Since 2001, stem cell science in the United States has been explicitly constrained by federal prohibitions. Under an executive order announced by President George W. Bush on August 9 of that year, U.S. researchers can only receive federal funding for work done on the limited number of embryonic stem cell lines (an estimated sixty to sevent-eight) created prior to the executive order. Continued research on embryonic stem cells (ESCs) is not expressly prohibited. But, under the Bush administration's executive order, no federal funds can be used to develop new embryonic stem cells lines, or even to work on new lines developed after August 2001.

The problems with these restrictions, according to their critics, are threefold. First, they sharply limit the funds available to a high-cost, early-stage endeavor, limiting the pace of scientific discovery in the process. Second, they force stem cell researchers to maintain an administratively absurd line between research conducted in federally-funded laboratories (which include most university facilities) and that conducted in spaces free of federal funds.

Someday soon, virtually any pregnant woman will be able to learn — with 98-99% accuracy — whether her fetus has contracted a serious genetic disorder by undergoing nothing more than an inexpensive, non-invasive blood test. For years, scientists have sought a method of prenatal testing that could boast both high levels of accuracy and low levels of risk. The most promising solution lies in an exciting recent discovery: tiny quantities of fetal cells and DNA cross over into the mother's bloodstream during pregnancy. If the fetal genetic material can be successfully isolated from the maternal blood, it can be used to diagnose a number of genetic disorders, such as Down Syndrome, cystic fibrosis, Tay-Sachs disease, and sickle cell anemia. Indeed, researchers have spent the last decade developing ways to accomplish this.

This well-known quotation from one of America's foremost judges provides an important admonishment about the role of history within the law. Holmes’ admonishment is that, even in common law systems, we should not allow ourselves to become too dependent on legal rules laid down in the past. Legal rules laid down long ago are as likely as newly constructed ones to have flaws in their reasoning or be difficult to implement in real-life situations. Furthermore, even in cases where the rule may have originally served some purpose, it may nevertheless be out of date and therefore have little continuing benefit to a particular legal system.

Since ancient times, people have yearned to attribute human behaviors to a physical source within the head. Recently, neuroimaging technologies have given us the technical ability to look at the living brain, its structures, and some of its functions without the need for invasive procedures. However, the science has a long way to go before these technologies can allow us fully to appreciate the anatomical and physiologic underpinnings of human thoughts, states of mind, motives, will, or behaviors.

In this Article, we use an historical overview to introduce the various new technologies for imaging the brain. Today, the goal of medical science is the same as it has always been: to make medical technologies valid, useful, effective, and safe; and to guide appropriate uses while protecting the public from the misuse of them. Brain images are particularly vulnerable to misuse because they are so visually attractive. This visual power can easily result in misunderstanding about what the images show and what they mean.

What mother or father does not want to give his or her child the best chance of leading a happy and successful life? Infertile couples today enlist assisted reproductive technologies (ARTs) such as in vitro fertilization (IVF) and preimplantation genetic diagnosis (PGD) to handpick from among available gamete donors or embryo arrays to implant for gestation. As advances in genetic science permit increasing prenatal control over offspring traits, even fertile couples may choose to relocate procreation from the bedroom into the laboratory.

The development of safe genetic therapies capable of curing debilitating conditions in embryos or fetuses would be unequivocal cause for celebration. Less straightforwardly worthy of embrace would be techniques that make it possible to choose offspring genes for non-health related characteristics, such as strength, intelligence, and memory. At present, neither state nor federal law regulates ARTs.

Now in its second decade, functional magnetic resonance imaging (fMRI) localizes changes in blood oxygenation that occur in the brain when an individual performs a mental task. Physicians and scientists use fMRI not only to map sensory, motor, and cognitive functions, but also to study the neural correlates of a range of sensitive and potentially stigmatizing conditions, behaviors, and characteristics. Poised to move outside the traditional clinical and research contexts, fMRI raises a number of ethical, legal, and social issues that are being explored within a burgeoning neuroethics literature.

In this Article, I place these issues in their proper historical context. The ethical, legal, and social issues raised by advances in functional neuroimaging are challenging and somewhat distinctive, but they are not entirely new. Earlier methods of body imaging and brain mapping, including phrenology, x-ray, positron emission tomography, and single-photon emission computed tomography, raised similar issues, and perhaps we can use our experiences with these sciences and technologies to help guide current functional neuroimaging policy.

