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50 Years of Health Law Brochure 2008

Mar 15, 2016

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BU Law has one of the finest health law curricula in the country, with courses taught by some of the most respected scholars in the field. Our highly regarded faculty, journal and dual degree programs with Boston University Schools of Public Health and Management prepare students to influence and shape health law and policy on such cutting-edge issues as patients’ rights, managed care and insurance, AIDS policy, Biotechnology, reproductive rights and research on human subjects.
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Page 1: 50 Years of Health Law Brochure 2008

50 years of health law

Page 2: 50 Years of Health Law Brochure 2008

This year, Boston University School of Law celebrates the 50th anniversary of our interdisciplinary collaboration in health law. From its beginnings as the Law-Medicine Research Institute in 1958, one of the first medical-legal institutional collaborations in the United States, the BU Health Law Program has grown in stature and complexity, mirroring the development of health care itself. Health law has evolved well beyond its original roots in forensic medicine and the doctor-patient relationship. Today, health law scholars cover very disparate domains including: embryonic stem cell research, food and drug law, genetic testing, antitrust, insurance, emergency preparedness, environmental health, product safety, privacy, torts and intellectual property. Health law is a dynamic field, with high demand for graduates who understand the nuances of the complex interface between health care and law.

Boston University offers an integrated array of academic and practical resources in health law and policy. Law students can take advantage of courses and internships at the School of Public Health, School of Management and at BU’s own Boston Medical Center. Clinical externships also exist at Boston’s health care institutions to test cutting-edge legal theory in the real world of patient care and biomedical research.

BU Law students may choose our health law concentration or enroll in dual-degree programs: Law and Health Care Management (JD-MBA), with the BU School of Management, and Law and Public Health (JD-MPH), with the BU School of Public Health, both of which offer a wide range of cross-disciplinary courses.

50 years of health law

Page 3: 50 Years of Health Law Brochure 2008

Health Law: A Rich HistoryFifty years ago, Boston University School of Law recognized

the importance of the emerging field of health law and built

the foundation for a growing and responsive Health Law

Program. Today, it is an innovative collaboration among

lawyers, physicians, academics and public health leaders.

The Law-Medicine Research InstituteBoston University established the Law-Medicine Research

Institute in 1958, when it first recognized the widening

scope of what was then called the medico-legal field. The

director was William J. Curran, Professor of Legal Medicine,

who published numerous journal articles about the need for

cooperation between doctors and lawyers and the “increasing

role of law in the regulation of medical practice, public health

and medical care programs.” Trained in law and in public

health, Professor Curran held dual appointments from the BU

Schools of Law and Medicine. In 1960 he compiled the first

comprehensive health law casebook, Law and Medicine: Text

and Source Materials on Medico-Legal Problems.

The Law-Medicine Institute’s three major functions were:

• interdisciplinary training for students from BU Law and

medical schools

• research on the current status of medico-legal education in

U.S. law and medical schools, and

• service with government and private agencies drafting

medical and health legislation.

Funded by the Schools of Law and Medicine, the Institute also

held a grant from the National Institutes of Health to develop

medico-legal courses and seminars in BU’s professional schools,

one of the many federal and state grants received throughout

its history. At this time, the institute was housed in downtown

Boston on Beacon Hill, near the State House.

At BU Law, the first course in health law began as

a seminar, Medico-Legal Trial Practice, taught by

professors from the Institute. Other courses introduced

interdisciplinary teaching: Domestic Relations, taught by

a lawyer and psychiatrist; and Law and Behavioral Science,

taught by two lawyers, a psychiatrist and a psychologist.

Institute professors also lectured at the Medical School.

One of the Institute’s first research projects, supported by the

National Institutes of Health, involved the legal, ethical and

moral problems with medical experimentation on human

subjects and patients. The principal investigator on the project,

Irving Ladimer, a BU professor from 1958–66, co-edited the

country’s first major collection of documents assembled on

3 50 years of health law

William J. Curran, first director of the Institute, pictured above left.

Page 4: 50 Years of Health Law Brochure 2008

The beginnings of the Boston University Law-Medicine Research Institute (William J. Curran pictured on right)

Page 5: 50 Years of Health Law Brochure 2008

human experimentation and the law, Clinical Investigations in

Medicine: Legal, Ethical, and Moral Aspects in 1963.

In 1962, Boston psychiatrist Leo Alexander, a consultant to

the U.S. Secretary of War during the 1947 international trial

of Nazi doctors, donated his papers to the Law-Medicine

Research Institute for inclusion in a new medico-legal library.

An Allied war crimes investigator, Alexander helped to convict

16 of the 23 defendants, most of whom were doctors, for the

murderous medical experiments. He also assisted the court

in formulating the Nuremberg Code, which became part of

its judgment on the legal principles governing permissible

experiments on humans, as well as the basis of all subsequent

codes of medical ethics in the United States and abroad. His

papers are currently housed at BU Law’s Mugar Library.

Other Institute projects included drafting the Massachusetts

Sanitary and Public Health Code; drawing up legislation

that reorganized the Massachusetts tuberculosis hospital

system and led to consolidating 18 institutions into five

regional hospitals; and drafting a statute for the first state

drug-addiction rehabilitation program. Members of a legal

psychiatry clinical program worked with Bridgewater State

Hospital for the Criminally Insane and established the first

professional training program in the institution’s history.

In 1970, the Institute was renamed the Center for Law and

Health Sciences to convey the expanding range of subjects in

the field. Judge David Bazelon chaired the Center’s new board

of directors, and Professor Baram and Law School Associate

Dean John P. Wilson co-directed the Center’s pilot projects.

