HealthLawProf Blog

Medicare Part D and Secretary Leavitt's Parents

Oops - looks like just about everyone is having difficulty figuring out the new Medicare Part D program, including HHS Secretary Leavitt's parents.  Accourding to the Salt Lake Tribune,

Not even the senior parents of Washington's top health official are immune from headaches caused by the new Medicare drug plan.  Dixie and Anne Leavitt - parents of Health and Human Services Secretary Mike Leavitt - recently were forced to change Medicare plans after learning that the one they chose imperiled their retiree medical coverage.

The elder Leavitts joined the program last fall with some fanfare and help from their son. Anne Leavitt, 73, was quoted in The Salt Lake Tribune touting the online enrollment as "smooth," and a guaranteed money-saver.

Neither she nor Dixie, 76 - who made his fortune in the insurance business - could be reached for comment on Thursday. But they reportedly suffered no real lapse in coverage. Secretary Leavitt's office confirmed that the couple signed up for another Medicare plan through their insurer, Utah's Public Employee Health Plan.

But the blunder is sure to prove fodder for critics who have labeled the drug benefit "plagued" with problems, from computer failures to overcharging for prescriptions. Troubles have been most acute for millions of low-income seniors and disabled people who were automatically transferred from their state Medicaid plans into Medicare plans that didn't cover their medications.

Thanks to americablog for the cite.  [bm]

Subpoenas for Pharmaceutical Companies

The KaiserNetwork.Org states that the Federal Trade Commission has issued subpoenas to 190  pharmaceutical companies.  According to the story,

The Federal Trade Commission on Wednesday announced that it plans to subpoena 190 drug companies in an investigation of possible anti-competitive practices in the pharmaceutical industry, the AP/Los Angeles Times reports. The subpoenas, which require approval from the Office of Management and Budget, would be part of a probe into whether pharmaceutical companies are suppressing competition by releasing authorized generic versions of their own brand-name drugs to coincide with the introduction of products from generic drug makers. Under federal law, after a generic pharmaceutical company successfully challenges a patent held by a brand-name manufacturer, it has six months of exclusivity to sell the drug in the generic market by itself. However, a loophole allows brand-name manufacturers to authorize their own generic versions, which increasingly are entering the market at the beginning of the six-month exclusivity period. Generic drug manufacturers depend on that exclusivity period to recover their costs and make a profit, but with authorized generics entering the generic market sooner, profit margins are falling for generic manufacturers. FTC plans to study whether the authorized-generic loophole benefits brand-name companies in the long run by discouraging generic drug makers from challenging patents. Lawmakers requested in May 2005 that the FTC conduct the investigation, and a final report is due by late 2007 (Bridges, AP/Los Angeles Times, 3/30).

Thanks to the HealthyPolicy blog for the website.  [bm]

Sleep Later to Prevent Smoking?

The New Scientist reports on a study that indicates that individuals who smoke may do so because they are getting up too early.   

                                                    

Till Roenneberg at Ludwig Maximilians University in Munich and his colleagues used questionnaires to assess the "chronotype" of more than 500 volunteers - a measure of how much of a night owl or early bird you are. As with previous large studies, they found that the average person prefers to sleep between 12.30 am and 8.30 am, although chronotypes vary so widely that the latest owls are still awake when the earliest larks are rising. . . .

Roenneberg believes his finding could help explain why most people who take up smoking begin as teenagers. Previous studies have shown that teenagers' chronotypes creep later until early adulthood before receding again, leaving them among the most likely to live beyond their chronotype's means.

                                                    

However, there may be a solution. Roenneberg suggests making school and work schedules flexible, as well as using bright light in the mornings to help the body adapt to unnatural routines. While such changes might be difficult, they could well save lives, as social jet lag may account for a large chunk of the smoking population, he says.

Well, I think I better go get some more sleep because I don't want to start an expensive and deadly habit . .  .[bm]

New Study Casts Doubt on Healing Power of Prayer

Today's NY Times reports that the American Heart Journal has released an article on its web site that will appear next week that questions whether intercessionary prayer has any healing effects.  Indeed, the article suggests that patients who know they are being prayed for have a higher rate of complications, perhaps because their expectations are higher as a result of that knowledge. This may be the largest study yet to look at the question.

The focus of the study was prayer offered by strangers without the knowledge of the patient.  The paper doesn't express an opinion about the power of prayer by patients themselves or by close family members.  [tm]

Brian Leiter on the Latest US News Rankings

Well, that didn't take long - Brian Leiter at Brian Leiter's Law School Reports has a critique of the latest US News rankings of law schools.  After reviewing the current set of rankings, he states,

Not a crazy set of results, but if we assume reasonably enough that "academic reputation" ought to track the quality of faculty and students, then some schools (UC Davis, Washington & Lee, Duke, Michigan, perhaps North Carolina, perhaps Northwestern) are too high, while others (UC Hastings, Illinois, NYU, BU) are too low, relative to the actual academic merits.  (Addendum:  It should go without saying, I hope, that these are my judgments about the relative merits only:  e.g., Michigan is "too high" in the sense that NYU is now clearly better; and so on.  Michigan can obviously have an outstanding faculty, which it does (and even before adding Laycock, Radin, et al.!), without it being sensible to rate Michigan on a par with NYU.  The same point applies to the other instances mentioned.)

