Clinical Review & Education
Special Communication
Oncofertility and the Rights to Future Fertility Ehren M. Fournier, JD Viewpoint and Editorial
The field of oncofertility, or fertility preservation for patients facing a cancer diagnosis, has seen significant scientific breakthroughs that allow adults and children undergoing fertility-threatening cancer treatment to preserve their fertility for a life after cancer. These breakthroughs also raise complex legal issues for patients and clinicians. While the current scholarship tangentially discusses the disposition of genetic material in regards to pediatric patients, this Special Communication examines the current legal framework as applied to disputes regarding the disposition of genetic material between the oncofertility patient and donor, and provides a potential new solution for courts to use in determining the rights of parties in disputes involving donated genetic material.
T
The Facts of Szafranski v Dunston In 2010, Dunston received a diagnosis of cancer and sought fertility preservation treatment at Northwestern Memorial Hospital.4 Her boyfriend at the time, Szafranski, volunteered to donate sperm for the purpose of creating preembryos for Dunston’s use after her treatment. The two signed a consent agreement with Northwestern Memorial Hospital titled “Informed Consent for Assisted Reproduction,” which stated that no use could be made of the preembryos “without the consent of both partners (if applicable).”5 The couple also met with an attorney, who provided them with a co-parenting agreement establishing both parties as legal co-parents ofthechild.6 Underthatagreement,thecouplewasrequiredtoattempt at least 1 in vitro fertilization (IVF) process for which Szafranski would provide the sperm to create the preembryos. The agreement also objamaoncology.com
Author Affiliation: Foley & Lardner LLP, Chicago, Illinois. Corresponding Author: Ehren M. Fournier, JD, Foley & Lardner LLP, 321 N Clark St, Ste 2800, Chicago, IL 60654 ([email protected]).
JAMA Oncol. doi:10.1001/jamaoncol.2015.5610 Published online January 28, 2016.
he scenario: a young woman of childbearing age receives a diagnosis of cancer. To save her life, she must undergo a life-preserving, but fertility-threatening, treatment. The solution is to harvest her eggs that are then fertilized by a sperm donor, frozen, and preserved for later implantation. Her boyfriend agrees to provide the sperm. After treatment is over, the two split up. Years later, she wants to use the cryopreserved preembryos to get pregnant, but the ex-boyfriend asserts a right to prevent her from doing so, and files suit to permanently enjoin her from using the embryos. Whose rights prevail? This issue significantly affects the field of oncofertility, or the practice of preserving fertility for patients with a cancer diagnosis who face treatment options that threaten their fertility.1 As survivor rates for patients with cancer increase, planning for a life after cancer is a growing part of cancer treatment plans in hospitals and cancer centers.2,3 The approaches adopted by several states are deficient in that they derive largely from factual situations that are inapplicable to the oncofertility scenario. This Special Communication provides a solution designed to meet the needs of oncofertility patients.
JAMA OncologyPatient Page
ligated Szafranski to undertake all “legal, custodial, and other obligations to the child regardless of change of circumstances.” Finally, under the terms of the agreement, Dunston retained sole control of the harvested eggs and “disposition of the preembryos” should the couple separate, and it was stated that Szafranski “acknowledges and agrees that [Dunston] is likely to be unable to create new healthy embryos subsequent to the chemotherapy regiment [sic] she will undergo, and [Szafranski] specifically agrees that [Dunston] should have the opportunity to use such embryos to have a child.”6 Thisshouldhaveendedthediscussion,butthecoupleneversigned the agreement.6 On April 6, 2010, Szafranski deposited his sperm and the couple fertilized all available eggs harvested from Dunston. In May 2010, Szafranski ended the relationship and, a little more than 1 year later, filed suit to prevent Dunston from using the preembryos claiming to “preserv[e] his right not to forcibly father a child against his will.”7 Dunston claimed that Szafranski breached their agreement. The Circuit Court for Cook County sided with Dunston. On appeal in Szafranski v Dunston,8 the Illinois Court of Appeals examined 3 common approaches (outlined here in further detail) and sent the case back to the Circuit Court ordering them to apply a different approach than it had usedinitsinitialdecision.TheCircuitCourt,applyingthenewtest,again sided with Dunston. Recently, the Illinois Court of Appeals, hearing the case again, sided with Dunston, finding that Dunston and Szafranski entered into an implied oral contract.9
Current Approaches to Cryopreserved Preembryos On appeal in Szafranski v Dunston, the Illinois court analyzed the law surrounding cryopreserved preembryos in other states and found 3 basic approaches to resolving disputes: (1) the contractual approach, (2) the mutual contemporaneous consent approach, and (3) the balancing approach.10
The Contractual Approach In the contractual approach, a court will look to see whether a contract, either written or oral, exists between the parties and, if there (Reprinted) JAMA Oncology Published online January 28, 2016