Frances Miller Reshapes the Study of Health Law at BU

Professor Frances Miller, also a member of the Center’s

Faculty Committee, began teaching a course on health care

organization, finance and delivery in 1971, moving the

curriculum away from a primary focus on forensics. Medicaid

and Medicare, enacted in 1965 to provide health insurance for

the poor and elderly, respectively, were already straining federal

and state budgets with increasing demand for government-

subsidized benefits, ranging from hospitalization to nursing

home care. By the late 1960s, the vast majority of Americans

were covered by public or private health insurance, which was

a new phenomenon. All of these programs not only stimulated

difficult contractual issues but also new health care legislation

and regulation to contain costs. These in turn raised new

administrative and adjudicative questions for lawyers.

“I knew back then health law was a much broader subject than

doctors in the courtroom”, said Professor Miller. “So I broke with

5 50 years of health law

“When I attend the American Health Lawyers Association meeting, I’m always amazed at the remarkable number of senior lawyers who graduated from the BU Health Law program. It’s a real testament to Professor Miller who thought about the field in ways that people hadn’t and helped to shape the industry.”

Linda V. Tiano ‘81Senior Vice President, General Counsel, Health Net, Inc. Woodland Hills, CaliforniaBS in Psychology, University of Cincinnati

Page 6: 50 Years of Health Law Brochure 2008

the past, developed my own course materials and taught students

how the law interacted with the economics of health care delivery.

The rest of the world caught up with the concept later.”

This was the beginning of a seismic shift away from the

way health law had been taught in the past. Congress

and the states were beginning to focus on health care

cost containment, initiating increasing legal complexity,

but achieving only modest financial success. Professor

Miller taught about health law antitrust, reimbursement

for Medicare and Medicaid providers, food and drug law,

rate structures and health care resource allocation. She

also served as a commissioner on the Massachusetts Rate

Setting Commission, which set Medicaid and Worker’s

Compensation rates of reimbursement, and approved Blue

Cross Blue Shield reimbursement, thus making her a leading

go-to scholar in the field.

George Annas Leads the Center for Law and Health Sciences

In 1973, Professor George Annas started his career at BU as

the new director of the Center for Law and Health Sciences.

Professors Miller and Baram were among the Center’s

Faculty Committee and Leonard Glantz, Barbara Katz

and Harry Beyer joined as staff attorneys. Under Professor

Annas’ leadership, the teaching, research and public-service

organization was dedicated to defining health law and its

role in public policy decisions, and developing effective

teaching modalities in health law at the graduate level.

Multidisciplinary courses were offered in patient rights,

human experimentation, mental health law, health

care regulation and genetics and the law.

“BU has the edge because we’ve been teaching legislative drafting for 30 years. We’re way ahead of the curve.”

—Professor Robert Seidman

Students in the Legislative Policy and Drafting Clinic work on both local and global health-related legislation under the direction of Law Professor Robert B. Seidman, who co-teaches the clinic with Professor Ann Seidman. One project drafted legislation to improve the importation and effective distribution of essential medicines throughout the East African Community, comprised of five member states: Uganda, Kenya, Tanzania, Rwanda and Burundi. At the local level, another bill would require improved access to second opinions on breast cancer diagnoses for Massachusetts residents.

In the Legislative Drafting Clinic, health law students learn the guiding legislative theory, methodology and techniques they need to draft proposed laws for real-life clients. Their clients include state legislators, state government agencies, representatives of nongovernmental advocacy organizations and, through the International Consortium for Law and Development (ICLAD), lawmakers in approximately 30 developing and transitional countries. Each student drafts a bill, accompanied by a substantial research report that provides the facts, logically organized, to demonstrate that the bill’s detailed provisions will likely prove effective in helping to resolve the targeted social problem. In addition, Professor Kevin Outterson and his students work with a network of state legislatures on consumer issues relating to drug safety and marketing.

Using skills learned in BU’s Legislative Drafting Clinic, ICLAD interns have begun to work in the five East African countries to assist their lawmakers in drafting a legislative program to establish a Health Research Commission and to introduce bills to improve health care for all East Africans.

“Engaging students in drafting real-world legislation equips them to think about law as society’s instrument to transform inherited institutions and foster development in the health care field,” Professor Robert Seidman explained. “Very few law schools concentrate on the lawmaking process. BU has the edge because we’ve been teaching legislative drafting for 30 years. We’re way ahead of the curve.”

Page 7: 50 Years of Health Law Brochure 2008

“Being editor-in-chief of the American Journal of Law and Medicine gave me a fantastic opportunity to hone my writing skills and to learn about the practice and issues people face as members of the health care bar.”

David T. Morris ‘95Associate General Counsel, Provider Relationships Group, Blue Shield of California, San Francisco, CaliforniaBA in Rhetoric/Political Science, UC Berkeley

From 1973–1977, the Center staff published four books,

Psychosurgery; The Rights of Hospital Patients; Genetics and

the Law; and Informed Consent to Human Experimentation:

The Subject’s Dilemma, as well as numerous articles in law

and legal-medicine journals. Professors Annas, Glantz and

Katz’s research on informed consent became the basis for

their recommendations to the National Commission for the

Protection of Human Subjects of Biomedical and Behavioral

Research. The Commission recommended federal regulations

for research with human subjects, culminating in the Federal

Policy for the Protection of Human Subjects, informally

known as the Common Rule.

