Recent Developments in Health Law

See Riegel v. Medtronic, Inc. , 128 S.Ct. 999, 1009 (2008).

“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.

See generally Riegel , supra note 1.

Wyeth v. Levine , 128 S.Ct. 1118 (U.S. January 18, 2008), granting cert. to Levine v. Wyeth, 944 A.2d 179 (Vt. 2006).

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).

Id., at 82.

See Riegel , supra note 1, at 1005.

Id., at 1006.

Medical Device Amendment (MDA), 21 U.S.C. § 360k(a)(1)-(2) (1976).

See Riegel , supra note 1, at 1009, 1015.

Id., at 1007.

Id., at 1008.

Id., at 1011.

See Wyeth , granting cert., supra note 4.

Levine v. Wyeth , 944 A.2d 179, 179 (Vt. 2006).

Id., at 180.

Id., at 181; Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §§ 301–399 (2001).

See Levine v. Wyeth, supra note 16, at 181.

Id., quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996).

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).

See Levine v. Wyeth, supra note 16, at 183.

Id., at 186.

Id., at 180; see also United States v. Dotterweich, 320 U.S. 277, 282 (1943).

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).

See Wyeth , granting cert., supra note 4.

See Riegel , supra note 1, at 1008.

Id., at 1010.

See Federal Register, supra note 2, at 3933–3934 (interpreting the FDCA to pre-empt state regulations dealing with safety, including state tort actions).

See Wyeth , supra note 16, at 188.

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).

See Riegel , supra note 1, at 1009.

U.S. Government Accountability Office, Drug Safety: Improvements Needed in FDA's Postmarket Decision-making and Oversight Process , GAO-06-402, March 2006.

See Thornton , supra note 5, at 82.

National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-11 (2000).

Greenhouse L. , “Justices Shield Medical Devices from Lawsuits,” New York Times, February 21, 2008.

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.

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).

See, e.g., American Society for Reproductive Medicine, available at <http://www.asrm.org> (last visited June 19, 2008).

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.

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.

As noted by Dr. Charles Sims, co-founder of California Cyrobank. Arguments and observations are attributed to symposium participants in endnotes.

See Elster , supra note 2.

See Rowland R. , “The Social and Psychological Consequences of Secrecy in Artificial Insemination by Donor (AID) Programs,” Social Science & Medicine 21 (1985): 391–396.

See supra note 5.

See, e.g., The Donor Sibling Registry, available at <http://www.donorsib-lingregistry.com> (last visited June 19, 2008).

Scheib J. E. 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.

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.

As discussed by Dr. Richard Scott, Director of Reproductive Medicine Associates of New Jersey.

Dr. David Adamson, President of the American Society of Reproductive Medicine, Dr. Scott, and Dr. Mark Hughes, founder of the Genesis Genetics Institute.

Professor Naomi Cahn and Susan Crockin, principal of the Crockin Law & Policy Group, discussed legal issues in donor registries and ART.

As discussed by Dr. David Adamson.

Dr. Charles Sims, Sean Tipton of the American Society of Reproductive Medicine, and Earl Furfine, founder of Cardinal Technologies, addressed feasibility and implementation issues.

As discussed by Dr. Charles Sims.

As noted by Ms. Wendy Kramer.

Professor Naomi Cahn, Ms. Susan Crockin, and Ms. Wendy Kramer noted the desirability of a mandatory national registry.

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.

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.

See Becker G. , The Elusive Embryo: How Men and Women Approach New Reproductive Technologies (Berkeley: University of California Press, 2000): At 19–21.

See Baum K. , “Golden Eggs: Towards the Rational Regulation of Oocyte Donation,” Brigham Young University Law Review (2001): 107–166, at 116–19.

See Alvare , supra note 7, at 12–14.

See Spar , supra note 1, at 44–46.

Angels Ron's , available at <http://www.ronsangels.com> (last visited June 19, 2008).

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).

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.

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.