- Email: [email protected]
Legal considerations for cryopreservation of sperm and embryos
FERTILITY AND STERILITY威 VOL. 80, NO. 1, JULY 2003 Copyright ©2003 American Society for Reproductive Medicine Published by Elsevier Inc. Printed on acid-free paper in U.S.A.
Legal considerations for cryopreservation of sperm and embryos Timothy G. Schuster, M.D.,a Kathryn Hickner-Cruz,b Dana A. Ohl, M.D.,a Edward Goldman, J.D.,c and Gary D. Smith, Ph.D.a,d,e University of Michigan Medical Center, Ann Arbor, Michigan
Received May 3, 2002; revised and accepted February 13, 2003. Reprint requests: Gary D. Smith, Ph.D., Department of Obstetrics and Gynecology, University of Michigan, 6428 Medical Science I, 1301 East Catherine Street, Ann Arbor, Michigan 481090617 (FAX: 734-936-9127; E-mail: smithgd@umich. edu). a Department of Urology, University of Michigan, Ann Arbor, Michigan. b Wayne State University Law School, Detroit, Michigan. c University of Michigan Health System Legal Office, Ann Arbor, Michigan. d Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan. e Department of Physiology, University of Michigan, Ann Arbor, Michigan. 0015-0282/03/$30.00 doi:10.1016/S0015-0282(03) 00503-X
Objective: To summarize the case law for cryopreservation of sperm and embryos and make recommendations for desirable characteristics that should be included in a cryopreservation clinic’s disposition agreements. Design: A literature review of case law and legal review articles was performed. Setting: Academic research center. Patient(s): None. Intervention(s): None. Main Outcome Measure(s): None. Result(s): Two court cases involving cryopreserved semen and five cases involving cryopreserved embryos are reviewed. Conclusion(s): The state of the law surrounding cryopreservation is recent and unsettled. Disposition agreements can provide cryopreservation clinics some degree of certainty in this unsettled area of law. Those drafting cryopreservation disposition agreements are assisted by lessons learned from cryopreservation cases and insight gained from law review articles. It is evident that cryopreservation agreements will be most successful and most likely to be enforced if they are unambiguous, consistent with public policy, and include: a duration provision, each individual’s contact information, the individual’s provisions for use of their gametes in case of death, and responsibilities of cryopreservation clinic and individuals. Individuals must enter into agreements with a true understanding of the contained provisions. (Fertil Steril威 2003;80:61– 6. ©2003 by American Society for Reproductive Medicine.) Key Words: Cryopreservation, sperm, embryo, legal, law
Over 100 semen banks are registered, and it is estimated that approximately 400,000 embryos are currently cryopreserved in the United States (1; personal communication from the American Society for Reproductive Medicine). These facts, coupled with the high divorce rate, have unsurprisingly resulted in disputes over the disposition of cryopreserved material. Although most struggles occur between divorcing couples or with third parties, some conflicts develop between cryopreservation clinics and individuals. Even when a clinic is not a party to litigation, it is somewhat impacted by conflict because it holds the cryopreserved material in dispute. Additionally, contents of the clinic’s disposition agreement as well as the manner in which documents were signed by couples can significantly impact the court’s decision. Cryopreservation case law deals with two central questions: [1] how cryopreserved se-
men and embryos should be categorized, and [2] how the disposition of frozen semen and embryos should be determined in case of a dispute. Although courts have rendered answers to each of these questions in several cases, both issues remain unsettled in case law. (Note that in case law there also is some dispute over what a fertilized cryopreserved egg should be called. Judicial opinions refer to the material with one of four terms: “embryo,” “pre-embryo,” “pre-zygote,” or “zygote.” When discussing a particular case, this article will refer to all material as embryos, although each particular court may have referred to the material differently within its opinion.) Although disputes over cryopreserved sperm and embryos raise a variety of different legal issues, there are desirable characteristics that should be included in a cryopreservation clinic’s disposition contract for any cryopre61
served material. First, this article will review court cases that have addressed the disposition of cryopreserved material. Then recommendations will be made regarding specific items that should be included in a cryopreservation clinic’s disposition contract.
CRYOPRESERVATION CASE LAW Cryopreserved Semen Hecht v Superior Court The decedent in Hecht v Superior Court (3, 4) deposited 15 vials of semen at a sperm bank for cryopreservation. He signed a “Specimen Storage Agreement” providing that, upon his death, the cryobank would continue to store or release the semen upon the request of the executor of the estate. The decedent authorized his semen to be released to his girlfriend and his girlfriend’s physician. He later committed suicide. Confirming the intent expressed in the cryopreservation agreement, the will left all property interest in the semen to his girlfriend. A conflict over the disposition of the semen arose when the decedent’s girlfriend signed a settlement agreement with the man’s family that would entitle her to only 20% of the semen. In the court’s first opinion in Hecht (3), the California Court of Appeals held that cryopreserved semen is property and therefore part of the individual’s estate. The court supported its conclusions by arguing that sperm banks treat sperm as property. Men who cryopreserve their sperm are required to pay maintenance fees and fees for withdrawal of sperm. Upon death of the gamete donor, sperm banks often dispose of deposits unless there is an expressed instruction in the individual’s will or a court order stating that the party wished that his widow be inseminated with the sperm. The court also cited an ethics statement from the American Fertility Society on in vitro fertilization (IVF): “it is understood that the gametes and concepti are the property of the donors. The donors therefore have the right to decide at their sole discretion the disposition of these items, provided such disposition is within medical and ethical guidelines” (3). The original categorization of cryopreserved semen by the California Court of Appeals was revised and narrowed when the court released its second opinion in the Hecht case (2). In its second opinion, the court held that semen is a “unique material” unlike other forms of property. The court reasoned that, unlike other forms of property, the disposition of semen cannot be controlled by contract or property law but can only be determined by the intent of the decedent. Therefore, the semen could not be distributed as assets of the decedent’s estate and was not subject to settlement agreements. Based on this reasoning, the court concluded that the girlfriend should have exclusive possession of the semen. 62
Schuster et al.
