Author Archives: glenncohen

Sex, People with Disabilities, Prostitution, and Universal Health Care: Reflections on “The Sessions”

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[Cross-Posted at PrawsBlawg)

One of my favorite initiatives at Harvard Law School, where I teach, is that faculty members get to offer an optional 10-12 student not-for-credit “First-Year Reading Groups” on a topic of interest to them that is related to law in some way but not too law-class like. I’ve taught a reading group on bioethics and law through film that pairs films with papers/topics in bioethics (e.g., A.I. with readings on personhood, Minority Report and neuroscience and law and predicting criminality, Dirty Pretty Things and organ sale and exploitation, The Constant Gardener with clinical trials in the developing world, Eternal Sunshine for the Spotless Mind and therapeutic forgetting and “cosmetic neurology” and many others…)

Next year I will add The Sessions, a film I found very enjoyable starring John Hawkes, Helen Hunt, and William H. Macy from last year that I also found very bioethically interesting. The film is based on a true story and follows Mark O’Brien, a poet who lives in an Iron Lung due to complications from Polio. After unsuccessfully proposing to his caretaker, and believing the end of his life may be nearing, he decides he wants to lose his virginity. He hires Cheryl Cohen-Greene, a professional sex surrogate, who will offer him a maximum of six sessions but makes clear to him this is therapy not romance. I will stop there to avoid ruining the film, but on to the bioethics…

There are fairly clear issues raised about commodification, exploitation, the difference between sex therapy and prostitution, that I have written about in various forms in various places. These are certainly interesting issues but familiar enough. What the film newly prompted me to think about, though, is actually universal health care. In particular, as I have written about indirectly in a couple of papers, what would some of the most prominent theories explaining why we need universal health care say about whether the state should pay for sex therapy (or perhaps even prostitution) for people with disabilities like Mark who find themselves otherwise unable to have sex?

For example, in his wonderful book Just Health, my colleague Norman Daniels, coming from a more Rawlsian tradition (i.e., a liberal tradition focused on promoting liberty and distributive justice through giving priority to the worst-off), grounds the state’s role in promoting health in the obligation, as a matter of political justice, to ensure access to the “normal opportunity range” to pursue the “array of life plans reasonable persons are likely to develop for themselves.” Although Daniels’ focus is on health care, it seems to me that sexual satisfaction is also part of that normal opportunity range and part of a life plan most of us would like to pursue.

Similarly, Martha Nussbaum in her great book Frontiers of Justice, writing from a more aretaic (i.e., Aristotelian, focusing on character and virtue) perspective, has argued that the state’s role is to enable human flourishing by raising people above the threshold level on a number of “capabilities.” Among these she mentions “bodily integrity,” as including “having opportunities for sexual satisfaction and for choice in matters of reproduction.” I have previously discussed how this kind of approach may justify funding reproductive technologies, but it seems to me as though it also fairly directly establishes an argument for funding Mark’s attempts to lose his virginity.

Now this is meant to be provocative, of course. And for some this is no doubt a reductio ad absurdum against universal health care. Fair enough. But for those who believe there is a moral case for funding universal health care, does the argument also lead to funding these kinds of sex therapies? Health is important, of course, but let’s be frank (and my parents can stop reading at this point) so is sexual satisfaction, and both seem to me essential parts of the normal opportunity range and/or human flourishing.

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Live Blogging from FDA in the 21st Century Conference, Panel 8: Food, Supplement, and Tobacco Regulation

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[Live blogging off-the-cuff, so apologies in advance for any errors in summarizing, typos, etc]

Moderated by Emily Broad Leib, Harvard Law School

Robin Craig, Leslie Francis, and Erika George, University of Utah The FDA’s Authority Over Labeling: Current Ironies and Future Improvements:

Goal is to look at FDA authority over safety and labeling of Genetically Modified (GM) foods argue that FDA should do more, and argue for human right to food approach.

By GM we mean rDNA modification not husbandry and not careful selection.

FDA has moved to use guidance and policy. In particular two are relevant here. First, in food additives there is GRAS – Generally Recognized as Safe. E.g., Cinnamon was treated as GRAS. Manufacturers can self-determine a product is GRAS without notifying FDA, or, if in doubt, request a GRAS notice letter from FDA. This was proposed in 1997 and final review never issued, but this is how they do it. Has increased frequency of GRAS review request from FDA. But the process is voluntary and relies entirely on info from producer not scientific separate work by FDA.

In 1992, FDA issued a policy document related to GM foods. Stated no scientific evidence that GM foods have more safety concerns than existing husbandry techniques, so GM technology is NOT material information. This was NOT a conclusion that GM foods were GRAS.

In 1996, FDA issued a guidance for GM foods. Consultation process to determine whether there are material differences between GM version and non, voluntary process, encouraged to get consumer trust. Like GRAS totally voluntary, totally reliant on FDA data. 95 reported consultations between 1996 and 2012.

Alliance for Biointegrity v. Shalala, challenged in 2000 in D.D.C., court deferred to agency on safety questions and whether the info on GM was “material” and therefore needs to be disclosed.

