DNA: Donors Not Anonymous

Special Guest Post by Wendy Kramer
[In response to Sperm donor anonymity and compensation: an experiment with American sperm donors, published in the Journal of the Law and Biosciences.]

My son Ryan and I were contacted by Family Tree DNA in 2004, as they thought that their new commercial DNA testing capabilities might be useful to Ryan, and to the others in our community of donor conceived people at the Donor Sibling Registry. At that time we thought it might be possible to find out more about one’s ancestry and countries of origin. Ryan was excited to learn more about his “invisible” paternal ancestry, so quickly agreed to swab his cheek, send in his sample and see what he might learn. He may have been the first donor-conceived person to throw his DNA into a public DNA database, making himself available to connect with previously unknown genetic relatives.

At first, he did learn a bit more about his paternal ancestry, specifically about countries of origin. He learned that he was mostly English, with some Irish and even a bit of Icelandic (which he thought was pretty cool). He also matched with people on his 12 and 25 Y Chromosome DNA markers, which meant that common ancestors related them from hundreds or even thousands of years ago. And for 9 months he was content with that little bit of information. Continue reading

REGISTER NOW (1/23/17)! PFC’s 5th Annual Health Law Year in P/Review

The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2016 and what to watch out for in 2017. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

This year’s Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard Health Publications at Harvard Medical School, Health Affairs, the Hastings Center, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund. 

Agenda Continue reading

“That I Don’t Know”: The Uncertain Futures of Our Bodies in America

By Wendy S. Salkin

I. Our Bodies, Our Body Politic

On March 30, at a town hall meeting in Green Bay, Wisconsin, an audience member asked then-presidential-hopeful Donald J. Trump: “[W]hat is your stance on women’s rights and their right to choose in their own reproductive health?” What followed was a lengthy back-and-forth with Chris Matthews. Here is an excerpt from that event:

MATTHEWS: Do you believe in punishment for abortion, yes or no as a principle?
TRUMP: The answer is that there has to be some form of punishment.
MATTHEWS: For the woman.
TRUMP: Yeah, there has to be some form.
MATTHEWS: Ten cents? Ten years? What?
TRUMP: I don’t know. That I don’t know. That I don’t know.

Much has been made of the fact that President-Elect Trump claimed that women who undergo abortion procedures should face “some sort of punishment.” Considerably less has been made of the fact that our President-Elect, in a moment of epistemic humility, expressed that he did not know what he would do, though he believed something had to be done. (He later revised his position, suggesting that the performer of the abortion rather than the woman undergoing the abortion would “be held legally responsible.”)

I am worried about the futures of our bodies, as, I think, are many. That a Trump Presidency makes many feel fear is not a novel contribution. Nor will I be able to speak to the very many, and varied, ways our bodies may be compromised in and by The New America—be it through removal from the country (see especially the proposed “End Illegal Immigration Act”), removal from society (see especially the proposed “Restoring Community Safety Act”), or some other means (see especially the proposed “Repeal and Replace Obamacare Act”).

But, I am like President-Elect Trump in this way: Like him, “I don’t know.” I don’t know what to say about what will happen to our bodies or to our body politic. So instead, today, I will take this opportunity to point to one aspect of the changing face of access to reproductive technologies that has already become a battleground in the fight over women’s bodies and will, I suspect, take center stage in the debate over the right and the ability to choose in coming years. Continue reading

Whole Woman’s Health and the Future of Abortion Regulation

By John A. Robertson

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

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

Surrogacy Contracts, Abortion Conditions, and Parenting Licenses

By Dov Fox

Everything went fine the last time for Melissa Cook, when the 48-year old mother of four carried a child for a family back in 2013 to supplement her office job salary. This time was different. First were the triplets. She had been impregnated with three embryos, created using eggs from a 20-something donor and sperm from the intended father who paid for everything. Then, it was that the man, Chester Moore, turned out to be a deaf 50-year-old postal worker who lived with his parents. Finally, was that Moore asked Cook to abort one of the fetuses. He said that he had run out of money to support a third child and worried the high-risk multiple pregnancy would endanger the health of any resulting children.

