The “Common Knowledge” Exception to the Expert Requirement in Medical Malpractice Actions under FTCA Categorized as “Substantive”

By Alex Stein

All expert requirements for medical malpractice actions (including merit certificates and affidavits) are categorized as “substantive” rather than “procedural” under both Erie (in diversity suits) and the Federal Tort Claims Act (FTCA). See here and here. The Fifth Circuit recently ruled in connection with a medical malpractice suit filed under FTCA that the “common knowledge” exception to the expert testimony requirement is “substantive” as well. Bush v. United States — F.3d —- 2015 WL 5472491 (5th Cir. 2015) (hereinafter: Bush). State law (Virginia law, in Bush) consequently trumps the federal law of evidence and procedure. Continue reading

NEXT WEEK (10/15): Obamacare, the Contraceptive Mandate, and Religious Freedom Discussion

Harvard Federalist SocietyObamacare, the Contraceptive Mandate, and Religious Freedom Discussion
Thursday, October 15, 2015 12:00 – 1:00 PM
Wasserstein Hall, Room 2012
Harvard Law School, Cambridge MA [Map]

The Harvard Federalist Society will be hosting Mark Rienzi next Thursday, October 15 to discuss the current contraceptive mandate and accommodation lawsuits. Petrie-Flom Center Executive Director Holly F. Lynch will offer her views in response.

The event will be at 12:00 PM on October 15 in WCC 2012. It will end just before 1:00 so that students can make it to 1:00 classes. The Federalist Society will provide lunch.

Which state will be the next to expand Medicaid?

The last week has yielded significant progress in several states currently debating Medicaid expansion. Thirty-one states and DC have already expanded the program, made an option for states due to the Supreme Court’s NFIB v Sebelius decision. Many state legislatures are coming back into session from summer recesses bringing into focus discussions on the budget implications of Medicaid. Additionally, as we approach a looming Presidential election with expected high voter turnout, politicians have an opportunity to push for the expansion to gain support from certain stakeholders. While significant action is needed in each of these states before any Medicaid expansion legislation is passed or their governors act to implement their plans, it is worth keeping an eye on all of these states in the coming months.

Utah- It has been over a year and a half since Governor Herbert announced his support for Medicaid expansion. This week, details of the new plan, UtahAccess+, have been released. The plan, formulated by the Governor and Republican legislative leaders, is similar to the Healthy Utah plan that was passed the Utah Senate but was struck down in the House with the exception of the financing model which puts the burden on providers that would benefit from additional funds through expansion.

Louisiana- This is one of the more surprising states to appear on a list of upcoming states to expand Medicaid, however the tides may be shifting in this largely conservative state. Louisiana is in the process of electing a new governor as Presidential candidate Bobby Jindal is ineligible due to term limits. All four candidates have indicated some level of support for expansion (to varying degrees) since April. These candidates’ positions reflect the push by business groups in the state which have called for expansion, as well as the recent legislative change that gave the new governor the necessary state authority to expand in the first months in office.

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NPRM Symposium: Escape for Many, Scant Relief for Those Left Behind

While the NPRM might do much to reduce the number of projects requiring IRB review, it would do little to improve the quality of review for those projects for which it is still required. This is a retreat from the more ambitious plans of the 2011 advance notice of proposed rulemaking.

[Cross-posted from Institutional Review Blog]

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Presidential Campaigns Focus on Drug Costs

By Katherine Kwong

Drug prices have become a hot topic on the presidential campaign trail following recent stories such as the sudden spike in price from $13.50 to $750 for the parasitic infection treatment Daraprim. This story is the latest example of a growing number of complaints about steep increases and high prices for many drugs, including those used to treat multiple sclerosis and cancer, as well as commonly-used generic drugs used to treat everything from high cholesterol to bacterial infections.

In contrast with the Republican presidential candidates, who have generally not supported additional government regulation of drug pricing, Democratic presidential candidates responded to the Daraprim story by urging greater government action to lower drug costs.

Hillary Clinton cited Daraprim as an example when unveiling a proposal to cap drug costs to $250 per month, require pharmaceutical companies to spend a minimum amount on research and development, and allow Medicare to negotiate drug prices. She would also end tax credits for drug advertising to consumers and allow the importation of drugs from other countries.