As part of its dedication to civic engagement, the Center

sponsored public symposia on such topics as recombinant

DNA research, psychosurgery, model malpractice trials, fetal

research and mental health law. Center staff also served on

the Health Facilities Appeals Board, which hears appeals

from Certificate of Need decisions for the Commonwealth of

Massachusetts (with Professor Miller chairing the board for

the better part of two decades.) In addition, Professor Annas

chaired the state’s Board of Registration and Discipline in

Medicine. The Center’s survey research on Boston’s largest

hospitals resulted in front-page Boston Globe coverage, which

prompted the hospitals to change their policy and allow

patients access to their medical records.

Beginning in 1976, Professors Annas and Glantz taught six

courses through the M.P.H. program, including Public Health

Law and Health Care Regulation. They also offered Regulating

Science Through Law jointly with the law school. Another

seminar, Law and Medicine: The Rights of Patients and Their

Providers, became a required course for the first-year medical

school class and remains part of BU’s required medical school

curriculum today.

The American Journal of Law and Medicine

The American Journal of Law and Medicine (AJLM), a

collaboration between the law school and the American

Society of Law, Medicine and Ethics (ASLME), was first

published in 1975. BU has a long association with ASLME,

founded by Professor Annas and Elliot Sagall, MD, of

Harvard Medical School. Dr. Sagall served as a member of

the Faculty Committee at BU’s Center for Law and Health

Sciences. Professor Annas also created the journal, Medicolegal

7 50 years of health law

Page 8: 50 Years of Health Law Brochure 2008

News, now named the Journal of Law, Medicine and Ethics.

By the late 1970s, the University had given ASLME a home

at the law school and shortly thereafter BU Law students

began editing AJLM as a student-run law review. The law

school and ASLME co-sponsor annual working conferences

for AJLM’s symposium issue. Past topics have included

“Genetic Disability: DNA Profiling of Embryos and Fetuses;”

“Globalization of Pharmaceuticals: International Regulatory

Issues;” “Brain Imaging and the Law;” and in 2008, “Tackling

Global Health Issues through Law and Policy.” The topic

for the 2009 AJLM symposium is “Access to HPV Vaccines:

Women’s Rights and Global Health.”

George Annas organizes the first Health Law Professors Conference

In 1978, Professor Annas organized the country’s first

workshop on teaching health law in medical schools, law

schools and schools of public health at BU Law. It was

“designed to categorize the differences, similarities and

parameters among health law courses; to exchange ideas on

curricula content; and to disseminate information on teaching

materials.” The program’s topics included: “Is Health Law a

Discipline?”; “Bioethics; Content of a Health Law Course”;

and “Materials in Teaching Health Law”. A second workshop

was again held at Boston University in 1980, and subsequent

meetings of what is now known as the annual Health Law

Professors Conference have rotated among law schools around

the country, co-sponsored by ASLME.

The Rise of Bioethics and Human Rights

By the late 1970s and early 1980s technological advances

in biology, chemistry, medical devices and pharmaceuticals

had dramatically changed the face—and the cost—of health

care. Procedures that had been unthinkable a few years

earlier became commonplace, including in vitro fertilization,

surrogate motherhood and increasingly complex organ

transplantation. Issues swirled around patient-provider

relationships, informed consent to treatment, access to health

records, biomedical and behavioral research involving human

subjects, refusal of treatment, the rights of hospital patients,

wrongful birth and life and euthanasia.

Stephen M. Weiner became the Center’s new director in

1978, when Professors Annas and Glantz joined the faculty

of the new BU School of Public Health to create its Health

Law Section (now the Department of Health Law, Bioethics

and Human Rights). This move strengthened the ties

between the BU Schools of Law and Public Health. A prolific

advocate for bioethics and patient rights, Professor Annas

addressed cutting-edge issues in his writings, which include

17 books, regular articles in the Hastings Center Report (“At

Law,” 1976–1991), the American Journal of Public Health

(“Public Health and Law,” 1983–1992), the New England

“ The faculty at BU Law School is excellent. The training was both practical and policy based. My job is incredibly challenging and diverse. In the course of a week, I can be negotiating with the Chinese government; talking with the press, consumer groups, and FDA scientists; and testifying before Congress.

Deborah Autor ’92Director, Office of Compliance, Center for Drug Evaluation and ResearchU.S. Food and Drug Administration, Bethesda, MarylandBA in Psychology, Barnard College

Page 9: 50 Years of Health Law Brochure 2008

“ After working on asylum and human rights cases in the Civil Litigation Clinic, students can go out and practice in the immigration area of the law.” —Clinical Professor Susan Akram

In 1993, Professor Akram joined the BU Civil Litigation Program faculty and brought her particular expertise in asylum and human rights law to the School’s clinical offerings.

“In any legal case pertaining to asylum, getting medical treatment and medical evaluations for our clients is the key to success,” said Professor Akram, who specializes in immigration and in human rights law, and is a co-founder of the Boston Center for Refugee Health and Human Rights with five Boston Medical Center physicians. The center is a major U.S. resource for survivors of torture, traumatized refugees, and those seeking asylum.

In the clinic, students learn pretrial and courtroom skills and collaborate with medical caregivers to represent torture survivors in their asylum and refugee-related cases. The attorney-physician collaboration is essential in both the legal representation and the provision of medical treatment for trauma, post-traumatic stress disorder, depression, and the physical effects of torture and persecution.

Students also learn to advocate for human rights in the international arena by working on “shadow reports,” submitted to the UN bodies that monitor states’ compliance with international human rights treaties. They have also

advocated on behalf of Guantanamo detainees who have been found eligible for release but

have valid refugee claims and worked on amicus briefs on national or international asylum and refugee issues.

