Health Law News
A Quarterly Publication of the University of Houston Health Law & Policy Institute. Established in 1978.
September 2000, Vol. XIV, No. 1

Special Section -- Supreme Court Review


Kuszler Joins Institute as Visiting Professor

Patricia KuszlerPatricia C. Kuszler, M.D., J.D., has joined the Health Law & Policy Institute as a Visiting Professor for the fall semester of 2000. She is teaching Health Care Organizations and Health Care Finance and Policy. Dr. Kuszler has been an Associate Professor at the University of Washington School of Law in Seattle since 1994, where she has been teaching various health law and related courses.

Since 1994, Dr. Kuszler has been an Adjunct Associate Professor in the Department of Medical History and Ethics at the University of Washington School of Medicine in Seattle, where she has been teaching Medical Ethics and Jurisprudence. Since 1996, she has been an Adjunct Associate Professor at the University of Washington School of Public Health in Seattle where she taught Public Health Law and was an Instructor in the Medical Management Certificate program for physicians.

Dr. Kuszler was an attorney with the firm of Hogan & Hartson in Washington, D.C. from 1991 to 1994, where her practice focused on health, regulatory and policy issues. She has also held the following positions: Medical Director for Blue Cross & Blue Shield of Connecticut in North Haven, Connecticut; Director of Emergency Services for Meriden-Wallingford Hospital (now Mid-State Medical Center), Meriden, Connecticut; Clinical Instructor in Emergency Medicine at New York Medical College, White Plains, New York; and Associate Director of Emergency Services at Good Samaritan Hospital, Suffern, New York.

Dr. Kuszler obtained her B.A. from Mills College in Oakland, California in 1974. She received her M.D. from the Mayo Medical School, Rochester, Minnesota in 1978, and completed her Postgraduate Residency Training in Emergency Medicine at Columbia University Affiliated Hospitals in New York, New York from 1978-1981. Dr. Kuszler received her J.D. in 1991 from Yale Law School, where she served as Senior Editor of the Yale Law Journal.

Dr. Kuszler's recent publications include Financing of Clinical Research and Investigational Therapies: Payment Due, But from Whom?, 3 DEPAUL J. HEALTH CARE LAW 441 (2000) and Telemedicine and Integrated Health Care Delivery: Compounding Malpractice Liability, 25 AM. J. LAW & MED. 297 (1999). Dr. Kuszler is a member of numerous professional organizations and her professional licenses include her Connecticut Physician License and membership in the Supreme Court Bar, the District of Columbia Bar, and the Connecticut Bar. Her other activities include serving as Chair of various committees, including the University of Washington School of Law Executive Council, the University of Washington Human Subjects Committee, and the University of Washington Conflict of Financial Interest Advisory Committee.

Marian Wright Edelman to Present Jenkens & Gilchrist Health Law Lecture 2001

On February 21, 2001, the Health Law & Policy Institute will present the Jenkens & Gilchrist Health Law Lecture featuring Marian Wright Edelman, founder and president of the Children’s Defense Fund. Her topic will be "Children's Health Needs for the Coming Years." Additional details will appear in the December issue of Health Law News.

Rothstein Resigns; Bobinski Named New Director of Institute

Mary Anne BobinskiHealth Law & Policy Institute director Mark A. Rothstein has announced his resignation effective at the end of the current calendar year. Rothstein, who has directed the Institute since 1986, will become the Distinguished Professor of Law and Medicine at the University of Louisville School of Medicine and Director of the school's new Institute of Bioethics, Health Policy, and Law effective January 1, 2001. He will also have a faculty appointment at the University of Louisville's Brandeis School of Law.

Mary Anne Bobinski, Professor of Law and Associate Dean for Academic Affairs, will be the new director. A member of the faculty since 1987, Bobinski is a co-author of a leading casebook on health law and has written on HIV-infected health care workers, conflicts of interest in the physician-patient relationship, and other issues.

Another change at the Institute is the resignation of Laura F. Rothstein, Law Foundation Professor of Law and Associate Dean for Graduate Studies and Special Programs. On August 1, 2000, she became Dean and Professor of Law at the Louis D. Brandeis School of Law at the University of Louisville. Professor Rothstein, a national expert on law and disabilities, joined the faculty at the University of Houston Law Center in 1986.

Institute Receives CDC Grant to Study Public Health Approach to Tuberculosis

The Centers for Disease Control and Prevention (CDC) has awarded a grant of $7,500 to the Health Law & Policy Institute to research the legal implications of policies proposed to eliminate tuberculosis in the United States.

The research project will supplement earlier efforts to construct an action plan to eradicate tuberculosis in this country. CDC commissioned the Institute of Medicine (IOM) of the National Academy of Sciences to write a report regarding what needs to be done to eliminate tuberculosis in the United States. On May 4, 2000, the IOM released the report of its Committee on the Elimination of Tuberculosis in the United States, entitled "Ending Neglect – The Elimination of Tuberculosis in the United States." The report calls for the nation to "commit to the abolition of the recurrent cycles of neglect of tuberculosis in the later part of the past century." An action plan is being developed to begin implementing various recommendations presented throughout the report.

Many of the recommendations have legal and public health policy implications. The Health Law & Policy Institute will provide a legal analysis of the IOM report and existing laws that would facilitate or impede the implementation of IOM recommendations. Specifically, the Health Law & Policy Institute will prepare a summary document of research of current general state, prison-related and immigration-related tuberculosis and tuberculosis/HIV control laws and the implications of the IOM recommendations in each of these areas.

Institute to Participate in Texas Genetics Grant

The University of Texas Health Science Center at San Antonio, in connection with the Texas Department of Health, the Texas Genetics Network, and the Interagency Council for Genetic Services, has commissioned the Health Law & Policy Institute to begin work on part of a two-year state planning grant entitled "The Development of the Texas State Genetics Plan and a Plan for Integrated Data Infrastructure for Genetic Services."

In an effort to improve the provision and coordination of genetic services in Texas, the grant has several goals: 1) to establish a State Genetics Advisory Council; 2) to develop a Texas State Genetics Plan; and 3) to conduct a feasibility assessment of the existing genetic surveillance systems and the potential for integration with other early intervention systems.

The role of the Institute is to assess current and proposed laws, regulations, and rulings affecting genetic activities in the state of Texas. The Institute will also explore the ethical, legal, and social implications of developing, implementing, and evaluating a state genetics plan and a system for integrated data management. Mark A. Rothstein has been appointed to the State Genetics Advisory Council and will serve as a consultant.

Institute to Contribute Regularly to Internal Medicine World Report

Internal Medicine World Report will launch a new quarterly department this fall called "The Health Law Report," which will offer in-depth discussions about medicolegal developments and the implications they could have for internists. Faculty of the Health Law & Policy Institute will contribute articles. Ronald L. Scott, research professor at the Institute, will be the department’s editor.

Levy Receives Public Service Award

Bruce LevyBruce A. Levy, M.D., J.D., a member of the Health Law & Policy Institute's advisory board, has received the Texas Osteopathic Medical Association's (TOMA) Public Service Award. The award recognizes outstanding works and accomplishments in promoting the health care needs of the state of Texas. The award was presented to Dr. Levy on June 17, 2000.