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is a preexisting contract, it will enforce the terms of that agreement.11 If the contract is ambiguous, courts will attempt to determine the intent of the parties when they entered the agreement. So far, 6 states have explicitly adopted the contractual approach: Illinois, New York, Oregon, Texas, Washington, and Massachusetts. While 4 of these states are discussed herein, Tennessee implicitly adopted the contractual approach in Davis v Davis.12 However, the court declined to follow that approach, since the parties had no explicit agreement. In addition, there is an inclination that Virginia, if faced with the same issue, may follow the contract approach13 (recognizing that cryopreservation agreements represent a bailment agreement between the progenitors and the clinic). As set forth in Kass v Kass,14 the contractual approach benefits parties by requiring them to “think through possible contingencies and carefully specify their wishes.”11 Courts have claimed that the contractual approach “avoids costly litigation” and where the stakes are high, emotional, and largely intangible, express agreement between the parties, clearly stated, saves courts and litigants from uncertainty.11 Further, written agreements provide stability to IVF clinicians, who, in the absence of a written agreement between the parties, may be dragged into disputes between litigants. However, scholars have criticized the contractual approach because it fails to adapt to the changing circumstances of the parties. As stated in In re Marriage of Witten,15 the contractual approach forces patients to make binding decisions in the present to govern unpredictable future events.11 This criticism particularly applies to oncofertility patients, for 2 critical reasons.3 First, the oncofertility patient and donor have little time to make a decision regarding fertility due to the immediate need for the patient to begin cancer treatment. Second, the oncofertility patient is faced with an existential crisis—save his or her fertility or save his or her life. Also pertinent to this point is Kass v Kass, which states, “Here, however, the uncertainties inherent in the IVF process itself are vastly complicated by cryopreservation, which extends the viability of prezygotes indefinitely and allows time for minds, and circumstances, to change.”14 Furthermore, as these cases demonstrate, many clinics provide only an agreement between the clinic and the donor/patient. This agreement is ultimately designed to reflect the rights and responsibilities between the patient and donor on one hand, and the clinic on the other. Therefore, clinical agreements may be inadequate to address preembryo use and/or disposal questions between the patient and donor.
The Mutual Contemporaneous Consent Approach As stated in In re Marriage of Witten,3,14,16 the mutual contemporaneous consent approach (the “contemporaneous consent approach”) requires that the donor and patient agree on using preembryos at the time that the preembryos are to be used.17 Under this approach, preexisting agreements are not binding but merely indicate the intent of the parties at the time they entered into an IVF agreement. If either the patient or donor changes his or her mind, that current position takes priority, and that individual may rescind the agreement. In the event that the patient and donor cannot reach a contemporaneous agreement, the preembryos must remain frozen until the parties can agree.17 Iowa is the only state, at present, that follows the mutual contemporaneous consent approach.18 This approach has been subject to criticism in that it is unrealistic—if the parties were able to reach E2
Oncofertility and the Rights to Future Fertility
an agreement, they would not involve the courts.19 In addition, Strasser20 points out that the party interested in destroying the preembryos has an unfair advantage over the party who wishes to preserve the preembryos by requiring that party to bear the costs of their preservation.21 If the parties never come to agreement, the nonconsenting donor can indefinitely block the patient’s use of his or her genetic material and deny the patient biological parenthood. An additional concern with the contemporaneous consent approach as applied to oncofertility practices is the emotionally charged circumstances under which a donor makes a decision to provide genetic material for a patient’s use. An unmarried donor watching a friend, lover, or companion face a cancer diagnosis and make difficult fertility decisions is also under emotional distress that may lead to rash decisions that the donor may later regret. The regretful donor wields a great deal of power under the contemporaneous consent approach to block the patient’s only opportunity to implant preembryos and fulfill their goal of biological parenthood.
The Balancing Approach Finally, in the absence of a clear agreement, some courts balance the interests of the 2 parties.21 It should be noted that the only court to apply the balancing approach to the oncofertility world was a Pennsylvania state court in Reber v Reiss,22 which bears a striking resemblance to the facts of Szafranski v Dunston. As observed in Reber v Reiss,23 the balancing approach largely presumes that an individual’s inability to have a child weighs strongly in his or her favor.24 This presumption creates a weighty burden for the donor to overcome and makes it unlikely that the donor will ever be able to prevent the patient from using his or her genetic material.