“Students interested in immigration law can’t learn only through theory,” Professor Akram said. “After working on asylum and human rights cases, students can go out and practice in the immigration area of the law.”

Journal of Medicine (“Health Law, Ethics & Human Rights,”

1991–present) and in various law journals. In 1995, Professors

Annas, Glantz and Patricia A. Roche drafted the Genetic

Privacy Act and Commentary, which is the final report for the

Guidelines for Protecting Privacy of Information in Genetic

Data Banks project, funded by the Ethical, Legal and Social

Implications (ELSI) on Human Genome Research project.

The report was unanimously endorsed by the ELSI Working

Group and has served as the basis for several state laws, most

notably in Oregon and New Jersey. In addition, together with

Professor Mariner, they have submitted amicus curiae briefs to

the U.S. Supreme Court in cases on abortion and physician-

assisted suicide.

Global Lawyers and Physicians

Professor Annas and Dr. Michael Grodin founded Global

Lawyers and Physicians (GLP), an NGO, in 1996 “to

reinvigorate the collaboration of the legal and medical/public

health professions to promote and protect the human rights

and dignity of all persons.” Today, one of GLP’s initiatives,

the Boston Center for Refugee Health and Human Rights

at Boston Medical Center, provides services for refugees and

asylum seekers from more than 60 countries and gives law

students hands-on experience in helping clients. Here, BU

students can gain experience in international health work

without leaving the country. Other projects have concentrated

on children held at Guantanamo, military medical ethics and

international research rules.

According to Professor Annas, most of the scholarly and

activist health law work at BU is grounded in two great

codes: the Universal Declaration of Human Rights and the

human genome. “Both address universals—humanity’s

shared values and humanity’s shared genetic structure,” he

said. “The challenge, of course, is to use these great codes

to promote equality, justice and human rights.”

9 50 years of health law

Page 10: 50 Years of Health Law Brochure 2008

The N. Neal Pike Institute for Law and Disability

By 1986, Henry Beyer became the director of the Center

for Law and Health Sciences. The Center focused

principally on two areas: rights of individuals with mental

and physical disabilities and the relationship between law

and maltreatment. The N. Neal Pike Institute for the

Handicapped, later the Institute for Law and Disability,

was established within the Center in 1983 with a generous

endowment from the Pike family.

Director Beyer’s long-term commitment to education and

advancing the rights of individuals with disabilities has been

internationally recognized and applauded. He helped to

organize and train human rights committees for people with

mental illnesses and disabilities in 1984. Until his retirement

in 1997, he directed research and advocacy projects for

the President’s Committee on Mental Retardation, the

National Institute of Mental Health, the Administration on

Development Disabilities, the U.S. Department of Education

and many New England state agencies.

At the Forefront of Health Law

In the 21st century, the Health Law Program remains at the

forefront of the ever-widening field of health law, continuing

the interdisciplinary collaboration that began with the Law-

Medicine Research Institute 50 years ago.

Professor Annas, Dr. Grodin and co-authors introduced

global human rights issues in health law with Health and

Human Rights (1999), which was dedicated to Jonathan

Mann and his work in health and human rights. In the

field of public health, Professors Mariner and Annas,

together with Ken Wing and Dan Strouse, co-authored the

first casebook, Public Health Law (2007).

The faculty in the Schools of Law and Public Health

collaborate and sponsor seminars and conferences, such

as the annual American Journal of Law and Medicine and

Pike Health Law Conferences. In recent years, public

conferences have addressed the broader topics of health

and human rights. One conference focused on the impact

“BU has unparalleled expertise in all aspects of health care.”

— Professor Ashley J. Stevens, BU School of Management

Two BU professors are championing the cause for less expensive drugs for low-income people around the globe: Law Professor Kevin Outterson has proposed a market-based Generic Open (GO) License and School of Management Professor Ashley J. Stevens has zeroed in on universities, the initial source for most drug research.

“Universities are very prolific in the discovery of drugs, biologics and vaccines,” said Professor Stevens, who also serves as Executive Director of the Office of Technology Development.

“They have to amend their licensing practices and take into account the needs of the developing world.”

“We need to make powerful new drugs available around the world on an equitable basis, without harming R&D incentives,” said Professor Outterson. “Universities have a significant role to play, as the source of many pharmaceutical innovations.”

In a forthcoming paper, Professor Stevens and his co-author, April E. Effort, cite a Boston University study that identified 131 vaccines, small molecule drugs, biologic drugs and in vivo diagnostics that were discovered in whole or in part at academic institutions since 1980, all of which were patented and licensed. They commend Universities Allied for Essential Medicines (UAEM), a student-led organization dedicated to ensuring that health-related university innovations are made available in the developing world at low costs.

Professor Stevens teaches “From Bench to Bedside” at the BU School of Management, a course co-listed at BU Law. The course focuses on translating biomedical innovation from the laboratory to the marketplace.

“Between the Health Law Program at the law school, the Health

Sector MBA in the School of Management, and the Health

Law, Bioethics and Human Rights Program at the School of

Public Health, BU has unparalleled expertise in all aspects of

health care,” Stevens said. “Most importantly, we work together.

Students learn more with the cross-disciplinary approach.”

Page 11: 50 Years of Health Law Brochure 2008

of interrogation and confinement on the mental health of

Guantanamo prisoners, particularly children. Another timely

health law conference was the symposium, “Beyond Cloning:

Protecting Humanity from Species-Altering Procedures.”