Dr. Levy served as executive director of the Texas State Board of Medical Examiners (Board) from 1993 until he recently accepted the newly created position of Deputy Executive Vice President at the Federation of State Medical Boards (Federation). His primary role will be to assist Federation Executive Vice President James Winn, M.D., in representing the Federation and serving as a liaison to external organizations.

Dr. Levy earned his medical degree from Hahnemann Medical College and Hospital in 1971, and his law degree from the University of Houston in 1992. Dr. Levy is board certified by the American Board of Anesthesiologists. He has taught in the anesthesiology departments at Baylor College of Medicine in Houston and the University of Washington, Seattle. Dr. Levy has served on numerous committees for the Federation of State Medical Boards of the United States, and most recently, concluded a term as a member of its Board of Directors. Dr. Levy is also a member of USMLE and National Board of Medical Examiners Committee on Irregular Behavior.

The Board is the state agency responsible for the licensure and discipline of physicians in Texas. Under Dr. Levy's leadership, the Board has implemented all statutory Sunset recommendations; completed all investigations over one year of age; increased disciplinary actions by 35%; established a consumer complaint notification procedure and a toll free phone number; created ethical guidelines for proper physician-patient sexual boundaries, appropriate advertising, and informed consent; and adopted rules related to therapeutic prescribing for chronic non-malignant pain, regulation of postgraduate medical training, and office-based anesthesia. Also, the Board of Acupuncture Examiners and the Board of Physician Assistant Examiners have been developed.

Health Law Organization Holds Fall Meeting

Health Law Organization OfficersHLO officers from left to right: Amy Yenyo, Tom Stuckey, Carol Chaffin, Diane Miller, Adria Conklin, and Susan Valka.

On August 30, 2000, the Health Law Organization (HLO) held its first meeting of the fall semester. The HLO introduced students to the Health Law & Policy Institute, and the University of Houston Law Center.

BOOK REVIEW

e-Healthcare
By: Douglas E. Goldstein
Aspen Publishers, Inc., Gaithersburg, Maryland 2000
$79.00 for book and CD ROM

Reviewed by: Ronald L. Scott, J.D., LL.M.
Research Professor
Health Law & Policy Institute
University of Houston Law Center

e-HealthcareLegislators at the state and federal levels are struggling to decide how best to control the delivery of health care via the Internet. On-line pharmacies and physicians associated with such enterprises have been targeted by regulators for providing prescription medications without adequate physical exams. The fees for certain types of elective surgery are available in an auction format. States are deciding whether to license automatic pharmacy dispensing machines. Companies are storing medical information on the Internet, raising privacy issues. Now, a very interesting book has been published that addresses many of these issues and others.

E-Healthcare addresses the impact of the Internet and related emerging technologies on the provision of health care. It is divided into four sections. The first section focuses on the electronic trends that are "revolutionizing health care and the entire world." One trend discussed is patients who use the Internet to research a medical condition, drug, or therapy and then take it to their physician for "validation." Another is the growth of alternative medicine information and products on the Internet.

The second section describes how current models of care delivery, disease management, and demand management are evolving into what the author says are care support and "e-care" models that allow patients to better guide their own care. The author predicts that telemedicine will grow in frequency with web-enabled applications and net devices.

The third section suggests ways to utilize the Internet in health care organizations, hospitals, and physicians’ offices. This section encourages physicians to "get on line" and communicate with their patients via e-mail. It also discusses the complexity of integrated on-line medical records. The last section discusses strategies for implementing "e" into health care organizations, including legal issues arising from e-healthcare. One stylistic criticism is that the book is filled with "e" jargon. In hundreds, if not thousands, of instances, "e" is used as a modifier—often unnecessarily. We don’t need to refer to patients as "e-patients" within the context of this book-readers are capable of understanding the point. I hoped (unsuccessfully) that the many references to "e" would eventually become invisible or at least neutral to the reader, but such was not the case.

The book credits twenty-four contributors in addition to main author Goldstein. Contributors include executives in Internet health care consulting companies, medical directors and officers for a variety of organizations, and one attorney. The large and somewhat varied group of contributors is helpful given the breadth of the book. However, the chapters are so different stylistically that the book is easier to read as a reference manual than as a unified work.

Some of the book’s predictions are already coming true. In Chapter 2 titled "e-commerce: The New Business Model," Goldstein discusses using the Internet to automate the process of sending reminders for appointments, annual physicals, and well-women exams. He also speculates ‘"Going once, going twice"-could medical e-auctions be the next step? Organs, bypass surgery, plastic surgery—all to the right bidder, on line." The prediction has already come true, with plastic surgery and other elective procedures available via forms of Internet auctions. However, the comment also illustrates another criticism of the book. Although the concept of selling organs via the Internet is introduced, no discussion of the legal, moral, or ethical concerns follows.

Some chapters are better than others at addressing barriers to the delivery of health care via the Internet. For example, Chapter 7, Telemedicine Becomes a Reality with Web-Enabled Applications and Net Devices not only does an excellent job of describing telemedicine applications and technology but also addresses "challenges" to telemedicine and e-care implementation. Such challenges include confidentiality, licensure and accreditation, reimbursement, and access to technology—a digital-divide version of the access to care problem.

In keeping with the high-tech subject matter, the book ships with a very useful CD-ROM version in PDF format, allowing links to the numerous web sites discussed in the book to be easily accessed without typing in the URL. E-healthcare should be read (or used as a reference) by anyone involved in the provision of health care via the Internet. Its discussion of trends and predictions for the future are valuable, and its description of current and emerging technology is clear and useful.

FROM THE WEB

The following articles appeared on the Health Law & Policy Institute's Web site between May 1, 2000 and August 3, 2000:

Institute Web Site Adds Statutes, Search Engine, Community

The Health Law & Policy Institute has recently added to its Web site at http://www.law.uh.edu/healthlaw Supplementary Materials on Health Law by Professors Mary Anne Bobinski and Seth J. Chandler. The Supplementary Materials are intended to provide students, teachers, and researchers of health law with additional resources by facilitating distribution of key materials, including federal statutes, state statutes, and recent cases. The site provides access to selected statutes, cases, and regulatory materials that are frequently of interest to those involved in health law studies. From the Supplementary Materials on Health Law homepage, users can link to 3 areas: (1) federal legislative and administrative materials; (2) state specific materials (right now the only state included is Texas) and (3) new cases or other materials of particular interest. The site attempts to provide each item in 4 formats (1) HTML; (2) Adobe PDF; (3) Word 97; and (4) Word Perfect.

We have also added a Health Law Perspectives Search Engine. Users can now search over 200 articles in Health Law Perspectives for ones addressing specific topics. Also, the Web site has added Health Law Community. Health Law Community lists upcoming health law events and conferences of the Institute and other institutions, features links to useful health law publications, and has announcements of interest to the health law community. To request an item be included in Health Law Community, contact the Institute at hlpi@central.uh.edu.

