ANATOMY OF A MEDICAL MALPRACTICE CASE (HLTH9521)
2 credits. Lecture. 
Prerequisite or Co-requisite: Medical Malpractice
Recommended: Evidence
NOTE: Not available to MSJ students.

This seminar provides students with the tools to prepare and try a medical malpractice case. Students are provided with three redacted (but otherwise complete) medical charts to analyze. They then conduct medical research, and learn how to locate expert witnesses.  Following this each participant prepares pleadings and serves and responds to discovery requests. Students take simulated depositions of parties and experts. They prepare pretrial motions, and attend portions of an on-going medical malpractice trial, a trial call, and motion days. The grade is based on demonstrated competence in preparation of pleadings, discovery documents, motions, and taking depositions.  * Not available to M.S.J. students.

BIOETHICS & PUBLIC POLICY (HLTH9516)
2 credits. Seminar.

This seminar will explore federal and state efforts to develop public policy on ethical issues in medical treatment and research.  Topics will be selected from a variety of current controversies, including research with human subjects, genetic testing and screening, assisted reproductive technologies, cloning and stem cell research, and decisions about life-sustaining medical care.  While some time will be devoted to historical and theoretical perspectives on these issues, the emphasis will be on the challenges facing policy makers accountable to multiple constituencies with vastly differing - an potentially irreconcilable - priorities and world views.  A seminar paper, which may be used to fulfill the advanced writing requirement, will be required.

BUSINESS LAW SURVEY (HLTH7400)
3 credits. Lecture.

This course introduces M.S.J students to principles of contract and corporate law necessary to provide an appropriate background to health law courses.  The course includes a writing component that focuses on drafting skills.

COMPLIANCE PLANNING: PLANNING AND IMPLEMENTING AN EFFECTIVE CORPORATE COMPLIANCE PROGRAM
(hlth7528)
2 credits. Lecture.

The course will focus on the managerial and legal aspects of corporate compliance programs including the need for, and development of, an effective corporate compliance program. The course will examine government regulations, guidance documents and enforcement initiatives which have created a framework for modern compliance programs in the health care industry. In addition, the course will examine other laws and standards such as Sarbanes-Oxley and NYSE and NASDAQ listing rules which mandate certain elements of a corporate compliance program. The course will provide a practical overview of how to design, implement and manage a corporate compliance program, focusing on the essential “seven elements” of an effective program.  Emphasis will also be placed on the incorporation of ethics into a compliance program with the goal of creating a culture of compliance within an organization.

CONSTITUTIONAL LAW SURVEY (HLTH7402)
3 credits. Lecture.
NOTE: This course is available only to students in the MSJ program.  

This M.S.J. course provides a general overview of the constitutional law doctrines that are most relevant to health professionals.  Particular attention is paid to separation of powers, privacy and reproductive rights, and the First Amendment as they relate to government regulation of health care.  The course also considers constitutional and other issues raised by the role of administrative agencies and the implementation of legislation in the health care system.

CURRENT ISSUES IN FOOD & DRUG ADMINISTRATION (HLTH7518)
3 credits. Lecture.

This course is an in-depth study of current issues that shape federal and state regulation of food and drug products, with a special emphasis on the treatment of pharmaceuticals. It considers changing areas of the law and examines options available to meet public concerns. Topics covered include legislative reform proposals, and the impact of managed care on pharmaceutical regulations. In addition, the course examines products liability law as it relates to drugs, including the impact of liability standards and the debate about changing standards.

NOTE: Students cannot apply both this course and Food and Drug Administration (HLTH8500) towards degree requirements.

DRUG INNOVATION, REGULATION AND COSTS (HLTH9508)
2 credits. Seminar.

This seminar will examine the process and rationale for the regulation of drugs and medical devices and current issues about the impact of the regulatory scheme. Topics to be covered include whether speeding up drug approval increases safety risks, what lessons are provided by Vioxx, and when comparative efficacy testing of drugs is warranted. Attention will be given to matters that can affect the cost of drugs including the standards for approval of generic drugs, non-patent regulatory protections, and OTC switches. FDA’s role with respect to innovative drugs such as those for human enhancement will be examined.

