Civil Procedure

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The Odd State of Twiqbal Plausibility in Pleading Affirmative Defenses, Washington & Lee Law Review (2013)

After its opinion in Ashcroft v. Iqbal, the U.S. Supreme Court has made clear that...

 

Weddle v. Bayer AG Corporation, TOP 20 FOOD & DRUG CASES, 2012, AND CASES TO WATCH, 2013 (2013)
 

Federal Civil Rules Handbook (2012)

Now in its 19th Edition, the Federal Civil Rules Handbook dissects each of the Federal...

 

A Student's Guide to the Federal Rules of Civil Procedure (2012)

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

 

Personal Jurisdiction after Goodyear and McIntyre, Food and Drug Law Institute Annual Meeting (2012)
 

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Goodyear Dunlop Tires Operations, S.A. v. Brown (and J. McIntyre Machinery, Ltd. v. Nicastro), Top 20 Food and Drug Cases, 2011 & Cases to Watch, 2012 (2012)

This chapter discusses the U.S. Supreme Court's two personal jurisdiction decisions from June 2011, and...

 

Federal Civil Procedure Logic Maps (2012)

Federal Civil Procedure Logic Maps is a full-color collection of graphical illustrations of the content...

 

Federal Practice & Procedure - CIVIL RULES: Quick Reference Guide (2012)

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

 

A Decade of Federal Civil Rules Upheaval: A Path Worth Emulating or Avoiding?, Southern High Court Conference (2011)
 

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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...

 

Ashcroft v. Iqbal and Pleading in Federal Drug and Device Cases, Food and Drug Law Institute Annual Meeting (2010)
 

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

Weddle v. Bayer AG Corporation, TOP 20 FOOD & DRUG CASES, 2012, AND CASES TO WATCH, 2013 (2013)
 

Personal Jurisdiction after Goodyear and McIntyre, Food and Drug Law Institute Annual Meeting (2012)
 

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Goodyear Dunlop Tires Operations, S.A. v. Brown (and J. McIntyre Machinery, Ltd. v. Nicastro), Top 20 Food and Drug Cases, 2011 & Cases to Watch, 2012 (2012)

This chapter discusses the U.S. Supreme Court's two personal jurisdiction decisions from June 2011, and...

 

Matrixx Initiatives v. Siracusano - The Supreme Court Tackles the Meaning of ADEs in Pharmaceutical Securities Litigation, Food and Drug Law Institute Annual Meeting (2011)
 

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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...

 

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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...

 

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.,...

 

Ashcroft v. Iqbal and Pleading in Federal Drug and Device Cases, Food and Drug Law Institute Annual Meeting (2010)
 

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...

 

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)
 

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

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

 

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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...

 

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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...

 

Law Teaching

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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...

 

Religion and the Law

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Led Blindly: One Circuit's Struggle to Faithfully Apply the U.S. Supreme Court's Religious Symbols Constitutional Analysis, West Virginia Law Review (2013)

The United States Supreme Court is a teaching court. Its primary role, once explained Justice...

 

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Toiling In The Lemon Groves: Prelude to the Endorsement Test, Charleston Law Review (2013)