Few areas of health law practice present as many quandaries for the ethical health lawyer as health care fraud and abuse. The activities addressed by the anti-fraud laws – such as payment for referrals and submission of false claims – not only have a direct impact on the financial viability of the federal health care programs, but go to the heart of the ethical behaviors expected of those who transact business with the government. The severe consequences of violating these proscriptions include significant monetary penalties, ineligibility to participate in the federal health care programs, and even imprisonment. It is no wonder, then, that compliance with the fraud and abuse laws is a key consideration in any health care venture. At the same time, ethical considerations make this area of health law particularly vexing for counsel, raising numerous challenges that include how to balance the strategic goals of current clients against the interests of future clients and whether to advise clients to self-report potential violations even when illegal intent may not easily be shown.

Concerns about the influence of financial interests on research have increased, along with research dollars from pharmaceutical and other for-profit companies. Researchers’ financial ties to industry sponsors of research have also increased. Financial interests in biomedical research could influence research design, conduct, or reporting, and could compromise data integrity, participant safety, or both. Investigators’ financial ties with for-profit companies may influence reported scientific results, and may have compromised research participant safety.

Disclosure is one commonly accepted method of managing financial relationships in order to minimize possible threats to scientific objectivity, the safety of research participants, or public trust in the integrity of clinical research. Disclosure is presumed useful to the extent that “it gives those who would be affected, or who are otherwise in a good position to assess the risks, information they need to make their own decision.”

Firearms were associated with 30,136 deaths in the United States in 2003; of these, 11,920 were homicides. For every firearm homicide, there are four people who suffer non-fatal firearm assaults. Like many other consumer products in the US, most guns are initially sold to the public through a network of retail dealers. Persons in the business of selling firearms must obtain a federal firearm dealer's license. There were more than 54,000 federally licensed gun dealers in the United States in 2005, though this reflects a seventy-eight percent decline since 1994. Some states also require a state license to sell firearms.

Licensed firearm dealers are an important source of guns for criminals and gun traffickers. In one analysis of gun trafficking investigations conducted by the Bureau of Alcohol, Tobacco and Firearms (ATF), licensed dealers accounted for a plurality of all guns diverted to the illegal market.

The United States Supreme Court has long recognized the value of scientific evidence – especially when compared to other types of evidence such as eyewitness identifications, confessions, and informant testimony. For example, in Escobedo v. Illinois, the Court observed: “We have learned the lesson of history, ancient and modern, that a system of criminal law enforcement which comes to depend on the –confession— will, in the long run, be less reliable and more subject to abuses than a system which depends on extrinsic evidence independently secured through skillful investigation.” Similarly, in Davis v. Mississippi, the Court commented:

In the past few years, medical practices surrounding the decision to resuscitate marginally viable newborns have received a fair amount of attention. Baroness Warnock, of the UK Nuffield Council on Bioethics, has recently suggested that Britain follow the recommended practice in Holland of setting a gestational age limit below which marginally viable newborns should not be routinely resuscitated, despite reported statistical probabilities of raw survival approaching twenty percent. In the US, a highly publicized case from Texas came to a controversial legal conclusion, permitting physicians to disregard parental preference for palliative care and unilaterally initiate resuscitation when faced with the birth of an extremely premature baby.

A serious risk associated with some treatments for infertility is multiple birth pregnancy. The term “supernumerary pregnancy” aptly conveys the idea of too much or too many in this context: too many fetuses developing in the womb to secure a reasonable probability of a good outcome for each. A supernumerary pregnancy can occur, for example, when infertility is treated by the aggressive use of ovulation-stimulating hormones. If pregnancy is then achieved either naturally or artificially, or if large numbers of eggs are retrieved, fertilized in vitro, and then transferred to the uterus in a single cycle, the risk of supernumerary pregnancy is increased. Egg donation coupled with artificial insemination, or straight embryo donation, followed in each case by the transfer of more than two or three embryos to the uterus can also increase the risk for supernumerary pregnancy.

