HealthLawProf Blog

Guest Blogger Professor Jessie Hill: Supreme Court grants cert in Cline v. Oklahoma Coalition for Reproductive Justice

For the past nine years, I have been litigating (together with attorneys from Planned Parenthood) the constitutionality of an Ohio law that requires physicians prescribing the abortion-inducing drug mifepristone (RU-486, which was approved by the FDA in 2000 and can be used safely to terminate pregnancy until at least 9 weeks of pregancy) to follow a particular, outdated protocol. On Thursday, the Supreme Court granted certiorari in an Oklahoma case raising almost identical issues. Because of some uncertainty about the meaning and scope of the state law, however, the Supreme Court took the unusual step of certifying two questions to the Oklahoma Supreme Court and suspending all proceedings (including, presumably briefing), until the Oklahoma court responds. This raises the possibility that the Court might end up dismissing the case, or that it won’t get argued this Term. But the case raises important, novel, and fascinating issues that most likely will ultimately be aired before the Court. 

The Oklahoma law prohibits the “off-label” use of any “abortion-inducing drug.” There are several problems with this. First, insofar as it appears to require that RU-486 be prescribed in accordance with the protocol outlined in the FDA labeling, that protocol is severely out-of-date. It was the protocol used during clinical trials in the 1990s, and virtually no physician uses it today (unless state law requires it). Notably, the FDA labeling protocol specifies that women take three times more of the drug mifepristone than they actually need to take under the current, evidence-based protocol. It also requires women to return for additional visits to the clinic, which they otherwise do not need to make. (In the Oklahoma case, there is also some question whether the law also completely prohibits the use of misoprostol, which is used in conjunction with mifepristone to complete the abortion, and methotrexate, which is often used to terminate ectopic pregnancies).   

Assuming the law’s doesn’t outlaw use of misoprostol and methotrexate but does require women to follow the outdated RU-486 protocol (an issue that the Oklahoma Supreme Court will clarify), the problems are that the off-label prohibition makes the drug more expensive, increases side effects, requires additional visits to the clinic, and makes takes the medication abortion option off the table for women between 7 and 9 weeks of pregnancy, for whom it would be safe and effective. But is it unconstitutional? I believe there are strong arguments that these factors, certainly in combination, could constitute an “undue burden” under Planned Parenthood v. Casey. In addition, there is a strong argument that, by forcing some women to have a surgical abortion when a safe, medical option is available, the law impinges on women’s fundamental right to bodily integrity. Finally, the Constitution requires a health exception, allowing the drug to be used for some women for whom it is safer than surgical abortion (such as women with anatomical anomalies or obesity). Time will tell whether the Supreme Court agrees.

- Jessie Hill

[KVT]

 

Here Comes Hobby Lobby...

The Tenth Circuit issued yesterday a divided and quite lengthy opinion in Hobby Lobby Stores Inc. v. Sebelius.  The court has held that Hobby Lobby has rights under the Religious Freedom Restoration Act, despite being a corporation, that are likely to protect the entity from compliance with the ACA's contraceptive coverage requirements. The case is remanded to the district court for additional findings as to whether the Hobby Lobby stores should be exempted from the ACA's statutory requirements, consistent with the Tenth Circuit's interpretation of RFRA.  For more summary and analysis, see Lyle Denniston at SCOTUSblog.  The slow march to the Supreme Court continues.

[NH]

US v. Windsor: Some Constitutional Uncertainty, Many Healthcare Implications

The Court's decision striking down section 3 of DOMA in United States v. Windsor was unsurprising, yet still a relief to many.  Section 3 defined marriage for federal statutory purposes to mean only marriage between one man and one woman.  Based on the late March oral arguments in Windsor, as well as Justice Kennedy's majority opinions in Lawrence v. Texas and Romer v. Evans, the common wisdom was that federalism would be the prevailing reasoning because the states historically have governed family law matters, including marital status.  One of Justice Kennedy's projects has been revitalization of the Court's enforcement of federalism to protect the states, especially as a method to protect individual liberties (see, e.g., Bond v. United States). 

And so it was.  Justice Kennedy provided both structural and substantive reasons for striking down section 3 of DOMA.  From a structural perspective, Justice Kennedy's majority emphasized traditional state dominion over marriage, writing: "By history and tradition, the definition and regulation of marriage ... has been treated as being within the realm of the separate States."  Though the opinion walked right up to the federalism line, it stopped short of holding that DOMA exceeded congressional authority or violated the Tenth Amendment.  Instead, the majority moved forward on substance and held that the federal government cannot take away the marriage right and its attendant societal status once conferred by the states.  To do so was a violation of gay couples' liberty and dignity.  The Court also hinted at an equal protection analysis, condemning Section 3 as creating second class marriages in states that recognize same-sex unions.  The majority applied only rational basis review, rather than heightened scrutiny, holding that DOMA was motivated by anti-gay animus and served no legitimate governmental purpose. 

