Please join us for a brown bag talk with Professor Paola Bergallo, Faculty of Law, Universidad de San Andrés, Buenos Aires, and HRP Visiting Fellow. Bergallo served as an expert witness in the landmark case Artavia Murillo et al. (“In Vitro Fertilization”) v. Costa Rica, which discusses human rights definitions regarding the right to life, among other health and human rights matters. Professor Gerald Neuman of Harvard Law School will moderate.
This event is being co-sponsored by Harvard Law Students for Reproductive Justice and HLS Advocates for Human Rights.
Those who deal in alternative ways of making families use euphemisms that obscure the market mechanisms at work when individuals ‘‘donate’’ their eggs or sperm, couples ‘‘contribute’’ their embryos, surrogates ‘‘offer’’ their wombs, and orphans are ‘‘matched’’ to adoptive parents. Make no mistake, family formation is big business. The question of first impression before a San Diego Tax Court judge is whether that business is taxable.
Nichelle Perez, like almost 17,000 other women every year in the U.S. alone, received payment (in her case $20,000) for providing her eggs to the infertile through an invasive and risky process of ‘‘superovulation.’’ When the IRS sought to tax that payment as business earnings from self-employment, Perez objected that it ought to be exempted, lest she ‘‘be penalized for doing something good for another person.”
Should the sale of eggs that have grown inside a woman’s body be taxed like property that’s subject to a long-term capital gain? Or does the pain and suffering that the transaction involves make it more like a settlement from a personal-injury lawsuit? Does the answer turn on the legal (or moral) status of human eggs? Or on whether the conditions under which a woman agrees to their extraction are meaningfully ‘‘voluntary’’?
I have previously blogged about an important case — Halbig v. Sebelius — before the U.S. District Court for the District of Columbia (DDC). The case concerned whether the Affordable Care Act permits the IRS to issue tax credits to individuals purchasing insurance through federally facilitated exchanges. In short, the challengers argued that because section 1401 of the ACA calculates tax credits only for individuals purchasing insurance through “an Exchange established by the State,” individuals purchasing insurance through an exchange established by the federal government cannot receive such tax credits.
Yesterday, DDC sharply rejected this argument, finding that the ACA — read as a coherent whole – requires the IRS to issue tax credits to individuals purchasing insurance through either a state or a federal exchange. Needless to say, this case represents a triumph for the government. For now (cases on the same issue are still pending in other districts, and this opinion will almost certainly be appealed to the D.C. Circuit), the government has dodged today’s biggest threat to the vitality of the ACA.
The substance of the case was summarized well by Professor Bagley over at the Incidental Economist. So rather than dwell on the (very persuasive) reasoning of the court, I want to focus on one important doctrinal move in the case (after the jump):
Art Caplan has published a new op-ed piece in the LA Times addressing the case of Marlise Munoz, the brain-dead, pregnant Texas woman from whom doctors are refusing to withdraw “life-sustaining treatment” despite her family’s wishes. The hospital where Munoz argues that it cannot withdraw such treatment because of a Texas law forbidding the removal of such treatments from a pregnant patient. Caplan argues:
Given the clarity of this statutory language, it is hardly surprising courts have determined it inapplicable after a determination of death. For example, in a similar case in Houston, a Texas court ordered a hospital to continue treatment for a comatose Tammy Martin, who was then 15 weeks pregnant. But the court reversed the order, a few weeks later, once Martin had been declared dead.
Not only does the Texas law not apply, it is almost certainly unconstitutional. Continue reading →
Here’s her abstract (posted a few weeks ago before cert was granted):
As of November 2013, over 60 lawsuits have been filed under the First Amendment and the Religious Freedom Restoration Act (“RFRA”), challenging the contraceptive coverage requirement (“CCR”) of The Patient Protection and Affordable Care Act, more than half brought by for-profit employers with religious objections to providing insurance coverage for contraception. The conflict combines questions of the reach of the regulatory state, the nature and purpose of free exercise rights, women’s social and economic equality, and a lightning-rod political debate. No wonder then that these cases have produced a circuit split, and are now primed for a Supreme Court ruling, as two cert petitions in these cases were filed in September 2013. It is no surprise that these cases have produced such divergent results, because the problem lies not with the courts, but with the doctrine, which frames the conflict as being between the State and the religious objector. But as the CCR cases make clear, this relationship is often beside the point entirely. Rather, some religious accommodation cases regulate not only the relationship between the State and the objector, but a variety of conflicts and relationships between the religious objectors and various other rights-holders. The courts and the scholarship have occasionally noticed that such conflicts may exist but have not suggested any systematic way of thinking about or resolving them. To remedy this lacuna, I propose a framework for identifying and analyzing these under-theorized conflicts, elaborating on strands of concern for third parties in the doctrine that have never been fully fleshed out. I argue that once we identify the set of cases in which there are sufficiently weighty third-party interests at stake – whether practical or expressive – to merit deviation from the standard doctrinal framework, the question should be whether the State can provide a solution that respects all the rights in question. If so, it should have an obligation to do so. If not, the group with equality-implicating rights (again, whether practical or expressive) should “win” – with any “tie” going to the third parties, because the purpose of religious accommodation law is to protect the equality of religious objectors, not to privilege religion. The CCR suits present a paradigmatic example in which the State’s most important interest lies in its representation of the rights of third parties, and in which comprehensive solutions respecting all parties’ rights are possible but not doctrinally required, thus providing a clear illustration of why the framework I suggest would be an improvement in religious accommodation law. Nevertheless, there are also ways to better balance the interests involved through use of the existing doctrine, as the last part of this paper demonstrates.
