to help address chronic child asthma).  Some of my students have also externed in the general counsel’s office of our academic hospital.  I also like to bring students with me to our clinical bioethics meetings, and some of those interactions have led to research projects and student presentations to the committee.  I have also engaged some of our top law students in helping me lead discussion sections for undergrads on some of the big health law cases, such as Jacobson, Griswold, Roe, and Raich.  (I firmly believe that teaching is a kind of experiential education, which develops core lawyering skills.)

I would love to hear from our readers in the comments section .  Do you know of other experiential education programs that focus on health law?  What do you do?  What works well?

CFP: Symposium on Blinding as a Solution to Conflicts of Interest

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When does less information result in better decisions?

CALL FOR PROPOSALS

A Multidisciplinary Symposium on Blinding as a Solution to Institutional Corruption

Symposium:  November 1-2, 2013
Proposal Deadline:  February 15, 2013

Harvard University

With the support of the Edmond J. Safra Center for Ethics at Harvard University, Christopher Robertson (James E. Rogers College of Law at the University of Arizona) and Aaron Kesselheim (Harvard Medical School) are organizing a multidisciplinary symposium to examine potential solutions to institutional corruption that use the strategy of concealing biasing information from decision makers.  The symposium will take place on November 1 and 2, 2013 at Harvard University.

This event is part of the Institutional Corruption Lab.  Larry Lessig (Safra Center Director and Roy L. Furman Professor of Law and Leadership at Harvard Law School) has defined ‘institutional corruption’ as the consequence of an influence within an economy of influence that illegitimately weakens the effectiveness of an institution especially by weakening the public trust of the institution.  The concept provides a more systematic approach to decision-making problems that can arise as a result of financial relationships and other conflicts of interest.

Institutional corruption may arise in many contexts, from medical research to forensic science, from political campaign finance to financial auditing.  There are many potential solutions to institutional corruption, but we are particularly interested in practical mechanisms that acknowledge the existence of potential influences, but prevent that biasing information from reaching a decision maker.  Such mechanisms may include blinding, masking, placebos, strategic ignorance, information aversion, veil of ignorance rules, blind trusts, walls of separation, or similar concepts.  We are interested in reviews of relevant literature, and new laboratory, empirical, historical, and theoretical research that explores the functions, modalities, costs, benefits, and limitations of concealing a source of information to improve decision making.   We are interested in established uses of blinding, and potential new applications.

We welcome contributions that have been previously published, as well works in progress.  We plan for this symposium to generate collaborative research opportunities, and anticipate publishing many of the presented works in an edited volume from a major academic book press or journal.

To apply, please send a one-page abstract describing your proposed contribution by February 15, 2013, as a PDF attachment, to Professors Robertson and Kesselheim ( chris.robertson at law.arizona.edu and  akesselheim at partners.org).  Include a link to or copy of your CV.  We encourage applications from newer scholars and practitioners, as well as those more established in their fields.  Travel stipends will be available for some speakers.  Please indicate whether you request such a stipend, and the likely origin of your travel.  Please also indicate whether you would be interested in publishing your contribution in the edited volume, pending further information.  The organizers also welcome preliminary inquiries about potential topics and approaches.

Here is a PDF of this Call for Proposals.  Feel free to circulate.

Is Health Law the Problem Underlying the Physician Shortage?

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This week, the New York Times Sunday Review has an editorial arguing that the shortage of primary care physicians could be reduced if we drew more heavily upon other professions, including pharmacists and nurse practitioners, who may be able to provide care more efficiently.  The Affordable Care Act’s efforts to increase insurance coverage and eliminate cost-sharing for preventative care, will only exacerbate the shortage of primary care physicians.  More to the point, the editorial alleges that various state and federal laws create barriers to the sort of integration of healthcare professionals to address the shortage.

Those “scope of practice” laws were enacted to either protect consumers from incompetent healthcare or protect physicians from competition in the healthcare marketplace, or likely some mixture of both.  We know where mainstream physicians stand anyway.  In the words of the American Medical Association’s own newsletter,  ”physicians [have] fought a blitz of scope-of-practice expansions by other health professionals on legislative, legal and regulatory fronts.”

The shortage of physicians is also a product of the number of young doctors that our medical schools are producing.  Although several new schools have launched in recent years, others are have actually shrunk due to budget cuts.

