Section Review

IVF: New Horizons in Informed Consent

Jeffrey B. Catalano is an attorney with Todd & Weld LLP.
A. Introduction

There are approximately 400,000 frozen embryos in this country created by in vitro fertilization (IVF). The question of what may be done with these embryos is sending shock waves across the country. The epicenter of this debate is in Washington, where politicians, special interest organizations, religious groups, and cryopreservation banks argue passionately whether these embryos may be discarded, used for stem cell research, or given up for adoption. Almost overlooked are the rights of the individuals who donated the genetic materials to create the frozen embryos. These “donors” have a bedrock right, established in law and medicine, to decide what may be done.

An interesting and well-publicized case our firm tried last year (Gladu v. Boston IVF et al.) reaffirmed this right and demonstrated the legal consequences of failing to obtain the informed consent of one of the donors prior to creating another pregnancy via IVF. More broadly, it emphasized the fundamental importance of informed consent in an evolving area of medicine.

The case resulted from a fertility clinic’s creation of a child through IVF without one donor’s knowledge or consent.1 In 1989, Richard Gladu and his wife (at the time) were referred to Boston IVF for infertility treatment. The defendants determined that his wife was infertile (and had no viable eggs), but that Mr. Gladu was not. As a result, Mr. Gladu donated his sperm, which was used to fertilize oocytes from an anonymous donor in order to achieve viable embryos. Defendant #1 implanted three embryos in Mr. Gladu’s wife’s uterus on June 5, 1993, and the remaining two embryos were frozen. This procedure was successful, and resulted in the birth of their son in February 1994.

Prior to the first implantation procedure, Mr. Gladu and his wife signed a form concerning the disposition of the remaining frozen embryos, pursuant which Mr. Gladu and his wife elected to freeze any embryos that were in excess of the fresh embryos used immediately. Mr. Gladu believed that, according to the provisions in these documents, he was agreeing that if the pregnancy attempt was not successful, then the frozen embryos were available for another attempt. He always intended to have just one pregnancy through IVF. He further thought that, if a successful pregnancy did result, the remaining frozen embryos either would be discarded or donated to another patient couple. Mr. Gladu never imagined that, by signing the form, he was providing his “advance consent” to the defendants to create another child in the future.

In fact, with the birth of his son in 1994, Mr. Gladu had his hands full with two children: he and his wife had, in 1992, adopted a daughter who had cerebral palsy. The plaintiff was the children’s primary care giver, and worked full time as a firefighter. In October 1995, Mr. Gladu filed for divorce due to serious marital problems. However, he put the divorce on hold in order to undergo marriage counseling while he lived with his wife and children. In these circumstances, Mr. Gladu did not want any other children and told his wife this.

However, in late 1995, after Mr. Gladu had filed for divorce, Mr. Gladu’s wife returned to Boston IVF in order to become pregnant again. Mr. Gladu had no advance knowledge of this. Defendant #2 thawed the two remaining embryos and, on December 28, 1995, Defendant #1 implanted these embryos in Mr. Gladu’s wife’s womb. This procedure resulted in a second pregnancy. Neither defendant called Mr. Gladu to request his permission, nor did either make certain that Boston IVF had obtained his consent. In fact, this procedure took place when Mr. Gladu was out of state. The consequence of this procedure was profound: the creation of another child.

Mr. Gladu only became aware of this procedure a month later, when his wife informed him that she was pregnant. Mr. Gladu immediately telephoned Defendant #2 to complain that he was never informed of this second procedure. He testified that, during this telephone conversation, Defendant #2 told him that a terrible mistake had been made. In September 1996, his wife gave birth to a girl, whom Mr. Gladu has been supporting financially.

Mr. Gladu’s life tumbled downhill after the birth of his third child. Although he had been the primary caretaker, he lost custody of his children. He became withdrawn and depressed, and began intensive psychotherapy. Mr. Gladu, a lifelong fireman, was forced to resign from the Fire Department for emotional reasons. He also suffered emotional distress because his love of his daughter is entangled with feelings of guilt, betrayal, resentment, and anger about her conception.