A New Approach in Oncofertility Cases The approaches outlined herein largely derive from marriage dissolution cases, which are significantly different from disputes between oncofertility patients and potential donors. Imagine a regime that simply states that before a donor, regardless of that donor’s relationship to the patient, may contribute genetic material to an oncofertility patient, that donor must affirmatively waive his or her right to prevent the patient from using the material in the future. This approach better incentivizes parties to plan ahead and discuss their expectations. As stated by Kass v Kass,14 if the goal of a contractual regime is to provide stability to the parties by setting expectations,11 the waiver approach goes 1 step further by affirmatively granting the oncofertility patient exclusive rights to the genetic material from the donor, regardless of that donor’s relationship to the patient. This default rule ensures that parties will plan ahead and clearly discuss their expectations and will do so while the bargaining power between them is relatively equal, before any donation is made and before any preembryos are cryopreserved for later use.25 The waiver approach also has significant advantages for the oncofertility patient over the contemporaneous consent approach by requiring the donor to carefully consider affirmatively waiving rights to the genetic material, and in the presence of equivocation on the part of the donor, allowing the patient to obtain alternative sources for the genetic material in advance of the decision to use the embryos. Furthermore, by requiring affirmative waiver regardless of the relationship between the donor and the patient, the waiver ap-
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Oncofertility and the Rights to Future Fertility
Special Communication Clinical Review & Education
proach recognizes that even married donors and patients may separate and that the cryopreserved preembryos from the patient’s marriage may be the only path available to natural childbirth. Finally, the waiver approach arguably conserves judicial resources by requiring the donor to clearly and unequivocally waive his or her rights, thereby preventing costly litigation. The waiver approach, however, may implicate fundamental constitutional rights. Many states (though not Illinois26) have recognized a constitutional right not to parent a child based on 2 series of cases (commonly known as the “contraception cases”27-30 and the “abortion cases”27,31-33) in which the United States Supreme Court decided that individuals have a right to obtain and use contraception and to terminate pregnancy, implying a right to not be a parent.26,27 Worth noting, the United States Supreme Court has never explicitly declared that individuals have a constitutional right not to parent a child.27 As Cohen27 suggests, an additional complicating factor is that much of the legal system views parental rights as binary: either an individual is a “parent,” entitled to the full panoply of rights and responsibilities that befall traditional parentage, or they are not. Reality is simply not as neat. Cohen27 points out that one can provide the genetic material to become a parent (“genetic parentage”), without assuming the legal rights and responsibilities of parenting (“legal parentage”), or even giving birth to a child (“gestational parentage”). In fact, many states have passed laws that specifically bar semen donors who are not the husbands of the recipient from being considered parents for the purposes of paternity suits to protect (1) the married couple seeking the anonymous donor’s semen, (2) the resulting children, and (3) the anonymous donor,25 as ruled in People v Sorensen.34,35 Likewise, one can be a legal parent without having contributed any genetic material. Courts have yet to grapple with the spectrum of parenthood appropriately, making the abortion and contraception cases poor bases on which to establish a fundamental right not to be a parent. Furthermore, the contraception and abortion cases were designed to address different factual situations dealing with a different (and specific) set of constitutional rights than those at issue in the oncofertility patient/ donor dispute, and it would read these cases too broadly to infer a general right to avoid genetic parentage.27 Indeed, there are circumstances in which courts have recognized that individuals may waive fundamental constitutional rights.26,27 For example, in Snepp v United States,36 a former Central Intelligence Agency official was found to have waived his First ARTICLE INFORMATION Published Online: January 28, 2016. doi:10.1001/jamaoncol.2015.5610. Conflict of Interest Disclosures: Mr Fournier is an associate at Foley & Lardner LLP in the Business Litigation and Dispute Resolution practice and also has worked on matters with the Government Enforcement, Compliance and White Collar Defense practice group. No other disclosures are reported. Disclaimer: The Oncofertilty Consortium is funded by grants administered through the National Institutes of Health. Neither the Oncofertility Consortium nor the National Institutes of Health funded any portion of the research into this article. Additional Contributions: Teresa K. Woodruff, PhD, Thomas J. Watkins Professor of Obstetrics and jamaoncology.com
Amendment rights by agreeing in his employment contract not to publish a book about agency activities without its prior consent. We have all heard the phrase “anything you say can and will be used against you in court,” when law enforcement is required to inform an arrestee that by volunteering information, that arrestee can waive the Fifth Amendment right against self-incrimination. Furthermore, individuals can choose to represent themselves in criminal cases, waiving their Sixth Amendment right to counsel. An individual may forgo a jury trial, waiving the Seventh Amendment right to a trial by a jury of one’s peers. An individual may allow law enforcement to enter his or her home and conduct a search without a warrant, waiving Fourth Amendment rights. However, there are certain rights that society recognizes as sacrosanct. Addressing this argument squarely, the Appellate Court of Illinois in Szafranski v Dunston determined that it would not infringe on Szafranski’s constitutional rights to uphold the agreement giving Dunston the sole right to dispose of her cryopreserved preembryos.26 While a detailed discussion of the constitutional implications of the waiver regime is too extensive for this commentary, there are compelling arguments in favor of requiring a donor to waive his or her rights to genetic material that allay fears that requiring a genetic donor to waive their right to dictate the disposition of genetic material violates the Constitution.
