Published Works - Articles

PDF

Iqbal Plausibility in Pharmaceutical and Medical Device Litigation, Louisiana Law Review (2011)

This Article studied the actual effect of the United States Supreme Court’s decision in Ashcroft...

 

PDF

Plotting A Teacher's Journey: From Courtrooms to Classrooms, Update (Food and Drug Law Institute) (2011)

This article discusses the path of shifting from a career in the active practice of...

 

OpenURL

Ethnic / Race Niche Drugs, UPDATE – FOOD AND DRUG LAW, REG. & EDUC. (2006)

This article explores the prudence and legal validity of approaching pharmaceutical development at a level...

 

OpenURL

FDA’s Independent Drug Safety Board: The Quest To Restore Confidence In FDA’s Stamp Of Approval, PHARMACEUTICAL LITIGATION REPORTER (2005)

Co-authored with Royce W. Smith, Esq. of Philadelphia.

 

OpenURL

Group Justice? Legal Moves That Lump Pharma Cases Together Are Bad For Justice And Bad For The Industry, PHARMACEUTICAL EXECUTIVE (2004)

This article critiques the judicial penchant for combining drug and device tort cases together for...

 

Published Works - Books

Federal Civil Rules Handbook (2011)

Now in its 16th Edition, the Federal Civil Rules Handbook dissects each of the Federal...

 

A Student's Guide to the Federal Rules of Civil Procedure (2011)

Gathering principal text from the practitioner's/judicial publication (Federal Civil Rules Handbook), the Student's Guide assembles...

 

Federal Civil Procedure Logic Maps (2011)

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

 

Federal Practice & Procedure - CIVIL RULES: Quick Reference Guide (2011)

With this Volume 12B, the principal text of the Federal Civil Rules Handbook is incorporated...

 

Contributions to Books

Siracusano v. Matrixx Initiatives, Inc., Top 20 Food And Drug Cases, 2010 & Cases to Watch, 2011 (2011)

This chapter discusses the U.S. Court of Appeals' decision in Siracusano v. Matrixx Initiatives, Inc.,...

 

Ascroft v. Iqbal, Top 20 Food And Drug Cases, 2009 & Cases to Watch, 2010 (2010)

This chapter discusses the U.S. Supreme Court's 2009 opinion in Ashcroft v. Iqbal, with early...

 

A Historical Perspective on Off-Label Medicine: From Regulation, Promotion, and the First Amendment to the Next Frontiers, Off-Label Communications (2009)

This chapter introduces the concept of "off-label medicine" (namely, off-label use, prescription, and promotion), by...

 

A Historical Perspective on Off-Label Medicine: From Regulation, Promotion, and the First Amendment to the Next Frontiers, Off-Label Communications (2008)

In FDLI's principal work on off-label medicine, this Chapter summarizes the evolution of off-label practices...

 

Postmarketing Requirements, Bringing Your Medical Device to Market (2006)

This chapter introduces the intricate regulatory scheme of postmarketing regulations that restrict the commercialization of...

 

Medicine Meets Madison Avenue: The Direct-to-Consumer Advertising of Prescription Drugs, ADVERTISING & PROMOTION OF BIOMEDICAL PRODUCTS (2005)

This chapter surveys and analyzes the legal dimensions of advertising prescription medical products directly to...

 

Selecting the Jury, Defense Counsel Training Manual (1995)

A strategic overview of the process of jury selection. Co-authored with Walter R. Milbourne, Esq....

 

Presentations

PROMOTION & ADVERTISING OF MEDICAL DEVICES, Food and Drug Law Institute’s “Introduction To Medical Device Law And Regulation: Understanding How FDA Regulates The Medical Device Industry” (2007)
 

MONITORING DEVICE PERFORMANCE, ADVERSE EVENTS/PRODUCT PROBLEMS, PRODUCT RECALLS, AND CORRECTIONS AND REMOVALS, Food and Drug Law Institute’s “Introduction To Medical Device Law And Regulation: Understanding How FDA Regulates The Medical Device Industry” (2006)
 

POST-MARKETING REQUIREMENTS, Food and Drug Law Institute’s “Introduction To Medical Device Law And Regulation: Understanding How FDA Regulates The Medical Device Industry” (2005)