Legal considerations for cryopreservation
Woodward v Commissioner of Social Security The couple in the Woodward v Commissioner of Social Security case (6) was married for 3.5 years when the husband was diagnosed with leukemia. The husband cryopreserved his semen before his unsuccessful treatment for his leukemia. Two years after his death, the wife gave birth to twins conceived through artificial insemination using the husband’s sperm. A dispute arose when the wife applied for Social Security survivor benefits for her children. The court ruled that a marriage is ended with death; therefore, posthumous conception of children is nonmarital. Similar to other nonmarital conception cases, to receive inheritance rights under the Massachusetts intestacy statute the wife must first establish the children’s genetic relationship to their father. Additionally, the courts ruled the gamete donor must “clearly and unequivocally consent not only to posthumous reproduction but also to the support of any resulting child” (4).
Cryopreserved Embryos Litowitz v Litowitz In Litowitz v Litowitz (5, 6), a couple used the husband’s sperm to fertilize five donated eggs, of which two were cryopreserved. The cryopreservation agreement signed by the couple stated that any disposition decision required the mutual consent of the couple. If a disagreement arose, a court was authorized to decide the disposition of the embryos. Upon the couple’s divorce, the wife wanted custody of the embryos for the purposes of transferring them into a surrogate while the husband “wanted to place the embryos with an out-of-state couple.” The Washington Court of Appeals found that the evidence of the couple’s intent and the provisions of the cryopreservation agreement were insufficient to exclusively control the future of the embryos. The court then addressed the constitutional rights of the parties. Because the wife’s gametes were not used to create the embryos in dispute, the court held she did not have a constitutional right to procreate. In contrast, the court held that under the circumstances the husband could “exercise his right not to procreate in a limited way that allows the embryos to develop but avoids placing him in the unwanted parenting role” (5). It is interesting that the court of appeals decision was reversed by the Washington Supreme Court, which based its decision solely on the parties’ contractual rights associated with the original cryopreservation agreement (6). The original contract stated that, unless the couple mutually requested an extension of the contract beyond 5 years, the cryopreserved embryos should be “thawed out but not allowed to undergo further development” (6). Because the appeal was reviewed greater than 5 years after the contract was signed, the court enforced the contract. Vol. 80, No. 1, July 2003
Davis v Davis
A.Z. v B.Z.
The couple in Davis v Davis (7) created seven embryos that were cryopreserved during their marriage. The parties did not sign an informed consent agreement or a disposition contract with the cryopreservation clinic. Upon their divorce, a dispute arose between the parties over the disposition of the cryopreserved embryos. The husband wanted to prevent the embryos from developing while the wife desired to donate the embryos to a third party.
Similar to other cases, in A.Z. v B.Z. (9) the couple participated in an IVF program. After some embryos were transferred into the wife, a pregnancy occurred and twins were born; the remaining embryos were cryopreserved. Eventually the couple divorced, after which a dispute arose over the disposition of the frozen embryos.
The Tennessee Supreme Court in Davis adopted a stepwise approach to deciding the fate of the disputed cryopreserved embryos. The court believed that the intent of the parties is the controlling authority on disposition of cryopreserved embryos. When intentions are conflicting or unclear, cryopreservation contracts should control disposition. In a situation in which there was no agreement signed (as in Davis), the court would conduct a balancing of interests of parties to the dispute.
The wife had undergone seven egg retrievals, during which the couple signed seven cryopreservation contract forms. On the forms a blank line existed where the couple could insert a provision for the disposition of the embryos. The provision written by the couple stated that, if the parties were separated, “the embryo(s) should be returned to the wife for implant” (9). After signing the initial form, however, “the husband always signed a consent form before the wife filled in the disposition provision” (9). The form that controlled the embryos at issue in A.Z. v B.Z. was not the initial form but rather one signed subsequently.
The Davis court stated that the right to procreate or not to procreate is a fundamental right. The court stated that, in general, the party who objects to procreation should be favored unless the other party has no other means of becoming a parent. Here, the husband’s interest in preventing procreation outweighed the wife’s interest in allowing procreation, and the embryos were awarded to the husband. The court felt this weighing of interests was especially appropriate to the Davis case because the wife did not wish to transfer the embryos into her own body but rather to donate the embryos to another couple.
The court refused to enforce the contract form under the circumstances of A.Z. v B.Z. Reasons cited for the court’s opinion were [1] the purpose of the form, [2] the lack of a duration provision, [3] the lack of the term “divorce,” and [4] the way in which the form was executed (i.e., the husband had signed the pertinent form while it was blank and without the provision regarding the disposition of the embryos upon divorce). In addition, the court stated that, even if the agreement was mutually agreed on and unambiguous, the court would not enforce such a provision because it is against public policy to force an individual to become a parent against his or her will.
Kass v Kass
In areas of new law, courts often turn to arguments based on what is felt to be in the “best interest of the public” to assist in the legal resolution of cases. For example, in a case where a physician writes language into a consent document saying the patient gives up her right to sue even if there is malpractice, a court would hold that language unenforceable because it is contrary to public policy. In the above case, the court supported its assertion by citing laws on marriage contracts and adoption that allow people to change their mind after an agreement has been entered. The court concluded that the public interest in not enforcing such an agreement outweighs the public interest in freedom to contract. Thus, the court concluded that the former wife could not transfer the embryos against her former husband’s wishes.