“Sex” is a complex thing. The word conjures up many images according to how it is used. When narrowed to the context of the law, however, a person’s sex can be broken down into three primary categories: biological sex, common law sex, and legal sex.

Biological sex has traditionally been determined according to the presence or absence of genitals and gonads (phenotype), and the configuration of the sex chromosomes (karyotype).

Sales of brand and generic pharmaceuticals in the United States reached $274.7 billion in 2006. Consumers in this country, including the federal government, are paying tremendous amounts of money for drugs and the cost continues to be a growing concern for all parties involved. Part of this increased cost encountered by consumers can be directly attributed to the ever-increasing costs manufacturers must cope with in the development of new drugs. Economists estimate that it takes twelve to fifteen years to develop a single new drug and have it approved by the Food and Drug Administration (“FDA”). The average cost: $800 million. For every 10,000 compounds investigated, only five are ever tested as potential medicines in clinical trials and only one is ever approved for patient use. Of all the drugs approved by the FDA, only three out of ten generate revenues that meet or exceed average research and development costs.

The most important safety decision concerning MRIs was to change the name of the procedure. In the late 1970s, the procedure known as nuclear magnetic resonance (NMR) became magnetic resonance imaging (MRI) because of the negative connotations the word “nuclear” invited. Since then, the use of MRIs has flourished. The procedure is now routinely conducted to make medical diagnoses and to study the brain functioning of healthy volunteers participating in research studies devised by, among others, neuroscientists and economists.

There is nothing intrinsically wrong with changing a procedure's name to respond to a public perception of risk, especially when experts do not share that perception. Yet, while MRIs rarely injure patients or test subjects, there is reason to believe that they have important health and safety consequences not captured in standard informed consent forms. These concerns ironically involve perception of risk. On the one hand, unexpected incidental findings of clinically significant conditions in volunteer research subjects raise a host of ethical concerns.

Amidst a lavish ceremony in Boston’s Faneuil Hall on April 12, 2006, Massachusetts Governor Mitt Romney signed into law Chapter 58 of the Acts of 2006: An Act Providing Access to Affordable, Quality, Accountable Health Care. At that time, Chapter 58 represented the most comprehensive state health reform ever passed in the country, and the first with the potential to provide near universal health coverage. Since Romney signed Chapter 58, it has been the focus of a great deal of national media attention. Other states are evaluating whether Chapter 58’s complicated bipartisan formula could be effective within their borders, and Romney plans on basing his presidential campaign to a large extent on Chapter 58’s potential as a model for national health reform. However, Chapter 58 faces a potential legal challenge under the preemption clause of the federal 1974 Employee Retirement Income Security Act (ERISA). In part, ERISA acts to limit the burden on employee benefit plans established by multi-state employers from state regulation.

In 2003, the University of Hawaii proposed patenting the Native Hawaiian genome with the purpose of generating both economic- and healthrelated benefits for the Native Hawaiian people. This proposal, however, was strongly opposed by the Native Hawaiian community, which viewed it as an unwelcome imposition of Western property concepts upon their traditional ideology. Population-based genetic databases are not an entirely new concept. The governments of Iceland and Estonia have created national genetic databases and assumed authority over their ownership and operation. Iceland has even licensed its genome to a private company. Furthermore, the United States has previously been involved in patenting the genetic code of other indigenous groups, such as the Hagahai tribe in Papua New Guinea and the native inhabitants of the Solomon Islands. A patent on the Native Hawaiian genome, however, would be unique because it would concern the rights of American citizens.

The problem of the uninsured in this country continues to grow. Over the past five years, proportion of uninsured Americans has risen from 14.6% to 15.9% of the population. The statistics show disparities in insurance coverage among the various races, between native-born and non native-born citizens, and between other groups. The Center on Budget and Policy Priorities partially links this change to the continuous decline in employer sponsored health insurance plans. This is a problem that needs to be addressed and addressed quickly.

Further exacerbating this problem is the cost of the uninsured and the government-insured to the taxpayers of the country. It is estimated that Medicare and Medicaid, the two largest government financed health care programs, will cost $301.5 and $176 billion respectively. These costs are projected to increase at a rate above GDP.