He has some other thoughts as well that you can review here.  Thanks for Paul Caron for the cite.  [bm]

Health Care Quality Improvement

Over at the Health Care Blog, Matthew Holt reviews a recent article by Brian Smedley, entitled, "Sliding Down the Back Side of the Health Care Quality Curve: Who's at Greatest Risk?"  He discusses the rather mediocre medical care provided to all citizens in the United States and also addresses the racial and gender disparities in the quality of care.  It is a great read and interesting points about what choices need to be made to ensure a better quality health care for all.  [bm]

Avian Flu - NYTimes Science Section

For all the latest on the Avian Flu - the always excellent Science section of the New York Times contains many interesting and informative articles about the potential for a pandemic:  potentially yes here, and potentially no here; some of the latest testing, here; the impact on a variety of birds.  [bm]

US News Rankings - An Early Peek

I know that these are not supposed to be important but it is always interesting to see where your school falls each year.  So, here is an advanced look at the US News Rankings - thanks to Paul Caron at TaxProfBlog.  I hope that you find them interesting . . .

[bm]

Schiavo Books Released

Both Michael Schiavo, Terri's husband, and the Schindler's, Terri's parents, have both released books on the anniversary of her death.   Unfortunately for both sides, the bitter feud does not seem to have been resvolved.   For more information, ABC news has a brief story, which states,

Schiavo's book, "Terri: The Truth," is being released today, one day before Bob and Mary Schindler's "A Life That Matters" hits stores.

In his book, Schiavo admits he's settling some scores. He unloaded his feelings Sunday on NBC's "Dateline" in his first interview since his wife died. Among his accusations is that Terri's family, including her father, demanded the money from a malpractice award.

"First, he asked when the money was coming down, and then he asked me, 'How much money am I going to get?''' Schiavo told "Dateline."

"I said. … 'I'm giving it all to Terri.' Then with some anger in his voice, he pointed at Terri and said, 'Well, how much is she going to give me?' She's not going to give you anything. That money is entrusted with a guardian."

On "Good Morning America," the Schindlers admitted there was a disagreement over money. They said it was because they wanted the money from the malpractice suit to go to Terri's rehabilitation and Schiavo spent it on legal fees.

"The money Michael promised for Terri's therapy and rehabilitation. … Instead it went to Michael's attorney to have Terri killed," said Bobby Schindler, Terri's brother.

An ABC poll shows that 64% of Americans agree with Michael Schiavo's decision to remove the feeding tube (However, it is unclear to me how this question was asked - if people were saying that they believed the husband when he said that this was Terri's wish or whether they felt it was appropriate for him to make the decision for her).  [bm]

Single Payer - When?

The Washington Monthly has a post concerning some recent data released by Steven Benen discussing public support for a single payer health care in the United States.  He states,

I'm convinced Americans would embrace the idea if it were on the policy table. Consider the polling data:

Many adults in the United States believe their federal administration is not doing enough to help them with the cost of medical services, according to a poll by Princeton Survey Research Associates for the Pew Research Center for the People and the Press. 70 per cent of respondents think the government spends too little on health care.

Asked if they thought the government spends too much, too little or the right amount on health care, it wasn't even close — 70% of poll respondents said the government spends too little. Asked if they thought the average American spends too much, too little or the right amount on health care, the results were nearly identical — 65% said people spend too much.

[bm]

Post-Schiavo Symposium

It's been like Grand Central Station keeping up with journal articles recently.  Here's the latest: a symposium issue of the Loyola University Chicago Law Journal on "The Law of Death and Dying" (37 Loy. U. Chi. L.J. 279-454 (2006):

Colby, William H. From Quinlan to Cruzan to Schiavo: what have we learned? 37 Loy. U. Chi. L.J. 279-296 (2006). [L][W]

Shepherd, Lois. Terri Schiavo: unsettling the settled. 37 Loy. U. Chi. L.J. 297-341 (2006). [L][W]

Cerminara, Kathy L. Critical essay: musings on the need to convince some people with disabilities that end-of-life decision-making advocates are not out to get them. 37 Loy. U. Chi. L.J. 343-384 (2006). [L][W]

Clark, Annette E. The right to die: the broken road from Quinlan to Schiavo. 37 Loy. U. Chi. L.J. 385-405 (2006). [L][W]

Cantor, Norman L. On hastening death without violating legal and moral prohibitions. 37 Loy. U. Chi. L.J. 407-431 (2006). [L][W]

Bentley, Philip J., DD. The shattered vessel: the dying person in Jewish land ethics. 37 Loy. U. Chi. L.J. 433-454 (2006). [L][W]

The [L] and [W] links are to Lexis and Westlaw (paid subscriptions required), all courtesy of the Marian Gould Gallagher Law Library at the University of Washington. [tm]

Latest Health Law Downloads from SSRN

Yesterday, I posted links and abstracts for the papers that have been posted to the SSRN Public Health Law and Policy web page in March (so far).  Today, it's the same exercise, this time for papers on the SSRN Health Law web page.  Links are to abstract pages, from which it is easy to get to the full paper (if one is available).

