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 Buckman. Buckman 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 OF TRUTHFUL 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