The parties in Kass v Kass (8) created five embryos during participation in an IVF program, at which time they also signed a cryopreservation disposition contract stipulating that, in case of divorce, the embryos would be donated to the IVF program for research purposes. Eventually the parties divorced. Both parties signed an uncontested divorce agreement indicating that the parties wished the embryos to be disposed of in the manner indicated on the disposition agreement. The former wife later wished to abandon the agreement and wanted to transfer the embryos; the former husband objected to the transfer as he did not want to become a father. The court in Kass enforced the cryopreservation disposition agreement. Kass held that, in the case of a dispute, disposition contracts are generally presumed to be valid and binding. The court reasoned that enforcing such agreements is crucial because of their value to couples and cryopreservation clinics. If the court refused to enforce disposition agreements, the seriousness and integrity of the contracts would be destroyed. Thus, the court in Kass ordered that the embryos be donated to the IVF program for research purposes as stipulated in the original disposition agreement. FERTILITY & STERILITY威
J.B. v M.B. The parties in J.B. v M.B. (10, 11) cryopreserved embryos during their attempt to conceive a child. The cryopreservation agreement signed by the parties and the IVF center stated that the embryos would be “relinquished to the IVF program” in the event of a divorce “unless the court specifies who takes control” of the embryos (10). Eventually the parties divorced, after which the wife wanted to destroy the 63
embryos while the husband wanted to preserve them for future use either in a woman with whom he developed a relationship or for donation to an infertile couple. The court in J.B. v M.B. agreed with the court in A.Z. v B.Z. that it is against public policy to enforce a contract to procreate and thus force an individual to become a biological parent. The court stated that contracts to create familial relationships should not be enforced against the will of those who entered the agreements. The court reasoned that these cryopreservation agreements were similar to contracts to marry or to give children up for adoption. In both marriage and adoption cases, parties are permitted to revoke consent. Similarly, women should be able to prevent the transfer of their embryos if they so desire. In addition, the court held that it would be a violation of the wife’s reproductive rights to force her to become a biological parent against her will and then allow her no parental rights for the child produced when the embryo is given to a stranger. The appellate decision in J.B. v M.B. was affirmed by the Supreme Court of New Jersey, which found that the parties had agreed that a court should determine the disposition of the embryos (11). In its reasoning, the court stated that courts facing similar disputes should enforce agreements “subject to the right of either party to change his or her mind about disposition up to the point of use or destruction of any stored [embryos]. . . Only when a party affirmatively notifies a clinic in writing of a change in intention should the disposition issue be reopened” (11). In the event of a disagreement, the courts should consider the interests of both parties. The court held that in most circumstances “the party wishing to avoid procreation should prevail” (11). Upon applying this analysis, the court decided that it would favor the rights of the party opposed to implantation. The court concluded that the embryos should either be destroyed or continued to be stored at the cost of the party favoring such storage, as neither party objected to continued storage. Case Law Summary There are numerous philosophies as to how the disposition of cryopreserved material should be determined. Awareness of all ideas is important because of the underdeveloped and unsettled state of the case law. However, it is important to note that to date no judicial precedent considered good law has held that the disposition of cryopreserved embryos or semen should be determined by the following methods: parens patriae (the best interests of the child), a rule that unused embryos be automatically discarded or transferred, a rule that embryos be equally divided between the parties, or a rule stating that either the female (based on her gender alone) or the cryopreservation clinic should have exclusive and unconditional authority over the disposition of cryopreserved material. The persuasive case law has embraced four methods for determining the disposition of semen or pre-embryos. First, 64
Schuster et al.
Legal considerations for cryopreservation
Hecht and Davis held that courts should honor the individuals’ intent when possible. Second, Kass and Litowitz held that a valid cryopreservation contract addressing the disposition of cryopreserved embryos should be enforced. Additionally, Davis stated that the court should enforce the cryopreservation agreements when there is otherwise insufficient or ambiguous evidence of the parties’ intent. Third, Davis determined the disposition of embryos by balancing the interests of the parties. Finally, A.Z. v B.Z. and J.B. v M.B. held that disposition of embryos should sometimes be determined by public policy. It is interesting to note that, although each court used a different decision-making approach in determining the disposition of cryopreserved material, all cases ultimately favored the individual who wished to avoid procreation.
WHAT DESIRABLE CHARACTERISTICS SHOULD CRYOPRESERVATION CLINICS INCORPORATE INTO THEIR DISPOSITION AGREEMENTS? Because of the controversial and unsettled issues surrounding cryopreservation, outcomes of future disputes over disposition of cryopreserved semen and embryos are uncertain. One way to minimize unpredictability is through the use of cryopreservation contracts addressing disposition of semen and embryos. Although cryopreservation contracts are subject to the unsettled state of case law and any statutes that are ratified in the future, it is likely that courts will, within the bounds of acceptable public policy, enforce disposition agreements because they allow individuals to clarify and express their intent. As outlined in the cases above, the courts have generally enforced cryopreservation disposition agreements unless they were ambiguous or contrary to public policy (2, 7–10). When enforced, written disposition agreements may prevent some emotionally and financially costly litigation (8). When litigation does occur, contracts may insulate clinics and individuals from the unpredictability and subjectivity of balancing tests that are used in situations where evidence of intent and a valid, binding disposition agreement are lacking (7). Case law and law review articles assist drafters of cryopreservation disposition agreements because they highlight five characteristics that should be included in every disposition contract. First, those who draft cryopreservation disposition contracts should prevent possible ambiguities in their forms because courts will only enforce those disposition agreements that are unambiguous. Courts have been unwilling to imply terms into a disposition contract (5, 7, 9). If the document does not specifically take a situation into account, courts have been unwilling to apply the document to such a situation. Thus, disposition agreements should contain all conditions that are intended to trigger the disposition agreement provisions and all the desired options for disposition. Although the most common changes in circumstances that Vol. 80, No. 1, July 2003