In the Meantime Until advances in oncofertility make cases like Szafranski v Dunston obsolete, or courts and legislatures recognize and enforce waivers of donors’ rights to their genetic material, what can clinicians do to protect their patients and practices? First, clinicians should educate themselves on the approach their state follows. Furthermore, clinicians should take steps to ensure that their patients receive proper legal counseling, preferably by a neutral third-party attorney, either through partnerships through local legal aid organizations or law firms (or clearly indicate that they waive such counseling). Before providing treatment to a patient, a clinician should ensure that the patient’s paperwork clearly addresses the disposition rights between the patient and the donor. Finally, the law in this field is changing almost as rapidly as the technology, and clinicians and patients should seek the advice of legal experts when facing these difficult legal issues.
Gynecology at the Feinberg School of Medicine at Northwestern University, provided insight into the current state of oncofertility research and assisted with proper nomenclature. David B. Goroff, JD, Foley & Lardner LLP, provided assistance in evaluating the legal arguments and structure of the article. Neither Dr Woodruff nor Mr Goroff were compensated for their contributions.
3. Dolin G, Roberts DE, Rodriguez LM, Woodruff TK. Medical hope, legal pitfalls: potential legal issues in the emerging field of oncofertility. Santa Clara Law Rev. 2009;49:673-716.
REFERENCES
6. Szafranski v Dunston, 373 Ill Dec 197, 198, 993 NE2d 502, 504 (Ill App Ct 2013).
1. About the Oncofertility Consortium. Oncofertility Consortium website. http://oncofertility .northwestern.edu/about-oncofertility-consortium. Accessed January 6, 2016. 2. Patients. Oncofertility Consortium website. http://oncofertility.northwestern.edu/resources /patients. Accessed January 6, 2016.
4. Szafranski v Dunston, 373 Ill Dec 197, 197, 993 NE2d 502, 503 (Ill App Ct 2013). 5. Szafranski v Dunston, 373 Ill Dec 197, 198, 993 NE2d 502, 503-504 (Ill App Ct 2013).
7. Szafranski v Dunston, 373 Ill Dec 197, 198-199, 993 NE2d 502, 504-505 (Ill App Ct 2013). 8. Szafranski v Dunston, 373 Ill Dec 197, 993 NE2d 502 (Ill App Ct 2013). 9. Szafranski v Dunston, 393 Ill Dec 604, 34 NE3d 1132 (Ill App Ct 2015).
(Reprinted) JAMA Oncology Published online January 28, 2016
Copyright 2016 American Medical Association. All rights reserved.
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10. Szafranski v Dunston, 373 Ill Dec 197, 200 993 NE2d 502, 506 (Ill App Ct 2013). 11. Szafranski v Dunston, 373 Ill Dec 197, 993 NE2d 502, 506 (Ill App Ct 2013). 12. Davis v Davis, 842 SW2d 588, 597 (Tenn 1992). 13. York v Jones, 717 F Supp 421, 425 (ED Va 1989).
20. Strasser MP. You take the embryos but I get the house (and the business): recent trends in awards involving embryos upon divorce. Buffalo Law Rev. 2009;57(4):1159-1225. 21. Szafranski v Dunston, 373 Ill Dec 196, 206, 993 NE2d 502, 512 (Ill App Ct 2013).
28. Griswold v Connecticut, 381 US 479 (1965). 29. Eisenstadt v Baird, 405 US 438 (1972). 30. Carey v Population Services International, 431 US 678 (1977). 31. Roe v Wade, 410 US 113 (1973).
14. Kass v Kass, 696 NE2d 174, 180 (NY 1998).
22. Reber v Reiss, 42 A3d 1131, 1136 (Pa Super Ct 2012).
32. Planned Parenthood of Central Missouri v Danforth, 428 US 52 (1976).
15. In re Marriage of Witten, 672 NW2d 768, 777 (Ia 2003).
23. Reber v Reiss, 42 A3d 1131, 1140 (Pa Super Ct 2012).
33. Planned Parenthood v Casey, 505 US 833 (1992).
16. In re Marriage of Witten, 672 NW2d 768, 778 (Ia 2003).
24. Szafranski v Dunston, 373 Ill Dec 196, 207, 993 NE2d 502, 513 (Ill App Ct 2013).
34. In re K.M.H., 169 P3d 1025, 1034 (Kan 2007).
17. Szafranski v Dunston, 373 Ill Dec 196, 204-205, 993 NE2d 502, 510-511 (Ill App Ct 2013).
25. In re K.M.H., 169 P3d 1025, 1039 (Kan 2007).
35. People v Sorensen, 437 P2d 495, 498-501 (Cal 1968).
26. Szafranski v Dunston, 373 Ill Dec 196, 210, 993 NE2d 502, 516 (Ill App Ct 2013).
36. Snepp v United States, 444 US 507, 510-516 (1980).
18. In re Marriage of Witten, 672 NW2d 768, 782 (Ia 2003). 19. Reber v Reiss, 42 A3d 1131, 1135 (Pa Super Ct 2012).
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27. Cohen IG. The Constitution and the rights not to procreate. Stanford Law Rev. 2008;60:1135-1196.