While there is no prerequisite for the seminar, a course in Food and Drug law is recommended.

DRUGS & DEVICES: LAW AND CURRENT ISSUES IN THE PRACTICE (HLTH7512)
2 credits. Lecture.

This course will cover the basic legal requirements for both prescription drugs and over the counter drugs as well as devices for marketability in US commerce. There will be discussion on the government bodies which have jurisdiction over these products and the enforcement tools they have to assure safe and efficacious drugs and devices in the US. We will cover some of the major current issues and cases which affect constitutional limits on the FDA regulations as it relates to 1st amendment rights and other compliance issues regarding advertising, constraints on distribution of new clinical trial results and methods which allow new data to reach the medical population.

FOOD & DRUG LAW (HLTH8500)
2 credits. Lecture.

This course provides an overview of the laws and regulations of the Food and Drug Administration that restrict the sale of unsafe, deceptive or unproven foods and drugs. The pre-market approval system governing drugs will be examined along with the debate about the length of testing. Other topics include the prescription status of drugs, consumer advertisements, and the impact of commercial speech protections. Major issues concerning food regulation are considered such as the appropriateness of a no-risk policy for carcinogens and the use of biotechnology in foods. The justification for the deregulation of dietary supplements will also be explored. The course aims to provide students with an understanding of the principal regulatory means used by the agency, such as rulemaking, and court enforcement. In addition students will be able to consider the appropriateness of schemes based on disclosure and those that impose additional restrictions.

HEALTH CARE ACCESS AND PAYMENT (HLTH8502)
2 credits. Lecture.

This course examines the rapidly-shifting means by which patients gain access to health care, and through which sponsors of health coverage organize and compensate health care providers.  It begins by surveying issues of health coverage across a social spectrum including the uninsured, those covered by Medicare, Medicaid and other government programs, and the privately insured.  The course focuses on financing, administrative and legal structures through which quality, cost and access are balanced.  It then discusses issues raised by the dominance of managed care systems of health finance and delivery, focusing on cost containment mechanisms.  The course examines a range of statutory and common law devices employed to balance the interests of providers, payers and patients.  It will survey such topics as tort claims against managed care plans, the "right"  to health care, discrimination in health insurance, antitrust and fraud applications in health care finance and delivery, and the relationship between markets and regulation in health care delivery and finance.

Students cannot apply both this course and Managed Care toward degree requirements; this course replaces Managed Care in the curriculum.

HEALTHCARE ANTITRUST (HLTH 8509)
2 credits. Lecture.
Prerequisite: Health Law
NOTE: This course is not available to MSJ students

The course in health care antitrust law is structured to expose the students to the fundamentals of antitrust law through a review of antitrust policy, the basic antitrust statutes and foundational case law. The concepts of standards of legality, relevant antitrust markets, market power, monopoly power and enforcement/penalties will be explored. The course will apply these legal principles, using health care industry cases when available, to explore Sherman Act §1: horizontal agreements among competitors (i.e. price fixing, market allocation, concerted refusal to deal or boycott); Sherman Act §1 vertical agreements (i.e. tying arrangements, and exclusive dealing agreements); Sherman Act §2: monopolization, attempted monopolization and conspiracy to monopolize; and Clayton Act §7: Horizontal mergers and joint ventures.
Finally, the course will review traditional antitrust exemptions and defenses and the regulatory agencies’ Statements of Enforcement relating to the health care industry.
 

HEALTH CARE FINANCE (HLTH9511)
2 or 3 credits. Seminar.

The financing of health care is a fundamental aspect of the U.S. health care system.  Health care finance has grown and changed over the years and has become an increasingly complex and confusing mix of fragmented private and public mechanisms.  The extent and rapidity of the changes that have taken place have created a number of problems which relate to such basic issues as: who provides care, where it is provided, what incentive exists, and who receives services.  This course examines and explores the current issues and problems in health care finance policy and offers an in-depth study of the finance dimensions of specific topics (e.g., politics and players in health care financing: government, providers, payers and consumers; reimbursement methodologies; regulating and rate setting; ect.).
 

