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Syllabus contents:
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Genetics and the Law
PHG
523/LAW E564 (2 Credits) Winter, 2004 |
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Instructor Teaching Assistant: Professor Patricia C. Kuszler,
MD, JD Josh
Carlson, MPH (candidate) Gates Hall 374 Health
Sciences F363 Phone: 206/685-0511 Phone: 206/310-0268 E-mail: kuszler@u.washington.edu E-mail:
carlsojj@u.washington.edu Office Hours: Contact Jennifer Snider for Office Hours: By Appointment Appointment (jsnider@u.washington.edu) |
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This class extends the discussion of issues originating in PHG 512 (Legal, Ethical and Social Issues in Public Health Genetics) by examining in greater depth the legal consequences of genetic technologies and information. It will begin with an overview of genetic science, the recent explosion of knowledge about the genome, and the products and services flowing from advances in genetics. The course will first consider genetics research and some of the policy challenges it has presented. It will then move on to look at the movement from bench to marketplace, including patenting, technology transfer, and conflicts of interest. The course will then consider the use, abuse and medical mistakes in genetic testing and information, focusing on reproductive decision-making, parenting, and domestic relations. The course will then turn to liability issues, including breach of confidentiality, insurance access and coverage disputes, and employment discrimination. The course will finish with an exploration of the use of DNA in the courtroom, forensics, behavioral genetics, and use of genetic evidence in the civil and criminal context. The overarching context for the course will be on what the response of the law and legal system to advances in genetic information and technologies has been heretofore and should be in the future. Your course grade will be based on an examination (50%), a short 5-10 page paper (40%), and class participation (10%). The required text is Lori B Andrews, Maxwell J. Mehlman, Mark.A. Rothstein, Genetics: Ethics, Law and Policy (West, 2002)[hereinafter Text]; the text is available at University Bookstore. In addition, there are a few articles and recent cases that will be handed out as supplementary materials during the course. This
course is designed to engender active discussion of the issues. I will be distributing weekly study
questions to assist you in focusing your reading for each class session. An essential component of this course will
be your active and voluntary participation in class discussion. The expectation is that you will have read
the assigned readings, considered the study questions, and fully engage in
the discussion. The following syllabus outlines the course, reading assignments and sets forth a preliminary timetable. It is possible that the timetable and reading assignments will be amended during the course, depending on our pace and new developments in public health genetics. January 6
I. Introduction A. Genes and the Past B. Genes and the Future C. Genes and the Present Reading Assignment: Text: Pages 2-14* John Avise, “The Genetics Gods: Evolution and Belief in Human Affairs” Luigi
Luca Cavalli-Sforza, “Remarks Upon Being Awarded the Balzan Prize for the
Science of Human Origins” Matt Ridely, “Genomes: The Autobiography of a Species in 23 Chapters” Philip Kitcher, “The Lives to Come: The Genetic Revolution and Human Possibilities” Mark A. Rothstein, “Genetics and the Work Force of the Next Hundred Years” C.S. Lewis, “The Abolition of Man” Francis S. Collins and Victor McKusick, “Implications of the Human Genome Project for Medical Science” Neil A. Holtzman, “Putting the Search for Genes in Perspective” Barbara Katz Rothman, “Genetics Maps and Human Imaginations” *For non-scientists or those who did not take PHG 512, please read
pages 15-40 as well. January 13
II. Genetics Research A. Regulation of Research B.
Research on
Previously-Collected Tissue Samples:
Right of the Source “Patient” C.
The Human
Genome Diversity Project Reading
Assignment Text: Pages 84-126 Henry T. Greely, The Control of Genetic Research; Involving the
"Groups Between" U.S. Dept. of Health and Human Services, Office of Protection
From Research Risks, Protecting Human Research Subjects: Institutional Review Board Guidebook Zsolt Harsanyi & Richard Hutton, Genetic Prophecy: Beyond
the Double Helix American Society of Human Genetics, Statement on Informed
Consent for Genetic Research National Bioethics Advisory Commission, Research Involving Human
Biological Materials: Ethical Issues and Policy Guidance Zeshan Q. Khan, Colonialism Revisited: Insights into the Human
Genome Diversity Project Eric T. Juengst, The Perils of Genetic Genealogy Morris W. Foster et al., A Model Agreement for Genetic Research
in Socially Identifiable Populations January 20
III. Commercialization of Genetic Research: Property, Patents and Conflicts of Interest A. Patenting of Genetic Materials B. Concerns About the Patenting of Genes C. Technology Transfer: Laws and Commercialization D. Patients: The Sources of Genes and Cell Lines Reading
Assignment Text: Pages 145-165; 169-180;
195-221 Lila Feisse & Brian Stanton, Are
Biotechnology Patents Important Matthew Erramouspe, Staking Patent Claims on the Human Blueprint:
Rewards and Rent-Dissipating Races Diamond v.
