Civil Procedure

A Student's Guide to the Federal Rules of Civil Procedure (2009)
Gathering principal text from the practitioner's/judicial publication (Federal Civil Rules Handbook), the Student's Guide assembles...
 

Federal Practice & Procedure - CIVIL RULES: Quick Reference Guide (2009)
With this Volume 12B, the principal text of the Federal Civil Rules Handbook is incorporated...
 

Federal Civil Rules Handbook (2008)
Now in its 16th Edition, the Federal Civil Rules Handbook dissects each of the Federal...
 

Selecting the Jury, Defense Counsel Training Manual (1995)
A strategic overview of the process of jury selection. Co-authored with Walter R. Milbourne, Esq....
 

Drug & Device Law

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...
 

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)
 

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...
 

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)
 

Postmarketing Requirements, Bringing Your Medical Device to Market (2006)
This chapter introduces the intricate regulatory scheme of postmarketing regulations that restrict the commercialization of...
 

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.
 

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)
 

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...
 

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...