The Octuplets: A Medical Mistake Needing More Regulation?
By Bruce Patsner, M.D., J.D.
The spotlight and story line have been shifting continuously since the news of the
delivery of octuplets by Nadya Suleman was first announced by Kaiser Permanente
Medical Center in California on January 26, 2009.1 Staged photo shoots of the smiling
faces of dozens of physicians and nursing staff involved in the historic Cesarean delivery
of the eight premature infants (only the second known living set of octuplets in the U.S.)2
were quickly replaced by interviews with family members and efforts to secure multimillion dollar contracts for morning talk show appearances.3 However, public amazement
quickly turned to consternation and in some cases outrage when it was revealed that the
birth mother was divorced, unemployed, disabled, on food stamps, had a history of
psychiatric disease, and already the mother of six other children.4 Uncertainty over
whether Kaiser Permanente or the citizens of the State of Califoria will end up paying for
millions of dollars of medical care for the eight premature infants hasn’t helped the
situation.
Infertility specialists almost immediately began to question the rational for implanting
eight embryos,5 and a noted medical ethicist soon labeled the conduct of all parties
concerned “unethical.”6 A determined but unsuccessful effort began to keep the identity
of the infertility specialist who implanted the eight embryos from becoming known in the
face of mounting public and medical criticism. Two weeks after the octuplets’ birth, the
California Medical Board announced that it would investigate the infertility specialist for
potential violations of the standard of care.7 Ms. Suleman may have summed up part of
the problem when she asserted in an interview with NBC News that “Those [the
1
Joe Neel, California Woman Gives Birth to Octuplets, NATIONAL PUBLIC RADIO, All Things Considered,
January 27, 2009, available at http://www.npr.org/templates/story/story.php?storyId=99919372 (last
accessed February 11, 2009).
2
Lawrence K. Altman, For Surviving Octuplets, Progress Comes in Ounces, THE NEW YORK TIMES,
January 17, 1999 at A1. In December 1998 Nkem Chukwu of Houston, Texas became the mother of the
first known living set of octuplets. One of the children died one week after delivery.
3
Associated Press, Octuplets mom gets TV, book offers. The mother of the longest-living octuplets in the
U.S. is in high demand, MSNBC NEWS, February 2, 2009, available at
http://www.msnbc.msn.com/id/28984255/print/1/displaymode/1098/ (last accessed February 10, 2009).
4
Linda Carroll, Octuplets backlash: From celebration to boos, MSNBC NEWS, February 6, 2009, available
at http://www.msnbc.msn.com/id/29039266/print/1/displaymode/1098 (last accessed February 11, 2009).
5
Associated Press, Medical society probes octuplets’ conception. Group says it has ethical guidelines on
number of embryos implanted, MSNBC NEWS, February 10, 2009, available at
http://www.msnbc.msn.com/id/2912731/print/1/displaymode/1098/ (last accessed February 10, 2009).
6
Linda Carroll, Octuplets: Cautionary tale not triumph, say experts, MSNBC NEWS, January 29, 2009,
available at http://www.msnbc.msn.com/id/28902137/print/1/displaymode/1098 (last accessed February
11, 2009).
7
Shaya Tayefe Mohajer, Fertility Physician under investigation, THE HOUSTON CHRONICLE, February 8,
2009 at A12.
embryos] are my children, and that’s what was available and I used them. So, I took a
risk.”8
The octuplets story circles around uncomfortable social issues which run the gamut from
parental rights and responsibilities to the obligations of society to support unwed
mothers. There is also what is perceived to be a condescending, elitist attitude by some
towards women who elect to have large families.9 The entire spectacle has already taken
on a somewhat tawdry air: allegedly incompetent physicians, greedy single mothers on
the dole, media hype, and outraged medical ethicists.
Ethical issues aside, there remains the critical question of whether the medical profession
is capable of adequately self-regulating infertility specialist conduct or whether the
fertility industry curbs require greater government oversight and intervention.10 The only
certainty in all of this is that the road to correcting any alleged flaws in the medical and
social system that allowed the current events to transpire will run right through the law.
Medical Standards of Care, but No Federal Rules and Few Laws Governing ART
Although there are laws in some other countries which actually regulate the practice of
assisted reproductive technology (ART), of which in-vitro fertilization is just one of
several potential routes to achieving pregnancy, there is no over-arching law in the U.S.
which places limits on the number of embryos that can be placed in a mother’s womb. In
some European countries (Germany, for example)11 there are federal laws which limit the
number of embryos which may be transferred during IVF procedures, and provide robust
mechanisms for monitoring such medical treatments. There are monetary fines and in
some cases prison terms for knowing violations of such laws.12 The existence of such
legal standards for ART is not at all arbitrary, and represents one of those instances where
the law, medical science, and the facts on patient outcomes are all aligned.13 Patient (both
8
Mike Celizic, Octuplet mom defends ‘unconventional’ choices, THE TODAY SHOW, February 6, 2009,
available at http://www.msnbc.msn.com/id/29038814/print/displaymode/1098/ (last accessed February 10,
2009).
