Assisted reproductive technology law: Obtaining informed consent for the commercial cryopreservation of embryos

Journal of Legal Medicine

Volumn 21, Issue 1, 2000, Pages 67-78

  Vukadinovich, David M ^a  

^a NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CONTRACT; DOCUMENTATION; HUMAN; INFERTILITY THERAPY; INFORMED CONSENT; LAW; POLICY; RESPONSIBILITY; UNITED STATES;

EID: 0034055871     PISSN: 01947648     EISSN: None     Source Type: Journal    
DOI: 10.1080/019476400272800     Document Type: Article

References (34)

1. 1 See Keith Alan Byers, Infertility and In Vitro Fertilization: A Growing Need for Consumer-Oriented Regulation of the In Vitro Fertilization Industry, 18 J. Legal Med. 265, 282-89 (1997). In this article, the term ART is used to designate the various technologies that utilize cryopreservation of embryos and sperm to assist reproduction. Typically, such technology is used in conjunction with in vitro fertilization. For a discussion of various types of reproductive technologies, see Ethics Committee of The American Fertility Society, Ethical Considerations of Assisted Reproductive Technologies, 62 Fert. & Ster. 35S (Supp. I, Nov. 1994).
2. 2 See Byers, supra note 1, at 282-89.
3. 3 On the need for state regulations, see Byers, supra note 1, at 289-313.
4. 4 For example, the trial court, in the case of In re Marriage of Buzzanca, 72 Cal. Rptr. 2d 280 (Cal. App. 1998), found that an infant born through reproductive technology utilizing a donor embryo, donor sperm, and a surrogate had no legal parents.
5. 5 See, e.g., Davis v. Davis, 842 S.W.2d 588, 590 (Tenn. 1992) (noting that, of the state legislatures, only Louisiana had enacted legislation relevant to disposition of cryopreserved embryos).
6. 6 64 Fed. Reg. 39373 (July 21, 1999).
7. 7 See, e.g., Monica Shaw, Comment, Modern Reproductive Technologies: Legal Issues Concerning Cryo-preservation and Posthumous Conception, 17 J. Legal Med. 547 (1996); Karen T. Rogers, Note, Embryo Theft: The Misappropriation of Human Eggs at an Irvine fertility Clinic Has Raised a Host of New Legal Concerns for Infertile Couples Using New Reproductive Technologies, 26 Sw. U.L. Rev. 1133 (1997). The news media have been quick to exploit advances in fertility technology with sensationalistic headlines that sometimes sound like science fiction. See, e.g., Frozen Embryos Spawn Ethical Debates: Are They Human Beings or Medical Waste?, Cinci. Enq., Aug. 8, 1999, at A01; Judy Peres, Children from Beyond the Grave; Surrogate Carrying Dead Woman's Baby, Chi. Trib., Dec. 15, 1997, at 1; Kathryn Dore Perkins, Ethical Debate Surrounds Use of Dead Men 's Sperm, Sac. Bee, Aug. 27, 1997, at G1.
8. 7 See, e.g., Monica Shaw, Comment, Modern Reproductive Technologies: Legal Issues Concerning Cryo-preservation and Posthumous Conception, 17 J. Legal Med. 547 (1996); Karen T. Rogers, Note, Embryo Theft: The Misappropriation of Human Eggs at an Irvine fertility Clinic Has Raised a Host of New Legal Concerns for Infertile Couples Using New Reproductive Technologies, 26 Sw. U.L. Rev. 1133 (1997). The news media have been quick to exploit advances in fertility technology with sensationalistic headlines that sometimes sound like science fiction. See, e.g., Frozen Embryos Spawn Ethical Debates: Are They Human Beings or Medical Waste?, Cinci. Enq., Aug. 8, 1999, at A01; Judy Peres, Children from Beyond the Grave; Surrogate Carrying Dead Woman's Baby, Chi. Trib., Dec. 15, 1997, at 1; Kathryn Dore Perkins, Ethical Debate Surrounds Use of Dead Men 's Sperm, Sac. Bee, Aug. 27, 1997, at G1.
9. 8 See, e.g., John A. Robertson, Reproductive Technology and Reproductive Rights: In the Beginning: The Legal Status of Early Embryos, 76 Va. L. Rev. 437 (1990); Clifton Perry & L. Kristen Schneider, Cryopreserved Embryos: Who Shall Decide Their Fate?, 13 J. Legal Med. 463, 469-88 (1992).
