Volume 58 Issue 2
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Table of Contents
> Can FDA Seek Restitution
or Disgorgement?
by Jeffrey N. Gibbs & John R. Fleder, Members in the law firm
of Hyman, Phelps & McNamara, P.C., in Washington, D.C.
> The Authority of a Court to Order Disgorgement for
Violations of the Current Good Manufacturing Practices Requirement
of the Federal Food, Drug, and Cosmetic Act
by Erika King, Assistant General Counsel, Pharmaceutical Research
and Manufacturers of America, Washington, D.C. She was an associate
at Covington & Burling when the firm represented Schering-Plough
in connection with its 2002 consent decree, and was involved in
that representation. The views expressed in this article are her
own.
Elizabeth M. Walsh, Associate in the law firm of Covington & Burling, Washington, D.C. Ms. Walsh was involved in Covington & Burling's representation of Schering-Plough. The views expressed in this article are her own.
> Universal Management, Abbott, Wyeth, Schering-Plough,
and . . . : Restitution and Disgorgement Find Another Home at
the Food and Drug Administration
by Eric M. Blumberg, Deputy Chief Counsel for Litigation, U.S.
Food and Drug Administration, Rockville, MD. The views expressed
herein are solely those of the author and do not necessarily reflect
the views of FDA.
> Remarks of the Commissioner of Food and Drugs
by Mark B. McClellan, M.D., Ph.D., Commissioner of Food and Drugs,
Food and Drug Administration (FDA), Rockville, MD. These remarks
were presented by the Commissioner at the Food and Drug Law Institute's
(FDLI's) 46th Annual Educational Conference, Washington, D.C.
(Apr. 1-2, 2003).
> Remarks at FDLI's 46th Annual Educational Conference
by Henry A. Waxman (D-CA), Member of the U.S. House of Representatives
and the Ranking Member of the House Government Reform Committee.
This article was the basis of Rep. Waxman's keynote address at
the Food and Drug Law Institute's 46th Annual Educational Conference,
Washington, D.C. (April 1-2, 2003).
> Scientific Dispute Resolution: First Use of Provision
404 of the Food and Drug Administration Modernization Act of 1997
by Karen M. Becker, Ph.D., President of Becker & Associates
Consulting, Inc., Washington, D.C.
Ellen J. Flannery, Partner in the law firm of Covington & Burling, Washington, D.C.
Thomas O. Henteleff, Managing Partner in the law firm of Kleinfeld, Kaplan and Becker, Washington, D.C.
> Proving Causation: The Use and Abuse of Medical
and Scientific Evidence Inside the Courtroom-An Epidemiologist's
Critique of the Judicial Interpretation of the Daubert Ruling
by David Egilman, M.D., M.P.H., Clinical Associate Professor of
Bio-Medicine and Community Health at Brown University, Providence,
RI. He has served as an expert witness in toxic tort cases at
the request of both individuals and corporations.
Joyce Kim, J.D. candidate at Columbia University School of Law, New York, NY
Molly Biklen, J.D. candidate at Columbia University School of
Law, New York, NY
> Financial Conflict of Interest in Medical Research:
Overview and Analysis of Institutional Controls
by Jennifer A. Henderson, J.D., M.P.H., Administrative Director
and Senior Research Associate, Regulatory Affairs Program, Center
for Integration of Medicine and Innovative Technology, Boston,
MA
John J. Smith, M.D., J.D., Associate Radiologist, Massachusetts General Hospital; Associate Professor of Radiology, Harvard Medical School; and Director of Regulatory Affairs, Center for Integration of Medicine and Innovative Technology, Boston, MA
> Recent Developments in Pharmaceutical Products Liability Law: Failure to Warn, the Learned Intermediary Defense, and Other Issues in the New Millenniumby Bernard J. Garbutt III, Partner at Morgan, Lewis & Bockius LLP, New York, NY
Melinda E. Hofmann, Associate at Morgan, Lewis & Bockius LLP, New York, NY
> A State of Extinction:
Does Food and Drug Administration Approval of a Prescription Drug
Label Extinguish State Claims for Inadequate Warning?
by James T. O'Reilly, Visiting Professor, University of Cincinnati,
College of Law, Cincinnati, OH
Can FDA Seek Restitution or Disgorgement?
Authors: Jeffrey N. Gibbs & John R. Fleder
Issue: 58 Food and Drug Law Journal 129 (2003)
In the last few years, the Food and Drug Administration (FDA) has collected
for the U.S. Treasury hundreds of millions of dollars-including $500
million from one company alone—using theories of liability that
cannot be found in FDA's governing statute, the Federal Food, Drug,
and Cosmetic Act (FDCA), namely the theories of "restitution"
and "disgorgement of ill-gotten profits." Only one court has
clearly granted FDA restitution or disgorgement of profits in a contested
proceeding. This decision, however, is inconsistent with the terms of
the FDCA, prior court decisions, FDA's assertions in a subsequent filing
with the U.S. Supreme Court, and applicable principles of statutory
construction. This article examines the asserted legal underpinnings
for FDA's invocation of these powerful enforcement tools, as well as
the arguments for and against the use of restitution and disgorgement.