Neither the federalism, nor the equal protection, nor the due process analysis was either complete or clear cut, and each opens more questions than it closes.  For example, Justice Kennedy views the experiment of the states to protect individual liberty, and here, it happens that twelve states do protect liberty, more than the federal government.  But, this view of federalism's aspirational work does not address the 37 or so states that do not protect the liberty interests of their gay citizens from state discrimination let alone the federal government's limited view of gay rights.  And, this reversion to assessing traditional state law domains does not advance modern conceptions of federalism that acknowledge most state law is ineffibly intertwined with federal law by virtue of statutory interconnectedness, conditional spending, or other cooperative federalism mechanisms.  Instead, Justice Kennedy seemed to be reaching back to the dual sovereign model of doctrinal federalism.

Fortunately, this regressive model of federalism does not seem to hinder the work that Windsor is likely to do with regard to DOMA's far-reaching effects on healthcare.  For example, marital status influences not only access to affordable private health insurance (which is usually easier and cheaper through marriage), but also qualification for the Federal Employees Health Benefits Program as well as Social Security, the gateway for Medicare at age 65.  Section 3 also affected Medicaid enrollment and spend-down requirements for the elderly entering nursing homes.  The Medicaid/DOMA issue was presented to the Court in a petition for certiorari that the Court has not granted or denied yet.  Back in October, I highlighted the First Circuit's decision in Massachusetts v. Department of Health and Human Services, which was mentioned in passing by Justice Kennedy as a case that would suffer vacatur if the Court dismissed for lack of standing.  It seems fair to read approval of the First Circuit's decision into Kennedy's cite, which makes me think the Court will not grant the petition.

In addition to public and private health insurance issues, some healthcare delivery issues are likely to be resolved by Windsor as well.  For example, many stories have detailed how hospitals have turned away same-sex partners under the guise of HIPAA privacy.  Other tales have highlighted how substituted decision-making at the end of life can devolve to estranged family members when same-sex partnerships are not recognized as giving the gay spouse decisional authority that would ordinarily be given without a second thought to a heterosexual spouse.  Doctors' offices have refused to recognize same-sex spouses as parents of children who need medical attention.  And, care for infants of same-sex couples may become easier now that the Family Medical Leave Act will apply to same-sex marriages.  It seems that the federal recognition of gay marriage that will flow from Windsor will be beneficial in many healthcare situtations, even in states that do not recognize same-sex marriage.  Federal agencies have much work to do interpreting the word marriage in the coming days, but it seems that these decisions will facilitate a more functional approach to families' experiences in the healthcare system.

[NH]

Fathers and Their Responsibility to Their Children

Once again, we have a judicial ruling that undermines efforts to encourage fathers to take responsibility for their children. The Supreme Court today sided with adoptive parents over a man who wants to raise his biological daughter.

To be sure, the man had relinquished his parental rights when the birth mother was pregnant, and he had not provided any financial assistance during the pregnancy or the first four months of his daughter's life. But he did object to the adoption when he was notified about it and asked that he be able to raise his daughter. If we want fathers to take responsibility for their children, we should not interfere with their reasonable efforts to assert their paternal roles.

Today's case unfortunately follows in the footsteps of other Supreme Court precedents which give mothers greater rights than fathers. For example, in 1983 case (Lehr v. Robertson), Court held that biological mothers always are entitled to notice about adoption proceedings, while biological fathers may forfeit their rights to notice if they do not take enough steps to assert their paternity.

When we have a serious problem with absent dads, we should do all we can to foster relationships between children and their fathers.

[The case, Adoptive Couple v. Baby Girl, involved interpretation of Native American law, with the interpretation driven by the Court's inadequate concern for fathers.]

Robert Wood Johnson Foundation Makes Impressive Committent to Public Health Law

 

I am just back from Austin where I was privileged to attend the "launch" meeting of the Scholars in Residence Program, one of five fellowship programs funded by the Robert Wood Johnson Foundation in order to enhance and promote public health law.  This press release  put out by the Network for Public Health Law gives more detail on the scholars (I'm proud to say I'm one of them) and our projects.  They are:

Jennifer S. Bard, Alvin R. Allison Professor of Law and Director of the Health Law Program and JD/MD program at Texas Tech University School of Law, will explore the interface between property rights and public health needs relating to nuisance and disease-spreading insects such as bed bugs and mosquitos. She will work with the City of Lubbock, Texas.    

Alex Capron, University Professor at the University of Southern California and the Scott H. Bice Chair in Healthcare Law, Policy and Ethics at the Gould School of Law, will examine federal rules on human subjects research relating to the surveillance of pathogens and viruses. He will work with the Los Angeles County Department of Public Health.

Mary Crossley, Professor of Law and former Dean at the University of Pittsburgh School of Law, will identify innovative ways in which California health officials can use their legal authority to address the growing burden of chronic diseases through interventions targeting risk behaviors and social and economic factors that impact health. She will work with the San Francisco Department of Public Health.

