HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

A Member of the Law Professor Blogs Network

Saturday, March 25, 2006

Latest Public Health Downloads from SSRN

Here are the March papers that have been posted (to date) on the Social Science Research Network's Public Health Law website (in reverse chronological order).  Links are to the Abstract page; full papers can usually be downloaded through links found on there.

Abstract:     
Security matters to health. Crime victimization causes death, injury and illness. Injury or death is an occupational hazard for police. The criminal justice system causes injury and illness in the course of attempting to punish and deter crime. Policing policies and practices can have a significant impact on the ability of other public and private agencies to successfully implement health interventions. Police themselves routinely deal with people who have serious health needs, and even on occasion are the primary agents implementing health interventions. The health consequences of law enforcement are far from trivial, making it important for health to be integrated as a matter of concern into criminological research and law enforcement practice. The link between health and policing, and the significance of health outcomes, should be more fully accepted in criminology. Likewise, the governance of security is an important matter for public health research and practice.

If health outcomes are seen as an important product of security arrangements, conventional policing can be reconfigured to reduce negative health consequences and promote positive ones. There are, however, limits to the extent that state-centered policing can be expected to change. The theory of nodal governance and the programmatic work of innovators in the "governance of security" movement offer useful insights into the coordination of health and security outside the state-centered policing framework. Experience with both health and security-based schemes shows the promise of "microgovernance" strategies that promote health and security by mobilizing local knowledge and capacity among poor people with historically poor relations with conventional police systems. Serious practical and theoretical questions can be raised about the long-term prospects of these strategies, particularly the capacity of small groups of poor people to manage events flowing from more generalized and more powerful sources. While valid in some respects, however, such criticism misses the "democratic experimentalism" as the heart of the governance of security approach.

Date Posted:March 24, 2006
Last Revised:March 24, 2006
Accepted Paper Series
2 downloads

Abstract:     
This Essay calls for a repositioning of two distinct legal regimes - inalienability and contract - that govern the imposition of liability for medical malpractice upon doctors and institutions, respectively. The inalienable right to tort remedies places opportunistic patients - who file unmeritorious lawsuits against doctors and increase the cost of medical care - in the same pool with honest patients, who cannot credibly promise doctors not to sue them opportunistically. The contract regime allows managed care organizations (MCOs) not to monitor their doctors, which enables bad doctors to pool with good doctors. MCOs' functioning as a platform in a two-sided market for medical services intensifies this pooling. Good doctors and honest patients consequently suffer. Good doctors earn less than they should and their prospect for being erroneously adjudicated liable for malpractice looms larger than it should. Honest patients subsidize the opportunists by paying for medical care more than they should.

A complete switchover between inalienability and contract would make good doctors, honest patients, and society at large better off. MCOs' institutional liability should become patients' inalienable right; the law also should stop treating the patient's entitlement to tort remedies as inalienable. Under this system, an MCO can offer patients a menu of agreements. The menu's baseline agreement must honor the patient's inalienable right to tort remedies; other agreements are free to limit the MCO's liability. The price-difference between the agreements would credibly inform patients about the quality of the MCO's doctors. To attract patients, the MCO would have to keep this difference at its lowest, which would motivate it to hire good doctors only. Honest patients would then agree to limit their entitlement to tort remedies and get inexpensive quality care in return. An opportunistic patient would prefer the full-liability agreement - a self-selection that would not only cost more, but would also expose the patient to defensive medicine.

Date Posted:March 23, 2006
Last Revised:March 24, 2006
Working Paper Series
1 downloads

Abstract:     
During the mid-19th century, the United States acquired Texas and large parts of Mexican territory with the vast Mexican-born population. This paper considers the biological standard of living of the part of this population that was incarcerated in American prisons. We use their physical stature as a proxy for their biological welfare. These data confirm earlier results which showed that adult heights tended to stagnate in Mexico during the late-19th century despite considerable social and political turmoil. While there is some evidence of a decline in height among youth, the decline is slight (<1 cm). As in other 19th century samples, farmers were the tallest. Americans were taller than Mexican prisoners by about 2 cm.

Date Posted:March 23, 2006
Last Revised:March 23, 2006
Accepted Paper Series

Abstract:     
How should states classify embryos? The war has often waged between two classifications, people versus property. But what if a state assumed something in between, finding the embryo to be a potential person entitled to special respect? If a state adopted this position, how would the law affect medical research?

Presuming embryos constitute potential persons, the debate would continue with how to define “special respect.” The status of a potential person runs along a spectrum between property and personhood. How one defines “special respect” determines where the potential person falls along this spectrum. Special respect would create a spectrum of treatment that extends from a property-like limitation of ownership rights to something resembling rights afforded to an absolute person.

This comment theorizes about the impact of a state that statutorily regards an embryo as a potential person. Such a statute may assert that embryonic material with the active potential to develop into a live born offspring is a potential person due special respect. If special respect was presumed to lie on the person-oriented side of the spectrum, it would afford the potential person something akin to the most fundamental human rights. Such a definition draws into question the common practice of destroying embryos in IVF and stem cell research.

Part I assesses the current perception of embryos as persons, potential persons afforded due respect, and property. Part II discusses the potential insufficiency of characterizing embryos as persons and property. Part III analyzes variances within the spectrum of interpreting embryos as potential persons, including property that offers its owner a limited bundle of rights and persons who possess limited rights of their own. Part III also explains the value of treating embryos as more akin to persons than property. Part IV reflects on the implications that regarding an embryo as a person with limited rights would have upon medical technology. This includes an analysis on IVF, a consideration of traditional techniques for culturing stem cell lines, and an assessment of the most recent medical advances in deriving embryonic stem cells.

Date Posted:March 23, 2006
Last Revised:March 23, 2006
Working Paper Series
2 downloads

Abstract:     
Any human endeavor is prey to human error. The consequences of human error in the area of assisted reproductive technologies are magnified by our playing in the field of creation of new human lives and lifelong relationships. Stories of assisted reproductive technology (ART) mistakes continue to fascinate the media and popular culture, pain their multiple victims, and haunt the nightmares of ART participants, past, present, and future. Though there are many kinds of mistakes that can arise in these complex processes, this Article focuses on mistakes or mix-ups involving the accidental use of incorrect gametes (sperm, ova, and embryos) during in vitro fertilization (IVF) procedures. After examining the reported mistakes and the ways that courts have resolved issues of ART mistakes, this article looks at a proposed Model Act and suggests an alternative approach that has a particular sensitivity to women’s labor-based, gestational contributions to reproduction.