Where would FDA get authority to regulate GM foods? May pose allergy risks? May be relevant to nutrition or quality. Maybe an additive not GRAS. But each of these arguments apply to specific GM food not GM foods as a whole.

Their argument: Consumers have a right to know so they can make their own consumption risks, and consumer or religious views are not merely preferences but a ground for the information that is material to consumers.

On why this is best understood as Human Right to Food. Adequate right to food is an HR right framed after WWII about enough food that is not adulterated and not against your faith or ethics (kosher, halal, vegan) and respectful of environment. U.S. is not part to Socioeconomic rights convention, which is most explicit protection of this right, but are signatories to other treaties that protect the right more indirectly.

Whole Foods has moved ahead on this as have others. Even if not a worry as GRAS, consumption may be inappropriate. We need a national strategy. More of a precautionary take that understands material to matter to consumers.

Jennifer Pomeranz, Yale, A Comprehensive Strategy to Overhaul FDA Authority for Misleading Food Labels:

Obesity and diabetes is the big problem in public health. And also people showing nutritional deficiencies because too much processed food. Current labeling is misleading makes people think food is healthier than they are. This is a unique public health problem. FDA has very weak authority and power here.

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Live Blogging from FDA in the 21st Century Conference, Panel 5: Major Issues in Drug Regulation

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 [Live-blogging off-the-cuff, all errors, typos, etc, are my fault]

Geoffrey Levitt, Pfizer, Drug Safety Communication: The Evolving Environment

A drug by itself is just an object. Because of that fact it creates turf, governance. You must have effective processes for communicating accurate info.

Pharmacovigilance is the accuracy part. Spontaneous adverse event reports are flooding to companies. 600,000 of such reports go to Pfizer a year, with 2000 a day on avg. Each has to be classified, reported, and followed-up. If you mess up you get a warning letter. But it has limits: passive, haphazard, poor signal to noise value. Main value is generating safety signals to follow up on. But studies of that kind for follow-up are very expensive and competing with other possible safety studies and new drug development for funding.

For this reason there has been interest in active real-time drug safety monitoring, like Sentinel.

Once you have accurate and up to date info, how do you communicate it to the audiences that need it. It is not static info, dynamic and constantly changing, and often not fully baked. Timing is everything. That leads to governance. Who owns it? Which stakeholders get to drive it. In Wyeth v. Levine, S. Ct says drug sponsor owns the label, and is responsible at all times for content of the label, including safety info. In reality not that simple. Today there is a number of players outside health authority and drug sponsor who have emerged as powerful forces. Academic researchers, drug payers, detailers, and many others.  This is not by accident. One reason is emergence of vocal critics who have critiqued the sponsors ability to directly communicate. Claim that this is a form of collusion  of which Levitt does not agree.

Vioxx sparked a few important developments. IOM produced one of the most important recommendations that led to FDAAA especially as to post-market surveillance and power over the safety label. Balance of authority shifted from that authority towards FDA. FDA also began to be more proactive about communicating, even before fully confirmed and without participation of sponsor. Also put into place obligations to post clinical trial results on public website, so clinicaltrials.gov is born. In retrospect, that was the opening shot in a full barrage of FDA on clinical trial transparency. In Europe this had led to a drastic new policy of affirmatively publishing clinical study reports full-scale not just trial results.

Critics of the current model want to tear down the gate, and reinterpret data themselves by own standards. That may lead to different results and different conclusions. Will the erosion of the primacy of the sponsor and FDA lead to more truth or more confusion?

W. Nicholson Price II, Petrie-Flom Center, The Role of Innovation Policy in Pharmaceutical Manufacturing

M & M manufacturing is more precise than drug manufacturing. Poor innovation in drugs. 200 to 300 billion dollars a year are spent on drug manufacturing. This is very expensive and inefficient, contrary to the typical story that drug manufacturing is cheap. Drugs are way behind computers and electronics. Uses same processes as decades ago. A 20% reduction in manufacturing costs would lead to a gain annually 50 billion for consumers if paid back directly, or even more if invested in R & D. Connected also to drug shortages.

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Live Blogging from FDA in the 21st Century Conference, Panel 1: FDA in a Changing World

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[This is off-the-cuff live blogging, so apologies for any errors, typos, etc]

Panel 1: FDA in a Changing World: Lewis Grossman, Ted Ruger, Barbara Evans, moderated by Holly Fernandez Lynch

Lewis Grossman, FDA in the Age of the Empowered Consumer

Begins his analysis by comparing a hypothetical consumer in 1960 and today.

Consumer was passive. Today’s consumer is active, more unmediated choice, more direct citizen involvement.

Why the change? 1970 was the decade of advocacy, culminating in 1972 Patient’s Bill of Rights from AMA. Central them was informed consent and thus complete information from physician.

1998 saw disruption of WebMd and now even more disrupted by web search technology which is how most patients get there info.

Food: 1966, recipe standards. Relatively little variety and consumer choice. Very little info on  nutrition, “batman white bread.” Turning point was 1969 White House conference that led to more choice and more info.

Health clams as the portal where 1st Amendment law entered into FDA law. The image of the intelligent consumer who need not be shielded from information.

