The Octuplets: A Medical Mistake Needing More Regulation?

Bruce PatsnerGUEST BLOGGER Bruce Patsner, M.D., J.D.

The spotlight and the 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.  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.) were quickly replaced by interviews with family members and efforts to secure multi-million dollar contracts for morning talk show appearances.  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 and already the mother of six previous children.  Kaiser Permanente is asking California taxpayers to foot the bill for the octuplets' seven-figure hospital bill.

Infertility specialists almost immediately began to question the rationale for implanting all eight embryos, and a noted medical ethicist immediately labeled the conduct of all parties concerned "unethical."  A determined but unsuccessful effort began to keep the identity of the infertility specialist who implanted 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.  Ms. Suleman asserted in an interview with NBC News that "Those [the embryos] are my children, and that's what was available and I used them. So, I took a risk. It's a gamble. It always is."

The octuplets story circles around several uncomfortable social issues running the gamut from parental rights and responsibilities and the obligations of society to support unwed mothers to what is perceived by some to be a condescending, elitist attitude by some towards women who elect to have large families.  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 is also the critical question of whether this is yet another example of the medical profession's inability to self-regulate physician conduct.  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.

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 which can be placed in a mother's womb. In some European countries (Germany, for example) there are federal laws which limit the number of embryos which may be transferred during IVF procedures, robust mechanisms for monitoring such medical treatments, and both monetary fines and in some cases prison terms for knowing violations of such laws.  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.  Patient (both 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 live-born term pregnancy success rate when more than two embryos are transferred.

In the U.S. what exists on the legislative side for all intents and purposes 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, a law designed to prevent consumers from being misled by success claims made by infertility specialists.

The exploding technologies of ART have escaped 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).  The current U.S. cultural climate of the past several decades has relegated efforts to regulate ART to the status of just another casualty in the abortion wars.

Even though there is a marked absence of legislative guidelines at the 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).  The ASRM guidelines recommend the transfer of one, or at most two, embryos into women like Ms. Suleman who are under age 35.  These 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 and may be used by state medical boards if they elect to investigate medical practice.  Focusing on the issue of potential disciplinary actions on the physician's medical practices, or possible medical-ethics violations, raises the meta-issue of whether self-regulation by the medical profession is sufficient protection against the present situation repetitively occurring, or whether there is the need for more direct government intervention.  This could take the form of either greater involvement by individual state medical boards, the passage of specific state legislation designed to regulate ART, or of federal laws specifically aimed at regulating IVF medical practices and procedures.

Despite the existence of such medical practice standards, however, it must be pointed out that 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 even though such medical practices have been criticized by experts in the field of reproductive medicine.  Lastly, 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, 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 for both as well as for family law.

Not unexpectedly, there is firm opposition to the imposition of federal laws, and guidelines, on the number of fertilized eggs which may be transferred during IVF procedures.  The arguments have been heard before:  medicine is an "art" and inflexible rules will not be universally applicable to all infertility patients, innovation in the field will be stifled, and the medical profession—in particular professional medical societies such as the American Society of Reproductive Medicine (ASRM)—have been successful in policing its members.

Currently, there are just 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 super-twin pregnancy) and the second at best will result only in either professional shame or loss of accreditation/membership; this leaves only state medical board actions against medical licensure status as the only enforcement mechanism with real legal bite.  Unfortunately, state medical board actions are lengthy, time-consuming, and may be contested over years while wealthy infertility physicians "lawyer-up" and continue to practice.

The advantage of government regulation through federal rules is that definitive and substantive penalties could be imposed immediately on medical care which falls below an agreed-upon national standard.  The advantage of one federal law, as opposed to fifty individual state laws regulating IVF and ART, is uniformity in both application and penalties, and the prevention of physicians moving to other states to practice sub-standard infertility care.  The spectre of government regulation of medical procedures aside, it seems difficult to argue with the successful imposition of such governmental rules overseas and their results, particularly when the law and medical science perfectly align.  And, as the U.S. Supreme Court decision in Carhart v. Gonzales which banned partial-birth abortion in the U.S. demonstrated, the federal government is not above outlawing specific surgical procedures in the U.S.

Bruce Patsner, M.D., M.B.A. and J.D., is a Research Professor at the University of Houston Law Center.  He r
eceived his M.D. from Baylor College of Medicine, his M.B.A. from Rutgers, and his J.D. from Boalt Hall (U.Cal. Berkeley).  His primary areas of research are food and drug law and regulation of the medical profession.

2 thoughts on “The Octuplets: A Medical Mistake Needing More Regulation?

  1. As a practicing embryologist, I read your blog with particular interest. Almost every commentator on this issue has mentioned the urgent need for even more government regulation in reproductive medicine and almost every commentator has produced an example of european countries where such regulation has been put in place.
    All of these commentators do not mention that some european countries also limit assisted reproduction by age and marital status – an approach that our country has dismissed. Our government, at least at the moment, does not stipulate who, when, with whom and under what circumstances consenting adults may or may not create a child. Nor has our government placed a limit on how many children should one have.
    The mother of 14 is not the only person who has a large family dependent of welfare checks – should we require that obstetricians conduct asset verifications for all patients of childbearing age? If we as a society are concerned, should we not be concerned equitably about the welfare of children born into families with no fertility problems?
    My personal professional experience has been that physicians and embryologists routinely suggest to patients such treatment options that are in full compliance with the established recommendations. However, we live and function in a society in which patients are entitled to disregard recommendations. And this is a crucial difference between our society and the european societies – whereas the europeans are more comfortable accepting governmental instructions on how to procreate, the american public, I would argue, is not prepared to accept such severe limitations.

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