Date Posted:March 23, 2006
Last Revised:March 23, 2006
Accepted Paper Series
1 downloads

Abstract:     
Evolutionary biology - or, more precisely, two (purported) applications of Darwin's theory of evolution by natural selection, namely, evolutionary psychology and what has been called “human behavioral biology" - is on the cusp of becoming the new rage among legal scholars looking for "interdisciplinary" insights into the law. We argue that as the actual science stands today, evolutionary biology offers nothing to help with questions about legal regulation of behavior. Only systematic misrepresentations or lack of understanding of the relevant biology, together with far-reaching analytical and philosophical confusions, have led anyone to think otherwise.

Evolutionary accounts are etiological accounts of how a trait evolved. We argue that an account of causal etiology could be relevant to law if (1) the account of causal etiology is scientifically well-confirmed, and (2) there is an explanation of how the well-confirmed etiology bears on questions of development (what we call "the Environmental Gap Objection"). We then show that the accounts of causal etiology that might be relevant are not remotely well-confirmed by scientific standards. We argue, in particular, that (a) evolutionary psychology is not entitled to assume selectionist accounts of human behaviors, (b) the assumptions necessary for the selectionist accounts to be true are not warranted by standard criteria for theory choice, , and (c) only confusions about levels of explanation of human behavior create the appearance that understanding the biology of behavior is important. We also note that no response to the Environmental Gap Objection has been proferred. In the concluding section of the article, we turn directly to the work of Professor Owen Jones, a leading proponent of the relevance of evolutionary biology to law, and show that he does not come to terms with any of the fundamental problems identified in this article.

Date Posted:March 23, 2006
Last Revised:March 23, 2006
Working Paper Series
191 downloads

Abstract:     
This research studies the perception of the risks associated with impaired driving - probability of being apprehended or of having an accident - and the relation between the perception of risks and driving behavior. The most important determinants of perceptual biases are age, an accumulation of violations in the year preceding the survey, being a non-drinker, knowledge of the legal alcohol limit for driving, opinion about zero tolerance for impaired driving, and family income. Perceptual biases are shown to influence driving behavior, as captured by drivers' accumulated violations, demerit points and bodily injury accidents, in the years preceding and in the year following the survey. In conclusion, we analyze the results in terms of public policy for road safety.

Date Posted:March 22, 2006
Last Revised:March 22, 2006
Working Paper Series
1 downloads

Abstract:     
With an impending Avian influenza or bird flu pandemic, the issue of patents and public health has once again taken centre stage. Oseltamivir (known by its brand name 'Tamiflu'), a patented antiviral pill, has emerged as the world's first line of defence against bird flu. A key priority for most nations is to create sufficient stockpiles of this pill that can then be easily distributed and administered during a pandemic. Keeping this end in mind, this paper explores the patent position in India and looks at ways to work around a patent, should one issue in future. The paper recommends various strategies for creating an optimal and affordable stockpile and calls on the government to take a more definite stand in the matter.

Date Posted:March 21, 2006
Last Revised:March 21, 2006
Accepted Paper Series
2 downloads

Abstract:     
This Article reveals that many already issued and actively enforced medical biotechnology patents are invalid. Biologics, medical therapeutics derived through biotechnology techniques, are the fastest growing and most promising pharmaceutical sector. They represent a $30 billion a year industry that is anticipated to double in five years and already provides novel treatments for diabetes, cancer, and heart disease. Due to unforeseen consequences of century-old decisions, generic manufacturers currently are not able to make biologics even after biologic patents expire. As early biologics are just starting to go off-patent, this regulatory mix-up is now having a notable impact on the availability of biologics and significantly raising the cost of health care.

The generic biologics debate has dramatically heated-up recently, with the biotechnology and pharmaceutical industry arguing for the status quo, senators threatening legislation, and the Food and Drug Administration struggling to handle the situation. This Article exposes for the first time that industry’s own arguments have an unintended, striking consequence - their biologic patents fail enablement, and therefore are not valid in the first instance.

Date Posted:March 21, 2006
Last Revised:March 22, 2006
Working Paper Series
3 downloads

Abstract:     
This article considers several parameters of the late twentieth and early twenty-first-century debate in the U.S. about ethics, politics, science, and ideology (popularly referred to as the "culture wars"). The article focuses, in particular, on shifting understandings of the embryo. The article reviews developments in science (especially the advent of stem-cell research and cloning) that have affected understandings of embryo, the history of debate about abortion in the U.S., and the place of discourse about abortion in a more far-reaching social debate about family, personal relationships, and the scope of personhood in the U.S.

Date Posted:March 20, 2006
Last Revised:March 23, 2006
Accepted Paper Series
3 downloads

Abstract:     
This paper attempts to present a comprehensive and coherent picture of the role performed by science under the SPS Agreement and SPS case law. It argues that the approach adopted by the Appellate Body is predominantly based on a technical paradigm, supplemented, however, with some considerations arising from other paradigms. The paper argues that the approach adopted in the case law is generally compatiblewith the text of the SPS Agreement and provides a coherent SPS system. However, it also identifies certain areas which lack coherence, as certain standards seem to violate the right of the member states to establish an appropriate level of protection. These are: ascertainability of the risk as a precondition for valid risk assessment; strict specifity of the risk assessment in low-risk situations; the proportionality between the risk identified and the SPS measure; the notion of negligible risks; and the concept of likelihood in the quarantine risk assessments. The paper claims that these standards cannot be generally applied in SPS disputes as, in certain situations, they will result in the violation of the right of member states to establish an appropriate level of SPS protection. Finally, a number of specific issues are highlighted which require further clarification in case law, such as the issue of the quality of minority scientific opinions and the relationship between the insufficiency of scientific evidence and scientific uncertainty. The paper suggests that the ultimate role ascribed to science under the SPS Agreement can be assessed only after an interpretation of those issues is provided by future case law.

Date Posted:March 20, 2006
Last Revised:March 20, 2006
Working Paper Series
1 downloads

Abstract:     
An unexplained death in custody represents an important focal point for public scrutiny of the criminal justice system, especially when excess deaths occur in those of minority ethnic descent. Sickle cell anaemia is a serious inherited blood disorder disproportionately affecting minority ethnic groups. Sickle cell trait is the genetic carrier state and not an illness. The evidence suggests that the treatment of sickle cell in the criminal justice system is twofold. Justice authorities have misused sickle cell trait to explain away ten sudden deaths, often associated with forced restraint, of African-Caribbean people in custody. Meanwhile, seven deaths have been attributable to lack of provision of health care for those prisoners suffering from the illness sickle cell anaemia.