9
Kate Zernike, And Baby Makes How Many? In an era of shrinking broods, larger families can feel under
attack, THE NEW YORK TIMES, Sunday February 8, 2009, at 1, “Many mothers, in fact, shared the revulsion
and the ethical questions about the in vitro fertilization that led to the birth of the eight babies by the unwed
and unemployed California mother. Yet they also say that the reaction to her turned harsh when it was
revealed that she had six additional children. Octuplets were amazing; 14 is gross.”
10
Scott LaFee, Octuplet case sparks calls for fertility-industry curbs, SAN DIEGO UNION TRIBUNE,
February 12, 2009, available at
http://www.signonsandiego.printthis.clickability.com/pt/cpt?action=cpt&title=Octuplet+case+sparks (last
accessed January 14, 2009).
11
IVF News, Germany’s embryo protection law is “killing embryos rather than protecting them,” July 5,
2007, available at
http://www.ivf.net/ivf/germany_s_embryo_protection_law_is_killing_embryos_rather_than (last accessed
February 13, 2009).
12
Id. The German embryo protection law passed in 1991 stipulates that no more than 3 embryos created per
IVF cycle may be transferred.
13
Tarun Jain, Stacey A. Missmer, and Mark D. Hornstein, Trends in embryo-transfer practice and in
outcomes of the use of assisted reproductive technology in the United States, 350 N. ENGL. J. MED. 1639
(2004).
maternal and fetal) outcomes are generally best when no more than two fertilized eggs
are transferred. More importantly, there is no statistically significant increase in the liveborn term pregnancy success rate when more than two embryos are transferred.14
In the U.S. what exists on the legislative side is a hodge-podge of different laws in
different states regulating this aspect of the medical profession. There is currently only
one federal law which explicitly and directly regulates the provision of infertility
services: The Fertility Clinic Success Rate and Certification Act of 1992,15 a law
designed to prevent consumers from being misled by success claims made by infertility
specialists. This law aside, there is no other formal direct federal regulation of ART. At
best, some indirect regulation of in-vitro-diagnostic and laboratory tests used in IVF
clinics by the Center for Medicare and Medicaid Services (CMS) exists under the 1988
Clinical Laboratory Improvement Amendments (CLIA),16 but it provides no federal
oversight of infertility services per se.
The exploding technologies of ART have escaped federal regulation to a large degree
because many of the reproductive health issues involve questions which also raise the
spectre of termination of pregnancy (i.e. disposal of unused embryos). Individual state
efforts to fully regulate ART and pre-implantation gender diagnosis have never been
enacted into law in part due to such concerns.
Does the Medical Profession Adequately Self-Regulate?
Even though there is a marked absence of legislative guidelines at the state and federal
level for regulation of ART, there are national standards for medical practice in several
areas of infertility care which have been published by the American Fertility Society, The
American College of Obstetricians and Gynecologists, and the American Society of
Reproductive Medicine (ASRM).17 There is also separate oversight of the medical
profession at the state level conducted by individual state medical boards.
Medical professional society guidelines are not binding on physicians and do not have the
force of law, but they are admissible as evidence in court should a specific infertility
practice or outcome allegedly fall below the standard of care. They may be used by state
medical boards if they elect to investigate an infertility specialist’s medical practice, and
can be used to remove subspecialty society membership from physicians whose practices
patterns repetitively fall below medical society standards. In the case at hand, the ASRM
guidelines on the appropriate number of embryos which should be transferred in a
woman under the age of 35 explicitly state that no more than 2 embryos should be
transferred in the absence of extraordinary circumstances.18
14
Practice Committee of the Society for Assisted Reproductive Technology and the American Society for
Reproductive Medicine, Guidelines on the number of embryos transferred, 90 FERTILITY AND STERILITY
S163, NOVEMBER 2008 [hereafter ASRM Guidelines].
15
THE FERTILITY CLINIC SUCCESS RATE AND CERTIFICATION ACT OF 1992, 42 U.S.C. § 263A-1 et sq.
16
CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA), PUBLIC LAW 100-578 (1988).
17
ASRM Guidelines, supra note 14.
18
Id.
Despite the existence of such medical practice standards, there is a small subset of
obstetrician-gynecologists who have tacitly encouraged the practice of multiple-birth
pregnancies and have publicly made it a routine part of their medical practice,19 even
though such medical practices have been criticized by experts in the field of reproductive
medicine.20 In addition, even though “fetal reductive surgery” has been strongly
advocated by many infertility experts to limit the number of pregnancies, and minimize
concomitant maternal and fetal medical risks from “super-twin” pregnancies,21 the legal
reality is that once fetal reductive surgery is offered and refused, there is little to prevent
a determined woman or couple from attempting to carry an inordinately large number of
fertilized eggs implanted through in vitro fertilization to term. Surgical innovation, as a
rule, is not regulated by the federal government, nor is the practice of medicine; state
medical boards, and state laws, are the regulatory default in this area.22
Not unexpectedly, there is firm opposition to the imposition of federal laws or guidelines,
on the number of fertilized eggs which may be transferred during IVF procedures by
infertility specialists. Some of the arguments have been heard before: medicine is an
“art;” inflexible rules will not be universally applicable to all infertility patients, and
innovation in the field will be stifled. One of the unstated arguments is that ART in
general and IVF in particular are big businesses and have enjoyed a very profitable
twenty-year run with little formal government intervention.23 And there is always the
danger that an over-reaction by state and federal regulators to this isolated instance of
octuplets will prove worse than the event itself. So the question remains: how well does
the medical profession self-regulate, at least as far as the IVF is concerned?