New Health Law LL.M. Students Join Program

LLM StudentsSeven new students have entered the Health Law & Policy Institute's Masters Program.

Dean J. Haas received a B.S.B.A. in Accounting in 1980 and a J.D. from the University of North Dakota in 1983, where he co-authored the article "An Introduction to North Dakota Workers Compensation" in the North Dakota Law Review. Since 1995, he has been a partner in the firm of Diets, Little & Haas.

Charles R. Hicks received a B.S. in Psychology in 1976 and a J.D. in 1979 from the University of Arkansas at Little Rock. He has been an adjunct professor at the University of Arkansas College of Medicine. In the area of health law, he has served as Special Arkansas Circuit Judge, and most recently, as managing partner at the Hicks Law Firm.

Morris A. Landau received a B.S. in Speech Communications and a B.A. in History from The University of Texas at Austin in 1988, a J.D. from the University of Tennessee, and a Master in Health Administration from the University of Memphis in May 2000. Since 1998, he has been a Graduate Fellow with the University of Tennessee College of Medicine, Boling Center for Developmental Disabilities.

Yvette M. Mastin received a B.S. in Social Work in 1992 from Southwest Texas State University, a Masters in Social Work from The University of Texas at Austin in 1995, and a J.D. from St. Mary’s University in May 2000. In 1999, she was the second place winner of the Health Law Writing Competition by the Health Law Section of the State Bar of Texas. In the fall of 1999, her article "Sentenced to Purgatory: The Indefinite Detention of Mariel Cubans," was published in the St. Mary’s Law Review on Minority Issues.

Brian T. Mulligan received a B.A. in Criminal Justice in 1994, a J.D. in 2000, and a Master in Health Administration in 2000 from the University of Florida. He was a Congressional Fellow with Congressman Michael Bilirakis (9th District, Florida) in 1998. He has been a member of both the American Health Lawyers Association and the American Society of Law, Medicine and Ethics since 1999.

Matthew L. Robey received a B.A. in International Studies in 1990, and a J.D. in 1994 from American University. He has been a contract attorney with various law firms in Houston since 1995. He is a member of the State Bar of Texas, the Kentucky Bar Association, and the Virginia State Bar.

Lendy DeLane Van Slyke received a B.A. in 1995 and a Masters of Business in 1997 from Millsaps College, and a J.D. in 2000 from the University of Mississippi. She served on the editorial board of the Mississippi Law Journal.

American Cancer Society Grants for Health Services and Health Policies Outcomes Research and Training

The American Cancer Society, the largest private not-for-profit funding source for cancer research in the United States, is pleased to invite applications for the following grants:

Complete descriptions of grants, eligibility requirements, instructions, and applications are available on the American Cancer Society Web site at http://www.cancer.org. Click on "Research Program" and "Funding Opportunities" or call 404-329-7558 or e-mail: grants@cancer.org.

Focus on Our Graduates

Susan Kerr (J.D. 1996) wrote an article entitled "The Application of the Americans with Disabilities Act to the Termination of Parental Rights of Individuals with Mental Disabilities," which appeared in the Summer 2000 issue of the Journal of Contemporary Health Law & Policy.

Marcus L. Stevenson (LL.M. 1998) wrote an article entitled "Regulating Reproductive Technology: Human Cloning," that was published in the Journal of Medicine and Law (Spring 1999).

Doug Witten (LL.M. 1997) has recently accepted a position as an associate in King & Spalding's healthcare practice group in Atlanta, Georgia.

Publications

Mary Anderlik

"Don't Exploit Genes to Discriminate," Newsday, June 27, 2000

Mary Anne Bobinski

"Legal Issues in Hospital Infection Control," in Hospital Epidemiology and Infection Control (C. Glenn Mayhall, ed.)(Baltimore: Williams & Wilkins; revised 2d edition 1999).

Seth Chandler

"Insurance Regulation" in Encyclopedia of Law and Economics, vol. 3.

His article on the Texas-Aetna settlement (published in Health Law Perspectives http://www.law.uh.edu/healthlawperspectives) has been featured by Texas Attorney General John Cornyn in an explanation of that litigation to the Texas House Insurance Committee

Mark A. Rothstein

Cases and Materials on Employment Law (4th ed.) (with Lance Liebman) (2000 Supplement)

Ronald Turner

'Membership' Obligations Under NLRA Section 8(a)(3): A Proposal for Statutory Change 17 Hofstra Lab. & Emp. L.J. 323 (2000)

Presentations

Mary Anderlik

"The ADA as a Framework for Approaching Public Policy," The Rehabilitation Institute of Chicago Conference on ADA and Health Care, Chicago, Illinois, June 19, 2000

"Disability Issues and Public Insurance," The Rehabilitation Institute of Chicago Conference on ADA and Health Care, Chicago, Illinois, June 19, 2000

Mary Anne Bobinski

"Health Law," National Youth Leadership Forum, Houston-Galveston, Houston, Texas, July 13 and 27, 2000

Phyllis Griffin Epps

"Pharmacogenomics and Minority Populations" in "The Human Genome Project: The Challenges and Impact of Human Genome Research for Minority Communities," Zeta Phi Beta Sorority, Inc. National Educational Foundation, Philadelphia, Pennsylvania, July 8, 2000

"Pharmacogenomics," National Institutes of Health (NIH) National Institute of General Medical Sciences (NIGMS) Populations Advisory Group, August 2, 2000, Bethesda, Maryland

Seth Chandler

"Visualizing Adverse Selection - And Understanding the Insurance/Genetic Testing Debate Too," American Society of Law, Medicine and Ethics Meeting, Case Western Reserve University Law School, Cleveland, Ohio, June 10, 2000

"What Actuaries Have to Contribute to the Insurance/Genetic Testing Debate," Southwest Actuaries Club Annual Meeting, Galveston, Texas, June 16, 2000

"Impact of Genetic Testing on Small Health and Life Insurers," Insurance Alliance of America's Annual Meeting, San Antonio, Texas, July 31, 2000

Mark A. Rothstein

"Science and the Courts," Ninth Circuit Judicial Conference, Sun Valley, Idaho, August 24, 2000

"Behavioral Genetics and the Law," Southern University School of Law, Baton Rouge, Louisiana, September 15, 2000

"Privacy and Confidentiality Issues under the Human Genome Project," Greater Houston Partnership, Houston, Texas, September 27, 2000

William J. Winslade

"Goals and Strategies for Teaching Death and Dying in Medical Schools," Journal of Palliative Medicine, Vol. 3, Number 1, 2000, p. 7-16. (Dr. Winslade is 1 of 14 authors)

"Sex Offenders, Sentencing Laws and Pharmaceutical Treatment: A Prescription for Failure," Behavioral Sciences and the Law, 2000, 18:83-110. (Dr. Winslade co-authored with 2 others)

Appointments

Mary Anne Bobinski

Phyllis Griffin Epps Ronald Turner

Special Section -- Supreme Court Review
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SUPREME COURT REVIEW

Introduction: Supreme Court Review of Health Law, 1999 - 2000 Term

Edward P. Richards, J.D., M.P.H.
Professor of Law
Director of the Center for Public Health Law
University of Missouri Kansas City School of Law
http://plague.law.umkc.edu/cphl

Ed RichardsThe health law cases during the 1999 - 2000 United States Supreme Court term reflect the larger trends in the Court's decisionmaking. There are cases with a near consensus court that provide clear guidance to the bar, cases with bitterly contested opinions with narrow majorities, and cases that raise as many questions as they answer. Federalism continues as a divisive issue on the Court, but the most watched issue - whether the Americans with Disabilities Act can be privately enforced against the states - did not reach the Court this term in the wake of strategic settlements.