• Justice O'Connor and the "Right to Die": Constitutional Promises Unfulfilled
  14 William & Mary Bill of Rights Journal, Vol. 14, No. 000, pp. 1-22, 2006
  Michael Patrick Allen
  Stetson University - College of Law

Abstract:     
After nearly twenty-five years on the bench, Justice Sandra Day O’Connor left the Supreme Court at the end of January 2006. There has been much discussion of Justice O’Connor’s decisions in areas such as federalism, the First Amendment’s Establishment Clause, and affirmative action, among other topics. But very little has been written about her important role in the development of federal constitutional law concerning the “right to die.”

This Essay seeks to fill this gap in the literature by exploring Justice O’Connor’s important concurring opinions in Cruzan and Glucksberg. I argue that these opinions created constitutional promises of a sort that remain unfulfilled as Justice O’Connor retires. I also explain why this need not have been the case while highlighting the real world consequences of the failure to live up to the promises.

Date Posted:March 26, 2006
Last Revised:March 26, 2006
Accepted Paper Series

• Causing Death for Compassionate Reasons in American Law
  American Journal of Comparative Law (Supplement), Vol. 53, 2006
  Richard S. Kay
  University of Connecticut School of Law

Abstract:     
This essay, a revised version of the United States report on "Euthanasia" to be presented at the XVII International Congress of Comparative Law, surveys the state of the law, both decisional and statutory, on the permissibility of compassionately motivated actions to terminate human life. It deals with a range of legal categories, suicide, attempted suicide, euthanasia, assisted suicide and the termination of life-sustaining treatment. It highlights the deeply ambivalent attitudes held toward these actions in contemporary America and how this ambivalence has resulted in obscure and artificial distinctions.

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

• The Three Faces of Retainer Care: Crafting a Tailored Regulatory Response
  Frank A. Pasquale
  Seton Hall University - School of Law

Abstract:     
Retainer care arrangements allow patients to pay a fee directly to a physician’s office in order to obtain special access to care. Practices usually convert to retainer status by concentrating their attention on a small panel and dropping the majority of their patients. Proponents call retainer care a triumph of consumer-directed health care; opponents deride it as “boutique medicine.” Both sides are deploying a variety of legal tactics in order to attain their goals.

After surveying these conflicts, this article clarifies what is at stake by analyzing the three key features of retainer care: preventive care, queue-jumping, and amenity-bundling. Most commendably, retainer physicians are aggressively counseling their patients on how to avoid getting ill. More questionably, they are trading faster access to better health care for cash. Most troublingly, they are bundling medical care with unrelated amenity services.

Each of these "faces" of concierge care deserves a different legal response. This article develops a normative framework for tailored intervention. Regulators have taken some promising steps toward mitigating the worst aspects of retainer care conversions. However, taxation may be the only approach sufficiently targeted to reduce incentives for queue-jumping and amenity-bundling while promoting innovation in preventive care.

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

• Behavioral Economics, Neurophysiology, Addiction and the Law
  Michael L. Corrado
  University of North Carolina at Chapel Hill - School of Law

Abstract:     
Has science anything to tell us about responsibility? Addiction is a particularly interesting test case. Two fields of science, behavioral economics and neurophysiology have lately given us a great deal of information about addiction, much of which may be useful to the law. When it comes to addiction, unfortunately, the two fields seem to point in opposite directions.

Economics has provided us with models of addictive behavior based upon the supposition that addiction is the result of choice, a development that appears to support the conclusion that addictive behavior is not the product of “non-volitional forces.” If addictive behavior can be fully accounted for in terms of the addict’s choices, and if there is no need to postulate the existence of forces overwhelming the addict’s will, is there any reason not to hold the addict fully responsible for what he does?

Neurophysiology, on the other hand, has demonstrated that substance abuse causes significant changes in brain physiology, which appears to support the conclusion that addiction is a disease. If addiction corresponds to physical changes in the nervous system, then addiction is a disease, and addictive behavior is merely a symptom of the disease. We may be responsible for contracting a disease, but can we be held responsible for the symptoms once we have it?

Science does have a good many things to tell us about addiction, but so far whether or not the addict is responsible for what he does is not among them. The fact that choice theories–rational addiction, behavioral economics–can develop models in which addiction is the result of choice should not surprise us: Did anyone ever believe that addicts did not intend to do what they were doing? Did anyone ever believe that addicts did not choose to do what they did? The question has always been whether those choices were free, and whether the addict was fully in control of his choices. That is the question that the law must deal with, and in this paper I argue that choice theories have nothing to say to that question. Neurophysiology, on the other hand, has made remarkable strides in tracing down the effects of heavy drug use on the brain. But that behavior should effect brain changes is not by itself remarkable, and does not entail that behavior is not fully voluntary.

There are three possible conclusions. The first is that although science has yielded no results so far, we may hope for results in the future. The general nature of the arguments against drawing conclusions about responsibility from the existing literature makes that, if not entirely a vain hope, at least implausible. The second is that responsibility is simply one of the areas of human experience that is cut off from science; there must, therefore, be other ways of knowing what we do about addiction, control, and responsibility. And the third conclusion may be the most pessimistic of all, namely that responsibility itself is a confused notion, and that we should be skeptical about its role in the law.