Since states are partially responsible for Medicaid costs and have a responsibility for the health of their citizenry, many states have taken it upon themselves to try to correct these problems.

Neuroimaging has advanced our understanding of how the living brain operates, providing structural and functional images of both healthy and diseased brains. This technology pervades today's society, particularly affecting the legal arena. Some judges argue that scientific evidence, which offers insight into the offender's mental state, is crucial because it is the only means of determining whether an offender's punishment is proportional to his crime. Other judges argue that “objective” evidence does not “wholly determine the controversy,” and focus instead on their duty as gatekeepers to independently evaluate scientific evidence. If courts use brain images to make their culpability determinations more objective and sound, these images must meet pertinent legal standards and shed light on medical conditions. For neuroimaging to meet these legal and medical standards with scientific integrity, scientists must convincingly correlate the dynamic images in a person's brain with the way the person is thinking or acting at that moment.

Brain imaging is one of the most remarkable technological advances towards understanding the relationship of behavior to brain anatomy and physiology. Brain images provide insight to understanding behavior. Additionally, the images themselves carry great impact, particularly when used to show differences in either the anatomy or the biological functioning of two different brains. For these reasons, brain images have increasingly been used in both criminal and civil trials.

After describing some general features of brain imaging, we will focus on functional magnetic imaging (fMRI), as many believe this technology has the most potential for advancing our understanding of how parts of the brain function, including perhaps linking specific functions with cognition and behavior. Brain imaging as a field is vast and therefore our discussion will be limited. First, we will assess the advantages and limitations of fMRI, including research efforts towards standardizing equipment thereby assuring reliability and reproducibility.

In a typical magnetic resonance imaging (“MRI”) study of the brain, subjects are screened for contraindications before being placed in the bore of a large machine, the MRI scanner, which contains a powerful magnet. The scanner produces cross-sectional images of brain tissue as the subjects undergo a series of brief electromagnetic pulses, perceptible only as noise and vibration. If the protocol involves functional MRI (“fMRI”), a popular research technique for obtaining indirect measurements of brain activity, equipment might be used to present stimuli (sounds or pictures) during the scan, but generally the study involves no invasive procedures, no physical discomfort, and no ionizing radiation. Upon completion of the scan, MRI data is transferred to an investigator's computer for further analysis, often in combination with behavioral test results and clinical information obtained from subjects or their medical records.

This procedure sounds benign, and usually is. But an MRI scanner is a powerful medical device, capable of causing serious injury or death if operated carelessly.

Picture this: a party to a lawsuit proposes to show jurors images of a human brain to support its claim or defense. The other party objects, and the trial judge must make a ruling. What determines how the judge will rule? That is the question I attempt to address.

I begin in Part II by describing very briefly some existing methods of brain imaging—how they work and what they try to do—and cataloging some possible uses of these methods in courtrooms. Part III discusses current legal standards of admissibility of scientific evidence under the Federal Rules of Evidence (FRE). Part IV examines the particular problem of scientific evidence offered to establish that a person was or was not telling the truth. Part V provides a brief history of some past attempts to introduce brain-imaging evidence into courtrooms. The article concludes with some general comments on the issues facing judges when parties to lawsuits offer brain-imaging evidence.

We are told that functional magnetic resonance imaging (fMRI) is “not ready for use, despite optimism about its commercial potential.” This is probably true—it is also, in terms of legal analysis, irrelevant. Although the development of fMRI technology is still in its relative infancy, there is no guarantee that the law governing its use will wait for it to grow up. Thus, the recent backlash against the initial flurry of articles, both academic and general, on the promise and legal issues surrounding fMRI is unwarranted. The conclusion that so many—even many of the contributors to this volume—seem to be drawing, namely, that law, as a field, must abstain from analyzing the legal implications of fMRI until those with more scientific expertise deem it ready to look at, is at best wrong and, at worst, irresponsible.

The development of a successful lie detector has been a dream of governments and law enforcement since ancient times. A Hindu Veda written around 900 B.C.E. suggests a strategy for detecting lying behavior in suspects:

Six hundred years later, the Greeks were attempting to detect lies by feeling the suspect's pulse. What is interesting about both the early Hindu and Greek examples is that the methods employed were empirical; the interrogators were looking for physiological changes in the body that corresponded to the mental state in question.