JAMA Oncology Published online January 28, 2016 (Reprinted)
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Special Communication
Oncofertility and the Rights to Future Fertility Ehren M. Fournier, JD Viewpoint and Editorial
The field of oncofertility, or fertility preservation for patients facing a cancer diagnosis, has seen significant scientific breakthroughs that allow adults and children undergoing fertility-threatening cancer treatment to preserve their fertility for a life after cancer. These breakthroughs also raise complex legal issues for patients and clinicians. While the current scholarship tangentially discusses the disposition of genetic material in regards to pediatric patients, this Special Communication examines the current legal framework as applied to disputes regarding the disposition of genetic material between the oncofertility patient and donor, and provides a potential new solution for courts to use in determining the rights of parties in disputes involving donated genetic material.
T
The Facts of Szafranski v Dunston In 2010, Dunston received a diagnosis of cancer and sought fertility preservation treatment at Northwestern Memorial Hospital.4 Her boyfriend at the time, Szafranski, volunteered to donate sperm for the purpose of creating preembryos for Dunston’s use after her treatment. The two signed a consent agreement with Northwestern Memorial Hospital titled “Informed Consent for Assisted Reproduction,” which stated that no use could be made of the preembryos “without the consent of both partners (if applicable).”5 The couple also met with an attorney, who provided them with a co-parenting agreement establishing both parties as legal co-parents ofthechild.6 Underthatagreement,thecouplewasrequiredtoattempt at least 1 in vitro fertilization (IVF) process for which Szafranski would provide the sperm to create the preembryos. The agreement also objamaoncology.com
Author Affiliation: Foley & Lardner LLP, Chicago, Illinois. Corresponding Author: Ehren M. Fournier, JD, Foley & Lardner LLP, 321 N Clark St, Ste 2800, Chicago, IL 60654 ([email protected]).
JAMA Oncol. doi:10.1001/jamaoncol.2015.5610 Published online January 28, 2016.
he scenario: a young woman of childbearing age receives a diagnosis of cancer. To save her life, she must undergo a life-preserving, but fertility-threatening, treatment. The solution is to harvest her eggs that are then fertilized by a sperm donor, frozen, and preserved for later implantation. Her boyfriend agrees to provide the sperm. After treatment is over, the two split up. Years later, she wants to use the cryopreserved preembryos to get pregnant, but the ex-boyfriend asserts a right to prevent her from doing so, and files suit to permanently enjoin her from using the embryos. Whose rights prevail? This issue significantly affects the field of oncofertility, or the practice of preserving fertility for patients with a cancer diagnosis who face treatment options that threaten their fertility.1 As survivor rates for patients with cancer increase, planning for a life after cancer is a growing part of cancer treatment plans in hospitals and cancer centers.2,3 The approaches adopted by several states are deficient in that they derive largely from factual situations that are inapplicable to the oncofertility scenario. This Special Communication provides a solution designed to meet the needs of oncofertility patients.
JAMA OncologyPatient Page
ligated Szafranski to undertake all “legal, custodial, and other obligations to the child regardless of change of circumstances.” Finally, under the terms of the agreement, Dunston retained sole control of the harvested eggs and “disposition of the preembryos” should the couple separate, and it was stated that Szafranski “acknowledges and agrees that [Dunston] is likely to be unable to create new healthy embryos subsequent to the chemotherapy regiment [sic] she will undergo, and [Szafranski] specifically agrees that [Dunston] should have the opportunity to use such embryos to have a child.”6 Thisshouldhaveendedthediscussion,butthecoupleneversigned the agreement.6 On April 6, 2010, Szafranski deposited his sperm and the couple fertilized all available eggs harvested from Dunston. In May 2010, Szafranski ended the relationship and, a little more than 1 year later, filed suit to prevent Dunston from using the preembryos claiming to “preserv[e] his right not to forcibly father a child against his will.”7 Dunston claimed that Szafranski breached their agreement. The Circuit Court for Cook County sided with Dunston. On appeal in Szafranski v Dunston,8 the Illinois Court of Appeals examined 3 common approaches (outlined here in further detail) and sent the case back to the Circuit Court ordering them to apply a different approach than it had usedinitsinitialdecision.TheCircuitCourt,applyingthenewtest,again sided with Dunston. Recently, the Illinois Court of Appeals, hearing the case again, sided with Dunston, finding that Dunston and Szafranski entered into an implied oral contract.9
Current Approaches to Cryopreserved Preembryos On appeal in Szafranski v Dunston, the Illinois court analyzed the law surrounding cryopreserved preembryos in other states and found 3 basic approaches to resolving disputes: (1) the contractual approach, (2) the mutual contemporaneous consent approach, and (3) the balancing approach.10
The Contractual Approach In the contractual approach, a court will look to see whether a contract, either written or oral, exists between the parties and, if there (Reprinted) JAMA Oncology Published online January 28, 2016
Copyright 2016 American Medical Association. All rights reserved.