In 2006, the Pike Health Law conference considered the

legal, medical, ethical and political lessons of Terri Schiavo’s

tragic situation. U.S. Rep. Barney Frank provided the

keynote address and other speakers included the trial court

judge, George Greer, who was awarded the law school’s

Pike Prize, and Dr. Ronald Cranford, the prinicipal expert

witness in the case.

In 2007, the annual Pike Conference revisited the event

that marked the beginning of the health law, bioethics and

human rights movement. “The Nuremberg Doctors’ Trial:

60 Years Later” examined the role of military physicians in

World War II and the relevance of the Nuremberg Code

to the war on terror today. In 2008, fittingly, the topic was

“The Future of Health Law,” and former BU Professor

Irving Ladimer joined the list of illustrious recipients of the

Pike Award.

This year, Boston University will celebrate a half-century

of health law. Held on September 24-27, 2008, the 50th

Anniversary Celebration, “From Forensic Medicine to

Global Human Rights,” will span four days of symposia at

the Schools of Law, Public Health and Medicine.

11 50 years of health law

“The Health Law Program at BU Law taught me how to sift through complex fact patterns to identify and analyze the underlying legal issues. As a general counsel, I use that skill to help Harvard Pilgrim manage its legal and business risks.”

Laura S. Peabody ’83Senior Vice President, General Counsel, Harvard Pilgrim Health Care, Inc., Wellesley, MassachusettsBS in Genetics, State University of New York at Binghamton

Health Law at Boston University: Upcoming Lectures and Symposiums

From Forensic Medicine to Global Human Rights

Human Rights and Health

September 24, 2008

Health Law: Past and Future

September 25, 2008

Election 2008: A Health Reform Agenda

September 26, 2008

Voices of Experience

September 27, 2008

AJLM Symposium: HPV Vaccines

Human Rights and Global Health

February 7, 2009

Pike Conference

March 20, 2009

Page 12: 50 Years of Health Law Brochure 2008

A Tradition of Faculty CollaborationCollegial collaboration is a hallmark—and a tradition—at

BU Law, which has one of the best law faculties in the nation.

The Leiter Law School Rankings and the Princeton Review have

rated BU Law # 1 for Teaching quality. Our health law faculty

are scholars who love to teach, and their expertise is sought

by government agencies, industry and nongovernmental

organizations as well as by the legal profession.

The law school’s six health law professors are internationally

recognized authorities in their fields and productive scholars,

often co-writing articles and books with each other. Professor

Annas, often called the “father of patient rights” after writing

the first book on the subject, The Rights of Hospital Patients

(1975), is renowned for his scholarship and advocacy in the

field of health law, bioethics and human rights.

Frances Miller, J.D. ’65, the law school’s N. Neal Pike

Scholar, is an expert in American health care law and policy

and a specialist on comparative health systems. Wendy Mariner is a member of the Massachusetts Health Care

Quality and Cost Council Advisory Committee, which helps

implement the state’s landmark 2006 health care reform

legislation, and has served on committees for the World

Health Organization and National Institutes of Health.

Michael S. Baram, an advisor to Congress, the United

Nations and the European community, is a specialist in

biotechnology law and ethics and in environmental law. A

gifted teacher, Leonard H. Glantz concentrates in public

health interventions, including privacy, the rights of children

and mental health law. Kevin Outterson has testified about

his innovative work regarding global pharmaceutical markets

and health disparities before the U.S. Senate Committee on

Health Education, Labor and Pensions, as well as many state

legislative and regulatory bodies.

Prof. George J. Annas with Judge George Greer and Ronald Cranford BU School of Public Health

BU School of Law

Page 13: 50 Years of Health Law Brochure 2008

BU School of Public Health

GeorGe J. AnnASProfessor of Law, Boston University School of Law; Edward R. Utley Professor and Chair, Department of Health, Bioethics and Human Rights, Boston University School of Public Health; Professor of Socio-Medical Sciences and Community Medicine, Boston University School of Medicine

Professor Annas is internationally renowned for his

scholarship and advocacy in the fields of health law,

bioethics and human rights. He is a member of the

Institute of Medicine, a fellow of the American Association

for the Advancement of Science (AAAS) and a member

of the National Academies’ Human Rights Committee.

He is the author or editor of 16 books on health law and

bioethics including: The Rights of Patients (3rd ed., 2004),

American Bioethics: Crossing Human Rights and Health Law

Boundaries (2005), and Public Health Law (2007). He

also writes a regular feature on “Health Law, Ethics, and

Human Rights” for the New England Journal of Medicine,

the world’s most respected medical journal. His current

teaching focuses on health care regulation and bioethics.

As co-founder of Global Lawyers and Physicians, a

nongovernmental organization of lawyers and physicians

working collaboratively to promote human rights and

health, Professor Annas is at the forefront of the human

rights and health movement.

13 50 years of health law

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MichAeL S. BArAMProfessor of Law, Boston University School of Law; Professor of Health Law, Boston University School of Public Health; Professor, Boston University Bioinformatics Department

Professor Baram has advised national, state, international

and private sector organizations including the United

States Congress, the Environmental Protection Agency,

the United Nations, the World Health Organization, the

Commonwealth of Massachusetts, the Conservation

Law Foundation and several industrial associations. He

has served on committees of the National Academy of

Sciences, the Department of Energy, the American Bar

Association and other organizations. His seven books

discuss alternatives to regulation, safety management, risk

communication and right-to-know law. In more than 110

published papers, he has dealt with issues related to social

control of science and technology, and the regulation

and management of technological risks to health, safety

and the environment. His recently published papers

deal with gene therapy, biotech foods and agriculture,

products liability, corporate safety culture, and the

governance of workplace safety.