create a dispute over the future of cryopreserved semen and embryos are divorce and death, many others should be considered such as separation, disease, aging, incapacity, disappearance, and the inability of parties to agree on disposition. Options for disposition of cryopreserved material include destruction, donation to an infertile individual or couple, transfer to another individual or cryopreservation laboratory, donation to research, or release for use in assisted reproductive technology upon the individual’s request. Additionally, if an individual wishes for his or her spouse to use the gametes posthumously, this must be clearly stated as well as a declaration of the individual’s intent to support the offspring that arise from the use of the gametes. Second, all provisions of the disposition contract should be consistent with public policy. Just as courts will not enforce an ambiguous agreement, they have stated that cryopreservation disposition agreements will not be enforced if the provisions are contrary to public policy (8 –10). The courts in A.Z. v B.Z. and J.B. v M.B. held that forcing an individual to procreate is contrary to public policy. The cases indicate that a disposition agreement provision stating that one person will receive custody of cryopreserved material for transfer over the objection of the other individual would not be enforced. Thus, such a disposition option should probably not be included in a cryopreservation contract. Third, in addition to ensuring that disposition contracts are consistent with public policy and lack ambiguity, those drafting cryopreservation disposition agreements should remember to include a clause addressing the duration of the disposition agreement. The lack of duration provision was one of four reasons that the court in A.Z. v B.Z. decided not to enforce the cryopreservation agreement. Fourth, a cryopreservation disposition contract should also include abundant contact information for the individuals signing the agreement (12). The cryopreservation clinics should be able to locate the individuals in the event financial issues arise, the facility closes or relocates, and other unforeseen circumstances (12). Having a greater ability to contact the individuals may also prevent cryopreserved embryos from being abandoned (12). There are currently 3,000 embryos in the United States that have probably been abandoned (12). Clinics need to prevent embryos from being abandoned because of the legal liability, financial cost, and ethical responsibility of storing such embryos (12). Fifth, cryopreservation contracts should include the responsibilities of both the cryopreservation clinic and the individuals in the context of their ongoing contractual relationship regarding the cryopreserved material (12). One journal article suggests several provisions that cryopreservation clinics should include in their cryopreservation agreements (12). First, the article suggests clinics should include the amount of fees and the actions that the facility will take if the FERTILITY & STERILITY威
individuals are delinquent in paying their fees (12). Second, the clinic should agree what steps it will take before taking actions that may harm the semen or embryos in any way (12). Third, clinics should include a provision that the facility can transfer the cryopreserved material if such a transfer is necessary and the facility has been unable to contact the individuals (12). Fourth, the agreement should provide that the individuals be financially responsible if the facility incurs costs during the transfer of cryopreserved material (12). Finally, the agreement should state a default disposition option that cryopreserved material be discarded (12). Those drafting disposition contracts should also ensure that the written document is consistent with the parties’ intent at the time they enter the agreement. Courts look for evidence of mutual assent when deciding whether to enforce a contract. Drafters of disposition agreements should include certain characteristics to serve as persuasive evidence that the parties understood and contemplated the contents. Obviously, the disposition agreement should be clear and conspicuous. The vocabulary, font, and design should be easily digestible for the average reader. Furthermore, in J.B. v M.B., the New Jersey Supreme Court suggested that a “qualified clinic representative . . . review the terms with the parties prior to execution” (11). In addition to the more obvious characteristics that evidence that an agreement was formed with mutual assent, one law review article argues among other points that cryopreservation disposition agreements should be free-standing contracts separate from the cryopreservation informed consent agreement (1). This would encourage couples to be more aware of the significance of the disposition agreements they are signing, because careful consideration of disposition contracts contained in an informed consent agreement is unlikely (1). The disposition agreements contained within the cryopreservation informed consent agreements are often overlooked and not adequately considered because of the complex information, the unique subject matter, the fine and single-spaced print, and the heightened emotions of the IVF context (1). In addition, couples have a difficult time imagining disposition of the cryopreserved material in the event of a dispute because they are making sacrifices to have it preserved (1). The article also argues that couples will better understand the true purpose of the disposition contract if it is independent from the informed consent agreement (1). Consequently, couples would be more likely to truly understand and agree to provisions of the disposition contract (1). There would be a greater chance that agreements would represent the intent of the parties, and thus the independent disposition agreement would be more likely to be enforced. Finally, in addition to considering issues of mutual assent when drafting the forms, clinics should also take steps to ensure mutual assent during the execution process. In A.Z. v B.Z., the way in which the disposition agreement was exe65
cuted was one of the reasons that the court decided not to enforce the contract. Because the husband had signed the preprinted form before the wife wrote in the applicable disposition provision, this meant that his signature did not demonstrate that he intended the cryopreserved material to be controlled by the term the wife inserted later.
CONCLUSION In conclusion, the state of the law surrounding cryopreservation is recent and unsettled. Although reasoning and holdings differ significantly in some respects, judicial decisions are generally similar in that they tackle two primary issues: [1] whether cryopreserved semen and embryos should be categorized as persons, property, or unique materials that are neither persons nor property, and [2] how the disposition of cryopreserved semen and embryos should be determined in case of a dispute. Although courts ask both questions, the cases are generally resolved by looking at the parties’ intent coupled with sound public policy instead of granting the semen and embryos some independent personal or property rights. Cryopreservation disposition contracts can provide cryopreservation clinics some degree of certainty in this unsettled area of law. Such agreements are generally enforced unless
66
Schuster et al.
Legal considerations for cryopreservation
they are contrary to public policy. Those drafting cryopreservation disposition agreements are assisted by lessons learned from cryopreservation cases and insight gained from law review articles. It is evident that cryopreservation contracts will be most successful and most likely to be enforced if they are unambiguous and consistent with public policy, and include a duration provision, each individual’s contact information, each individual’s provisions for use of their gametes in case of death, the responsibilities of the cryopreservation clinic and the individuals. Individuals must enter into such contracts with a true understanding of the contained provisions. References 1. Waldman EA. Disputing over embryos: of contracts and consents. Ariz State Law J 2000;32:897–940. 2. Hecht v Superior Court, 50 Cal. App. 4th 1289 (1996). 3. Hecht v Superior Court, 16 Cal. App. 4th 836 (1993). 4. Woodward v Commissioner of Social Security, 760 N.E. 2d 257 (Mass. 2002). 5. Litowitz v Litowitz, 102 Wn. App. 934 (2000). 6. Litowitz v Litowitz, 48 P. 3d 261 (2002). 7. Davis v Davis, 842 S.W. 2d 588 (1992). 8. Kass v Kass, 91 N.Y. 2d 554 (1998). 9. A.Z. v B.Z., 431 Mass. 150 (2000). 10. J.B. v M.B., 331 N.J. Super. 223 (2000). 11. J.B. v M.B., 170 N.J. 9 (2001). 12. Vukadinovich DM. Assisted reproductive technology law. Obtaining informed consent for the commercial cryopreservation of embryos. J Leg Med 2000;21:67–78.
