About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline

5 Yale J. Health Pol'y L. & Ethics 741 (2005)
Regulatory Paternalism in the Market for Drugs: Lessons from Vioxx and Celebrex

handle is hein.journals/yjhple5 and id is 745 raw text is: Regulatory Paternalism in the Market for Drugs:
Lessons from Vioxx and Celebrex
Richard A. Epstein, LL.B.*
The trials and tribulations of the pharmaceutical industry made front-page
news in the Fall of 2004. On September 30, 2004, Merck & Co. announced that it
would voluntarily pull its Cox-2 inhibitor, Vioxx, from the market.' To say the
least, the decision to take the drug off the market caused no little stir. Vioxx,
which had entered the market with great fanfare in 1999, had become an instant
blockbuster drug with over one hundred million prescriptions,2 twenty million
users,3 and about $2.5 billion in annual sales.4 The success of the drug paralleled
that of two Pfizer Cox-2 inhibitors, Celebrex and Bextra.5 The success of all
* James Parker Hall Distinguished Service Professor of Law, The University of Chicago;
Peter and Kirsten Bedford Senior Fellow, The Hoover Institution. My thanks to Anup Malani,
Henry I. Miller, M.D. and Cass R. Sunstein for comments on an earlier draft, to the participants at
the pharmacoeconomics workshop at UCLA, and the public policy workshop at Stanford Law
School for their helpful comments, and to Eric E. Murphy, University of Chicago Law School,
class of 2005 for his excellent research assistance. For the record, I should like to state that I have
worked on a wide variety of issues that pertain to pharmaceutical regulation and liability as a
consultant for PhRMA, and as a consultant to Pfizer Company on a number of matters, including
the Rezulin litigation. The views in this paper are entirely my own.
1. Bamaby J. Feder, Criticism of Drug May Leave Pfizer Awash in Lawsuits, N.Y. TIMES,
Dec. 18, 2004, at Cl; see also Anahad O'Connor & Denise Grady, Pfizer and Celebrex: The
Patients; Problems May Send Many Patients Back to Age-Old Aspirin, N.Y. TIMES, Dec. 18, 2004,
at Cl.
2. Andrew Leckey, Prognosis Is Cautious for Merck Shares, Analysts Say, CHI. TRIB., Nov. 7,
2004, at C8.
3. Theresa Agovino, Lawsuits Threaten Health of Merck; Vioxx Litigation May Cost Billions,
CHI. TRIB., Nov. 8, 2004, at Al. The article estimated that potential tort liability could amount to
$17.6 billion over the next decade.
4. Leckey, supra note 2.
5. For the FDA's cautious position on the decision to take Vioxx off the market, see FDA,
Vioxx (rofecoxib) Questions and Answers, Question 12, at http://www.fda.gov/cder/drug/infopage/
vioxx/vioxxQA.htm (Sept. 30, 2004) (noting that [t]he results of clinical studies with one drug in a

What Is HeinOnline?

HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.

Short-term subscription options include 24 hours, 48 hours, or 1 week to HeinOnline.

Contact us for annual subscription options:

Already a HeinOnline Subscriber?

profiles profiles most