Changes in standard by which FDA decided if something was misleading. Until 2002 unsure if reasonable or gullible consumer standard. In 2002 for food FDA chose the reasonable consumer standard.

Liberal and conservatives got scrambled on these matters in interesting ways.

Also a revolution in advertising, leading to revolution of patient’s relationship to his or her drugs.

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Sleep No More: Sleep Deprivation, Doctors, and Error or Is Sleep the Next Frontier for Public Health?

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[Cross-Posted at Prawfsblawg]

How often do you hear your students or friends or colleagues talk about operating on very little sleep for work or family reasons? In my case it is often, and depending on the setting it is sometimes stated as a complaint and sometimes as a brag (the latter especially among my friends who work for large law firms or consulting firms). To sleep 7-8 hours is becoming a “luxury” or perhaps in some eyes a waste – here I think of the adage “I will sleep when I am dead” expresses that those who need sleep are “missing out” or “wusses.” My impression, anecdotal to be sure, is that our sleep patterns are getting worse not better and that many of these bad habits (among lawyers) are learned during law school.

One profession that has dealt with these issues at the regulatory level is medicine. In July 2011, the Accreditation Council for Graduate Medical Education (ACGME) – the entity Responsible for the accreditation of post-MD medical training programs within the United States – implemented new rules that limit interns to 16 hours of work in a row, but continue to allow 2nd-year and higher resident physicians to work for up to 28 consecutive hours. In a new article with sleep medicine expert doctors Charles A. Czeisler and Christopher P. Landrigan that just came out in the Journal of Law, Medicine, and Ethics, we examine how to make these work hour rules actually work.

As we discuss in the introduction to the article

Over the past decade, a series of studies have found that physicians-in-training who work extended shifts (>16 hours) are at increased risk of experiencing motor vehicle crashes, needlestick injuries, and medical errors. In response to public concerns and a request from Congress, the Institute of Medicine (IOM) conducted an inquiry into the issue and concluded in 2009 that resident physicians should not work for more than 16 consecutive hours without sleep. They further recommended that the Centers for Medicare & Medicaid Services (CMS) and the Joint Commission work with the Accreditation Council for Graduate Medical Education (ACGME) to ensure effective enforcement of new work hour standards. The IOM’s concerns with enforcement stem from well-documented non-compliance with the ACGME’s 2003 work hour rules, and the ACGME’s history of non-enforcement. In a nationwide cohort study, 84% of interns were found to violate the ACGME’s 2003 standards in the year following their introduction.

Whether the ACGME’s 2011 work hour limits went too far or did not go far enough has been hotly debated. In this article, we do not seek to re-open the debate about whether these standards get matters exactly right. Instead, we wish to address the issue of effective enforcement. That is, now that new work hour limits have been established, and given that the ACGME has been unable to enforce work hour limits effectively on its own, what is the best way to make sure the new limits are followed in order to reduce harm to residents, patients, and others due to sleep-deprived residents? We focus on three possible national approaches to the problem, one rooted in funding, one rooted in disclosure, and one rooted in tort law. I would love reactions to our proposals in the paper, but wanted to float the more general idea in this space.

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Why North Dakota’s Ban on Genetic Selection Matters (Online Abortion and Reproductive Technology Symposium)

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[Ed Note: Posted on behalf of Jaime King]

On March 26, 2013, North Dakota Governor, Jack Dalrymple, signed into law two of the nation’s most restrictive abortion bills. The first, HB 1456, prohibits providers from performing an abortion once a fetal heartbeat can be detected, which can be as early as six weeks gestation (Fetal Heartbeat Ban).  The second, HB 1305, prohibits providers from knowingly performing abortions sought solely because of the sex of the fetus or because the fetus has been diagnosed with a genetic abnormality or the potential for a genetic abnormality (Sex and Genetic Selection Ban).

Much of the press coverage and discussion of these unprecedented laws has focused on the Fetal Heartbeat Ban. This is largely because the prohibition eliminates nearly all access to abortion in the state and poses a direct challenge to a woman’s right to choose to have a pre-viability abortion free from undue state interference, as delineated in Planned Parenthood v. Casey.   Viability has typically been established around 24 weeks gestation, which is generally considered the end of the second trimester. The sweeping nature of this prohibition essentially negates the impact of a prohibition on sex or genetic selective abortions, as testing for those conditions, even with non-invasive prenatal testing techniques, cannot be performed reliably prior to nine or ten weeks gestation. By that point, the Fetal Heartbeat Ban would already prohibit any form of selective abortion.

But we should not ignore this law, as it is the more insidious of the two. As a direct threat to abortion access for all women, the Fetal Heartbeat Ban is very likely to be found unconstitutional, short of a complete overturning of Roe v. Wade. The Sex and Genetic Selection Ban, however, is subject to more debate. Since Roe, we have largely assumed that women can have an abortion for any reason prior to viability, but the courts have never directly addressed the issue.  Recent polls have found that over 3/4 of Americans would support bans on sex selective abortions,[1] and five states have already passed sex selection bans.[2]  The question of whether a woman’s reason matters is upon us.