The most bitterly contested case, one that reflects a long-standing stalemate on the Court, is Stenberg v. Carhart, 120 S.Ct. 2597 (2000), the partial-birth abortion case. As Professor Shepherd explains, the Court split 5-4, with the majority finding the law unconstitutional because it did not include an exception for the health of the mother and because it was sufficiently vague as to potentially ban common and safe abortion techniques. This case indicates that the Court's divisions on the abortion issue are no closer to resolution and the stalemate will continue as long as does the current composition of the Court.

The case that most interested Wall Street, health care insurers, and patients' rights advocates is Pegram v. Herdrich, 120 S.Ct. 2143 (2000). This case clearly holds that managed care organizations (MCOs) cannot be sued as ERISA fiduciaries when making personal medical care decisions. This was hailed as a triumph by the MCOs and some of the health law bar. However, as detailed by Professor Hall, the Court's reasoning that such decisions are not covered by ERISA implies that they will be subject to state tort actions, leaving the health law bar split as to whether this case will ultimately result in more, rather than less litigation against MCOs.

Two of the Court's health care decisions have broader administrative law implications. In FDA v. Brown & Williamson Tobacco Corp., 120 S. Ct. 1291 (2000), the Court wrestled with the deference to be granted to an agency when it embarks on regulations that are clearly beyond the mandate Congress intended to give the agency, but are arguably within its enabling legislation. As Professor Noah explains, the politics of the case clearly influence what could otherwise be a dry application of the Chevron doctrine. While the final result is consistent with administrative law precedent, it leaves many heath lawyers unsatisfied that Congress will resolve the issue sent them by the Court.

The second administrative law case is Shalala v. Illinois Council on Long Term Care, 120 S.Ct. 1084 (2000). This is a complex case, involving congressional limitations on judicial review of agency decisions under the Medicare Act. While Congress has broad latitude to limit such judicial review, the courts view such limitations with suspicion and construe them narrowly. As Professor Kinney explains, the Court's holding was driven by prior precedent and by its recognition that a system as large as Medicare cannot be effectively administered if it faces constant litigation and the potential of reconciling differing rulings in the circuits.

The only criminal law case this term is Fischer v. United States, 120 S. Ct. 1780 (2000). Professor Blumstein's review of this case and the RICO and qui tam cases illustrates the role that federalism plays in the Court's recent decisions. Fisher was convicted under the federal bribery statute for illegal conduct related to provider payments under the Medicare program. Fisher appealed his conviction, claiming that the bribery act only applied to beneficiaries of federal programs, not to persons who contract to provide services to beneficiaries of the program. The Court recognized that an expansive definition of beneficiary under the bribery act could federalize many crimes traditionally left to state prosecution. At the same time, precedent and congressional intent were that defendant's actions should be covered by federal law. The Court resolved the issue by a factual inquiry into the nature of the payments to providers under Medicare, and found that they include substantially more than a pure fee-for-service reimbursement system. These extra payments, intended, among other things, to assure the provision of services in the community, make providers beneficiaries under Medicare and thus supported the application of the bribery act.

The RICO case, Rotella v. Wood, 120 S. Ct. 1075 (2000), arose in a health care context, but its resolution is independent of any specific health care facts. This is a civil RICO action triggered by a criminal plea agreement by the defendants, made some 9 years after the alleged RICO injury to plaintiff, with more than 12 years elapsing between the injury and the filing of plaintiff's lawsuit. The Court rejected the plaintiff's claim that the statute should be tolled until he learned of the plea agreement, thus putting him within the 4 year RICO limitations period. The Court disagreed, finding this action barred, but it did not reach the issue of whether there might circumstances that justified a discovery rule under RICO.

One of the most contentious issues in health care is the role of qui tam plaintiffs in policing health care fraud under the False Claims Act (FCA). Providers fear both the civil damages and the potential that such lawsuits will trigger federal criminal prosecution. Plaintiffs argue that these suits, especially under the whistle blower provisions of the act, are the only recourse for individuals to fight illegal actions by health care businesses. Providers had hoped that the Court would find federal qui tam actions unconstitutional in Vermont Agency of Natural Resources v. United States ex rel. Stevens, 120 S. Ct. 1858 (2000). The Court did not go so far. In an opinion rooted in history, the Court found that Congress did have the power to allow private litigants to "stand in the shoes" of the federal government and upheld the general principle of qui tam lawsuits and their use in the FCA. In the specific case, however, the Court found that Congress had not included states in its definition of person under the FCA and thus dismissed plaintiff's claims in this case and barred future cases brought by FCA qui tam plaintiffs against states. The Court did not decide whether Congress had the power to give citizens standing to sue states as qui tam plaintiffs, only that it had not done so in this case.

FRAUD, FEDERALISM, AND REPOSE

James F. Blumstein, M.A., LL.B.
Centennial Professor of Law
Vanderbilt Law School
and
Director, Health Policy Center
Vanderbilt Institute for Public Policy Studies

Fischer v. United States: Fraud and Federalism

James BlumsteinFor the health law field, Fischer v. United States, 120 S. Ct. 1780 (2000), is about the federal bribery statute and its application to fraud perpetrated on organizations participating in Medicare. More generally, however, the Court’s analysis was sensitive to considerations of federalism principles. Indeed, in all three cases discussed here, underlying issues of policy largely unrelated to fraud or health care had an important role in shaping the Court’s analysis.

The federal bribery statute prohibits defrauding organizations that "receiv[e], in any one year period, benefits in excess of $10,000 under a Federal program involving … Federal assistance." 18 U.S.C. §666(b). The issue in Fischer was whether health care providers receive "benefits" within the meaning of the statute. The Court held that payments to providers under Medicare constituted "benefits," thereby triggering application of the federal bribery statute.

Petitioner, as president of a company that performed billing audits for health care organizations, was accused of defrauding a municipal agency responsible for operating two hospitals, both of which participated in Medicare and each of which received millions of dollars in Medicare funds. Petitioner’s conviction under the federal bribery statute was affirmed by the Supreme Court.

Petitioner contended that the Medicare program provides "benefits" to its beneficiaries, not to health care providers. Justice Thomas’ dissent (joined by Justice Scalia) accepted that position -- providers receive "payment[s]" but only program beneficiaries receive "benefits." For the dissent, construing Medicare payments to providers as "benefits" extends the reach of the federal bribery statute "to any federal assistance program that provides funds to any organization" and stretches the reach of federal criminal law to the constitutional limit. 120 S. Ct. at 1793. The source of authority to enact and enforce the statute is the federal spending power. Without a link to the federal program at issue (Medicare), the federal statute "would criminalize routine acts of fraud or bribery" which would "upse[t] the proper federal balance." Id. at 1793 n.3 (dissent).