Cook, who is pro-life, refused. A battle over parental rights of the triplets, all boys, began even before they were born (prematurely, at 28 weeks). Moore argued that his surrogacy contract with Cook, explicitly enforceable under California law, made clear that he was the sole legal parent. Cook sued for custody, notwithstanding her prior agreement that any children resulting from the pregnancy would be his to raise. She argued that the statute, by authorizing private contracts for gestation of a human being, reduces children to “commodities” for sale, and a surrogate like her to a “breeding animal or incubator.” Continue reading

Reproduction Gone Awry

The Daily Journal published an op-ed article by Blogger and University of San Diego (USD) School of Law Associate Professor of Law and Dov Fox titled, “Reproduction Gone Awry.”

In his article, Fox points to last month’s lawsuit against a Beverly Hills fertility clinic — the same one sued by Sofia Vergara’s ex in a dispute over control of frozen embryos — arguing it would be a mistake to write it off as another aberration. The clinic is accused of having negligently destroyed the only seven frozen embryos that a Sherman Oaks woman created using her donor-fertilized eggs.

The article argues that high-tech procreation goes largely unregulated makes these mistakes more common than you might think. A comprehensive study by Johns Hopkins University of U.S. fertility clinics found that more than one in five report errors in diagnosing, labeling and handling genetic samples or embryos. See “Genetic testing of embryos: practices and perspectives of US in vitro fertilization clinics” (2008).

Mistakes like these can also frustrate efforts to avoid parenthood or to have children who are born healthy. Fox refers to one recent case in which a pharmacist filled birth control prescriptions with prenatal vitamins.

Fox goes on to state that the victims of such transgressions have little recourse under the law and they almost always lose in court. Contract claims can’t vindicate patient interests where providers, despite their negligence, haven’t broken any specific promises. Like all doctors, reproductive specialists are careful to avoid guaranteeing particular results of their care. And they usually insist that patients waive liability for even implied breaches of contract.

Moreover, Fox also argues that ordinary medical malpractice won’t work either because patients in the reproductive context don’t sustain bodily intrusion or impairment beyond the treatment they agreed to. Nor can recovery for economic setbacks or emotional distress capture the deepest injury at stake. Indeed, it is one our law doesn’t recognize: namely, having been robbed of the ability to determine the conditions under which to become pregnant or have children.

Read the full article online. 

From Chance to Choice to Court

[Cross-posted from the Huffington Post Blog]

By Dov Fox

It used to be that whether you got the child you wanted — or one you hadn’t planned on — was left to cosmic fate or the randomness of reproductive biology. Now, new powers of reproductive medicine and technology promise to deliver us from the vagaries of the natural lottery.

The likes of voluntary sterilization and embryo screening give people who can afford them greater measures of control over procreation. Except, that is, when reproductive professionals make mistakes that frustrate efforts to pursue or avoid pregnancy or parenthood.

When, for example — just a few recent cases — a pharmacist fills a woman’s birth control prescription with prenatal vitamins. Or when a fertility clinic implants embryos carrying the hereditary disease that a couple underwent in vitro fertilization (IVF) to screen out. Just this week comes another report of losing IVF embryos.

Continue reading

Uterus Transplants: Challenges and Potential

[Cross posted at the OUPBlog]

By John A. Robertson

The birth of a healthy child in Sweden in October, 2014 after a uterus transplant from a living donor marked the advent of a new technique to help women with absent or non-functional uteruses to bear genetic offspring. The Cleveland Clinic has now led American doctors into this space, performing the first US uterine transplant in February, 2016 as part of an Institutional Review Board (IRB)-approved series of ten transplants using cadaveric donors. Dallas and Boston medical centers have also been approved for this program, as will other programs as progress continues. An estimate of 50,000 American women are potential clients.