Downloaded From: http://oncology.jamanetwork.com/ by a New York University User on 02/10/2016
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Clinical Review & Education Special Communication
is a preexisting contract, it will enforce the terms of that agreement.11 If the contract is ambiguous, courts will attempt to determine the intent of the parties when they entered the agreement. So far, 6 states have explicitly adopted the contractual approach: Illinois, New York, Oregon, Texas, Washington, and Massachusetts. While 4 of these states are discussed herein, Tennessee implicitly adopted the contractual approach in Davis v Davis.12 However, the court declined to follow that approach, since the parties had no explicit agreement. In addition, there is an inclination that Virginia, if faced with the same issue, may follow the contract approach13 (recognizing that cryopreservation agreements represent a bailment agreement between the progenitors and the clinic). As set forth in Kass v Kass,14 the contractual approach benefits parties by requiring them to “think through possible contingencies and carefully specify their wishes.”11 Courts have claimed that the contractual approach “avoids costly litigation” and where the stakes are high, emotional, and largely intangible, express agreement between the parties, clearly stated, saves courts and litigants from uncertainty.11 Further, written agreements provide stability to IVF clinicians, who, in the absence of a written agreement between the parties, may be dragged into disputes between litigants. However, scholars have criticized the contractual approach because it fails to adapt to the changing circumstances of the parties. As stated in In re Marriage of Witten,15 the contractual approach forces patients to make binding decisions in the present to govern unpredictable future events.11 This criticism particularly applies to oncofertility patients, for 2 critical reasons.3 First, the oncofertility patient and donor have little time to make a decision regarding fertility due to the immediate need for the patient to begin cancer treatment. Second, the oncofertility patient is faced with an existential crisis—save his or her fertility or save his or her life. Also pertinent to this point is Kass v Kass, which states, “Here, however, the uncertainties inherent in the IVF process itself are vastly complicated by cryopreservation, which extends the viability of prezygotes indefinitely and allows time for minds, and circumstances, to change.”14 Furthermore, as these cases demonstrate, many clinics provide only an agreement between the clinic and the donor/patient. This agreement is ultimately designed to reflect the rights and responsibilities between the patient and donor on one hand, and the clinic on the other. Therefore, clinical agreements may be inadequate to address preembryo use and/or disposal questions between the patient and donor.
The Mutual Contemporaneous Consent Approach As stated in In re Marriage of Witten,3,14,16 the mutual contemporaneous consent approach (the “contemporaneous consent approach”) requires that the donor and patient agree on using preembryos at the time that the preembryos are to be used.17 Under this approach, preexisting agreements are not binding but merely indicate the intent of the parties at the time they entered into an IVF agreement. If either the patient or donor changes his or her mind, that current position takes priority, and that individual may rescind the agreement. In the event that the patient and donor cannot reach a contemporaneous agreement, the preembryos must remain frozen until the parties can agree.17 Iowa is the only state, at present, that follows the mutual contemporaneous consent approach.18 This approach has been subject to criticism in that it is unrealistic—if the parties were able to reach E2
Oncofertility and the Rights to Future Fertility
an agreement, they would not involve the courts.19 In addition, Strasser20 points out that the party interested in destroying the preembryos has an unfair advantage over the party who wishes to preserve the preembryos by requiring that party to bear the costs of their preservation.21 If the parties never come to agreement, the nonconsenting donor can indefinitely block the patient’s use of his or her genetic material and deny the patient biological parenthood. An additional concern with the contemporaneous consent approach as applied to oncofertility practices is the emotionally charged circumstances under which a donor makes a decision to provide genetic material for a patient’s use. An unmarried donor watching a friend, lover, or companion face a cancer diagnosis and make difficult fertility decisions is also under emotional distress that may lead to rash decisions that the donor may later regret. The regretful donor wields a great deal of power under the contemporaneous consent approach to block the patient’s only opportunity to implant preembryos and fulfill their goal of biological parenthood.
The Balancing Approach Finally, in the absence of a clear agreement, some courts balance the interests of the 2 parties.21 It should be noted that the only court to apply the balancing approach to the oncofertility world was a Pennsylvania state court in Reber v Reiss,22 which bears a striking resemblance to the facts of Szafranski v Dunston. As observed in Reber v Reiss,23 the balancing approach largely presumes that an individual’s inability to have a child weighs strongly in his or her favor.24 This presumption creates a weighty burden for the donor to overcome and makes it unlikely that the donor will ever be able to prevent the patient from using his or her genetic material.
