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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 ARGUMENT AGAINST FEDERAL PREEMPTION OF STATE CLAIMS FOR INJURIES RESULTING FROM DEFECTIVE DRUGS Jonathan V. O'Steen* and Van O'Steen** INTRODUCTION 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 Gina Kolata, A Widely Used Arthritis Drug Is Withdrawn, N.Y. TIMEs, Oct. 1, 2004, at Al. 2.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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