Ethical and Legal Issues Arising from the Informed Consent Process in Fertility Treatments
By Catherine Tucker, Concord, NH
As with any medical procedure, patients must provide informed consent to fertility treatments such as artificial insemination and in vitro fertilization (“IVF”).1 Informed consent occurs when a patient understands the nature of the proposed treatment as well as the potential benefits and risks of the treatment and potential alternatives, and voluntarily chooses to proceed with the treatment.2
Many fertility clinics have standardized forms for patients to complete as part of the informed consent process. Typically, the physician will have the informed consent discussion with patients simultaneously with the completion of the informed consent paperwork. However, it is unrealistic to expect a physician to understand the nuances of the unsettled field of parentage law.
The informed consent paperwork often goes beyond the concepts of procedures, benefits and risks, and delves into issues such as the establishment and relinquishment of parental rights. Traditionally, legal claims to parentage for children born via medical assistance came about in the context of the use of anonymous donor sperm to inseminate married women, and thus many states passed laws to provide that the husband would be the legal father if the insemination were performed with his consent.3 For these straightforward traditional situations, boilerplate parentage provisions in clinic consent forms were typically sufficient. However, as fertility treatments have become more medically advanced and available to persons other than married heterosexual couples, the legal issues surrounding parentage have become more complex and cannot be resolved by such boilerplate provisions in consent forms. Despite the importance to patients of ensuring that legal parental rights are properly established and relinquished, this paperwork is typically completed by patients without the benefit of legal counsel. It is in these contexts that ethical and legal issues arise.
INAPPROPRIATELY USED CLINIC CONSENT FORMS
Clinic consent forms can be the source of problems when the patients’ legal needs do not fit neatly into the framework intended to be addressed by the forms, which as noted above are typically designed for the needs of married heterosexual couples. Problems can occur, for instance, when the patients are not married, when the patients are a same-sex couple, or when the patient is a single individual.
For example, in one California case, a lesbian couple sought IVF treatment, with one partner providing the eggs and the other partner gestating the pregnancy. After the birth, the women separated and a custody battle ensued. Because the egg-providing partner had signed the clinic’s standardized known egg donor consent form that provided that she relinquished any claim to the eggs or offspring, she faced an uphill battle establishing her legal rights as a parent. The known egg donor consent form had been designed for use with typical non-anonymous donations, such as a sister to a sister or a friend to a friend, and contained provisions appropriate to most such donations, such as the waiver of rights to and relinquishment of any claims to the eggs and resulting children.4 Both the trial court and the intermediate appellate court found that the egg-providing partner had relinquished any claim to parentage because she knowingly and voluntarily signed the consent form despite her claims that this was not the type of “true ‘egg donation’” contemplated by the consent form.5 Ultimately, the Supreme Court of California reversed, finding her to be a legal mother and holding that the attempted relinquishment of rights was not applicable when the resulting child was to be raised in the joint home of two partners in a lesbian relationship.6
A Florida case involved a very similar set of facts with a lesbian couple deciding to proceed with IVF with eggs being retrieved from one partner and the resulting embryos being transferred to the other partner for pregnancy. Again, the egg-providing partner was given a consent form not appropriate for her circumstances, and upon the termination of the couples’ relationship, the gestational partner argued that the eggs had been donated to her pursuant to the language of the clinic consent form which stated that the donor forever waived any claims to the resulting offspring.7 The treating physician submitted an affidavit to the Court explaining that the clinic consent form was a standardized form that he chose to use even though some of the provisions were inapplicable to this lesbian couple because such provisions were intended only for anonymous donations.8 The Court found that the waiver provisions did not apply to the particular facts of this case where the parties intended to jointly procreate.9
It is clear that these lengthy court battles could have been avoided with the use of appropriate consent forms that accurately reflected the status of the two women as same-sex partners who intended to procreate together by splitting the two biological methods of female reproduction (genetics and gestation) amongst themselves.
