 On behalf of the McLean Center for Clinical Ethics, the Department of Obstetrics and Gynecology, and the Bucksbaum Institute, I welcome you to this, the 15th lecture in our 2016-17 lecture series on reproductive ethics. It is now my pleasure to introduce today's speaker, Valerie Koch. Professor Koch is the director of law and ethics at the McLean Center. In this capacity, Professor Koch teaches a two-quarter course on medicine law and ethics to each class of ethics fellows. Professor Koch received her AB in bioethics and graduated magna cum laude from Princeton University's Woodrow Wilson School and received her JD from the Harvard Law School. She was a visiting professor at the Chicago Kent College of Law for several years and currently is a visiting fellow at the DePaul University College of Law. Professor Koch has also served as a special advisor for the New York State Task Force on life and the law. Professor Koch's research interests include human subjects research, emerging technologies, genomics and privacy, and intellectual property issues. She serves as co-chair of the Law Affinity Group of the American Society for Bioethics and the Humanities and currently is the chair of the American Bar Association's Special Committee on Bioethics and the Law. Along with Nanette Elster, who gave a lecture in this room just a couple of weeks ago, Professor Koch is the guest editor of a forthcoming issue of the Journal of Law, Medicine, and Ethics. The issue's topic is under attack, Reconceptualizing Informed Consent. When will that come out? This spring. This spring, good. Professor Koch's talk today is titled Pre-implantation Genetics, Liabilities and Limitations. Please join me in giving a warm welcome to our own faculty member, Valerie Koch. Well thank you, thank you for the introduction. I'm excited to be here. So the seminar series has already demonstrated how assisted reproduction, the choices, the technologies, and the interventions that are available to would-be parents raise a panoply of legal and ethical questions and issues. Today, I'm going to be taking on one such technology and using it in the context of exploring many of the legal issues that are related to its use. So I'll be focusing specifically on pre-implantation genetic diagnosis or pre-implantation genetic testing, actually. While the analysis of some of the issues that I'll discuss apply across the board to assisted reproductive technologies, some are pretty technology specific. By focusing on pre-implantation testing, I'm going to attempt to highlight some of the more holistic liability issues that are related to assisted reproduction. So a quick roadmap of where we're going. I'm going to start with a brief overview of the current and perhaps some of the more imagined uses of pre-implantation genetic testing. As I do, I'll highlight some of the key ethical questions that arise in each context. Then I'll briefly discuss the oversight, or actually lack thereof, of pre-implantation genetic testing at both the state and federal level. And finally, I'm going to turn to the issue of liability associated with the use of pre-implantation genetic testing, and in particular, informed consent, wrongful birth, and wrongful life claims. In other words, I'll be talking about tort liability. What happens when something goes wrong with the use of these technologies? But first, some a little bit of background on pre-implantation genetic testing. So it's used in conjunction with in vitro fertilization or IVF. Potential parents undergo IVF, and then after the harvested egg is fertilized, the embryos are left to develop to the eighth cell stage, at which point one cell is removed. The genetic material from the blastomere is then tested through various diagnostic services. And those four boxes represent one of the four processes that are currently available. And these are tested for genetic or chromosomal abnormalities. An unaffected embryo is then transferred to the woman's uterus to implant. In 1990, Alan Handyside and colleagues out of London, and we actually have seen throughout the seminar series that a lot of the assistive reproductive technologies and the innovations involved with assistive reproductive technologies happened to occur in England. But Alan Handyside and his colleagues reported the first established pregnancies after pre-implantation genetic testing was performed for X-linked disorders. Now, pre-implantation genetic testing, or either diagnosis or screening, is actually used in at least 4% of all IVF cycles. At the outset, I've already used a bunch of different terms, so I want to clarify a little bit as far as definitions go. Pre-implantation genetic diagnosis, or PGD, actually refers to cases in which one or both of the intended parents have a known risk of passing on a genetic abnormality. And so diagnostic testing is done on the embryo to determine if it's inherited that abnormality. In contrast, pre-implantation genetic screening, or PGS, is refers to techniques where embryos from presumed chromosomally normal parents are screened for chromosomal abnormalities, for example, or an abnormal number of chromosomes. Thus, although we hear it used a lot, PGD used for everything, a sort of holistic term, it's arguably inaccurate to be using PGD as an umbrella term in the context of any genetic testing of embryos or gametes prior to implantation. Because doing so connotes the existence or the identification of the cause of a particular illness or trait, and omits screening embryos for chromosomal abnormalities, which we're going to see as the largest number of the use of pre-implantation genetic testing, the highest incidence is four is actually with the use of PGS and not PGD. Instead, I'm going to try my best to use this umbrella term, pre-implantation genetic testing. I would refer to it as PGT, but nobody else in the field seems to do that, so I'm not sure I'm ready to coin a new acronym. So instead, I'll just say the whole thing. So there are two major ethical arguments against the use of pre-implantation genetic testing, or at least that revolve around the use of such testing. The first is, and we've heard this a number of times, is a wholesale objection to the use of the technology at all. And this is due to the fact that it involves the intentional destruction of human embryos. These concerns are, as we've seen, and we'll probably see further, based on the moral status of the embryo, and arguments that no human embryo should ever be discarded. The second type of ethical objection is the act of selecting for or against certain traits in an embryo, so selecting a certain embryo based on the testing involved. And throughout this seminar series, as I've mentioned, we've explored the first type of objections quite a bit, and they are not specific to the use of pre-implantation genetic testing. So I want to focus on the second type of ethical objections. These types of objections hinge on the question of why individuals are seeking to use pre-implantation genetic screening or testing. To better understand these ethical concerns, I want to explore the reasons for using PGT, or pre-implantation genetic testing. Importantly, and just as a disclaimer or at the outset, none of these uses is, per se, illegal in the United States. Currently, this technology could be used for almost any purpose conceived, at least as far as reproduction goes. If we're talking about research, it's a different story. But at least in the assisted reproductive