Vol. 80, No. 1, July 2003
Legal considerations for cryopreservation of sperm and embryos Timothy G. Schuster, M.D.,a Kathryn Hickner-Cruz,b Dana A. Ohl, M.D.,a Edward Goldman, J.D.,c and Gary D. Smith, Ph.D.a,d,e University of Michigan Medical Center, Ann Arbor, Michigan
Received May 3, 2002; revised and accepted February 13, 2003. Reprint requests: Gary D. Smith, Ph.D., Department of Obstetrics and Gynecology, University of Michigan, 6428 Medical Science I, 1301 East Catherine Street, Ann Arbor, Michigan 481090617 (FAX: 734-936-9127; E-mail: smithgd@umich. edu). a Department of Urology, University of Michigan, Ann Arbor, Michigan. b Wayne State University Law School, Detroit, Michigan. c University of Michigan Health System Legal Office, Ann Arbor, Michigan. d Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan. e Department of Physiology, University of Michigan, Ann Arbor, Michigan. 0015-0282/03/$30.00 doi:10.1016/S0015-0282(03) 00503-X
Objective: To summarize the case law for cryopreservation of sperm and embryos and make recommendations for desirable characteristics that should be included in a cryopreservation clinic’s disposition agreements. Design: A literature review of case law and legal review articles was performed. Setting: Academic research center. Patient(s): None. Intervention(s): None. Main Outcome Measure(s): None. Result(s): Two court cases involving cryopreserved semen and five cases involving cryopreserved embryos are reviewed. Conclusion(s): The state of the law surrounding cryopreservation is recent and unsettled. Disposition agreements can provide cryopreservation clinics some degree of certainty in this unsettled area of law. Those drafting cryopreservation disposition agreements are assisted by lessons learned from cryopreservation cases and insight gained from law review articles. It is evident that cryopreservation agreements will be most successful and most likely to be enforced if they are unambiguous, consistent with public policy, and include: a duration provision, each individual’s contact information, the individual’s provisions for use of their gametes in case of death, and responsibilities of cryopreservation clinic and individuals. Individuals must enter into agreements with a true understanding of the contained provisions. (Fertil Steril威 2003;80:61– 6. ©2003 by American Society for Reproductive Medicine.) Key Words: Cryopreservation, sperm, embryo, legal, law
Over 100 semen banks are registered, and it is estimated that approximately 400,000 embryos are currently cryopreserved in the United States (1; personal communication from the American Society for Reproductive Medicine). These facts, coupled with the high divorce rate, have unsurprisingly resulted in disputes over the disposition of cryopreserved material. Although most struggles occur between divorcing couples or with third parties, some conflicts develop between cryopreservation clinics and individuals. Even when a clinic is not a party to litigation, it is somewhat impacted by conflict because it holds the cryopreserved material in dispute. Additionally, contents of the clinic’s disposition agreement as well as the manner in which documents were signed by couples can significantly impact the court’s decision. Cryopreservation case law deals with two central questions: [1] how cryopreserved se-
men and embryos should be categorized, and [2] how the disposition of frozen semen and embryos should be determined in case of a dispute. Although courts have rendered answers to each of these questions in several cases, both issues remain unsettled in case law. (Note that in case law there also is some dispute over what a fertilized cryopreserved egg should be called. Judicial opinions refer to the material with one of four terms: “embryo,” “pre-embryo,” “pre-zygote,” or “zygote.” When discussing a particular case, this article will refer to all material as embryos, although each particular court may have referred to the material differently within its opinion.) Although disputes over cryopreserved sperm and embryos raise a variety of different legal issues, there are desirable characteristics that should be included in a cryopreservation clinic’s disposition contract for any cryopre61
served material. First, this article will review court cases that have addressed the disposition of cryopreserved material. Then recommendations will be made regarding specific items that should be included in a cryopreservation clinic’s disposition contract.
CRYOPRESERVATION CASE LAW Cryopreserved Semen Hecht v Superior Court The decedent in Hecht v Superior Court (3, 4) deposited 15 vials of semen at a sperm bank for cryopreservation. He signed a “Specimen Storage Agreement” providing that, upon his death, the cryobank would continue to store or release the semen upon the request of the executor of the estate. The decedent authorized his semen to be released to his girlfriend and his girlfriend’s physician. He later committed suicide. Confirming the intent expressed in the cryopreservation agreement, the will left all property interest in the semen to his girlfriend. A conflict over the disposition of the semen arose when the decedent’s girlfriend signed a settlement agreement with the man’s family that would entitle her to only 20% of the semen. In the court’s first opinion in Hecht (3), the California Court of Appeals held that cryopreserved semen is property and therefore part of the individual’s estate. The court supported its conclusions by arguing that sperm banks treat sperm as property. Men who cryopreserve their sperm are required to pay maintenance fees and fees for withdrawal of sperm. Upon death of the gamete donor, sperm banks often dispose of deposits unless there is an expressed instruction in the individual’s will or a court order stating that the party wished that his widow be inseminated with the sperm. The court also cited an ethics statement from the American Fertility Society on in vitro fertilization (IVF): “it is understood that the gametes and concepti are the property of the donors. The donors therefore have the right to decide at their sole discretion the disposition of these items, provided such disposition is within medical and ethical guidelines” (3). The original categorization of cryopreserved semen by the California Court of Appeals was revised and narrowed when the court released its second opinion in the Hecht case (2). In its second opinion, the court held that semen is a “unique material” unlike other forms of property. The court reasoned that, unlike other forms of property, the disposition of semen cannot be controlled by contract or property law but can only be determined by the intent of the decedent. Therefore, the semen could not be distributed as assets of the decedent’s estate and was not subject to settlement agreements. Based on this reasoning, the court concluded that the girlfriend should have exclusive possession of the semen. 62
Schuster et al.