The Court was quite sensitive to the federalism critique. While holding that Medicare payments to providers were "benefits" under §666(b), the Court asserted that not all payments to providers/vendors under a federal assistance program constituted "benefits." Such a construction, which the "statute does not employ," would be "almost limitless," turning "almost every act of fraud or bribery into a federal offense, upsetting the federal balance." Id. at 1788. Determining whether an organization that participates in a federal assistance program receives "benefits," under the Court’s decision, requires an examination of the program’s "structure, operation, and purpose." Id.

For the Court, Medicare is more than a program of "compensating providers or reimbursing them for ordinary course expenditures." Id. at 1787. That is, the government operates as more than a purchaser on the demand side of the market. It is, as well, directly concerned about the supply-side infrastructure of the Medicare program and marketplace. Under Medicare, the government is more than a passive payor in the market. It regulates hospitals, pays for graduate medical education, and carries out quality assurance. These additional supply-side policies and objectives "suffice to make the payment [to providers] a benefit within the meaning of the statute." Id. at 1788.

One of the ironies of this case is that it feeds the cynical critique of federal assistance programs – that their political strength lies in the alliance between advocates for program beneficiaries and program providers. Although the Court does not say directly, as some critics/cynics suggest, that a true beneficiary of a public assistance program is the provider community, that is a fair construction of the outcome of the case. Still, as the Court points out, context is important, and the context here was that of fraud perpetrated on an entity that ran hospitals that received Medicare funds.

Fischer is definitive regarding the application of the federal bribery statute to Medicare health care providers. It is much less so regarding the application of that federal law to other federal assistance programs. The Court purported not to accept the broad "limitless" reading that any federal payment to a provider under an assistance program constitutes a "benefit." However, focusing on a program’s "structure, operation, and purpose" -- the standard adopted by the Court in Fischer -- is not exactly a blueprint for future cases.

Rotella v. Wood: Issues of Repose -- When Does the Limitations Period Start to Run Under Civil RICO?

Rotella v. Wood, 120 S. Ct. 1075 (2000), involved the question when the limitations period on civil RICO claims begins to run. Civil RICO, 18 U.S.C. §1964(c), does not contain an express statute of limitations, but an earlier case established a uniform 4-year limitations period. Agency Holding Corp. v. Malley-Duff & Associates, 483 U.S. 143, 156 (1987). It did not, however, address the question when the limitations period began to run.

A RICO claim requires a showing of a "pattern of racketeering activity," 18 U.S.C. §1962(c), consisting of "at least two acts of racketeering activity." 18 U.S.C. §1961(5). Under petitioner’s theory, the so-called "injury and pattern discovery" rule, a civil RICO claim "accrues only when the claimant discovers, or should discover, both an injury and a pattern of RICO activity." 120 S. Ct. at 1080.

Petitioner was admitted to a private mental health facility in 1985 and discharged in 1986. The facility’s parent company pleaded guilty to criminal fraud in 1994. Petitioner learned of the guilty plea in 1994. The fraud related to improper relationships and illegal agreements between the company and its doctors, apparently at the time of petitioner’s treatment. 120 S. Ct. at 1082 n.4. In 1997 petitioner filed a civil RICO claim, alleging that respondents had conspired to "admit, treat, and retain him" in the facility "not for any medical reason but simply to maximize their profits." Id. at 1079.

Petitioner conceded that his injury arose and was discovered in 1986. He also conceded that his civil RICO claim "was complete and subject to suit at that time." Id. at 1083. Under an "injury discovery" rule, the limitations period would have expired in 1990. But, although the pattern of racketeering activity had occurred while petitioner was under treatment, that pattern had not been discovered until 1994, the time of the plea agreement. Petitioner urged that the limitations period extend to 1998, four years after he discovered the pattern of racketeering activity. Under petitioner’s theory, the limitations period does not start running until a plaintiff discovers or should have discovered "both the injury and the pattern of racketeering activity." Id. at 1079.

The Supreme Court rejected petitioner’s theory, leaving open the question whether an "injury discovery" or an "injury occurrence" principle would apply under civil RICO. Id. at 1080 n.2. The Court also left open the question "whether civil RICO allows for a cause of action when a second predicate act follows the injury, or what limitations accrual rule might apply in such a case." Id at 1082 n.4.

The Court was clearly concerned about closure on RICO claims, establishing "certainty about a plaintiff’s opportunity for recovery and a defendant’s potential liabilities." Id. at 1081. Where a federal statute has been silent about a limitations period, the Court has customarily applied a "discovery accrual" rule. In those cases, "discovery of the injury, not discovery of the other elements of the claim, is what starts the clock." Id. Ignorance of one’s legal rights does not toll the running of the limitations period.

Civil RICO provides for civil litigation to supplement government enforcement: "The object … is … not merely to compensate victims but to turn them into prosecutors, ‘private attorneys general,’ dedicated to eliminating racketeering activity." Id. at 1082. Extending the period for enforcement would "postpon[e] whatever public benefit civil RICO might realize," id., and "disserve the congressional objective of … rewarding the swift who undertake litigation in the public good." Id. at 1083.

The Rotella Court was concerned about the uncertainty of petitioner’s open-ended limitations principle. It took seriously the objective of repose and was determined not to allow a broad federal cause of action such as civil RICO to remain uncabined. To the extent that individual cases of injustice might arise, "equitable principles of tolling" can be applied to offset particularly harsh consequences of the limitations approach adopted in Rotella. Id. at 1083-84.

Vermont Agency of Natural Resources v. United States ex rel. Stevens: Relator Standing Under the Qui Tam Provisions of the False Claims Act

Vermont Agency of Natural Resources v. United States ex rel. Stevens, 120 S. Ct. 1858 (2000), dealt with the question whether a private individual (a "relator") may bring an action in federal court on behalf of the United States against a state agency under the so-called qui tam provisions of the False Claims Act (FCA), 31 U.S.C. §§3729-33. The Court addressed two quite distinct issues: whether a private individual has standing under Article III to maintain such an action; and whether a state agency can be sued for an FCA violation in federal court. The Court held that a private individual has standing to enforce the FCA but that the FCA does not apply to states or state agencies.

The FCA imposes civil liability upon "[a]ny person" who "knowingly presents, or causes to be presented to an officer or employee of the United States Government… a false or fraudulent claim for payment or approval." 31 U.S.C. §3729(a). The FCA can be enforced directly by the government, or a private relator may bring a qui tam civil action on behalf of the government against the alleged false claimant. 31 U.S.C. §3730(b)(1).