The path to womb transplants, however, will not be easy. On 7 March, the Cleveland Clinic celebrated its transplant with a media announcement full of joy and celebration. Two days later in a decidedly different key, the Clinic informed the world that the organ was surgically removed because the recipient had “suddenly developed a serious complication.” One can only imagine the disappointment of the patient and medical team, who had smiled so happily in media coverage. Of course, early failure is not surprising with innovative surgery, and no doubt the Cleveland clinic will proceed with other patients. The case is a reminder that the road to success is long, and initial steps should be closely monitored by IRBs, as is occurring in Cleveland, Sweden, and elsewhere. Continue reading

Stem cell patenting on the other side of the pond

We are pleased to announce a new publication in the International Review of Intellectual Property and Competition Law (IIC). Our paper analyzes new case law in European stem cell patenting and compares these developments with the US situation and International treaties. Further information and an abstract is available below:

Authors: Ana Nordberg & Timo Minssen, University of Copenhagen, Centre for Information and Innovation Law (CIIR)

Title: A “Ray of Hope” for European Stem Cell Patents or “Out of the Smog into the Fog”? An Analysis of Recent European Case Law and How it Compares to the US
Journal: IIC – International Review of Intellectual Property and Competition Law, 47(2), 138-177
DOI: 10.1007/s40319-016-0449-x

ABSTRACT:  Continue reading

TOMORROW (2/10) Fetal Pain: An Update on the Science and Legal Implications

fetalpain_slideFetal Pain: An Update on the Science and Legal Implications
February 10, 2016 12:00 PM
Wasserstein Hall, Milstein East C
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Amanda Pustilnik, JD and Maureen Strafford MD will discuss fetal pain, including advances in neuroscience and treatment and their implications for the law. Continue reading

Breaking News: NAM Releases Report on Mitochondrial Replacement Therapy (Part II My First Take)

By I. Glenn Cohen

My last post was a summary of the NAM’s Recommendations on Mitochondrial Replacement Therapy (MRT). Now here is my take on the report. But keep in mind the report was just released and all I could give it was a quick read, so these are really more like initial impressions: Continue reading

Breaking News: NAM Releases Report on Mitochondrial Replacement Therapy (Part I Summary)

By I. Glenn Cohen

As readers know I’ve written on mitochondrial replacement therapy and its attendant ethical and regulatory issues. Today the National Academy of Medicine (formerly known as the IOM) released a terrific report today with its recommendations. I’ll have a second post with my reactions but here is a summary from the report of their recommendations. The big headline is they have recommended FDA largely move towards allowing it to go forward under a regulatory pathway with restrictions, the most important of which is the transfer only of male embryos (to avoid germ-line issues).

In the NAM’s own words:

Recommendation 1: Initial clinical investigations of mitochondrial replacement techniques (MRT) should be considered by the U.S. Food and Drug Administration (FDA) only if and when the following conditions can be met: Continue reading

Thought about Breastfeeding and Civil Liberties

Breastfeeding is known for being an extremely politicized issue. Past decades introduced us to different interest groups advocating for and against the ideal of “Breast is best”. A recent book by Courtney Jung called ‘Lactivism: How Feminists and Fundamentalists, Hippies and Yuppies, and Physicians and Politicians Made Breastfeeding Big Business and Bad Policy’ describes how the ideal of breastfeeding became a focal point of consensus among conflicting political groups like environmentalists and capitalists, leftists and conservatives and many more. The book reveals troubling regulatory schemes which sanction non-breastfeeding moms by denying benefits and iron rich food for their babies. This pattern of body governance echoes Dorothy Roberts’ book ‘Killing the Black Body’ which described how procreation decisions made by poor-black-women, are constantly sanctioned and regulated by the state in order to achieve social objectives, for example, by conditioning welfare benefits in an installation of permanent contraceptives.