Date Posted:March 17, 2006
Last Revised:March 17, 2006
Accepted Paper Series

  • Dimensions of Informed Consent to Treatment
    International Journal of Gynecology and Obstetrics, Vol. 85, pp. 309-314, 2004
    Bernard Dickens and Rebecca J. Cook
    University of Toronto - Faculty of Law and University of Toronto - Faculty of Law

Abstract:     
Modern law approaches patients’ consent to treatment not only through liability for unauthorized touching, namely criminal assault and/or civil (non-criminal) battery, but also through liability for negligence. Physicians must exercise appropriate skill in conducting procedures, and in providing patients with information material to the choices that patients have to make. The doctrine of informed consent serves the ethical goal of respecting patients’ rights of self-determination. Information is initially pitched at the reasonable, prudent person in the patient’s circumstances, and then fine-tuned to what is actually known about the particular patient’s needs for information. Elements to be disclosed include the patient’s prognosis if untreated, alternative treatment goals and options, the success rate of each option, and its known effects and material risks. Risks include medical risks, but also risks to general well-being such as economic and similar reasonable interests. Consent is a continuing process, not an event or signed form.

Date Posted:March 10, 2006
Last Revised:March 10, 2006
Accepted Paper Series
1 downloads

Abstract:     
This paper is a case study of the use of public use administrative data for the estimation of empirical relations when key dependent variables are not available in the data. It is shown that the out-of-hospital mortality rates can be identified using the patient discharge data without post-discharge death records. Using data on the lengths of hospitalizations and out-of-hospital spells, the mortality rates before and after discharge as well as discharge and re-hospitalization rates are estimated for a sample of heart-attack patients hospitalized in California between 1992 and 1998. The results suggest that ignoring variation of discharge rates among hospital types could be misleading in evaluating hospital performance regarding mortality risks.

Date Posted:March 10, 2006
Last Revised:March 10, 2006
Working Paper Series
2 downloads

Abstract:     
Obstetric fistula can be explained to result from different causes. These holes in the tissue wall between the vagina and bladder and/or rectum are most prevalent in resource-poor countries, attributable to prolonged obstructed labour and absent or inaccessible remedial prenatal services. Obstructed labour is often due to small pelvic size, resulting from women’s youth and premature childbearing and/or malnutrition. Poverty at national health-service and family levels often predisposes pregnant populations to suffer high rates of fistula. Global estimates showing up to 100,000 new cases each year and 2 million affected girls and women are probably gross underestimates. Fistula devastates lives of sufferers, who are often expelled by husbands and become isolated from their families and communities. Failures of states to provide prenatal preventive care (including medically indicated cesarean deliveries) and timely fistula repair violate women’s internationally recognized human rights, especially to healthcare in general and reproductive healthcare in particular.

University of Toronto - Faculty of Law and University of Toronto - Faculty of Law
Date Posted:March 10, 2006
Last Revised:March 10, 2006
Accepted Paper Series

Abstract:     
Political reorganizations like that of the National Performance Review in the United States fundamentally alter hierarchical relations within public agencies. This study includes a set of formal exercises to examine two logical consequences of reinvention: the increased likelihood of coordination failures, and the reduction in political leaders’ hierarchical status in the organization. These effects are discussed in the context of a substantial change in the public organization of health services: the alteration of the U.S. Department of Health and Human Services’ structure. This study shows that reinvention fundamentally alters the power and status of political appointees, the standing of top leadership, and the likelihood of conflict resolution within the organization.

Date Posted:March 10, 2006
Last Revised:March 10, 2006
Working Paper Series

Abstract:     
Political reorganizations like that of the National Performance Review in the United States fundamentally alter hierarchical relations within public agencies. This study includes a set of formal exercises to examine two logical consequences of reinvention: the increased likelihood of coordination failures, and the reduction in political leaders’ hierarchical status in the organization. These effects are discussed in the context of a substantial change in the public organization of health services: the alteration of the U.S. Department of Health and Human Services’ structure. This study shows that reinvention fundamentally alters the power and status of political appointees, the standing of top leadership, and the likelihood of conflict resolution within the organization.

Date Posted:March 6, 2006
Last Revised:March 9, 2006
Accepted Paper Series
14 downloads

Abstract:     
The debate over both cloning and stem cell research has been intense and polarizing. It played a significant role in the recently completed presidential campaign, mentioned by both candidates on the stump, at both parties' conventions, and was even taken up directly during one of the presidential debates. The topic has been discussed and debated almost continuously by the members of the legal, scientific, medical, and public policy commentariat. I believe that it is a heartening tribute to our national polity that such a complex moral, ethical, and scientific issue has become a central focus of our political discourse. But, as you have no doubt noticed, the content of the discourse itself has been sometimes quite impoverished and unsatisfying. No one camp in this debate is solely to blame for these difficulties - partisans on all sides bear some measure of responsibility for the current state of the public discourse. In the interests of improving the quality of public deliberation and discussion on this matter, I will provide a few modest suggestions for how the public debate might be improved. I begin with a few general observations applicable to both domains under consideration today, stem cell research and cloning. Then I focus on each separately; first, directing my comments to stem cell research, and then turning to the distinct (though obviously closely related) matter of cloning.

Date Posted:March 6, 2006
Last Revised:March 14, 2006
Accepted Paper Series
13 downloads

Abstract:     
For many years, institutional psychiatry was a major tool in the suppression of political dissent. Moreover, it appears painfully clear that, while the worst excesses of the past have mostly disappeared, the problem is not limited to the pages of history. What is more, the revelations of the worst of these abuses (and the concomitant rectification of many of them) may, paradoxically, have created the false illusion that all the major problems attendant to questions of institutional treatment and conditions in these nations have been solved. This is decidedly not so.

Remarkably, the issue of the human rights of persons with mental disabilities had been ignored for decades by the international agencies vested with the protection of human rights on a global scale. Within the legal literature, it appears that the first time disability rights was conceptualized as a human rights issue was as recently as 1993 when, in a groundbreaking article, Eric Rosenthal and Leonard Rubenstein first applied international human rights principles to the institutionalization of people with mental disabilities.

For people with mental disabilities, in particular, the development of human rights protections may be even more significant than for people with other disabilities. Like people with other disabilities, people with mental disabilities face degradation, stigmatization, and discrimination throughout the world today. But unlike people with other disabilities, many people with mental disabilities are routinely confined, against their will, in institutions, and deprived of their freedom, dignity, and basic human rights. People with mental disabilities who are fortunate enough to live outside of institutions often remain imprisoned by the social isolation they experience, often from their own families. They are not included in educational programs, and they face attitudinal barriers to employment because they have not received the education and training needed to obtain employment or because of discrimination based on unsubstantiated fears and prejudice. Only recently have disability discrimination laws and policies in the United States and elsewhere focused on changing such attitudes and promoting the integration of people with disabilities into our schools, neighborhoods, and workplaces.