Chakrabarty Amgen Inc. v. Chugai
Pharmaceutical Co., Ltd. U.S, Department of
Energy Office of Science, Office of Biological and Environmental Rebecca Eisenberg, Reexamining the Role of Patents
in Appropriating the Value of
DNA-Sequencing Michael Heller & Rebecca Eisenberg, Can
Patents Deter Innovation?—The Anticommons in Biomedical Research Nicholas Thompson, Gene Blues: Is the Patent
Office Prepared to Deal with the Genomic Revolution Melissa L. Sturges, Who Should Hold Property
Rights to the Human Genome? An Application of the Common Heritage of
Humankind ACMG Position Statement ACP Advocacy on the Issues James V. Lacy, et al., Technology Transfer Laws
Governing Federally Funded research and Development Sheldon Krimsky, The Profit of Scientific
Discovery and Its Normative Implications Lori Andrews & Dorothy Nelkin, Body Bazaar:
The Market for Human Tissue in the Biotechnology Age. Moore v. Regents of the University of California AMA Council on Ethical and Judicial Affairs, Code
of Medical Ethics, Current Opinions with Annotations HUGO Ethics Committee Statement on Benefit Sharing January 27
IV. Genetic Testing and Reproduction A. Regulation of Genetic Testing Products and Services B. Prenatal Screening C. Reproductive Technology and Genetics
Text: Pages 222-280 Lori Andrews, “Assessing Genetic Risks: Implications for Health
and Social Policy” Lori B. Andrews, “Future Perfect:
Confronting Decisions About Genetics” Lori B. Andrews, “Torts and the Double Helix; Malpractice
Liability for Failure to Warn of Genetic Risks” Keel v. Banach Curlender v. Bio-Science Laboratories Doolan v. IVF America (MA)Inc Lori B. Andrews, “Prenatal Screening and
the Culture of Motherhood” Mary Z. Pelias & Margaret M. DeAngelis, “The New Genetic
Technologies: New Options, New Hope, and New Challenges” Minimal Genetic Screening For Gamete Donors, Approved by the
Board of Directors of the American Society for Reproductive Medicine Johnson v. Superior Court of Los Angeles
County Harnicher v. University of Utah Medical
Center February
3
IV. Parentage and Family Laws A. Reassessing Traditional Presumptions of Paternity in the DNA Era B. Genetics and Switched Babies C. Paternity and Assisted Reproduction D. Genetics and Immigration Reading Assignment Text: Pages 444-492 Michael H. v. Gerald D. Richard Willing, “DNA and Daddy” Lack v. Welch Mays v. Twigg Perry-Rogers v. Fasano People v. Sorensen Jhordan C. v. Mary K. SODS v. Superior Court In Re Marriage of Buzzanca February
10 IV. Parentage and Family Laws E. Genetics, Adoption, and Disability F. Unanticipated Misattributed Paternity V. Genetic Testing and Screening for Newborns, Children, and Adolescents A. Newborn Screening Programs B. Genetic Testing of Children and Adolescents Reading Assignment Text: Pages 494-516; 343-347;299-333 Cesnik v. Edgewood Baptist Church Meracle v. Children's Service Society of Wisconsin Amanda Trefethen, “The Emerging Tort of Wrongful Adoption” American Society of Human Genetics Social Issues Committee and
American College of Medical Genetics Social, Ethical, and Legal Issues
Committee, “Genetic Testing in Adoption” In Re Marriage of Carney Jean McEwen, “Genetic Information, Ethics, and Information
Relating to Biological Parenthood” American Academy of Pediatrics, “Report
of the Task Force on Newborn Screening” Ellen Wright
Clayton, “Screening and Treatment of Newborns” Ruth R. Faden
et al., “Parental Rights, Child Welfare, and Public Health: The Case of PKU Screening” Norman Fost,
“Genetic Diagnosis and Treatment: Ethical Considerations” American Society of Human Genetics and
American College of Medical Genetics, “Points to Consider:
Ethical, Legal, and Psychosocial Implications of Genetic
Testing in Children and Adolescents” Dorothy C.
