Selected Works @ Charleston School of Law

A Historical Perspective on Off-Label Medicine: From Regulation, Promotion, and the First Amendment to the Next Frontiers

William M. Janssen — Thu, 08 Dec 2011 14:12:02 PST

This chapter introduces the concept of "off-label medicine" (namely, off-label use, prescription, and promotion), by definition, historical development and evolution, and current status and controversy.

Siracusano v. Matrixx Initiatives, Inc.

William M. Janssen — Thu, 08 Dec 2011 14:07:31 PST

This chapter discusses the U.S. Court of Appeals' decision in Siracusano v. Matrixx Initiatives, Inc., and its rejection of the "statistical significance" test for the reportability of adverse event report data to securities investors.

Ascroft v. Iqbal

William M. Janssen — Thu, 08 Dec 2011 14:04:22 PST

This chapter discusses the U.S. Supreme Court's 2009 opinion in Ashcroft v. Iqbal, with early thoughts on its possible implications for the drug and device industries.

Plotting A Teacher's Journey: From Courtrooms to Classrooms

William M. Janssen — Thu, 08 Dec 2011 14:00:15 PST

This article discusses the path of shifting from a career in the active practice of law to a career in legal education.

Iqbal Plausibility in Pharmaceutical and Medical Device Litigation

William M. Janssen — Thu, 08 Dec 2011 13:56:36 PST

This Article studied the actual effect of the United States Supreme Court’s decision in Ashcroft v. Iqbal on the cohort of more than 264 federal pharmaceutical and medical device cases of every type, released from the day of the decision in Iqbal through August 31, 2010. The results of this study of more than 15 months of case law suggest that Iqbal is not having a dramatic impact on this cohort, although its impact cannot be conclusively dismissed as inconsequential either. There have been aggressive applications of Iqbal on occasion. In the 21.2% of the time when Iqbal appears facially to be impactful, a closer examination reveals that this observed effect is, in large measure, decreasing in incidence, coupled with an ability for correction, and frequently avoidable through accessible sources of information. Moreover, it is possible that those perceived effects may be phantoms, because repeated, longstanding, and frequently cited federal precedent among the lower federal courts may well have led to functionally identical results even without Iqbal‘s emergence.

Federal Civil Procedure Logic Maps

William M. Janssen — Thu, 08 Dec 2011 13:48:00 PST

A set of full-color graphical illustrations of the operation of the leading principles, rules, and concepts of federal civil procedure.

Relighting the Charitable Deduction: A Proposed Public Benefit Exception

Kristin Balding Gutting — Wed, 07 Dec 2011 07:40:54 PST

Bad Faith: Building a House of Straw, Sticks, or Bricks

Constance A. Anastopoulo — Sun, 04 Sep 2011 08:30:55 PDT

This article is a fifty state survey of the definition and application of bad faith claims arising from insurance contracts under state law. The article concludes with a comparison of the Model Rules of Claims Practices as promulgated by the National Association of Insurance Commissioners and how the states have adopted and incorporated those rules.

Accreditation Expands Law School's Role in Community

Andy Abrams — Mon, 29 Aug 2011 06:54:08 PDT

Presenter, The Law Governing the Admissability of a Defendant's Statements

Margaret M. Lawton — Tue, 21 Jun 2011 08:38:40 PDT