The question remains, however: to what extent has institutional, state-sponsored psychiatry been used as a tool of political suppression, and what are the implications of this pattern and practice? In Part I of this article, I discuss the first revelations of the dehumanization inflicted on persons with mental disabilities, primarily (but not exclusively) in Soviet Bloc nations. In Part II, I discuss developments after these revelations were publicized. In Part III, I weigh the extent to which the post-revelation reforms have been effective and meaningful. In Part IV, I explain the meanings of sanism and pretextuality, and discuss how they relate to the topic at hand. Then, in Part V, I raise questions that have not yet been answered, and that, I believe, should help set the research agendas of those thinking about these important issues.

Date Posted:March 4, 2006
Last Revised:March 20, 2006
Working Paper Series
15 downloads

Abstract:     
The "Three R's" seek to reduce, refine, and replace the use of animals in experiments. The Three R's have been accepted by researchers who use animals in experiments and by animal welfare advocates who argue in favor of regulating animal use rather than abolishing it. The Three R’s are incorporated into the federal Animal Welfare Act, and over the past twenty years have to a considerable degree become the primary legal and non-legal mechanism for regulating animal experimentation.

This article takes a systematic and critical look at the Three R's and concludes that they are ineffective in preventing unnecessary animal suffering even if animal experimentation is generally regarded as legitimate. The Three R's fail for three main reasons. First, they do not allow for challenges to a researcher's purpose in conducting experiments that will use animals, even if that purpose is questionable. Second, loopholes in the Animal Welfare Act have allowed researchers to avoid application of the Three R's in practice. Finally, the Three R's have no application to new and emerging areas of biomedical research that have the potential to greatly escalate the use of animals in experiments, including stem cell research, cloning, xenotransplantation, genetic modification, and bioterrorism defense.

Date Posted:March 4, 2006
Last Revised:March 19, 2006
Accepted Paper Series
29 downloads

Abstract:     
In reviewing patent applications and prior art references in biotechnology, the patent system often focuses on the extent to which these documents explicitly disclose structural formulae for specific nucleic acid molecules. This Article argues that this approach to patentability has caused well-known generic and methodological references to be disregarded as potentially relevant prior art. To provide empirical support for this doctrinal argument, this Article also describes the creation and publication of an “artfully drafted” prior art reference that provides an enabling disclosure of more than 11 million DNA sequences on CD-ROM and has already been cited in a number of patents and patent applications. The reference is still too small to offer a complete solution to the problems caused by the patent system’s approach. Because the size of the reference is constrained only by the capacity of the CD-ROM, however, the reference provides a “proof of concept” that may be generalized and extended as more capacious storage media become available.

Date Posted:March 3, 2006
Last Revised:March 3, 2006
Accepted Paper Series
13 downloads

Abstract:     
The bitter dispute over the proper treatment of Theresa Marie Schiavo - a severely brain-damaged woman, unable to communicate and with no living will or advance directive - has garnered enormous attention in the media, both national and international. What began as a heated disagreement between Ms. Schiavo's husband and parents mushroomed into a massive political conflict involving privacy advocates on one side, and right-to-life and disability activists on the other. The battle raged on the editorial pages of the world's newspapers, in the courts, and ultimately, in the legislative and executive branches of the Florida state government. After nearly three years of acrimonious litigation between Michael Schiavo (Ms. Schiavo's husband) and the Schindler family (Ms. Schiavo's parents), a Florida court ordered that nutrition and hydration for Ms. Schiavo be discontinued. Six days after implementation of the court's order, the Florida Legislature passed "Terri's Law," authorizing the Governor, under certain prescribed circumstances, to issue a one-time stay of court-ordered withdrawal of life-sustaining measures, and to appoint a guardian ad litem to review the matter and report back to the executive branch and the chief judge of the relevant Florida court. Pursuant to this new authority, the Governor stayed the order issued by the court, and nutrition and hydration were restored to Ms. Schiavo.

To date, the public debate on this matter has been framed as a conflict between or a balancing of abstract concepts such as "the right to die," "the sanctity of life," and "the rights of the disabled." Little scholarly attention has been paid, however, to an enormously important question at the heart of this matter, namely, what the proper roles of the various branches of government are in a case such as Schiavo's. The proper question is not whether the government has a role in a dispute such as this - it clearly became involved once the matter moved to the state courts - but rather how the government should be involved. Which branch, if any, should have the last word in such a dispute? In these cases, should the relationship between governmental branches be hierarchical or complementary? Which branch of government is best situated to resolve these disputes? This Article, using the Schiavo case as the relevant point of departure, essays to address these questions. Specifically, the questions presented are twofold: (1) Were the Florida Legislature's (and by extension, the Governor's) actions in the Schiavo case consistent with the constitutional principles of separation of powers? (2) If so, did the actions of the executive and legislative branches in this case promote or undermine the purposes and logic of the Florida laws governing end-of-life decisionmaking, taken as a whole? That is, is Terri's Law wise public policy from a structural, governmental view?

Date Posted:March 2, 2006
Last Revised:March 3, 2006
Accepted Paper Series
9 downloads

Abstract:     
This book chapter provides a gender perspective on the international human rights treaty provisions that are of particular importance to female refugees. These treaties address a range of issues that female refugees face in relation to their rights, including rights violations that take place during flight and in refugee camps; difficulties encountered in the asylum application and adjudication process; and problems refugees face once settled that result from discrimination by both state and non-state actors in such areas as housing, employment, and education. The pertinent General Comments of the committees that monitor implementation of these treaties are examined, as are the concluding observations and recommendations under the reporting procedure of the treaty regime, and relevant jurisprudence under the individual complaint procedures established by four of the treaties.

Underlying the rights in all these treaties is the prohibition of discrimination on the basis of sex and the right to equal protection of the law. This paper recommends that to protect these rights, states should take into account the gender-related ways in which female refugees and asylum seekers experience the deprivation of rights. Rape and other sexual violence, gender-specific manifestations of racial and ethnic prejudice, limitations on freedom of movement on the basis of sex, violations of reproductive rights, and inequality in the economic realm are just some of the gender-related issues faced by female refugees. States should take account of these forms of rights violations in developing and implementing programs to fulfill their obligations under the international human rights treaties. States should also recognize the diversity among female refugees as they develop their programs in order to ensure maximum effectiveness.