10. 8 See, e.g., John A. Robertson, Reproductive Technology and Reproductive Rights: In the Beginning: The Legal Status of Early Embryos, 76 Va. L. Rev. 437 (1990); Clifton Perry & L. Kristen Schneider, Cryopreserved Embryos: Who Shall Decide Their Fate?, 13 J. Legal Med. 463, 469-88 (1992).
11. 9 The term "embryo" is used herein to refer to what is more technically known as a "preembryo." For a discussion of the cryopreservation of preembryos, see The American Fertility Society, supra note 1, at 56S. Much of the discussion in this article applies equally to cyropreservation of semen specimens, although reference generally is made to cryopreservation of embryos.
12. 10 See Cobbs v. Grant, 104 Cal. Rptr. 505 (Cal. 1972). Requirements for information that must be disclosed to patients in obtaining informed consent may vary by jurisdiction.
13. 11 For example, California regulations require that patients of hospitals, as well as ART programs operated by hospitals, "[r]eceive as much information about any proposed treatment or procedure as the patient may need in order to give informed consent or to refuse this course of treatment." Cal. Code Regs. tit. 22, § 70707(a)(5) (1999). Additionally, documentation of patient informed consent can aid in defending against a cause of action brought against a provider for battery. See Bommareddy v. Superior Court, 272 Cal. Rptr. 246 (Cal. App. 1990).
14. 11 For example, California regulations require that patients of hospitals, as well as ART programs operated by hospitals, "[r]eceive as much information about any proposed treatment or procedure as the patient may need in order to give informed consent or to refuse this course of treatment." Cal. Code Regs. tit. 22, § 70707(a)(5) (1999). Additionally, documentation of patient informed consent can aid in defending against a cause of action brought against a provider for battery. See Bommareddy v. Superior Court, 272 Cal. Rptr. 246 (Cal. App. 1990).
15. 12 If one of the donors is known but uninterested, and relinquishes future parental rights, then it is advisable that the facility obtain a written statement from the individual to that effect. Whether a court will find such a statement to be binding is not certain. However, obtaining such a statement may provide some degree of protection to the facility in the event that the facility disposes of the embryos in compliance with instructions executed by the interested party but in contravention of the wishes of the seemingly uninterested party. For a discussion of disposition agreements entered into by gamete donors for purposes of creating embryos, see Robertson, supra note 8, at 463-73.
16. 13 See, e.g., Kass v. Kass, 663 N.Y.S.2d 581 (N.Y. App. Div. 1997) (dispute over custody of five frozen embryos after divorce); Davis, 842 S.W.2d at 588 (dispute over frozen embryos upon divorce of donors). The Texas Supreme Court agreed to hear a paternity dispute arising over a child born from a cryogenically preserved embryo after the biological parents divorced. See Court Agrees to Hear Frozen Embryo Case, Hous. Chron., Aug. 27, 1999, at A31.
17. 13 See, e.g., Kass v. Kass, 663 N.Y.S.2d 581 (N.Y. App. Div. 1997) (dispute over custody of five frozen embryos after divorce); Davis, 842 S.W.2d at 588 (dispute over frozen embryos upon divorce of donors). The Texas Supreme Court agreed to hear a paternity dispute arising over a child born from a cryogenically preserved embryo after the biological parents divorced. See Court Agrees to Hear Frozen Embryo Case, Hous. Chron., Aug. 27, 1999, at A31.
18. 14 See Robertson, supra note 8, at 463-73. See also Perry & Schneider, supra note 8, at 490-96.
19. 14 See Robertson, supra note 8, at 463-73. See also Perry & Schneider, supra note 8, at 490-96.
