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., 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., 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., 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

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

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

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

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

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