A New Approach in Oncofertility Cases The approaches outlined herein largely derive from marriage dissolution cases, which are significantly different from disputes between oncofertility patients and potential donors. Imagine a regime that simply states that before a donor, regardless of that donor’s relationship to the patient, may contribute genetic material to an oncofertility patient, that donor must affirmatively waive his or her right to prevent the patient from using the material in the future. This approach better incentivizes parties to plan ahead and discuss their expectations. As stated by Kass v Kass,14 if the goal of a contractual regime is to provide stability to the parties by setting expectations,11 the waiver approach goes 1 step further by affirmatively granting the oncofertility patient exclusive rights to the genetic material from the donor, regardless of that donor’s relationship to the patient. This default rule ensures that parties will plan ahead and clearly discuss their expectations and will do so while the bargaining power between them is relatively equal, before any donation is made and before any preembryos are cryopreserved for later use.25 The waiver approach also has significant advantages for the oncofertility patient over the contemporaneous consent approach by requiring the donor to carefully consider affirmatively waiving rights to the genetic material, and in the presence of equivocation on the part of the donor, allowing the patient to obtain alternative sources for the genetic material in advance of the decision to use the embryos. Furthermore, by requiring affirmative waiver regardless of the relationship between the donor and the patient, the waiver ap-
JAMA Oncology Published online January 28, 2016 (Reprinted)
Copyright 2016 American Medical Association. All rights reserved.
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Oncofertility and the Rights to Future Fertility
Special Communication Clinical Review & Education
proach recognizes that even married donors and patients may separate and that the cryopreserved preembryos from the patient’s marriage may be the only path available to natural childbirth. Finally, the waiver approach arguably conserves judicial resources by requiring the donor to clearly and unequivocally waive his or her rights, thereby preventing costly litigation. The waiver approach, however, may implicate fundamental constitutional rights. Many states (though not Illinois26) have recognized a constitutional right not to parent a child based on 2 series of cases (commonly known as the “contraception cases”27-30 and the “abortion cases”27,31-33) in which the United States Supreme Court decided that individuals have a right to obtain and use contraception and to terminate pregnancy, implying a right to not be a parent.26,27 Worth noting, the United States Supreme Court has never explicitly declared that individuals have a constitutional right not to parent a child.27 As Cohen27 suggests, an additional complicating factor is that much of the legal system views parental rights as binary: either an individual is a “parent,” entitled to the full panoply of rights and responsibilities that befall traditional parentage, or they are not. Reality is simply not as neat. Cohen27 points out that one can provide the genetic material to become a parent (“genetic parentage”), without assuming the legal rights and responsibilities of parenting (“legal parentage”), or even giving birth to a child (“gestational parentage”). In fact, many states have passed laws that specifically bar semen donors who are not the husbands of the recipient from being considered parents for the purposes of paternity suits to protect (1) the married couple seeking the anonymous donor’s semen, (2) the resulting children, and (3) the anonymous donor,25 as ruled in People v Sorensen.34,35 Likewise, one can be a legal parent without having contributed any genetic material. Courts have yet to grapple with the spectrum of parenthood appropriately, making the abortion and contraception cases poor bases on which to establish a fundamental right not to be a parent. Furthermore, the contraception and abortion cases were designed to address different factual situations dealing with a different (and specific) set of constitutional rights than those at issue in the oncofertility patient/ donor dispute, and it would read these cases too broadly to infer a general right to avoid genetic parentage.27 Indeed, there are circumstances in which courts have recognized that individuals may waive fundamental constitutional rights.26,27 For example, in Snepp v United States,36 a former Central Intelligence Agency official was found to have waived his First ARTICLE INFORMATION Published Online: January 28, 2016. doi:10.1001/jamaoncol.2015.5610. Conflict of Interest Disclosures: Mr Fournier is an associate at Foley & Lardner LLP in the Business Litigation and Dispute Resolution practice and also has worked on matters with the Government Enforcement, Compliance and White Collar Defense practice group. No other disclosures are reported. Disclaimer: The Oncofertilty Consortium is funded by grants administered through the National Institutes of Health. Neither the Oncofertility Consortium nor the National Institutes of Health funded any portion of the research into this article. Additional Contributions: Teresa K. Woodruff, PhD, Thomas J. Watkins Professor of Obstetrics and jamaoncology.com
Amendment rights by agreeing in his employment contract not to publish a book about agency activities without its prior consent. We have all heard the phrase “anything you say can and will be used against you in court,” when law enforcement is required to inform an arrestee that by volunteering information, that arrestee can waive the Fifth Amendment right against self-incrimination. Furthermore, individuals can choose to represent themselves in criminal cases, waiving their Sixth Amendment right to counsel. An individual may forgo a jury trial, waiving the Seventh Amendment right to a trial by a jury of one’s peers. An individual may allow law enforcement to enter his or her home and conduct a search without a warrant, waiving Fourth Amendment rights. However, there are certain rights that society recognizes as sacrosanct. Addressing this argument squarely, the Appellate Court of Illinois in Szafranski v Dunston determined that it would not infringe on Szafranski’s constitutional rights to uphold the agreement giving Dunston the sole right to dispose of her cryopreserved preembryos.26 While a detailed discussion of the constitutional implications of the waiver regime is too extensive for this commentary, there are compelling arguments in favor of requiring a donor to waive his or her rights to genetic material that allay fears that requiring a genetic donor to waive their right to dictate the disposition of genetic material violates the Constitution.
