Legal Issues of the 21st Century
Rich Seifert
Spring 2004

Legal Research: Human Reproductive Technology

 

Part I:    Federal Statutes, Proposed Statutes, and Executive Actions Regarding Human Cloning Technology

 

1. Following the first successful cloning of a mammal from adult somatic cells (“Dolly”, the sheep, in 1997), President Clinton created the National Bioethics Advisory Commission to study various aspects of cloning technology, ethics and religious attitudes, and law. The commission released its report and recommendations in June 1997. They concluded, inter alia, that “at this time it is morally unacceptable for anyone in the public or private sector, whether in a research or clinical setting, to attempt to create a child using somatic cell nuclear transfer cloning”, and recommended that the moratorium on federal funding for human cloning research instigated by President Clinton be continued. The full report (125 pages) is provided at:

NATIONAL BIOETHICS ADVISORY COMMISSION, CLONING HUMAN BEINGS, REPORT AND RECOMMENDATIONS OF THE NATIONAL BIOETHICS ADVISORY COMMISSION, Rockville, Maryland (June 1997)

 

2. Five years later, the President’s Council on Bioethics reconsidered the issues surrounding human cloning in the light of new scientific developments, and concluded: “… the Council is in full agreement that cloning-to-produce-children is not only unsafe but also morally unacceptable, and ought not to be attempted.” Their report is available at:

THE PRESIDENT’S COUNCIL ON BIOETHICS, HUMAN CLONING AND HUMAN DIGNITY:  AN ETHICAL INQUIRY, Washington, D.C., (July 2002)

 

3. There is currently a moratorium on federal funding of human cloning research, implemented by Executive Order (President Clinton). There have been a number of attempts to permanently ban such funding, and to implement statutory prohibitions against human cloning.

   The HUMAN CLONING PROHIBITION ACT OF 2001 would have banned both research as well as reproductive cloning of human embryos. It passed the House (263-162), but failed in the Senate due to the ban on research.

H.R. 2505, 107th Cong. 1st Sess. (2001)

 

   A similar bill was introduced in 2003, that would permanently ban both reproductive and research cloning. Under this bill, any person who performs or participates in human cloning within the United States commits a federal crime punishable by fines and ten years in prison.  If the violation involves a pecuniary gain, a civil penalty of one million dollars or twice the gain also applies. The bill passed in the House (249-155), and is currently pending in the Senate.

H.R. 534, 108th Cong. 1st Sess. § 2 (2003)

 

   The Senate has proposed an alternative bill that would ban reproductive but not research cloning:

S. 303, 108th Cong. 1st Sess. § 2 (2003)

 

   No final action has been taken on these bills (and none is expected before the end of the 108th Congress).

 

4. The Federal Food and Drug Administration (FDA) has declared that they have the authority to regulate human cloning (under their authority to regulate “biological products”). In a “Dear Colleague” letter sent to firms and laboratories working in the biologics field, they informed the industry: (1) that an IND (Investigational New Drug) application would be required before any laboratory in the U.S. could perform human reproductive cloning research, and; (2) that the FDA will NOT approve any such application for safety reasons. While many believe that the FDA’s claimed authority in this area is not supported by law, their declaration may put a serious damper on attempts to proceed with reproductive cloning research. The FDA letter is available at:

 

Dr. Stuart Nightingale, Dear Colleague Letter About Human Cloning (October 26, 1998)

 

Part II:    State Statutes and Executive Actions Regarding Human Cloning Technology

 

1. The state of California also created a committee to study and advise the legislature regarding policy and actions to take with respect to human cloning. They concluded: (1) “that California should ban human reproductive cloning”; (2) “[that] most Committee members [would also prohibit] human reproductive cloning even if it were proven physically safe”; and (3) “California should not prohibit but should reasonably regulate human non-reproductive cloning.” Their report is available at:

CALIFORNIA ADVISORY COMMITTEE ON HUMAN CLONING, CLONING CALIFORNIANS?, REPORT OF THE CALIFORNIA ADVISORY COMMITTEE ON HUMAN CLONING, Sacramento, California (January 11, 2002)

 

2. A combination of California codes implement a five-year ban on human cloning (starting in 1997), and declare a violation of that ban to constitute “unprofessional conduct”, potentially triggering sanctions, loss of business or medical licenses, and penalties of  up to $1 million.

Cal. Business & Professions Code § 2260.5 (2004)
Cal. Business & Professions Code § 16004 (2004)
Cal. Business & Professions Code § 16105 (2004)
Cal. Health & Safety Code § 24185 (2004)
Cal. Health & Safety Code § 24187 (2004)

 

   The five-year sunset provision was eliminated in 2002, making the California ban on human reproductive cloning permanent:

Cal. Sen. Bill 1230 (2001-2002 session)

 

   However, it is the official policy of the state of California to permit research (as opposed to reproductive) cloning:

Cal. Health & Safety Code § 125115 (2003)

 

3. A number of other states have also implemented bans on human cloning:

 

Ark. Stat. Ann. § 20-16-1001 through 1004 (2003)

 

Iowa Code § 707B.1 through B.4 (2003).