Date Posted:March 2, 2006
Last Revised:March 20, 2006
Accepted Paper Series

Abstract:     
This article develops the first measures of age-industry job risks to examine the age variations in the value of statistical life. Because of the greater risk vulnerability of older workers, they face flatter wage-risk gradients than younger workers, which we show to be the case empirically. Accounting for this heterogeneity in hedonic market equilibria leads to estimates of the value of statistical life-age relationship that follows an inverted-U shape. The estimates of the value of statistical life range from $6.4 million for younger workers to a peak of $9.0 million for those age 35-44, and then a decline to $3.7 million for those age 55-62. The decline of the estimated VSL with age is consistent with there being some senior discount in the Clear Skies Initiative analysis.

Date Posted:March 2, 2006
Last Revised:March 4, 2006
Working Paper Series
21 downloads

Abstract:     
A survey of the commentary following the conclusion of the Theresa Marie Schiavo matter leaves one with the impression that the case was a victory for the cause of autonomy and the right of self-determination in the end-of-life context. In this essay, I seek to challenge this thesis and demonstrate that, contrary to popular understanding, it is the defenders of autonomy and self-determination who should be most troubled by what transpired in the Schiavo case. In support of this claim, I will first set forth (in cursory fashion) the underlying aim of the defenders of autonomy in this context. Then, I will provide a brief sketch of how the law - both as enacted and interpreted - might ideally serve to promote and defend the goods of autonomy and self-determination. I will thus assess the process and outcome of the Schiavo case by carefully examining the positive law governing the case, as well as the specific evidence relied on by the Florida courts to assess Ms. Schiavo’s actual wishes (the touchstone of autonomy). Moreover, I will contrast the manner in which the Florida courts evaluated this evidence with the seemingly consistent and uniform approach taken by courts from other jurisdictions. I will additionally explore the significance of the Florida courts’ decision to focus the majority of their resources and time on inquiries not oriented towards Ms. Schiavo’s actual wishes, but rather on matters relating to paternalistic considerations, such as her present and future quality of life. In light of the foregoing analysis, I conclude that the Schiavo matter cannot rightly be understood as a victory for self-governance at the end of life. To the contrary, it is instead a cautionary tale of what can happen when the legal preconditions for the exercise of autonomy are absent or ignored.

Date Posted:March 2, 2006
Last Revised:March 10, 2006
Accepted Paper Series
13 downloads

TOMORROW: The March Health Law papers from SSRN.  [tm]

March 25, 2006 | Permalink | Comments (0) | TrackBack (0)

Choosing a Medicare Drug Plan

The Wall Street Journal has been running a series of articles examining some of the concerns and difficulties that seniors have experienced in choosing a Medicare drug plan.   In yesterday's piece, the WSJ interviewed a couple with several options for prescription drug coverage.  The couple, who currently buy many of their drugs outside the United States, discussed their difficulty making an economically sound decision on a drug plan.  The wife, in particular, seems to feel pressured to make a decision that she doesn't feel ready to make and has worries that the costs will change.  The story states,

Originally, Mr. Marten planned to sign up for the AARP MedicareRx plan. This month, he enrolled in a different plan, offered by Humana Inc. Mrs. Marten, meanwhile, had said she wouldn't sign up for a Medicare drug plan at all, then later said she'd enroll, reluctantly. Now, she's back to her original position.

Mrs. Marten says she's been wary of the drug benefit all along, mainly because she's concerned it wouldn't end up saving her any money. "She had felt too much pressure from me and that's why she agreed the last time around," Mr. Marten says. "I eased up and she [decided against enrolling] again."

To view the other stories, click on the Medicare Dairy link on the Wall Street Journal home page (subcription required), you can also look to the following links for additional stories:

• WSJ.com discusses the benefit with Medicare chief Mark McClellan

Medicare May Limit Number of Plans.

Many Seniors Pass on Drug-Benefit Plan

[bm]

March 25, 2006 | Permalink | Comments (0) | TrackBack (0)

Friday, March 24, 2006

Lack of Charity Care

CNN.Com reports on a study documenting a decline in doctor's providing charity care to patients.  The story states,

About three-quarters of physicians provided charity care in the mid-1990s, compared with about two-thirds now, according to a study released Thursday by the Center for Studying Health System Change.

The numbers have declined across all major specialties. The highest rate of free care, 78.8 percent, comes from surgeons, perhaps because many of these doctors treat uninsured patients in emergency rooms.

Just over 60 percent of pediatricians provided free care, the lowest rate among the specialties. That could be because children are more likely than adults to have insurance coverage.

I am sure that there are a number of reasons for this.  The article mentions the low reimbursement rates from the government and the decline in solo practicioners as two.  I am sure that there are some who fear malpractice liability as well as the fact that managed care often places time pressure on doctors to see as many patients (insured patients) as possible, leaving little time for the uninsured.   

On another note, CNN also hosts a video of a hospital dumping a patient on skid row.   It is rather shocking!.  [bm]

March 24, 2006 | Permalink | Comments (0) | TrackBack (0)

Is the New Budget Bill Unconstitutional?

Remember the Budget Deficit Reduction Act of 2005 that the president signed on Feb. 8?  (Here are the links to the public law (Pub. L. No. 109-171), the president's signing statement, and our earlier blog entries on the bill [here, here, and here].)  Among other things, the law extends the moratorium on specialty hospitals, plus there's lots of other health-law goodies in there.

Well, it turns out that the House and Senate versions of S.1932 didn't match exactly -- which raises at least a question under the Constitution's bicameralism clause, and it's even possible the president knew that when he signed the bill, at least according to a letter from Nancy Pelosi and Henry Waxman.  As reported by the AP:

The Senate version of the bill said Medicare can pay to rent some types of medical equipment for 13 months, as intended by congressional negotiators. A clerk erroneously wrote down 36 months before the bill was sent back to the House for a final vote, and that's what the House approved Feb. 1.

By the time the bill was shipped to Bush, the number was back to 13 months as passed by the Senate.

Recognizing the problem, the Senate passed a resolution hours after Bush signed the bill confirming that the measure transmitted to the president was "deemed the true enrollment reflecting the intention of the Congress" [Sen. Con. Res. 80, with the House concurring]. The White House considers the matter settled.

Public Citizen has sued to have the law declared unconstitutional (press release, complaint). The interesting constitutional question is whether the House and Senate can cure the problem after the fact of the president's signing one of two inconsistent versions of a bill.  The more interesting question is whether all of the law's Medicare changes have been thrown into a cocked hat, at least until the House can pass a clean version of S.1932 and the president can re-sign it.

