The Bazelon Center for Mental Health Law (the Center), founded as the Mental Health Law Project by a group of attorneys and mental health professionals, has been a major advocacy force promoting the civil rights of persons with mental disabilities since the 1972 New York Willowbrook litigation.

Named for D. C. Circuit Court of Appeals Judge David L. Bazelon, whose opinions first articulated the principles that the mentally disabled have a right to treatment in the least restrictive alternative setting, the Center has actively pursued greater rights for the mentally disabled in housing, education, and federal entitlements such as Medicaid, as well as in treatment-related issues.

The above bit string encodes personal information about one of the authors of this essay. Of course, without rules to decode the bit string, it is impossible to say whether it is genetic information, weight, age, fingerprint, religion, etc. Layered on top of that technical decoding process is a social decoding process – how sensitive is this information? How useful is it to the government for various purposes? The objective of this paper is to offer some key lessons for the regulation of genetic information collected by the state for law enforcement purposes. In the first part of the paper, we discuss two fundamental principles of informational privacy theory. Utilizing these, we then examine the statutory regimes that have emerged for the regulation of the information that the government collects in three different domains – fingerprints, department of motor vehicle (DMV) records, and tax records. In the third and final part we use the results of our analysis as analogies for similar regulatory challenges in the regulation of genetic information collected for law enforcement purposes, and make some tentative recommendations.

Almost everyone involved in the legal profession today is aware of the wide, and perhaps insurmountable, chasm between the scholarly research that takes place in elite law schools and the actual work of practicing lawyers and judges. To a greater extent than other academic professions like medicine and public health, law professors too often have little to say to working lawyers and judges, even those judges on the U.S. Supreme Court. Perhaps this has been the case from the beginning, but the gap appears more dramatic in recent decades, as legal scholarship has departed from traditional doctrinal analysis and moved in more interdisciplinary and abstract theoretical directions.

In his deliciously funny book, Medicare Meets Mephistopheles, Professor David Hyman argues that Medicare corrupts our most base impulses. It urges us, for example, to grab for more than our fair share of benefits while offering providers “the prospect of staggering amounts of money – even as…actuaries were promising Congress that the Medicare program would be easily affordable.” Modeled on C.S. Lewis’ The Screwtape Letters, Professor Hyman's satirical examination of Medicare takes the form of a memo to Satan from an underling demon in the Department of Illness and Satanic Services (DISS), reporting on the success of Satan's diabolical plot to corrupt humanity. Sprinkled with political cartoons, absurd (but true) stories of Medicare's over-the-top fraud enforcement efforts, and a historical account of Medicare's genesis (replete with Congressmen and strippers), Medicare Meets Mephistopheles gives us a well-researched and easy-to-read primer on the biggest pot of gold in medicine.

DNA profiling and databasing have become commonplace in criminal investigation and prosecution. There is a body of both state and federal legislation enabling the establishment and operation of profile databases for law enforcement purposes. Most legislation is specific as to who (or what evidence) may be profiled for inclusion in a database. The majority of state laws permit DNA profile databasing of offenders convicted of certain defined crimes, of missing persons and their relatives, and of DNA profiles from criminal-case evidence where the depositor is unknown. More recently, a few states have acted to permit databasing profiles of suspects of certain types of crimes, and there appears to be a trend toward wider adoption of this practice. The legislation adopted or proposed thus far defines whose DNA profiles can be databased, and under what circumstances. Less attention has been given to the matter of specimen retention following profiling and databasing.

In his State of the Union address on January 31, 2006, President George W. Bush asserted: “for all Americans, we must confront the rising cost of care, strengthen the doctor-patient relationship, and help people afford the insurance coverage they need.” Soon thereafter, the White House National Economic Council released a summary of President Bush's plans for health care reform. The Bush plan argues that increased consumer control over health care purchasing decisions will go a long way to solving America's health care woes. By making patients more value-conscious consumers, the Bush Administration hopes to reduce costs, improve quality and increase competition within the health care sector.

The problem of rising health care costs is not new. In fact, President Bush's statement could have come from any American President in the last fifty years.