 

Mich. Comp. Laws, Public Health Code, §§ 333.16274, 333.16275, 333.20197 (2003)
Mich. Comp. Laws, Penal Code, § 750.430a (2002)  
(Bans both reproductive and research cloning; human cloning is a felony that is punishable by imprisonment for up to 10 years and/or a ten million dollar fine

 

N.D. Cent. Code § 12.1-39-02 (2003)

 

R.I. Gen. Laws §§ 23-16.4-1 through 23-16.4-4 (2003)

 

Va. Code Ann. §§ 32.1-162.21 through 32.1-162.22 (Michie 2003)

 

Part III:   A Sampling of State Statutes Regarding Other Assisted Reproductive Technologies (ART)

 

1. In California, the child of a wife cohabiting with a husband who is not impotent or sterile is conclusively presumed to be a child of the marriage, per:

Cal. Family Code § 7540 (2004)

   This presumption of legitimacy applies to incest prosecutions, i.e., a father who has intercourse with his “legal child” to whom he is not biologically related can be found guilty of incest nonetheless.

People v. Russell, 22 Cal. App. 3d 330, 99 Cal. Rptr. 277 (1971)

2. Both California and Louisiana make it a crime to use sperm or egg cells for assisted reproduction without the written consent of the donor:

Cal. Pen. Code § 367g (2004)

La. R.S. 14:101.2 (2003)

 

3. Florida provides expedited affirmation of parental status for the biological parents when a gestational surrogate is used:

Fla. Stat. § 742.16 (2003)

 

4. In Michigan, a child conceived by a married woman with consent of her husband following the utilization of assisted reproductive technology (ART) is considered to be the legitimate child of the husband and wife for all purposes, including intestate succession. Note, however, that the husband’s consent to the use of ART is required for legitimacy.

Mich. Comp. Laws § 333.2824 (2003)
Mich. Comp. Laws § 700.2114 (2003)

 

Part IV:   Selected Case Law on Cloning and Assisted Reproductive Technologies (ART)

 

1. Sheils v. University of Pa. Med. Ctr., 1998 U.S. Dist. LEXIS 3918 (E.D. Pa., 1998)

An infertile couple sued both the federal and state (Pennsylvania) governments, citing various grounds for injunctive relief. The suit named the University, Tom Ridge (governor of PA) and Janet Reno (representing the U.S.) as defendants.

 

In addition to their state law claims (related to screening procedures for IVF candidates), they wanted to enjoin the current federal administrative ban on human cloning (e.g., the FDA "Dear Colleague" letter) and all federal policies aimed against the use of cloning on the grounds that (1) they unlawfully discriminate against people with reproductive disabilities under the Americans with Disabilities Act, and (2) such bans are an unconstitutional intrusion into the right to make reproductive choices free of government interference.

 

The federal claims were dismissed due to lack of standing; since cloning is not currently feasible, the plaintiffs suffered no actual injury by being denied the right to clone. However, the judge expressly noted, "I do not reach the issue of whether the federal ban on funding for embryo splitting and/or human cloning

 

2. United States v. Arora, 860 F. Supp. 1091 (Md., 1994)

   Holding a stem cell line is a property interest, and that destroying the stem cells constitutes a tort of conversion. However, contrast with:

   Moore v. Regents of Univ. of Cal., 51 Cal. 3d 120; 793 P.2d 479 (1990)
which held that cells taken from a patient were not a property interest. Removal and use of patient cells did not constitute a tort of conversion.

 

3. Mid-South Ins. Co. v. Doe, 274 F. Supp. 2d 757 (S.C., 2003)

   The insurer of a surrogate mother and her husband was not liable for the child's medical expenses but was liable for the mother's expenses; the biological parents' insurer was liable for the child's expenses.

 

4. Lamaritata v. Lucas, 823 So. 2d 316 (2d. Dist. Fla., 2002)

   Upholding a Florida statute that denies any parental rights to sperm donors.

 

5. Mitchell v. Banary, 203 Ill. 2d 526; 787 N.E.2d 144 (2003)

   Illinois statute makes a husband (including a boyfriend who becomes a common-law spouse) the legal father of a child conceived through artificial insemination only if he gives written consent to the procedure.

 

6. Culliton v. Beth Isr. Deaconess Med. Ctr., 435 Mass. 285; 756 N.E.2d 1133 (2001)

   Genetic parents (sperm and egg donor) can, immediately at the time of birth, be declared the legal parents of child fertilized via IVF and implanted in surrogate womb; i.e., there is no requirement to wait until the surrogate mother relinquishes any rights to the child before recording the genetic parents’ names on the birth certificate. However, contrast with:

   A.H.W. v. G.H.B., 339 N.J. Super. 495; 772 A.2d 948 (2000)

   where the genetic parents could not be immediately declared the legal parents in the identical situation as in Culliton. In New Jersey, genetic parents have to wait until the surrogate releases her rights after birth to be named as parents on the birth certificate.

 

7. A.Z. v. B.Z., 725 N.E.2d 1051 (Mass., 2000)

   Upheld an injunction preventing a former wife from using preembryos frozen during the marriage. The husband's interest in avoiding procreation outweighed his former wife’s interest in having additional children, and public policy dictated that a husband not be forced against his will to become a parent. Similarly,

 

   J.B. v. M.B., 170 N.J. 9; 783 A.2d 707 (2001)

   where an ex-husband was enjoined from using frozen preembryos against the will of his former wife.

 

   Kass v. Kass, 91 N.Y.2d 554; 696 N.E.2d 174 (1998)

   Holding that pre-zygotes are not recognized as persons for constitutional purposes. A contract stipulating that unimplanted pre-zygotes be donated for research was enforceable.