Hostname: page-component-cd9895bd7-mkpzs Total loading time: 0 Render date: 2024-12-26T22:27:32.762Z Has data issue: false hasContentIssue false
  • English
  • Français

Recent Developments in Health Law

Published online by Cambridge University Press:  01 January 2021

Jeffrey M. Jacobstein  and
Pamela Foohey
Get access Rights & Permissions [Opens in a new window]

Abstract

An abstract is not available for this content so a preview has been provided. Please use the Get access link above for information on how to access this content.
Image of the first page of this content. For PDF version, please use the ‘Save PDF’ preceeding this image.'
Type
JLME Column
Information
Journal of Law, Medicine & Ethics , Volume 36 , Issue 3 , Fall 2008 , pp. 594 - 601
Copyright
Copyright © American Society of Law, Medicine and Ethics 2008

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

References

See Riegel v. Medtronic, Inc., 128 S.Ct. 999, 1009 (2008).Google Scholar
“Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products,” Federal Register 71 (January 24, 2006): 3922–3997, at 3933–3934.Google Scholar
See generally Riegel, supra note 1.Google Scholar
Wyeth v. Levine, 128 S.Ct. 1118 (U.S. January 18, 2008), granting cert. to Levine v. Wyeth, 944 A.2d 179 (Vt. 2006).Google Scholar
Thornton, R. J., “Preemption, Tort Reform, and Pharmaceutical Claims,” Baylor University Medical Center Proceedings 21 (2008): 82–92, at 82 (in 2005 there were over 89,000 adverse reactions to prescription drugs; the annual cost of these injuries in 2002 was estimated at over $90 billion).CrossRefGoogle Scholar
Id., at 82.Google Scholar
See Riegel, supra note 1, at 1005.Google Scholar
Id.Google Scholar
Id., at 1006.Google Scholar
Medical Device Amendment (MDA), 21 U.S.C. § 360k(a)(1)-(2) (1976).Google Scholar
See Riegel, supra note 1, at 1009, 1015.Google Scholar
Id., at 1007.Google Scholar
Id., at 1008.Google Scholar
Id., at 1011.Google Scholar
See Wyeth, granting cert., supra note 4.Google Scholar
Levine v. Wyeth, 944 A.2d 179, 179 (Vt. 2006).Google Scholar
Id.Google Scholar
Id., at 180.Google Scholar
Id., at 181; Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §§ 301–399 (2001).Google Scholar
See Levine v. Wyeth, supra note 16, at 181.Google Scholar
Id., quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996).Google Scholar
Id., at 182; Supplements and Other Changes to an Approved Application, 21 C.F.R. § 314.70 (2007) (creating a streamlined approval process for a manufacturer that wants to “add or strengthen a…warning” on an approved product).Google Scholar
See Levine v. Wyeth, supra note 16, at 183.Google Scholar
Id., at 186.Google Scholar
Id., at 180; see also United States v. Dotterweich, 320 U.S. 277, 282 (1943).Google Scholar
Id. (Levine v. Wyeth), at 186 (Congress explicitly amended the FDCA to emphasize that it overruled state law only where there was a “direct and positive conflict” between state law and the FDCA).Google Scholar
See Wyeth, granting cert., supra note 4.Google Scholar
See Riegel, supra note 1, at 1008.Google Scholar
Id.Google Scholar
Id., at 1010.Google Scholar
See Federal Register, supra note 2, at 3933–3934 (interpreting the FDCA to pre-empt state regulations dealing with safety, including state tort actions).Google Scholar
See Wyeth, supra note 16, at 188.Google Scholar
See generally Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), but see Food and Drug Administration v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000) (refusing to allow the FDA to regulate tobacco products after the agency had insisted for years that it lacked the authority to do so).Google Scholar
See Riegel, supra note 1, at 1009.Google Scholar
U.S. Government Accountability Office, Drug Safety: Improvements Needed in FDA's Postmarket Decision-making and Oversight Process, GAO-06-402, March 2006.Google Scholar
See Thornton, , supra note 5, at 82.Google Scholar
National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-11 (2000).Google Scholar
Greenhouse, L., “Justices Shield Medical Devices from Lawsuits,” New York Times, February 21, 2008.Google Scholar
Id.Google Scholar

