FREE NEJM E-TOC    HOME   |   SUBSCRIBE   |   CURRENT ISSUE   |   PAST ISSUES   |   COLLECTIONS   |   Search Term  Advanced Search

Sign in | Get NEJM's E-Mail Table of Contents — Free | Subscribe

Previous Volume 360:559-561 February 5, 2009 Number 6 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

	Full Text PDF PDA Full Text Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

The U.S. Supreme Court is currently considering the case of Wyeth v. Levine, whose central question is whether approval of a pharmaceutical product's label by the Food and Drug Administration (FDA) should protect the manufacturer from litigation by patients alleging that they were inadequately warned about potential adverse effects. The FDA has suggested that if such protection (or "preemption") were granted, it might extend to health care practitioners, thereby insulating them, as well, from tort claims "related to dissemination of risk information to patients beyond what is included in the labeling."¹ The more likely scenario, however, is that preemption of . . . [Full Text of this Article]

Source Information

Dr. Kesselheim is an instructor in medicine in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital, Harvard Medical School, Boston. Dr. Studdert is a Federation Fellow in the Schools of Law and Population Health at the University of Melbourne, Melbourne, Australia.

Related Letters:

Preemption and Malpractice Liability
Hauser R. G., Kesselheim A. S., Studdert D. M.
Extract | Full Text | PDF  
N Engl J Med 2009; 360:2257-2258, May 21, 2009. Correspondence

This article has been cited by other articles:

• Hauser, R. G., Kesselheim, A. S., Studdert, D. M. (2009). Preemption and Malpractice Liability. NEJM 360: 2257-2258 [Full Text]  
• Gostin, L. O. (2009). Regulating the Safety of Pharmaceuticals: The FDA, Preemption, and the Public's Health. JAMA 301: 2036-2037 [Full Text]