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Big Data, Genetics, and Re-Identification

by Zachary Shapiro

While all scientific research produces data, genomic analysis is somewhat unique in that it inherently produces vast quantities of data. Every human genome contains roughly 20,000-25,000 genes, so that even the most routine genomic sequencing or mapping will generate enormous amounts of data. Furthermore, next-generation sequencing techniques are being pioneered to allow researchers to quickly sequence genomes. These advances have resulted in both a dramatic reduction in the time needed to sequence a given genome, while also triggering a substantial reduction in cost. Along with novel methods of sequencing genomes, there have been improvements in storing and sharing genomic data, particularly using computer and internet based databases, giving rise to Big Data in the field of genetics.

While big data has proven useful for genomic research, there is a possibility that the aggregation of so much data could give rise to new ethical concerns. One concern is that promises of privacy made to individual participants might be undermined, if there exists a possibility of subject re-identification.

Re-identification of individual participants, from de-identified data contained in genetic databases, can occur when researchers apply unique algorithms that are able to cross-reference numerous data sets with the available genetic information. This can enable diligent researchers to re-identify specific individuals, even from data sets that are thought to be anonymized. Such re-identification represents a genuine threat to the privacy of the individual, as a researcher could learn about genetic risk factors for diseases, or other sensitive health and personal information, from combing through an individual’s genetic information.

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Job Opportunity: Legal Research Associate

Come join our team!

The Public Health Law Research program is hiring legal research associates to work on our policy surveillance project. The legal research associate will conduct legal research using Lexis and Westlaw, build historical law using HeinOnline, and conceptualize legal domains for empirical research. The associate will also code law for the creation of quantitative legal datasets at, and write legal briefs and other materials for

Learn more and apply today!

What’s the Difference Between Anorexia Nervosa and Hunger Strike?

My last post presented the debate over force feeding hunger striking prisoners in Israel. This post will discuss another group subjected to the dramatic means of force feeding in extreme circumstances, Anorexia Nervosa patients (AN).

Although ethical justifications for force-feeding are similar for both Anorexics and Hunger strikers (save life), the legal framework is completely different in each context. Whereas hunger striking prisoners were dealt with via ad-hoc legislation meant to answer national security threats, AN patients are handled within the framework of mental health law.  In the U.S., compulsory hospitalization of mental patients occurs through the state’s Civil Commitment Laws, which require dangerousness resulting from a mental illness to be evaluated by a psychiatrist.

Is the different legal attitude justified? How is it that the same act performed by prisoners is viewed as a political assertion but when done predominantly by adolescent middle-upper class girls, it is considered mental illness?

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RFRA Jumps The Shark: The 8th Circuit Strikes Down the Contraception Accommodation (Part 2)


Flickr/Creative Commons – Bill Ward

By Gregory M. Lipper

Thomas Jefferson famously said that “[i]t does me no injury for my neighbour to say there are twenty gods, or no god. It neither picks my pocket nor breaks my leg.” Note what Jefferson did not say: “my neighbor is entitled to pick my pocket and break my leg, so long as the government can refill my pocket and pay for a cast on my leg.”

But the latter formulation seemed to influence last week’s Eighth Circuit ruling that the Religious Freedom Restoration Act (RFRA) bars the government from implementing an accommodation for employers with religious objections to including contraception in their health plans. In my previous post, I explained why the Eighth Circuit reduced RFRA’s substantial-burden requirement to a mere formality, potentially subjecting any and every federal law or regulation to strict scrutiny. Once things get to strict scrutiny, the Eighth Circuit goes even further, suggesting that a federal regulation cannot be sustained if the government could, in theory, provide the benefit or service itself.

The Eighth Circuit first applied this approach to the process by which employers obtain the religious exemption. Under the current rules, an objecting organization need only send a written notice to the government and identify its insurance provider or third-party administrator; the government then works with the insurance provider or third-party administrator to arrange for the employees to receive the contraceptive coverage to which they are entitled by law.

The Eighth Circuit, however, reasoned that there is a less-restrictive alternative to requiring this information, since the government could identify the necessary insurance providers and third-party administrators on its own—well, maybe: “Even if the [third-party administrators] are not known, the government has not shown at this stage of the proceedings that the inconvenience of identifying the [third-party administrators] likely would create an administrative problem of sufficient magnitude to make its entire scheme unworkable.” According to the Eighth Circuit, then, no disclosure requirement can be sustained unless the government can prove that it would be unable to discover the information after its own investigation.

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Generic Drug Price Increases: Implications for Medicaid

The internet (not just the health policy part of the internet!) is fascinated by today’s New York Times story about dramatic recent increases in the costs of many decades-old drugs.  The story focuses on the case of Daraprim, the standard of care for treating the parasitic infection toxoplasmosis.  Daraprim was recently acquired by a start-up, which then raised the drug’s price from $13.50 a pill to $750 a pill.  Daraprim has been around for decades, and as the story notes, it’s just one of many recent examples of dramatic price increases for generic drugs, often after their acquisition by other companies (as in this case).

