WASHINGTON, DC - MAY 21, 2019: A crowd of women hold signs supporting reproductive justice at the #StopTheBans rally in DC.

A Radical Reorientation for U.S. Abortion Rights

By Joanna Erdman

There is something inappropriate, even uncomfortable, about Chief Justice John G. Robert’s love letter to precedent in June Medical Services, LLC v. Russo.

On June 29, 2020, the U.S. Supreme Court held unconstitutional a Louisiana law that required doctors who perform abortions in the state to have admitting privileges at nearby hospitals. If the law went into effect, a single provider, or, at most, two, would remain in the state. The vote was 5 to 4. Roberts cast the fifth vote, but he did so in a separate opinion compelled by precedent.  The Louisiana law and its burdens on the right to abortion were nearly identical to those in Whole Woman’s Health, and therefore “Louisiana’s law cannot stand under our precedents” – even a precedent that he believes is wrongly decided.

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Washington, DC, USA -- March 4, 2020. Wide angle photo of a throng of protesters at an abortion rights rally in front of the Supreme Court.

June Medical v. Russo Reflects Ongoing Struggle with Black Women’s Constitutional Equality

By Michele Goodwin

The Supreme Court’s June Medical v. Russo case was more than just another cog in the wheel of the intensifying battle against the constitutional right to terminate a pregnancy.

Though, on its face, the case was about access to abortion, just beneath the surface, the law at issue represented a continuation of Louisiana’s historic resistance to sex and race equality. Read More

Ohio state flags waving in front of the Ohio State House

Ohio’s Efforts to Centralize Control Over Opioid Claims

By Daniel Aaron

On October 21, two Ohio counties are slated to present their opioid claims in a federal trial. However, last week, 13 states and the District of Columbia signed onto a brief requesting that the 6th Circuit Court of Appeals stay the upcoming trials. Their reasoning? States should control lawsuits for harms within the state; cities and counties do not have authority to sue on their own. While it makes sense that Ohio’s attorney general, spearheading this effort, would want more power and control over opioid claims, the move has the potential to harm public health by disempowering local governments from addressing public health crises. Ohio’s three main arguments will be discussed in turn.

Argument 1: Violation of State Sovereignty

First, Ohio argues that the county lawsuits violate state sovereignty and disrupt the “federal dual-sovereign structure” of the United States:

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Pro-choice and pro-life protesters face off in front of the Supreme Court

“Fetal Heartbeat” Bans are Gaining Momentum, but Abortion Restrictions Come in Many Forms

By Alexandra Hess

Alabama, Georgia, and Ohio have passed laws in recent weeks that ban many, if not all, abortions in their state. These bans are the latest additions to the litany of laws and policies that severely limit or totally prevent access to abortion for women in the United States.

“Fetal heartbeat” bans, like those enacted in both Ohio and Georgia, are some of the most restrictive types of gestational limitations on abortion in the U.S. They prohibit abortion at the point a fetal heartbeat is detectable by ultrasound—as early as six weeks’ gestation. This is often a point before many discover they are pregnant. Ohio and Georgia are not the first states to have enacted fetal heartbeat bans, however, and current legislative trends suggest they will not be the last. In 2019 alone, lawmakers have proposed heartbeat bans in at least 14 other state legislatures. Read More

Abortion rights protest following the Supreme Court decision for Whole Women's Health in 2016

Louisiana TRAP Law Challenge Could Leave Thousands of Women without Abortion Access

By Adrienne Ghorashi

UPDATE: Late Thursday, February 7, the Supreme Court granted Plaintiff’s stay application, meaning Louisiana’s TRAP law may not be enforced while the challengers file an appeal. The Supreme Court will then decide whether to hear the case or deny the petition, letting the Fifth Circuit’s ruling stand.

Justice Roberts sided with the Court’s liberal justices to grant the stay, while Justices Alito, Thomas, Gorsuch, and Kavanaugh would deny it. Kavanaugh also wrote a dissent, saying he would want to see the law go into effect before deciding whether the stay was necessary.

Although this is only a temporary win for the women of Louisiana, these actions could be a sign that a majority of justices have their doubts as to the law’s constitutionality in light of Whole Woman’s Health.

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Whole Woman’s Health and the Future of Abortion Regulation

By John A. Robertson

Whole Woman’s Health v. Hellerstedt (WWH) is the most important abortion case since Casey in 1992, and a major setback for the anti-choice movement.  By allowing courts to weigh the importance of the health benefits of a regulation, it will most likely invalidate most TRAP laws, which usually only marginally advance health while making it more difficult for women to access abortion.  WWH, however, will not stop the anti-choice movement from pressing its fight against abortion in other ways.  It now controls many state legislatures, and more legislation in areas left open by WWH may be expected.