The November 2013 issue of the Yale Law Journal features a very interesting comment on an important issue at the intersection of health law and policy. A First Amendment Approach to Generic Drug Manufacturing, by Connor Sullivan, argues that the First Amendment principles underlying the Supreme Court’s opinion in Sorrell v. IMS Health Inc. provide a viable legal avenue for challenging the FDA regulations that prevent generic drug manufacturers from sending letters warning physicians of the risks of their drugs.
These FDA regulations became a source of legal controversy when the Supreme Court heard PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), a case concerning whether the FDA’s requirement that generic drug manufacturers use the same labels as brand name manufacturers preempts state tort laws that allow injured parties to challenge the sufficiency of a generic manufacturer’s warnings. The Court held that the FDA requirements did pre-empt state tort law on the theory that a generic drug manufacturer could not comply with both the FDA labeling requirements and state tort law at the same time because state tort law might require different, greater warnings than the brand name manufacturer of that same drug used. The Court noted the unfortunate inconsistency that had befallen the plaintiffs in the case; had they taken the brand name drug, they could challenge the labeling requirements of the brand name manufacturer, which has the flexibility under federal law to change their labeling scheme. But because the plaintiffs took the generic version of the same drug, their suit was foreclosed.
We might intuitively assume that these plaintiffs could simply sue the brand name manufacturer; after all, it is their poor labeling scheme that the plaintiffs were challenging by noting the deficiencies in the generic manufacturer’s similar label. But the law is not so wise. After many attempts and subsequent failures to convince a court of such an argument, the law has virtually foreclosed any mechanism for an injured party to recover from a brand name manufacturer for the labeling deficiencies that are passed onto a generic manufacturer. Indeed, Sullivan cites to Gardley-Starks v. Pfizer, Inc., 917 F. Supp. 2d 597, 604 n.4 (N.D. Miss. 2013), which noted that “sixty-six decisions applying the law of twenty-three different jurisdictions [have held] that brand name manufacturers of a drug may not be held liable under any theory for injuries caused by the use of a generic manufacturer’s product.”
In sum, the combination of FDA rules and a Supreme Court pre-emption decision has created a real inconsistency in how people experience the tort laws as applied to their drug manufacturers. After the jump, I’ll explain Sullivan’s idea for solving this problem.
International trends in gamete donor identifiability v. anonymity – I. Glenn Cohen, Professor of Law, Harvard Law School; Faculty co-Director, Petrie-Flom Center
The politics of evidence and expertise in domestic and international abortion litigation – Aziza Ahmed, Associate Professor of Law, Northeastern University School of Law; Visiting Scholar, Petrie-Flom Center (Spring 2014)
Use of international fora, including courts and treaty bodies, to advance reproductive rights – Mindy Jane Roseman, Lecturer on Law, Harvard Law School; Academic Director, Human Rights Program
More than one year has passed since the Supreme Court decided NFIB v. Sebelius, the major case concerning the constitutionality of the individual mandate and Medicaid expansion. As you might remember, the Supreme Court upheld the individual mandate as a valid exercise of Congress’s taxing power, but Chief Justice Roberts and the four Justices in the joint dissent wrote that Congress did not have the power under the Commerce Clause to compel individuals to enter the health insurance market. Importantly, the Court drew a distinction between activity and inactivity, finding that Congress could not regulate the latter. Some argued that this decision may have wide implications for other regulatory efforts by Congress.