In his State of the Union address on January 31, 2006, President George W. Bush asserted: “for all Americans, we must confront the rising cost of care, strengthen the doctor-patient relationship, and help people afford the insurance coverage they need.” Soon thereafter, the White House National Economic Council released a summary of President Bush's plans for health care reform. The Bush plan argues that increased consumer control over health care purchasing decisions will go a long way to solving America's health care woes. By making patients more value-conscious consumers, the Bush Administration hopes to reduce costs, improve quality and increase competition within the health care sector.

The problem of rising health care costs is not new. In fact, President Bush's statement could have come from any American President in the last fifty years.

The United States Court of Appeals for the Second Circuit recently upheld United States District Court for the Eastern District of New York Judge's denial of petitioner's application for a writ of habeas corpus. The Court held that it was not objectively unreasonable for the Appellate Division to conclude, in light of clearly established federal law as expressed by the Supreme Court of the United States, that a New York statute providing for the recommitment of specific defendants who plead not responsible by reason of mental disease or defect (NRRMDD) under a mere “preponderance of the evidence” standard does not violate either due process or the equal protection clause of the Fourteenth Amendment.

The topic of offender DNA databases and the retention of offender's DNA samples are issues that continue to generate debate between privacy advocates and forensic DNA scientists. Considered previously by both the Federal DNA Advisory Board and the National Commission on the Future of DNA Evidence, recommendations were made that the existing statutory frameworks were sufficient to protect the confidentiality and use of the DNA samples solely for forensic identification purposes and that the issue be revisited. Now, approximately five years since these debates, privacy advocates and forensic scientists retain divergent views on this issue. This brief essay is not intended to fuel the debate, but rather, to describe the protections and safeguards currently in place for the protection of the offender DNA samples.

Surrounding the discussion of the sample retention issue are the underlying principles for the establishment of the Combined DNA Index System (CODIS) Program and the National DNA Index System (NDIS).

On August 29, 2006, the United States Court of Appeals for the District of Columbia Circuit held that an injured ERISA plan beneficiary need not be “made whole” by any injury-related recovery from a third party in order for her ERISA plan to assert subrogation or reimbursement rights if the plan's terms either 1) “unambiguously establish a plan priority” to any funds a beneficiary recovers from a third party, or 2) are reasonably interpreted to establish such a priority by an ERISA plan fiduciary clearly authorized to do so.

In 1991, appellants William and Judith Moore (the Moores) purchased an ERISA health insurance policy (the plan) from Blue Cross Blue Shield of the National Capital Area and its wholly-owned subsidiary CapitalCare (CC/BCBS). On September 10, 1992, the Moores’ daughter Alistaire, a plan beneficiary, was seriously injured in an automobile accident.

Wherever we go, we leave behind skin cells containing copies of our DNA molecule – unless we go forth hermetically sealed. This makes construction and maintenance of DNA identification databases enormously useful to crime investigators. DNA databases, linking numerical representations of a tiny portion of individuals' DNA with their names and other identifying information, are useful to identify suspects directly by matching DNA found at a crime scene with a DNA profile in a DNA identification database. They are useful indirectly too, because criminal investigations proceed by a process of elimination; and identifying the person whose DNA was found at a crime scene can make it unnecessary to continue investigating others. When the incriminating crime scene sample does not match the DNA of a “person of interest,” that person is freed from the hassles and risks of criminal investigation, including the risk of false conviction.

Over the past fifteen years, the United States has witnessed an extraordinary expansion in the banking and mining of DNA for law enforcement purposes. While the earliest state laws governing forensic DNA limited collection and retention of DNA samples to sexual offenders – on the theory that these persons were especially prone to recidivism and most likely to leave behind biological evidence – today forty-three states collect DNA from all felons, twenty-eight from juvenile offenders, and thirty-eight from those who commit certain categories of misdemeanors.

A few states have expanded their databases beyond convicted criminals. Virginia, Louisiana, Texas, and California have authorized DNA retention from persons merely arrested for various offenses, although to date only Virginia has implemented such a program. At the federal level, an ill-considered statute that allows for the seizure and storage of DNA from anyone arrested and from non-U.S. citizens detained under federal authorities was recently signed into law.

In Pabon v. Wright, the Second Circuit held that the Fourteenth Amendment right to refuse medical treatment contained a corollary right to the information necessary to make an informed decision. Plaintiff, William Pabon, was an inmate at Green Haven Correctional Facility in New York (Green Haven). He named two groups of defendants: his doctors and nurses at Green Haven and his doctors at Dutchess Gastroenterologists, P.C. (Dutchess).