Wertz et al., “Genetic Testing for Children and Adolescents: Who Decides?” Council on Ethical and Judicial Affairs,
“American Medical Association,
Code of Medical Ethics: Current Opinion 2.138 February 17
V. Legal Liability and Genetic Information (to be continued on February 25) A Privacy and Confidentiality B. Third Party Liability: Duty to Warn Reading Assignment Text: Pages
609-617; 623-627; 358-364; 637-655 Whalen v. Roe George J. Annas, Leonard H. Glantz & Patricia A. Roche, “The
Genetic Privacy Act and Commentary” Philip R. Reilly, “The Impact of the Genetic Privacy Act on
Medicine” Wendy E. Parmet, “Legislating Privacy: The HIV Experience” Health Insurance Portability and Accountability Act James M. Humber, “Protecting the Privacy of Patients' Health
Information: Summary of the Final Regulation, in Privacy and Health Care” Pate v. Threlkel Safer v. Pack Mark A. Hall, “Legal Rules and Industry Norms: The Impact of
Laws Restricting Health Insurers' Use of Genetic Information” Katskee v. Blue Cross/Blue Shield Supplementary Readings: Reisner
v. University of California February 24
VI. Legal Liability and Genetic Information (Continued) C. Insurance a.
Discrimination b.
Access to
Benefits D. Genetic Discrimination in
Employment Reading
Assignment Text: 650-665; 667-672; 690-718 Steven E. Zimmerman, “The Use of Genetic Tests by Life Insurance
Companies: Does This Differ From the Use of Routine Medical
Information?” Robert J. Pokorski, “Genetic Information and Life Insurance” Cathleen D. Zick et al., “Genetic Testing, Adverse Selection, and
the Demand for Life Insurance” Chabner v. United of Omaha Life Insurance Co. Paul Steven Miller, “Is There a Pink Slip in My Genes? Genetic
Discrimination in the Workplace” EEOC Compliance Manual Sutton v. United Airlines Laws v. Pact, Inc. Americans with Disabilities Act Norman-Bloodsaw v. Lawrence Berkeley Laboratory Mark A. Rothstein, “Genetics
and the Work Force of the Next Hundred Years
March 2
XI. Forensics: Genetic Testing for Identification A. Admissibility of DNA Evidence in Criminal Cases B. DNA Banks C. DNA Identification Outside the Criminal Setting Reading Assignment
Text: 517-561 The National Commission on the Future of DNA Evidence, “The
Future of Forensic DNA Testing: Predictions of the Research and Development
Working Group” National Research Council, “The Evaluation Of Forensic DNA
Evidence” Eric Lander, “DNA Fingerprinting: Science, Law and the Ultimate
Identifier” Lori Andrews & Dorothy Nelkin, “Body Bazaar: The Market for
Human Tissue in the Biotechnology Age” Edward Imwinkelried & D. H. Kaye, “DNA Typing: Emerging or
Neglected Issues” Jones v. Murray Mark A. Rothstein & Sandra Camahan, “Legal and Policy Issues
in Expanding the Scope of Law Enforcement DNA Data Banks” Michelle Hibbert, “DNA Databanks: Law Enforcement's Greatest
Surveillance Tool?” Mayfield v. Dalton March 9
XII.
Genetics in
the Courtroom A
Behavioral Genetics B. Criminal Law C. Tort
Law and Civil Litigation
Reading
Assignment Text: Pages 564-592; 735-747 Mark A Rothstein, Behavioral Genetic Determinism: Its Effects on Culture and Law Stephanie L. Sherman, et al., Behavioral Genetics ’97 Lori B. Andrews, Predicting and Punishing Criminal Acts: How the Criminal Justice System Might Use Behavioral Genetics Millard v. Maryland
Stewart v. Gramley
Kansas
v. Hendricks Carlson
v. Wackenhut Corp. Bryson
v. Pillsbury Wintz
v. Northrup Corp. Mark A. Rothstein, Preventing Discovery of Plaintiff Genetic Profiles by Defendants Seeking to Limit Damages in Personal Injury Litigation
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