The jury found Boston IVF liable for breach of contract for creating another child without his knowledge or consent, and awarded Mr. Gladu the present value of the future cost of raising the child as well as emotional distress damages.2

B. Informed consent of IVF donors is required

In the first instance, the Gladu case confirmed that emerging medical specialties such as reproductive endocrinology are held to the same ethical principles of informed consent that govern all areas of medicine. It is well established in Massachusetts that a physician owes to his patient the duty to disclose all significant medical information that is material to the patient’s ability to make an informed judgment whether to give or withhold consent to a medical or surgical procedure.3 The requirement of obtaining consent prior to administering treatment is an ethical issue applicable to all areas of medicine and has been codified by the American Medical Association in the Code of Medical Ethics since the code’s inception in 1847.4 Failing to advise a patient that a specific procedure will be performed is a direct violation of this Code.5

These principles have been reiterated by prominent medical societies, particularly as they relate to reproduction. The American College of Obstetricians and Gynecologists (ACOG) specifically described the standard of care regarding informed consent in its 1992 committee opinion on “Ethical Dimensions of Informed Consent”.6 In that publication, ACOG listed nine statements pertaining to the ethical requirement of informed consent including the following:

Informed consent is an expression of respect for the patient as a person; it particularly respects a patient’s moral right to . . . self-determination regarding . . . reproductive capacities.

The opinion also states that “Informed consent includes . . . freedom from being acted upon by others when they have not taken account of and respected one’s own preference and choice.”7

In 1994, The American Fertility Society published “Ethical Considerations of Assisted Reproductive Technologies.”8 Within this document, The American Fertility Society specifically states:

With respect to decisions about the disposition of cryopreserved preembryos, the gamete providers (or those to whom they transfer their gametes) should have primary decisional authority, within the limits set by institutional policies and applicable law. The gamete providers thus may jointly decide whether their cryopreserved embryos will be thawed for transfer. (Emphasis added.)9

The plaintiff in Gladu argued that informed consent extended beyond the corpus of the patient to the use of the material obtained from that patient, such as sperm. The jury then found that the clinic breached its contract with Mr. Gladu in creating a second child without his informed consent.

The defendants in Gladu contended that from 1993 to 1995, when the events at issue in this case occurred, it was not the practice of IVF specialists to request separate consent prior to each thawing and transfer procedure. However, in the area of informed consent, it is not customary practice which determines a physician’s duties, but, rather, the vital public policy of protecting the patient’s right to decide for himself.10 “The Commonwealth of Massachusetts . . . has [explicitly] rejected the customary practice standard as providing insufficient protection of the patient’s autonomy, which is the very purpose of disclosure.”11 Furthermore, the Supreme Judicial Court has concluded that “[n]egligence throughout a trade should not excuse its members from liability.”12 Therefore, IVF physicians, by uniformly failing to obtain a father’s consent prior to creating his child from his frozen embryo, cannot exempt themselves from the above well-defined ethical standards and legal principles of informed consent.13

Regardless, although consent forms now are universally used within the field of reproductive medicine to obtain such consent, it is important to remember that “consent forms cannot take the place of the communication required by the doctrine of informed consent.”14

C. IVF consent forms must be clear and unambiguous

The Gladu jury also determined that consent forms are contracts for entering familial relationships, which must evince clear and unequivocal consent.15 At trial, the defendants argued that the original disposition form regarding freezing the additional embryos provided Mr. Gladu’s “advance consent” for them, over two years later, to thaw and transfer the embryos into his wife without returning to him for his permission. However, the relevant language in the disposition form was confusing and misleading:

We agree to have the embryos returned to the body (womb) of the female spouse so named on this form within three years from the date of embryo freezing. Our wishes regarding the ultimate disposition of the embryos will be signed now.16

The defendants argued that this provision meant that Mr. Gladu definitively intended to have the embryos “returned to the womb” within three years, and that they did not need to go back to him to get his express consent to create another child. The plaintiff, however, read that to mean, if they subsequently chose to use the frozen embryos, they needed to use them within the three year time limit during which they would be stored at Boston IVF. In either instance, these phrases were ambiguous and, therefore, unenforceable under the law.