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

• Fixing Medical Torts by Repositioning Inalienability and Contract
  Alex Stein
  Cardozo Law School

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

• Marketing, Product Differentiation and Competition in the Market for Antiulcer Drugs
  Charles King III
  Greylock McKinnon Associates

Abstract:     
This paper investigates one of the largest pharmaceutical markets using a discrete choice model that allows marketing to affect product differentiation. Four main results emerge from an analysis of monthly panel data on antiulcer drugs from 1977 to 1993. Observed drug characteristics became less important relative to marketing in determining demand. Total marketing by all firms reduced product differentiation and raised the cost of entry significantly. Although increasingly rivalrous, marketing expanded the market, increasing social welfare. Finally, estimated returns to eliminating one adverse drug interaction in the pioneer drug approximately equal its first two years of sales.

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

• The Children of Science: Property, People, or Something in Between
  Star Lopez
  University of California, Los Angeles - School of Law

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

• To Err is Human: ART Mix-ups - A Labor-Based, Relational Proposal
  Iowa Journal of Race, Gender & Justice, Forthcoming
  Leslie Bender
  Syracuse University - College of Law

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

• Explorations of the Effect of Experience on Preferences: Two Health-Care Case Studies
  Einat Neuman and Shoshana Neuman
  Academic College of Tel-Aviv Yafo and Bar Ilan University - Department of Economics

Abstract:     
The standard assumption in economic theory is that preferences are stable. In particular, they are not changed as a result of experience with the good/service/event. Behavioral scientists have challenged this assumption and claimed (providing evidence) that preferences are constantly changing when experience is accumulated. This paper tests the effect of experience on preferences for attributes of health-care events. We are using two very different samples and a methodology that facilitates the estimation of marginal utilities of various attributes of a composite non-traded health-care service. Discrete Choice Experimental design is employed for the analysis of samples of (1) women who gave birth, and (2) women who were diagnosed with breast cancer. For each group we had information on experience. In the case of women who gave birth, the sample was decomposed into 3 sub-samples: pregnant women with their first child (no experience); women after one delivery (single experience); and mothers after more than one delivery (multiple experience). Preferences of the 3 sub-groups have then been compared. The breast cancer patients reported the number of chemotherapy/radiation treatments they have already received, thus enabling the construction of an experience variable and testing for the effect of experience on preferences. The basic finding is that preferences for health-care attributes are significantly changed as a result of experience with the health event. However, the amount of experience is irrelevant.

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

• Medical Negligence Lawsuits in Oklahoma: An Empirical Study
  Oklahoma City University Law Review, Vol. 31, No. 1, 2006
  Chris D. Jones
  Oklahoma City University - School of Law

Abstract:     
This empirical study focuses on medical negligence lawsuits filed in Oklahoma, addressing the following question. Do the number of medical negligence cases filed and the amount of subsequent lawsuit payouts indicate a need for tort reform in Oklahoma? First, the backdrop leading to the enactment of tort reform is set, followed by a presentation of a portion of Oklahoma's 2004 public hearings testimony regarding tort reform. Next, the availability of empirical data for Oklahoma is addressed. The results of the Oklahoma empirical study is provided, followed by a presentation of statistics regarding medical negligence payouts. Finally, the conclusions drawn from this empirical study are set forth, including the conclusion that Oklahoma should adopt a state-wide system whereby statistics regarding case filings are maintained.

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

• The Generic Biologics Debate: Industry's Unintended Admission that Biotech Patents Fail Enablement
  Gregory N. Mandel
  Albany Law School

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

• What We Know About Malpractice Settlements
  Philip G. Peters Jr.
  University of Missouri Law School

Abstract:     
The enclosed Article is the first comprehensive synthesis of two decades of empirical research on medical malpractice settlement. The portrait that emerges from this synthesis is both more reassuring and more complex than popular portrayals. Although the fit is not perfect, the merits generally drive the settlement process. Weak claims consistently fare the worst, toss-ups cases do better, and strong cases have the most success.

Prior scholarship on malpractice outcomes has understated the strength of this correlation because it has focused principally on the impact of negligence on the settlement rates and has largely ignored the importance of settlement amount. The studies examining the relationship between settlement rate and case quality have invited mixed reactions because they have found a correlation that, while strong, leaves room for improvement. In 10-20 percent of the weakest cases, the plaintiff receives a settlement payment. In a similar fraction of the strongest cases, the plaintiff recovers nothing.

Yet, settlement rates, standing alone, paint a misleading picture. Equally important is the relationship between the strength of the plaintiff’s case and the size of the payment received in settlement. As long as the payments received by the plaintiffs in weak and toss-up cases are appropriately discounted to reflect case quality, then settlement of the case is fully consistent with fair treatment of the defendant. For that reason, settlement rate data inherently overstates the prevalence of “error.” Settlement size must be considered as well.

In malpractice litigation, the amount paid to settle a case is routinely adjusted to match the strength of the plaintiff’s case. Although only a few studies have collected this data, they show that payments in weak and toss-up cases are heavily discounted. In fact, the data on settlement size suggest that defendants are able to extract an even deeper discount than is warranted by the merits. The ability of insurance companies to extract this discount suggests that malpractice defendants enjoy a systematic advantage in bargaining power. Although the source of this asymmetry has yet to be determined, the studies justify several interesting hypotheses.

