Recent Developments in Health Law

See O'Reilly J. T. , “Losing Deference in the FDA's Second Century: Judicial Review, Politics and a Diminished Legacy of Expertise”, Cornell Law Review 93, no. 5 (2008): 939–979.

Id.

For example, the Catholic Church considers Emergency Contraception problematic. See United States Conference of Catholic Bishops, Ethical and Religious Directives for Catholic Health Care Services, 4th ed., 2001.

Tummino v. Torti, No. 05-CV-366 (F.Supp.2d Mar 23, 2009).

467 U.S. 837 (1984).

See Chevalier B. , “The Constitutionality of the FDA's Age-Based Plan B Regulations: Why the FDA Made the Wrong Decision”, Wisconsin Women's Law Journal 22, no. 2 (2007): 235–266 (arguing that the FDA's restriction of access to Plan B represents a burden on the right to privacy and should have to pass strict scrutiny); Metzger G. E. , “Abortion, Equality, and Administrative Regulation”, Emory Law Journal 56, no. 4 (2007): 865–906 (placing the FDA's treatment of Plan B within the abortion jurisprudence); M. Slacketka, “Getting to Plan B: A History of Contraceptive Rights in the United States and an Argument for a Private Right of Action against the FDA”, William & Mary Bill of Rights Journal 16, no. 3 (2007): 345–377 (arguing that the FDA has violated the right to privacy).

Id. (Chevalier), at 240–241.

See Tummino, supra note 4, at 1.

Associated Press, “Sales Soaring for Morning After Pill, But Opposition Persists”, Foxnews.com, August 23, 2007.

Id.

See Tummino, supra note 4, at 4.

Food and Drug Administration, available at <http://www.fda.gov/OHRMS/D0CKETS/ac/03/briefing/4015b1.htm> (last visited July 2, 2009).

CenterWatch , “Drugs Approved by the FDA”, available at <http://www.centerwatch.com/patient/drugs/dru476.html> (last visited July 2, 2009).

See supra note 12.

See Tummino, supra note 4, at 7.

Id., at 9.

Id., at 9.

Id., at 13.

Id., at 15.

Id., at 14.

Id., at 17.

Id., at 17.

U.S. Government Accountability Office, Food and Drug Administration: Decision Process to Deny Initial Over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual 7, 2005, available at <http://oversight.house.gov/Documents/20051116110800-24167.pdf> (last visited July 2, 2009) [hereinafter GAO Report].

Id., at 5.

Id.

See Tummino, supra note 4, at 30.

Id.

Id.

Id., at 29.

5 U.S.C. § 706(2)(A).

See Tummino, supra note 4, at 22, quoting Latecoere Int'l, Inc. v. U.S. Dept. Of Navy, 19 F.3d 1342, 1356 (11th Cir. 1994); see also James Madison Ltd. v. Ludwig, 82 F.3d 1085, 1096 (D.C. Cir. 1996) (bad faith is “material to determining whether the Government acted arbitrarily”).

Id.

Id., at 29; see also Sierra Club v. EPA, 346 F.3d 955, 963 (9th Cir. 2003) (quoting Smolen v. Chater, 80 F.3d 1273, 1292 (9th Cir. 1996).

Id.

See Connecticut Griswold v. 381 U.S. 479 (1965); see also Carey v. Population Serv. Int'l, 431 U.S. 678, 685 (1977) (discussing the importance of Griswold in the development of the right to decide to procreate or not).

See Eisenstadt v. Baird, 405 U.S. 438, 453 (1972).

See Carey, 431 U.S. at 686; see also Harper S. , “The Morning After? How Far Can States Go to Restrict Access to Emergency Contraception?” Columbia Human Rights Law Review 38, no. 1 (2006): 221–262, at 248.

Id., at 700–701.

Sunstein C. , “Neutrality in Constitutional Law (with Special Reference to Pornography, Abortion and Surrogacy)”, Columbia Law Review 92, no. 1 (1992): 1–51, at 32–33.

See O'Reilly , supra note 1.

417 U.S. 484, 496 n. 20 (1974).

Id.

§353(b)(1)(A).

See Tummino, supra note 4, at 5.

Wyeth v. Levine, 129 S. Ct. 1187 (2009).

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

Federal Food, Drug, and Cosmetic Act 21 U.S.C. §§301–397 (2000).

U.S. Const., Art. VI, § 2.

See, e.g., City of Columbus v. Ours Garage and Wrecker Service, Inc., 536 U.S. 424 (2002).

See, e.g., Aetna Health Inc. v. Davila, 542 U.S. 200 (2004).

See, e.g., Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947).

See, e.g., Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).

Copland J. R. and Howard P. , In the Wake of Wyeth v. Levine: Making the Case for Federal Preemption and Administrative Compensation, Manhattan Institute-Project FDA Report, 2009, at 1, available at <https://www.policyarchive.org/bitstream/handle/10207/15825/fda_01.pdf> (last visited July 2, 2009).

