Health Law and Policy Commons^™

Pharma On The Hot Seat, Nicole Huberfeld

Faculty Scholarship

The pharmaceutical industry has been receiving greater scrutiny lately due in large part to the many public and private legal enforcement actions taken against pharmaceutical manufacturers. These enforcement actions, along with legal developments such as the OIG Compliance Guidance for Pharmaceutical Manufacturers, the Sarbanes-Oxley Act’s statutory guidelines for public corporations, the HIPAA privacy regulations, and the Medicare Modernization Act, have the potential to encourage the pharmaceutical industry to self-regulate beyond the bounds currently required by the law. After a brief overview of enforcement actions and compliance programs directed toward the pharmaceutical industry, this Article reviews a similar situation the hospital …

Consolidating Pharmaceutical Regulation Down Under: Policy Options And Practical Realities, Frances H. Miller

Faculty Scholarship

Pharmaceutical regulatory agencies struggle worldwide to maintain public trust these days. Drug safety issues proliferate,' the costs of lharmaceuticals take increasingly larger shares of most countries' health service spending, and conflicts of interest afflicting the drug approval and marketing processes capture more and more public attention. The Australian and New Zealand governments are keenly aware of these problems, and have been attempting to forge a regulatory alliance to combine their respective pharmaceutical regulatory agencies, Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medicines and Medical Devices Safety Authority (Medsafe), into the pending Trans Tasman Therapeutic Products Authority (ANZTPA, or TPA). …

Foreword: Globe-Hopping Pharmaceuticals, Frances H. Miller

Faculty Scholarship

No abstract provided.

Bioterror And “Bioart”: A Plague O' Both Your Houses, George J. Annas

Faculty Scholarship

Since September 11, 2001, the threat of bioterrorism has caused Congress and the President to dramatically increase research funding for countermeasures, including funding for new biosecurity laboratories. The new kind of war against non-state actors who use terror to intimidate populations has also made the creation of new ethical and legal rules for researchers seem critical. New laws have been passed, and there have been proposals for new codes of ethics for bioterrorism-related research. Almost five years after September 11, however, the outcome of the development of new research rules remains uncertain.

Intelligent Judging: Evolution In The Classroom And The Courtroom, George J. Annas

Faculty Scholarship

Religious arguments have permeated debates on the role of the law in medical practice at the beginning and the end of life. But nowhere has religion played so prominent a role as in the century-old quest to banish or marginalize the teaching of evolution in science classes. Nor has new genetics research that supports evolutionary theory at the molecular level dampened antievolution sentiment. Requiring public-school science teachers to teach specific religion-based alternatives to Darwin's theory of evolution is just as bad, in the words of political comedian Bill Maher, as requiring obstetricians to teach medical students the alternative theory that …

Congress, Controlled Substances, And Physician-Assisted Suicide: Elephants In Mouseholes, George J. Annas

Faculty Scholarship

The U.S. Supreme Court's decision in Gonzales v. Oregon to reject the U.S. attorney general's authority to prohibit physicians in Oregon from prescribing Schedule II drugs for their terminally ill patients to commit suicide can seem paradoxical and confusing. How is it that California cannot permit the patients of physicians who recommend marijuana, a Schedule I drug, to possess legally and use marijuana that they may need to survive, but Oregon can legally permit physicians to prescribe Schedule II drugs and patients to possess and use such drugs to end their lives?

Hunger Strikes At Guantanamo: Medical Ethics And Human Rights In A “Legal Black Hole”, George J. Annas

Faculty Scholarship

Being Human, a collection of readings assembled by President George W. Bush's Council on Bioethics, contains a powerful description of the force-feeding of Soviet political prisoner Vladimir Bukovsky, who was on a hunger strike to protest the refusal of prison authorities to provide a lawyer for a fellow inmate who was awaiting trial:

They started feeding me forcibly through the nostril. By a rather thick rubber tube with a metal end on it. . . . The procedure will be that four or five KGB guys will come to my cell, take me to a medical unit, put a straitjacket …

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The Patient's Right To Safety: Improving The Quality Of Care Through Litigation Against Hospitals, George J. Annas