The authors explain how FDA's use of restitution and disgorgement is
unsupported by statutory authority, case law, and fundamental canons
of statutory construction.
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The Authority of a Court to Order Disgorgement for Violations of the Current Good Manufacturing Practices Requirement of the Federal Food, Drug, and Cosmetic Act
Authors: Erika King & Elizabeth M. Walsh
Issue: 58 Food and Drug Law Journal 149 (2003)
This article responds to an article, published in the Food and Drug
Law Journal in 2000, in which the Food and Drug Administration's (FDA's)
Deputy Chief Counsel for Litigation presented a legal justification
for the disgorgement award included in the agency's 1999 consent decree
with Abbott Laboratories. It explains that the Sixth Circuit case on
which FDA relies does not support disgorgement for distribution of drugs
manufactured in a facility that is not fully good manufacturing practice
(GMP)-compliant. Neither the text nor the legislative history of the
Federal Food, Drug, and Cosmetic Act (FDCA) supports a statutory disgorgement
remedy. While a court may fashion equitable remedies to effect the purposes
of a remedial statute, courts in fact have been cautious about ordering
any nonstatutory remedy in cases arising under the FDCA. Further, the
limited jurisprudence permitting equitable disgorgement in lawsuits
brought under remedial statutes cannot be applied logically to GMP violations.
The authors conclude that FDA has, without congressional approval or
judicial review, forced several companies to agree to a remedy that
Congress never intended and that a court would not order.
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Universal Management, Abbott, Wyeth, Schering-Plough, and . . . : Restitution and Disgorgement Find Another Home at the Food and Drug Administration
Author: Eric M. Blumberg
Issue: 58 Food And Drug Law Journal 169 (2003)
Co-authors Gibbs and Fleder, in an article entitled "Can FDA Seek
Restitution or Disgorgement?" and co-authors King and Walsh, in
an article entitled "The Authority of a Court to Order Disgorgement
for Violations of the Current Good Manufacturing Practices Requirement
of the Federal Food, Drug, and Cosmetic Act," raise a question
that is being asked by many Food and Drug Administration (FDA)-regulated
companies and their counsel. This article will show that although the
question has acquired a new currency following the Sixth Circuit's decision
in United States v. Universal Management Services, Inc. and three
recent consent decrees obtained by FDA, the answer is not in serious
doubt. The basic premise of both articles-i.e., because the Federal
Food, Drug, and Cosmetic Act does not expressly provide for equitable
relief, FDA may not obtain it-misapprehends, in the most fundamental
way, the principle of inherent equitable relief. Courts must presume
that they have the power to grant equitable relief unless there is express
statutory language depriving the courts of such power.
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Remarks of the Commissioner of Food
and Drugs
Author: Mark B. McClellan
Issue: 58 Food and Drug Law Journal 191 (2003)
The text of this article is based on Dr. McClellan's prepared remarks,
as presented at the Food and Drug Law Institute's (FDLI's) 46th Annual
Educational Conference, held in Washington, D.C. in April 2003. The
Commissioner suggests that, for the sake of the public health, FDA must
find fundamentally better ways to address its regulatory responsibilities,
including the threat of terrorism and the need to control healthcare
costs without sacrificing the great potential of medical innovation
in the twenty-first century. In some cases, this is requiring re-examination
and updating of the way FDA does its job. To bring all this together—new
challenges, new opportunities, and the most creative thinking from inside
and around the agency to prioritize and address them—FDA has undertaken
a major strategic action plan within the agency. That process identified
five top priorities for the agency, including three specific areas of
major new initiatives and two general approaches that are being reinforced
to achieve FDA's mission objectives. This article provides an update
on the agency's progress and highlights some of the challenges and next
steps ahead.
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Remarks at FDLI's 46th Annual Educational Conference
Author: Henry A. Waxman
Issue: 58 Food and Drug Law Journal 205 (2003)
In this article, based on a presentation at the Food and Drug Law Institute's
(FDLI's) 46th Annual Educational Conference in April 2003, U.S. Representative
Henry A. Waxman (D-CA) suggests that the Food and Drug Administration
(FDA) will be "front and center" in dealing with the most
pressing health challenges facing the United States. Successfully facing
these challenges will depend upon how well the agency performs its key
role-supporting medical progress and public health through science-based
regulation. Congressman Waxman argues that failure lurks where politics
and ideology are allowed to skew the agency's mission, and he warns
against the trend toward the politicization of health science.
