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:
September 30, 2005,
March 28, 2006 (explaining the FDA's strengths and weaknesses), and April 12, 2006.
January 24, 2006:
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:
US Amicus Brief in Buckman Co. v. Plaintiffs' Legal Committee
September 13, 2000:
US Amicus Brief on the Merits in Buckman Co.
November 13, 2000:
US Statement of Interest, Bernhardt v. Pfizer, Inc.
March 25, 2002:
US Amicus in Dowhal v. SmithKline Beecham, CA appellate court
September 3, 2002:
US Amicus Brief in Motus v. Pfizer, Inc. (9th Circuit)
September 5, 2002:
Brief of the US, In re Paxil Litigation
July 18, 2003:
Second US Amicus, Dowhal v. SmithKline Beecham, CA Sup. Ct.
December 12, 2003:
US Statement of Interest, Murphree v. Pacesetter
May 14, 2004:
US Amicus Letter Brief in Horn v. Thoratec (3rd Circuit)
September 15, 2005:
US Amicus Brief in Kallas v. Pfizer (D. Utah)
May 10, 2006:
US Amicus Brief in Colacicco v. Apotex Corp. (E.D. Pa.)
September 21, 2006:
US Amicus Letter Brief in Perry v. Novartis Pharmaceuticals (E.D. Pa.)
December 4, 2006:
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.