Sharona Hoffman, Edgar A. Hahn Professor of Law and Professor of Bioethics at Case Western Reserve University, as well as Co-Director of the Law School’s Law-Medicine Center, will develop enforcement guidance for regulation of in-home care agencies in order to improve compliance and protect the well-being of the vulnerable individuals served by these agencies. She will work with the Oregon Health Authority in Portland.

Browne Lewis, Leon & Gloria Plevin Professor of Law and Director of the Center for Health Law & Policy at Cleveland-Marshall College of Law, will focus on current state and federal preemption issues regarding local government regulation of the labeling, marketing and sale of small cigars. She will work with both the Cleveland Department of Public Health and the Shaker Heights Department of Public Health.

Polly J. Price, Professor at Law at Emory University School of Law, will address the coordination of public health agencies in providing long-term tuberculosis therapy among migrants along the U.S. border with Mexico.  She will work with public health agencies in El Paso, Texas and Las Cruces, New Mexico.

 

 

The meeting gave the six scholars, their supervisors from health departments all over the country, project leader Professor Fran Miller, RWJ liason and senior program officer Angela K. Mcgowan and consultant Nancy Kaufman and the team from the Network for Public Health Law, Judy Schector and Jackie Rose (Sara Rohde stayed behind to keep things running) a chance to meet and learn about the exciting projects and plans.

If anyone is not yet familiar with the Network for Public Health Law or their work, take a minute right now to join (its free).   This is how it describes itself: "The Network for Public Health Law provides insightful legal assistance, helpful resources and opportunities to build connections for local, tribal, state and federal officials; public health practitioners; attorneys; policy-makers; and advocate."  And indeed the assistance it provides is remarkable--it has put together a group of experts available to answer, free of charge, public health law questions.

The Network is linked with an impressive array of other RWJ funded public health law programs specifically:

• The National Policy & Legal Analysis Network to Prevent Childhood Obesity (NPLAN), a project of ChangeLab Solutions, provides leaders in the childhood obesity prevention field with educational resources and technical assistance on legal issues related to policies to improve nutrition and physical activity.
• The Northwest Center for Public Health Practice (NWCPHP) promotes excellence in public health by linking academia and the practice community, including developing training materials for public health law professionals.
• The Public Health Law Association (PHLA), a non-profit membership organization, serves as a vibrant and active community of public health law practitioners and stakeholders and provides opportunities for all members to learn and share ideas, best practices and research on public health law.
• Public Health Law Research (PHLR) builds the evidence for and increases the use of effective regulatory, legal and policy solutions to protect and improve population health and the public health system.
• Tobacco Control Legal Consortium, America’s tobacco control legal network, provides technical assistance to support public health professionals, attorneys and advocates as they develop, implement, interpret and defend tobacco control policies.

In addition to the Scholars in Residence, RWJ has already launched the the Visiting Attorney Fellows Program

There is also an active, and free of charge, students network designed to support law students interested in public health.

In the fall, a program directed by Charity Scott, Catherine C. Henson Professor of Law and center director, and
Stacie Kershner (J.D. ’08), associate director at The Georgia State College of Law's Center for Law, Health and Society will start accepting applications for "an intensive summer institute, work on course development, and create and direct
externships, clinics and other experiential-learning opportunities in public
health law. Experienced faculty mentors will guide these efforts, which will be
supplemented with connections to resources and organizations focused on public
health law in the practice setting."

Anyone with an interest in using the law to protect the public's health should be closely following the RWJ Foundation's innovative programing.

 

Guest Blogger Professor Jessie Hill - Agency for International Development v. Alliance for Open Society: Brief Thoughts and Implications

Yesterday, the Supreme Court decided AID v. Alliance of Open Society Int’l, holding that it violated the First Amendment for the government to require organizations to have an explicit policy opposing prostitution in order to receive funding under the Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003. The opinion was 6-2, with Justices Scalia and Thomas dissenting; Justice Kagan did not participate. 

The opinion strikes me as a relatively straightforward application of the unconstitutional conditions doctrine, as much as that doctrine can ever be straightforward. Following the line of cases including Rust v. Sullivan, Regan v. Taxation with Representation, and FCC v. League of Women Voters, the Court restated the principle that the government, in executing a spending program, can place viewpoint-based speech restrictions on the program in which its own funds are being used, but it cannot restrict the grantee’s activity outside the program. In the words of Chief Justice Roberts’s opinion for the majority, the government can impose “conditions that define the limits of the government spending program—those that specify the activities Congress wants to subsidize,” such as anti-prostitution advocacy and other advocacy of safe-sex practices, but it cannot impose “conditions that seek to leverage funding to regulate speech outside the contours of the program itself” – i.e., the speech activities and advocacy of organizations that is conducted on those organization’s own time and dime.

Though the principle may be straightforward, application is difficult. How do we distinguish between program-defining conditions and conditions that restrict speech outside the program? And how far is the majority willing to go with this view? As Justice Scalia’s dissent demonstrates, the anti-prostitution policy requirement could simply be seen as “nothing more than a means of selecting suitable agents to implement the Government’s chosen strategy to eradicate HIV/AIDS.” After all, if the government cannot limit its speech “agents” in this way, then is it also required to allow the Free Love Society to carry its message of abstinence, so long as the organization expresses its own, opposing, views of abstinence separately with its own funds? The majority’s opinion is insufficiently precise in response to this concern.