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Scientific Dispute Resolution: First Use of Provision
404 of the Food and Drug Administration Modernization Act of 1997
Authors: Karen M. Becker, Ellen J. Flannery & Thomas O. Henteleff
Issue: 58 Food and Drug Law Journal 211 (2003)
Utilizing a formal dispute resolution process provided for in section
404 of the Food and Drug Administration Modernization Act of 1997, the
Center for Devices and Radiological Health (CDRH) convened in September
2001 the first, and to date only, Medical Devices Dispute Resolution
Panel (MDDRP) to adjudicate a scientific controversy between CDRH and
a sponsor pertaining to the approvability of a premarket application
(PMA). This proceeding was convened at the sponsor's request, prompted
by a not-approvable determination issued by CDRH. The MDDRP concluded
that the not-approvable determination by CDRH was incorrect, and the
Center Director concurred with this finding. Subsequently, the PMA was
approved. This article reviews the legal and scientific basis for the
request for formal dispute resolution by the sponsor, describes the
procedures utilized and precedents established in the course of this
administrative process, and explores the potential use of this process
to resolve future scientific disputes.
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Proving Causation: The Use and Abuse of Medical and
Scientific Evidence Inside the Courtroom-
An Epidemiologist's Critique
of the Judicial Interpretation of the Daubert Ruling
Authors: David Egilman, Joyce Kim & Molly Biklen
Issue: 58 Food and Drug Law Journal 223 (2003)
This article explores the issues relating to the exclusion of expert
testimony under the Daubert and Joiner decisions. In recent years, the
legal and scientific methods relied on for the establishment of disease
causation have diverged. Several courts' exclusive reliance on epidemiology
and statistical bright-line tests are discussed, and these judicial
standards are compared to accepted scientific standards for determining
general causation. Courts have misinterpreted epidemiologic evidence
by requiring a doubling of the disease rate in exposed populations as
a sine qua non for the establishment of causation. In their quest
for a simple quantitative rule, courts have created an erroneous standard
that serves as a one-sided gate to courtroom entrée. This deviation
from normal science flouts the spirit of justice to which our courts
should aspire.
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Financial Conflict of Interest in Medical Research:
Overview and Analysis of Institutional Controls
Author: Jennifer A. Henderson & John J. Smith
Issue: 58 Food and Drug Law Journal 251 (2003)
Collaboration between academia and industry, while creating new opportunities,
has given rise to financial conflicts of interest. Institutional policies,
influenced by regional conditions, institutional values, and state and
federal controls, represent local approaches to financial conflict issues,
resulting in widespread policy variation. More importantly, institutional
practices, in terms of the way in which policies are interpreted and
the manner in which policies are implemented, influence the complexity
of financial conflict issues. To maximize the potential benefits of
industry-academia partnerships and to avoid eroding public trust in
important medical research endeavors, existing institutional variations,
both at the policy and practice levels, must be thoughtfully addressed.
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Recent Developments in Pharmaceutical Products Liability
Law:
Failure to Warn, the Learned Intermediary Defense, and Other Issues
in the New Millennium
Authors: Bernard J. Garbutt III & Melinda E. Hofmann
Issue: 58 Food and Drug Law Journal 269 (2003)
Failure-to-warn claims against pharmaceutical companies are typical
in products liability cases involving both prescription and over-the-counter
(OTC) drugs. Under the learned intermediary doctrine, a pharmaceutical
company is relieved of its duty to warn a patient of side effects associated
with a drug when the company has provided an adequate warning to the
patient's physician, but this defense has come under greater attack
lately. This article discusses the basis of a failure-to-warn claim
generally, and reviews some new issues that impact the learned intermediary
defense, including direct-to-consumer (DTC) marketing, the Internet,
and OTC sales. Also considered are new claims that plaintiffs have asserted
in an attempt to avoid the learned intermediary doctrine, such as claims
based on state consumer fraud and unfair trade practices statutes. Finally,
the article reviews the judicial response to section 6 of the products
liability section of the new Restatement (Third) of Torts, which
was intended to replace section 402A and comment k of the Restatement
(Second) of Torts.
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A State of Extinction: Does Food and Drug Administration
Approval of a Prescription Drug Label Extinguish State Claims for Inadequate
Warning?
Author: James T. O'Reilly
Issue: 58 Food and Drug Law Journal 287 (2003)
Federal and state courts in the twenty-first century, as well as Federalist
Papers author Alexander Hamilton in the eighteenth century, would regard
state courts as competent to determine the adequacy of warnings on prescription
drugs. Department of Health and Human Services (DHHS) General Counsel,
Alex Azar, told FDLI's 2003 Annual Educational Conference that states
should be preempted from such tort findings, because Food and Drug Administration
(FDA) label decisions are exclusively within federal control. This article
dissents from that view, and explores the history and policy debates
about federal-state coordination of various aspects of drug regulatory
controls. Congress might someday settle the issue by granting such preemptive
authority, but until it does, DHHS's view of preemptive power appears
to stretch beyond FDA's ability to invoke Supremacy Clause powers.
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