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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The Economist on Contraceptive Coverage and Misleading Metaphors

By Gregory M. Lipper

The Economist is not buying the challengers’ claim that the provision of contraceptive coverage—by third parties—is an act of “hijacking”:

When the government arranges for contraceptive coverage with the insurance company used by the religious charity, it is not commandeering anybody’s property. Nor is it taking metaphorical control of the group’s health insurance plan. Instead, the government is seeking to fulfil Obamacare’s near-universal guarantee to female employees by working with the same insurance company or third-party plan administrator that provides the rest of the employee’s health benefits. Neither the insurance company nor the plan is the property of the religious charity: Aetna is not a wholly owned subsidiary of Catholic Charities. The non-profit and the insurer are independent entities.  When a school brings a child to a playground that his parents (for some reason) opt to avoid, the teachers are not “hijacking” the swingset. They are using a resource for the child’s benefit. The parents may be displeased about the school trip to the forbidden playground, but any complaint they raise would necessarily have a paternalistic flavour. Employers do not have such a role vis-a-vis their employees.

Read the full essay here.

Greg Lipper (@theglipper) is Senior Litigation Counsel at Americans United for Separation of Church and State.

The Zubik v. Burwell Oral Argument

Photo: Zubik v. Burwell Signs
Tim Ritz / Americans United for Separation of Church and State

By Gregory M. Lipper

Over at Rewire, I’ve analyzed yesterday’s oral argument in Zubik v. Burwell. Among other things, I address the recurring claim that the government was “hijacking” religious objectors’ health plans by arranging for third party insurers and plan administrators to provide contraceptive coverage to affected women:

The fear of hijacking might have made sense if we were talking about a plane instead of a plan. But an insurance company is not an employer’s personal property. If the insurance company, separately from the employer, wants to provide extra coverage to the employees, that’s none of the employer’s business—especially since that contraceptive coverage is guaranteed to women by federal law. At the argument, Clement compared the accommodation to the government running a contraception clinic out of the Little Sisters’ home, but the more apt analogy is that the government has set up shop across the street: The challengers simply have no legitimate interest in preventing the government from “hijacking” a nearby vacant lot.

You can read the full article at Rewire’s freshly redesigned website. And more on the “hijacking” argument here.

Greg Lipper (@theglipper) is Senior Litigation Counsel at Americans United for Separation of Church and State.

Zubik v. Burwell, Part 6: The Accommodation is the Least-Restrictive Option

Photo: Demonstration
Flickr/Creative Commons—Joe Brusky

By Gregory M. Lipper

(Read Part 1, Part 2, Part 3, Part 4, and Part 5 of this series)

The plaintiffs in Zubik v. Burwell and its siblings seek to block their students and employees from receiving contraceptive coverage from third-party insurance companies and plan administrators. Even though the plaintiffs need neither provide nor pay for contraceptive coverage, they argue that the government can and must adopt one or more purportedly less-restrictive alternatives, including (1) providing contraceptives or contraceptive-specific coverage to women directly; (2) offering grants to other entities that provide contraceptives; (3) offering tax credits or tax deductions to women required to pay for contraceptives; or (4) expanding eligibility for programs that provide contraceptives to low-income women. (The University of Notre Dame, whose petition for Supreme Court review is pending, has also argued that it could provide coverage for natural family planning; the Seventh Circuit correctly noted that natural family planning “is not contraception at all.”)

These proposed alternatives would not achieve the government’s interest as effectively as the accommodation; they would, instead, impose financial or logistical barriers on women, thwarting their seamless access to contraceptives and demoting contraceptives to junior-varsity care. Women would be forced to identify and register for yet another new program, perhaps see a different doctor for contraception-related care, and possibly pay out of pocket. (For more on the problems with the proposed alternatives, see my organization’s brief on behalf of 240 students, faculty, and staff at religiously affiliated universities, as well as the brief of health law policy experts prepared by Hogan Lovells.)

By requiring women to jump through logistical hoops and incur additonal costs, the proposed alternatives would reduce access to and use of contraceptives. Studies show that even minor barriers can dramatically reduce contraceptive access: Read More

Zubik v. Burwell, Part 5: These Exceptions are Unexceptional

Photo: Bronze IUD
Flickr/Creative Commons—Sarah Mirk

By Gregory M. Lipper

(Read Part 1, Part 2, Part 3Part 4, and Part 6 of this series)

Despite birth control’s considerable benefits, the challengers in Zubik v. Burwell argue that the government lacks a compelling interest in applying the contraceptive accommodation to religious objectors. No matter how important it is to ensure that women have access to contraceptive coverage, the challengers say, the presence of other exceptions to the coverage requirements makes the interest in providing contraceptive coverage less than compelling. If contraceptive coverage were truly important, the argument goes, then there wouldn’t be any exceptions at all.

This argument proves too much—way too much. Almost all laws have exceptions. As the government explains in its brief to the Supreme Court, “Numerous organizations are not required to pay taxes; half the country’s draft-age population is exempt from registering for the draft; and Title VII does not apply to millions of employers with fewer than 15 employees, see 42 U.S.C. 2000e(b). Yet no one would suggest that raising tax revenue, raising an army, and combating employment discrimination are not compelling interests.” Indeed, despite Title VII’s exemption for small employers, the Supreme Court in Hobby Lobby reiterated that “[t]he Government has a compelling interest in providing an equal opportunity to participate in the workforce without regard to race…”

Despite these examples, the plaintiffs claim that the government’s interest in contraceptive coverage is undermined by three exceptions: (1) employers with fewer than fifty employees need not provide health insurance at all; (2) houses of worship are exempted from the contraceptive-coverage requirement; and (3) grandfathered employers are exempted from some coverage requirements, including the one pertaining to contraceptives. But none of these make the government’s interest any less compelling.

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Zubik v. Burwell, Part 4: The Compelling Interest in Contraceptive Coverage

Photo: Birth Control Rally
Flickr/Creative Commons—Women’s eNews

By Gregory M. Lipper

(Read Part 1, Part 2Part 3Part 5, and Part 6 of this series.)

If the Supreme Court were to conclude that the plantiffs in Zubik v. Burwell plaintiffs have established a substantial burden on religious exercise, the case is not over. Under the Religious Freedom Restoration Act, the government may enforce even a law that substantially burdens religious exercise if that law advances a compelling governmental interest and is the least-restrictive means of advancing that interest. In the 2014 Hobby Lobby decision, the Supreme Court majority assumed, without deciding, that the coverage regulations advanced a compelling interest. And in his concurring opinion, Justice Kennedy went further: It was “important to confirm,” he wrote, that “a premise of the Court’s opinion is its assumption that the HHS regulation here at issue furthers a legitimate and compelling interest in the health of female employees.”

The government’s interest in ensuring that women have contraceptive coverage is compelling indeed. Access to contraception has many benefits—some of them obvious, others less so. And these benefits explain why the CDC has listed family planning as one of the 10 most important public-health advances of the 20th century.

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