In the Meantime Until advances in oncofertility make cases like Szafranski v Dunston obsolete, or courts and legislatures recognize and enforce waivers of donors’ rights to their genetic material, what can clinicians do to protect their patients and practices? First, clinicians should educate themselves on the approach their state follows. Furthermore, clinicians should take steps to ensure that their patients receive proper legal counseling, preferably by a neutral third-party attorney, either through partnerships through local legal aid organizations or law firms (or clearly indicate that they waive such counseling). Before providing treatment to a patient, a clinician should ensure that the patient’s paperwork clearly addresses the disposition rights between the patient and the donor. Finally, the law in this field is changing almost as rapidly as the technology, and clinicians and patients should seek the advice of legal experts when facing these difficult legal issues.
Gynecology at the Feinberg School of Medicine at Northwestern University, provided insight into the current state of oncofertility research and assisted with proper nomenclature. David B. Goroff, JD, Foley & Lardner LLP, provided assistance in evaluating the legal arguments and structure of the article. Neither Dr Woodruff nor Mr Goroff were compensated for their contributions.
3. Dolin G, Roberts DE, Rodriguez LM, Woodruff TK. Medical hope, legal pitfalls: potential legal issues in the emerging field of oncofertility. Santa Clara Law Rev. 2009;49:673-716.
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6. Szafranski v Dunston, 373 Ill Dec 197, 198, 993 NE2d 502, 504 (Ill App Ct 2013).
1. About the Oncofertility Consortium. Oncofertility Consortium website. http://oncofertility .northwestern.edu/about-oncofertility-consortium. Accessed January 6, 2016. 2. Patients. Oncofertility Consortium website. http://oncofertility.northwestern.edu/resources /patients. Accessed January 6, 2016.
4. Szafranski v Dunston, 373 Ill Dec 197, 197, 993 NE2d 502, 503 (Ill App Ct 2013). 5. Szafranski v Dunston, 373 Ill Dec 197, 198, 993 NE2d 502, 503-504 (Ill App Ct 2013).
7. Szafranski v Dunston, 373 Ill Dec 197, 198-199, 993 NE2d 502, 504-505 (Ill App Ct 2013). 8. Szafranski v Dunston, 373 Ill Dec 197, 993 NE2d 502 (Ill App Ct 2013). 9. Szafranski v Dunston, 393 Ill Dec 604, 34 NE3d 1132 (Ill App Ct 2015).
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10. Szafranski v Dunston, 373 Ill Dec 197, 200 993 NE2d 502, 506 (Ill App Ct 2013). 11. Szafranski v Dunston, 373 Ill Dec 197, 993 NE2d 502, 506 (Ill App Ct 2013). 12. Davis v Davis, 842 SW2d 588, 597 (Tenn 1992). 13. York v Jones, 717 F Supp 421, 425 (ED Va 1989).
20. Strasser MP. You take the embryos but I get the house (and the business): recent trends in awards involving embryos upon divorce. Buffalo Law Rev. 2009;57(4):1159-1225. 21. Szafranski v Dunston, 373 Ill Dec 196, 206, 993 NE2d 502, 512 (Ill App Ct 2013).
28. Griswold v Connecticut, 381 US 479 (1965). 29. Eisenstadt v Baird, 405 US 438 (1972). 30. Carey v Population Services International, 431 US 678 (1977). 31. Roe v Wade, 410 US 113 (1973).
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32. Planned Parenthood of Central Missouri v Danforth, 428 US 52 (1976).
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23. Reber v Reiss, 42 A3d 1131, 1140 (Pa Super Ct 2012).
33. Planned Parenthood v Casey, 505 US 833 (1992).
16. In re Marriage of Witten, 672 NW2d 768, 778 (Ia 2003).
24. Szafranski v Dunston, 373 Ill Dec 196, 207, 993 NE2d 502, 513 (Ill App Ct 2013).
34. In re K.M.H., 169 P3d 1025, 1034 (Kan 2007).
17. Szafranski v Dunston, 373 Ill Dec 196, 204-205, 993 NE2d 502, 510-511 (Ill App Ct 2013).
25. In re K.M.H., 169 P3d 1025, 1039 (Kan 2007).
35. People v Sorensen, 437 P2d 495, 498-501 (Cal 1968).
26. Szafranski v Dunston, 373 Ill Dec 196, 210, 993 NE2d 502, 516 (Ill App Ct 2013).
36. Snepp v United States, 444 US 507, 510-516 (1980).
18. In re Marriage of Witten, 672 NW2d 768, 782 (Ia 2003). 19. Reber v Reiss, 42 A3d 1131, 1135 (Pa Super Ct 2012).
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27. Cohen IG. The Constitution and the rights not to procreate. Stanford Law Rev. 2008;60:1135-1196.
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