In Roberts’ book, a clear distinction is made with respect to the reproductive liberty of black and white women. The contraceptive pill, which symbolizes the emblem of reproductive freedom and is highly identified with the feminist movement, was the product of a scientific endeavor greatly motivated by conservative groups’ desire to control population through family planning schemes, historically targeting the fertility of poor black women. In a similar way, the ideal of “breast is best” has also been operating differently with respect to race and economic status. In Linda Blum’s bookAt the Breast: Ideologies of Breastfeeding and Motherhood in Contemporary United States’ she conducts interviews with women who didn’t nurse. She found that in contrast to white women who strove for outer respectability and experienced their lack of breastfeeding as a failure to conform with the breastfeeding imperative, black women emphasized their use in feeding instruments as significant for their independence which was highly evaluated. Accordingly, statistics show generally lower breastfeeding rates among black women in the US.

Continue reading

Surrogacy Contracts Directly Enforcible in Pennsylvania

Surrogacy is legal in many states.  Some, like California, directly enforce gestational carrier contracts.  Others, like Texas, Illinois, and Virginia, enforce only those contracts that are entered into by a married couple who need a surrogate for medical reasons which a judge approves before embryo transfer occurs.  A Pennsylvania court has now shown why gestational surrogacy contract should be directly enforced in the absence of legislation.  Its well-reasoned opinion suggests that more states may be open to this approach to surrogacy.

The Pennsylvania case, In re Baby S., arose out of a gestational surrogacy agreement involving embryos created with donor eggs and husband sperm. The written agreement was indisputably clear that that the intended parents would be the legal rearing parents, their names would appear on the birth certificate, and the carrier would have no rearing rights or duties.  Unlike previous cases questioning the validity of a surrogacy contract, the challenge here came not from the carrier who now wished to assert rearing rights (see In re Baby M and Calvert v. Johnson) but from the wife (the intended rearing mother).  She had praised the carrier’s willingness to help her have a child, which she repeated both at the embryo transfer and at a 20 week ultrasound at 20 weeks of pregnancy, which both intended parents attended.  A month later she informed the parties that “irreconcilable marital difficulties” would make it difficult for her to co-parent the child with the intended father.  She also refused to complete the paperwork for her name to appear on the birth certificate as the mother.

Continue reading

Abortion and the Fetal Personhood Fallacy

By David Orentlicher

[cross-posted at HealthLawProfs blog and orentlicher.tumblr.com]

Marco Rubio, Mike Huckabee, and other politicians continue to assert a common fallacy about abortion—because human life begins at conception, fetuses are persons, and abortion must be prohibited. Indeed, Huckabee and Rubio claim that the U.S. Constitution requires such a result.

But they are wrong. And not just because people disagree about the beginning of personhood. The flaw in the Rubio/Huckabee logic was pointed out more than 40 years ago, even before the U.S. Supreme Court recognized a constitutional right to abortion in Roe v. Wade. In “A Defense of Abortion,” Professor Judith Jarvis Thomson correctly observed that even if we assume that personhood begins at conception, it does not follow that abortion must be banned before the fetus is viable. Indeed, as she wrote, a ban on abortion before fetal viability would be inconsistent with basic principles of law. Continue reading

Payments to Egg “Donors”

By David Orentlicher

[cross-posted at HealthLawProfs blog and orentlicher.tumblr.com]

Interesting article in today’s Wall Street Journal about a lawsuit over limits on payments by fertility clinics to women who supply eggs for infertile couples. Under influential, though not mandatory, guidelines issued by the American Society for Reproductive Medicine, payments to egg “donors” above $5,000 “require justification,” and payments greater than $10,000 “are not appropriate.” (When I was in the Indiana legislature, a statute was passed limiting payments to $4,000, plus out-of-pocket expenses.)

In one view, payment caps are needed to “prevent coercion and exploitation in the egg-donation process.” But one also can view the guidelines as an “illegal conspiracy to set prices in violation of antitrust laws.” More to come in a case that could go to trial next year.

