Back in 1998, Bexis published the first major law review article about off-label use of drugs and medical devices and tort liability, James Beck & Elizabeth Azari, “FDA, Off-Label Use, & Informed Consent:  Debunking Myths & Misconceptions,” 53 Food & Drug L.J. 71 (1998).  This article came to be cited twice by the United States Supreme Court in BuckmanBuckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 350, 351 n.5 (2001), and by a raft of other cases, and helped give “off-label use” its name (as opposed to the more pejorative references preferred by the FDA and the other side of the “v.”).

Anyway, a lot has happened on the off-label use front over the past 23 years, and Bexis has often been in the thick of those developments.  A couple of aspects of off-label use – pertaining to preemption and to First Amendment protection – did not even exist back in 1998 in any meaningful sense.  After much urging, Bexis has written a second, more comprehensive article about off-label use issues that has just been published in the UIC John Marshall Law Review.  See James M. Beck, “Off-Label Use in the Twenty-First Century:  Most Myths and Misconceptions Mitigated,” 54 UIC J. Marshall L. Rev. 1 (2021), available here online.

The article took over a year to write, and reflecting Bexis’ obsession with thorough research, is a lengthy read.  To decide if you’re interested, here is the table of contents for the article:

Page 2:            I. INTRODUCTION

Page 4:            II. OFF-LABEL USE – THE MEDICAL AND LEGAL FRAMEWORK

Page 14:          III. OFF-LABEL USE IS A RECOGNIZED AND ACCEPTED ASPECT OF MEDICAL PRACTICE

Page 14           A. The General Status of Off-Label Use

Page 35:          B. Distinctions Between “Experimental,” “Investigational,” and “Off-Label” Use

Page 42:          C. The Conundrum of Off-Label Promotion

Page 49:          IV. FIRST AMENDMENT CONSTRAINTS ON FDA PROHIBITION OFTRUTHFUL OFF-LABEL SPEECH/PROMOTION

Page 50:          A. First Amendment Protection of Off-Label Speech in Commercial Contexts

Page 57:          B. First Amendment Protection of Off-Label Speech as Scientific Speech

Page 58:          C. First Amendment Protection of Off-Label Against Tort Claims

Page 60:          V. EFFECT OF OFF-LABEL USE AND PROMOTION ON PREEMPTION

Page 63:          A. Express Preemption and Off-Label Use

Page 66:          B. “Parallel” Violation Claims Involving Off-Label Use

Page 75:          C. Implied Preemption and Off-Label Use

Page 84:          VI. OFF-LABEL USE ISSUES INVOLVING INFORMED CONSENT

Page 84:          A. Informed Consent and Off-Label Use

Page 86:          B. Informed Consent and Medical Experimentation

Page 88:          C. FDA Regulated Intended Uses and the Medical Standard of Care

Page 91:          D. Independent Physician Investigation of Off-Label Uses

Page 92:          E. Off-Label Informed Consent Claims Against Manufacturers or Their Sales Representatives

Page 94:          VII. OFF-LABEL USE AND PRODUCT LIABILITY LITIGATION

Page 95:          A. The Learned Intermediary Doctrine and Off-Label Use

Page 98:          B. Product Manufacturers and Their Representatives Have No Duty to Intervene to Prevent Physician Off-Label Use

Page 104:        C. Duty To Warn Of Risks Of Off-Label Use

Page 104:        1. Decisions Predicated On A Greater Duty To Warn

Page 107:        2. Decisions Predicated On A Standard Duty To Warn

Page 111:        3. Decisions Predicated On A Lesser Duty To Warn

Page 104:        4. Decisions Finding No Duty To Warn Of An Off Label Use

Page 113:        5. Causation Issues in Warning-Based Off-Label Use Cases

Page 119:        D. Off-Label Use and Express Warranty Claims

Page 120:        E. Duty-To-Test Claims Involving Off-Label Uses

Page 122:        VIII. CONCLUSION