Faculty Scholarship

It is the consensus of experts in the patient-safety field that little has changed to improve the safety of hospital care since the Institute of Medicine's 1999 report, To Err Is Human. The report noted that in order to be successful, “safety must be an explicit organizational goal that is demonstrated by clear organizational leadership. . . . This process begins when boards of directors demonstrate their commitment to this objective by regular, close oversight of the safety of the institutions they shepherd.” Leape and Berwick agree, noting that safety cannot become an institutional priority “without more sustained and …

Dna Testing, Banking, And Genetic Privacy, George J. Annas

Faculty Scholarship

"Who am I?” has always been a fundamental philosophical question that may require decades of reflection to answer. With the advent of DNA analysis, there is a growing public impression that the answer may be found in our genes. Various Internet sites offer descriptions of our ancestral history on the basis of our DNA, as well as testing for specific “disease genes” or general profiles that are used to recommend lifestyle changes, such as foods to be eaten or avoided. Researchers have even suggested that although the scientific evidence is speculative and at best probabilistic, many people will want to …

Law And Public Health: Beyond Emergency Preparedness, Wendy K. Mariner

Faculty Scholarship

This Article examines three questions: What is public health? What is public health law? What roles can lawyers play in public health? It first describes the breadth of public health, highlighting six trends shaping its future: social determinants of health; synergy between medicine and public health; shifts in focus from external (e.g., environmental and social) to internal (behavioral) risks to health; federalization of public health law; globalization of health risks and responses; and bioterrorism. Because the domains of law that apply to public health are equally broad, the Article next offers a conceptual framework for identifying the types of laws …

Unspeakably Cruel: Torture, Medical Ethics, And The Law, George J. Annas

Faculty Scholarship

Torture is a particularly horrible crime, and any participation of physicians in torture has always been difficult to comprehend. As General Telford Taylor explained to the American judges at the trial of the Nazi doctors in Nuremberg, Germany (called the “Doctors' Trial”), “To kill, to maim, and to torture is criminal under all modern systems of law . . . yet these [physician] defendants, all of whom were fully able to comprehend the nature of their acts . . . are responsible for wholesale murder and unspeakably cruel tortures.” Taylor told the judges that it was the obligation of the …

Pharmaceutical Arbitrage: Balancing Access And Innovation In International Prescription Drug Markets, Kevin Outterson

Faculty Scholarship

While neoclassical economic theory suggests that arbitrage will undermine global differential pricing of pharmaceuticals, the empirical results are more complex. Pharmaceutical regulation, IP laws, global trade agreements, and company policies support differential pricing despite the pressure of arbitrage. For essential access programs in particular, the theoretical threat of pharmaceutical arbitrage is shown to be rarely observed empirically. Counterfeiting is demonstrated to be the more serious threat. These conclusions call for changes in the U.S. PEPFAR program for AIDS and in the implementation of the WTO TRIPS Agreement.

A more fundamental question, however, is whether pharmaceutical differential pricing is appropriate for …

I Want To Live: Medicine Betrayed By Ideology In The Political Debate Over Terri Schaivo, George J. Annas

Faculty Scholarship

The public's view of the political intrusion into the medical care of Theresa Marie Schiavo is well illustrated by two political cartoons. The first, by Tony Auth, reprinted in the Boston Globe shortly after Congress passed a law authorizing intervention by the federal courts, pictures a horde of congressmen charging mindlessly out of the Capitol, all dressed as physicians-one carrying a saw, another an I.V. pole-with the caption, "Coming Soon to a Sickbed Near You . .. [tihe United States Congress." The second, by Tom Toles, published in the Washington Post shortly after the results of the autopsy report were …

Family Privacy And Death: Antigone, War, And Medical Research, George J. Annas

Faculty Scholarship

Death ends the doctor–patient relationship, and legally the patient's right of privacy dies with the patient. Other privacy interests survive, the most central of which are those of the patient's family to bury the body and to prevent the disclosure of some personal information, such as medical information, about the deceased relative. Just what privacy interests encompass and when they can be overridden by other interests — such as freedom of speech or the claims of public policy or medical research — are evolving.1 Family privacy concerning a family member who has died is at the forefront of a …

Jumping Frogs, Endangered Toads, And California's Medical-Marijuana Law, George J. Annas

