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.

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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.

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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

Surrogacy, Israel, and the Nepal Earthquake

The Nepal earthquake has shocked with the devastation and suffering inflicted on a long suffering people.  Foreigners in Nepal were also affected, but most of them will be able to leave and carry on their lives without the poverty, housing, and health care deficits the Nepalese will be dealing with for years.  One sub-group of foreigners were Israelis awaiting the birth of children carried by Nepalese surrogates or the legal papers needed to bring home those infants who had already been born.  They have, of course, no moral priority over others hit by the earthquake, but their situation shines yet another light on the complexities of national surrogacy policy and surrogacy tourism.

Nepal has become a major surrogacy destination for Israelis who because they are unmarried or gay cannot obtain surrogacy in Israel.  India and Thailand had been the prime choice for surrogates, but those countries two years ago restricted surrogacy to married couples.  Indian women already pregnant with children commissioned by unmarried persons then went to Nepal to give birth.   With surrogacy available in Nepal for $30,000-$50,000, rather than $150,000 in the United States, Israeli surrogacy agencies started arranging surrogacy births there, even while Indian rather than Nepalese women are usually the carriers. Continue reading

Bioethicist Art Caplan: Actress Sofia Vergara Can’t Destroy Her Embryos

A new piece by contributor Art Caplan on NBC News:

Nick Loeb and Sofia Vergara once were a huge item. Today, they are back in the tabloid press because of a dispute over frozen, human embryos.

The 42-year-old actress and star of “Modern Family,” one of the top-earning women in Hollywood, announced her engagement to the wealthy, 40-year old businessman in 2012. Last May, Vergara announced they had split amid a host of abuse allegations.

Their squabble now has grown to include Loeb suing Vergara in California to prevent her from destroying two frozen female embryos, which court documents say they created using in vitro fertilization in November 2013. […]

Read the full article here.

The Rights of Donor-Conceived Offspring

Guest Post by Naomi Cahn
Harold H. Greene Professor of Law at The George Washington University Law School
[Cross-posted from the Concurring Opinions Blog]

Today’s Washington Post prints an interesting article on regulation and the fertility industry.   One issue that it addresses is the rights of donor-conceived offspring to learn the identity of their egg and sperm donors. As I’ve written in numerous articles and books, it is a fundamentally important right for all donor-conceived offspring to learn the identity of their donors (the strength of my advocacy on this issue may not be clear from the Post article).

Other academics disagree with this position, believing it important to protect the identity of gamete donors for a variety of reasons.  I disagree, and I think the  law has a critical role to play in ensuring respect for the rights of donor-conceived people.   Parents can make the legal choice never to find out the identity of their donor.  By contrast, donor-conceived offspring have no such legal right in the United States: unless their parents opted into a known donor program, they are unable to learn the identity of their donors.  While their parents’ choices affect them as children, donor-conceived children grow up, and many become curious about their origins. Yet the law’s tight focus on the parent-child relationship excludes legal questions relating to donor-conceived adults. Continue reading

Bioethicist Art Caplan: German Mom Expecting Quads at 65 is ‘Irresponsible’

A new piece by contributor Art Caplan on NBC News:

Berlin school teacher Annegret Raunigk is proudly prolific and, at age 65, not done making babies — pregnant with quadruplets that would enlarge her family from 13 to 17 children. Why?

Raunigk said she became pregnant again because her 9-year-old daughter asked for a younger sibling. (Her first 12 children — by five men — are ages 22 to 44). She told German tabloid Bild that donated eggs were fertilized and implanted at a clinic in Ukraine. Multiple attempts were required to get the eggs to fertilize. She did not say whose sperm was used or if the egg donor was paid.

Some media outlets have trotted out the usual fluffy descriptions of “miracle” and “gift” while trying to figure out if she is the oldest woman ever to have a child (she isn’t) or to have quadruplets (almost certainly she is). But this line of reporting completely misses the mark.

What she is doing is unethical. […]

Read the full article here.

The Brocher Summer Academy 2015: Ethical, Legal and Social Issues in assisted Reproductive Technologies.

The Brocher Summer Academy 2015 will address a much controversial topic: Ethical, Legal and Social Issues in assisted Reproductive Technologies.

The Brocher Summer Academy on Ethical, Legal and Social Issues (ELSI) in Assisted Reproductive Technologies (ART) brings together distinguished professors from different disciplines and countries and highly promising researchers willing to acquire a strong background on a ELSI in ART. It gives the participants a rare opportunity to meet personally and exchange ideas with many established international professors in an intimate and collegiate atmosphere.  The sessions take place at the Brocher Centre in Geneva, Switzerland in an amazing and peaceful environment on the shore of the Lake of Geneva.

Deadline for applications: 30 April 2015

Further information is available at:  Posted in Events, Reproductive Technology, Timo Minssen | Tagged , ,

Bioethicist Art Caplan: UK Man, His Surrogate Mom and Their Baby Are Family

A new piece by contributor Art Caplan on NBC News:

A British high court has permitted Kyle Casson, a single man, to adopt an eight-month-old boy who was carried and delivered by a surrogate — Casson’s own mother.

To diagram this family tree, Casson, 27, technically adopted not his son but his brother because the woman who carried the baby to term is, legally, the mother. That also means that Casson’s mom gave birth, technically, to a son and a grandson at the same time.

Biologically, the child is her grandson.

The ruling traverses an array of ethical twists and turns. Let’s start with the more common fault lines. […]

Read the full article here.