Now, a few brief observations about the opinion’s implications for other cases. First, I was surprised that neither the majority nor the dissent explicitly referred to the term “government speech.” The notion that the government has the right to control its own message is clearly implicated here, and the use of the “government speech doctrine” by lower courts to justify all sorts of viewpoint-discriminatory government actions has been widespread. Though the concept of government speech lurks in the AID opinions, the term does not, and I wonder whether anything is to be made of this. 

Second, I wonder what effect this case will have on state efforts to de-fund Planned Parenthood. Many states have passed or are considering laws that prohibit any entity that provides abortions services, or is affiliated with an abortion provider, from receiving family planning funds. Some such rules have been successfully challenged as preempted by Medicaid’s requirement that patients have a free choice of providers for medical services (42 U.S.C. § 1396a(a)(23)).But when only state funds are at issue, as in a recent Texas case (Planned Parenthood v. Suehs), Planned Parenthood can still argue that the denial of funds based on its affiliation with an abortion provider is an unconstitutional condition. 

Assuming that Planned Parenthood has a constitutional right either to perform abortions or affiliate with an abortion provider, does AID help it make the case that such funding restrictions unconstitutionally require them to waive such rights in return for funding? If, as in Texas, the program is set up such that Planned Parenthood cannot remain “Planned Parenthood” (indeed, it cannot even keep that name if it wants to receive funds under the Texas Program), then it seems to fall right within AID’s holding. The Texas rule, in excluding Planned Parenthood entirely based on its constitutionally protected activity, regulates the grantee and not just the program. If Planned Parenthood cannot receive funds in one entity and perform abortions even in a physically, legally, and financially separate entity, then the law “does not afford a means for the recipient [i.e., Planned Parenthood] to express its beliefs” or engage in its desired, protected activity, and it is therefore unconstitutional. 

Of course, the doctrinal lines are hazy enough here that we can’t say anything for sure. Whether AID has implications for Planned Parenthood remains to be seen.

- Jessie Hill

[KVT] 

Conditional spending for the cause of public health

The Supreme Court decided Agency for International Development v. Alliance for Open Society International yesterday, a lower-profile case about unconstitutional conditions placed on federal funding.  My initial reaction is that the opinion can be read in at least two ways.  On the surface, this decision reads like the long line of First Amendment unconstitutional conditions cases such as Rust v. Sullivan and Legal Services Corp. v. Velazquez.  Chief Justice Roberts' majority opinion held that the "Leadership Act" could offer federal funding to eradicate HIV/AIDS throughout the world, and that funding can express discouragement of prostitution by refusing to allow the funds to be used for the promotion of prostitution, but the Court held that the conditions on the funds cannot go so far as to require the organizations using the federal funds to explicitly oppose prostitution.  (Fund recipients had expressed the fear that taking an overt stance against prostitution would harm their public health efforts by scaring those in the sex trade away from their doors.)  The majority's opinion is a non-controversial read of that line of cases and even attempts to make sense of the somewhat inconsistent application of the doctrine by describing the difference between "conditions that define the limits of the government spending program" and "conditions that seek to leverage funding to regulate speech outside of the contours of the program itself."  I don't necessarily buy this distinction.  After all, conditions by necessity define the contours of a program - unless they are nongermane, which seems to underly the Chief Justice's leveraging concept but was never explicitly stated.  But, it is one way to describe the differing outcomes in this line of cases that is worth considering.

But then I come to a second possible take: this case reiterates the Roberts Court's willingness to rein in congressional exercises of the spending power.  On the heels of NFIB v. Sebelius, the spending aspect of this case is notable, given that this is the second case in two years to express disapproval of conditions on federal spending.  Unlike NFIB, which created a novel coercion doctrine without contours, this decision tread familiar ground in its conclusion that conditions on spending cannot violate First Amendment rights.  However, even during oral arguments, there were shadows of the ACA controversy from last term.  And, although NFIB was not cited in the opinion, both the majority and the dissent (authored by Justice Scalia) contained familiar language about leveraging, coercion, and offers that can't be refused.  It is unclear why Justices Scalia and Thomas would uphold this condition on federal funding when they so readily and forcefully rejected the Medicaid expansion last year.  The simplest answer is probably that these justices have long rejected the unconstitutional conditions doctrine.  (Another possibility is that the dissenting justices agree with the policy of rejecting prostitution (see Justice Scalia's bizarre "free love" comparison) but disagreed with the policy of universal health coverage.)  

While the spending power is still robust, I am not sanguine about the conversation the Court is trying to have with Congress about the Spending Clause.  It will be interesting to see how the Court furthers this project in the same-sex marriage cases that are sure to be handed down next week.  If the cases turn on the doctrine of federalism, then read in combination, the Roberts Court may be continuing its adventures in the Federalism Revolution, once thought done and gone, and now revived through the spending power.