Given the minimal regulation of fertility clinics with regards to the informed consent procedure, it is likely that such situations will continue to arise. Clinicians need to be mindful that it is not unheard of for a fertility clinic to be held responsible for errors in the informed consent process despite the birth of a healthy child.10
MISPLACED RELIANCE ON CLINIC CONSENT FORMS TO PROTECT LEGAL RIGHTS
For many patients, the clinic consent forms are the only formal paperwork completed during the fertility treatment process. This can have devastating consequences, as many important legal issues cannot be appropriately addressed in clinic consent forms. Most importantly, in some situations, legal parentage cannot be properly established without a court order.11 Additionally, state law may not provide an adequate method for a given couple to establish parental rights as desired. Consider the California case where the Court came to the drastic conclusion that an unmarried male who provided his sperm to a physician for insemination of his girlfriend was not the legal father of the resulting child since the statute required the patients to be married.12 The Court interpreted the language of the California artificial insemination statute strictly and thus refused to create an exception for sperm provided by a man to a woman who was not his wife, even when the man intended to be the father of the resulting child.
For lesbian couples, problems often arise, quite ironically, in states that have expanded the rights of same-sex couples by permitting them to marry. Typically, one wife is artificially inseminated and, after the child’s birth, the non-gestating wife is able to have her name placed on the birth certificate without difficulty. Many couples then mistakenly rely on the birth certificate as proof of parentage, not realizing that the non-gestating wife’s legal rights can be terminated or voided by a court.13 The problem can be solved, in states that permit it, by completing a second or step-parent adoption of the child. However, patients have to be savvy enough to realize the importance of such an adoption, and many patients do not have that knowledge.
Consider also a scenario where a single woman uses an anonymous egg donor, with the clinic consent forms providing that the recipient will have full legal rights to the resulting child and that the egg donor relinquishes all of her rights. If the woman gives birth outside of the United States, she may find herself unable to obtain a U.S. passport to bring the baby home because the federal government will only recognize the egg donor as the legal mother of the child for citizenship purposes.14
MISSTATEMENTS OF THE LAW
Misstatements of the law relating to the disposition of any remaining cryopreserved embryos in the event of a divorce or death are not uncommon in clinic consent forms.15 For example, one clinic consent form states “Embryos cannot be used to produce pregnancy against the wishes of the partner. For example, in the event of a separation or divorce, embryos cannot be used to create a pregnancy without the express, written consent of both parties.”16 This is not an entirely accurate statement of the law. At least two courts have permitted ex-wives to use embryos created during the marriage over the opposition of the ex-husbands.17 Thus, patients can be left with a mistaken impression as to their legal rights.
DECISION-MAKING AS TO THE DISPOSITION OF CRYOPRESERVED GENETIC MATERIAL
Clinic consent forms have played an important role in litigation surrounding the use of cryopreserved genetic material following the divorce of the intended parents. Courts have taken different approaches toward evaluating the preferences expressed in the clinic consent forms.18 The clinic consent forms at issue would typically be filled out by the intended parents before the creation of the embryos, at a time when the patients’ interests are typically focused only on maximizing the chance of success of their upcoming IVF cycle. The thoughtful deliberation necessary to determine the ultimate disposition of their unused cryopreserved embryos is typically not present at this stage of the process. Given this problem, is it appropriate for dispositional directives to be addressed pre-cycle as part of the informed consent process? Perhaps a better practice would be to also contact patients post-cycle, despite the logistical difficulties that would be entailed in tracking down former patients.19
CLINIC CONSENT FORMS AS A POOR SUBSTITUTE FOR DIRECT DONOR AGREEMENTS
In many gamete and embryo donation cycles, the informed consent paperwork is used as a substitute for direct agreements between the donors and recipients.20 With clinic consents, important issues such as warranties of truthfulness relative to donor-provided medical and personal information, maintenance of anonymity, sharing of future medical information, and the consequences of the failure of the donor to comply with the treatment plan cannot be adequately addressed. Unfortunately, it is not uncommon for an egg donor to fail to comply with the rigorous treatment plan, resulting in no viable eggs. Without the benefit of a direct agreement with the donor, the recipients are often without recourse for the expenses involved in the process — typically thousands of dollars paid out-of-pocket. This expanded role of the clinic consent documents as a substitute for direct donor agreements that place the patients in privity cannot offer the same protections to the patients, and places the physician and clinic squarely in the middle of any disputes between donors and recipients.
