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FDA Preemption and Pharmaceutical Product Liability
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FDA Preemption and Pharmaceutical Product Liability

AEI's Federalism Project hosted a conference in April 2006, covering many facets of preemption, including in the pharmaceutical industry.  All the materials from that event (including a paper from Former Chief Counsel for the FDA, Dan Troy), along with articles by AEI's Michael Greve, are available on one page.  Greve previously tackled the issue of preemption in Federalism Outlook #14: States' Rights on Steroids (2002), and spoke at a Federalist Society event on the subject in March 2006.

On September 7, 2005, AEI's Liability Project hosted a conference discussing the implications of Vioxx litigation.  Dan Troy was on the panel, and spoke to the issue of preemption.  Ted Frank's working paper on Vioxx litigation (in two parts), also discussed the issue.  AEI's Jack Calfee has also commented on this issue: Download file September 30, 2005, Download file March 28, 2006 (explaining the FDA's strengths and weaknesses), and April 12, 2006.


January 24, 2006: Download file Excerpts from FDA Rulemaking on Labeling.  Selections from the FDA's new rule change regarding labeling and preemption, including a brief summary, an explanation of the preemption of state law, and a justification based on Executive Order 13132.

FDA Briefs on Preemption
For an excellent run-down of these briefs' significance, see this December 14, 2006 post at the Drug and Device Law blog.

June 7, 2000:  Download file US Amicus Brief in Buckman Co. v. Plaintiffs' Legal Committee

September 13, 2000:  Download file US Amicus Brief on the Merits in Buckman Co.

November 13, 2000:  Download file US Statement of Interest, Bernhardt v. Pfizer, Inc.

March 25, 2002: Download file US Amicus in Dowhal v. SmithKline Beecham, CA appellate court

September 3, 2002: Download file US Amicus Brief in Motus v. Pfizer, Inc. (9th Circuit)

September 5, 2002: Download file Brief of the US, In re Paxil Litigation

July 18, 2003: Download file Second US Amicus, Dowhal v. SmithKline Beecham, CA Sup. Ct.

December 12, 2003: Download file US Statement of Interest, Murphree v. Pacesetter

May 14, 2004: Download file US Amicus Letter Brief in Horn v. Thoratec (3rd Circuit)

September 15, 2005: Download file US Amicus Brief in Kallas v. Pfizer (D. Utah)

May 10, 2006: Download file US Amicus Brief in Colacicco v. Apotex Corp. (E.D. Pa.)

September 21, 2006: Download file US Amicus Letter Brief in Perry v. Novartis Pharmaceuticals (E.D. Pa.)

December 4, 2006: Download file Second US Amicus Brief in Colacicco v. Apotex Corp. (3rd Circuit)

 

If any reader has materials that would add to this page, please send them to Philip Wallach at pwallach@aei.org.

Liability Outlook No. 3, 2007 - The Roberts Court and Liability Reform

In the the third Liability Outlook of 2007, Ted Frank analyzes the unexpected turns of the Supreme Court's October Term 2006.


Liability Outlook No. 2, 2007 - The Class Action Fairness Act Two Years Later
In the second Liability Outlook of 2007, Ted Frank gives an assessment of how CAFA has fared in its first two years and what challenges remain in the context of mass torts.

Liability Outlook No. 1, 2007 - Rollover Economics
In this first Liability Outlook of 2007, Ted Frank examines a nine-figure verdict against Ford for alleged "defective design" in its SUVs and analyzes the legal problems that led to it.

The Sarbanes-Oxley Debacle: What Have We Learned; How to Fix It

Henry N. Butler and Larry E. Ribstein detail the scant benefits and monumental costs of SOX.


The Vioxx Litigation

In this two-part working paper, Ted Frank examines the perils of over-deterrence created by the on-going Vioxx litigation.


Harm-Less Lawsuits

Michael Greve describes the origins of consumer class actions and analyzes their theoretical and practical problems. 


Competition Laws in Conflict

In this volume, edited by Richard A. Epstein and Michael S. Greve, leading experts explore routes to a new and better institutional design for global antitrust in the national and international contexts.

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