Legal considerations for cryopreservation
Woodward v Commissioner of Social Security The couple in the Woodward v Commissioner of Social Security case (6) was married for 3.5 years when the husband was diagnosed with leukemia. The husband cryopreserved his semen before his unsuccessful treatment for his leukemia. Two years after his death, the wife gave birth to twins conceived through artificial insemination using the husband’s sperm. A dispute arose when the wife applied for Social Security survivor benefits for her children. The court ruled that a marriage is ended with death; therefore, posthumous conception of children is nonmarital. Similar to other nonmarital conception cases, to receive inheritance rights under the Massachusetts intestacy statute the wife must first establish the children’s genetic relationship to their father. Additionally, the courts ruled the gamete donor must “clearly and unequivocally consent not only to posthumous reproduction but also to the support of any resulting child” (4).
Cryopreserved Embryos Litowitz v Litowitz In Litowitz v Litowitz (5, 6), a couple used the husband’s sperm to fertilize five donated eggs, of which two were cryopreserved. The cryopreservation agreement signed by the couple stated that any disposition decision required the mutual consent of the couple. If a disagreement arose, a court was authorized to decide the disposition of the embryos. Upon the couple’s divorce, the wife wanted custody of the embryos for the purposes of transferring them into a surrogate while the husband “wanted to place the embryos with an out-of-state couple.” The Washington Court of Appeals found that the evidence of the couple’s intent and the provisions of the cryopreservation agreement were insufficient to exclusively control the future of the embryos. The court then addressed the constitutional rights of the parties. Because the wife’s gametes were not used to create the embryos in dispute, the court held she did not have a constitutional right to procreate. In contrast, the court held that under the circumstances the husband could “exercise his right not to procreate in a limited way that allows the embryos to develop but avoids placing him in the unwanted parenting role” (5). It is interesting that the court of appeals decision was reversed by the Washington Supreme Court, which based its decision solely on the parties’ contractual rights associated with the original cryopreservation agreement (6). The original contract stated that, unless the couple mutually requested an extension of the contract beyond 5 years, the cryopreserved embryos should be “thawed out but not allowed to undergo further development” (6). Because the appeal was reviewed greater than 5 years after the contract was signed, the court enforced the contract. Vol. 80, No. 1, July 2003
Davis v Davis
A.Z. v B.Z.
The couple in Davis v Davis (7) created seven embryos that were cryopreserved during their marriage. The parties did not sign an informed consent agreement or a disposition contract with the cryopreservation clinic. Upon their divorce, a dispute arose between the parties over the disposition of the cryopreserved embryos. The husband wanted to prevent the embryos from developing while the wife desired to donate the embryos to a third party.
Similar to other cases, in A.Z. v B.Z. (9) the couple participated in an IVF program. After some embryos were transferred into the wife, a pregnancy occurred and twins were born; the remaining embryos were cryopreserved. Eventually the couple divorced, after which a dispute arose over the disposition of the frozen embryos.
The Tennessee Supreme Court in Davis adopted a stepwise approach to deciding the fate of the disputed cryopreserved embryos. The court believed that the intent of the parties is the controlling authority on disposition of cryopreserved embryos. When intentions are conflicting or unclear, cryopreservation contracts should control disposition. In a situation in which there was no agreement signed (as in Davis), the court would conduct a balancing of interests of parties to the dispute.
The wife had undergone seven egg retrievals, during which the couple signed seven cryopreservation contract forms. On the forms a blank line existed where the couple could insert a provision for the disposition of the embryos. The provision written by the couple stated that, if the parties were separated, “the embryo(s) should be returned to the wife for implant” (9). After signing the initial form, however, “the husband always signed a consent form before the wife filled in the disposition provision” (9). The form that controlled the embryos at issue in A.Z. v B.Z. was not the initial form but rather one signed subsequently.
The Davis court stated that the right to procreate or not to procreate is a fundamental right. The court stated that, in general, the party who objects to procreation should be favored unless the other party has no other means of becoming a parent. Here, the husband’s interest in preventing procreation outweighed the wife’s interest in allowing procreation, and the embryos were awarded to the husband. The court felt this weighing of interests was especially appropriate to the Davis case because the wife did not wish to transfer the embryos into her own body but rather to donate the embryos to another couple.
The court refused to enforce the contract form under the circumstances of A.Z. v B.Z. Reasons cited for the court’s opinion were [1] the purpose of the form, [2] the lack of a duration provision, [3] the lack of the term “divorce,” and [4] the way in which the form was executed (i.e., the husband had signed the pertinent form while it was blank and without the provision regarding the disposition of the embryos upon divorce). In addition, the court stated that, even if the agreement was mutually agreed on and unambiguous, the court would not enforce such a provision because it is against public policy to force an individual to become a parent against his or her will.
Kass v Kass
In areas of new law, courts often turn to arguments based on what is felt to be in the “best interest of the public” to assist in the legal resolution of cases. For example, in a case where a physician writes language into a consent document saying the patient gives up her right to sue even if there is malpractice, a court would hold that language unenforceable because it is contrary to public policy. In the above case, the court supported its assertion by citing laws on marriage contracts and adoption that allow people to change their mind after an agreement has been entered. The court concluded that the public interest in not enforcing such an agreement outweighs the public interest in freedom to contract. Thus, the court concluded that the former wife could not transfer the embryos against her former husband’s wishes.