See, e.g., Harris G. , “Justices Add Legal Complications to Debate on F.D.A.'s Competence”, New York Times, February 21, 2008, available at <http://www.nytimes.com/2008/02/21/washington/21fda.html?ref=washington> (last visited July 2, 2009).

Brief of Amici Curiae Former FDA Commissioners Dr. Donald Kennedy and Dr. David A. Kessler In Support of Respondent, August 14, 2008, available at <http://www.abanet.org/publiced/preview/briefs/pdfs/07-08/06-1249_RespondentAmCuKennedyKessler.pdf> (last visited July 2, 2009).

Riegel, 128 S. Ct. 999.

Id., at 1009.

Id.

Student Note, “Preemption of State Common Law Claims: Riegel v. Medtronic, Inc.”, Harvard Law Review 122, no. 1 (2008): 405–415.

See, e.g., Abramowitz v. Cephalon, Inc., No. BER-L-617-04, 2006 WL 560639, at 3–4 (N.J. Super. 2006); Morris v. Wyeth, Inc., 582 F. Supp.2d 861 (W.D. Ky. 2008).

Wyeth, 129 S. Ct. at 1191–93.

Id., at 1192.

Id., at 1192 (note 1).

Id., at 1191–1193.

Id.

Id., at 1192.

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

Id., at 184.

Id.

Id., at 197 (Rieber, C.J., dissenting).

Id., at 203.

Id., at 203.

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

Brief of the Generic Pharmaceutical Association as Amicus Curiae in Support of Petitioner, available at <http://www.abanet.org/publiced/preview/briefs/pdfs/07-08/06-1249_Petitioner-AmCuGenPharmAssoc.pdf> (last visited July 2, 2009); Brief of the United States as Amicus Curiae, available at <http://www.usdoj.gov/osg/briefs/2007/2pet/6invit/2006-1249.pet.ami.inv.pdf> (last visited July 2, 2009).

Calfee J. E. , “FDA Preemption and Patient Welfare in Wyeth v. Levine”, American Enterprise Institute Policy Outlook, 2008, available at <http://www.aei.org/docLib/20081030_0923637HPOCalfee_g.pdf> (last visited July 2, 2009).

See Brief for PhRMA and BIO as Amici Curiae Supporting Petitioner, at 5 (asserting that “state-law tort claims challenging prescription drug labeling undermine FDA decision making and pose a threat to public health”), available at <http://www.abanet.org/publiced/preview/briefs/pdfs/07-08/06-1249_PetitionerAmCuPhRMABIO.pdf> (last visited July 2, 2009).

Forbes S. , “Supremely Destructive Stupidity”, Forbes Magazine, April 13, 2009, available at <http://www.forbes.com/forbes/2009/0413/013-supremely-destructive-stupidity.html> (last visited July 2, 2009).

See Brief for the Consumers Union of the United States in Support of Respondent, available at <http://www.abanet.org/publiced/preview/briefs/pdfs/07-08/06-1249_RespondentAmCuCon-sumersUnion.pdf> (last visited July 2, 2009); Brief for Members of Congress in Support of Respondent, available at <http://www.abanet.org/publiced/preview/briefs/pdfs/07-08/06-1249_RespondentAmCuMembersCongress.pdf> (last visited July 2, 2009); Brief for Vermont, Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, West Virginia, Virginia, Washington, Wisconsin, and Wyoming in Support of Respondent, available at <http://www.abanet.org/publiced/preview/briefs/pdfs/07-08/06-1249_RespondentAmCu47States.pdf> (last visited July 2, 2009).

Curfman G. D. Morrissey S. and Drazen J. M. , “Why Doctors Should Worry about Preemption”, New England Journal of Medicine 359, no. 1 (2008): 1–3.

See Harris , supra note 10.

21 CFR Parts 201, 314, and 601, available at <http://www.fda.gov/OHRMS/DOCKETS/98fr/00n-1269-nfr0001-01.pdf> (last visited July 2, 2009).

Wyeth, 129 S. Ct. at 1190.

Id., at 1202.

Id., at 1203.

Id., at 1190.

Id.

Id., at 1204 (Breyer, J., concurring).

Id., at 1205 (Thomas, J., concurring).

Id., at 1217 (Alito, J., dissenting).

Id., at 1218 (Alito, J., dissenting).

Id., at 1219 (Alito, J., dissenting).

Id.

See “Health Leaders Introduce Legislation Reversing Supreme Court's Medical Device Decision,” Committee on Energy and Commerce, April 6, 2008, available at <http://energycommerce.house.gov/index.php?option=com_content&task=view&id=1518&Itemid=1> (last visited July 2, 2009); H.R. 1346 (2009), available at <http://www.govtrack.us/congress/billtext.xpd?bill=h111–1346> (last visited July 2, 2009); S. 540 (2009), available at <http://www.govtrack.us/congress/bill.xpd?bill=s111-540> (last visited July 2, 2009).

Joseph Colacicco v. Apotex, Inc., No. 06-3107 (3rd Cir., 2009).