context, the pre-implantation genetic testing can be used for almost any reason legally in the United States. So I'm going to go through the list of reasons why PGT is used. First, pre-implantation genetic screening is increasingly used to avoid embryos with a normal set of a number of chromosomes, which is the leading cause of implantation failure, miscarriage, and congenital abnormalities. Such screening is intended to transfer embryos with high reproductive potential. Research indicates that pre-implantation genetic screening improves implantation rates. And it may be particularly useful for couples where previous IVF cycles have been unsuccessful or when the intended mother is of advanced maternal age. But when we think of PGD specifically, we usually think of intended parents who hope to lower the risk of transmitting medical conditions and traits to offspring, particularly childhood diseases. Thus, PGD may be used to rule out implantation of embryos with Tasex disease or other devastating diseases that manifest in infancy or early childhood. In many cases, IVF combined with PGD is an alternative to prenatal testing and subsequently pregnancy termination for would-be parents seeking to have a child with these diseases. But what about genetic diseases that manifest later in life? Some distinguish between testing for Mendelian conditions such as Huntington's disease and susceptibility conditions such as cancer. Many argue that the use of PGD to select against implantation of embryos with a mutation in the HTT gene, which causes Huntington's disease, is acceptable. With such diseases, the mutation is an effective on-off switch, meaning that the resulting child will eventually develop the devastating diseases as an adult. Some have challenged whether PGD should be used to screen embryos for risk of later onset diseases, such as Alzheimer's disease or certain types of cancer, for example, screening for BRCA mutations because these only confer an increased risk of developing a disease in adulthood. In light of emerging treatments, the promise of future cures and the inconclusive predictive nature of these tests, PGD for diseases that may not present themselves for many decades or at all necessitates increased ethical scrutiny. So in 2013, the Ethics Committee of the American Society for Reproductive Medicine, or ASRM, issued its guidance for use of PGD for adult onset conditions. And it came to two major conclusions. First, it stated that it is ethically justifiable when the condition is serious and when there's no known intervention for the condition or the available interventions are either inadequately or significantly burdensome. Further, the ASRM opined that for conditions that are less serious or of lower penetrance, PGD for adult onset conditions is ethically acceptable as a matter of reproductive liberty. It should be, however, discouraged if the risks of PGD are found to be more than merely speculative. So another potential, although less frequent, relatively infrequent use of PGD, is for the creation of so-called savior siblings. In such cases, families have an already born child with a congenital or acquired bone marrow disease and that child needs a bone marrow transplant or stem cell transplant to live. The parents undergo IVF with PGD for human leucoside antigen HLA typing in order to have another child who would serve as a source of stem cells, either obtained from the new child's umbilical cord, blood or from that child's bone marrow later. So this photograph is one of the first known savior siblings. This is Adam Nash and his older sister, Molly. Then Molly had been born with a severe type of Fanconia anemia. Molly's parents underwent IVF and embryonic testing for both the disease and HLA type so that the resulting child here, Adam, could donate his umbilical cord, blood, to save his sister's life. We could undergo an entire, we could devote an entire lecture to the legal and ethical implications of creations of savior siblings. But briefly, the concerns that arise with regards to creating a sibling in order to save an older sibling's life and using PGD and IVF to do so include the imposition of the risks of IVF or embryo biopsy and later possibly intrusive medical interventions on a healthy child and otherwise absolutely healthy child for the benefit of someone else. The arguments against the commodification or exploitation of a child and the argument against treating children or a child as a means to an end. In response to such arguments, scholars have countered that the child would be no less loved or cared for due to the circumstances of his or her birth. So John Robertson, a law professor at the University of Texas, Austin has stated that in fact, because the child's birth might save the life of an existing loved child, it might only increase its specialness. And we know, couples have children for all sorts of reasons, including saving a marriage because their peers are doing so or because contraception failed. So supporters of the use of PGD with HLA typing maintain that the donor child would still be desired or loved by his or her own family. PGD may also increasingly be used for non-therapeutic purposes. So choosing four certain traits, hair color, eye color, height, all sorts of other things, intelligence. One of the most controversial currently is sex selection. So although pre-implantation genetic testing for sex discernment may be used to test for single gene diseases that may only present in one sex, for example, X-linked diseases, that is considered non-therapeutic when it's used for family balancing. So of course, rather than avoiding those sex-linked diseases. Although in the United States, research indicates that patient preferences appears to be equally divided between the sexes, many worry that sex selection could lead to great disparities in the sex ratio of the population, like in other countries, like in China or India. Others express concern that sex selection will further emphasize and reinforce unnecessary and archaic gender expectations. Regardless of these concerns, embryos are currently being chosen and implanted based on sex. For example, recently model Chrissy Teigen and her husband John Legend made news and experienced a severe Twitter backlash by undergoing IVF and implanting only female embryos. And they are by no means the only celebrities using PGD for sex selection. The previous year, in 2014, I believe, 15, in attempting to have their second child, Kim Kardashian and Kanye West, chose to implant only male embryos. So I guess that's evidence of the even split right between male and female embryos. And clinics are increasingly offering sex selection as an option in providing pre-implantation genetic testing. A 2008, and unfortunately it's an older study, but Johns Hopkins study found that 42% of IVF PGD clinics used this technologies for non-medical sex selection. However, only 41% of those clinics that offered it reported that they would provide the service for a second or subsequent child only and not for a first born child. In 2015, the Ethics Committee of the ASRM published its guidance titled Use of Reproductive Technology for Sex Selection for Non-Medical Reasons. This replaced two previous documents by the ASRM on the same subject. Rather than reaching consensus on the advisability of non-medical uses of preconception sex selection and IVF with pre-implantation screening, the committee instead quote, outlined arguments foreign against these practices as a