Saturday, September 26, 2009

Good law from tragic facts--Congress, the FDA, and preemption

Good law from tragic facts--Congress, the FDA, and preemption.
Annas GJ.
N Engl J Med. 2009 Sep 17;361(12):1206-11. No abstract available.
PMID: 19759383 [PubMed - indexed for MEDLINE]
Related Articles

The New York Times heralded "A Win for Injured Patients,"1 while the Wall Street Journal said that the U.S. Supreme Court was "Pre-empting Drug Innovation."2 To the New York Times, the Court's decision in Wyeth v. Levine was "wise and surprising."1 To the Wall Street Journal, it was a "defeat for drug innovation and public health"2; the editorial expressed surprise because the Supreme Court had earlier ruled that Congress had preempted state civil lawsuits alleging device misbranding, and many persons thought that the Court had turned relentlessly pro-business and would therefore also rule that civil lawsuits alleging drug misbranding . . . [Full Text of this Article]
The Facts in Wyeth
The Law of Preemption
"Tragic Facts"
Preemption after Wyeth

Source Information
From the Department of Health Law, Bioethics, and Human Rights, Boston University School of Public Health, Boston.

  1. A win for injured patients. New York Times. March 5, 2009. 
  2. Pre-empting drug innovation. Wall Street Journal. March 5, 2009:A16.
  3. Rosen J. Supreme Court, Inc. New York Times Magazine. March 16, 2008.
  4. Wyeth v. Levine, 129 U.S. 1187 (2009).
  5. Curfman GD, Morrissey S, Drazen JM. Why doctors should worry about preemption. N Engl J Med 2008;359:1-3. [Free Full Text]
  6. Northern Securities v. United States, 193 U.S. 197, 400 (1904).
  7. Glantz LH, Annas GJ. The FDA, preemption, and the Supreme Court. N Engl J Med 2008;358:1883-1885. [Free Full Text]
  8. Kennedy D. Misbegotten preemptions. Science 2008;320:585-585. [Free Full Text]
  9. Warning signs. Nature 2008;452:254-254. [Medline]
  10. Committee on the Assessment of the US Drug-Safety System. The future of drug safety: promoting and protecting the health of the public. Washington, DC: National Academies Press, 2007.
  11. Psaty BM, Burke SP. Protecting the health of the public -- Institute of Medicine recommendations on drug safety. N Engl J Med 2006;355:1753-1755. [Free Full Text]
  12. Gilhooley M. Drug preemption and the need to reform the FDA consultation process. Am J Law Med 2008;34:539-561. [Web of Science][Medline]
  13. Wyeth v. Levine, 944 A.2d 179 (Vt. 2006).
  14. Riegel v. Medtronic, 128 U.S. 999 (2008).
  15. 71 C.F.R. § 3922 (2006).
  16. Geier v. American Honda Motor Co., 529 U.S. 861 (2000).
  17. Curfman GD, Morrissey S, Drazen JM. The Medical Device Safety Act of 2009. N Engl J Med 2009;360:1550-1551. [Free Full Text]
  18. Obama B. Memorandum for the heads of executive departments and agencies: preemption. Washington, DC: White House, May 20, 2009. (Accessed August 27, 2009, at

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