Category: David Orentlicher

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Appeals Court Overturns FDA’s Partial Ban on Shock Devices: Analysis of Ruling

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By David Orentlicher

In its regulation of medical devices, the U.S. Food and Drug Administration (FDA) may ban devices that pose “an unreasonable and substantial risk of illness or injury.” But earlier this month, the U.S. Court of Appeals for the D.C. Circuit decided that the FDA may not issue a partial ban of a medical device.

The case, Judge Rotenberg Educational Center v. FDA, addressed the use of electrical stimulation devices to treat self-injurious or aggressive behavior, as in patients with serious intellectual or developmental disabilities.

In March 2020, the FDA attempted to prohibit this use of electrical stimulation (or electrical shock) because of the risks it poses to patients. As the FDA observed, persons with self-injurious or aggressive behavior may have “difficulty communicating pain and other harms caused by” electrical stimulation, and consent to the use of electrical stimulation is typically made by a third party, limiting the patient’s control over use of the device.

In other settings, including smoking cessation treatment, or treatment of substance use disorder, the FDA permits the practice. Hence the partial, rather than total, ban of electrical stimulation devices.

But by a 2-1 vote, the Judge Rotenberg Educational Center court held that prohibiting electrical stimulation in some settings, but not others, runs afoul of a “practice of medicine” statutory provision. This provision precludes the FDA from limiting or interfering with a health care practitioner’s authority “to prescribe or administer any legally marketed device to a patient for any condition or disease.” In the majority’s view, once the FDA permits use of a medical device, it must defer to the states for regulation of decisions regarding which patients are appropriate candidates for the device.

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CHICAGO, ILLINOIS, USA - JUNE 8, 2019: First ever Medicare for All rally led by Bernie Sanders held in The Loop of Chicago. Crowd holds up a sign that says "Medicare for All Saves Lives".

Medicare for the Poor

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By David Orentlicher

While Medicare-for-All has proved controversial, every Democratic presidential candidate should embrace one of its key elements—folding the Medicaid program into the Medicare program. That would be much better for patients, doctors, and hospitals. It also would be much better for public school children.

Medicare would be a much better program for patients, doctors, and hospitals in several ways. Lower-income families suffer because Medicaid is a federal-state partnership, and some states have stingier Medicaid programs than do other states. In particular, Florida, Texas, and twelve other states have not signed up for the Affordable Care Act’s Medicaid expansion, leaving more than two million lower-income Americans uninsured. Under our current Medicaid system, access to health care for the indigent depends where they live. Folding Medicaid into Medicare would give the poor access to health care in every state.

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CHICAGO, ILLINOIS, USA - JUNE 8, 2019: First ever Medicare for All rally led by Bernie Sanders held in The Loop of Chicago. Crowd holds up a sign that says "Medicare for All Saves Lives".

Sustaining the Promise of Universal Access

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By David Orentlicher

Should the United States achieve universal access to health care by adopting a single-payer, Medicare-for-All kind of system? Or should we build on the Affordable Care Act (ACA) and not disrupt the health care coverage of the 160 million Americans who have private health insurance?

Both reforms rely on important arguments about affordability, feasibility, and consumer choice. But there is one key reason to favor a single-payer system over an expansion of our current system. Experience with public benefit programs in the United States tells us that such programs thrive only when they serve all Americans.

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A photograph of miniature figures of people standing on top of piles of coins at different heights

Promoting Health, Not Just Health Care

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By David Orentlicher

Once again this past Thursday, the Democratic presidential candidate debate began on the topic of health care reform, and moderator George Stephanopoulos quickly steered the discussion to what he termed “the heart” of the debate. Should the United States increase access to care by building on the Affordable Care Act (ACA) or by replacing ACA with a single-payer, Medicare-for-All system?

While this is an important question, there is an even more important question for the candidates to discuss. We need to hear them talk more about health than about health care.

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How the GOP Misread Public Anger over Obamacare

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By David Orentlicher

In today’s New York Times, Kate Zernike reports on the lack of excitement among conservative activists for the Republican health care legislation. As Zernike observes, “President Trump and congressional leaders are getting little support from what were once the loudest anti-Obamacare voices.”

Some observers think that activists are disappointed in the failure of the GOP proposals to go far enough in repealing the Affordable Care Act. But that’s not the real story. In general, the public likes many of Obamacare’s key provisions, such as the protections for people with preexisting medical conditions or the ability of parents to insure their children up to age 26. Even among Republicans, there is majority support for the ban on higher premiums because of preexisting conditions and also for the mandate that insurers cover “essential health benefits.” And by 2014, Obamacare had faded as a campaign issue for Republican candidates for Congress.

So why don’t grassroots Republicans care so much about repealing the Affordable Care Act? Tea Party activists and other voters were genuinely mad about Obamacare, and they fueled the Republican wave in the 2010 House elections that saw Republicans gain 63 seats. But what made them angry was the feeling that President Obama cared more about health care than he did about the economy. In March 2010, when Obama signed the Affordable Care Act into law, the unemployment rate was 9.7 percent. The public cared much more about jobs than about health care insurance, and they saw their President focusing on health care. Remember how many times Obama promised to “pivot” back to the economy?

Voters elected President Trump and gave Republicans majorities in the House and Senate because they wanted more jobs at better pay. If the GOP lets health care distract it from economic stimulus, we may see another wave election in 2018.