In October 1996, a laboratory test indicated that Plaintiff may have contracted Hepatitis C. The Green Haven doctors referred Plaintiff to Dutchess for additional testing, where additional tests confirmed that Plaintiff had Hepatitis C. In July 1997, Plaintiff returned to Dutchess for additional evaluation, and the physicians told him that he must undergo a liver biopsy in order to receive treatment for his condition.

In 1890 a man sold the rights to his body after death to the Royal Caroline Institute in Sweden for research purposes. Later, he tried to return the money and cancel the contract. In the subsequent lawsuit, the court held that he must turn his body over to the Institute and also ordered him to pay damages for diminishing the worth of his body by having two teeth removed.

Today, it would be an anathema for a person's body to be used against his wishes and for a research subject not to be allowed to withdraw from a study. In fact, the Uniform Anatomical Gift Act allows people to change their minds and withdraw a previous agreement to donate organs and tissue after their death and the federal research regulations allow people to withdraw from studies without penalty or loss of benefits.

The currently evolving debate over ethical and legal approaches to DNA data banks reflects, in part, shifting societal perceptions of dividing lines between humanity and commodity, definitions of genetic inheritance between individuals and families, and the rights of the individual versus the rights of the community. Tensions arise whether the data bank has been created for medical or for forensic purposes. The authors, through their work as community activists described more fully below, have come to realize that the key to resolving these tensions and developing ethically acceptable DNA data bank practices is meaningful community engagement. Not unlike medical DNA data banks, personally identifiable DNA samples are routinely retained by states long after a convict's or arrestee's DNA profile has been derived from it and entered into the state database. The question arises, then, as to what, if any, non-forensic uses can these samples – ethically – be put.

Organ transplantation remains one of modern medicine's remarkable achievements. It saves lives, improves quality of life, diminishes healthcare expenditures in end-stage renal patients, and enjoys high success rates. Yet the promise of transplantation is substantially compromised by the scarcity of organs. The gap between the number of patients on waiting lists and the number of available organs continues to grow. As of January 2006, the combined waiting list for all organs in the United States was 90,284 (64,933, 17,269, and 3,006 for kidney, liver, and heart respectively). Unfortunately, thousands of potential organs are lost each year, primarily due to lack of consent to donation from the deceased before death, or from the family thereafter. Only fifty percent of potential donors – the “conversion” rate – become actual donors. The costs attributed to organ shortage are substantial – Medicare paid over $15.5 billion in 2002 for treating patients with end-stage renal-disease, who predominate on organ waiting lists.

Bioethics is currently witnessing unprecedented debate over the moral and legal norms governing the conduct of clinical research. At the center of this debate is the duty of care in clinical research, and its most widely accepted specification, clinical equipoise. In recent work, we have argued that equipoise and cognate concepts central to the ethics of clinical research have been left unnecessarily vulnerable to criticism. We have suggested that the vulnerability lies in the conspicuous absence of an articulated foundation in moral and legal theory of the physician-researcher's duty of care to the patient-subject. We have repeatedly suggested that the requisite foundation is in the ethics of trust and the law of fiduciaries.

Curiously, despite the absence of a published thorough exposition of our position, some have preemptively criticized our suggestion that the relationship between physician-researcher and patient-subject is fiduciary. Others have offered their own accounts of the implications of fiduciary law for the relationship.

In her recent article, “Evidence, Belief, and Action: The Failure of Equipoise to Resolve the Ethical Tension in the Randomized Clinical Trial,” Deborah Hellman gives a new twist to an old objection against clinical equipoise. Roughly, clinical equipoise is the requirement that there exist credible uncertainty in the expert medical community regarding the preferred treatment for a particular condition. This uncertainty is widely regarded as a necessary condition for enrolling participants in a clinical trial. The old objection is that clinical equipoise represents an overly permissive, and therefore morally unacceptable, mechanism for resolving the fundamental tension in clinical research between fidelity to the interests of the individual research participant, and fidelity to the statistical and scientific methods that are necessary to produce generalizable data in a reliable manner. Hellman's new twist on this objection utilizes some of the rudimentary architecture of Bayesian statistical theory to argue that clinical equipoise focuses our moral attention on the wrong issue.