The plaintiff relied heavily on the Supreme Judicial Court case of A.Z. v. B.Z., 431 Mass. 150, 152 (2000), which was analogous to the Gladu case in several very important respects. In A.Z. v. B.Z., a husband and wife underwent IVF treatment and conceived twin daughters in 1992. Prior to that conception, the couple decided to freeze excess embryos for possible future implantation. The form at issue required the couple to decide on the disposition of the frozen embryos. The form, signed by both husband and wife, provided that, if they should become separated, the embryos were to be returned to the wife for implantation. Several years later in 1995, before they became separated, the wife had one of the remaining vials of frozen embryos thawed and implanted without informing her husband. No pregnancy resulted. The husband then learned of her attempt to get pregnant, and they separated. He filed for divorce, and then filed a motion to obtain a permanent injunction prohibiting his wife from implanting the remaining frozen embryos.17

In determining whether to grant the motion, the court considered the effect of the consent form between the couple and the IVF clinic regarding the disposition of the frozen embryos. The court determined that the consent form was “legally insufficient” in committing the husband to having additional children. In particular, the consent form’s primary purpose was to explain to the donors the benefits and risks of freezing embryos and to record the donors’ desires for disposition of the frozen embryos at the time the form was executed in order to provide the clinic with guidance if the donors (as a unit) no longer wished to use the frozen embryos. The form did not indicate that the husband and wife intended it to act as a binding agreement between them should they later disagree as to the disposition.

Similarly, Mr. Gladu argued that the disposition form he signed was legally insufficient to provide advance permission for the defendants to create another child from his frozen embryos. First, as in A.Z. v. B.Z., the primary purpose of the disposition form at issue clearly was to explain to the donors the benefits and risks of freezing, and to record the donors’ desires for disposition of the frozen embryos at the time the form was executed if they later could not or chose not to use the frozen embryos. In fact, the body of the form dealt mostly with contingencies in the event of death, separation, divorce, menopause, and unclaimed embryos.

However, unlike the Court in A.Z. v. B.Z., the jury in Gladu found there was a contract between Mr. Gladu and the clinic for only one pregnancy. They found that the clinic breached this contract in creating a second pregnancy without his consent.

Also relevant to this inquiry is Woodward v. Commissioner of Social Security, 435 Mass. 536, 551 (2002), which held that a decedent sperm donor’s silence, or his equivocal indications of a desire to parent posthumously through artificial insemination, “ought not to be construed as consent.” That case held that the prospective donor must clearly and equivocally consent not only to posthumous reproduction, but also to the support of any resulting child. This prevents the physician from making paternalistic assumptions about what the donor wants. Indeed, in Gladu, one defendant suggested at trial that he felt he knew Mr. Gladu well enough to know that he wanted more children after the birth of his son, despite knowing nothing of his personal or marital problems.

D. Binding contracts for
parenthood are

Even if the consent form is clear and unequivocal, the courts of Massachusetts will not enforce a contract that binds a donor to become a parent against his will.

The Gladu defendants’ interpretation of the disposition form would have bound Mr. Gladu to becoming a parent of another child (or children) several years after he signed it, regardless of whether or not he changed his mind. As they interpreted it, his signature abrogated his right to elect to not have another child within three years after he signed the form, regardless of intervening events. Coincidentally, in both Gladu and A.Z. v. B.Z., the couple already had two children and their marriages broke down. These are two of the most obvious events that affect whether both parents wish to have additional children.

The courts of the commonwealth have long recognized the “freedom of personal choice in matters of marriage and family life.”18 Respect for liberty and privacy requires that individuals be accorded the freedom to decide whether to enter into a family relationship. Language that is construed as giving up the right to choose in such intimate matters, especially when intervening events may arise that affect one’s life-altering decision to undergo the additional burdens associated with growing a family, is and always has been, unenforceable.19

In A.Z. v. B.Z., the court reiterated that any agreement that compels a donor to become a parent against his subsequent desire or will violates public policy and, therefore, is unenforceable.20 Specifically, the court stated that “prior agreements to enter into familial relationships (marriage or parenthood) should not be enforced against individuals who subsequently reconsider their decisions.”21

As a result, the court declined to enforce the form against the husband and to force him to become a parent over his present objections. Thus, the Gladu verdict and A.Z. v. B.Z. decision stand for the principle that binding agreements to create a child cannot be enforced.

