Hostname: page-component-586b7cd67f-vdxz6 Total loading time: 0 Render date: 2024-11-27T23:04:41.107Z Has data issue: false hasContentIssue false

Wyeth v. Levine: Challenging Implied Pre-emption for drugs

Published online by Cambridge University Press:  01 January 2021

Extract

In March 2009, the Supreme Court held in Wyeth v. Levine that federal drug labeling laws do not pre-empt state tort claims against drug manufacturers. The decision surprised many Court watchers, coming on the heels of a 2008 decision, Riegel v. Medtronic, in which the Court found that the Food, Drug, and Cosmetic Act (FDCA) does pre-empt state-law claims for injuries caused by medical devices that received premarket approval from the Food and Drug Administration. Wyeth dealt an immediate and surprising blow to the pharmaceutical industry’s principal strategy for avoiding tort lawsuits, but failed to clarify the Court’s overall pre-emption jurisprudence.

Type
Recent Developments in Health Law
Copyright
Copyright © American Society of Law, Medicine and Ethics 2009

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Wyeth v. Levine, 129 S. Ct. 1187 (2009).CrossRefGoogle Scholar
Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008).Google Scholar
Federal Food, Drug, and Cosmetic Act 21 U.S.C. §§301-397 (2000).Google Scholar
U.S. Const., Art. VI, § 2.Google Scholar
See, e.g., City of Columbus v. Ours Garage and Wrecker Service, Inc., 536 U.S. 424 (2002).Google Scholar
See, e.g., Aetna Health Inc. v. Davila, 542 U.S. 200 (2004).Google Scholar
See, e.g., Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947).Google Scholar
See, e.g., Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).Google Scholar
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).+(last+visited+July+2,+2009).>Google Scholar
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).+(last+visited+July+2,+2009).>Google Scholar
Riegel, 128 S. Ct. 999.Google Scholar
Id., at 1009.Google Scholar
Student Note, “Preemption of State Common Law Claims: Riegel v. Medtronic, Inc.”, Harvard Law Review 122, no. 1 (2008): 405415.Google Scholar
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).Google Scholar
Wyeth, 129 S. Ct. at 1191–93.Google Scholar
Id., at 1192.Google Scholar
Id., at 1192 (note 1).Google Scholar
Id., at 11911193.Google Scholar
Id., at 1192.Google Scholar
See Levine v. Wyeth, 944 A.2d 179 (Vt., 2006).Google Scholar
Id., at 184.Google Scholar
Id., at 197 (Rieber, C.J., dissenting).Google Scholar
Id., at 203.Google Scholar
Id., at 203.Google Scholar
Wyeth v. Levine, 944 A.2d 179 (Vt., 2006), cert. granted.Google Scholar
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).+(last+visited+July+2,+2009);+Brief+of+the+United+States+as+Amicus+Curiae,+available+at++(last+visited+July+2,+2009).>Google Scholar
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).+(last+visited+July+2,+2009).>Google Scholar
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).+(last+visited+July+2,+2009).>Google Scholar
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).+(last+visited+July+2,+2009).>Google Scholar
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).+(last+visited+July+2,+2009);+Brief+for+Members+of+Congress+in+Support+of+Respondent,+available+at++(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++(last+visited+July+2,+2009).>Google Scholar
Curfman, G. D., Morrissey, S. and Drazen, J. M., “Why Doctors Should Worry about Preemption”, New England Journal of Medicine 359, no. 1 (2008): 13.CrossRefGoogle Scholar
See Harris, , supra note 10.Google Scholar
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).+(last+visited+July+2,+2009).>Google Scholar
Wyeth, 129 S. Ct. at 1190.Google Scholar
Id., at 1202.Google Scholar
Id., at 1203.Google Scholar
Id., at 1190.Google Scholar
Id., at 1204 (Breyer, J., concurring).Google Scholar
Id., at 1205 (Thomas, J., concurring).Google Scholar
Id., at 1217 (Alito, J., dissenting).Google Scholar
Id., at 1218 (Alito, J., dissenting).Google Scholar
Id., at 1219 (Alito, J., dissenting).Google Scholar
Joseph Colacicco v. Apotex, Inc., No. 06-3107 (3rd Cir., 2009).Google Scholar