benefit to ASRM members. It concluded that practitioners offering assisted reproductive services are under no obligation to provide or refuse to provide non-medically indicated methods of sex selection. So it's up to you. Finally, and a particular interest to many scholars or at least legal and philosophical scholars is the potential use of PGD to select four certain traits that society generally views as undesirable. In such cases, parents who often have certain society as what society would perhaps call a defect, for example deafness or a chondroplasia, will seek to transfer embryos that test positive for these same traits. It's argued that in these instances, the child is still able to live a worthwhile life while also enabling the child to be like the child's parents and a member of the child's community and culture. In many such instances, the trait is considered an identity rather than a medical illness that should be avoided or treated or cured. For example, although it did not actually involve PGD, but it I think represents cases that we're seeing more and more of today. In 2002, a same sex lesbian couple that both members were deaf and they saw a deaf sperm donor to increase the chances that their child would also be deaf. This led to incredibly intense media scrutiny and public scrutiny and has yet been resolved at least societally about the desirability of doing this. So because of reporting requirements in the United States and I'll discuss those in a little bit, it's difficult to determine exactly how pre-implantation genetic testing is actually being used in the United States. What I will say right now is the CDC, the Centers for Disease Control and Prevention asks that all clinics that provide IVF report pregnancy success rates annually to its web-based national ART surveillance system. But reporting of PGD specifically, its use and its outcomes is not required. Our best estimates come from reported data though from this surveillance system. And according to numbers from 2011 and 2012, 9% of the approximately 107,000 IVF cycles performed utilized PGD, this 9,833. 55.6 of these were performed for screening for chromosomal abnormalities, which is oops, it's right there, 28%, wait, where am I, 15.3% provided it for genetic testing. So this is this PGD genetic and 29% for other reasons which didn't seem to really clarify what that was. And although this is the study we saw before, although it's a few years old, this Johns Hopkins study did survey the provision of pre-implantation genetic testing for US clinics for various purposes. So 28% of the population, or sorry, 28% of the clinics provided PGD for adult onset disorders such as hunting disease, Alzheimer's disease, and cancer. Approximately 24% had performed PGD for HLA typing in order to create the so-called savior sibling. And 3% had provided PGD to select for an embryo with the genes predisposing the child to a disability. So when weighing the risks and benefits of pre-implantation testing, it is important to note that while generally safe, PGD is not without risk. The 2013 ASRM guidance on the use of PGD for adult onset disorders explained that, well first, noted the risks that are associated with IVF generally, which we've seen before, and then concluded, thus, long-term consequences for the offspring after PGD cannot be ruled out with certainty at present. While with the available PGD technology, moreover, testing is only available for single gene disorders and risk of diagnostic error remain. And this last observation is gonna be important as we start to talk about liability. So in the context of the ethical limits and then the legal liabilities for using pre-implantation testing, we have to ask what's special about pre-implantation genetic testing? So unlike other assisted reproductive technologies and interventions, PGD occurs after conception, but before implantation, and also after conception. So it's a little bit of a strange place. The concept of potential life is at play, but generally questions of privacy and bodily integrity of the gestational mother are not as salient as they might be later. In other words, because when all goes well, only unaffected embryos are implanted, pre-implantation genetic testing is presented as an attractive alternative to some post-implantation genetic procedures, for example, amniocentesis or CVS, which are frequently then followed by the difficult decision of pregnancy termination if results aren't desirable. So this brings us into a previously uncharted territory that may require a different balancing of interests and some important metaphysical questions. From a legal perspective, which is more my purview, it means that the harms arise might be somewhat unique compared to the harms that occur when either a pregnancy occurs but it's not wanted or when a pregnancy is sought but is not obtained. Dove Fox, a law professor at the University of San Diego, refers to harms that occur at this stage as confounded reproduction, meaning that a desired pregnancy or birth will occur but the fetus or baby has traits that are not intended based on the use of assisted reproduction. Besides PGD gonorrhoi, which is sort of the focus of this talk, Professor Fox also uses confounded reproduction to refer to situations where eggs or sperm or where eggs are fertilized with the wrong sperm or where embryos are implanted into the wrong uterus or the switched baby scenarios. And the ASRM is ethical guidance for such situations, for those kinds of confounded reproductive situations. In 2016, it updated its disclosure of medical errors involving gametes or embryos. Its recommendations address ensuring that gametes and embryos are not switched or harmed during the assisted reproductive process. However, the organization's recommendations focus on disclosure of such egregious errors as switched embryos that result in, quote, the birth of a child with a different genetic parentage than intended. And in considering cases involving medical errors in assisted reproduction, the ASRM emphasizes autonomy and fairness due to the unique aspects of reproductive analogies and the unique aspects of the doctor-patient relationship within the use of reproductive technologies. It highlights the sensitive nature of the DPR in the reproductive context. And that's actually this quote here. The principles of open and honest communication with patients have special significance in reproductive medicine. Fertility treatments are often stressful and patients may be particularly sensitive to the statements of their healthcare providers. In addition, errors in reproductive medicine may affect the couple's ability to have a child. In situations in which errors are particularly serious where embryos are mistakenly transferred to the wrong patient, the error may lead to the birth of a different child than the one intended. Such births can lead to significant emotional turmoil and the burdens of parentage or custody lawsuits, which can adversely affect all involved parties, including the children. Thus, it recommended that clinics disclose such errors. This call for disclosure is significant, though, as we get into the discussion of the liability for mistakes that are made during pre-implantation genetic testing and IVF. So is there any oversight of this technology at the state or federal level? Well, importantly, and compared to most medical interventions, current oversight mechanisms do very little to protect participants' health and safety when