Faculty Scholarship

Mark Twain wasn't thinking about federalism or the structure of American government when he wrote “The Celebrated Jumping Frog of Calaveras County.” Nonetheless, he would be amused to know that today, almost 150 years later, the Calaveras County Fair and Jumping Frog Jubilee not only has a jumping-frog contest but also has its own Frog Welfare Policy. The policy includes a provision for the “Care of Sick or Injured Frogs” and a limitation entitled “Frogs Not Permitted to Participate,” which stipulates that “under no circumstances will a frog listed on the endangered species list be permitted to participate in the …

“Culture Of Life” Politics At The Bedside: The Case Of Terri Schiavo, George J. Annas

Faculty Scholarship

For the first time in the history of the United States, Congress met in a special emergency session on Sunday, March 20, to pass legislation aimed at the medical care of one patient — Terri Schiavo. President George W. Bush encouraged the legislation and flew back to Washington, D.C., from his vacation in Crawford, Texas, so that he could be on hand to sign it immediately. In a statement issued three days earlier, he said: “The case of Terri Schiavo raises complex issues. . . . Those who live at the mercy of others deserve our special care and concern. …

The Supreme Court's Limitation Of Managed-Care Liability, Wendy K. Mariner

Faculty Scholarship

This article summarizes and critiques the U.S. Supreme Court's decision in Aetna Health Inc. v. Davila, which limited managed care organizations' liability for negligent decisions about the care of patients in private employer-sponsored health plans governed by ERISA. It contrasts the Court's dichotomous view of health benefit plans, in which insurers administer contracts and treating physicians make medical judgments, with the more complicated relationships that affect decisions about both coverage and treatment.

Why Don’T Doctors & Lawyers (Strangers In The Night) Get Their Act Together?, Frances H. Miller

Faculty Scholarship

Health care in America is an expensive, complicated, inefficient, tangled mess – everybody says so. Patients decry its complexity, health care executives bemoan its lack of coherence, physicians plead for universal coverage to simplify their lives so they can just get on with taking care of patients, and everyone complains about health care costs. The best health care in the world is theoretically available here, but we deliver and pay for it in some of the world’s worst ways. Occam’s razor (“Among competing hypotheses, favor the simplest one”) is of little help here. There are no simple hypotheses – everything …

Medical Malpractice And Contract Disclosure: An Equilibrium Model Of The Effects Of Legal Rules On Behavior In Health Care Markets, Kathryn Zeiler

Faculty Scholarship

This paper develops a theoretical model of how specific legal rules affect the types of contracts managed care organizations ("MCOs") use to compensate physicians. In addition, the analysis provides insights into how physician treatment decisions and the rate of medical malpractice lawsuits react to different legal rules. In particular, the model predicts that outcomes in jurisdictions forcing MCOs to disclose physician contract terms to patients differ from those that do not. Contracts vary depending on the disclosure rule and how treatment costs relate to expected damages and litigation costs. Moreover, the model predicts that jurisdictions forcing contract disclosure observe higher …

Free Trade Against Free Riders?, Kevin Outterson

Faculty Scholarship

The US is using free trade agreements to address the global free rider problem in pharmaceutical R&D. This brief article outlines several objections to that approach.

Extremely Preterm Birth And Parental Authority To Refuse Treatment: The Case Of Sidney Miller, George J. Annas

Faculty Scholarship

Disputes between physicians and patients over medical care have tended toward resolution in both the courts and ethics committees, with each of these bodies ultimately deciding that the informed, competent patient must be the final decision maker. Parents, too, have the authority to make medical decisions for their children, but these decisions can be challenged if physicians do not believe they are medically reasonable. One bioethical issue, however, is as intractable today as it was 30 years ago, when it began to be publicly discussed: the extent of parental authority to refuse life-sustaining medical treatment for an extremely premature infant. …

American Bioethics And Human Rights: The End Of All Our Exploring, George J. Annas

Faculty Scholarship

In his compelling novel Blindness, José Saramago tells us about victims stricken by a contagious form of blindness who were quarantined and came to see themselves as pigs, dogs, and “lame crabs.” Of course, they were all human beings - although unable to perceive themselves, or others, as members of the human community. The disciplines of bioethics, health law, and human rights are likewise all members of the broad human rights community, although at times none of them may be able to see the homologies, even when responding to a specific health challenge.