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LeonArD h. GLAnTZProfessor of Law, Boston University School of Law; Associate Dean and Professor of Health Law, Boston University School of Public Health; Professor of Socio-Medical Sciences and Community Medicine, Boston University School of Medicine

Professor Glantz is the author of numerous articles on a

wide array of health law issues. He has served on several

national task forces, including the Task Force on Public

Health Ethics of the Association of Schools of Public

Health, and has been a member of the Institutional

Review Board of Boston University School of Medicine

for more than 20 years. Professor Glantz’s current

research and teaching focuses on the regulation of human

subjects of research, constitutional aspects of public health

interventions, tobacco control policies, reproductive rights,

the rights of children, the rights of people with mental

illnesses and the rights of people with disabilities. He and

Professors Annas and Mariner have submitted amicus

briefs on behalf of bioethics professors in several U.S.

Supreme Court cases.

15 50 years of health law

Page 16: 50 Years of Health Law Brochure 2008

WenDY K. MArinerProfessor of Law, Boston University School of Law; Professor of Health Law, Bioethics and Human Rights, Boston University School of Public Health; Professor of Socio-Medical Sciences and Community Medicine, Boston University School of Medicine; Chair, Boston University Faculty Council

Professor Mariner is an internationally recognized authority

in health law, teaching and publishing in the specialties of

health insurance, ERISA, patient rights, public health and

biomedical research. She is a member of the Massachusetts

Health Care Quality and Cost Council Advisory

Committee, which helps implement the state’s 2006 health

reform legislation. She has served on numerous national

and international committees, including the WHO/

CIOMS Committee on International Ethical Guidelines

for Research Involving Human Subjects, the National

Institutes of Health’s AIDS Program Advisory

Committee, and several Institute of Medicine Study

Committees. As legal director of the Boston

University School of Public Health Project on

Reform Legislation in the Russian Federation,

Professor Mariner traveled to Russia to provide

technical assistance in developing health care

legislation. Professor Mariner is also faculty

coordinator for the J.D./M.P.H. dual degree program

at the School of Public Health.

Page 17: 50 Years of Health Law Brochure 2008

FrAnceS h. MiLLerProfessor of Law, N. Neal Pike Scholar, Health Law Faculty Advisor, Boston University School of Law; Professor of Public Health, Boston University School of Public Health; Professor of Health Care Management, Boston University School of Management

Frances H. Miller, a BU Law graduate, is a national

authority on health law. Appointed a Fulbright Scholar

for the UK in 1991 and again in 1998, and a Kellogg

Foundation Fellow from 1983-1986, Professor Miller has

written widely for law review publications and medical

journals on health care policy, antitrust in the health sector

and food and drug law. Her current research interest

focuses on pharmaceutical regulation in the global context.

She is also a specialist on comparative health systems and

publishes extensively comparing competition initiatives in

the British National Health Service with competition in

the U.S. health care sector. Professor Miller is currently

a member of the Institutional Review Board of Partners

Healthcare, the parent corporation for Massachusetts

General, Dana Farber and Brigham & Women’s Hospitals.

Professor Miller also serves on the boards of the Joslin

Diabetes Center, Adolescent Consultant Services, Inc., and

is a trustee of Mount Holyoke College.

17 50 years of health law

Page 18: 50 Years of Health Law Brochure 2008

KeVin oUTTerSon Associate Professor of Law, Boston University School of Law

Kevin Outterson’s research work focuses on two primary

areas: global pharmaceutical markets and health disparities.

Before joining BU Law in 2007, Professor Outterson

taught at West Virginia University where he received the

WVU College of Law Outstanding Research award for

his article “Pharmaceutical Arbitrage” in the Yale Journal

of Health Policy, Law & Ethics. In 2007, he received

the Professor of the Year award at the College of Law at

WVU. Prior to teaching at WVU, he was an income

partner in the Tax and International groups at McDermott

Will & Emery and a capital partner in the Health Law

group at Baker Donelson. In 2004, he was appointed

by Governor Wise to the West Virginia Pharmaceutical

Cost Management Council, where he worked to reduce

the cost of prescription drugs. He serves on the board of

Prescription Policy Choices and consults with governments

and NGOs concerning pharmaceutical pricing and

access to medicines. He is a graduate of the University of

Cambridge (LL.M.) and Northwestern University (B.S. &

J.D.). Professor Outterson teaches courses in health care,

business law and globalization. For several years, Professor

Outterson has led annual foreign study trips to Brazil in

which participating students have the opportunity to study

international and comparative law.

Page 19: 50 Years of Health Law Brochure 2008

BU’s Health Law Program is consistently ranked among the top

ten in the nation by U.S. News & World Report, ranking #7 in

the most recent edition. Its health law curriculum is unparalleled

in breadth and depth.

BU’s health law journal, the American Journal of Law and

Medicine is the #1 cited health law journal in the United States

as ranked by impact factor. According to a study by John Doyle,

law librarian at Washington & Lee University, it is cited more

often than the principal law review of many other schools.

The journal has been published at BU Law in conjunction

with the American Society of Law, Medicine and Ethics for

more than 20 years. It publishes professional articles, student

notes, case comments, summaries of recent legislative and

judicial developments and book reviews on the subject of health

law and policy. The journal has an international circulation

and specializes in both traditional health law issues and less

conventional subjects such as dietary supplement regulation,

brain imaging and the globalization of pharmaceuticals.