[NH]

Beyond Medicaid--How the Affordable Care Act Will Change Mental Health Treatment--and some helpful Apps for further research

This is a helpful article from a mental health perspective about how the Affordable Care Act will change mental health treatment. 

Given the volume of material health lawyers need to review about not just law directly but also health policyFor anyone who has not yet entered the world of content aggregation, I'm also recommending Zite, a free app that will create a personalized "magazine" consisting of any specific website you visit on a regular basis and also sites within a content area that help you get the news you are looking for without having to visit dozens of individual sites.  Another similar app is Feedly and less serious (more fun) is Stumbleupon which is similar to the experience of browsing in a library.

JSB

Tax credit litigation on the move

For those of you who thought we could forget about ongoing ACA litigation, here's a little update: the issue of premium assistance through tax credits for insurance purchased in federal exchanges is alive and well.  The plaintiffs in the recently filed Halbig v. Sebelius claim that the ACA does not permit tax credits in federally run exchanges (opponents state that this is merely a statutory oversight, as I wrote in September.)  A nice summary of the ongoing litigation on this issue was published yesterday on California Health Line. 

These challenges seem to reveal the angst that the ACA is producing as the January 1, 2014 deadline creeps nearer.  They also seem to reveal the upside-down federalism occuring in the states that have rejected the state-based exchanges.  Those states have exercised their sovereign prerogative, but they are also inviting more federal power into the state, which aggrandizes federal power.  Though I don't think these cases have a strong chance of success, if the plaintiffs are successful, undoubtedly we'll see more testing of the fence by states and private litigants.

[NH]

Breaking News - Supreme Court Rules Human Genes May Not Be Patented

According to a news release by the NYT:

Human genes may not be patented, the Supreme Court ruled on Thursday. The case concerned patents held by Myriad Genetics, a Utah company, on genes that correlate with increased risk of hereditary breast and ovarian cancer. The central question for the justices in the case was whether isolated genes are “products of nature” that may not be patented or “human-made inventions” eligible for patent protection. For more, see here.

[KVT]

Guest Blogger Professor Jessie Hill - Regulating Reasons:The ACLU Challenges Arizona’s Ban on Sex- and Race-Selective Abortion (Part I)

In my earlier post on the ACLU lawsuit challenging the Arizona state law that criminalizes performing an abortion for race-selection or sex-selection, I discussed the plaintiffs’ choice to pursue an equality claim, rather than a privacy claim.  

There is also second, related issue I wanted to discuss: the plaintiffs’ standing to pursue this claim. The plaintiffs are the Maricopa County Branch of the National Association for the Advancement of Colored People (NAACP) and the National Asian Pacific American Women’s Forum (NAPAWF). Because the theory of the case, as I described in my prior post, is that the law stigmatizes and stereotypes the reproductive choices of black and Asian women based on their race and ethnicity, it makes sense that this challenge would be brought by groups that promote the interests of those racial and ethnic groups.

But what is the plaintiffs’ injury-in-fact? It seems that the stigma itself is the only possible injury that can be claimed, but this is a highly uncertain basis for standing.  It is often (though not consistently) considered to lack the concreteness and particularity that must characterize injury-in-fact under the Court’s increasingly strict standing jurisprudence.  

It is important, moreover, to note a couple of things. First, the law imposes its prohibitions and penalties only on physicians, not on women seeking race- or sex-selective abortions. Thus, though physicians are subject to the act’s penalties, they are not among the plaintiffs, and so they are not asserting third-party standing on behalf of their patients.  Second, the plaintiffs obviously do not indicate any desire to engage in race- or sex-selective practices, and the complaint specifically asserts that the NAPAWF opposes sex-selection bans but also advocates and educates around the issue of sex-selection abortion. Thus, it is clear that no one challenging the law actually seeks to engage in the conduct that is being prohibited. (For obvious reasons, such an individual would not be the most desirable plaintiff.) Nor can the plaintiffs make any argument that their injury-in-fact is that they are being chilled from making certain reproductive choices by the threat of criminal penalties, since they are not subject to such penalties under the law (and in fact are specifically exempted from criminal prosecution). 

Essentially, the injury that the plaintiffs are asserting, therefore, is purely an expressive one—that the law expresses a negative stereotype about Asian and black women. Of course, they may also be claiming that their reproductive choices are more likely to be questioned by their physicians—a point that would support the disparate impact required in order to make out an Equal Protection claim. But this harm, too, is probably too speculative to work for standing purposes.   

One might claim that the real injury is that the law prohibits women from choosing abortion for whatever reason they believe is appropriate—that it infringes on their reproductive autonomy in the most basic sense. But again, this is a claim that sounds in the right to privacy, not the right to equal protection. The law on its face regulates reasons for all women, not just minority women.  

In conclusion, though this is an important and worthy challenge to the law, I suspect it will be an uphill battle.