The boundaries between bioethics, health law, and …

Be Not Afraid Of Change: Time To Eliminate The Corporate Practice Of Medicine Doctrine, Nicole Huberfeld

Faculty Scholarship

This article argues that the corporate practice of medicine doctrine is a physician-centric, guild type doctrine that is misplaced in the present incarnation of the American healthcare system and that does nothing to improve quality, efficiency, or accountability. The paper focuses on three key reasons that the corporate practice of medicine doctrine should be laid to rest. First, the motives for creating the corporate practice of medicine doctrine are long gone, as physicians have not been able to operate as a guild of autonomous providers of healthcare for quite some time. Second, it is disingenuous to pretend that physicians are …

Can Consumer-Choice Plans Satisfy Patients? Problems With Theory And Practice In Health Insurance Contracts, Wendy K. Mariner

Faculty Scholarship

Much scholarship has considered whether health care - and insurance - should be distributed by voluntary contract or subject to government standards or regulation. Contracts will likely play a key distributive role in any future health care system. Yet we do not fully understand where private contracting does and does not work to further the goals of equitable access to affordable care. This article examines the role of health insurance policies in defining and enforcing access to medical care, focusing on private employment-based group health benefit plans. It describes models of consumer choice health plans and critiques their capacity for …

Forcible Medication For Courtroom Competence: The Case Of Charles Sell, George J. Annas

Faculty Scholarship

The right to refuse treatment is firmly recognized in U.S. law. Competent persons have the legal right to refuse treatment, even life-sustaining treatment, and incompetent patients can also refuse treatment through an advance directive, by naming a health care agent to make decisions for them or by having a person who knows their wishes express them.

Politics, Morals And Embryos, George J. Annas, Sherman Elias

Faculty Scholarship

Bioethics in the United States reflects US culture and tends to be pragmatic, market-oriented and insular. Add embryo politics to this mix and, over the past few years, the result has been a bioethics that has become so narrow and selfabsorbed as to be virtually irrelevant to the rest of the world. Not all the blame for this can be placed on President George W. Bush’s political agenda for his President’s Council on Bioethics, now in its third year of operation, but much can. The council has made public bioethics the servant of politics by pursuing a narrow, embryo-centric agenda. …

Parks As Gyms? Recreational Paradigms And Public Health In The National Parks, Jay D. Wexler

Faculty Scholarship

When scholars and policymakers think about the relationship between public health and environmental law and policy, they likely think first about controlling pollution and other toxic substances. As other articles have amply demonstrated, water pollution, air pollution, and other environmental toxins can have significant deleterious effects on the public's health. Scholars rightly pay serious attention to these relationships, and policymakers wisely devise methods and strategies to ameliorate the public health risks posed by these polluting substances.

Although pollution control might be the most obvious and important intersection between environmental policy and public health, legal and policy decisions regarding the management …

Bodily Integrity And Informed Choice In Times Of War And Terror, George J. Annas

Faculty Scholarship

Law is the dominant force behind American medical ethics, and has been for at least the past half-century. That ' lawyers and judges, rather than physicians, have set the agenda for medical ethics in the United States is a bit surprising to many in the field of medical ethics, but it should not be. Medicine has historically been based on paternalism. The Hippocratic physician was obligated to act in the best interests of the patient-as the physician judged those interests-and to "do no harm." American law, on the other hand, is based on liberty and justice, principles that, among other …

Arbitrage, Bioethics, And Cloning: The Abcs Ofgestating A United National Cloning Convention, Rosario M. Isasi, George J. Annas

Faculty Scholarship

America's inability to craft a regulatory ethics of abortion has led to a
/="/">wild west of unregulated research with human embryos and pregnant
/="/">women by our private infertility industry. Because of an "all or nothing"
/="/">research mentality, it is becoming increasingly impossible to suggest
/="/">outlandish and reckless reproductive research possibilities without seeing
/="/">them actually pursued. And if even the wild west seems a bit inhospitable
/="/">to particular research goals, such as cloning to produce the genetic duplicate
/="/">of an existing person, media darlings like Severino Antinori and Zavos
/="/">Panos, and even members …

Hipaa Regulations: A New Era Of Medical-Record Privacy?, George J. Annas

Faculty Scholarship

The new privacy regulations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) become effective April 14, 2003. This article outlines the implications of the new policy for practicing physicians. The regulations will affect virtually every physician, because they apply to any health care provider who conducts any business electronically, including billing. The regulations require health care providers to provide patients with a privacy notice that informs them who will have access to their records without their explicit consent and about patients' rights to inspect and amend their own records.