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

• Surrounding Embryos: Biology, Ideology, and Politics
  Health Matrix, Vol. 16, No. 27, 2006
  Janet L. Dolgin
  Hofstra University - School of Law

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

• 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
2 downloads

• Estimating the Out-of-Hospital Mortality Rate Using Patient Discharge Data
  Geert Ridder and Mehdi Farsi
  University of Southern California and Eidgenossische Technische Hochschule Zurich (ETHZ) - Department of Management, Technonlogy and Economics (D-MTEC)

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

• Obstetric Fistula: The Challenge to Human Rights
  International Journal of Gynecology and Obstetrics, Vol. 87, pp. 72-77, 2004
  Rebecca J. Cook and Bernard Dickens
  University of Toronto - Faculty of Law and University of Toronto - Faculty of Law

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.

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

• Kidney Exchange with Good Samaritan Donors: A Characterization
  Tayfun Sonmez and M. Utku Unver
  Boston College - Department of Economics and University of Pittsburgh - Department of Economics

Abstract:     
We analyze mechanisms to kidney exchange with good samaritan donors where exchange is feasible not only among donor-patient pairs but also among such pairs and non-directed alturistic donors. We show that you request my donor-I get your turn mechanism (Abdulkadiroglu and Sonmez [1999]) is the only mechanism that is Pareto efficient, individually rational, strategy-proof, weakly neutral and consistent.

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

• Preparing the Groundwork for a Responsible Debate on Stem Cell Research and Human Cloning
  New England Law Review, Vol. 39, No. 701, pp. 479-488, 2005
  O. Carter Snead
  Notre Dame Law School

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 9, 2006
Accepted Paper Series
14 downloads

• The Pedagogical Significance of the Bush Stem Cell Policy: A Window into Bioethical Regulation in the U.S.
  Yale Journal of Health Policy, Law, and Ethics, Vol. 5, pp. 491-504, 2005
  O. Carter Snead
  Notre Dame Law School

Abstract:     
The enormous significance of the Bush stem cell funding policy has been evident since its inception. The announcement of the policy on August 9, 2001 marked the first time a U.S. president had ever taken up a matter of bioethical import as the sole subject of a major national policy address. Indeed, the August 9th speech was the President's first nationally televised policy address of any kind. Since then, the policy has been a constant focus of attention and discussion by political commentators, the print and broadcast media, advocacy organizations, scientists, elected officials, and candidates for all levels of office (including especially the 2004 Democratic nominee for President, Senator John Kerry, who made his opposition to the Bush policy a centerpiece of his domestic campaign, mentioning it explicitly in his acceptance speech at the Democratic National Convention). The biotechnology industry has taken a keen interest in stem cell research as a possible avenue for medical therapies; one study suggests that as of 2002 private sector companies had spent an aggregate of $208 million on research and development of stem cell technologies. In response to the policy, there has been a flurry of state legislation proposed and enacted, with some states affirming and others condemning the Administration's approach. Finally, the great prominence of the national and international debate on human cloning has drawn further attention to the issue of embryonic stem cell research (and by extension, the Bush policy), given that one application of somatic cell nuclear transfer is the production of cloned human embryos from which stem cells may be derived (so-called Therapeutic Cloning).

To date, the significance of the Bush stem cell policy has been framed and publicly debated in terms of its practical import: Does it impede the scientific and medical progress that the research seems to promise? Is it adequately protective and respectful of embryonic human life? Aside from its great practical significance, however, the Bush policy is arguably one of the most important recent legal developments for the field of bioethics for an additional reason: its deep pedagogical significance. The Bush policy provides an unparalleled window into the nature and substance of bioethical regulation within the unique framework of the American system of government. And it does so in dramatic fashion, against the backdrop of some of the most enduring and vexing questions in all of bioethics: What is owed to developing human life, and how does this obligation stand in relation to the aim of science to advance knowledge with the ultimate aspiration of alleviating human suffering? Reflecting on the nature and scope of the policy yields insights into a number of crucial matters that are central to the problem of whether and how to govern science and medicine according to bioethical principles. This Essay will briefly explore five areas in which the Bush policy is thus instructive: (1) the conceptual understanding of regulation as a legal category; (2) the principles of federalism; (3) the significance of federal funding; (4) the nature of governance according to a particular type of moral principle (e.g., bright line); and (5) the influence of political prudence and respect for pluralism.

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

• International Human Rights and Comparative Mental Disability Law: The Role of Institutional Psychiatry in the Suppression of Political Dissent
  Michael L. Perlin
  New York Law School

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

• The Puzzle of IVF
  Dena S. Davis
  Cleveland State University - Cleveland-Marshall College of Law

Abstract:     
This essay seeks to address a puzzling element of the current political and legal struggles over abortion in the United States: if, as pro-life activists insist, embryos are morally equivalent to born, living persons, then why do these activists not oppose in vitro fertilization (IVF) as aggressively as they oppose abortion? IVF accounts for a significant number of destroyed embryos. Constitutionally, IVF appears to be a much more vulnerable target than abortion. And yet, legislative and political attempts to attack and restrict IVF are few, while attempts to erode women's capability to terminate pregnancies are a constant feature of our political and legal landscape.