Bad to the Bone

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I just came across this excellent story by Mina Kimes, which gives a detailed chronicle of how the lines between physician discretion, off-label promotion, and human subjects research can be blurred by an aggressive manufacturer, in a context where life or death is on the line (bone cement used in spine surgery).  The article also suggests themes about medical malpractice, products liability, and physicians’ conflicts of interest too.

A Different Take on the New Murtagh Study on MedMal Disclosures, and A Few Thoughts on Friendly Attorneys

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On these pages, Michelle Mello recently posted a discussion of her new article with Lindsey Murtagh, Thomas Gallagher, and Penny Andrew, called “Disclosure-And-Resolution Programs That Include Generous Compensation Offers May Prompt A Complex Patient Response.”

In this vignette-based online study, the authors put respondents in clinical scenarios with medical errors, and then added experimental conditions where the error was simply confessed, or confessed with an offer of waiver of the medical bills, with an offer to reimburse a limited amount of out-of-pocket expenses related (specifying $25,000 out of pocket plus $5,000 lost time), or with an offer of “full compensation.”  As the headline suggests, the authors conclude that offers of full compensation may be sometimes be bad ideas for self-interested hospitals.  I’m a big fan of this sort of vignette-based research, because it allows randomized manipulation that is impossible in observational field research.  Still, allow me to offer some of my own questions and interpretations below the fold.

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Court Says Off-Label Promotion is Legal, and the Difference Between Warrant and Truth

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Invoking the First Amendment protection of speech, the Second Circuit today reversed a criminal conviction for a drug salesman’s promotion of a drug beyond its FDA-approved uses.  The case in U.S. v. Caronia; the opinion is here, and here’s the Reuters story.

In First Amendment cases like Western States Medical Center and Sorrell v. IMS, the Supreme Court has been nibbling around the edges of the FDA’s regulatory regime, but nobody — not the industry, the FDA, or the Supreme Court — has seemed eager to really take it on directly.  For decades the FDA has relied on the regulation of speech as a primary tool.  Those regs turn on the distinction between drugs’ on-label uses (for which companies can promote) and off-label uses (for which companies are not allowed to promote, since the companies have declined to prove to the FDA that the drug is safe and effective for those uses).  Physicians are free, however, to use drugs off-label, so the crux of the FDA regulation really is about whether the company can talk about (promote) a transaction that is otherwise perfectly legal.  With Caronia, the Second Circuit is striking right at the heart of this regulatory regime.

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Does Your Hospital Make You Sicker?

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New hospital safety scores were released this week, and around the country, those that scored well are crowing (see e.g., here and here).  The data is provided by a nonprofit called Leapfrog Group, which compiles survey-responses  and CMS data on a website called hospitalsafetyscore.org.  Check out your own hospitals.  The Leapfrog Group includes several leaders in the hospital safety movement, including Peter Pronovost (of checklist fame) and Lucian Leape (author of the seminal 1994 JAMA article on the topic).  Is anyone aware of an empirical study that looks at the relationship between these scores and medical malpractice liability claims or payouts?  Any attorneys that use this sort of data in the litigation of individual cases?

Tobacco Companies Must Punch Selves in Face, Court Orders

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The Washington Post covers a new order by DC district court judge Gladys Kessler, arising out of an old RICO case brought by the federal government, requiring that the tobacco companies publish advertisements to confess publicly that they previously lied about the safety of smoking and manipulated cigarettes to make them more addictive.  I have pulled the district court order and posted it here, along with this appendix.  The order provides the exact language of the mandated advertisements, but no analysis.  Below the fold, I trace the convoluted path this case and a related case have taken through the compelled speech doctrine around the First Amendment, all thanks to a single judge on the Court of Appeals.

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WaPo on Industry Influence of Clinical Trials

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The Washington Post has an extensive story about the drug and device industry’s influence on the outcomes of clinical trials, which are published in leading medical journals and which then shape the prescribing decisions of physicians everywhere.  Below the fold, I share some of my own thinking on this issue, and link to some of my relevant publications.   Continue reading →

The New Diagnostic Scan for Alzheimer’s Disease

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[Ed. Note: We're happy to announce that after a great month of guest blogging, Chris Robertson will be joining Bill of Health as a regular contributor.]