pursuing assisted reproduction. There are no federal legal standards that directly regulate the use of pre-implantation or prenatal genetic testing, nor has any state passed such laws or assumed oversight of fertility clinics. However, assisted reproduction is not entirely the wild west of medicine, although lots of people would argue that it is. Various statutes and regulations govern the use of assisted reproductive technologies, including the Federal Fertility Clinic Success Rate and Certification Act, it's a mouthful, of 1992, the FCSRCA, which requires standardized reporting of pregnancy success rates to the CDC. And a lot of the research that we've seen thus far uses the reporting that's been done due to the statute. So however, remember that the Act does not require reporting of PGD of pre-implantation genetic diagnosis or pre-implantation genetic screening specific information. It allows it, so that's why we have some numbers. But the Act does task the CDC to develop a model program for states for certification of embryo laboratories. The CDC does not oversee the certification itself of such laboratories because the federal government does not have direct jurisdiction over the practice of medicine. Instead, the individual states oversee the practice of medicine within their own jurisdictions. However, states have been relatively reluctant to legislate the practice of assisted reproduction. And as of 2008, which was the most recent survey of this, no state has actually enacted the model CDC program. In 2004, the FDA promulgated federal standards for regulation or for registration and regular inspection of all US assisted reproductive technology clinics to ensure that the children resulting from donated embryos are mentally and physically healthy. They also established good agency practices or good industry practices, sorry, that include follow-up with participants involved in all embryo transplantation procedures. And as we've already seen in the absence of federal or state regulation, professional societies and other policy-making bodies have recognized the need for assisted reproductive providers to self-regulate. Many reports and guidance documents recommend that new fertility treatments be thoroughly researched and approved by IRBs and that measures be taken to minimize high-order births. As we've already seen, the ASRM, and they're probably the most active in this field, periodically release guidelines to its members. However, these guidelines are voluntary and non-binding, although member clinics, member clinics of the ASRM must adhere to the organization's practice and ethics committee guidelines. ASRM members are also required as a condition of their membership to report their clinical outcomes to the CDC under the FCSRCA. That's not an acronym I say a lot. So, to the primary question of this talk, in light of the dearth of statutory and regulatory oversight of pre-implantation genetic testing, what happens when something goes wrong? And this isn't a hypothetical question. A 2008 comprehensive study here of US fertility clinics found that more than one in five of these clinics report errors in diagnosing, labeling, and handling donor samples and embryos for implantation. Here, they stated that 21% of IVF-PGD clinics report that they have been aware of inconsistencies between the results of genetic analysis of embryos and later genetic testing of the fetus post-implantation or of the resulting child. So specifically, what kind of errors or wrongs can occur? Well, the wrongs that can occur include the negligent testing selection and implantation of IVF embryos, often grounded in a provider's failure to detect a genetic anomaly or warn of the potential for a genetic anomaly and then the resulting birth of a child with that anomaly. This can occur when risks are not properly communicated or where the wrong embryo is implanted. And on the flip side, it's possible that when parents seek to have a child with a certain, at least socially anomalous trait, as we discussed before, these might include seeking to have a child who like her parents is deaf or has a contraplasia and that child is born without that trait. It's possible that they might also seek compensation. Further, parents might claim that the provider failed to properly inform them of the inherent errors associated with pre-implantation genetic testing, failed to inform them of a facility's minimal experience in providing such services, or failed to inform parents or patients of pre-implantation genetic testing as a treatment option. And when these wrongs occur, there may be significant medical, psychological, and economic implications for those individuals who pursued pre-implantation genetic testing to avoid a genetic disease or to improve the chance of achieving a pregnancy. Those who are harmed due to a misdiagnosis or a mistake may rely on a number of types of claims, most of which sound in tort law. Or in tort law, in other words, a civil law that governs private wrongs that's in contrast to criminal law. So IVF facilities and physicians that provide these procedures have been sued for genetic misdiagnosis on a number of types of claims. The most basic type of claim is a negligence claim. And that's what we see the most often, or types of negligence claims. And most claims that have or can be brought by one party against another with respect to pre-implantation genetic testing do sound in negligence. Negligence, or often referred to as medical malpractice, and it depends sort of on the jurisdiction, whether the same or they're sort of split out. But these types of claims are based on negligent testing, selection and implantation of embryos, often grounded in a provider's failure to detect a genetic anomaly or warn of the potential. Currently, there are no consistent liability rules specific to the provision of or the failure to provide pre-implantation testing, particularly due to the variation between state laws. So to prevail on a negligence claim, little law 101, the plaintiff has to prove four elements. It has to prove that the defendant owed a duty to the plaintiff, usually the duty of care, that the defendant breached that duty, that the breach caused the harm, otherwise known as causation, and that the harm resulted in damages or an injury. Plaintiff seeking to recover in these negligence cases typically rely on one of three types of claims with respect to the use of assisted reproduction and in particular, pre-implantation genetic testing. So while I discuss each of these types of claims, I'm gonna rely on some illustrative cases. Many of these types of claims are actually settled way before they see the inside of a courtroom. So there's not a lot of data about how often these types of claims are broad, how often they're successful, and how much they're settled for. So the first type of claim is an informed consent claim. And these are based on the failure of healthcare providers to disclose information regarding medical options. In the case of pre-implantation genetic testing, such claims may include the failure to disclose the risk of fetal abnormality, birth defects, or even undesirable traits in the resulting child. So in one case, a couple alleged that IVF providers at Columbia University and Columbia Presbyterian Medical Center failed to conduct PGT, pre-implantation genetic testing, to ascertain whether the donor egg had any genetic diseases. The couple's child was subsequently born with cystic fibrosis. The couple alleged