References

See Spar, D. L., The Baby Business: How Money, Science, and Politics Drive the Commerce of Conception (Boston: Harvard Business Press, 2005): At 31–67.Google Scholar
See Elster, N., “All or Nothing? The International Debate over Disclosure to Donor Offspring, Institute on Biotechnology and the Human Future,” available at <http://www.thehumanfuture.org/commentaries/assisted_reproductive_technology/art_commentary_elster01.html> (last visited June 19, 2008).+(last+visited+June+19,+2008).>Google Scholar
Id.Google Scholar
Id.Google Scholar
See, e.g., American Society for Reproductive Medicine, available at <http://www.asrm.org> (last visited June 19, 2008).+(last+visited+June+19,+2008).>Google Scholar
See D’Orazio, P., Note, “Half of the Family Tree: A Call for Access to a Full Genetic History for Children Born by Artificial Insemination,” Journal of Health & Biomedical Law 2 (2006): 249–276, at 258–61.Google Scholar
See Elster, , supra note 2; Alvare, H. M., “The Case for Regulating Collaborative Reproduction: A Children's Rights Perspective,” Harvard Journal on Legislation 40, no. 1 (2003): 1–63, at 7–32; Cahn, N., “Children's Interests and Information Disclosure: Who Provided the Egg and Sperm? Or Mommy, Where (and Whom) Do I Come From?” Georgetown Journal of Gender & Law 2 (2000): 1–27, at 3–4.Google Scholar
As noted by Dr. Charles Sims, co-founder of California Cyrobank. Arguments and observations are attributed to symposium participants in endnotes.Google Scholar
See Elster, , supra note 2.Google Scholar
Id.Google Scholar
Id.Google Scholar
See Rowland, R., “The Social and Psychological Consequences of Secrecy in Artificial Insemination by Donor (AID) Programs,” Social Science & Medicine 21 (1985): 391–396.CrossRefGoogle Scholar
See supra note 5.Google Scholar
See, e.g., The Donor Sibling Registry, available at <http://www.donorsib-lingregistry.com> (last visited June 19, 2008).+(last+visited+June+19,+2008).>Google Scholar
Scheib, J. E. and Cushing, R. A., “Open-Identity Donor Insemination in the United States: Is It on the Rise?” Fertility and Sterility 88, no. 1 (2007): 231–232.CrossRefGoogle Scholar
Id.Google Scholar
Id.Google Scholar
As discussed by Wendy Kramer, co-founder of the Donor Sibling Registry, Bette Galen, LCSW, Andrea Braverman, Ph.D, both of Reproductive Associates of New Jersey, and Jean Benward, LCSW, co-president of the Sperm Bank of California.Google Scholar
As discussed by Dr. Richard Scott, Director of Reproductive Medicine Associates of New Jersey.Google Scholar
Id.Google Scholar
Dr. David Adamson, President of the American Society of Reproductive Medicine, Dr. Scott, and Dr. Mark Hughes, founder of the Genesis Genetics Institute.Google Scholar
Professor Naomi Cahn and Susan Crockin, principal of the Crockin Law & Policy Group, discussed legal issues in donor registries and ART.Google Scholar
As discussed by Dr. David Adamson.Google Scholar
Dr. Charles Sims, Sean Tipton of the American Society of Reproductive Medicine, and Earl Furfine, founder of Cardinal Technologies, addressed feasibility and implementation issues.Google Scholar
As discussed by Dr. Charles Sims.Google Scholar
As noted by Ms. Wendy Kramer.Google Scholar
Professor Naomi Cahn, Ms. Susan Crockin, and Ms. Wendy Kramer noted the desirability of a mandatory national registry.Google Scholar
See Storrow, R. F., “The Bioethics of Prospective Parenthood: In Pursuit of the Proper Standard for Gatekeeping in Infertility Clinics,” Cardozo Law Review 28 (2007): 2283–2320.Google Scholar
See Manning, P. J., “Baby Needs a New Set of Rules: Using Adoption Doctrine to Regulate Embryo Donation,” Georgetown Journal of Gender & Law 5, no. 2 (2004): 677–721.Google Scholar
See Becker, G., The Elusive Embryo: How Men and Women Approach New Reproductive Technologies (Berkeley: University of California Press, 2000): At 19–21.CrossRefGoogle Scholar
See Baum, K., “Golden Eggs: Towards the Rational Regulation of Oocyte Donation,” Brigham Young University Law Review (2001): 107–166, at 116–19.Google Scholar
See Alvare, , supra note 7, at 12–14.Google Scholar
See Spar, , supra note 1, at 44–46.Google Scholar
Angels, Ron's, available at <http://www.ronsangels.com> (last visited June 19, 2008). (last visited June 19, 2008).' href=https://scholar.google.com/scholar?q=Angels,+Ron's,+available+at++(last+visited+June+19,+2008).>Google Scholar
See Schneider, J., “It's Time for an Egg Donor Registry and Long-Term Follow-Up,” Center for Genetics and Society, available at <http://geneticsandsociety.org/article.php?id=3820> (last visited June 19, 2008).Google Scholar
See Alvare, , supra note 7, at 24–25; Malinowski, M., “Creating Life? Examining the Legal, Ethical, and Medical Issues of Assisted Reproductive Technologies: A Law-Policy Proposal to Know Where Babies Come From During the Reproductive Revolution,” Journal of Gender, Race & Justice 9 (2006): 549–568, at 553–55; Strong, C., “Too Many Twins, Triplets, Quadruplets, and So On: A Call for New Priorities,” Journal of Law, Medicine & Ethics 31, no. 2 (2003): 272–282, at 274.Google Scholar
Yuen, S., Comment, “An Information Privacy Approach to Regulating the Middlemen in the Lucrative Gamete Market,” University of Pennsylvania Journal of International Law 29, no. 2 (2007): 527–562, at 537–540.Google Scholar