Unsurprisingly, it did not take long for litigants to begin using the Court’s Commerce Clause analysis in an attempt to invalidate other federal statutes. I undertook a review of federal circuit cases that have applied (not merely cited) NFIB‘s Commerce Clause analysis to determine how these litigants have fared. After the jump, I have categorized the cases I found into those discussing the validity of criminal statutes and those discussing the validity of federal regulations on states (please let me know in the comments section if I missed some). The main takeaway from my review is that, as of today, no circuit court has used NFIB as its justification for striking down a statute under the Commerce Clause.
But before I get there, I should note from the outset that it is not clear whether the Court’s “decision” on the Commerce Clause is binding on future courts. David Post at the Volokh Conspiracy has a rather compelling take on why the Court did not need to reach the Commerce Clause issue, and thus that portion of the decision should be viewed as mere dicta. Of course, Chief Justice Roberts insisted that the Commerce Clause portion of his opinion was necessary because that the most natural read of the statute did not lend itself to review under the Taxing Power, and only after deciding the Commerce Clause issue was he willing to construe the statute otherwise. Post responds to that argument here. On my review of the federal circuit cases, no circuit has actually reached the merits of this issue (although at least a couple of these courts have mentioned the issue without deciding it, and one court — the Ninth Circuit in United States v. Henry — even cited to David Post’s second article cited above). I intend to take a broader look at the district court cases to determine whether a federal court has addressed this issue; I’ll have that post for you all in the near future.
In a new piece at the Huffington Post, Bill of Health Contributor Dov Fox explores “The Forgotten Holding of Roe v. Wade“ — that states have a valid reason to regulate reproductive conduct because of an interest in “potential life.”
That “the State may [legitimately] assert” that interest, Roe held, “as long as at leastpotential life is involved,” explains why the government may, as a constitutional matter, restrict stem cell research that destroys human embryos, for example, whether or not those frozen embryos might otherwise be brought to term. That the fetus “represents only thepotentiality of life,” on the other hand, and accordingly lacks any interests of its own under the Constitution, explains why states may not, as many have tried, accord the legal status of personhood to human life beginning at conception.
The potential-life holding helps to resolve these and many other disputes over embryo contracts, fetal pain, and sex selection, for example, as I show in a forthcoming article. Arecent lawsuit exemplifies the enduring significance of Roe‘s potential-life holding. The case marks the first-ever federal challenge to fetal protection laws that punish women for using drugs during pregnancy.
The Gilardi v. HHS decision is out today (on scribd), blocking the PPACA contraception mandate for the plaintiffs. Two brothers own Freshway Foods and a related company that offer a self-insured health plan to their 400 employees. For non-grandfathered plans with an annual enrollment period starting on or after September 23, 2010, PPACA required zero deductibles and cost sharing for a package of preventative services. One component of that package includes FDA-approved contraception. The Gilardi brothers claimed this requirement violates the Religious Freedom Restoration Act (RFFA). A majority of the Court agreed, sending the case back to the District Court for a reconsideration of the injunction.
This case raises an interesting point about pluralism in our society. When do we get to abstain from generally-applicable laws that violate our moral beliefs? Even more attenuated, when do we get to opt out because other people’s actions violate our beliefs? Can the Freshway companies decide to drop hospice care for their employees as violating their Catholic beliefs? Could a Muslim employer prevent employees from bringing home the bacon with their paychecks? Could a Baptist employer fire employees for watching porn at home on HBO?
A little over two weeks ago, the Supreme Court heard oral argument in a rather obscure ERISA case—Heimsehoff v. Hartford Life & Accident Ins. Co. The case asks a rather basic question without a readily apparent answer: when a beneficiary of an ERISA-regulated insurance plan seeks to claim benefits, may the statute of limitations period for judicial review of the benefit decision begin before the completion of the plan’s mandatory internal resolution process? In other words, can a statute of limitations for judicial review begin to run before a beneficiary is permitted to file suit?
The problem this lawsuit seeks to address can be clarified through a hypothetical: Imagine beneficiary B has an ERISA-regulated disability insurance plan with (i.e. provided by her employer but issued and administered by) insurer I. B’s contract with I states that a three-year statute of limitations for judicial review of benefit decisions begins running at the date that B sends I proof of loss. Then the following takes place:
B sends I her proof of loss on January 1, 2010.
I’s internal resolution process is completed on January 2, 2013, and B is denied her claim.
B believes the decision was erroneous and seeks to challenge it in court.
The court informs B that she has no claim because the statute of limitations—three years from January 1, 2010, the date that B sent I her proof of loss—has run.
B’s case certainly seems rather compelling. After all, I has functionally denied B any opportunity to receive independent review of I’s benefit decision. But at oral argument, the Justices raised several interesting arguments that make the outcome of this case far from clear.