that they were told that the donor, they used an egg donor, did not have a history of mental illness or genetic disease, and that they were never given information about even the potential for cystic fibrosis. The New York court stated that the parents would be allowed to vigorously pursue recovery from monetary damages resulting for caring for a child with cystic fibrosis. The parties actually later settled for $1.3 million before trial. In a similar case, parents sued an IVF clinic for failure to inform them, again, of the option of pre-implantation genetic testing. After their child was born with Down syndrome, the South Carolina couple sued the fertility clinic that they went to in Charlotte, North Carolina, that provided those services, the IVF services, alleging that the clinic's failure to offer IVF patients the option of pre-implantation genetic diagnosis led to substantial financial expenses. They claimed that they should have been informed of the option for pre-implantation genetic testing before their initial IVF cycle. And this case was actually never decided on the merits because it was dismissed due to a lack of jurisdiction. I think there was a lot of confusion about where they should be suing and when. So the second type of claim, wrongful birth claims. These arise when parents object to the birth of an unwanted or unplanned child. In such cases, the parents alleged that the physician or the institution failed to warn them of the risks of conceiving or giving birth to a child with serious genetic anomalies, arguing that the birth of an ill or disabled child caused the parents' harm. In these cases, parents recover from the harm that they experienced from the healthcare provider's negligence, which resulted in the birth of an unwanted or disabled child. More than half of the states in the United States permit wrongful birth actions. Because these claims are intended to help the parents be compensated for their own injury, damages what the parents can recover is are limited to the cost of raising the child until the age of majority. This seems pretty comprehensive, but it's still limited. It doesn't address the individual's ability to choose whether to continue or even start, in the case of pre-implantation genetic testing, a pregnancy. And more intangible losses can generally just be difficult to compensate. But in the largest jury award in Washington state history of any type, a jury awarded $50 million to a couple whose son was born with unbalanced chromosomal translocation, leading to profound mental and physical disabilities. The parents brought a wrongful birth case against the medical center and lab, alleging that the lab missed the translocation because the medical center mishandled the lab, no, the center, mishandled the genetic test and failed to send vital information to the lab. The couple claimed that had they known of the genetic defect, they would have ended the pregnancy. In another case, a couple underwent IVF with PGD with the sole intention of avoiding a child, having a child with cystic fibrosis. The parents were known carriers of cystic fibrosis and they underwent IVF of 10 eggs by NYU personnel. But biopsies of each embryo were then sent to Genesis Genetics, which is a genetics testing company that specializes in providing pre-implantation genetic testing to be tested. The report faxed to the NYU IVF facility, identified two of the 10 embryos, those numbered eight and 10, as carrier maternal okay to transfer. The embryologists and endocrinologists at NYU instead substituted embryo number seven for embryo number 10. Embryo number seven had already been identified as a carrier at worst. Two weeks after the child's birth, the daughter was diagnosed with cystic fibrosis. So the couple alleged that NYU IVF facilities and Genesis Genetics were negligent in their embryo screening program. The gross bombs sought damages for emotional distress, cost and expenses of medical care and continuing care for the child after the age of majority. So beyond the damages that are usually allowed in such a case. The court granted the defendants motion, the NYU and the genetics company, granted this motion for summary judgment on procedural grounds, it did not decide the merits of the case. So it's not really clear what happened after the published decision in this case. So finally, wrongful life cases, the ones that really get people's ire. Wrongful life claims are those in which the child, as represented by the child's parents or a guardian, claims that he or she would have been better off never having lived at all. And but for the physicians or the parents negligence would not in fact have lived. In other words, the child sues based on the argument that he or she shouldn't have been born. In such cases, have the defendants done their job properly, the argument goes, the plaintiff again would never have been born. And so wrongful life claims are not about whether, but for the defendants negligence, the child would have had a healthy unimpaired life. Instead, the claim is that without the doctor or parents negligence, that child would never have existed and should never have existed. Joel Feinberg and others have argued that in certain extreme cases, generally, when the resulting life of the child is not worth living, it is rational to prefer not to have come into existence at all. Most jurisdictions refuse to recognize this cause of action. Only the Supreme Courts of California and Washington and New Jersey have recognized wrongful life claims. And even in those jurisdictions, however, recovery, what one can be compensated for, is limited to the extraordinary medical and educational expenses associated with the particular impairments that the child was born with. So one of the key objections to this type of claim rests on the problem of the slippery slope. So this case did not, Zepeda versus Zepeda, Illinois case in 1963, did not obviously involve pre-implantation genetic testing or even IVF. But the court stated and worried that finding for the son in a wrongful life came against his father would encourage others to, quote, seek damages for being born of a certain color, another because of race, one for being born with a hereditary disease, another for inheriting unfortunate family characteristics, one for being born into a large and destitute family, another because a parent has an unsavory reputation. So until recently, plaintiffs sought to bring wrongful life claims in cases where the child was born with an impairment that was detectable during pregnancy, alleging that he or she should not have been brought into this world at all, and those claims were both brought against the practitioners, the healthcare providers, and the parents for not terminating the pregnancy when they learned of the abnormality or for not undergoing CVS or amniocentesis in order to detect such an anomaly. These claims raised issues of a woman's right to make decisions about her own body during pregnancy and were relatively easily dismissed because of the rather straightforward argument that the woman could not be held liable for choosing not to have an ultrasound or amniocentesis or because a mistake was made during pregnancy. And there's no legal precedent for the argument that a woman could be held liable for failing to terminate a pregnancy even after learning that a child's going to have a devastating disease. So therefore, to some, wrongful life cases may seem more accessible in pre-implantation genetic