Though no conclusive data is available, there is at least some evidence that professional
medical societies such as the ASRM have been somewhat successful in policing its
members.24 The ASRM has both Quality Assurance and Violation Committees, which
routinely investigate infertility practices whose pregnancy rates are more than two
standard deviations below the national average for three years in a row or whose higher
multiple pregnancy rates are above average.25 These Committees formally request
clinical information and allow clinicians to implement changes in their practices to self-
19
Mary Carmichael, The Baby Keeper. A Phoenix obstetrician uses controversial methods to help infertility
patients and their babies survive high-risk multiple-birth pregnancies. But is he promising more than he
can deliver?, NEWSWEEK WEB, January 30, 2009, available at
http://www.newsweek.com/id/182355/output/print (last accessed January 30, 2009).
20
Id.
21
The American College of Obstetricians and Gynecologists, Multifetal Pregnancy Reduction, ACOG
Committee Opinion Number 369, June 2007.
22
Angelique M. Reitsma and Jonathan D. Moreno, Ethics of Innovative Surgery: US Surgeons’ Definitions,
Knowledge, and Attitudes, 200 J. AM. COLL. SURG. 103 (2005).
23
Gina Kolata, Fertility Inc.: Clinics Race to Lure Clients, THE NEW YORK TIMES, January 1, 2002, at E1.
“Couples seeking IVF now spend $44,000 to $200,000 to achieve a single pregnancy.”
24
See the American Society of Reproductive Medicine website, available at
http://www.asrm.org/Patients/topics/ivf.html (last accessed February 13, 2009). Also personal
communication William Gibbons, Director IVF Services and Reproductive Endocrinology and Infertility,
Baylor College of Medicine, Houston, Texas, February 12, 2009.
25
Id.
correct; they also allow outside investigators to evaluate infertility practices.26 Failure to
self-correct can result in disciplinary actions including loss of ASRM membership, loss
of coverage for services by insurance companies (admittedly less of a penalty in what is
often a cash business), and notification to state medical boards of loss of professional
society status.27 Since the passage of clinical guidelines and the establishment of a peerreview mechanism by ASRM for IVF clinics to monitor both pregnancy success rates and
“super-twin” gestation rates, the number of IVF clinics with poor pregnancy results has
declined and the number of multi-fetal pregnancies has declined by 70%.28
Conclusion
Currently there are three meaningful ways to regulate the conduct of IVF physicians in
the U.S.: (1) medical malpractice law; (2) professional medical society supervision of
clinical activity; and (3) state medical board oversight of physician practice patterns and
conduct. The first only applies if patients bring a claim (unlikely in a successful supertwin pregnancy). The second may result in loss of accreditation, membership, income,
professional shame, and state medical board action. Even so, state medical board actions
against medical licensure status are the only enforcement mechanism with real legal bite.
Unfortunately, state medical board actions can be lengthy, time-consuming, and may be
contested over years while profitable infertility providers “lawyer-up” and continue to
practice. If transferring eight embryos were a felony, for example, the suspension or
revocation of a medical license could be carried out by a state medical board almost
immediately.29
One advantage of comprehensive government regulation through federal rules would be
that definitive and substantive penalties could be imposed immediately in response to
medical care which fell below an agreed-upon national standard regardless of how the
medical profession itself and state medical boards elect to proceed against an individual
physician. A second advantage of one federal law, as opposed to fifty individual state
laws regulating IVF and ART, would be consistency and uniformity in application and
penalties, and lessening the likelihood that physicians may move to other states with
looser regulations or oversight.
This “fourth” approach to regulation of infertility specialists has only been adopted by
governments outside the U.S., but federal micro-management of select aspects of medical
practice is not without precedent if social and political conditions are right. The U.S.
Supreme Court decision in Gonzales v. Carhart30 banning partial-birth abortion in the
U.S. demonstrates that the federal government is willing to outlaw specific surgical
procedures. No doubt, the spectre of dramatic federal intervention in ART is one reason
why ASRM and other professional medical societies have worked so hard to reign in
26
Id.
Id.
28
Id.
29
TEXAS OCCUPATIONS CODE §§ 164.001 et seq. a. The board shall suspend a physician’s license on proof
that the physician has been initially convicted of : i. a felony.
30
Gonzales v. Carhart, 550 U.S. 124 (2007).
27
rogue medical practice, and cooperated so closely with state medical boards. Perhaps, in
select circumstances, the medical profession can adequately self-regulate after all.
Health Law Perspectives (March 2009), available at:
http://www.law.uh.edu/healthlaw/perspectives/homepage.asp