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48 Ariz. L. Rev. 67 (2006)
The FDA Defense: Vioxx and the Argument against Federal Preemption of State Claims for Injuries Resulting from Defective Drugs

handle is hein.journals/arz48 and id is 83 raw text is: THE FDA DEFENSE: VIOXX® AND THE
Jonathan V. O'Steen* and Van O'Steen**
On September 30, 2004, Merck & Co. announced an immediate
withdrawal of its arthritis drug Vioxx following a clinical study indicating it more
than doubled the risk of heart attack and stroke.' A Food and Drug Administration
(FDA) study published after the recall estimated that Vioxx caused as many as
140,000 heart-related injuries and may have led to as many as 56,000 deaths in the
United States alone in the five years the drug was on the market.2 In the days and
weeks following the withdrawal, law firms were flooded with calls from Vioxx
patients seeking representation for injury claims. By March 9, 2005, Merck was
already facing 1357 claims in connection with its defective drug.3 It is likely that
thousands more will be filed in the foreseeable future.
*     Partner, O'Steen & Harrison, PLC, Phoenix, Arizona. I am grateful to
Kathryn McCormick and Professor Betsy Grey, Arizona State University College of Law,
for valuable editorial input.
**     Founding partner, O'Steen & Harrison, PLC, Phoenix, Arizona.
1.    Gina Kolata, A Widely Used Arthritis Drug Is Withdrawn, N.Y. TIMEs, Oct.
1, 2004, at Al.
2.    Thomas H. Maugh II, Banned Report on Vioxx Published, L.A. TIMES, Jan.
25, 2005, at A18; see also F.D.A. Releases Memo on Vioxx, N.Y. TIMES, Nov. 3, 2004, at
C8; Memorandum from David J. Graham, Assoc. Dir. of Sci., Office of Drug Safety, to
Paul Seligman, Acting Dir., Office of Drug Safety, Risk of Acute Myocardial Infarction and
Sudden Cardiac Death in Patients Treated with Cox-2 Selective and Non-Selective NSAIDS
(Sept.  30,   2004),   available  at  http://www.fda.gov/cder/drug/infopage/vioxx/
vioxxgraham.pdf (estimating that Vioxx caused approximately 27,000 heart attacks and
strokes between 1999 and 2002).
3.    Theresa Agovino, Pretrial Process for Vioxx Litigation Begins, LAW.COM,
Mar. 21, 2005, http://www.law.com/jsp/article.jsp?id=l111140312583 (noting that 127 of
the 1357 cases filed were transferred to Judge E. Fallon of the U.S. District Court for the
Eastern District of Louisiana for pretrial hearings). Even firms outside the United States are
actively soliciting cases. See, e.g., Hundreds of Lawsuits Expected Over Vioxx,

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