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.
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.
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.
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?
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.
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. Read More
[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. Read More
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.
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.
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. Read More