Opening the door to permit states to invade and assess women’s private thoughts regarding her reasons for having an abortion strikes directly at the heart of the reproductive liberties protected by the Fourteenth Amendment. If states can regulate access to abortion based on a woman’s reasons for having it, they can significantly limit access in a piecemeal fashion – slowly and deliberately circling in on the right. Continue reading →

Impact of the “Lander Brief” in the Myriad Case – and an answer to Justice Alito’s Question

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 [Cross posted at Prawfsblawg.com]

The Supreme Court heard oral arguments on April 15 in Association of Molecular Pathology et al. v Myriad, concerning whether human genes are patent-eligible subject matter. The case focused on Myriad’s patents on two genes, BRCA1 and BRCA2, involved in early-onset breast cancer.

Surprisingly, many of the Court’s questions for Myriad’s counsel focused on what Justice Breyer dubbed the “Lander Brief” – an amicus filed on behalf of neither party by one of the country’s leading scientists, Dr. Eric Lander. (Lander was one of the leaders of the Human Genome Project and co-chair’s the Presidents Council of Advisors on Science and Technology.) [Full Disclosure: I am one of the authors of this brief.] Justices Breyer, Ginsburg and Alito referred to the brief by name, and several other Justices were clearly influenced by the information in the brief.

I believe that the “Lander brief” was a hot topic of conversation because the Justices realized that it was central to applying the Court’s product-of-nature doctrine to DNA. Importantly, the brief demolished the scientific foundation of the Federal Circuit decision on appeal. The Federal Circuit panel held that human chromosomes are not patent-eligible because they are products of nature, but a majority found that “isolated DNA” fragments of human chromosomes (such as pieces of the breast cancer genes) are patent-eligible. The Federal Circuit’s distinction rested on its assumption that (unlike whole chromosomes) isolated DNA fragments do not themselves occur in nature, but instead only exist by virtue of the hand of man. Continue reading →

Transplant Tourism: Hard Questions Posed by the International and Illicit Market for Kidneys, New Article I Wrote

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[Cross-Posted at Prawfsblawg]

The Journal of Law, Medicine, and Ethics has just published an article by me on transplant tourism, that discusses the burgeoning international market for buying and selling kidneys. I review the existing data from Pakistan, Bangladesh, and India, which is pretty deplorable. As I show the vast majority of these sellers are poor and using the money (which is a significnat sum in terms of what they earn, even though in the end only 2/3 is paid) to try to buy themselves out of bonded labor, pay off familial debts, or try to mount a dowry. Many are misinformed or decieved about the health consequences for them and the needs of the person who will receive their kidney. Once they have agreed to sell they are often pressured not to renege. They are often released too soon post-transplant compared to what is optimal for a transplant, and their self-reported health post-transplant is worse. Many experience significant social stigma as a “kidney man” (or woman)and the 20-inch scar (the more expensive way of doing the procedure would reduce the scar size) marks them for life and makes it difficult for them to marry. Most express significant regret and would advise others not to undertake the operation.

Despite these grave facts, as I argue in the paper (and in greater depth for many of these arguments in the chapter on transplant tourism in my new book on medical tourism under contract at Oxford University Press), many of the traditional justifications from the anti-commodification literature — arguments relating to corruption, crowding out, coercion, and exploitation — do not make a convincing case in favor of criminalization. If a ban is justified, I argue the strongest arguments are actually about defects in consent and justified paternalism, on the assumption that criminal prohibition is a second best regulation in the face of the impossibility of a more thoroughly regulated market.

I then examine what means might be used to try to crack down on the market if we concluded we should. I evaluate possibilities including extraterritorial criminalization, professional self-regulation, home country insurance reimbursement reform, international criminal law, and of course better organ retrieval in the patient’s home country.

I will keep writing on this topic, including for my new book, so even though this paper is done feel free to email me your thoughts.

Will Your Law Firm (or Other Employer) Pay for Your Egg Freezing? Should It? (Online Abortion and Reproductive Technology Symposium)

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As John Robertson mentioned in his post earlier this week, in order to avoid age-related infertility many women are considering or will soon consider using egg freezing, as the technology has dramatically improved. As compared to freezing preembryos, for example, this is an attractive option since many of these women (heterosexual or otherwise) may not yet have chosen a reproductive partner, and also may want to hedge their bets to have options should they divorce. Still, the technology is not cheap.

At least one participant at the the bricks-in-mortar symposium reported to me that they knew of one Am Law 100 firm that will cover egg freezing for its lawyers. I would be grateful if folks in the comments section could indicate whether they knew whether their firm covers it as well. [Ed. Note: If you have any trouble with the comment function on the blog, which is still giving us trouble, send a note and we'll get it posted for you through the admin account.] My own impression is that this is not yet widespread, but that might change as the practice becomes more common and thus the market converges (perhaps with a push from Above the Law).