testing circumstances because they do not generally elicit arguments concerning a woman's ability to make decisions about her own body during a pregnancy as the embryo hasn't yet been implanted. Thus, pre-implantation genetic testing does not seem to implicate the right to seek a legal abortion. In other words, it may seem easier to bring a wrongful life case in a situation where the embryo has not yet been implanted because one needed focus on balancing fetal interests with a woman's bodily integrity. So we see in 2000, a child attempting, obviously with a guardian on his behalf, to distinguish PGD from the general wrongful life jurisprudence, arguing that a wrongful life claim is appropriate in the context of pre-implantation testing even if it wasn't regarding pre-natal testing. The doulins were both carriers of the gene, again, for cystic fibrosis, and it already had a child with a disease. And so they underwent IVF with PGD solely for the purpose of avoiding having another child with CF. Despite these efforts, a child, Thomas, was born with cystic fibrosis and he sued the IVF providers for wrongful life. The court, however, held that Thomas did not have a claim, noting that the same fundamental problem of logic existed as with previously wrongful life cases. There's no way the infant could have ever been born without cystic fibrosis. The court could therefore not compare the value of existence with the value of non-existence. So as you may already understand from what I've talked to have said thus far about wrongful life claims, there are a number of problems with these types of claims. For one, recall that negligence claims require a duty between the person causing the harm and the person harmed. In these cases, it can be quite unclear to whom the duty of care is owed. Is it owed by the physician or parent to the not yet implanted embryo? Is it owed to the future child, whomever that might be, or may it just be the duty of care to the parents? Do prospective children have rights such that parents and physicians owe them a duty of care? There is an inherent problem with considering the embryo a legal person or a prospective person. What would that mean for other areas of the law where embryos are not given the same legal status as born persons? What would it mean for abortion law? What would it mean for the law governing the disposition of embryos upon divorce? What would it mean for the law governing gestational surrogacy contracts? And even when there is an established duty by the provider to the would be parents, no court really has recognized a duty on the part of the parents to inform them of the option of pre-implantation genetic testing. Recall to that in order to prevail in a tort claim, a plaintiff must demonstrate that the harm resulted in damages. This raises a number of important questions and this really gets to the meat of the problem with wrongful life claims. First, can a life, can a life itself ever really be considered an injury? As the Illinois Supreme Court stated in 1985 and another case, public policy mandates against the quote judgment that an individual life is so wretched that one would have been better off not to exist. And the disability rights community in particular has countered that considering life itself to be an injury demonstrates unacceptable discrimination against existing individuals with disabilities. These arguments often arise in the context of prenatal testing, particularly in the context of Down syndrome which is the standard of care currently in prenatal testing usually. But professors Adrian Ash and Eric Perens have famously written that the act of choosing to terminate a pregnancy after prenatal testing reflects the belief that quote disability itself not societal discrimination against people with disabilities is the problem to be solved. In tort law generally, damages are awarded in an effort to compensate those who are harmed. In other words, they are intended to return the injured individual to the position he or she would have been had the harm not occurred. Proof of actual injury in typical negligence cases is difficult enough, but in wrongful life cases the question arises of how, assuming that we can say that life itself is an injury, how to calculate the value of an individual's own existence since that very existence is the wrong that's being claimed. Even courts that have recognized wrongful life claims limit damages to recovery of extraordinary medical expenses and not damages for the loss of enjoyment of life including a child's diminished capacity. So under this formulation, we're not there yet, one could recover for the negligent implantation of the wrong embryo where the parents sought pre-implantation genetic testing for non-therapeutic purposes. Instinctively, not being able to recover for these wrongs might seem like the correct outcome. One should not be able to claim that they should not have been born at all because they were born with the wrong color eyes or the wrong height or in the case where parents select four a certain disease because they were born without traits such as deafness. But what about the hypothetical case where pre-implantation genetic diagnosis is sought to produce a savior sibling? But it was negligently performed, thereby resulting in the birth of an infant with an HLA type which does not match the older sibling. Might perhaps the older sibling have a cause of action, if so, how would the value of that injury even be calculated? And the question of how to calculate the value of the injury if the injury is life itself also implicates the now famous non-identity problem as posed by the recently passed Eric Parfit. In his 1984 Reasons in Persons, he presented a hypothetical of a 14-year-old girl who seeks to have a child. He acknowledges, Parfit acknowledges, that the child would not receive the same start in life had the girl decided to wait several years before having a baby. However, that later-born child would be a different child from the particular child she would have had at 14 years old. Parfit rejects the rights-based argument that having the child at 14 violates the child's right to a good start in life because the girl could not have had that particular child at any other point in her life. As long as the child is given a life worth living, and he does acknowledge that there might be times that a life might not be worth living, but as long as it is, it cannot claim to have been harmed by being created. Thus, there's no way to calculate the value of the injury since the resulting child would not exist but for the actions of the parents and healthcare providers. In cases, for example, where we saw the embryos being switched using pre-implantation genetic testing, the parents, or in cases where parents choose to implant an embryo with certain genetic defects, there's no chance that that particular child would have been born any other way. So scholars have raised the question of whether these arguments regarding the non-identity problem would similarly apply to cases involving genetic modification, and I bring this up because there's a lot of news about this in the last 24 hours. Although this lecture has been focused on pre-implantation genetic screening and testing, which is a technology that's already being used in at least 4% of all IVF clinics, considerations of genetic modifications are not just the stuff of science fiction. In fact, CRISPR, a technology that makes it possible to alter the genetic makeup