HEALTH CARE FRAUD & ABUSE (HLTH8505)
2 credits. Lecture.
Prerequisite: Health Law I

The complex business of health care finance and delivery is increasingly structured by reference to an array of federal regulatory and statutory requirements. Attorneys reviewing relationships among the providers and between providers and payors must be familiar with the anti- kickback laws, the False Claims Act, Stark I & II, and RICO. This course examines the application of those laws in the context of commercial relationships, regulatory reviews, and criminal investigation and prosecutions. It also examines the burgeoning area of corporate compliance programs.

HEALTH LAW (HLTH7503)
3 credits. Lecture.
Pre/co-requisite: Business Associations

This survey course introduces students to the major legal and policy issues surrounding the provision of health care. Topics include the organization and governance of nonprofit hospitals and other health care organizations, financing of care through public and private insurance programs, health care fraud and abuse, quality control in health care, confidentiality of medical information, informed consent, reproductive health care, medical decisions at the end of life, and medical research with human subjects.

HEALTH LAW FOR MSJs I: Health Care Organizations (HLTH7515)
3 credits. Lecture.

This course will examine the means by which patients gain access to health care and through which sponsors of health coverage organize and compensate health care providers.  It will include a study of private and public means of health insurance and different types of third party payors, including Medicare, Medicaid, and managed care organizations.  The class will also survey the organization of hospitals and other health care entities and introduce students to the issues, laws, regulations and accreditation standards essential to understanding the structure and permitted functions of health care entities.  The course will introduce students to the physician-patient relationship, which includes studying the confidentiality of medical information, informed consent, and the standard of care used for malpractice actions.

HEALTH LAW FOR MSJs II: Patient Rights and Public Health (HLTH7517)
2 credits. Lecture.

This course will examine the major legal and ethical issues surrounding patients' rights and varied approaches to medical practice and research. Topics will include medical decisions at the end of life, procreative rights and parenting issues, and the use of human subjects in medical research and drug development.  The course will also examine alternative medicine and the means by which medicine is regulated.  The class will also introduce students to a variety of public health issues.

Health Policy and Professional Development (HLTH7525)
2 credits. Lecture.
Note: For MSJ students only.

This seminar focuses on understanding the formation of health policy and how it relates to one’s personal development and professional advancement within an organization. Students will explore the dynamics of policy process and formation as they relate to specific health care issues facing our society today, while gaining an understanding of the interplay between those issues and the missions of various health care industries. Emphasis will be placed on ways to become involved in the policy process within various health care industries, the governmental institutions that regulate those industries, and related professional associations. The organizational structures, cultures, behaviors and politics of these entities, and potential opportunities for career advancements within or through them will be considered. The importance of developing one’s management and leadership skills to achieve professional goals in an ethical manner will be discussed.

HEALTHCARE BANKRUPTCY (HLTH9512)
2 credits. Seminar.

As the health-care industry continues to have financial difficulties, more hospitals, physician practice groups, clinics, nursing homes and home health agencies are filing for bankruptcy or restructuring their debt. This seminar will focus the following topics: how some health-care providers became financially distressed; legal issues surrounding a health-care debtor in bankruptcy under the Bankruptcy Code and the recently enacted Bankruptcy Abuse Prevention and Consumer Act of 2005; and public policy issues that may provide a solution to what some call a "health-care financial crisis".  Students will also gain practical experience by working in groups to present what legal advice they would provide to a health-care debtor, physicians,
patients, and general creditors in a pre and post bankruptcy scenario.

HIPAA and HEALTH PRIVACY (HLTH7504)
2 credits. Lecture

This seminar provides a comprehensive analysis of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) health privacy provisions, which pose substantial technology and privacy requirements for health plans, health care clearinghouses, and many health care providers. Topics include HIPAA's administrative simplification provisions, the Privacy Rule, the Transaction Rule, and an overview of electronic data interchange concepts as applied to health information. Students will also explore the developing body of case law in this area. Practical experience will be offered in drafting and negotiating HIPAA business associate contracts as well as in developing privacy policies and procedures.

THE LAW OF DEATH & DYING (HLTH9509)
2 or 3 credits. Seminar.

