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Most Myths and Misconceptions Mitigated, 54 UIC J. Marshall L. Rev. 1 (2021) UIC Law Review Volume 54 Issue 1 Article 1 2021 Off-Label Use in the Twenty-First Century: Most Myths and Misconceptions Mitigated, 54 UIC J. Marshall L. Rev. 1 (2021) James Beck Follow this and additional works at: https://repository.law.uic.edu/lawreview Part of the Food and Drug Law Commons, Health Law and Policy Commons, and the Medical Jurisprudence Commons Recommended Citation James M. Beck, Off-Label Use in the Twenty-First Century: Most Myths and Misconceptions Mitigated, 54 UIC J. Marshall L. Rev. 1 (2021) https://repository.law.uic.edu/lawreview/vol54/iss1/1 This Article is brought to you for free and open access by UIC Law Open Access Repository. It has been accepted for inclusion in UIC Law Review by an authorized administrator of UIC Law Open Access Repository. For more information, please contact [email protected]. OFF-LABEL USE IN THE TWENTY-FIRST CENTURY: MOST MYTHS AND MISCONCEPTIONS MITIGATED JAMES M. BECK* I. INTRODUCTION ................................................................... 2 II. OFF-LABEL USE – THE MEDICAL AND LEGAL FRAMEWORK ....................................................................... 4 III. OFF-LABEL USE IS A RECOGNIZED AND ACCEPTED ASPECT OF MEDICAL PRACTICE. .................................................... 14 A. The General Status of Off-Label Use ........................ 14 B. Distinctions Between “Experimental,” “Investigational,” and “Off-Label” Use ..................... 35 C. The Conundrum of Off-Label Promotion .................. 42 IV. FIRST AMENDMENT CONSTRAINTS ON FDA PROHIBITION OF TRUTHFUL OFF-LABEL SPEECH/PROMOTION ................... 49 A. First Amendment Protection of Off-Label Speech in Commercial Contexts ................................................ 50 B. First Amendment Protection of Off-Label Speech as Scientific Speech ........................................................ 57 C. First Amendment Protection of Off-Label Against Tort Claims ................................................................ 58 V. EFFECT OF OFF-LABEL USE AND PROMOTION ON PREEMPTION ..................................................................... 60 A. Express Preemption and Off-Label Use ................... 63 B. “Parallel” Violation Claims Involving Off-Label Use .............................................................................. 66 C. Implied Preemption and Off-Label Use .................... 75 VI. OFF-LABEL USE ISSUES INVOLVING INFORMED CONSENT .......................................................................... 84 A. Informed Consent and Off-Label Use ...................... 84 B. Informed Consent and Medical Experimentation .... 86 C. FDA Regulated Intended Uses and the Medical Standard of Care ........................................................ 88 D. Independent Physician Investigation of Off-Label Uses ............................................................................ 91 E. Off-Label Informed Consent Claims Against Manufacturers or Their Sales Representatives ....... 92 VII. OFF-LABEL USE AND PRODUCT LIABILITY LITIGATION .... 94 A. The Learned Intermediary Doctrine and Off-Label Use ............................................................................. 95 B. Product Manufacturers and Their Representatives Have No Duty to Intervene to Prevent Physician Off- Label Use .................................................................... 98 C. Duty To Warn Of Risks Of Off-Label Use .............. 104 1. Decisions Predicated On A Greater Duty To Warn ................................................................... 104 2. Decisions Predicated On A Standard Duty To Warn ................................................................... 107 3. Decisions Predicated On A Lesser Duty To Warn ................................................................... 111 4. Decisions Finding No Duty To Warn Of An Off- 1 2 UIC John Marshall Law Review [54:1 label Use ............................................................ 113 5. Causation Issues in Warning-Based Off-Label Use Cases ........................................................... 114 D. Off-Label Use and Express Warranty Claims ........ 119 E. Duty-To-Test Claims Involving Off-Label Uses ..... 120 VIII. CONCLUSION ............................................................ 122 I. INTRODUCTION In 1998 this author published the first comprehensive law review article examining legal issues surrounding the “off-label use”1 of Federal Drug Administration (“FDA”) approved prescription drugs and medical devices.2 That article was cited twice by the United States Supreme Court,3 then by many other courts,4 and served as a catalyst for a great deal of subsequent legal * James M. Beck is an attorney and Senior Life Sciences Policy Analyst at Reed Smith LLP. The author would like to thank Stephen S. Phillips, Esq., recently retired Special Counsel for Medtronic, Inc., for his persistent encouragement, without which this Article would probably not have been undertaken. 