The J.D. concentration in health law is comprised

of seven health law classes plus a major research paper on a

related topic. A wide range of cross-disciplinary courses are

available through the Schools of Law, Public Health and

Management, which are taught by some of the professions’s

leading scholars. Health law concentration courses can also

count toward an accelerated dual degree program.

Dual Degrees

J.D./M.B.A. in Law and Health Care Management

The J.D./M.B.A. dual degree program in Law and Health

Care Management, offered jointly by the Schools of Law and

Management, provides a comprehensive understanding of

the interaction between legal and management principles in

the field of health service delivery. The program is limited to

a select group each year, with students earning both the J.D.

and M.B.A. degrees in an accelerated program of four years

rather than the usual five.

J.D./M.P.H. in Law and Public Health

The J.D./M.P.H. dual degree program in Law and Public

Health is an accelerated four-year course of study leading to

the award of both the J.D. and M.P.H. degrees. Offered by the

Schools of Law and Public Health, the program trains students

for leadership roles in both the public and private sectors. Public

health courses in epidemiology, biostatistics, environmental

health, social sciences, health policy and management are

combined with the health law courses to provide a systematic

understanding of the health field.

The Health Law Program at BU Law Today

“BU Law was a wonderful yet challenging experience. My professors were talented and highly regarded in their fields. Most importantly, in teaching us how to think as lawyers, they were genuinely interested in what we as students had to say.”

Stephanie Switzer ’94Associate Counsel, Health Care and TaxCleveland Clinic Foundation, Cleveland, OhioBS in Chemistry, Oberlin College

19 50 years of health law

Page 20: 50 Years of Health Law Brochure 2008

Boston University is located in one of the world’s foremost

cities for health care delivery and medical and biotechnology

research. Boston’s Massachusetts General and Brigham &

Women’s hospitals were recognized as two of the top 11

hospitals in the nation by U.S. News and World Report. In

addition, Boston is a major center for national and global

health policy, and home to the Massachusetts Legislature, a

frequent innovator in health care legislation.

Boston offers ample opportunity for pursuing any health law

interest, whether it be protection of participants in clinical

trials, pharmaceutical regulation or cutting-edge legislation

designed to cover the uninsured. Boston’s biotechnology

industry leads the world; Genzyme and Biogen are located

here, along with the 550 other members of the Massachusetts

Biotechnology Council.

BU Law has one of the finest health law curricula in the

country, one that melds academic theory with hands-

on experience. Opportunities extend far beyond formal

course work and include health law externships, clinics and

interdisciplinary research activities.

Program Opportunities at BU Law

The Legal Externship Program in Health Law

allows students to work in a health law field placement in one

of Boston’s world-class nonprofit health institutions including

hospitals, health insurers and government agencies. Recent

placements have included Boston Medical Center, Beth

Israel, Deaconess, Massachusetts General and Brigham

& Women’s Hospitals, the Joslin Diabetes Center, the

Center for Integration of Medicine and Innovative

Technology at Massachusetts General Hospital and the

New England Organ Bank. Other externs serve the

legal needs of children in poverty with BU Medical

School Professor Barry Zuckerman’s innovative program

in childhood and adolescent health, the Medical Legal

Partnership for Children at Boston Medical Center.

The Legislative Counsel Clinic gives students

the opportunity to work on bills that will be considered

by the Massachusetts Legislature, a consistent leader

in health law issues in the U.S. Under the guidance of

a director with extensive experience as a legal advisor

and counsel to committees of the Massachusetts

legislature, students assist senators and representatives

on a variety of health care bills. Students recently

worked on the innovative Massachusetts bill designed

to cover the uninsured. In addition, the Legislative Internship Program offers students the chance to

work in the office of a Massachusetts legislator, gaining

an internal perspective on the process. One student in

the Internship program recently produced a proposed

statute banning gifts from pharmaceutical and medical

device companies to doctors.

The Legislative Drafting and Policy Clinic offers students the opportunity to draft health related

global, national and state statutes. Students learn

client interviewing, fact investigation, legal research,

drafting and revision, while producing a draft bill with

extensive accompanying documentation. A board of

student editors and faculty advisors assists through all

stages of drafting the bill and writing the supporting

memorandum. Clients include state legislators and

agencies, nongovernmental advocacy organizations

Real-World Health Law Experience in Boston

Page 21: 50 Years of Health Law Brochure 2008

“We work with real bills that are under consideration, some of which become law. It’s a great day to see the governor sign your bill.”

—Clinical Associate Professor Sean Kealy

A BU Law student is researching an amendment to the

Massachusetts stem-cell law. The issue: developing ethical

alternatives to paying women for donating their eggs for

medical research. Another student is working in the Senate

offices on Beacon Hill, crafting the $1 billion bill to

expand life sciences research, industrial development and

workforce training.

“The Massachusetts Legislature is involved in high-profile

health issues, so we don’t have to work on hypothetical

cases,” said Sean Kealy, Clinical Associate Professor

and Director of the Legislative Counsel Clinic and the

Legislative Internship programs. “We work with real bills

that are under consideration, some of which become law.

It’s a great day to see the governor sign your bill.”

Massachusetts is a national model for health law reform.

In 2006, the state continued that tradition with the Act

Providing Access to Affordable, Quality, Accountable

Health Care. Recognizing the significance of this

legislation, Professor Kealy has spearheaded a project to

archive the full legislative history of the Act. A team of

Counsel Clinic students is contacting House and Senate

offices, collecting summaries, expert testimonies, floor

speeches and legislative sources.