of cells, was named 2015 Science Breakthrough of the Year. But that same year, Congress added a writer to the US Department of Health and Human Services Appropriation Bill, which forbids the FDA from considering any proposal to create genetically modified offspring. Regardless, just yesterday, in a bit of a surprise, a panel of the National Academies of Science recommended that germline modification of human beings be permitted in the future in certain narrow circumstances to prevent the birth of a child with serious disease or conditions, but only with stringent oversight. The authors of this report distinguish between preventing disease and doing enhancements, or changes as they define it, changes that go beyond mere restoration or protection of health, the latter of which they said should not be pursued at this time. But if this report is any indication of the future of reproductive interventions, questions of liability will inevitably arise when things go wrong. And as some scholars have noted, the argument that the non-identity problem precludes recovery for wrongful life when pre-implantation genetic testing is used would perhaps not apply when we're talking about cases involving pre-implantation genetic modification. Whether modifying a human embryo to include or exclude genetic traits would change the identity of the resulting child is not one I'm attempting to answer at this point. In raising this issue, I'm simply pointing out the difficulties in applying the non-identity problem to modern technology. I'm gonna leave it to the philosophers to define the line at which a single embryo would become so altered by genetic modification that it would result in a child with a different identity. On the whole, these tort claims give rise to a number of ethical concerns which necessitate a determination of the extent that our liability rules do and should influence social outcomes. It's worth considering how our liability rules affect healthcare providers and institutions' actions and parental decisions. As we reflect back on the various uses of pre-implantation and genetic testing and the ethical implications of both, among other things we should ask ourselves how society approaches issues of disability, what societal duties there might be to use pre-implantation genetic testing and whether pursuing genetic enhancement is ever acceptable and if so, under what conditions? Before I finish, I want to briefly touch on just one of those questions, whether there's an obligation to use pre-implantation genetic testing to reduce risk and burden on society. Judith Dar, a law professor at Whittier Law School, and others have explored the possibility of parental choice shifting to parental responsibility to use pre-implantation testing to benefit medically future children. For example, it's been argued that an ethical and legal case can be made in favor of using PGD when potential parents are aware that a possible future child is at substantial risk of inheriting a serious genetic condition. In such cases, there may be liability then against parents for failing to pursue PGD. Dar calls this pressure to utilize genetic technologies to avoid genetic anomalies, the expectation problem. This problem raises the specter of eugenics as the state becomes more and more involved in parental reproductive choices. And as Dar provocatively states in her new book, quote, the true eugenic impact of modern day reproductive technologies is not in their use, but in their deprivation. Thus raising, of course, important questions of justice. And this problem implicates our understanding of the best interests of the child standard and notions of disability and discrimination. Although these concerns raise important questions that we must continue to grapple with, currently, as Dar puts it, the idea of a universal expectation to use PGD seems clinically unrealistic. Mother nature is a far more compelling, efficient, and successful alternative to technically assisted appropriation. Thank you. Can we say it? Professor Koch's paper is open for comments and questions. Very nice talk, Valerie. So I was wondering, it seems like there's a very little federal oversight. Basically, they make sure the lab meets certain standards. But their ethics committee seems like they're very busy saying, do what you like to do, pretty much. It sounds like. Do you think there should be more supervision about what kind of testing is offered? Or do you think there should be any more federal oversight than there already is? To some extent, yes. I do believe there should be some increased oversight, at least, I think, at the state level. The problem with imposing, but the states, imposing any sort of regulation on the clinics within their state is reproductive tourism. People are just going to go across state line to access the same technologies right next door. And so there is a problem with that because therefore there's a race to the bottom in that nobody is really overseeing these technologies in any way. And these technologies, this is probably one of the only areas of medicine that really does not have the same level of oversight than most technologies, most medical interventions do, to some extent, at least the state level when or at least when it comes to, say, licensure and oversight by state departments of health for providers who might be doing things that they shouldn't be doing. Very simple question. How expensive is this pre-implantation genetic testing and who pays for it? So as we've seen in previous lectures, IVF itself is very expensive. Each cycle, I believe, is somewhere around $12,000 a cycle. PGD adds another, I think, $4,000 to $6,000 per cycle. Those are generally paid out-of-pocket insurance companies do not usually cover PGD. Even when there is disease or carrier states in the parents, the insurance company still would not pay. Generally not. Usually they will do, they'll cover genetic testing before IVF. It's a good question. Because most insurance companies don't cover IVF at all, they're not going to be covering this additional aspect. I guess I don't worry so much about here because we have such a tradition of freedom, but maybe I'm just naive. But I could imagine someplace like, I don't know, Russia using something like this to produce super athlete or someplace else using this to try to breed scientists or something. Well, use of pre-implantation genetic diagnosis even more so if you're talking about genetic modification, I think is even more that sort of that specter of eugenics that I referred to at the end, and state involvement in using of these technologies. At this stage, it's still very expensive. It's still very unclear. And most of these are one-trade screening. So it's one single mutation screening. That said, I think that's a very real concern that many scholars have raised, is whether there is an obligation to use these technologies in order to have the perfect child. I mean, it raises sort of the Gadica reference that everyone likes to refer to of bringing into the world a race of perfect children or something like that. At this stage, as I said in the United States, there's no oversight of it. There are countries that do forbid the use of PGD unless under very, very specific circumstances. So for example, Germany does not allow generally the use of pre-implantation genetic testing with IVF for parents seeking to use these technologies. I mean, there are other countries as well that do that as well. Yeah, it's expensive