On April 3, 2013, the First Circuit issued decisions in three cases in which third-party payers sought compensation from Pfizer for damages sustained as a result of fraudulent pharmaceutical promotion. The decisions were noteworthy because in them the First Circuit lent its imprimatur to a causal chain of injury running from a pharmaceutical company’s fraudulent promotion, through the prescribing decisions of thousands of individual physicians, to the prescriptions for which a third-party payer paid. In the lead case, brought by Kaiser Foundation Health Plan and Kaiser Foundation Hospitals, the appellate court upheld a jury verdict that, after trebling, came to $142 million.
Not surprisingly, Pfizer has petitioned for certiorari, arguing that the First Circuit’s decisions “warrant review because they…raise important and recurring questions concerning the proper test for proximate cause under RICO and the permissibility of aggregate statistical proof in collective fraud cases.” Amici briefs filed by BIO, PhRMA, and the Washington Legal Foundation echo these arguments, leaning heavily on the spectre of a “staggering” increase in suits founded on “pharmaceutical companies’ alleged off-label promotion.” In addition to the financial burden posed by the “likely surge”, amici argue that it would chill their “truthful and constitutionally protected speech concerning beneficial off-label uses of FDA-approved drugs.”
Civil RICO claims cannot be predicated on “off-label promotion”, however. To state a claim, a plaintiff has to allege that the defendant pharmaceutical company engaged in one of the predicate acts enumerated in the RICO statute, typically mail or wire fraud. In this case, the jury found that Pfizer promoted the anti-seizure drug Neurontin as a safe and effective treatment for indications for which Pfizer knew it was no more effective than a placebo. On appeal, Pfizer did not contest the jury’s finding that it committed fraud. This distinguishes this case from those decided by other circuits and suggests that the First Circuit’s decisions may not open the floodgates quite as wide as Pfizer and its amici claim.
There is also reason to question the claim that the First Circuit adopted a new, more “relaxed” standard of causation in the case. Continue reading →
Perspectives on Abortion, Assisted Reproductive Technologies,
and Judicial Review
Abortion and reproductive technologies have historically occupied separate realms in law, policy, and academia. In spite of some obvious and natural overlap, scholarship exploring the relationship between abortion and assisted reproduction is sparse. In 2014, Judith Daar (Whittier Law School) and Kimberly Mutcherson (Rutgers Law-Camden) will co-guest edit an issue of the Journal of Law, Medicine & Ethics devoted to articles reflecting on this relationship. JLME is a peer-reviewed journal published by the American Society of Law, Medicine & Ethics.
The guest editors are open to a wide range of scholarship from authors steeped in various aspects of reproductive justice, reproductive rights and reproductive technologies who can explore the future of assisted reproduction and abortion as matters of scholarly concern and legal regulation, especially when viewed as part of a larger movement for reproductive rights and reproductive justice. The term reproductive technologies should be interpreted broadly in this context to go beyond IVF and include a range of techniques used in conjunction with assisted methods of conception.
Questions papers might choose to tackle include, but are in no way limited to:
A sound scheme of public regulation seeks to find the best way to align the incentives of public regulators with the interests of the public at large. That task has proven to be particularly acute with the U.S. Food and Drug Administration, which possesses vast powers to regulate the manufacture and distribution of drugs and medical devices in the United States, which it all too often overuses.
That case examined the line between the regulation of pharmaceutical products on the one hand and the practice of medicine on the other. It is well established that the FDA has power over the former, but lacks power over the latter. That distinction is of no small consequence because it allows, for example, for the rise of an extensive market in “off-label use” by physicians of drugs for purposes for which they have not received FDA approval. This class of drug use is very large, and in cancer cases is thought to be more common than treatment using FDA-approved products.
The persistence of off-label drug use should caution people about allowing the FDA to exert extensive control over the drug licensing process. It could be that the thousands of physicians, hospitals, and patients that use drugs off-label have, time after time, all made some major mistake. Or it could just be possible that the accumulated level of institutional knowledge post-release demonstrates that the FDA has been too restrictive in its decisions as to whether a new drug should be allowed into the marketplace in the first instance. The FDA is heavily incentivized to be tough in its approval process lest it take heavy criticism for the all-too-visible injuries that may be caused by approved drugs. But in the social calculus, the individual losses that occur to people who are denied treatment by the heavy-handed actions of the FDA count every bit as much. Yet these diffuse losses, often undocumented, bring much less heat to the FDA, which accordingly is prepared to shrug them off as a cost of supplying people the “protection” that is so central to the FDA mandate.