Thanks to Jurist.com for the tip. [tm]

March 24, 2006 | Permalink | Comments (0) | TrackBack (0)

Wednesday, March 22, 2006

When Doctors Disagree

The New Yorker has a moving story about how a woman Alice Stewart Trillin, dealt with disagreement between her doctors on her treatment.  The article begins, "Jerome Groopman has written in this magazine about the dilemma a doctor faces when giving medical advice that strongly contradicts the diagnosis of another doctor, and about the difficulty of waiting rather than taking swift action in the face of a dire medical situation. He recalled an admonition he heard as a medical student: "Don't just do something—stand there." But what about a patient who has to bet his life on one doctor's best guess against another's, and stands there, waiting to see which way the possibly loaded dice will roll? "
[bm]

March 22, 2006 | Permalink | Comments (0) | TrackBack (0)

Health Insurance and Finding a Date

Erza Klein notes the increased mention of health insurance as a means of attracting a date, a mate and even true love. For example, Slate.com cites the following ads: "1) A woman's ad asks, "Do you make at least $75,000 a year and have health insurance?" 2) A man's ad says he "can supply all the little things like health insurance and the big things like a nice place to live." 3) Another man's ad says, "If you are able to add someone to your health insurance as a 'spousal equivalent' have I got a deal for you."

Although quite funny at first glance, it is rather sad that access to health insurance is being used in this manner.   Yet another reason to re-think our health care system . . . [bm]

March 22, 2006 | Permalink | Comments (0) | TrackBack (0)

Tuesday, March 21, 2006

Price Transparency for Health Care

The Health Care blog has a great post discussing Paul Ginsberg's recent article concerning price transparency in health care.  He concludes,

. . . . The need for consumers to compare prices of providers and treatment alternatives   is increasing and has the potential to improve the value equation in health care. But we need to be realistic about the magnitude of the potential for improvement from making consumers more effective shoppers for health care. Whatever the gains from increased shopping activity, rising health care costs will, nevertheless, price more consumers out of the market for health insurance and burden governments  struggling to pay for health care from a revenue base that is not growing as fast as their financing commitment. For those who have health insurance, their health plan will be a key agent in facilitating their obtaining better value. Government needs to take care not to interfere with this relationship and should  focus instead on the needs of those without insurance

[bm]

March 21, 2006 | Permalink | Comments (0) | TrackBack (0)

Find Your Spot

Just for fun - if you are thinking about retiring or just moving to a different location as a means to improve your health - you may want to check out the findyourspot.com website.  You do need to register.  It provides a comprehensive survey of questions and then provides you with a list of places where you would be happy living.  I apparently should be in Medford, Oregon.  [bm]

March 21, 2006 | Permalink | Comments (0) | TrackBack (0)

More on SCOTUS' Big Patent Case

Monday's NY Times had a very good piece on the correlation patent issue about which the Court will hear oral argument today ("Justices Reach Out to Consider Patent Case").  My earlier post is here Take this with the proverbial grain of NaCl, but according to the article, "Both sides say the case, which involves a blood test for a vitamin deficiency, could have a wide-ranging impact on the development of diagnostics, perhaps threatening many of the underlying patents for genetic and other medical tests." [tm]

March 21, 2006 | Permalink | Comments (0) | TrackBack (0)

Blood-Substitute Study Hit Again

Yesterday's Wall Street Journal reported (paid subscription required) that three bioethicists -- Nancy King (UNC), Robert Nelson (UPenn), and Ken Kipnis (Hawaii) -- have written an open letter expressing their concerns to the 31 institutions conducting clinical trials of a blood substitute for seriously bleeding emergency department patients.  The Office of Human Research Protection has already announced that it is looking into the research, as has the SEC (see Newsday story).  The Wall Street Journal's March 10 article on this study is here[tm]

March 21, 2006 | Permalink | Comments (0) | TrackBack (0)

Monday, March 20, 2006

RU-486 Safety Controversy

Ever since the FDA approved RU-486, the abortion pill, it has been mired in a variety of controversies.  Recent challenges have been made to its safety because several women allegedly have died due to the drug.  Thoughts of an Average Woman has some of the recent studies and write-ups.  [bm]

March 20, 2006 | Permalink | Comments (0) | TrackBack (0)

Bird Flu Likely Coming to US This Year

Reuters reports that a number of Bush administration officials, including Interior Secretary Gail Norton, Agriculture Sectretary Mike Johanns, and Secretary of Health and Human Services Michael Leavitt,  have indicated that "it was "increasingly likely" that bird flu would be detected in the United States as early as this year but added it would not mean the start of a human pandemic."  Today, these officals also disclosed "a plan to increase monitoring of migratory birds that are likely to bring the bird flu virus to U.S. shores."

For all things concerning bird flu and other public health issues, see effect measure. [bm]

March 20, 2006 | Permalink | Comments (0) | TrackBack (0)

Harvard Overhauls Physician Training

It's not exactly health law, but an article in The Boston Globe caught my eye anyway, maybe because I spend a substantial part of every school year with MSIII's who rotate through Pediatrics and with fourth-years getting ready to leave school and start their residencies.  The article ("Learning the Patient's View: Harvard Alters Doctors' Training" [requires free registration]) describes the biggest changes in the medical school's curriculum in 20 years:

The biggest shift will occur in the third year, which is the first time that students leave the classroom to see patients. At present, students go from hospital to hospital for one- to three-month stints, a practice that gives them few opportunities to get to know patients or senior doctors.

Under the new curriculum, students will stay in one hospital and follow some patients the entire year.

Senior doctors would be able to better spot students' strengths and weaknesses, and they will hold twice-monthly conferences in which students will discuss not only their patients' medical issues but also ethical dilemmas, family problems, and health insurance snafus.

Harvard will extend the first year by two weeks to give students an introduction to the profession. Students also will be required to take one-semester classes on the effect of social and economic conditions on disease, medical ethics and professionalism, and health policy. These changes, among others, will be phased in over the next three years, starting in August.

The changes aren't being embraced at all the teaching hospitals in the Harvard system, but if they help the next generation of doctors better understand and deal with patients' "ethical dilemmas, family problems, and health insurance snafus," this has to be progress, doesn't it?    [tm]

March 20, 2006 | Permalink | Comments (0) | TrackBack (0)

Conflicts of Interest at the Cleveland Clinic

Glenn McGee & Peter Levin's editorial in the current issue of the American Journal of Bioethics is posted on their bioethics blog for all to read. It paints a pretty damning picture of COI practices at the home of the leading cardiovascular practice group in the world and is well worth reading.  One tidbit worth thinking about: Of its 87 board members, more than half are in business relationships with the Clinic . . . not exactly a group that inspires confidence in the institution's ability to police conflicts of interest. [tm]

March 20, 2006 | Permalink | Comments (0) | TrackBack (0)

Doctor Pleads Guilty to Drug Misbranding Charge

This ought to be pretty simple: A doctor can prescribe an FDA-approved drug for an unapproved ("off-label") use but cannot prescribe an unapproved drug for an approved use.  And he especially can't use the unapproved drug while claiming he is using (and billing for) the approved version.  That's misbranding and fraud.