The article raises an enormous number of issues of interest to intellectual property and health policy scholars, both explicitly and implicitly, and other commentators have begun to canvass them.  But I want to spend the rest of this blog post unpacking a single point made in the article, because it actually contains an enormous amount of complexity.  As the author notes, “[the company’s] price increase could bring sales to tens or even hundreds of millions of dollars a year if use remains constant. Medicaid and certain hospitals will be able to get the drug inexpensively under federal rules for discounts and rebates. But private insurers, Medicare and hospitalized patients would have to pay an amount closer to the list price.”

The author is right that there’s one sense in which Medicaid and entities eligible for the 340B program (I assume this is what the author is referring to when he says “certain hospitals”) will be able to obtain this drug “inexpensively” – but there’s another sense in which they won’t be able to.

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How Privacy Law Affects Medical and Scientific Research

[Cross-posted from the Genomics Law Report blog]

By John Conley

Over the last five or so years my law practice has focused increasingly on privacy law, both domestic and international. In hindsight, this was a predictable outcome: as an intellectual property lawyer, many of my clients do business on the Internet or are engaged in scientific research and development, with many of the latter in the health care area. These are the very kinds of people who need to worry about privacy—of their customers, users, patients, and subjects. As they started on focusing on privacy concerns, these clients turned to their IP lawyers for help, and my Robinson Bradshaw colleagues and I have tried to stay ahead of their needs.

As a consequence of my growing privacy practice, I am regularly called on to give overviews to other lawyers as well as non-lawyers in the scientific and business communities. I thought it might be useful to devote a GLR post to a privacy law summary targeted at readers who conduct medical and other scientific research. Privacy law is a transnational mess, so this will be a bit longer than I’d like—my apologies, and please don’t shoot the messenger—but I’ll try to cut through the legal jargon.

Sources of Modern Privacy Law Continue reading

RFRA Jumps The Shark: The 8th Circuit Strikes Down the Contraception Accommodation (Part 1)

Flickr/Creative Commons – Bill Ward

Flickr/Creative Commons – Bill Ward

By Gregory M. Lipper

On Thursday, the Eighth Circuit all but assured that major parts of the Affordable Care Act will return to the Supreme Court’s chopping block. This time the issue is whether an accommodation—enabling religious objectors to opt out of offering contraceptive coverage to their employees—itself violates the Religious Freedom Restoration Act (RFRA). The Eighth Circuit ruled for the plaintiffs in Sharpe Holdings, Inc. v. U.S. Department of Health and Human Services, along with a companion case brought by Dordt College. The court concluded that the accommodation substantially burdened plaintiffs’ religious exercise and that the accommodation was not the least-restrictive means of ensuring that the plaintiffs’ employees had contraceptive coverage.

The Eighth Circuit’s substantial-burden ruling is unprecedented. Indeed, the contraception coverage cases appear to be the first time that exempted entities have sued to prevent the government from implementing a religious exemption. Like the other nonprofit organizations challenging the contraception regulations, the plaintiffs in this case are not required to cover contraceptives. All they have to do is provide written notice (to either their plan administrator or the Department of Health and Human Services) that they object to providing contraceptive coverage and wish to opt out. Once they provide that notice, the government arranges for the plan administrator to arrange for contraceptive coverage—at no charge to either the plaintiffs or their employees.

The plaintiffs insist that by opting out of providing contraceptive coverage, they “indirectly provide, trigger, and facilitate that objectionable coverage through the … accommodation process.” Every other federal appeals court to have addressed these challenges—even courts as conservative as the Fifth Circuit—has rejected this argument. Indeed, the plaintiffs are being asked to do what they have already done voluntarily: state, in writing, that they object to providing contraceptive coverage to their employees. And it is the HHS regulations, not the plaintiffs’ written notice, that facilitates the provision of contraceptive coverage to plaintiffs’ employees.

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Bioethicist Art Caplan: Science Anyone?

Bill of Health Contributor Arthur Caplan has a new piece up on From the piece:

Plenty of pundits are analyzing the Wednesday night GOP debate in terms of who won and who lost. They are missing the point. There was a huge loser in the back and forth among the contenders—the public health of the American people. Why?–the resurrection in the debate of the heinous canard that vaccination causes autism.