Should law firms cover egg freezingt? I have made the argument elsewhere for coverage of reproductive technologies by insurance more generally from a moral and economic perspective. In the case of law firms, I am curious about the PR implications for the firm. Would potential female associates welcome this option knowing that they can work hard early on and still reproduce, if they so desire, later on? Or would they take this as a signal that the firm thinks that working there as an associate and pregnancy are incompatible? Would this option help remedy the deficits faced by women who want to have children on the partnership track or would it in fact exacerbate discrimination against women who do choose to have families early on while at the firm, with the thinking being “she could have waited.” More generally, would this be a blow for or against gender equity at law firms?

Myriad (Gene Patent) Oral Argument and the “Lander Brief”

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First, and unrelated to this post, I wanted to say that like everyone here in Boston (and it seems throughout the U.S.) my heart goes out to the folks injured by Monday’s blast and their friends and family.

Now on to the substance. I have participated in a number of Supreme Court amicus briefs  both in my life as a litigator and as an academic. In big name cases the Court is often inundated with them, and one can only hope that the brief is read, let alone put to good use. This is why I was incredibly happy and honored that the Supreme Court devoted a significant chunk of its oral argument time on Monday in the Association for Molecular Pathology v. Myriad Genetics, No. 12-398, the gene patent case,  to discussing the brief I authored with Gideon Schor and Vern Noviel on behalf of Dr. Eric S. Lander. As Nature reported on the argument:

“The justices seemed to have been heavily influenced by a friend-of-the-court brief filed by Eric Lander, genomics whiz and founding director of the Broad Institute in Cambridge, Massachusetts. The brief argued against a lower court’s ruling that a snippet of DNA isolated from its chromosome does not occur in nature and is therefore patentable. To the contrary, wrote Lander, isolated DNA fragments do exist and are found circulating free in the blood. Indeed, a search of two public databases of DNA sequence data obtained from fetal DNA circulating in maternal blood revealed fragments that contained the BRCA1 and BRCA2 genes. “I think that raised a whole new ‘oops’,” said Robert Cook-Deegan, a policy researcher who has studied the case at Duke University in Durham, North Carolina. The justices never heard a proper response to Lander’s argument from Myriad’s attorney, who seemed to have either misunderstood the Lander brief or confused it with another when questioned.”

I reproduce some snippets from the actual transcript below the fold discussing our brief and its significance for how the Court rules.

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John Robertson on Cohen and Adashi on Made-to-Order Embryos for Sale

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[Ed. Note: Posting on behalf of John Robertson]

Glenn Cohen and Eli Adashi have an interesting Sounding Board piece in the latest NEJM[i] on made-to-order embryos for sale.  A California clinic offering this option has garnered enormous publicity.  It might, however, have stimulated more bioethical thinking than actual demand for its services.

On the bioethical side, Glenn and Eli survey the relevant issues and conclude that what is most “new and unique here is the lack of clear legal guidance as to the parentage of the embryos in question.”[ii]  My impression is different– existing laws give sufficient support about parentage, if anyone wants to use them.  The clinic creating the embryos from separate gamete donations will have dispositional control of them, but no parenting questions arise until the embryos are gestated and brought to term.  True, there are few state laws on embryo donation as such. But in states with no specific embryo donation laws, those who have commissioned gestation will most likely have rearing rights and duties once a child is born until they arrange for an adoption.[iii]

Nor would the gamete donors in such states be able to claim rearing rights or be subject to rearing duties after such a birth.   Most states recognize gamete donor relinquishment of rearing rights and duties in resulting children with their consent to donation.  After the birth of a child, the gamete donors ordinarily would have no right to change their mind and acquire rearing rights or be subject to rearing duties, whether the donation was of sperm or egg separately or both combined into an embryo.

One aspect of this transaction that is ethically unique is that divvying up embryos created from the same egg and sperm donor would lead to different recipients giving birth to full rather than half siblings, as is the usual situation with gamete donation (it could happen with excess embryos donated after successful IVF by an infertile couple, but that is rarer). Whether it creates a higher risk of full sibling consanguinity would depend on clinic practices in distributing embryos from the same batch to different recipients.  As Glenn and Eli note, donor registries might solve this problem, but none yet exist in the United States.

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New Paper in the New England Journal of Medicine “Made-to-Order Embryos for Sale — A Brave New World?”

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The New England Journal of Medicine just published a new article by me (and my frequent co-author Dean Eli Adashi) entitled “Made-to-Order Embryos for Sale — A Brave New World?”  As we note in the article:

The proliferation of commercial gamete sources (e.g., sperm and oocyte banks) has opened the door to a made-to-order embryo industry in which embryos are generated with a commercial transaction in mind. This prospect of a for-profit embryo bank is no longer theoretical. Indeed, as recently as November 2012, the Los Angeles Times reported on one such clinic that “sharply cuts costs by creating a single batch of embryos from one oocyte donor and one sperm donor, then divvying it up among several patients.” The report went on to state that “the clinic, not the customer, controls the embryos, typically making babies for three or four patients while paying just once for the donors and the laboratory work.

The paper then analyses the legal and ethical issues raised by the development of these kinds of banks. In so doing, a key question we ask is how this practice is similar or different from embryo donation (sometimes called “embryo adoption”), the sale of sperm and eggs for reproductive purposes, and the use of sperm and egg to produce stem cell lines that require embryo destruction.