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

• Dynamic Complementarity: Terri's Law and Separation of Powers Principles in the End-of-Life Context
  Notre Dame Legal Studies Paper No. 06-04
  O. Carter Snead
  Notre Dame Law School

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
10 downloads

• The (Surprising) Truth about Schiavo: A Defeat for the Cause of Autonomy
  Constitutional Commentary, 2006
  O. Carter Snead
  Notre Dame Law School

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
14 downloads

• Therapeutic Forgetting: The Legal and Ethical Implications of Memory Dampening
  Adam J. Kolber
  University of San Diego School of Law

Abstract:     
Neuroscientists have made surprising advances in identifying drugs to dampen the emotional intensity of traumatic memories. Such drugs hold promise for those plagued by painful memories of terrorism, military conflict, assault, car accidents, and natural disasters. Yet some ethicists, including members of the President's Council on Bioethics, claim that memory-dampening drugs may lead us to forget people and events that we are obligated to remember. They also fear that such drugs will reduce the value of eyewitness testimony and help criminals hide their tracks.

After describing the legal and ethical implications of memory dampening, I argue that the Council is unnecessarily alarmed. While memory is an essential component of personal identity and we do sometimes have obligations to remember, the Council's concerns are founded on controversial premises that unjustifiably privilege our natural cognitive abilities. Furthermore, while perhaps we ought sometimes restrict memory dampening, a general prohibition would be unjustified: We have a deeply personal interest in controlling our own minds that entitles us to a certain freedom of memory.

Date Posted:March 2, 2006
Last Revised:March 16, 2006
Working Paper Series
87 downloads

• An Institutional Sociology Perspective of the Implementation of Activity Based Costing by Spanish Health Care Institutions
  Ignacio Urrutia
  IESE Business School - University of Navarra

Abstract:     
According to institutional sociology, hospitals will respond to external environmental pressures and adopt Activity-Based-Costing (ABC). This theory overemphasizes conformity and fails to consider the advantages of organizational non-conformance. A conflict of interests between physicians and management leads to physician resistance to accepting ABC. This paper investigates the Spanish government's response to this resistance by creating new public foundation hospitals, and involves a case study of the Alcorcón foundation hospital. Population ecology is offered as an explanation for the emergence of new entities as a result of inert existing entities' resistance to reform.

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

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Elder Care Benefits

The New York Times ran an informative piece on the increasing number of employees (mostly women) who are struggling to keep their jobs and care for aging relatives.  The article notes the fact that most employers do not have policies that provide leave or other services to help an employee care for elderly family members and that childcare policies are not a good fit for these employees.  It states,

According to the Society for Human Resource Management, which represents more than 200,000 human resource and other corporate officials, 39 percent of its members said in 2003 that elder care benefits were "too costly to be feasible." Only 1 percent of their companies subsidized any elder care benefits last year. And only 3 percent offered the emergency backup care — subsidized or otherwise — that experts say saves money by keeping workers at work. . . .

"These benefits fall under the same umbrella but are fundamentally different," Mr. Gatti said. "Child care programs are relatively straight-forward and easy to administer compared to elder care, which is a maze with lots of sharp corners and dark secluded places."

The distinctions between child care and elder care have become apparent as the first of the 77 million baby boomers turn 60 and their parents live past 85, joining the fastest-growing segment of the population.

The most obvious is that children's schedules are predictable — a school holiday next Monday — while elderly parents' needs — a trip to the emergency room — are crisis-driven. Also, children are raised at home; an elderly parent often lives far away.

Guiding the decisions of an elderly parent also requires mastery of arcane legal, financial and medical matters.

It is an interesting piece and provides insight into an issue that will require action on someone's part to make it possible for employees to continue working while dealing with a host of issues that arise when family members require greater attention as they age.  [bm]

Maybe It Really Is 'The Other White Meat'

From the AP (MyWay):

Geneticists have mixed DNA from the roundworm C. elegans and pigs to produce swine with significant amounts of omega-3 fatty acids - the kind believed to stave off heart disease.

Researchers hope they can improve the technique in pork and do the same in chickens and cows. In the process, they also want to better understand human disease.

"We all can use more omega-3 in our diet," said Dr. Jing Kang, the Harvard Medical School researcher who discovered the omega-3-making gene in the worm.

Kang is one of 17 authors of the paper appearing Sunday in an online edition of the journal Nature Biotechnology.

The cloned, genetically engineered pigs are the latest advance in the agricultural biotechnology field, which is struggling to move beyond esoteric products such as bug-repelling corn and soy resistant to weed killers.

The day will yet come, mark my words (and remember Woody Allen's brilliant 1973 film, "Sleeper"), when we'll be adding a side order of bacon or sausage to our breakfasts for the heart-healthy benefits. [tm]

Medical Marijuana Issue Back Before the Ninth Circuit

As reported by the AP (Yahoo), the Raich case is going to be argued in the 9th Circuit on Monday, this time to urge the narrower "right to life theory: that marijuana should be allowed if it is the only viable option to keep a patient alive or free of excruciating pain":

It would apply only to the sickest patients and their suppliers, regardless of whether they live in one of the 11 mostly Western states that allow medical marijuana.

"A victory would affect people who are very seriously ill, facing death or great physical suffering," said Randy Barnett, a Boston University law school professor working on the case.