- Jessie Hill

[KVT]

 

 

In Reversal, Obama to End Effort to Restrict Morning-After Pill

The New York Times reports that

[t]he Obama administration has decided to stop trying to block over-the-counter availability of the most popular morning-after contraceptive pill for all women and girls, a move fraught with political repercussions for President Obama.

The reversal by the government means that anyone, no matter how young, will soon be able to walk into a drugstore and buy the pill, Plan B One-Step, without a prescription.

The Justice Department had been fighting to prevent that outcome, but said late Monday afternoon that it would drop its appeal of a judge’s order to make the drug more widely available. In a letter to Judge Edward R. Korman of the United States District Court for the Eastern District of New York, the administration said it would comply with his demands that the Food and Drug Administration be allowed to certify the drug for nonprescription use.

[KVT]

Looking Ahead to the Supreme Court's Remaining Health Law Related Cases

 Although it's probably true that with some imagination every Supreme Court decision could be related back to some aspect of Health Law, today's Post (which, yes, was supposed to be up Friday) is intended to highlight the as yet unreleased Supreme Court decisions of particular interest to Health Law.  We don't know exactly which cases will be announced but Scotus believes this will
happen on Thursday June 13th--and they will be "live-blogging" starting "shortly before" 10 AM EST in anticipation of the announcements-- but we do know which ones are left.

Below is an email I sent out today to both our Health Law Certificate Students here at Texas Tech School of Law and to the students enrolled in my new class Constitutional Issues in Health Law.  As a side note, I would certainly be interested in hearing from anyone who is/has taught this particular class.  My model for it is the one taught by Mary Anne Bobinski when she was at the University of Houston Law Center. 

Here, in relevant part, is what I sent out:

" Unlike last year where everyone was a health care lawyer and had something to say about National Federation of Independent Business v. Sebelius (the Affordable Care Act decision) (me included), the cases yet to be decided are not all waving the banner "Health Law"--but are likely to have significant impact in the practice of health law.    There are so many sources of information about these cases and what they mean that it would almost be impossible to give a complete list. 

Each decision will be posted almost immediately to the Supreme Court's website--and what I recommend is that you read it yourself--and then compare it to the press coverage!  CNN will long remember this episode and Jon Stewart's take on it!

Also, it is never possible to avoid the "spin" that anyone describing an issue inevitably puts on it.  I've included information when  an organization or media outlet has created clarifying material but at this point.  Here's an NPR Overview and one from Fox News.

 Here are the cases (with parentheticals from Scotus): 

Association for Molecular Pathology v. Myriad Genetics Inc.("whether human genes are patentable")

Agency for International development v. Alliance for Open

Society;

("Whether the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of

2003, 22 U.S.C. § 7631(f), which requires an organization to have a policy explicitly

opposing prostitution and sex trafficking in order to receive federal funding to provide HIV

and AIDS programs overseas, violates the First Amendment. (Kagan, J., recused.)")

  Mutual Pharmaceutical Co. V. Bartlett 

("Whether the First Circuit Court of Appeals erred when it created a circuit split and held – in

clear conflict with this Court’s decisions in PLIVA v. Mensing, Riegel v. Medtronic, and

Cipollone v. Liggett Group – that federal law does not preempt state law design-defect

claims targeting generic pharmaceutical products because the conceded conflict between

such claims and the federal laws governing generic pharmaceutical design allegedly can be

avoided if the makers of generic pharmaceuticals simply stop making their products.")

 The press is most interested in Hollingsworth v. Perry “gay marriage” and  Fisher v. University of Texas (“affirmativeaction” )cases—and we should be interested too.  In Hollingsworth because it is possible (although not certain) that the court will add to our understanding of the Constitutionality of statutes (like the one in Texas) which only allow a married couple consisting of a man and a woman to enter into a binding contract with a surrogate mother.  It may also change the ability of physicians in states to refuse to treat patients on the basis of sexual orientation, gender identity or any other factor not currently required by Federal Law or a previous decision of the Supreme Court.  LAMBDA Legal has put together an infographic for those wanting to get up to speed quickly. 

And in Fisher because it may well affect medical school admissions even though it is a case about undergraduates.

 

There are also some cases involving important employment law  issues—which are often the biggest part of a health lawyer’s case load.

You may not want to be poised at your computer 10 AM Thursday EST to hear what decisions the court is releasing—but you will certainly want to read them for yourself when they are available online.

JSB

 

Guest Blogger Professor Jessie Hill - Regulating Reasons:The ACLU Challenges Arizona’s Ban on Sex- and Race-Selective Abortion (Part I)

As a long-time lurker on the HealthLawProf Blog, I want to thank Katharine Van Tassel for inviting me to guest blog during the month of June. My scholarship and primary interest are at the intersection of health law and constitutional law, especially reproductive rights, which will be the subject of my posts this month.  

In this first post I’d like to explore the recent ACLU lawsuit challenging the Arizona state law that, among other things, prohibits anyone from providing an abortion “knowing that the abortion is sought based on the sex or race of the child or the race of a parent of that child.” The complaint is available here.  