This one is sure to be controversial, and while this short piece in the New England Journal is now published I would love to hear readers’ thoughts as I may write more on the subject.

John Robertson on “Is Selective Reduction Covered by State Abortion Law?” (Online Abortion and Reproductive Technology Symposium)

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[Guest post on behalf of John Robertson]

The meeting at Rutgers-Camden on convergences and divergences between abortion and assisted reproduction (to use Glenn Cohen’s term) was stimulating and interesting on many fronts.  To pick up on one such issue, must physicians who reduce pregnancies to twins or singletons comply with state regulations for abortion?  Many of us thought that they were probably covered, even if they view themselves differently than physicians at abortion clinics.

In fact, selective reductions might not fit all state definitions of abortion.  Texas defines abortion as “the use of any means to terminate the pregnancy of a female known by the attending physician to be pregnant with the intention that the termination of the pregnancy by those means will, with reasonable likelihood, cause the death of the fetus.”  Texas Health & Safety Code # 171.002.

Since protection of fetuses is a main purpose of such statutes, a natural reading of the statute would be to view the termination of the pregnancy of a particular fetus, as occurs with selective reduction, to be covered.  On the other hand, precision in language is also necessary.  Since the intention of the physician is not to terminate the entire pregnancy, one could argue (perhaps with less support) that selective reduction where at least one fetus remains and the pregnancy continues is not covered.  Under prevailing notice jurisprudence, there is a plausible argument that this definition doesn’t give reasonable physicians, enforcers, or patients fair notice that selective reduction is covered by abortion statutes. (Of course, the legislature could easily revise the statute).

As a practical matter, a physician doing such procedures might prudently following state law in all respects, such as informed consent, 24 hour waiting periods, ultrasound if required, notice of adoption alternatives, etc. to avoid trouble.  There may, however, be situations in which compliance with such requirements in this already heavily freighted emotional context is especially onerous.  There may also be questions as to whether it extends to postviability abortions, where selective reduction is done to protect the health of other fetuses or newborns, though many of those cases might fall within the mother’s health exception.

In the end, the greatest importance of this question is to enrich the discussion and make us aware of the different situations that bring women to termination choices.  If one such path is through assisted reproduction, it reminds us that much more attention needs to be paid to hyperstimulation and transfer protocols so that the need for to “reduce” pregnancy is itself reduced.  Would laws that limit embryo transfer be constitutional?  Probably not, but that is another discussion.

I would be interested in hearing whether other state statutes are clearer and whether anything beyond what I have mentioned hinges on it.

Introducing our Online Abortion and Reproductive Technology Symposium

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[Editor's Note: This is Glenn Cohen guest posting on behalf of Kim Mutcherson, what follows below is her post. I will be posting on behalf of several symposium contributors over the next few days.]

On Friday, April 5, a group of almost 30 (mostly legal) scholars gathered at Rutgers Law-Camden to have difficult conversations about abortion and assisted reproduction. The event, sponsored by Rutgers Law and the Law School Initiative of the Center for Reproductive Rights (http://reproductiverights.org/en/our-work/law-school-initiative) sought to initiate discussion about the seeming gulf between those working on issues related to abortion and those working on assisted reproduction and assisted reproductive technology (ART).  Friday’s conversation was the first of at least three planned events with the other two to be sponsored at some future point by the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School and the Program for the Study of Reproductive Justice in the Information Society Project at Yale Law School. If the nature of the conversation at this kick-off event is a harbinger of things to come, I am anticipating that top-notch and cutting edge scholarship related to reproductive rights and reproductive justice will emerge from workshop participants.

While it might seem intuitive that scholars of reproduction would talk often, much of the work in this arena exists in silos. Those writing about abortion have plenty of work to do in keeping up with the flurry of state laws seeking to destroy what remains of Roe v. Wade in a post-Planned Parenthood v. Casey world. And those working in the world of assisted reproduction have to keep abreast of emerging science that is always light years ahead of what the law has done or seems capable of doing. As a consequence, opportunities to study the intertwining and divergence between the right to end a pregnancy and a right to create one are sparse.

And so, in the year that we commemorate the 40th anniversary of Roe, we engaged in a respectful, honest, and richly complex dialogue about the appropriate paradigm for understanding the right to abortion and the right to use assisted reproduction—liberty, equality or some new paradigm that we have yet to fully embrace or articulate.

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New Paper on Sperm Donor Anonymity and Mandatory Paternal Testing for Coital Sex

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I have a new peer-commentary paper in the American Journal of Bioethics, entitled “Of Modest Proposals and Non-Identity: A Comment on the Right to Know Your Genetic Parents.”  This is a response to An Ravelingien and Guido Pennings’s very interesting article “The Right to Know Your Genetic Parents: From Open-Identity Gamete Donation to Routine Paternity Testing” in the same journal, wherein they argue that the same arguments underlying mandatory sperm donor identification should support a regime of mandatory routine paternity testing to deal with the phenomenon of misattributed paternity.