The parties in Kass v Kass (8) created five embryos during participation in an IVF program, at which time they also signed a cryopreservation disposition contract stipulating that, in case of divorce, the embryos would be donated to the IVF program for research purposes. Eventually the parties divorced. Both parties signed an uncontested divorce agreement indicating that the parties wished the embryos to be disposed of in the manner indicated on the disposition agreement. The former wife later wished to abandon the agreement and wanted to transfer the embryos; the former husband objected to the transfer as he did not want to become a father. The court in Kass enforced the cryopreservation disposition agreement. Kass held that, in the case of a dispute, disposition contracts are generally presumed to be valid and binding. The court reasoned that enforcing such agreements is crucial because of their value to couples and cryopreservation clinics. If the court refused to enforce disposition agreements, the seriousness and integrity of the contracts would be destroyed. Thus, the court in Kass ordered that the embryos be donated to the IVF program for research purposes as stipulated in the original disposition agreement. FERTILITY & STERILITY威
J.B. v M.B. The parties in J.B. v M.B. (10, 11) cryopreserved embryos during their attempt to conceive a child. The cryopreservation agreement signed by the parties and the IVF center stated that the embryos would be “relinquished to the IVF program” in the event of a divorce “unless the court specifies who takes control” of the embryos (10). Eventually the parties divorced, after which the wife wanted to destroy the 63
embryos while the husband wanted to preserve them for future use either in a woman with whom he developed a relationship or for donation to an infertile couple. The court in J.B. v M.B. agreed with the court in A.Z. v B.Z. that it is against public policy to enforce a contract to procreate and thus force an individual to become a biological parent. The court stated that contracts to create familial relationships should not be enforced against the will of those who entered the agreements. The court reasoned that these cryopreservation agreements were similar to contracts to marry or to give children up for adoption. In both marriage and adoption cases, parties are permitted to revoke consent. Similarly, women should be able to prevent the transfer of their embryos if they so desire. In addition, the court held that it would be a violation of the wife’s reproductive rights to force her to become a biological parent against her will and then allow her no parental rights for the child produced when the embryo is given to a stranger. The appellate decision in J.B. v M.B. was affirmed by the Supreme Court of New Jersey, which found that the parties had agreed that a court should determine the disposition of the embryos (11). In its reasoning, the court stated that courts facing similar disputes should enforce agreements “subject to the right of either party to change his or her mind about disposition up to the point of use or destruction of any stored [embryos]. . . Only when a party affirmatively notifies a clinic in writing of a change in intention should the disposition issue be reopened” (11). In the event of a disagreement, the courts should consider the interests of both parties. The court held that in most circumstances “the party wishing to avoid procreation should prevail” (11). Upon applying this analysis, the court decided that it would favor the rights of the party opposed to implantation. The court concluded that the embryos should either be destroyed or continued to be stored at the cost of the party favoring such storage, as neither party objected to continued storage. Case Law Summary There are numerous philosophies as to how the disposition of cryopreserved material should be determined. Awareness of all ideas is important because of the underdeveloped and unsettled state of the case law. However, it is important to note that to date no judicial precedent considered good law has held that the disposition of cryopreserved embryos or semen should be determined by the following methods: parens patriae (the best interests of the child), a rule that unused embryos be automatically discarded or transferred, a rule that embryos be equally divided between the parties, or a rule stating that either the female (based on her gender alone) or the cryopreservation clinic should have exclusive and unconditional authority over the disposition of cryopreserved material. The persuasive case law has embraced four methods for determining the disposition of semen or pre-embryos. First, 64
Schuster et al.
Legal considerations for cryopreservation
Hecht and Davis held that courts should honor the individuals’ intent when possible. Second, Kass and Litowitz held that a valid cryopreservation contract addressing the disposition of cryopreserved embryos should be enforced. Additionally, Davis stated that the court should enforce the cryopreservation agreements when there is otherwise insufficient or ambiguous evidence of the parties’ intent. Third, Davis determined the disposition of embryos by balancing the interests of the parties. Finally, A.Z. v B.Z. and J.B. v M.B. held that disposition of embryos should sometimes be determined by public policy. It is interesting to note that, although each court used a different decision-making approach in determining the disposition of cryopreserved material, all cases ultimately favored the individual who wished to avoid procreation.
WHAT DESIRABLE CHARACTERISTICS SHOULD CRYOPRESERVATION CLINICS INCORPORATE INTO THEIR DISPOSITION AGREEMENTS? Because of the controversial and unsettled issues surrounding cryopreservation, outcomes of future disputes over disposition of cryopreserved semen and embryos are uncertain. One way to minimize unpredictability is through the use of cryopreservation contracts addressing disposition of semen and embryos. Although cryopreservation contracts are subject to the unsettled state of case law and any statutes that are ratified in the future, it is likely that courts will, within the bounds of acceptable public policy, enforce disposition agreements because they allow individuals to clarify and express their intent. As outlined in the cases above, the courts have generally enforced cryopreservation disposition agreements unless they were ambiguous or contrary to public policy (2, 7–10). When enforced, written disposition agreements may prevent some emotionally and financially costly litigation (8). When litigation does occur, contracts may insulate clinics and individuals from the unpredictability and subjectivity of balancing tests that are used in situations where evidence of intent and a valid, binding disposition agreement are lacking (7). Case law and law review articles assist drafters of cryopreservation disposition agreements because they highlight five characteristics that should be included in every disposition contract. First, those who draft cryopreservation disposition contracts should prevent possible ambiguities in their forms because courts will only enforce those disposition agreements that are unambiguous. Courts have been unwilling to imply terms into a disposition contract (5, 7, 9). If the document does not specifically take a situation into account, courts have been unwilling to apply the document to such a situation. Thus, disposition agreements should contain all conditions that are intended to trigger the disposition agreement provisions and all the desired options for disposition. Although the most common changes in circumstances that Vol. 80, No. 1, July 2003