The case was brought by Angel Raich, a 40-year-old mother of two from Oakland who suffers from scoliosis, a brain tumor, chronic nausea and other ailments. She uses marijuana every couple of hours to ease her pain and bolster her appetite.

"She'd probably be dead without marijuana," said her doctor, Frank Lucido, who has recommended marijuana for some 3,000 patients. "Nothing else works."

The DOJ lawyers deny there is a "fundamental right to distribute, cultivate or possess marijuana." The Supreme Court upheld the constitutionality of the Controlled Substances Act, as applied to state medical marijuana laws, in 2005 in Gonzales v. Raich. [tm]

AHLA "Health Lawyers Weekly"

The March 24 issue of Health Lawyers Weekly is now available on the AHLA website.  It's a "free" member benefit and, week in an week out, it's one of the best reasons I can think of to be a member of the American Health Lawyers Association.  Here's this week's table of contents:

• Top Stories
  • DHHS Computer System Weaknesses Leave Medical Data Vulnerable, GAO Finds -- Department of Health and Human Services (DHHS) computer networks have significant weaknesses, which increases the risk of unauthorized access to medical data, the Government Accountability Office (GAO) found in a recent report. The report, “Information Security: Department of Health and Human Services Needs to Fully Implement Its Program,” (GAO-06-267), was issued in response to a request by Senate Finance Committee Chairman Charles Grassley (R-IA).
  • OIG Says CMS Needs To Improve Performance Evaluations Of Medicare Contractors Used To Fight Fraud  -- The Centers for Medicare and Medicaid Services (CMS) needs to do a better job of evaluating the performance of the contractors it uses to detect and deter fraud in the Medicare program, the Department of Health and Human Services Office of Inspector General (OIG) found in a recent report. CMS’ contractor performance evaluation reports were missing key information about the results achieved by these contractors in detecting fraud and abuse, making it difficult to determine whether to renew their contracts, the OIG noted.
• Articles & Analyses
  • Annual Increase In Hart-Scott-Rodino Thresholds -- By Alan D. Rutenberg, Partner, Foley & Lardner LLP
  • HIPAA Security Rule Compliance for Small Group Health Plans: A Step-By-Step Guide -- By Wendy Bunnell, Halleland Lewis Nilan & Johnson, PA
• Current Topics
  • Antitrust
    • New Jersey Appeals Court Upholds Approval Of United Healthcare’s Acquisition Of Oxford Health Plans 
  • Employment and Labor
    • U.S. Court In Nevada Allows Nurse’s Claim Of Retaliation For Reporting Sexual Harassment To Go Forward 
    • Oregon Appeals Court Holds Physician Cannot Establish Wrongful Discharge Claim Without Identifying Public Duty Or Employment-Related Right 
  • Fraud and Abuse
    • Eighth Circuit Affirms Dismissal Of FCA Complaint For Lack Of Specificity
    • Update 
      • OIG Deputy Chief Counsel Highlights Fraud And Abuse Issues For Hospitals, Physicians At AHLA Program 
      • Grassley Asks DOJ And DHHS To Prevent States From Enacting Legislation That Undermines FCA Whistleblowers 
  • Healthcare Spending
    • Deficit Reduction Act Is Invalid, Lawsuit Alleges 
    • Senate Clears FY 2007 Budget Resolution 
  • HIPAA
    • Ohio Supreme Court Finds HIPAA Does Not Protect Records Required To Be Disclosed Under State Law 
  • Insurance
    • U.S. Court In Mississippi Finds Material Issues Remain Regarding Amount Of Subrogation Due Health Plan 
  • Medicaid
    • Study Examines States’ Use Of Clinical Evidence To Curb Medicaid Drug Costs 
      Medical Malpractice
    • California Appeals Court Holds Physician Was Acting As “Good Samaritan” And Therefore Immune From Suit 
  • Medicare
    • Schwarzenegger Requests Government Extend State Reimbursement For Emergency Drug Program 
    • Short Stay Outlier Policy For LTCHs Proposed By CMS Too Severe, MedPAC Says 
    • U.S. Court In Virginia Upholds DHHS Secretary’s Decision To Deny Additional Medicare Reimbursement Sought By Ambulance Service 
    • Medicare To Automatically Enroll About 1 Million Low-Income Beneficiaries In Part D 
    • Medicare Part D Enrollment Rises To 27 Million, DHHS Reports 
    • Revised Data Results In Lower State Clawback Payments, Report Says 
  • News in Brief
    • HealthGrades Provides Price-Comparison Website For Certain Hospital Procedures 
    • Medicare To Cover Additional Diagnostic Test For Patients With Cardiac Condition 
    • Wisconsin Governor Signs Medical Malpractice Damages Cap Legislation Into Law 
    • CMS Announces Expanded Opportunity For Physicians To Participate In Pay-For-Performance 
  • Physicians
    • Utah Supreme Court Holds Physician Cannot Claim Privilege For Patient Medical Records Subpoenaed By State In Fraud Investigation 
    • Kansas Supreme Court Finds Medical Board Did Not Err In Revoking Physician’s License In Absence Of Actual Patient Injury 
    • Percentage Of U.S. Physicians Providing Charity Care Continues To Decline
  • Quality of Care
    • DHHS Proposes Expanding Scope Of National Practitioner Data Bank 

© American Health Lawyers Association. Reprinted with permission.