An Oregon doctor has learned this lesson the hard way.  He was charged with administering an unapproved (and cheaper) form of botulism toxin to more than 800 patients at his "A Younger You" clinics while claiming he was administering Botox, which is approved.  On Thursday, according to an article in The Oregonian, the physician pleaded guilty and accepted an 18-month prison sentence.  [tm]

March 20, 2006 | Permalink | Comments (0) | TrackBack (0)

Charity Care and Nonprofit Hospitals

Two developments noted in today's issue of AIS's Report on Medicare Compliance (and summarized in AIS's Government News of the Week):

  • A U.S. district court was right to dismiss the charges against Baptist Health System (BHS) in Alabama and the American Hospital Association (AHA), says the U.S. Court of Appeals for the Eleventh Circuit in a March 9 opinion. BHS and AHA were charged in a class-action suit with breach of contract by billing uninsured patients more for health care than insured patients, and for violating the Emergency Medical Treatment and Active Labor Act (EMTALA) by conditioning treatment on patients' ability to pay. The appeals court agreed that the breach-of-contract claims were barred because judgments had already been entered in state suits. And the EMTALA charges were dismissed because the patients did not file their suit within the two-year EMTALA statute of limitations, the court says.
  • Kansas Attorney General Phill Kline (R) says he is examining the billing and collection practices of not-for-profit hospitals in the state to "protect uninsured and underinsured Kansans from exploitation." Kline began the inquiry after receiving complaints by consumers who alleged questionable business practices by facilities throughout the state, a March 9 statement says. Kline has met with other attorneys general from midwestern states and with representatives of hospitals in Kansas to express concerns the state officials have about the issue. Former attorney general Robert Stephan has been appointed special assistant attorney general to lead discussions with hospitals and establish best practices for billing and collections, the statement says.

The opinion in the 11th Circuit case, Kizzire v. Baptist Health System, Inc., is here. The grounds for the appellate court's decision are narrow but worth noting to the extent the decision continues an almost unbroken string of losses for plaintiffs trying to use the federal courts to impose a charity-care requirement on hospitals that are exempt from taxation under § 501(c)(3) of the Internal Revenue Code.

Attorney General Kline's press release (not easy to find - his office's Press page has a bad link to this document) is here.

[tm]

March 20, 2006 | Permalink | Comments (0) | TrackBack (0)

Is There A Looming Physician Shortage? Possibly Not.

Health Affairs has published a provocative piece that casts doubt on widespread fears that the U.S. faces a physician shortage: 

Variations in End-of-Life Care Sow Doubt About Need For More Physicians
http://content.healthaffairs.org/cgi/content/abstract/25/2/521  (abstract)

In the March/April Health Affairs, Dartmouth's David Goodman and colleagues question the belief that the United States faces an impending physician shortage. As evidence, Goodman and colleagues offer a threefold variation in the amount of physician care given to patients at different academic medical centers in the last six months of life. They write that this variation is related to regional differences in physician supply, rather than any effects on the well-being of the patient. They assert that we should use our resources on replicating the efficient care offered by interdisciplinary practices such as the Mayo Clinic, rather than training more physicians who will only generate increased costs for the health system. (emphasis added)

Of perhaps greater interest than the conclusions about a supposed physician shortage is the authors' analysis of end-of-life resource allocation (measured in terms of physician labor).  [tm]

March 20, 2006 | Permalink | Comments (0) | TrackBack (0)

Sunday, March 19, 2006

"Correlation Patents" Hit by Crichton

Michael Crichton has an op-ed in today's N.Y. Times criticizing the Patent Office's approach to "correlation patents."  It may seem like an obscure topic, but it's on the Supreme Court's docket this term and has major implications for bioscience research and medical practice.

The Supreme Court case -- Laboratory Corporation of America Holdings, dba LabCorp v. Metabolite Laboratories, Inc. (U.S., No. 04-607) -- will be argued Tuesday.  Here's the question presented: "Whether a patent instructing a party to 'correlate test results' can validly claim a monopoly over a basic scientific relationship used in medical treatment such that a doctor infringes the patent by looking at a test result and thinking about that relationship."  Sound weird?  Or (as Crichton suggests) Kafkaesque?  Read on . . . .

Here's Duke Law School's synopsis of the case:

Metabolite sued LabCorp for patent infringement. In 1986 UPI filed a patent on a method for testing homocysteine levels in body fluids and specifically sought to protect the scientific connection between homocysteine levels and vitamin deficiency. B vitamins help metabolize homocysteine, which is an amino acid. UPI's patent describes a two-step process of testing for homocystine (an amino acid), and then correlating the level with the B vitamin levels in the body. UPI licensed Metabolite, which sublicensed Laboratory Corporation of America Holdings (LabCorp), to use the patent. From 1992-1998, LabCorp paid LabCorp paid Metabolite a royalty every time it supplied a doctor with a homocysteine test. After 1998, LabCorp began using a test developed by another company and Metabolite sued LabCorp for patent infringement.

After a trial, a jury found that the patent was valid and that LabCorp had willfully infringed Metabolite's patent, justifying enhanced damages. The United States Court of Appeals for the Federal Circuit affirmed. The Supreme Court granted certiorari only to resolve the question of whether the patent was valid since it involves detecting a natural correlation between homocysteine and vitamin B, and “laws of nature, natural phenomena, and abstract ideas” are not patentable.

Right.  So if laws of nature, natural phenomena, and abstract ideas are not patentable, how is it that a company can get damages when a doc looks at another company's test results and thinks about the relationship between homocysteine levels and vitamin B deficiency?  Good question.

Crichton, great populizer that he is, puts the question even more vividly:

Although Metabolite does not have a monopoly on test methods — other companies make homocysteine tests, too — they assert licensing rights on the correlation of elevated homocysteine with vitamin deficiency. A company called LabCorp used a different test but published an article mentioning the patented fact. Metabolite sued on a number of grounds, and has won in court so far.

But what the Supreme Court will focus on is the nature of the claimed correlation. On the one hand, courts have repeatedly held that basic bodily processes and "products of nature" are not patentable. That's why no one owns gravity, or the speed of light. But at the same time, courts have granted so-called correlation patents for many years. Powerful forces are arrayed on both sides of the issue.

"Powerful forces," indeed, judging from the list of amici who have filed briefs in this case, including the AMA, AARP, IBM, American Express and the US of A (plus the Intellectual Property Owners Association, People's Medical Society, American Clinical Laboratory Association, American Heart Association, Financial Services Industry, Patients Not Patents, Association of the Bar of the City of New York, Computer & Communications Industry, Affymetrix, Public Patent Foundation, Franklin Pierce Law Center, American Intellectual Property Law Association, Boston Patent Law Association, Perlegen Sciences, Mohr, Davidow Ventures, and the Federal Circuit Bar Association).