The Open Access Movement maintains that all scientific and scholarly literature should be available to all for free via the Internet. This concept is not new. Some scholars trace its roots as far back as 1963 when “hypertext” was first introduced. Although the Open Access Movement may have originated more than fifty years ago, it has been fueled by more recent events, including the unremitting escalation of journal subscription prices over the last two decades, resulting in massive cancellations of journals by academic libraries; the ubiquitous nature of the Internet and the parallel explosion of electronic resources; and the desire of authors to find a new publishing model which continues to offer the benefits of peer review while providing for more rapid publication and wide-spread distribution than the current labor-intensive, time-consuming model.

The Open Access Movement has resulted in a number of online repositories devoted to legal analysis and policy. This column explores the genesis of the movement, its value to researchers and policymakers, and provides an overview of the two principal open access products in the legal arena.

The emergence of post-conviction DNA testing has had profound effects on the American criminal justice system. Although changes in the formal legal landscape are readily noticeable, the DNA exonerations have also produced other consequences that may have potentially more significance. To comprehend and assess the influence of post-conviction DNA testing one must examine more than just the law on the books. After some introductory material, Part I of this essay looks at repercussions DNA exonerations are having on the basic operation of the criminal justice system, Part II examines new statutes that govern procedures for post-conviction DNA testing requests, and Part III briefly considers how these current developments may affect Supreme Court jurisprudence.

Post-conviction DNA testing has evolved in little more than a decade. Before 2000, only two states, New York and Illinois, had statutes that authorized post-conviction DNA testing. In other jurisdictions, no formally authorized procedures existed that allowed inmates to make requests for DNA testing of crime scene evidence.

In the wake of several highly publicized lawsuits over drugs recalled for safety – most notably, Vioxx and Paxil – the Food and Drug Administration (FDA) and the pharmaceutical industry have faced increasingly intense public scrutiny over the drug testing and approval process. Critics blame the FDA's shorter pre-market approval process that has resulted from the enactment of the Prescription Drug User Fee Act (PDUFA), which effected, among other changes, an increased number of reviewers, a higher review load for each reviewer, and the implementation of “user fees” from companies submitting drugs for review. While many have posited that the lack of safety in some FDA-approved drugs was caused by the enactment of PDUFA, the results of a recent study from the Tufts Center for the Study of Drug Development have indicated that there is no statistically significant correlation between the number of drugs recalled for safety and the enactment of PDUFA.

Nearly 2.5 million Americans currently reside in nursing homes and assisted living facilities in the United States, accounting for approximately five percent of persons sixty-five and older. The aging of the “Baby Boomer” generation is expected to lead to an exponential growth in the need for some form of long-term care (LTC) for this segment of the population within the next twenty-five years. In light of these sobering demographic shifts, there is an urgency to address the profound concerns that exist about the quality-of-care (QoC) and quality-of-life (QoL) of this frailest segment of our population.

In July of 2004, Cambodian sex workers staged a protest of an HIV prevention trial set to enroll 900 sex workers in Phnom Penh, charging the study planners with exploitation. The Cambodian study was one of a series of international clinical trials sponsored by the U.S. National Institutes of Health (NIH), U.S. Centers for Disease Control and Prevention (CDC), and the Bill and Melinda Gates Foundation (Gates Foundation) testing the safety and efficacy of tenofovir (Viread), an antiretroviral drug produced by Gilead Sciences, Inc., to prevent HIV transmission. To date, two of these international studies have been closed and one is suspended, prompting calls for re-examination of the ethics of HIV prevention trials.

“Relying on Science, Romney Files Death Penalty Bill.” With that headline, a press release on April 28, 2005 announced that Massachusetts Governor Mitt Romney was seeking to reintroduce by legislation the death penalty that the state's Supreme Judicial Court ruled unconstitutional in 1984. The remainder of the text left little doubt that science was a major basis for the governor's action. The press release quoted Romney as saying that the bill provided a “gold standard for the death penalty in the modern scientific age.” Positing a symmetry that will be questioned below, Romney also declared, “Just as science can free the innocent, it can also identify the guilty.” The bill itself deferred to science by calling for corroborating scientific evidence, multiple layers of review, and a novel “no doubt” standard of proof. By raising the required standard of evidence and by restricting the class of capital crimes, the proposed law hoped to correct the defects of other death penalty statutes.

