Final Report (all chapters)

and/or any organs derived from human fetuses. It also establishes substantial penalties for
violating its provisions. However, legal scholars agree that this act does not reach the trade of
human gametes. It appears that no judicial decision has ever construed the meaning of “human
organ” to include gametes. 34
Hence, for the purpose of this report, the National Organ
Transplantation Act is immaterial.
5.1.7 Regulation by Tort
Conceivably, the practice of reproductive medicine could also be regulated through the tort
system. Malpractice litigation is based on the notion that a plaintiff, in order to prevail, must
demonstrate that he or she is owed a duty of care, and that the attending physician has harmed
the plaintiff by violating this duty. Combined with often-draconian verdicts, this system is
supposed to induce medical professionals to establish appropriate standards of care and to ensure
that practitioners follow them scrupulously.
An obvious limitation of this system is its focus on procedures rather than on the merits of
an expected outcome. For example, whether sex selection for non-therapeutic uses is an ethically
acceptable reproductive procedure cannot be decided through tort litigation. Litigation in this
case can only determine whether a patient was harmed, and whether harm can be attributed to
medical malpractice. In the case of many ethically controversial treatments, making these twin
determinations is no easy task. For example, is it really possible to claim that failure to deliver a
baby of the desired sex amounts to medical malpractice? Certainly the “outcome” was undesired,
but can a baby of the “wrong” sex really produce harm? Assuming some notion of harm is
recognized by the court, what standard of care has been violated in this case?
One can easily imagine many variations on this scenario. Pre-implantation genetic diagnosis
to screen for dreadful diseases and ooplasm transfer to treat extreme cases of infertility provide
two examples. How the courts may decide these cases is an interesting question for legal scholars
to ponder, but it is beyond the scope of the present discussion. Presumably, litigation in this area
would prompt ART clinics to scrutinize more carefully the harm that novel reproductive
technologies and innovative treatments might cause and to establish appropriate standards of
care. 35
This development certainly would be most welcome, but standards of care all by
themselves are of little importance in adjudicating competing ethical claims.
5.1.8 Regulation by the Market
Regulation can occur through market mechanisms as well. There are many precedents in this
area. Consumers may prefer products certified to have been produced in an environmentally
34
35
President's Council on Bioethics, Reproduction and Responsibility: The Regulation of New Biotechnologies,
p.151-52.
In recent times, serious doubts have emerged about the effectiveness of malpractice litigation in improving
medical standards of care. An excellent introduction to this issue is Atul Gawande, Complications: Decisions
and Dilemmas of a Surgeon's Life (London: Profile Books, 2002).
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