The FCA’s qui tam provisions are important in the health care arena because these whistleblower actions are increasingly a source of fraud litigation under federal health care programs such as Medicare and Medicaid, which do not have private enforcement provisions. See, e.g., United States ex rel. Thompson v. Columbia/HCA Healthcare Corp., 125 F.3d 899 (5th Cir. 1997). The FCA also provides generous recoveries – up to treble damages, a civil penalty of up to $10,000 per claim, recovery by the relator of 15-30% of the total amount received in the litigation, and recovery of attorney’s fees. FCA’s application to the health care field is controversial, and whether relators have standing to bring such actions is of considerable importance. See Lisa Michelle Phelps, Calling Off the Bounty Hunters: Discrediting the Use of Alleged Anti-Kickback Violations to Support False Claims Actions, 51 Vand. L. Rev. 1003 (1998).

In Stevens, the Court held that the FCA effected a partial assignment of the government’s claims to relators, who have standing as partial assignees to enforce the federal government’s FCA claim. Suits under the FCA against states or state agencies are barred because states are not a "person" under the FCA. After Stevens, a major potential hurdle lurking for whistleblower actions in the health care arena has been eliminated. The tough statutory issues relating to the applicability of the FCA to enforce the federal antikickback law or the federal anti-self-referral law (Stark) remain to be adjudicated definitively.

Supreme Court Restricts Federal Question
Jurisdiction for Medicare Challenges:
Shalala v. Illinois Council on Long Term Care

Eleanor D. Kinney, J.D., M.P.H.
Samuel R. Rosen Professor of Law &
Co-Director, The Center for Law and Health
Indiana University School of Law -- Indianapolis

Eleanor KinneyThe United States Supreme Court, in Shalala v. Illinois Council on Long Term Care, 120 S. Ct. 1084 (2000), considered the question of whether a federal district court has jurisdiction under 28 U.S.C. § 1331 to hear a nursing home association's challenge that certain Medicare-related regulations violated various statutes and the Constitution. The Seventh Circuit had reversed the district court's dismissal of the suit on grounds that 42 U.S.C. § 1395ii (incorporating into the Medicare Act 42 U.S.C. § 405(h)) barred federal question jurisdiction to this challenge. Specifically, § 405(h) provides that "[n]o action ... to recover on any claim" arising under the Medicare laws shall be "brought under section 1331 ... of title 28"). In so doing, a divided Court reversed the Seventh Circuit on this important issue. To clarify the law, the Supreme Court granted certiorari.

The jurisdictional bar in § 405 has been controversial since inception of the Medicare program. In 1965, Congress established that Medicare appeals would be handled through administrative and judicial review procedures for the Social Security program in 42 U.S.C. § 405. Beginning in 1972, Congress later established various administrative and judicial processes for both Medicare beneficiaries and providers but expressly retained the bar to federal question jurisdiction in § 405(h). (See 42 U.S.C. § 1395ii). Not surprisingly, the jurisdictional bar in § 405 has generated challenges from both Social Security and Medicare beneficiaries on a variety of theories. The Supreme Court has consistently rejected these challenges and required litigants to proceed through administrative review under the Social Security Act before judicial review. See, e.g., Weinberger v. Salfi, 422 U. S. 749 (1975); Califano v. Sanders, 430 U.S. 99 (1977); Heckler v. Ringer, 466 U.S. 602 (1984).

However, in Bowen v. Michigan Academy of Family Physicians, 476 U.S. 667 (1986), the Court permitted a provider organization to challenge directly a Medicare physician payment policy. The Court ruled that § 405(h) did not bar federal question jurisdiction on an issue for which the Medicare statute provided for no judicial review. Reiterating the fundamental administrative law principle favoring judicial review in the absence of express statutory preclusion, the Court concluded that the relevant provisions of the Medicare Act "simply does not speak to challenges mounted against the method by which such amounts are to be determined rather than the determinations themselves." 476 U.S. at 675. (After Michigan Academy, Congress amended the provisions for judicial review in 42 U.S.C. § 1395ff to address appeals of policies for coverage of and payment for Medicare benefits.)

The Michigan Academy decision opened Medicare rules and policies on the methods of calculating payments as well as other program rules and policies to pre-enforcement review if the requirements of the traditional doctrines on exhaustion of administrative remedies and ripeness were met. Since the Michigan Academy decision, Medicare beneficiaries and providers have judicially challenged Medicare rules and policies directly with varying degrees of success. The federal circuits have varied in their interpretations of the degree to which the Michigan Academy case permits such challenges.

In the Illinois Council on Long Term Care case, the Seventh Circuit overturned the district court's dismissal on jurisdictional grounds and concluded that the Supreme Court in the Michigan Academy case modified earlier Supreme Court decisions by limiting the scope of 42 U.S.C. § 1395ii and § 405(h) to "amount determinations." 143 F.3d, at 1075-1076. The Seventh Circuit's reasoning was contrary to other circuits, which have taken a more restrictive view of the scope of the Michigan Academy case particularly in light of Congress' subsequent amendments to the Medicare appeal provisions in 42 U.S.C. § 1395ff.

Justice Breyer, writing for the majority in Illinois Council on Long Term Care, reasoned that, if it were not for the Michigan Academy case, § 405(h), as interpreted by the Court's earlier cases of Weinberger v. Salfi, supra, and Heckler v. Ringer, supra, would bar this lawsuit. Justice Breyer recognized that the major issue in this case was whether a challenge to a rule or regulation on general legal grounds is really an action, in the language of § 405(h), "to recover on any claim arising under" the Social Security or Medicare Acts? He concluded that § 405(h) prevents application of the "ripeness" and "exhaustion" exceptions in current administrative law and requires the "channeling" of virtually all legal attacks through the agency without permitting possibly premature interference by different individual courts applying "ripeness" and "exhaustion" exceptions case by case. This restriction, despite the possibility of an "occasional individual, delay-related hardship," was justified on the following grounds: "In the context of a massive, complex health and safety program such as Medicare, embodied in hundreds of pages of statutes and thousands of pages of often interrelated regulations, any of which may become the subject of a legal challenge in any of several different courts, paying this price may seem justified." 120 S.Ct. at 1093.

In distinguishing Michigan Academy, Justice Breyer emphasized that Michigan Academy emphasized the Medicare statute's total silence in the Medicare Act as to judicial review of "challenges mounted against the method by which . . . amounts are to be determined." 476 U.S. at 675. Because relevant statutes permitting judicial review in the Medicare Act were silent as to the particular issue in Michigan Academy for which review was sought, judicial review was available and § 405 not applicable. However, such was not the case in Illinois Council on Long Term Care as the Medicare Act provided avenues for judicial review in 42 U.S.C. § 1395cc with respect to the imposition of sanctions and the Medicare agency's termination of a nursing home's Medicare contract. Consequently, the jurisdictional bar in § 405(h) applied and the claim should be dismissed.

Illinois Council on Long Term Care clarifies and significantly restricts if not vitiates the authority of Michigan Academy to permit prospective challenges of Medicare program rules and policies outside the scope of statutory provisions for administrative and judicial review in the Medicare Act. However, the majority's decision is not without controversy as evidenced by a strong dissent by Justice Thomas which construed the Michigan Academy cases as permitting pre-enforcement review and was joined by Justice Stevens and, in part, by Justice Scalia. Both Justices Stevens and Scalia also entered dissents.