1. At the time, the same practice was variously denominated “unapproved use” (the term favored by FDA), “non-approved use,” “non-label use,” and “extra- label use.” E.g., Wash. Legal Found. v. Kessler, 880 F. Supp. 26, 28 n.1 (D.D.C. 1995) (discussing FDA terminology). “Off-label use” was chosen as the more accurate phrase because “unapproved use” incorrectly suggested that FDA “approves” how physicians therapeutically prescribe drugs and medical devices. See Part II infra. Perhaps due to the initial article, “off-label use” is now the predominate descriptive term. 2. See James Beck & Elizabeth Azari, FDA, Off-Label Use, & Informed Consent: Debunking Myths & Misconceptions, 53 FOOD & DRUG L.J. 71 (1998). Co-author Elizabeth Azari is now Senior Vice President of Operations of the National Board of Medical Examiners. There is “no difference between the ‘off label’ use of drugs and devices,” so this article does not distinguish between them, except where appropriate in addressing federal reimbursement and state- law duties to warn. Wolicki-Gables v. Arrow Int’l, Inc., 641 F. Supp. 2d 1270, 1283 (M.D. Fla. 2009), aff’d, 634 F.3d 1296 (11th Cir. 2011); see Christopher Wittich, Christopher Burkle, & William Lanier, Ten Common Questions (& Their Answers) About Off-Label Drug Use, 87 MAYO CLINIC PROC. 982, 986 (2012) (“In developing legal precedents for off-label therapies, courts have typically treated drugs and devices as coequals.”). 3. Buckman Co. v. Plaintiffs Legal Comm., 531 U.S. 341, 350, 351 n.5 (2001). 4. Cordray v. Planned Parenthood Cincinnati Region, 911 N.E.2d 871, 881 (Ohio 2009); Southard v. Temple Univ. Hosp., 781 A.2d 101, 104 (Pa. 2001); United States v. Caronia, 703 F.3d 149, 153 n.2 (2d Cir. 2012); Wash. Legal Found. v. Henney, 202 F.3d 331, 333 (D.C. Cir. 2000); In re Orthopedic Bone Screw Liab. Litig., 159 F.3d 817, 830 & n.1 (3d Cir. 1998), rev’d sub nom. Buckman, 531 U.S. 341 (2001); Blazoski v. Cook, 787 A.2d 910, 919 (N.J. App. Div. 2002); Richardson v. Miller, 44 S.W.3d 1, 9 (Tenn. App. 2000); Alvarez v. Smith, 714 So. 2d 652, 654 n.1 (Fla. App. 1998); United States ex rel. The Dan Abrams Co. v. Medtronic, Inc., No. LACV1501212JAKASX, 2017 WL 4023092, at *3 (C.D. Cal. Sept. 11, 2017), aff’d in pertinent part, rev’d in part on other grounds, ___ F. App’x ___, No. 19-56377, slip op. at 3-6 (9th Cir. Apr. 2, 2021); Shoemaker v. Cardiovascular Sys., Inc., No. CV 16-568 (DWF/KMM), 2017 WL 1180444, at *1 (D. Minn. Mar. 29, 2017); United States ex rel. D’Agostino v. 2021] Off-Label Use in The Twenty-First Century 3 and medical scholarship on the topic of off-label use.5 EV3, Inc., 153 F. Supp. 3d 519, 535 (D. Mass. 2015), aff’d, 845 F.3d 1 (1st Cir. 2016); United States ex rel. Modglin v. DJO Global, Inc. (Modglin II), 114 F. Supp.3d 993, 999 (C.D. Cal. 2015), aff’d, 678 F. App’x. 594 (9th Cir. 2017) (on district court opinion); United States ex rel. Modglin v. DJO Glob., Inc. (Modglin I), 48 F. Supp. 3d 1362, 1370 (C.D. Cal. 2014), aff’d, 678 F. App’x. 594 (9th Cir. 2017) (on district court opinion); Patteson v. Maloney, 968 F. Supp. 2d 169, 171 (D.D.C. 2013); McCormack v. Hiedeman, 900 F. Supp. 2d 1128, 1137 (D. Idaho 2013), aff’d, 788 F.3d 1017 (9th Cir. 2015); Riley v. Cordis Corp., 625 F. Supp. 2d 769, 778 (D. Minn. 2009); Ass’n of Am. Physicians & Surgeons, Inc. v. FDA, 226 F. Supp. 2d 204, 217 n.20 (D.D.C. 2002); Bober v. Glaxo Wellcome, No. 99 C 3243, 1999 WL 759364, at *2 (N.D. Ill. Sept. 3, 1999), aff’d, 246 F.3d 934 (7th Cir. 2001); Stirling v. Novartis Pharms. Corp., No. CV01-18-4880, 2019 WL 6456186, at *2 (D. Idaho Sept. 25, 2019); La. Mun. Police Emps.’ Ret. Sys. v. Pyott, 46 A.3d 313, 317 (Del. Ch. 2012), rev’d, 74 A.3d 612 (Del. 2013); Bay v. Abel, No. CJ200206805, 2004 WL 5453008 (Okla. Dist. Apr. 21, 2004); Baron v. Pfizer, Inc., 12 Misc. 3d 1169(A), 1169(a), 820 N.Y.S.2d 841, 841, 2006 WL 1623052, at *3 (N.Y. Sup. Ct. 2006), aff’d, 840 N.Y.S.2d 445 (N.Y. App. Div. 2007). 5. E.g., George Horvath, Off-Label Drug Risks: Toward a New FDA Regulatory Approach, 29 ANNALS HEALTH L. & LIFE SCI. 101 (2020); Wendy Teo, FDA & the Practice of Medicine: Looking at Off-Label Drugs, 41 SETON HALL LEGIS. J. 305 (2017); Colleen Conners, Illuminating the Off-label Fable: How Off-Label Promotion May Actually Help Patients, 13 J.L. ECON. & POL’Y 91 (2017); William Comanor & Jack Needleman, The Law, Economics, & Medicine of Off-Label Prescribing, 91 WASH. L. REV. 119 (2016); Rodney Smolla, Off-Label Drug Advertising & the First Amendment, 50 WAKE FOREST L. REV. 81 (2015); Marcia Boumil & Kaitlyn Dunn,
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