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American Health Lawyers Association 2006–2007 Year in Review

Cynthia Conner, Bianca Bishop, and Lisa Salerno

ABSTRACT: Every year, the American Health Lawyers Association assembles a Year in Review summary of the leading developments in case law, legislation, and administrative actions affecting healthcare. This article provides a comprehensive overview of these developments, demonstrating the increasingly complex and high profile nature of health law in the United States, as well as the inextricable links between health law and life sciences law.

Tort Reform by Regulation: FDA Prescription Drug Labeling Rules and Preemption of State Tort Claims

Michael P. Moreland

ABSTRACT: In 2006, the Food and Drug Administration (FDA) asserted in the preamble to a revised physician labeling rule for prescription drugs that FDA labeling requirements preempt state common law failure to warn claims. The FDA’s action reflects a wider effort of administrative agencies to preempt conflicting state law requirements. The debate over preemption raises a set of difficult issues, including the sufficiency of agency safety review, the scope of administrative deference, and federalism. This article surveys the background to the 2006 FDA labeling rule and the Supreme Court’s recent preemption jurisprudence in leading cases such as Cippollone v. Liggett Group, Inc., and Geier v. American Honda Motor Corp.

Scientific Misconduct in Research

Melissa L. Markey

ABSTRACT: Allegations of research misconduct, especially in federally-supported research, raise the specter of contentious, difficult confrontations. It is the obligation of the institution at which the research is conducted to ensure that a fair, competent, and thorough review of each allegation occurs. Recently revised Public Health Service research misconduct regulations set forth clear guidance and detailed requirements for institutional policies, inquiries, and investigations. Counsel to research institutions that receive federal support for research must be familiar with these regulations. Failure to prepare for, or respond quickly and compliantly to, allegations of research misconduct may result in injustice to an accused researcher, make definitive determinations impossible, expose an institution to regulatory penalties, and damage the reputation of both researchers and the institution.

ERISA as an Obstacle to Fair Share Legislation and Other State Initiatives to Expand Coverage to the Uninsured and Underinsured

Kathlynn Butler Polvino, Mazda K. Antia, and Jeremy P. Burnette

ABSTRACT: As states experiment with legislation designed to address problems of healthcare affordability and accessibility by requiring employers to offer or spend more on employee health benefit plans, courts increasingly will be called upon to determine whether such mandates run afoul of ERISA. This article examines the potential impact of existing case law on current legislative initiatives.

NOTES & COMMENTS

Executive Order 13,422, OMB’s Good Guidance Practices, and Implications for Health Rulemaking and Guidance

Marci Dale Harris

ABSTRACT: In early 2007, President Bush issued Executive Order 13,422, extending executive review to significant guidance documents, requiring the designation of a politically-appointed Regulatory Policy Officer (RPO) within each agency, and strengthening the review and consultation role of the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA). Almost simultaneously, the OMB issued its Final Bulletin for Good Guidance Practices (GGP) to address the growing agency practice of using non-binding guidance documents in lieu of rulemaking procedures to direct the conduct of regulated entities. This paper describes the evolution of executive review of rulemaking and guidance, the impetus for the current changes, and the possible implications of the executive order and OMB’s Final Bulletin on Good Guidance Practices for the health law arena.

Practice Resource

What Must Entities Do To Comply With Deficit Reduction Act Requirements For Information On Federal and State False Claims Act Provisions?

David E. Matyas, Beth Essig, Jason B. Caron, and Uri Bilek

CITATION: David E. Matyas, Beth Essig, Jason B. Caron, and Uri Bilek,What Must Entities Do To Comply With Deficit Reduction Act Requirements For Information On Federal and State False Claims Act Provisions?, J. Health & Life Sci. L., October 2007, at 151. Reprinted by the American Health Lawyers Association with permission. © 2007 Epstein Becker & Green PC. All rights reserved.