Pegram v. Herdrich

Timothy S. Hall, J.D.
Assistant Professor of Law
Louis D. Brandeis School of Law
University of Louisville

Timothy HallThe continuing transformation of the nation's health care delivery system by managed care and the current popular backlash against many managed care policies and practices, create a confusing mix of federal and state regulation of the health care industry. In a unanimous decision, the Supreme Court decided in Pegram v. Herdrich, 120 S. Ct. 2143 (2000), that an HMO making "mixed" treatment and plan eligibility decisions through its physician owners/employees under a health plan regulated by the Employee Retirement Income Security Act of 1974 (ERISA) is not a "fiduciary" as that term is defined by ERISA. The Court in this decision rejects the specter of a federalized common law of managed care financial incentives, and leaves further developments, absent congressional action, to the laboratory of the states.

On March 1, 1992, Cynthia Herdrich, a beneficiary of an ERISA plan sponsored by her husband's employer and administered by Carle Health Insurance Management Co., Inc. (Carle), sought medical care from Dr. Lori Pegram. On March 7, Dr. Pegram discovered a mass in Herdrich's abdomen. After this discovery, but before further diagnostic testing to determine the nature of the mass, Herdrich's appendix burst, necessitating emergency surgery. Dr. Pegram's decisions to have both the scheduled diagnostics and the surgery performed at a Carle-owned, and thus cheaper, facility, despite the delay and inconvenience to Herdrich, were arguably influenced by a direct relationship between the number of out-of-network referrals generated by Pegram and the size of her year-end bonus from Carle.

Herdrich filed a lawsuit against Dr. Pegram and Carle, alleging negligence in delaying the needed diagnostic procedure, as well as breach of fiduciary duty under ERISA, in that the cost-containment incentive plan created an impermissible conflict of interest between Dr. Pegram's duties to Herdrich as a plan beneficiary and Pegram's financial self-interest. The district court dismissed Herdrich's ERISA claim, but the Seventh Circuit reinstated it, holding that Carle met the statutory definition of a "fiduciary" due to the owner-physicians' control over the governance of the HMO and over the coverage decision process.

Carle sought and was granted certiorari to the Supreme Court. Writing for the unanimous Court, Justice Souter held that Carle was not acting as an ERISA fiduciary when it, through Dr. Pegram, determined (incorrectly) that Herdrich's condition was not an emergency, and that she was thus not entitled under the Plan to immediate treatment at a non-Carle owned facility. Under ERISA, unlike the common law of trusts, a single entity can permissibly "wear two hats," acting as fiduciary as to certain of its decisions and actions, but acting out of self-interest as to others. The Court noted that all of Pegram's decisions arguably affected by the financial incentive- whether to order an immediate ultrasound; whether Herdrich's condition constituted an "emergency" - contained a strong element of medical judgment or "treatment" in addition to their effect on the administration of Plan benefits, or "eligibility" decisions. The Court characterized these decisions as "mixed" treatment and eligibility decisions, and concluded that "mixed' decisions are not within the definition of "fiduciary" intended by Congress.

Herdrich claimed at oral argument that the mere existence of the incentive, independent of any particular act by Dr. Pegram, constituted a breach of fiduciary duty. Herdrich asked the Court to distinguish between the incentive plan used by Carle, which rewards a physician for her own decisions to deny care, and other incentive plans which base bonuses on the performance of a large group of physicians or the utilization of a population of patients. Although this distinction has support among both medical and legal commentators, the Court expressly declined the invitation to directly regulate physician incentives. Justice Souter claimed an inability to distinguish the "not … subtle" financial link between treatment and payment in the Carle network from any other compensation structure used by HMOs, and concluded that since Herdrich seeks disgorgement of part of the HMO's profits, recognition of this suit "would entail nothing less than elimination of the for-profit HMO." Since Congress has encouraged the formation and operation of HMOs since passage of the federal HMO Act in 1973, this result was unacceptable.

In addition to the slippery-slope argument, the Court rested its holding on doubts as to the courts' institutional competency to resolve disputes over the proper scope and structure of managed care incentives. While conceding, arguendo, that the Carle incentive "may not be … as socially desirable" as other possible incentives, the Court deferred to the judgment of Congress on this matter. "The … difficulty of these policy considerations, and Congress' superior institutional competence, … suggest that legislative not judicial solutions are preferable." If there are incentive structures which impede the effectiveness of the doctor-patient relationship, the Court here gives a clear statement that Congress, or perhaps state legislatures, must be the source of legal distinctions between permissible and impermissible incentives.

Although the Court clarifies that mixed treatment/eligibility decisions are not decisions for which a physician wears a fiduciary hat under ERISA, the consequences of this decision for health plans and beneficiaries remains unclear. Although the Court clearly signals that ERISA will not be the source of judicial regulation of physician financial incentives, plaintiffs will now look to state laws to support claims such as Herdrich's. Many states have passed or are considering laws which prohibit managed care organizations from entering into contracts with physicians which contain incentives to deny or delay care. In addition, state tort law may be invoked in cases where physicians fail to provide adequate care, whether that failure was caused by negligence or by financial incentive. In rejecting ERISA fiduciary status for Carle's physician owner/employees, the Court sends a signal that ERISA may no longer stand as a bar to the use of such state laws to regulate "mixed" treatment and eligibility decisions made by ERISA health plans. As state tort damages are generally regarded as much more generous for individual claimants than ERISA remedies, Carle's victory may be a Pyrrhic one as state courts expand their tort doctrines to encompass physician incentive structures adopted by managed care organizations and federal courts increasingly limit the scope of ERISA preemption.

Snuffing Out the FDA's Tobacco Restrictions

By Lars Noah, J.D.
Professor of Law, University of Florida College of Law
Visiting Professor, University of Texas School of Law

Lars NoahExactly five years ago, the Health Law News published a symposium about the Food and Drug Administration's then newly proposed rules to restrict tobacco product marketing. In my brief contribution to the September 1995 issue, I explained that the agency had exceeded the limits of its statutory authority. Earlier this year, in FDA v. Brown & Williamson Tobacco Corp., 120 S. Ct. 1291 (2000), the United States Supreme Court agreed (5-4), though the slim majority (composed of the more conservative wing of the Court) arrived at the correct result in a manner that deviates from several well-established interpretive principles.

Justice O'Connor's opinion for the majority in Brown & Williamson conceded at the outset that the case "involves one of the most troubling public health problems facing our nation today: the thousands of premature deaths that occur each year because of tobacco use." Even so, the Court held that the FDA does not have the power to address this serious problem, thereby leaving the matter for Congress. The majority opinion emphasized three interrelated points:

This is not the place to elaborate on a number of weaknesses in the majority's analysis. In brief, one should note that (1) agencies generally enjoy significant freedom to select among a range of remedial options (so the FDA probably could continue to finesse the issue and avoid banning tobacco products outright); (2) agencies are not estopped from changing their reading of an enabling statute; and (3) courts rarely accept the argument that congressional silence ratifies a particular interpretation. Indeed, as Justice Breyer's dissenting opinion pointed out, none of the subsequently enacted statutes had forbidden the FDA's exercise of jurisdiction (though they did explicitly strip other agencies, such as the CPSC and EPA, of any authority), and Congress also has failed to enact any number of bills that would have precluded the FDA from regulating tobacco products. At best, therefore, legislative intent on the subject seemed highly ambiguous, which usually triggers significant judicial deference under the Chevron doctrine to reasonable agency readings of the meaning of their enabling acts. Why didn't that happen in this case?