Donald Trump led the assault on the health of our children by proclaiming that “”We’ve had so many instances … a child went to have the vaccine, got very, very sick, and now is autistic.” Really? Donald produce your evidence or get your racist, misogynist, birther, comb-over tushy out of the race. There is no evidence that vaccines cause autism. None. No one should tolerate outright lying that puts vulnerable kids at risk from a would-be President. So Donald show us your proof or leave Americas kids alone. […]

Read more here.

A Circuit Split on Contraceptives Coverage

Perhaps foreshadowed by the dissent in the 10th Circuit that I wrote about here, the 8th Circuit has now officially launched a circuit split regarding the legal validity of the accommodation that allows modified compliance/objection to the contraceptives coverage mandate.  Unlike the seven other circuits to have considered the question since Hobby Lobby, the 8th Circuit yesterday issued opinions upholding preliminary injunctions in two cases (here and here), thereby preventing the mandate+accommodation from being enforced against the objecting non-profits.

First, the 8th Circuit determined that the accommodation still substantially burdens objectors’ religious beliefs because it imposes significant financial penalties if they refuse to comply with a requirement that they view as violative of those religious beliefs. As I explained previously, I do think the court was right to focus on the monetary consequences of objection, rather than assuming that merely filing the required paperwork for an accommodation does not or cannot actually make objectors complicit in the way they claim it does.

Like SCOTUS in Hobby Lobby, the 8th Circuit then went on to assume that the contraceptives coverage mandate advances a compelling government interest, which is the next step in the analysis under the Religious Freedom Restoration Act once the substantial burden test is met.  So far, so good.  But that’s the end of my agreement.

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Introducing New Contributor Jessie Hill

jessie_hill_peopleJessie Hill is joining Bill of Health as a regular contributor.

Jessie Hill is the Judge Ben C. Green Professor of Law and Associate Dean for Academic Affairs at Case Western Reserve University School of Law. She teaches and writes in the fields of constitutional law, health law, and law and religion. Her scholarship has been published in the Michigan Law Review, Duke Law Journal, Columbia Journal of Gender and Law, and the Texas Law Review, among others. Prior to teaching, Professor Hill worked at the Reproductive Freedom Project of the national ACLU office in New York, litigating challenges to state-law restrictions on reproductive rights, and then practiced First Amendment and civil rights law with a small law firm in Cleveland. She is a member of the Academic Advisory Board of Law Students for Reproductive Justice and is a frequent lecturer and consultant on reproductive rights issues.

Managing Diabetes: Is Silicon Valley the Solution?

By Emma Sandoe

According to a new study in JAMA, half of American adults either have diabetes or are pre-diabetic. The chronic condition costs the nation $245 billion annually in health care costs and lost wages. The diabetes technology industry has grown exponentially over the last several years, as the use of measuring and regulating devices has become the norm for monitoring and treating diabetes.

Last week, NPR examined how Google’s Life Sciences division is investing in the management of diabetes. Google’s Life Sciences division is part of its renamed company, Alphabet, and stems out of Google X — the same side of the company working on technology such as driverless cars and tracking the spread of disease outbreaks.

One of Google’s most anticipated products coming out of the new diabetes campaign is a contact lens that would be able to monitor glucose levels from water in the eye. This joint venture with Novartis was announced in January 2014 and is currently slated for research and developmental reviews.

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Tennessee: The Next State to Require Involuntary Outpatient Commitment?

By Bryan Kozusko, JD (Expected graduation: May 2016)

How will Tennessee address involuntary outpatient commitment hereon out? Currently, Tennessee is one of seven states that does not provide for direct involuntary outpatient commitment, pending a final disposition by a court with jurisdiction. According to general involuntary outpatient commitment law, whenever an individual is believed to require such commitment, a final hearing must be held allowing an adjudication on the merits and the establishment of grounds by clear and convincing evidence. The other states that do not allow for this process are Alaska, Connecticut, Kentucky, Maryland, Massachusetts, and New Mexico.

For six years Tennessee legislators have tried, but failed, to successfully implement a permanent statute authorizing direct involuntary outpatient commitment following the disposition of a final commitment hearing. In 2009, Bill H.R. 0297 of the 106th General Assembly passed through the Senate unanimously. Once received by the House, no further action was taken and the bill was never voted on. In 2012, the 107th General Assembly authorized the creation of an involuntary outpatient pilot program to operate two years in Knox County, Tennessee. In 2014, the 108th General Assembly amended their law to terminate the pilot program on June 30, 2015, citing the public welfare of their citizens.

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