As usual, the Medill School of Journalism's Supreme Court website provides the most detailed and intelligible discussion of the case:

It is well established in patent law that the laws of nature, including the body’s biological processes, cannot be claimed or owned.

But a patent infringement lawsuit is testing the boundaries of that precedent, asking if a laboratory can patent the correlation between the level of an amino acid found in body tissues with the levels of vitamins in the body that make that amino acid.

Researchers at University Patents Inc. (UPI) in the early 1980s discovered a relationship between elevated levels of the amino acid homocysteine and the deficiency of two B vitamins, folate and cobalamin.

These vitamins help form homocysteine, and the researchers noted that unusually high homocysteine levels often signaled dangerously low levels of the important vitamins. Elevated homocysteine levels have been connected with a variety of health problems, including lupus, renal disease, arthritis and Alzheimer’s disease.

As early as 1969, researchers discovered that elevated homocysteine levels could signal increased risk of heart disease.

In 1986 UPI filed a patent on a method for testing homocysteine levels in body fluids. In claim 13 of that patent, UPI sought to license the scientific connection between homocysteine levels and vitamin deficiency, describing a two-step process of testing for the amino acid, and then correlating the level with the B vitamin levels in the body.

Laboratory Corporation of America Holdings (LabCorp) obtained a sub-license for the patent from Metabolite Laboratories, Inc., which was licensed by UPI’s successor. Beginning in 1992, LabCorp paid Metabolite a royalty every time it supplied a doctor with a homocysteine test. But after LabCorp began using another company’s testing method in 1998, Metabolite sued LabCorp for patent infringement.

The jury in the November 2001 trial awarded Metabolite almost $5 million in damages after finding LabCorp liable for breach of contract and patent infringement. The trial judge assessed an additional $1 million in damages in finding the infringement intentional, and issued a permanent injunction barring LabCorp from using other tests.

LabCorp appealed to the Court of Appeals for the Federal Circuit, arguing that for the “correlation” step of the patent to have any meaning, a doctor must confirm the vitamin deficiency through physical diagnosis–simply thinking about the relationship should not violate the patent.

A panel of the appeals court rejected the argument, holding that an infringement “only requires association of homocysteine levels with vitamin deficiencies.”

To Jonathan Franklin, who represents LabCorp, that decision amounts to regulating the thought processes of doctors who receive the test results and try to diagnose their patients’ illnesses.

“The lower courts said that every doctor who orders a homocysteine test, for any reason, infringes the patent,” Franklin said.

In Funk Bros. Seed Co. v. Kalo Inoculant Co. [link], the U.S. Supreme Court ruled in 1948 that a previously unknown natural phenomenon cannot be patented, but an invention resulting from the discovery that has a “new and useful” application may be patentable.

To LabCorp, claim 13 has no new and useful application, and the patent is akin to discovering that high cholesterol may be linked to Alzheimer’s disease, and claiming a monopoly on that connection–and in doing so collecting a royalty every time a doctor connects the two.

After LabCorp sought review from the U.S. Supreme Court, the Court asked the Solicitor General in February 2005 to file a brief expressing the government’s opinion on whether the patent is invalid because “laws of nature, natural phenomena and abstract ideas” are not patentable.

The Solicitor General recommended the Court deny LabCorp’s petition for a writ of certiorari, but argued that the natural phenomenon issue hadn’t been sufficiently raised in the lower courts. The Solicitor General did not go so far as to conclude that the patent is valid on its merits alone.

On Oct. 31, 2005, the Court accepted review of the case limited to the question of whether a patent instructing a party to “correlate test results can validly claim a monopoly over a basic scientific relationship used in medical treatment” such that a doctor infringes the patent by looking at a test result and thinking about that relationship.

LabCorp argues claim 13 is too vague and offers no instructions as to how one should correlate the homocysteine levels with vitamin deficiency.

“If the Court allows the Federal Circuit opinion to stand, anyone could obtain a patent on any scientific correlation–that there is a link between fact A and fact B–merely by drafting a patent claiming no more than ‘test for fact A and correlate with fact B,’” Franklin argues in LabCorp’s brief.

Glenn Beaton, who will represent Metabolite before the Court, counters that this example “grossly oversimplifies what the researchers did.”

“The researchers came up with a new way of testing for homocysteine,” Beaton said. “That example is an exaggeration because the correlation was not known previously.”

Beaton noted in his response that the appeals court had no problems deciphering the correlation step, adding that even LabCorp’s own employees testified they “understood the meaning of ‘correlating’” at trial.

In addition to the interpretation of the correlating step, the Court’s decision is expected to clarify the issues surrounding patenting natural processes.

The Court may look to its 1981 opinion in Diamond v. Diehr [link] for direction. In Diehr the Court ruled that, while a mathematical formula is not patentable, a process for curing rubber that used the formula could be patented because the process involved a transformation to a “different state or thing.”

The Court may also rely on its 1978 decision in Parker v. Flook [link], in which it established that “the discovery of [a natural] phenomenon cannot support a patent unless there is some other inventive concept in its application.”

The question before the Court, then, is whether the correlation requirement of claim 13 is sufficiently inventive, as in Flook, or whether the process results in a “different state” to allow the monopoly of a natural phenomenon, as it held in Diehr.

In November Chief Justice John Roberts recused himself from the case. Roberts did not provide a reason, but he previously worked at Franklin’s law firm, Hogan & Hartson of Washington, D.C.

Noting that well-known and important medicine like drugs that treat AIDS were patented on the same correlation principle, Beaton says the precedent if Metabolite loses the case will lead to chaos in the scientific patent field.

“Thousands of correlation patents will be stripped, and there are huge investments in these patents,” Beaton said.

LabCorp, on the other hand, argues the precedent that will be set if it loses could lead to a “crippling liability” for sharing medical information.

“Medical professionals and others must be able to discuss such facts…without fear of liability,” Franklin said in the brief. “If the Federal Circuit’s decision is not reversed, the ultimate losers will be thousands of doctors and millions of their patients.”

[tm]

March 19, 2006 | Permalink | Comments (0) | TrackBack (0)

Robert Pear Writes About Nonprofit Hospitals Under Scrutiny

In Sunday's N.Y. Times: "Nonprofit Hospitals Face Scrutiny Over Practices."  Among those lining up to take their shot at the nonprofit hospital industry:

Not much new in this piece, but it's a good primer on some of the issues.  [tm]

March 19, 2006 | Permalink | Comments (0) | TrackBack (0)