I think that the most interesting aspect of the case only lurks in the background of the two opinions. In the final paragraph of the majority's opinion, Justice O'Connor reminds us that "an administrative agency's power to regulate in the public interest must always be grounded in a valid grant of authority from Congress," and a few paragraphs earlier she had suggested that courts should not extend Chevron deference to agency interpretations of ambiguities in their enabling statutes when the interpretive question asks whether Congress meant to delegate any authority to that agency in the first place. In dissent, Justice Breyer analogized agency enabling acts to flexibly interpreted "constitutions" and cited a series of decisions sustaining actions by other agencies that had exceeded the literal bounds of their legislative grants of authority but responded to pressing economic or technological challenges that Congress could not have foreseen. As explained at length in a recently published article, the majority did well not to embrace this constitutional metaphor. See Lars Noah, Interpreting Agency Enabling Acts: Misplaced Metaphors in Administrative Law, 41 Wm. & Mary L. Rev. 1463 (2000).

Has the U.S. Supreme Court fundamentally altered its approach to agency enabling acts, or is this decision just about tobacco? (Commentators have observed that Justice O'Connor often writes narrow opinions designed to resolve only the case before the Court and self-consciously resists the temptation to announce sweeping principles for future cases.) Is the FDA's recent (and I think equally dubious) assertion of jurisdiction to regulate human cloning experiments now in jeopardy? Or, to imagine an admittedly implausible example, what if this ever entrepreneurial agency decided to pursue what the CDC has identified as one of our latest public health scourges -- namely, guns and ammunition? It's less far-fetched than one might imagine: handguns clearly are intended to affect the structure or function of the body, though FDA officials have reassured Congress that the agency would not utilize its authority over medical devices in order to restrict the sale of such products.

The competing opinions in Brown & Williamson seem as much visceral as principled, leaving future regulatory initiatives at the mercy of the shifting policy preferences of the courts. I share the majority's sense that something about the FDA's assertion of jurisdiction didn't make sense, but the reasons are more nuanced than admitted in either of the polarized opinions. In any event, the Court unmistakably shifted the burden of decision back to Congress. Judging by the failed attempts in 1998 to codify the nationwide settlement brokered between the states and the tobacco industry, I wouldn't hold my breath waiting for a federal legislative response.

Stenberg v. Carhart: Supreme Court invalidates Nebraska’s "partial birth" abortion law

Lois Shepherd, J.D.
Associate Professor of Law
Florida State University College of Law

By a narrow 5-4 majority the Supreme Court this term struck down Nebraska’s "partial birth" abortion law, potentially nullifying similar laws in some 29 other states that had recently banned the procedure. In so doing, the Court affirmed the principle adopted in both Roe v. Wade, 410 U.S. 113 (1973) and Planned Parenthood of Southeastern Pa. v. Casey, 505 U.S. 833 (1992), that the State, if it chooses to prohibit abortion following viability, must permit an exception for the preservation of the health of the pregnant woman. The decision also revealed that the Court, or this majority at least, would demand that abortion regulations be adopted by carefully drafted language, so that their reach does not potentially spill over into areas of regulation already deemed impermissible. Because the decision was a narrow one, and the dissents emphatic, the Court’s future approach on abortion issues, and even its view of a differently drafted partial birth abortion ban, is up in the air, and will depend heavily on the views of any new Court appointees.

The Court’s opinion (in addition to some of the concurrences and dissents) contained detailed description and analysis of the statute at issue and the medical procedure it banned. Nebraska’s statute made criminal the performance of a "partial birth" abortion, which it defined as an abortion in which the doctor "partially delivers vaginally" a living unborn child before killing the unborn child and completing delivery. The statute further provided that "partially delivers vaginally" meant that the doctor "deliberately and intentionally delivers into the vagina a living unborn child, or a substantial portion thereof" for the purpose of killing the child. While the statute included an exception for such abortion procedures when the life of the pregnant woman was at stake, it did not include an exception when her health was endangered.

The opinion of the Court, written by Justice Breyer, declared the Nebraska statute unconstitutional on two grounds. With respect to post-viability abortions, the statute failed because it did not include an exception for the health of the mother. With respect to pre-viability abortions, it failed for this reason as well, but also because it imposed an "undue burden" (the standard of Casey) on a woman’s ability to choose the abortion procedure most commonly performed for second trimester abortions, the "dilation and evacuation" (D&E) procedure. Although the Nebraska legislature may have intended to ban only the later-term "dilation and extraction" (D&X) procedure, the statute’s language could be read to include the D&E method as well.

On the first issue, Nebraska argued that no health exception was needed, because there are other safe methods by which to perform abortions if the health of the pregnant woman requires. The record, however, contained significant medical evidence that in some circumstances, the D&X procedure was the safest among those available. In the D&X procedure, the doctor pulls the fetal body, but not the head, through the cervix and then collapses the skull and extracts the entire fetus. While the Nebraska statute did not completely prohibit women from securing an abortion, but only banned a particular method, the Court nevertheless held that "a risk to a woman’s health is the same whether it happens to arise from regulating a particular method of abortion, or from barring abortion entirely."

It is unclear what kind of health exception is required when a particular abortion procedure is proscribed. The Court did not have to address the issue directly because the Nebraska statute contained none. Justice O’Connor’s concurrence suggested that a carefully crafted partial birth abortion ban with an appropriate health exemption could pass constitutional muster. But the question remains whether the health exception would be so large and un-reviewable as to render the ban meaningless. The dissents of Justices Kennedy and Thomas charged that under the reasoning of the Court, it is the individual physician who is left to determine that one procedure is marginally safer than another and thereby give it constitutional protection. Both the issue of how much deference the individual physician should be given and how much additional health risk is too much to deny the availability of a procedure (especially if there are other "safe" procedures available), have been left open.

With respect to the second constitutional infirmity of the Nebraska statute, the Court found that although the legislature of Nebraska had intended this statute to cover only D&X procedures, the language of the statute reached beyond that to cover the common D&E procedure. In the D&E procedure, fetal parts, such as an arm or leg, may be pulled beyond the cervix and into the vagina as dismemberment of the fetus occurs. The Court held that because the D&E procedure can sometimes involve the introduction of a "substantial portion" of a still living fetus into the vagina, that procedure too was banned by the Nebraska statute. As a result, physicians might in the future be subject to prosecution for using the D&E procedure, the most commonly used procedure for pre-viability second trimester abortions, and this the Court held would impose an undue burden upon a woman’s right to choose an abortion.



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