DO PHYSICIANS HAVE AN OBLIGATION TO ADVISE PATIENTS TO OBTAIN LEGAL COUNSEL?
In line with the practice of other fields of medicine, reproductive endocrinologists do not routinely urge patients to seek their own legal counsel for review of the clinic consent forms. The question is whether physicians providing fertility services have an obligation, perhaps as part of a fiduciary duty, that goes beyond the obligation imposed on other physicians. Although an attorney review is not a substitute for the important informed consent discussion between physician and patient, many of the issues discussed above could have been averted simply by having the patients’ own attorneys involved.
Some clinic consent forms do inform patients that they can consult with an attorney, albeit in a non-assertive manner, using terminology such as “we have been informed that we may wish to consult a lawyer….if we have any questions or concerns” [emphasis added] and “You should consider consulting with a lawyer” [emphasis added].21 Such non-assertive approaches are unlikely to be heeded by patients who are often focused only on getting pregnant, and not focused on the potential legal ramifications.22 Ironically, some clinic consent forms urge in much stronger terms that patients consult with their religious community about pursuing treatment.23 While religious considerations are certainly important to many couples, the legal rights relative to resulting children (and the legal control of any excess embryos) would undoubtedly be paramount to all patients if they were aware that such rights they assume are firm could actually be subject to dispute.
It has been suggested that the fertility treatment process is just like any other transaction in which married couples participate, and the burden is on the patients to recognize the need to seek their own legal advice. This is a risky position for clinics to take, given the Stiver case where the Court assigned a heightened standard of care to the professionals, including the physicians, involved in a surrogacy arrangement that resulted in the surrogate contracting a sexually transmitted disease.24 In Stiver, the potential surrogate was artificially inseminated with the intended father’s semen, and subsequently became pregnant with what turned out to actually be her husband’s child. Unfortunately, the child had severe congenital problems resulting from prenatal exposure to Cytomegalovirus, which the surrogate claimed was contracted from the intended father’s untested semen that was used in the insemination. The defendants included the surrogacy broker25 (who also acted as an attorney for the intended father), who argued that he owed no duty to the surrogate, and the physician (along with his partners), who argued that following ordinary obstetrical standards used in non-surrogacy cases was sufficient to meet the standard of care.26 In reversing the grant of summary judgment to the defendants, the Court found that this was not “ an ordinary or routine situation in which the parties can escape liability in negligence so easily by fitting themselves into the framework of ordinary obstetrical practice” and imposed an “affirmative duty of protection, marked by a heightened diligence” that included testing for communicable diseases upon the treating physicians, the physician’s partners who profited financially from the transaction, and the surrogacy broker. The Court made special note of the fact that “without proper planning….confusion can arise as to the child’s parentage.”27 If other courts adopt the reasoning of the Stiver Court, physicians who fail to adequately advise patients to seek their own legal counsel are putting themselves at risk of getting dragged into protracted legal battles.
LOOKING TO SOLUTIONS
Appropriate boundaries are best maintained when clinicians are able to focus on the medical aspects of the treatment, including discussions with patients about the risks, benefits and alternatives associated with treatment plans, rather than having to venture into the messy territory of legal rights relative to parentage and embryo disposition. To best maintain this separation, physicians should adopt a routine practice of recommending that all patients undergoing artificial insemination or any form of IVF consult with legal counsel. For those medical procedures where the legal risks of parentage are particularly high, physicians should refuse to proceed with treatment until legal clearance from the patients’ counsel has been obtained.28 Clinics should also work with their own legal counsel to revise their consent forms to include language indicating a strong recommendation to patients to seek legal counsel and to remove legal statements upon which patients may — to their detriment — rely.