20. 15 Kerry Fehr-Snyder & Graciela Sevilla, One Side's Medical Waste Is Other's Living Being; Ethical Debate Hinges on Leftover Frozen Embryos, Ariz. Rep., July 14, 1999, at A1. It was reported that, upon preparing to retire, a physician specializing in reproductive medicine and operating an embryo and sperm storage facility in Arizona was unable to locate approximately 50 embryo donors and 70 sperm donors. To locate the donors, the physician ran a 12-line advertisement in the classified section of the local newspaper. The original advertisement stated that donors had less than one week to claim their specimens or the specimens would be destroyed. The deadline subsequently was extended. See id.; Kerry Fehr-Snyder, Fertility Clinic Extends Deadline; Will Trash Frozen Sperm, Embryos, Ariz. Rep., July 27, 1999, at B1; Clinic Raises Questions About Unclaimed Embryos, Balt. Sun, July 13, 1999, at 3A.
21. 16 Due to numerous mergers and acquisitions occurring among health care facilities, the possibility of a hospital that operates an ART facility being acquired by a new parent corporation and subsequently being required to discontinue its ART activities is not entirely unlikely. For example, such closures may occur if a hospital that operates an ART laboratory is acquired by a religiously affiliated parent corporation that objects to use of ART. See Deanna Bellandi, What Hospitals Won't Do for a Merger - Deals Involving Catholic Facilities Often Mean a Loss of Reproductive Services, Modern Healthcare, Sept. 28, 1998, at 28; Chris Rauber, CHW Buys a Rival: Pending Purchase of Hospital Near San Jose Raises Questions About Reproductive Services, Modern Healthcare, Sept. 13, 1999, at 17.
22. 17 The Ethics Committee of The American Society for Reproductive Medicine, Ethical Considerations of Assisted Reproductive Technologies, 67 Fert. & Ster. 1S (Supp. 1, May 1997).
23. 18 Many questions may arise with regard to the extent of efforts that must be taken by a facility to locate donors. For example, is a facility required to issue public notices, hire a missing person locator service, or even hire a private investigator to locate missing donors?
24. 19 Whether contract terms addressing or limiting an ART facility's continued storage obligations are legally enforceable is a question that, for the most part, remains unanswered. Consequently, in light of uncertain potential liability, a facility may be wise to continue to store the embryos for as long as financially feasible.
25. 20 The question of posthumous reproduction has become fairly common in the fertility industry. For the position of the American Society for Reproductive Medicine, see The American Society for Reproductive Medicine, supra note 17, at 8S.
26. 21 In this hypothetical, it is the male donor who grants possession of the embryos to the female donor. The converse of these same issues, however, also may arise in the event that the female donor grants possession to the male donor.
27. 22 State laws generally provide that medical information is confidential. Thus, an ART facility must take caution not to divulge donor confidences in attempts to locate the donors.
28. 23 See John A. Robertson, Legal and Ethical Issues Arising with Preimplantation Human Embryos, 116 Arch. Pathol. Lab. Med. 430 (1992) (discussing the emerging consensus that embryos should be afforded special respect).
29. 24 Continued storage also may be advisable because of the minimal expense associated with cryopreservation, assuming the storage takes place on the facility's premises and not under contract with another facility.
30. 25 See The American Society for Reproductive Medicine, supra note 17, at 1S.
31. 26 See supra note 13 and accompanying text.
32. 27 See Robertson, supra note 8, at 463-73.
33. 28 In response to an Arizona physician's classified advertisement stating that unclaimed embryos would be destroyed, the American Life League President issued a statement asking the physician to offer the embryos for adoption and comparing destruction of the embryos to the Holocaust. See All's Judie Brown Asks Phoenix Scientist to Offer Frozen Embryos to Adopting Families, PR Newswire, July 13, 1999.
34. 29 See The American Society for Reproductive Medicine, supra note 17, at 1S.