create a dispute over the future of cryopreserved semen and embryos are divorce and death, many others should be considered such as separation, disease, aging, incapacity, disappearance, and the inability of parties to agree on disposition. Options for disposition of cryopreserved material include destruction, donation to an infertile individual or couple, transfer to another individual or cryopreservation laboratory, donation to research, or release for use in assisted reproductive technology upon the individual’s request. Additionally, if an individual wishes for his or her spouse to use the gametes posthumously, this must be clearly stated as well as a declaration of the individual’s intent to support the offspring that arise from the use of the gametes. Second, all provisions of the disposition contract should be consistent with public policy. Just as courts will not enforce an ambiguous agreement, they have stated that cryopreservation disposition agreements will not be enforced if the provisions are contrary to public policy (8 –10). The courts in A.Z. v B.Z. and J.B. v M.B. held that forcing an individual to procreate is contrary to public policy. The cases indicate that a disposition agreement provision stating that one person will receive custody of cryopreserved material for transfer over the objection of the other individual would not be enforced. Thus, such a disposition option should probably not be included in a cryopreservation contract. Third, in addition to ensuring that disposition contracts are consistent with public policy and lack ambiguity, those drafting cryopreservation disposition agreements should remember to include a clause addressing the duration of the disposition agreement. The lack of duration provision was one of four reasons that the court in A.Z. v B.Z. decided not to enforce the cryopreservation agreement. Fourth, a cryopreservation disposition contract should also include abundant contact information for the individuals signing the agreement (12). The cryopreservation clinics should be able to locate the individuals in the event financial issues arise, the facility closes or relocates, and other unforeseen circumstances (12). Having a greater ability to contact the individuals may also prevent cryopreserved embryos from being abandoned (12). There are currently 3,000 embryos in the United States that have probably been abandoned (12). Clinics need to prevent embryos from being abandoned because of the legal liability, financial cost, and ethical responsibility of storing such embryos (12). Fifth, cryopreservation contracts should include the responsibilities of both the cryopreservation clinic and the individuals in the context of their ongoing contractual relationship regarding the cryopreserved material (12). One journal article suggests several provisions that cryopreservation clinics should include in their cryopreservation agreements (12). First, the article suggests clinics should include the amount of fees and the actions that the facility will take if the FERTILITY & STERILITY威
individuals are delinquent in paying their fees (12). Second, the clinic should agree what steps it will take before taking actions that may harm the semen or embryos in any way (12). Third, clinics should include a provision that the facility can transfer the cryopreserved material if such a transfer is necessary and the facility has been unable to contact the individuals (12). Fourth, the agreement should provide that the individuals be financially responsible if the facility incurs costs during the transfer of cryopreserved material (12). Finally, the agreement should state a default disposition option that cryopreserved material be discarded (12). Those drafting disposition contracts should also ensure that the written document is consistent with the parties’ intent at the time they enter the agreement. Courts look for evidence of mutual assent when deciding whether to enforce a contract. Drafters of disposition agreements should include certain characteristics to serve as persuasive evidence that the parties understood and contemplated the contents. Obviously, the disposition agreement should be clear and conspicuous. The vocabulary, font, and design should be easily digestible for the average reader. Furthermore, in J.B. v M.B., the New Jersey Supreme Court suggested that a “qualified clinic representative . . . review the terms with the parties prior to execution” (11). In addition to the more obvious characteristics that evidence that an agreement was formed with mutual assent, one law review article argues among other points that cryopreservation disposition agreements should be free-standing contracts separate from the cryopreservation informed consent agreement (1). This would encourage couples to be more aware of the significance of the disposition agreements they are signing, because careful consideration of disposition contracts contained in an informed consent agreement is unlikely (1). The disposition agreements contained within the cryopreservation informed consent agreements are often overlooked and not adequately considered because of the complex information, the unique subject matter, the fine and single-spaced print, and the heightened emotions of the IVF context (1). In addition, couples have a difficult time imagining disposition of the cryopreserved material in the event of a dispute because they are making sacrifices to have it preserved (1). The article also argues that couples will better understand the true purpose of the disposition contract if it is independent from the informed consent agreement (1). Consequently, couples would be more likely to truly understand and agree to provisions of the disposition contract (1). There would be a greater chance that agreements would represent the intent of the parties, and thus the independent disposition agreement would be more likely to be enforced. Finally, in addition to considering issues of mutual assent when drafting the forms, clinics should also take steps to ensure mutual assent during the execution process. In A.Z. v B.Z., the way in which the disposition agreement was exe65
cuted was one of the reasons that the court decided not to enforce the contract. Because the husband had signed the preprinted form before the wife wrote in the applicable disposition provision, this meant that his signature did not demonstrate that he intended the cryopreserved material to be controlled by the term the wife inserted later.
CONCLUSION In conclusion, the state of the law surrounding cryopreservation is recent and unsettled. Although reasoning and holdings differ significantly in some respects, judicial decisions are generally similar in that they tackle two primary issues: [1] whether cryopreserved semen and embryos should be categorized as persons, property, or unique materials that are neither persons nor property, and [2] how the disposition of cryopreserved semen and embryos should be determined in case of a dispute. Although courts ask both questions, the cases are generally resolved by looking at the parties’ intent coupled with sound public policy instead of granting the semen and embryos some independent personal or property rights. Cryopreservation disposition contracts can provide cryopreservation clinics some degree of certainty in this unsettled area of law. Such agreements are generally enforced unless
66
Schuster et al.
Legal considerations for cryopreservation
they are contrary to public policy. Those drafting cryopreservation disposition agreements are assisted by lessons learned from cryopreservation cases and insight gained from law review articles. It is evident that cryopreservation contracts will be most successful and most likely to be enforced if they are unambiguous and consistent with public policy, and include a duration provision, each individual’s contact information, each individual’s provisions for use of their gametes in case of death, the responsibilities of the cryopreservation clinic and the individuals. Individuals must enter into such contracts with a true understanding of the contained provisions. References 1. Waldman EA. Disputing over embryos: of contracts and consents. Ariz State Law J 2000;32:897–940. 2. Hecht v Superior Court, 50 Cal. App. 4th 1289 (1996). 3. Hecht v Superior Court, 16 Cal. App. 4th 836 (1993). 4. Woodward v Commissioner of Social Security, 760 N.E. 2d 257 (Mass. 2002). 5. Litowitz v Litowitz, 102 Wn. App. 934 (2000). 6. Litowitz v Litowitz, 48 P. 3d 261 (2002). 7. Davis v Davis, 842 S.W. 2d 588 (1992). 8. Kass v Kass, 91 N.Y. 2d 554 (1998). 9. A.Z. v B.Z., 431 Mass. 150 (2000). 10. J.B. v M.B., 331 N.J. Super. 223 (2000). 11. J.B. v M.B., 170 N.J. 9 (2001). 12. Vukadinovich DM. Assisted reproductive technology law. Obtaining informed consent for the commercial cryopreservation of embryos. J Leg Med 2000;21:67–78.
Vol. 80, No. 1, July 2003