The New York Times brings us an interesting story about a new brain scan technology that allows the diagnosis of Alzheimer’s Disease.  Below the fold, I sketch a few interesting themes for health law, including the FDA’s authority over the practice of medicine, the use of blinding to improve clinical decision making, the value of a clinical diagnosis for an untreatable condition, and the problems of pre-existing conditions clauses in long-term care insurance. Continue reading →

Variability in Local IRB Regulation: A Gold Mine for Future Research

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When I moved to the University of Arizona, I quickly discovered something that I’ll politely call “heterogeneity” in Institutional Review Board’s (IRB) policies and practices.  All of a sudden, some of the rather vanilla human subjects research practices I had been doing for years, with IRB approval, were now forbidden.  Turns out that I had been exerting “undue influence” on human subjects all along by — wait for it — telling them how much I proposed to pay them.  (Good thing there is no IRB jail for miscreants like me.)

I’ve since learned that there is a scholarly literature about the tendencies of IRBs to vary in how they decide the same cases.  For example, Green and colleagues (2006) described their experience getting IRB approval for an observational study in 43 Department of Veterans Affairs medical centers.  They explain:

The study was designed to be qualified under U.S. government regulations for expedited review. One site exempted it from review (although it did not qualify for exemption), 10 granted expedited review, 31 required full review, and one rejected it as being too risky to be permitted. Twenty-three required inapplicable sections in the consent form and five required HIPAA … consent from physicians although no health information was asked of them. … Twelve sites requested, and two insisted upon, provisions that directly increased the risk to participants.  Seventy-six percent of sites required at least one resubmission, and 15 percent of sites required three or more (up to six) resubmissions.

How can such disparate results come out of IRBs all applying the same Federal common rule?  And is that sort of variability justified by the 4,680 hours of staff time that Green reports spending navigating through this regulatory maze?  As I explain below the fold, this incident is not isolated.

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Opinion granting preliminary injunction on contraceptive coverage mandate

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Yesterday (Friday Nov 16), U.S. District Judge Reggie Walton granted a preliminary injunction barring enforcement of the contraceptive coverage mandate that was part of the regulations implementing the Affordable Care Act (ACA).  There is lots of news coverage (e.g., HuffPo and WaPo), but as usual, the news organizations do not link to the opinion.  For your convenience, I’ve linked to it in the prior sentence, and provide some very preliminary observations below the fold.

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Gowder on Death and Taxes in the individual mandate: The Finger-Wagging Lopsided Giant?

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Paul Gowder (Iowa Law) has shared a draft of his new article, Death and Taxes in NFIB v Sebelius.  Gowder thoughtfully develops some of the themes that I gestured towards in my “Lopsided Giant” post last week, trying to figure out how the Roberts opinion could uphold the constitutionality of the individual mandate as a regulatory tax but not as a regulation of commerce.  Drawing on a range of philosophical sources, Gowder tries “to aggressively apply the principle of charity to understand what the opinion actually means by making sense of it.”  (I love the ambiguity with the word, ‘making.’)

Gowder is smart in his use of philosophers (from Hayek to Raz, and others) to try to shed some light on Roberts’ ideas about coercion and regulation.  Gowder’s analysis makes me think that the Roberts’ opinion might deserve an even broader examination of whether there is a coherent theory of coercion between the individual mandate section and state mandate to expand Medicare section.  On the other hand, Gowder reaffirms my sense that the individual mandate’s Commerce Clause problem was not that it was too coercive.

The most provocative question is why the mandate was upheld as a tax.  On Gowder’s charitable reading, Roberts’ opinion does not provide Congress with unlimited power to mandate behavior using the tax power.  It is strictly limited.  But the limitation is merely one of “expressiveness”, depending on whether a mandate “labels those who break it as lawbreakers.”  (p16)  As I discuss below the fold, this creates a novel rule of Constitutional law — we might call it the finger-wagging-rule.    Continue reading →

The Lopsided Giant

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Professor Elhauge‘s provocative little book, Obamacare on Trial, has many of us rethinking and revisiting the NFIB v. Sebelius decision, and I had a chance to attend the nice book talk featuring Professor Elhauge and several interlocutors last week.

Chief Justice Roberts’ opinion in the case is not prominently textualist (since contemporaneous dictionary definitions of “regulate” are unhelpful to him, as Elhauge shows) nor historicist (since the founders themselves imposed healthcare insurance purchase mandates, as Elhauge also shows).  Instead, Chief Justice Roberts repeatedly relies on a slippery slope style of argument (or a reductio ad absurdum), not unlike those I heard from Fox TV commentators and friends on Facebook in the months prior to the decision.  Below the fold, I suggest that this form of argument is incoherent given the larger holding of the case.

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