Styled the “Susan B. Anthony and Frederick Douglass Prenatal Nondiscrimination Act of 2011,” the law seems to be premised on rather bizarre and racist notions.  According to the complaint, the law was motivated by legislators’ beliefs that 1) the disproportionately high abortion rate among black women indicates that these women are intentionally de-selecting fetuses of their own race, possibly as a partial result of a plot by some abortion providers to eliminate African-Americans; and 2) sex-selective abortion is going to be a problem in Arizona simply due to the fact that the state has a growing Asian population, who are assumed to engage in the practice of de-selecting female fetuses through abortion. I haven’t ersonally reviewed the legislative history, but some of the quotes contained in the complaint are, frankly, shocking.  

These sorts of laws raise all kinds of interesting issues, but I’d like to focus on two particularly interesting aspects of the complaint itself – one in this post and one in my next post.  

First, it is notable that this law is challenged as a violation of the Equal Protection Clause, not the substantive due process right to privacy. The equal protection theory is that the law stigmatizes black and Asian women as either intentionally engaging in a form of gender and race genocide (against members of their own race and gender, no less). It is based on stereotypes and assumptions about members of particular races that are wholly unfounded. Therefore, it has a discriminatory purpose. It also has a discriminatory impact in that its effect will be to single out the abortion choices of black and Asian women for particular scrutiny.  

This argument strikes me as fairly strong. Surely, there is a racial motivation behind this law, and it is hard to imagine that the legislature meant to raise doubts about the reproductive choices of white women in the same way. But it seems to me that there could be a privacy challenge to the law as well: the law regulates the subjective, personal reasons why a woman may choose abortion, which seems to fly in the face of the very notion of a right to “privacy.” Such a regulation is, to my knowledge, unprecedented since Roe v. Wade. Though this proposition has never been explicitly articulated by the Supreme Court, it seems to me that if the right to privacy in reproductive decision-making means anything, it means that individuals have the right to make those choices for whatever reason they deem appropriate, without government oversight or approval.  

Or does it? Human rights advocates decry the practice of sex-selective abortion in other countries, and my understanding is that India’s ban on the practice is not generally considered controversial among feminists. Why, then, does the ban seem particularly troubling and off-key in the American context? Is it simply because there is no reason to think that the practice is widespread here? Or because our constitutional jurisprudence and popular discourse place abortion in a “privacy” framework, rather than an “equality” framework? In any case, I can’t help but wonder whether the philosophical difficulties that opposition to a sex-selective abortion ban might create for feminist lawyers is the reason why the ACLU attorneys chose to frame the complaint as they did.

- Jessie Hill

[KVT]

A Ruling from the 5th Circuit: Pregnancy and Breastfeeding ARE Related

A case from the employment discrimination world that might be of interest to health law folks is EEOC v. Houston Funding II, Ltd., 2013 U.S. App. LEXIS 10933 (May 30, 2013).  The employee in the case, Donnicia Venters, was told that her position had been filled when she returned to work post partum and requested to use space in a back room to express milk.  The issue in the case was whether firing Venters for expressing breast milk is sex discrimination under Title VII of the Civil Rights Act.  The district court had concluded that it was not, as a matter of law, and the 5^th Circuit reversed.  Although at first glance this outcome is apparently a favorable one for women and children, it also reveals ongoing mismatches between anti-discrimination law in the US and the health needs of workers and their families.

The relevant detail of employment discrimination law is that the Pregnancy Discrimination Act (PDA) provides that discrimination “on the basis of” or “because of” sex includes discrimination on the basis of or because of “pregnancy, childbirth, or related medical conditions.” In holding that breastfeeding is a related medical condition of pregnancy, the 5^th Circuit stated “Lactation is the physiological process of secreting milk from mammary glands and is directly caused by hormonal changes associated with pregnancy and childbirth.”  Thus, on the 5^th Circuit’s plain meaning interpretation of the statute, breastfeeding is within the PDA.

Other courts have reached conclusions less favorable to breastfeeding.  The district court in Colorado wrote thus in deciding that a refusal to give breaks for breast feeding was not sex or disability discrimination:  “A plaintiff could potentially succeed on a claim if she alleged and was able to prove that lactation was a medical condition related to pregnancy, and that this condition, and not a desire to breastfeed, was the reason for the discriminatory action(s) that she suffered.” Falk v. City of Glendale, 2012 U.S. Dist. LEXIS 87278 (D. Colo. 2012).  Indeed, understaffing at the Glendale police department was so severe that no one was able to take breaks, even to use the restroom—so the court concluded that Falk’s problem was equal opportunity bad working conditions, not sex discrimination.