Most-Cited Health Law Scholars (with an update on multiple authors)

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By Mark A. Hall and I. Glenn Cohen

Based on the law faculty citation analysis done by Greg Sisk, Brian Leiter has compiled “most-cited” rankings of tenured law faculty in a number of different subject areas, but not health law.  Naturally, we would be curious to know how we and colleagues might show up in such a ranking, but more than this, we were curious how the field of Health Law as a whole would look, compared to other fields, and how well different component of health law might be reflected.  Health law (as many people conceive it) is a broad field that includes bioethics, biotechnology, medical malpractice, health care finance and regulation, health policy, and public health.

Using Leiter’s methods and the Sisk data (supplemented as noted below), we compiled a citation-count ranking of health law scholars over the five-year period 2010-2014 (which is the latest currently available from Sisk).  We classify faculty as health law scholars if publications in this field account for the bulk (roughly 2/3) of their more recent citations.  A research librarian at Wake Forest University supplemented the Sisk data by doing citation counts (using his same methods) for an additional two dozen prominent health law scholars who are not on the Sisk list because they are at lower-ranked schools (below the top 70) or are based at schools of medicine or public health.  To ensure maximum comparability between these rankings and those already existing for other legal fields we conformed to Leiter’s presentation, which entailed, among other things, rounding citations to the nearest ten and estimating the age of those ranked.  Read More

Is Mike Pence’s Medicaid Expansion a Blueprint for Donald Trump’s Health Care Reform?

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By David Orentlicher

[cross-posted at orentlicher.tumblr.com]

Donald Trump’s pledge to repeal and replace the Affordable Care Act has looked much more like a plan for repeal than a plan to replace, especially in light of the kinds of reform proposals advanced by leading Republicans in Congress, including Trump’s designee for Secretary of HHS, U.S. Rep. Tom Price.

But Trump’s recent promise of “insurance for everybody,” suggests that he might actually have a serious replacement in mind. While we cannot automatically take Trump at his word, it may be the case that he is following the example of his Vice President-elect Mike Pence, who as Governor of Indiana defied Republican positioning in signing on to the Affordable Care Act’s Medicaid expansion. Read More

Surrogacy Contracts Directly Enforcible in Pennsylvania

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By John A. Robertson

Surrogacy is legal in many states.  Some, like California, directly enforce gestational carrier contracts.  Others, like Texas, Illinois, and Virginia, enforce only those contracts that are entered into by a married couple who need a surrogate for medical reasons which a judge approves before embryo transfer occurs.  A Pennsylvania court has now shown why gestational surrogacy contract should be directly enforced in the absence of legislation.  Its well-reasoned opinion suggests that more states may be open to this approach to surrogacy.

The Pennsylvania case, In re Baby S., arose out of a gestational surrogacy agreement involving embryos created with donor eggs and husband sperm. The written agreement was indisputably clear that that the intended parents would be the legal rearing parents, their names would appear on the birth certificate, and the carrier would have no rearing rights or duties.  Unlike previous cases questioning the validity of a surrogacy contract, the challenge here came not from the carrier who now wished to assert rearing rights (see In re Baby M and Calvert v. Johnson) but from the wife (the intended rearing mother).  She had praised the carrier’s willingness to help her have a child, which she repeated both at the embryo transfer and at a 20 week ultrasound at 20 weeks of pregnancy, which both intended parents attended.  A month later she informed the parties that “irreconcilable marital difficulties” would make it difficult for her to co-parent the child with the intended father.  She also refused to complete the paperwork for her name to appear on the birth certificate as the mother.

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Fetal Personhood and the Constitution

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By John A. Robertson

The Rubio-Huckabee claim that actual and legal personhood start at conception has drawn trenchant responses from Art Caplan on the medical uncertainty of such a claim and David Orentlicher, drawing on Judith Thomson’s famous article, that even if a fetus is a person, woman would not necessarily have a duty to keep it in her body.

Their debate claim that the fetus is already a legal person under the constitution also deserves a response, for it has no basis in positive law.  In Roe v. Wade all nine justices agreed that the use of “person” in the Constitution always assumed a born person, and therefore that the 14th Amendment’s mention of person did not confer constitutional rights until after a live birth.  In the years since Roe, when the make-up of the court has changed, no justice has ever disagreed with that conclusion, including those who would overturn Roe and Casey. Read More

Abortion and the Fetal Personhood Fallacy

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By David Orentlicher

[cross-posted at HealthLawProfs blog and orentlicher.tumblr.com]

Marco Rubio, Mike Huckabee, and other politicians continue to assert a common fallacy about abortion—because human life begins at conception, fetuses are persons, and abortion must be prohibited. Indeed, Huckabee and Rubio claim that the U.S. Constitution requires such a result.

But they are wrong. And not just because people disagree about the beginning of personhood. The flaw in the Rubio/Huckabee logic was pointed out more than 40 years ago, even before the U.S. Supreme Court recognized a constitutional right to abortion in Roe v. Wade. In “A Defense of Abortion,” Professor Judith Jarvis Thomson correctly observed that even if we assume that personhood begins at conception, it does not follow that abortion must be banned before the fetus is viable. Indeed, as she wrote, a ban on abortion before fetal viability would be inconsistent with basic principles of law. Read More