In the meantime, there are other important concerns about payments for eggs and the costs to infertile persons. As with other assisted reproductive treatments, insurers generally do not cover those costs. This encourages the infertile to seek multiple births in one treatment cycle rather than single births over multiple treatment cycles, which puts mothers and their infants at greater risks to health. In addition, lack of coverage leaves treatment unaffordable for many of the infertile. As I have argued elsewhere (here and here), social policy treats infertile persons unfairly when coverage is denied for assisted reproductive services,

Bioethicist Art Caplan: Planned Parenthood’s awkward clash

A new opinion piece by contributor Art Caplan in The Chicago Tribune (free registration required):

Planned Parenthood finds itself under attack by anti-abortion activists. Not much new about that. But the terrain of the battle has shifted. The way in which fetal tissue for research is obtained at Planned Parenthood clinics is now center stage.

Planned Parenthood stands accused, as a result of a sting operation launched by anti-abortion political operatives, of selling “baby parts” for profit. Edited videos show individuals pretending to be tissue brokers discussing with Planned Parenthood doctors how to get fetal tissue, the cost for tissues, techniques for increasing the chance of obtaining particular tissues and other related issues. The doctors do not come across well. Discussions are in restaurants, there is wine on the table, the attitudes are cavalier and the doctors don’t seem to pick up on the cues that they are getting set up. […]

Read the full article here.

Hobby Lobby Fall Out

By David Orentlicher

[cross-posted at HealthLawProfs blog and orentlicher.tumblr.com]

For those who feared that the Supreme Court’s Hobby Lobby decision would open the door for employers to block contraceptive access for women in the workplace, welcome reassurance has come this week from the U.S. Court of Appeals for the Fifth Circuit. According to the Fifth Circuit, when the Affordable Care Act requires that contraception coverage be available for workers at religiously-affiliated institutions, the Act also accommodates the scruples of employers who have religiously-based objections to contraceptive use.

As the Fifth Circuit observed, employers with religious objections to contraception can shift the responsibility for coverage to their insurers or the federal government. Hence, there is no unlawful burden on those employers from the mandate that health care plans cover the costs of contraception. Continue reading

The Undue Burden Test in Texas Abortion Clinic Regulation

by John A. Robertson

[also published on Balkinization]

The Fifth Circuit decision in Whole Women’s Health v. Cole upholding Texas’ law requiring all abortions, including medication abortions, to be performed in a licensed ambulatory surgical center (ASC) by doctors with admitting privileges at nearby hospitals seems outrageous on several counts.  It defies a medical consensus that abortions performed in physician’s offices or licensed outpatient clinics are exceptionally safe.  With the risk of death less than 1% nationally and even lower in Texas, first trimester and many early second trimester abortions simply do not need the extensive sterility precautions and other operating room requirements needed for more invasive procedures. Indeed, colonoscopies, which have a higher morbidity and mortality rate, are permitted in non-ASC settings.

Nor does the admitting privilege requirement appreciably add to safety.  With hospitalists currently taking over care of most patients admitted to hospitals, the same doctor often does not provide both outpatient and hospital-based care, and emergency room doctors are trained to respond to any emergency.  Nor are admitting privileges necessarily an indication of a doctor’s clinical competence.  They are denied or awarded on many grounds unrelated to competency, i.e., likely frequency of future admissions, and thus do not usually impact the quality of outpatient care. Continue reading

Frozen Embryo Disputes and Unwanted Parenthood

By David Orentlicher

[cross-posted at HealthLawProfs blog and orentlicher.tumblr.com]

For the second time, a state court of appeals has given a woman permission to use frozen embryos over the objections of her former partner who supplied the sperm. In both cases, the new one from Illinois, the previous one from Pennsylvania, cancer chemotherapy left the women infertile and therefore unable to create new embryos with another man.

The results seem reasonable. As a general matter, courts have not been willing to impose unwanted parenthood on people who participate in the creation of frozen embryos via in vitro fertilization (IVF). However, when the frozen embryos provide the only chance for one of the embryo creators to have a genetically-related child, the desire of one person to have a child can trump the desire of the other person not to have a child. Continue reading