E. Conclusion

The Gladu case is much more than an anecdotal study in metaethics. As a practical matter, it demonstrated that one must ensure that the donors have conveyed their directives in an unambiguous and timely manner before taking any action with frozen embryos. More fundamentally, it confirmed that individuals have a paramount and inviolate right to decide what may be done with their bodies and their genetic material — a concept to be kept solidly in mind with the fate of 400,000 frozen embryos at stake.

End Notes

1. In vitro fertilization involves injecting the woman with fertility drugs to stimulate production of eggs, which can then be surgically harvested. After the eggs are removed, they are fertilized by combining them with sperm produced by the man. If fertilization of any of the eggs occurs, preembryos are formed; the preembryos are held for one or two days until a decision can be made as to which will be inserted in the womb, and which will be frozen and stored for a later use (a procedure called cryopreservation). A.Z. v. B.Z., 431 Mass. 150, 152 (2000).[back]

2. The jury did not find the individual physician defendants liable.[back]

3. The seminal case is Harnish v. Children’s Hospital Medical, 387 Mass. 152, 153-57 (1982); see also Shine v. Vega, 429 Mass. 456, 463 (1999).[back]

4. See American Medical Association Council on Ethical and Judicial Affairs, Code of Medical Ethics, § 8.08, §§ 2.04, 2.05 (1994)(informed consent in context of artificial insemination); see also Ketchup v. Howard, 543 S.E.2d 371, 376 (Ga. App. 2000) (1847 Code provides that “the patient has the right to receive information from physicians and to discuss the benefits, risks, and costs of appropriate treatment alternatives”); Culbertson v. Mernitz, 602 N.E.2d 98, 103 (Ind. 1992) (Code of medical ethics sets forth medical profession’s standard on informed consent).[back]

5. See Bowman v. Beghin, 713 N.E.2d 913, 917 (Ind. Ct. App. 1999).[back]

6. ACOG Committee Opinion, Committee on Ethics, Number 108, May 1992.[back]

7. Id. at 5. [back]

8. Ethical Considerations of Assisted Reproductive Technologies by the Ethics Committee of The American Fertility Society, November 1994.[back]

9. Id. at 58S[back]

10. Harnish, 387 Mass. at 156-57 (“Many jurisdictions have adopted the rule that a physician must disclose to his patient only such information as is customarily disclosed by physicians in similar circumstances. We think that the better rule is the one we adopt today. The customary practice standard overlooks the purpose of requiring disclosure, which is protection of the patient’s right to decide for himself.”).[back]

11. Harrison v. United States, 284 F.3d 293, 298 (1st Cir. 2002).[back]

12. Schrottman v. Barnicle, 386 Mass. 627, 641 (1982)(custom and practice among journalists not determinative of defendant’s negligence); see Holder v. Gilbane Building Co., 19 Mass. App. Ct. 214, 217 (1985) (“The jury were not required to accept testimony of Gilbane’s witnesses that it was customary in the trade not to remove snow and ice from roofs and that workmen were to put down planks. It was open to the jury to find that Gilbane did not take reasonable precautions to protect workmen sent up to the icy roof.).[back]

13. Torre v. Harris-Seybold Co., 9 Mass. App. Ct. 660, 677 (1980); The T. J. Hooper, 60 F.2d 737, 740 (2d Cir.), cert. denied sub nom. Eastern Transp. Co. v. Northern Barge Corp., 287 U.S. 662 (1932)) (jury entitled to consider feasibility of later-adopted safety devices on precision paper cutting machine).[back]

14. D.W. Louisell, 3 Medical Malpractice ¶ 22.08. See Keomaka v. Zakaib, 811 P.2d 478, 486 (Haw. Ct. App. 1991) (“a physician may not fulfill his affirmative duty of timely and adequate disclosure by merely having the patient sign a printed consent form”).[back]

15. Woodward v. Commissioner of Social Security, 435 Mass. 536, 552 (2002) (consent to posthumous parenting must be “clear and unequivocal”).[back]

16. In fact, the use of the word “returned” was especially confusing and inapplicable with regard to Mr. Gladu and his wife in that his wife did not donate her own eggs and, therefore, they were not actually being “returned” to her womb.[back]

17. Id. at 152-53.[back]

18. A.Z. v. B.Z., 431 Mass. at 162.[back]

19. See Woodward, 435 Mass. at 551.[back]

20. A.Z. v. B.Z., 431 Mass. at 160. [back]

21. Id. at 162.[back]

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