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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.

• From Security to Health
  Scott Burris
  Temple University Beasley School of Law

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

• Fixing Medical Torts by Repositioning Inalienability and Contract
  Alex Stein
  Cardozo Law School

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

• The Biological Standard of Living in 19th century Mexico and in the American West
  Economics and Human Biology, Vol. 3, No. 3, pp. 405-419, 2005
  Scott Alan Carson

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

• The Children of Science: Property, People, or Something in Between
  Star Lopez
  University of California, Los Angeles - School of Law

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

• To Err is Human: ART Mix-ups - A Labor-Based, Relational Proposal
  Iowa Journal of Race, Gender & Justice, Forthcoming
  Leslie Bender
  Syracuse University - College of Law

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

• Why Evolutionary Biology is (so far) Irrelevant to Law
  Brian Leiter and Michael Weisberg
  University of Texas at Austin - School of Law & Department of Philosophy and University of Pennsylvania

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

• Perception of the Risks Associated with Impaired Driving and Effects on Driving Behavior
  Georges Dionne , Claude Fluet and Denise Desjardins
  HEC Montreal - Department of Finance , University of Quebec at Montreal - Department of Economics and University of Montreal - Center for Research on Transportation

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

• Taming of the Flu: Working Through the Tamiflu Patients in India
  Journal of Intellectual Property Rights, Vol. 2, p. 113, March 2006
  Shamnad M. Basheer and Tahir Amin
  University of Oxford - Oxford Intellectual Property Research Centre (OIPRC) and Supreme Court of England and Wales

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

• The Generic Biologics Debate: Industry's Unintended Admission that Biotech Patents Fail Enablement
  Gregory N. Mandel
  Albany Law School

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

• Surrounding Embryos: Biology, Ideology, and Politics
  Health Matrix, Vol. 16, No. 27, 2006
  Janet L. Dolgin
  Hofstra University - School of Law

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

• The Role of Science in Risk Regulation under the SPS Agreement
  Lukasz Gruszczynski
  European University Institute Law Department

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

• Sickle Cell Anaemia and Deaths in Custody in the UK and the USA
  Howard Journal of Criminal Justice, Vol. 45, No. 1, pp. 14-28, February 2006
  Simon M. Dyson and Gwyneth Boswell
  De Montfort University - School of Allied Health Sciences and De Montfort University - Community and Criminal Justice Studies Unit

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

• Estimating the Out-of-Hospital Mortality Rate Using Patient Discharge Data
  Geert Ridder and Mehdi Farsi
  University of Southern California and Eidgenossische Technische Hochschule Zurich (ETHZ) - Department of Management, Technonlogy and Economics (D-MTEC)

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

• Obstetric Fistula: The Challenge to Human Rights
  International Journal of Gynecology and Obstetrics, Vol. 87, pp. 72-77, 2004
  Rebecca J. Cook and Bernard Dickens

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

• The Hierarchical Consequences of Reinvention
  Andrew B. Whitford
  University of Georgia - Department of Public Administration and Policy

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

• Preparing the Groundwork for a Responsible Debate on Stem Cell Research and Human Cloning
  New England Law Review, Vol. 39, No. 701, pp. 479-488, 2005
  O. Carter Snead
  Notre Dame Law School

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

• The Pedagogical Significance of the Bush Stem Cell Policy: A Window into Bioethical Regulation in the U.S.
  Yale Journal of Health Policy, Law, and Ethics, Vol. 5, pp. 491-504, 2005
  O. Carter Snead
  Notre Dame Law School

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

• International Human Rights and Comparative Mental Disability Law: The Role of Institutional Psychiatry in the Suppression of Political Dissent
  Michael L. Perlin
  New York Law School

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

• Reduce, Refine, Replace: The Failure of the Three R's and the Future of Animal Experimentation
  University of Chicago Legal Forum, 2006
  Darian M. Ibrahim
  University of Arizona - James E. Rogers College of Law

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

• Artful Prior Art and the Quality of DNA Patents
  Alabama Law Review, Vol. 57, 2006
  Andrew Chin
  University of North Carolina School of Law

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

• Dynamic Complementarity: Terri's Law and Separation of Powers Principles in the End-of-Life Context
  Notre Dame Legal Studies Paper No. 06-04
  O. Carter Snead
  Notre Dame Law School

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

• International Human Rights Treaties and the Rights of Female Refugees and Asylum Seekers
  HUMAN RIGHTS AND REFUGEES, INTERNALLY DISPLACED PERSONS, AND MIGRANT WORKERS, Anne Bayefsky, ed., Martinus Nijhoff, 2006
  Stephanie Farrior
  Pennsylvania State University, Dickinson School of Law

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

• Labor Market Estimates of the Senior Discount for the Value of Statistical Life
  W. Kip Viscusi and Joseph E. Aldy
  Harvard University - Harvard Law School and Resources for the Future

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

• The (Surprising) Truth about Schiavo: A Defeat for the Cause of Autonomy
  Constitutional Commentary, 2006
  O. Carter Snead
  Notre Dame Law School

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]

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]

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]

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]