Future health-related regulation will have to hew to the WWH line of providing real benefit, at least if substantially limits access to abortion.  But close questions may still arise.  What if a state has a valid health justification for a regulation that does limit access to abortion, as Jonathan Will notes would occur if a state law that directly promotes women’s health leads to that one clinic closing, as might occur in a state like Mississippi?  Here there would be a substantial burden on access, but given the health benefit of the law, which interest should take priority?  Neither Casey nor WWH are clear on this point.  In my view the question will turn on how great is the health benefit from the requirement.  A state, for example, should be able to close the only clinic in the state if it was as derelict as the Gosnell clinic.  In that case, however, one could show serious danger to women’s health and life that would be comparable or even greater than the risk of childbirth.  If the health benefit is less but still substantial, the question is harder.  Such a situation would call into question whether the state itself must allow even a sub-standard abortion facility even when acceptable facilities exist across a state line. (See Jackson Women’s Health v. Currier.) Read More

Whole Woman’s Health – Some preliminary thoughts on benefits, purposes, and fetal status

By Jonathan Will

The Supreme Court’s decision in Whole Woman’s Health is sure to be dissected in the coming days, weeks, and months.  In the meantime, I wanted to quickly reengage the discussion about the status of the “purpose prong” of Casey and what, if anything, Whole Woman’s Health tells us about it.  While Justice Breyer’s analysis in the majority opinion does not seem to be couched expressly in terms of Casey’s purpose prong, the majority’s willingness to assess the applicable laws’ benefits may ultimately be purpose dressed in different clothing.  If there is not sufficient evidence of a law’s benefit, there could be a problem.

As a quick refresher, recall that Casey prohibits laws that have either the purpose or effect of placing a substantial obstacle in the path of a woman seeking an abortion of a nonviable fetus.  While most folks can readily associate Casey’s “undue burden” test in terms of abortion restrictions that have the effect of placing obstacles, Priscilla Smith and Caitlin Borgmann, have written about courts seemingly ignoring Casey’s other mandate that laws should not have the purpose of even trying to place such obstacles (regardless of whether they succeed in creating that effect).  This avoidance of the purpose prong coupled with great deference to the asserted justifications of the legislature (without the kind of benefits inquiry seen in Whole Woman’s Health) has historically led to many TRAP (targeted regulation of abortion provider) laws being upheld.

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Amicus brief in Sequenom v. Ariosa: Why the U.S. Supreme Court should grant the petition for a writ of certiorari

By Timo Minssen

I am happy to announce that on April 20th the New York attorney Robert M. Schwartz and I have filed an amicus brief at the US Supreme Court with Berkeley-based Andrew J. Dhuey as Counsel of Record. The brief, which was signed by 10 prominent  European and Australian Law Professors as amici curiae, adds a European perspective to the many amicus briefs that have been submitted in support of Sequenom’s petition for certiorari to the United States Supreme Court. Sequenom’s petition in Case No. 15-1182 was filed on March 21, 2016 and seeks review of the Federal Circuit’s controversial decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, reh’g denied, 809 F.3d 1282 (Fed. Cir. 2015). The case concerns the revocation of Sequenom’s patent claims directed to inventive methods of genetic testing by detecting and amplifying paternally inherited fetal cell-free DNA (cffDNA) from maternal blood and plasma. Before the development of this highly beneficial, non-invasive prenatal diagnostic test, patients were placed at higher risk and maternal plasma was routinely discarded as waste. Distinguishing this case from previous Supreme Court decisions and highlighting the mitigating effects of other patentability requirements, we are concerned that the Federal Circuit’s overly rigid approach to claims eligibility decision might jeopardize the development of new therapies in an increasingly important area of modern medicine.

As most Bill of Health readers know, the US Supreme Court has in a recent series of cases (i.e. the combined effect of Bilski, Prometheus, Myriad and Alice) barred the patent eligibility for many genetic inventions as “products and processes of nature”. In Sequenom the CAFC interpreted these to mean – in essence- that “laws of nature” had to be entirely eliminated from the test of patent eligibility under §101 of the Patent laws. Should this interpretation be institutionalized it will contravene the tests for exclusions and exceptions under the EPC, arguably contradict longstanding US treaty policy and disrupt international patent harmonization. More importantly, we fear that the broader impact of such an restrictive interpretation may have grave consequences for a sustainable global drug delivery system, which should involve both public and private actors.