My new piece is behind a pay-wall, but if you’d like to read it shoot me an email as I have a limited number of “free passes” from the publisher. I have also written about these issues in greater depth in this article in the Georgetown Law Journal which is available for free download. Finally, I hope to soon blog about a new paper forthcoming in the Journal of Empirical Legal Studies and co-authored with Travis Coan, where we use experimental methods to examine whether reluctance to become a sperm ‘donor’ where identification is required can be overcome with increased payments to potential ‘donors’.

New Paper on Coercion and the Constitutionality of the Affordable Care Act

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I have a new paper on the Supreme Court’s decision on the Affordable Care Act, just published in the European peer-reviewed philosophy journal Ethical Perspectives. It is available for free download here.  Here is the abstract:

While NFIB v. Sebelius largely upheld the Affordable Care Act (ACA), it did not do so as as to the proposed expansion of Medicaid. Seven of the nine U,S, Supreme Court Justices (all except Justices Ginsburg and Sotomayor) endorsed a ‘coercion’ argument that gave individual States a right of objection grounded in the Constitution’s Spending Clause, wherein individual states could refuse to expand Medicaid as demanded by the federal government without being directly penalized by a denial of federal funding. Two Justices in dissent focused on the lack of judicial administrability of such a standard, and suggested it would open up a Pandora’s box of future constitutional challenges without any clear rules.

In this article, part of a symposium on philosophical analysis of the Court’s decision published in the peer-reviewed journal Ethical Perspectives, I discuss what I see as a more fundamental question: by what theory is the Medicaid expansion coercive, and even if coercive, by what theory is it coercive in a problematic way that justifies constitutional redress?

The Court’s failure to address this issue stems, in part, from confusion over what it means for an offer to be coercive. In some sense, Justice Kagan seemed to recognize this issue in a question to Paul Clement, the lawyer for the challengers to the ACA, at oral argument: “Why is a big gift from the federal government a matter of coercion?” Kagan asked. “It’s just a boatload of federal money for you to take and spend on poor people’s health care,” Kagan added. “It doesn’t sound coercive to me, I have to tell you.” The exchange is all the more curious because, despite her scepticism, Kagan signed on to the Court’s holding that the Medicaid expansion was coercive.

I will examine this issue by first discussing whether Medicaid itself and the ACA’s expansion are coercive (as stand-alone offers). I will then examine whether the offer to change from the existing Medicaid program to the ACA’s Medicaid expansion was problematic. I will analyze these questions under the assumption that the Court is not committing a category error by treating States as the kinds of entities subject to this kind of coercion inquiry. In my conclusion, however, I briefly consider whether that assumption is warranted.

Henrietta Lacks, Publishing Genomes, and Family Vetos

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Rebecca Skloot, author of the very interesting and well-written bestseller The Immortal Life of Henrietta Lacks — a book about the poor and badly treated black woman whose cells became the famous (and very heavily used) HeLa cells, medicine and the treatment of African-Americans, and who owns products derived from one’s genes — had an interesting op-ed in the New York Times on March 23, with the clever title The Immortal Life of Henrietta Lacks, the Sequel. As Skloot writes:

“On its own, the HeLa genome doesn’t say anything specific about Lacks: it’s a string of billions of letters that detail the genetic information that makes up a HeLa cell, which is useful for science. A news release from the European Molecular Biology Laboratory, where the HeLa genome was sequenced, said, “We cannot infer anything about Henrietta Lacks’s genome, or of her descendants, from the data generated in this study.”

But that’s not true. And a few scientists decided to prove it. One uploaded HeLa’s genome to a public Web site called SNPedia, a Wikipedia-like site for translating genetic information. Minutes later, it produced a report full of personal information about Henrietta Lacks, and her family. (The scientist kept that report confidential, sharing it only with me.) Until recently, few people had the ability to process raw genome data like this. Now anyone who can send an e-mail can do it. No one knows what we may someday learn about Lacks’s great-grandchildren from her genome, but we know this: the view we have today of genomes is like a world map, but Google Street View is coming very soon. . . .

After hearing from the Lacks family, the European team apologized, revised the news release and quietly took the data off-line. (At least 15 people had already downloaded it.) They also pointed to other databases that had published portions of Henrietta Lacks’s genetic data (also without consent). They hope to talk with the Lacks family to determine how to handle the HeLa genome while working toward creating international standards for handling these issues.

The publication of the HeLa genome without consent isn’t an example of a few researchers making a mistake. The whole system allowed it. Everyone involved followed standard practices. They presented their research at conferences and in a peer-reviewed journal. No one raised questions about consent.”

Skloot then quotes a number of scientists and bioethicists decrying the practice. I actually think things are not quite as Skloot sees them. Let me explain why:

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New Amicus Brief Filed on Behalf of Dr. Eric Lander in the Supreme Court in the Myriad (Gene Patent) Case

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I am pleased to announce that Gideon Schor, Vern Noviel, and I filed an amicus brief on behalf of Dr. Eric S. Lander in a pending Supreme Court case that will address whether human genes are patentable.  The case is Association for Molecular Pathology v. Myriad Genetics, No. 12-398 and will be argued April 15, 2013.  Lander is a leading genomics researcher and is President and Founding Director of the Broad Institute of Harvard and MIT. We think the brief will play a key role in helping the Supreme Court chart a path through this legal thicket.  The full brief can be downloaded here http://www.americanbar.org/content/dam/aba/publications/supreme_court_preview/briefs-v2/12-398_neither_amcu_lander.pdf. Here is an excerpt from the brief, the Summary of the Argument:

This case hinges on a scientific question: whether DNA fragments from a human chromosome are (1) products of Nature or (2) at least similar enough to products of Nature that they should not be considered “markedly different.” Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980).