for individual parents, but if the state gets behind a special program, then the state's got a lot of resources, plus. I said we have a lot of resources in Illinois. So some states have tried to pass legislation that protects physicians who knowingly withhold information that they believe could result in a woman or a family deciding to terminate a pregnancy. How are kind of the wrongful birth cases with PGD similar to or different from the cases, kind of wrongful birth cases around pregnancies that have been conceived and information was knowingly withheld from the woman and or couple. I think there aren't many of those cases, to my knowledge. Right, not necessarily legal cases. I mean, those would raise the latter where a child is or where an embryo is implanted and then the family does not have information about the genetic anomaly that results in a child with a disorder. Those cases, the big difference, of course, is that it would raise issues of conscience and one's ability to not disclose. Those cases have really not been litigated yet. I think that more and more states are passing laws like that. One of the reasons that this technology is appealing to many is because it occurs before implantation. And so when you have states, for example, that are currently passing laws to forbid abortion due to sex or abortion due to knowledge of Down syndrome or other abnormalities or other disorders, this, then, is sort of a way around that, around those laws. It's allowing parents to make those decisions before their force, then, to make a decision about what to do once they have that information as far as pregnancy termination goes. But then you have other states, like Louisiana, that's trying to pass laws that say that all embryos must be implanted. And so that is a question, right? I didn't really get into those questions about what do we do with the embryos that aren't being implanted. But I think that those are the questions that we've raised again and again in the abortion context. And I was trying to focus on the other issues, but, and those are, they're just as salient here as they are when we're talking about gestational contracts or any of the other, or egg donation or any of the other cases that we've been talking about this year. Is there, like, a right to information? You know, is that something that, as a concept, right? Like, if I'm getting testing, do I have a right to that information, whether it be pre-implantation, post-implantation? Not really. That it could come up in an informed consent claim. One could argue that one was not given all of the risks, benefits, and alternatives for proposed intervention. But when you have legislation that is specifically forbidding the disclosure of certain information, that would, those would be very hard claims to bring. The, I think the stronger argument is often made by the provider, by the healthcare provider that not being allowed to disclose certain information is a violation of their ability to, to practice in their field, to be the doctor that they're supposed to be, the provider that they're supposed to be. And those arguments usually see the language about chilling the practice of medicine. That's sort of language that comes up often in the abortion context, pregnancy termination context, about what physicians are and are not allowed to say and do. So I think that's probably a stronger argument than the patient arguing that they needed, that they had a right to that information. But there, I'm sorry, there are two kinds of laws. Some laws are that the physician is not allowed to disclose information to the patient. But there are, there are, like, Arkansas tried to pass a law such that if the physician does not want to disclose, they have a right to not disclose it. So, you know what I'm saying? There are two different kinds of arguments in terms of provision of information to the patient. I don't know if those are viewed differently, but we could talk offline. It was interesting to hear you say that there was so few federal laws, none, or state laws covering many of these issues. A number of years ago, I sat on a committee of the National Academy that looked at the issue of cloning. And we were amazed, we were simply amazed to find how few rules there were legislatively about reproduction in general. And the idea was that reproductive rights was such a powerful concept in the United States that there was a hesitancy to pass any law that seemed in any way, including laws against cloning, to impede the reproductive rights of individuals. It sounds like that issue continues to the present. Absolutely, a point that I didn't get to today in the interest of trying to save a little bit of time. But one of the things I do explore is whether there is a constitutional or some sort of right to access these technologies. And whether that might be one of the reasons we have a very limited set of oversight mechanisms for these technologies. And there are definitely Supreme Court cases that go to the right, at least with married couples within the, you know, to procreate or to attempt to procreate. So then the question becomes, how much can we expand that? Is there a right to access technologies to help a couple procreate? What does that mean? How do we do that? I thought it was very interesting about the wrongful birth in the situation where there's been a, say for example, a normal pre-genetic testing that's being performed. Because normally the reproductive endocrinologist is not the OB for the patient going forward. And the OB would still have, I think it would be rare that an OB would just accept that because it's not kind of a gold standard or widely used. So most of the time you'd still have other testing that would be offered, such as maternity 21 or your AFP testing, screening, as well as any further testing. I think it would be rare that a lot of OBs would be relying on that pre-genetic testing to make decisions at least for the trisomies or the things that we usually screen for. Yeah, and I think that's, as from the research that I've seen too, in most cases where the pre-implantation genetic testing is done, there's still prenatal screening after implantation. Of course these cases, the ones that I'm referring to are the ones that come up where a mistake was made, which is where the wrong embryo is implanted or something like that. Which could be picked up on pretty quickly. And for disease testing as well, I think a lot of times nowadays they do it in the trifectoderm stage, it's not the eight cell stage. So there are problems obviously with that coming from the origin of what would be the placenta, as well as potential problems with mosaicism going forward as well. So I think that an informed consent process by the reproductive endocrinologist and the lab that's performing it to really explain that to parents that this is not 100%, I think that would also be an area for potential improvement. Absolutely, I think that's right. There's, I had a whole bunch of other slides, but being a lawyer and not a practitioner, I figured others could speak to it better than I can, but going through all of the various things that can, not necessarily go wrong, but just uncertainties that occur during the testing process that go be, and so instead I was really focusing on what happens when something's mishandled, when it's labeled switched, kind of the more egregious examples where we really see these cases going to court. I want to thank you so much for everything.