“It’s exciting,” he said. “It’s a big complicated bill

that took a lot of negotiating to pass. At some

point there will be litigation, and the question

will be asked, ‘How did the Legislature intend

the law be read?’ The answer will be found in

the documents we gather.”

and lawmakers in developing countries, especially the East

African Community.

The Boston Center for Refugee Health & Human Rights is a multidisciplinary project of Boston University

School of Medicine, School of Public Health, School of

Law and the Boston Medical Center. The Center provides

comprehensive care for refugees and asylum applicants,

including survivors of torture and related trauma. Students

can participate and assist in the preparation of asylum cases

and work on refugee policy. The Center has provided legal

assistance, court testimony, medical evaluations, medical

and psychiatric care and social assistance to more than 750

patients from more than 67 countries.

The Civil Litigation Clinic allows students to collaborate

with the Boston Center for Refugee Health and Human

Rights, where they work with health care professionals, led by

Dr. Michael Grodin of the BU Schools of Medicine and Public

Health, and Professor Susan Akram, to represent clients in

refugee and asylum cases.

Numerous opportunities exist at BU Law to give

students practical, research-based experience. Students

may find employment as research assistants for

projects like the current work of Professor Mariner,

director of the J.D.-M.P.H. program, on the national

Institute of Medicine’s Committee on Smoking Cessation

in Military and Veteran Populations, or Professor

Miller’s work on injuries related to clinical trials.

Both law students and public health students

helped Professor Mariner develop health reform

Research & Fellowship Opportunities

21 50 years of health law

Page 22: 50 Years of Health Law Brochure 2008

legislation for the Russian Federation in a project funded

by the United States Agency for International Development

(USAID) and saw several proposed laws enacted.

An interdisciplinary project was completed by Carolina

Rossini, a student in BU Law’s LL.M. in Intellectual Property

law program, who, through her coursework, researched

socially responsible and open licensing arrangements to

facilitate access to medicines. Her thesis focused on the role of

universities in the research process, with an emphasis on access

to patented inventions and medicines.

For law students in the J.D.-M.P.H. dual-degree program who

are interested in teaching, the School of Public Health offers

two competitive fellowships: the Health Law and Bioethics

Fellowship and the Human Rights and Health Fellowship.

Fellows learn teaching skills, assist faculty in the Department

of Health Law, Bioethics and Human Rights and conduct their

own research for a publishable article. The fellowship covers

tuition to complete the M.P.H. program at the School of Public

Health. The 2006–2007 fellow helped Professors Annas and

Mariner prepare the Public Health Law casebook, in addition to

acquiring invaluable experience as a teaching assistant.

The Patients' Rights Program (PRP) at Boston

University's School of Public Health initiated the International

Committee on the Universal Rights of Patients, composed of

health law and human rights scholars from diverse countries,

to encourage effective implementation of patient rights

around the world. PRP conducts research on legislation,

court decisions and other events affecting patient rights. The

program offers semester and summer internships for law

students who want to participate in PRP projects.

Global Lawyers and Physicians (GLP) is a nonprofit

organization of lawyers and physicians from all over the

world who collaborate to promote human rights and health.

GLP offers a rare opportunity for lawyers and physicians

who are committed to justice and health to work together to

advance knowledge about the inextricable link between health

and human rights. Students can conduct research for GLP

projects, prepare amicus briefs in court cases raising human

rights and health issues, identify ways to implement the

health-related provisions of international covenants on human

rights and participate in educational conferences.

“My classes proved essential in discussing what has been negotiated in international treaties and arenas and in understanding the global politics surrounding medicines.”

carolina rossini ’08Former professor and researcher at Fundação Getulio Vargas Law School, Rio de Janeiro, BrazilLL. B. University of Sao Paulo, Brazil MBA Instituto de Empresa, Spain

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Administrative LawAntitrust Issues in Health Care (S)Biotechnology Law & Ethics (S)Biotechnology Law & PolicyCorporationsThe Dynamics of Health Care Reform (S)Ethical Dimensions of Public Health PolicyEthical Issues in Medicine and Public HealthFood and Drug LawForensic Mental Health Issues for LawyersGenetics, Law and Public HealthHealth Care Markets: Law & Policy (S)Health Insurance, Managed Care and the Law (S)Health LawHealth Law, Bioethics and Human RightsHuman Rights and Health (S)Independent Study (with faculty)Insurance LawLegal Rights of Individuals with Disabilities (S)Legal Strategies to Reduce Health RisksMedical Research and the Law (S)Mental Health Law and EthicsNonprofit OrganizationsRegulation of Research with Human BeingsWar on Drugs: 25 Years of U.S. Drug Policy (S)

(S) Seminar

Adjunct or part-time faculty play a key role in educating

BU Law students. The Law School welcomes the

following faculty who work in such practice areas as

forensics, child custody and domestic violence and

health care law and business.

Jeffrey Donohue ’97Corporate Counsel, Novartis Institutes for BioMedical

Research, Inc.

Alexandra GlazierGeneral Counsel, New England Organ Bank

Dr. Robert KinscherffDirector of Forensic Training for the Law and Psychiatry

Service, Massachusetts General Hospital; Senior Forensic

Psychologist, Boston Juvenile Court Clinic

A Sampling of Course Offerings

Adjunct Faculty

23 50 years of health law

Page 24: 50 Years of Health Law Brochure 2008

On the cover: Professor Fran Miller

www.bu.edu/law