This seminar engages the student in an extensive study and analysis of empirical data, current statutes and cases as well as proposed changes to the law dealing with issues related to death and dying.  Class topics include alternative definitions of death, organ donation, withholding and withdrawal of death-prolonging and life-sustaining treatment, advance directives, patient demands for futile treatment, the cost of end-of-life care, wrongful living, and physician-assisted death.

LEGAL MEDICINE & PUBLIC HEALTH (HLTH7506)
3 credits. Lecture.

This course undertakes an in-depth study of the classical discipline of legal medicine which includes consideration of the forensic sciences, legal principles and systems of death investigation, criminalistics, genetic markers and their use in court, and judicial receptivity to new scientific tests. The course then turns to consideration of the doctrinal boundaries and analytical methodology of American public health law. Topics include the public health sciences, sources of authority for public health control, health information privacy, government support for science and medicine and control of research in science and medicine.

THE LEGAL SYSTEM, RESEARCH & WRITING I (HLTH7390)
4 credits. Seminar.

This course provides M.S.J. students with an introduction to the legal system as well as basic legal research and writing skills, with a focus on topics relevant to the health and pharmaceutical industries.  Students will receive LEXIS, WESTLAW and Internet research training.

THE LEGAL SYSTEM, RESEARCH & WRITING II (HLTH7391)
3 credits. Seminar.

This course continues to hone the skills that students learned in The Legal System, Research & Writing I, with a particular focus on statutory and regulatory analysis.

LLM THESIS I - II (HLTH9500, 9502)
First semester; 2 credits.
Second semester; 3 credits.

The LLM student shall write his or her thesis independently of any course or seminar, with a full-time faculty member acting as a supervisor. In semester one, the student will select a topic, and a thesis supervisor. Before the conclusion of semester one, the student shall make an oral presentation of his or her work-in-progress to the health law faculty and other LLM students; submit a paper abstract of approximately ten pages; and submit an annotated bibliography. The student shall receive a Pass/D or Fail designation and an award of two credits for the completion of this work. The student shall complete the thesis in semester two, for which the student shall upon completion, be awarded three credits and a letter grade. The final thesis product must be of professional law review publishable quality, at least 50 pages in length unless otherwise waived. LLM students are expected to attend the oral presentations of their colleagues.

MAKING HEALTH CARE DECISIONS (HLTH9504)
2 credits. Seminar.

This seminar exposes students to medical, ethical and legal foundations and processes of health care decision-making.  It seeks to expose medical and law students to each other's analytical methods, and to the clinical contexts in which health care decisions are made.  Substantive topics will include the doctrine of informed consent, advance directives, DNR orders, brain death, treatment termination, organ transplantation, competency determinations, palliative care, pediatric decision-making, conflict resolution, and the intersection of race, culture, socio-economics and decision-making.  Students will participate in an ethics consultation, go on rounds, attend a case conference, and engage in as many clinical experiences as possible to integrate the three disciplines of the course.  This course takes place at the University of Medicine and Dentistry of New Jersey and is open to JD students, medical students and residents.  It will be taught by a medical professor, law professor and ethicist in a clinical setting. Transportation will be provided by the Law School.

The course is graded on a Pass/D or Fail basis.

MEDICAL MALPRACTICE (HLTH8508)
2 credits. Lecture.

This course focuses on traditional principles underlying New Jersey medical malpractice law, using a practical and substantive approach to the subjection, focusing on the standard of care, expert-related issues, causation and damages relating or pertaining to medical malpractice actions.  The school attendance will be in effect for this course, and class participation is expected. 

MENTAL HEALTH LAW (HLTH7511)
2 credits. Lecture.

This course focuses on the use of governmental authority to restrict or deprive individuals with mental disorder of liberty or property in a variety of civil contexts. These interventions are intended to either prevent future harm to self/others or "incompetent" choices. The civil commitment, both inpatient and outpatient, of individuals with major mental illnesses is the main context studied. The commitment of sex offenders, the right to refuse psychiatric medication, the duty to warn and competency determinations will also be examined. To provide a foundation for the legal analysis, the nature and treatment of mental disorders will be summarily explored. A variety of mental health professionals and advocates participate in the seminar to enhance understanding of the issues and provide diverse perspectives.