The members of the Federal Circuit panel below agreed that the DNA of a whole human chromosome was a product of Nature. But the majority held that isolated DNA fragments of a human chromosome were not products of Nature.

Because the majority made (without citing scientific support) a foundational assumption that isolated DNA fragments of the human genome do not themselves routinely occur in Nature, it considered whether they are similar enough to products of Nature. Employing analogies, the panel members debated whether isolated DNA cleaved from a chromosome was akin to a leaf plucked from a tree, or a kidney surgically removed from a human body.

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Peter Orszag on Former Petrie-Flom Center Fellow (now Prof.) Michael Frakes’ Work on Med-Mal, Sequestration, and the Budget

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In Bloomberg News earlier in the week, Peter Orszag praises a paper that Cornell Law Professor Michael Frakes wrote when he was a fellow at the Petrie-Flom Center.  As Orszag writes

“Most of the costs in the U.S. health-care system are incurred in a small number of expensive cases. The top 25 percent of Medicare beneficiaries ranked by cost, for example, account for 85 percent of total spending. And the expenses in those cases are driven significantly by the recommendations that doctors make to pursue one treatment path and not another.

In making these choices, doctors are influenced by various things, including medical-school training, traditions among their peers, financial incentives (which are distorted by fee- for-service payments) and, yes, the medical-malpractice system. Improving the criteria for what constitutes appropriate care could significantly change doctors’ behavior and also save money, recent research by Michael Frakes of Cornell Law School suggests.”

The paper “The Impact of Medical Liability Standards on Regional Variations in Physician Behavior: Evidence from the Adoption of National-Standard Rules” in the American Economic Review can be found here.

Israeli High Court of Justice Allows Sperm Donor to Take Back His Sample

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As Ha’aretz reports, (H/T Melanie Mader and Nir Eyal) the Israeli High Court of Justice has just decided a fascinating reproductive technology case. As the article reports:

Galit is a 39-year-old single mother who has a three-year-old daughter conceived through a sperm donation. After giving birth, Galit (who preferred that her real name not be revealed) purchased five more samples of sperm from the same donor and paid an annual fee to store them for her. When Galit, who lives in Florida, decided to try to become pregnant again she bought a plane ticket to Israel for that purpose. But one night, she got a surprising phone call. “I was told coldly that the donor had changed his mind. He had changed his lifestyle, become religiously observant and had written a letter to the Health Ministry confirming this. The caller ended by saying, ‘Of course we will return the payment for storing the sperm’ – a small, negligible amount.” At first, Galit continues, “I thought someone was playing a prank on me. I felt that my feelings were being totally ignored. This was about my future children. Maybe I wouldn’t be able to have more children from that donor, and therefore my daughter would not have biological siblings.”

Galit launched a legal battle, which ended two weeks ago with a High Court of Justice ruling rejecting her request to receive the sperm she had paid for. The court found that the donor’s right to change his mind after making the donation takes precedence over the recipient’s right to use the sperm in order to give birth to biological siblings for her daughter.

As it happens, these are the exact issues I wrote about in 2008 in a pair of articles, The Constitution and The Rights Not to Procreate, 60 Stan. L. Rev. 1135 (2008) and The Right Not to Be a Genetic Parent, 81 S. Cal. L. Rev. 1115 (2008). I have yet to get a hold of a translation of the new judgment into English, but from the reporting it seems as though the Court agreed in part and disagreed in part with the analysis I offer in these papers (particularly the latter one):

They agree with me that there is a “Right Not to Be a Genetic Parent” and my argument that it is best conceived of as a right to avoid a kind of emotional distress from what I call “attributional parenthood” — the attribution by oneself, third parties, and/or the resulting child of unwanted parenthood. Where we seem to part ways is that I view this as a right capable of waiver, and argue that it should clearly be waiveable by contract, which there appears to be in this case, while the Israeli High Court appears to treat it more as an inalienable right.

I may have more to say once I’ve read the whole opinion in English, but for now one sociological fact: As Ellen Waldman among others has noted, and born out by my own time teaching there, Israel is an incredibly pro-natalist society that strongly funds and favors the use of reproductive technology and family formation in general. This case is thus interestingly at variance with others the Israeli judiciary has decided in the reproductive technology context, such as the Nachmani v. Nachmani case (involving a dispute over frozen pre-embryos) where the court has been more disposed to favoring the right to be a genetic parent and allowing reproduction despite disputes.

The article reports that Galit will seek rehearing in front of a larger panel of the High Court soon, so perhaps this is not the end of the litigation.