The 5^th Circuit reads these cases as refusals to grant accommodations under Title VII or the ADA, and thus distinguishes them.  In her concurrence, Judge Edith Jones specifically calls out the court’s understanding that accommodations are not available for breastfeeding—and indicates as well that permitting accommodations might be problematically unlimited:  “Indeed, if providing a plaintiff with special accommodation to pump breast milk at work were required, one wonders whether a plaintiff could be denied bringing her baby to the office to breastfeed during the workday.”  (I can’t resist commenting that a pump and a bottle of milk are hardly the disturbance that a crying baby on site might be.)  The PDA prohibits differential treatment on the basis of sex but does not require any accommodations for pregnancy or lactation:  Venters won not because she asked for time to express milk but because her employer disapproved of her breastfeeding.  The Americans with Disabilities Act might be a different story as it is discrimination to fail to provide reasonable accommodations for qualified persons with disabilities—but for the fact that many courts have ruled that normal pregnancy and birth are not disabilities.

The American Academy of Pediatrics recommends breastfeeding as the exclusive source of infant nutrition for the first six months.  Healthy People 2020 targets are 60.5% breastfeeding for 6 months, 23.7 exclusive breastfeeding for 6 months, and 38% workplace support for lactation. Failure to breastfeed is associated with higher rates of hospitalization for respiratory illness, higher rates of otitis media, higher rates of gastrointestinal disease, higher rates of obesity and diabetes, and many other health problems.

The Family Medical Leave Act requires up to three months of unpaid leave for covered workers.  Women who try to return to work after exhausting their FMLA leave and who find themselves with unaccommodating workplaces may thus face a very unpleasant choice:  drop out of the work force (or be fired like Venters or Falk) or risk the health of their children.  US anti-discrimination law is of little help to them, all too often regarding breastfeeding as a “lifestyle” rather than a health issue.

[LPF]

 

Introducing Guest Blogger Professor Jessie Hill

HealthLawProf Blog is honored to introduce Professor Jessie Hill, BA 1992 (Brown), JD 1999 (Harvard), as our guest blogger for the month of June. Professor Hill is the Associate Dean for Faculty Development and Research and the Laura B. Chisolm Distinguished Research Scholar at Case Western Reserve School of Law. Here is her short bio:   

Ms. Hill joined the faculty in 2003 after practicing First Amendment and civil rights law with the firm of Berkman, Gordon, Murray & DeVan in Cleveland. Before entering private practice, Ms. Hill worked at the Reproductive Freedom Project of the national ACLU office in New York, litigating challenges to state-law restrictions on reproductive rights. She also served as law clerk to the Honorable Karen Nelson Moore of the United States Court of Appeals for the Sixth Circuit. Ms. Hill's teaching focuses on constitutional law, federal civil procedure, civil rights, reproductive rights, and law and religion. Her scholarship has been published in the Michigan Law Review and the Texas Law Review, among others.

 

[KVT]

Guest Bloggers Mary Ann Chirba and Alice A. Noble - Our Bodies, Our Cells: FDA Regulation of Autologous Adult Stem Cell Therapies

Stem cells have been an endless source of fascination and controversy since Dolly the sheep was cloned in 1996. This month’s announcement of a cloned human embryo from a single skin cell [1] came on the heels of Sir John B. Gurdon and Dr. Shinya Yamanaka’s receipt of the 2012 Nobel for Physiology and Medicine for their work with induced pluripotent stem cells. Pluripotent stem cells can be embryonic or induced. Embryonic stem cells (ESCs) can generally be obtained from human embryos or by cloning embryos through somatic cell nuclear transfer (SCNT), as was done for Dolly.  Gurdon and Yamanaka demonstrated that pluripotent cells may also be formed by reprogramming adult cells to an embryonic state, resulting in induced pluripotent stem (iPS) cells without having to use eggs or cloning, or destroy embryos. However derived, pluripotent cells are capable of differentiating into virtually any cell type in the human body. This imbues them with great promise for scientific breakthroughs and medical advances, but also raises serious ethical, legal and safety concerns about their use.

Less controversial are “multipotent” adult stem cells (ASCs) which do not involve embryos or raise as many safety concerns as pluripotent cells.  ASCs are found throughout the body.  Their ability to differentiate is more limited than pluripotent cells but is vast nonetheless. The NIH’s clinicaltrials.gov site lists some 4500 ASC trials as compared with 27 for embryonic stem cells and 21 for induced pluripotent stem cells. Recent announcements of new stem cell treatments usually involve ASCs, such as last month’s news that a toddler born without a trachea received a new one made from her own adult stem cells.  It is therefore no surprise that ASCs have captured the attention of researchers, investors, physicians, patients and – increasingly – regulators, both here and abroad. 

A growing number of physicians routinely offer treatments involving ASCs to their patients which can be performed in their offices.  Autologous adult stem cells, used to treat a variety of conditions, are harvested from the patient, processed, and returned to the same patient. It is no surprise that moving ASCs from laboratories to physician offices raises complex questions of law. We consider one of the more pressing ones: to what extent can the FDA regulate a physician’s ability to treat a patient with that patient’s own stem cells?  In the coming months, the D.C. Circuit Court of Appeals will hear oral arguments on this very issue in United States v. Regenerative Sciences.[2]

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