Although we believe that patents will remain the backbone of the industry, we acknowledge in our brief that  there are certain areas of biomedical innovations, such as antibiotics and orphan drugs, where the patent system does not work particularly well. We further recognize that both in Europe and in the US concerns have been raised about overly pre-emptive patents scope, but these are addressed at different levels. In contrast to Europe, the CAFC has interpreted the uncodified exception as part of a “threshold test” for patent-eligibility applied before other patentability requirements can be assessed. A strict and coherent application of these requirements, however, would invalidate overly-broad patent claims (including some of Sequenom’s arguably too broad and badly drafted claims), while also permitting, well-defined, narrower claims on diagnostic technology. In our view, the current approach conflates the patent eligibility test with issues that can be more sensibly addressed within a strict and coherent assessment of novelty, non-obviousness and sufficient disclosure criteria or at the post-grant level. We believe that, the Federal Circuit’s threshold test has not sufficiently considered the manner in which today’s statutory requirements have developed in both the U.S. and Europe to address policy rationales for patentability exceptions. To entirely transplant those issues into the patent eligibility assessment would categorically close the patentability door on many well-defined and beneficial inventions that deserve patent protection. In absence of sufficient public involvement and appropriate alternative incentives we risk that the wells driving technological progress run dry and that companies engage in business strategies, such as increased reliance on trade secrecy, that are not necessarily beneficial for our innovation system.

Accordingly, we urge the Supreme Court to clarify a patent eligibility test in line with its longstanding jurisprudence and in harmony with international and European law.

If the CAFC’s restrictive interpretation should prevail, however, I believe that it will be crucial to swiftly optimize the framework for PPPs and alternative innovation incentives, such as prizes and regulatory exclusivities. This would have to be done on an international level to allow for greater flexibilities and encompass further technological areas, such as biomedical diagnostics. Regarding regulatory exclusivities, Article 39 of the TRIPS agreement should provide sufficient leeway for such changes. The pros and cons of the different alternative approaches would of course have to be carefully considered.

The Amici curiae have no stake in the parties or in the outcome of the case. A full list of the Amici is appended at the end of the brief.

 

The Zubik Supplemental Briefs: The Objectors Push for Second-Class Coverage, With a Smile

Photo: Supreme Court rally
Tim Ritz/Americans United for Separation of Church and State

By Gregory M. Lipper

The first set of supplemental briefs in Zubik v. Burwell is in. The government seems willing to accept a modified version of the Court’s proposed compromise—if it means that the Court will halt the neverending legal challenges to the contraceptive-coverage regulations. The religious objectors, however, merely purport to accept the Court’s proposal; in practice, they are standing by their insistance that affected women should be forced to seek and obtain second-class, contraception-only policies that will sever their reproductive care from the rest of their healthcare. And they reserve the right to use the political process to oppose the creation of even those second-class plans.

Recall that the Court proposed a modified version of the government’s accommodation. The Court proposed that rather than provide separate written notice in order to become exempt from the coverage regulations, objectors coud simply “inform their insurance company that they do not want their health plan to include contraceptive coverage of the type to which they object on religious grounds”; at that point, and as contemplated by the existing accommodation, the insurance companies “would separately notify petitioners’ employees that the insurance company will provide cost-free contraceptive coverage, and that such coverage is not paid for by petitioners and is not provided through petitioners’ health plan.” (If you want more detail, here’s my earlier coverage of the Court’s order.) Read More

About that Order for Supplemental Briefing in Zubik v. Burwell

Photo: Pen & Parchment
Flickr/Creative Commons—Christa Uymatiao

By Gregory M. Lipper

This afternoon the Supreme Court requested supplemental briefing in Zubik v. Burwell and the other challenges to the contraceptive-coverage accommodation, as follows: “The parties are directed to file supplemental briefs that address whether and how contraceptive coverage may be obtained by petitioners’ employees through petitioners’ insurance companies, but in a way that does not require any involvement of petitioners beyond their own decision to provide health insurance without contraceptive coverage to their employees.”

And in so doing, the Court offered a proposal of its own (I’ve added paragraph breaks and numbering):

[1] For example, the parties should consider a situation in which petitioners would contract to provide health insurance for their employees, and in the course of obtaining such insurance, inform their insurance company that they do not want their health plan to include contraceptive coverage of the type to which they object on religious grounds.

[2] Petitioners would have no legal obligation to provide such contraceptive coverage, would not pay for such coverage, and would not be required to submit any separate notice to their insurer, to the Federal Government, or to their employees.

[3] At the same time, petitioners’ insurance company—aware that petitioners are not providing certain contraceptive coverage on religious grounds—would separately notify petitioners’ employees that the insurance company will provide cost-free contraceptive coverage, and that such coverage is not paid for by petitioners and is not provided through petitioners’ health plan.

Although it’s foolish to read tea leaves, read them I shall:

1. I think that this is a decent sign for the government. It was clear from last week’s argument that four Justices would vote to uphold the accommodation; but the potential fifth vote, Justice Kennedy, seemed to be skeptical of the government’s arguments. This order suggests that at least five Justices (including Justice Kennedy) seem to think that the challengers’ proposed alternatives to the accommodation (create separate, contraceptive-only policies and require women to seek them out; expand Title X clinics; and other Rube Goldberg-schemes) harm women by preventing them from receiving seamless and convenient coverage. If the Court thought that those other alternatives were sufficient, then it wouldn’t be looking for a way to ensure that women retained accommodation-style seamless coverage.

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