Catherine Tucker, a solo practitioner in Concord, NH, practices Assisted Reproductive Technology Law and can be reached at email@example.com.
|1||Artificial insemination involves the introduction of sperm into a woman’s body, typically into her uterus, by artificial means. IVF involves the pharmaceutical stimulation of a woman’s ovaries and the surgical removal of the resulting eggs; the mature eggs are combined with sperm and the resulting embryos are cultured in the laboratory for several days before one or two embryos are placed into the woman’s uterus with the goal of implantation. Any excess embryos can be cryopreserved (frozen) for use at a future time.|
See, e.g., Waldt v. University of Maryland Medical System Corp. , 956 A.2d 223 (Md.App. 2008) (elements of informed consent); Duffy v. Flagg, 905 A.2d 15, 20-21 (Conn. 2006) (same) ; see also Spaight v. Shah-Hosseini , Superior Court of Rhode Island No. C.A. PC 04-6802-Decided December 30, 2009 (discussion of doctrine of informed consent).
E.g., Mass. Gen. Laws c. 46 § 4B (2012) (providing that husband shall be the legal father of a child born to his wife via artificial insemination performed with his consent).
Id. at 486, 492-3. The Court also rejected arguments based on the California statutory scheme for sperm donation.
K .M. v. E.G., 117 P.3d 673 (Cal. 2005).
“‘ I, the undersigned, forever hereinafter relinquish any claim to, or jurisdiction over the offspring that might result from this donation and waive any and all rights to future consent, notice, or consultation regarding such donation. I agree that the recipient may regard the donated eggs as her own and any offspring resulting there from as her own children. I understand that the recipient of the eggs, her partner, their successors, offsprings and assigns have agreed to release me from liability for any mental or physical disabilities of the children born as a result of the Donor Oocyte Program and from any legal or financial responsibilities from an established pregnancy or medical costs related to that pregnancy or delivery.’” T.M.H. v. D.M.T., 79 So.3d 787, 801 (Fla. App. 5 Dist. 2011).
Id. at 802. Like the Supreme Court of California, the Court also rejected arguments based on the Florida statutory scheme for gamete donation.
See Gladu v. Boston IVF, 32 M.L.W. 1195 (Middlesex Sup. Ct., February 9, 2004) (clinic, but not physicians, found liable by jury for treatment of divorcing wife without her husband’s knowledge or consent; damages included financial support of resulting child and emotional distress).
|11||Most clinics recognize that parentage in cases involving gestational carriers (surrogates) is particularly complex, and insist that intended parents using such procedures hire lawyers.|
Steven S. v. Deborah D., 127 Cal. App. 4th 319 (2005) (considering the application of Cal. Fam. Code §7613(b) which provided that “The donor of semen provided to a licensed physician and surgeon for use in artificial insemination of a woman other than the donor’s wife is treated in law as if he were not the natural father of a child thereby conceived.”).
|13||While this is equally true in theory for heterosexual couples, it is in reality more of a problem for same-sex couples because not all states recognize same-sex marriages. The federal Defense of Marriage Act currently permits a state to refuse to recognize parental rights grounded solely in an out-of-state same-sex marriage, and thus parental rights derived through same-sex marriage are not automatically portable throughout the United States. SeeMiller-Jenkins, 637 S.E.2d 330 (Va. 2006) (discussion of Defense of Marriage Act in context of state recognition of same-sex parentage) ; In Re Sebastian, Surrogate’s Court of New York No. 38-08-Decided April 9, 2009 (discussion of adoption in context of same-sex parentage).|
E.g., http://usatoday30.usatoday.com/news/world/story/2012-03-19/in-vitro-citizenship/53656616/1; see also http://travel.state.gov/law/citizenship/citizenship_5177.html.