The promise of personalized medicine and the quest for a greater understanding of the genetic basis of disease has transformed the research enterprise. The Director of the National Institutes of Health (NIH), Elias A. Zerhouni, M.D., recently predicted “that comprehensive, genomics- based health care will become the norm, with individualized preventive medicine and early detection of illnesses.” This excitement about the potential scientific and clinical advances that may come from genomics- based research has led several NIH institutions to launch initiatives for genome-wide association studies (GWAS), calling on researchers and institutions to utilize the new DNA analysis technologies to study the genetic variation between individuals with a particular illness and healthy controls.

Combine the following: medicine, ethics, jurisprudence, behavioral genetics, and antisocial behavior (ASB). Given our level of scientific knowledge today, this combination is more akin to a cerebral smorgasbord than to a dinner where starter, entree, wine, and dessert are carefully chosen to complement one another. Hence, any survey of menus must be highly selective. We accept as a given that there is a noteworthy genetic influence on ASB no matter how it is defined. In terms of behavioral research, the magnitude of that genetic influence is substantial, but so is the impact from the environment, broadly defined to include pre-and post-natal, physical (e.g., anoxia, fetal alcohol syndrome, or crack) as well as psychosocial (e.g., quality of parenting, ethnic culture, or religion) elements.

We will discuss some of the major issues raised by this fact of genetic influence that have most applicability to topics usually raised by observers outside of behavioral genetics.

The flu has an interesting history with respect to health care rationing in the United States. Consider that just about two years ago, the American public faced a shortage of influenza vaccine. Dire predictions were made about how many people might perish, and rationing protocols were created. However, many of the rationing protocols were ignored. Luckily, that flu season did not result in the horrible fatalities that were predicted. For these reasons, problems of health care rationing around issues of the flu were postponed, rather than resolved.

Over the last year, the public has focused its anxious attention on the possible avian influenza pandemic. Last week I noticed that at least once each day I heard mention in some discussion or another of the threat of this disease becoming easily transmissible from human to human.

What happens when being a good doctor requires being a bad citizen? What should a doctor do when living up to the requirements of a professional code of ethics or staying true to deeply held personal values requires breaking the law? What should a health care professional do when the appropriate conduct in a particular case is inconsistent with a more generalized principle that has been incorporated into law? Further, what is the role of the ethical health lawyer who advises a health care provider facing such a dilemma?

As health care lawyers advising individuals and institutions, is it our job to advise our clients of all the options available to them, and all the potential legal consequences, or is our role simply to keep our clients acting within the law? Are we information providers, policy counselors, risk managers, or some combination of these?

When a health care professional contacts a health care attorney for advice about how to deal with a medical error involving a patient, what is the most ethically appropriate response? Honesty is the best policy; the ethical health lawyer should advise the client to tell the patient the truth. This advice is neither naïve nor impractical, as we will show. More importantly, it is without question the right thing to do for a number of sound reasons. It may not be a natural inclination or an easy task to accomplish; several countervailing factors discourage health professionals from telling patients the truth about medical errors. However, we will argue that resistance to truthful disclosure can and should be overcome by rational arguments that also take into consideration the psychodynamics of the patient-health professional relationship.

In the trauma surrounding mass disasters, the need to identify victims accurately and as soon as possible is critical. DNA identification testing is increasingly used to identify human bodies and remains where the deceased cannot be identified by traditional means. This form of testing compares DNA taken from the body of the deceased with DNA taken from their personal items (e.g. hairbrush, toothbrush etc.) or from close biological relatives. DNA identification testing was used to identify the victims of the terrorist attack on the World Trade Center in New York on September 11, 2001, and of the victims of the Tsunami that hit Asia on December 26, 2004. Shortly after the 9/11 attack, police investigators asked the victims' families for personal items belonging to the missing, and for DNA samples from family members themselves. The New York medical examiner's office coordinated the DNA identification testing program; however, some of the identification work was contracted out to private laboratories.