It is very common for clinic consent forms to have patients specify how they would like to have the embryos used in the event of the death of one or both patients, or in the event of a divorce. Typical options offered include donation to research, destruction or donation to a third party for reproductive purposes. Some clinic consent forms also offer the option of having the embryos transferred to the exclusive control of one of the patients.
The clinic consent documents referenced in this article were obtained by the author through the Google search engine, and represent documents available to the general public on the Internet. The author thanks the clinics for making these documents available to the general public, as it allows for both transparency in the process and for patients to review the documents well in advance of their meeting with their physician. Citations to the forms are not included here, in order to avoid identifying and singling out the clinics, but citations will be provided by the author upon request.
See Reber v. Reiss , 42 A.3d 1131 (Pa.Super. 2012) and Mbah v. Anong , CAD11-11394, CAD10-24995 (consolidated) (Md. Circ. Ct., 7 th Jud. Dist., December 21, 2012).
|18||See, e.g., In Re Witten, 672 N.W.2d 768 (Iowa 2003); Davis v. Davis, 842 S.W.2d 588 (Tenn. 1992).|
|19||It is for these types of reason that some courts have refused to enforce pre-treatment embryos disposition provisions in clinic consent forms. See, e.g., A.Z. v. B.Z. , 725 N.E.2d 1051 (Mass. 2000) . The American Society for Reproductive Medicine’s guidelines recommend that couples re-evaluate their disposition options after concluding their own reproductive attempts. The Practice Committee of the American Society for Reproductive Medicine and the Practice Committee of the Society for Assisted Reproductive Technology, Recommendations for Gamete and Embryo Donation: A Committee Opinion, 99 Fertility and Sterility 47 (2013). But cf., § 742.17, Fla. Stat. (2012), requiring that the commissioning couple and treating physician enter into a written agreement to provide for the written disposition of embryos in the event of divorce, death or other unforeseen circumstances. A related issue is that many patients mistakenly believe that their desires as expressed on the clinic consent forms are binding and will be followed in the case of death or divorce.|
|20||The American Society for Reproductive Medicine goes so far as to recommend that clinic consent documents address both parental rights and “legal procedures and/or dispute resolution” for embryo donations. The Practice Committee of the American Society for Reproductive Medicine and the Practice Committee of the Society for Assisted Reproductive Technology, Recommendations for Gamete and Embryo Donation: A Committee Opinion, 99 Fertility and Sterility 47 (2013).|
See supra note 16.
|22||For example, is it reasonable for patients to realize on their own initiative that the language “At the moment of embryo transfer to the recipient patient . . . full parental rights will be vested in the intended parents” means that the egg donor can change her mind after the eggs have been retrieved and mixed with the husband’s sperm? See supra note xvi.|
For example, “We encourage patients and their spouses or partners who so desire to consult with trusted members of their religious or ethics community for guidance on their infertility treatment” [emphasis added]. See supra note 16.
|24||Stiver v. Parker, 975 F.2d 261 (6th Cir. 1992).|
|25||Id. at 268-9.|
|26||Id. Note that Reproductive Endocrinology — the area of medicine that deals with fertility — is a subspecialty of Obstetrics and Gynecology.|
|27||Id. at 269.|
|28||Most attorneys would agree that gestational and traditional surrogacy, known sperm donation, and embryo donation are legally high risk. Agreement as to the benefits of legal consults for egg donation, anonymous sperm donation, and treatments involving only the patients’ own gametes are less uniform, although it is the author’s position that patients can greatly benefit from legal consults in all such situations.|
The ABA Health eSource is distributed automatically to members of the ABA Health Law Section . Please feel free to forward it! Non-members may also sign up to receive the ABA Health eSource.