1 The lived experience of one of the co-authors, Kate.

2 Hippocrates, Of the Epidemics 360 (Francis Adams trans., 1849).

3 “Opioid crisis” is a misnomer because most overdose deaths involve multiple substances used in combination and because the crisis is evolving to include non-opioid drugs. See, e.g., Haylea A. Hannah et. al., Using Local Toxicology Data for Drug Overdose Mortality Surveillance, International Society for Disease and Surveillance (2016) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5462295 [https://perma.cc/ENV3-B357] (average number of substances involved in overdose deaths was six); Mass Dep't of Pub. Health, Data Brief: Stimulants, Health Disparities, and the Impact of the Opioid Epidemic on Maternal Health and High Risk Populations (2019) https://www.mass.gov/files/documents/2019/03/13/PHD-1.0-Combined-Data-Brief.pdf [https://perma.cc/28GE-23LF] (fewer than 1 in 5 overdose deaths involved only opioids (and primarily illicit)); see generally, Centers for Disease Control and Prevention [hereinafter “CDC”], Opioid Overdose: Other Drugs (Aug. 12, 2019), https://www.cdc.gov/drugoverdose/data/otherdrugs.html [https://perma.cc/GR5R-L59G] (showing data on non-opioid drugs and use in combination). Thus, “polypharmacy” or “polysubstance” crisis is a more apt label. The authors recognize that co-prescribing (especially of opioids with benzodiazepines or other CNS depressants) places patients at higher overdose risks but have confined our discussion to opioid prescribing because it has garnered the most attention and has been the focus of changing prescribing practices.

4 Richard J. Bonnie et al., Pain Management and the Opioid Epidemic 62–63 (2017).

5 Id.

6 See, e.g., National Academy of Medicine, First Do No Harm: Marshaling Clinician Leadership to Counter the Opioid Epidemic (2017); Roger A. Rosenblatt & Mary Catlin, Opioids for Chronic Pain: First Do No Harm, 10 Annals Fam. Med. 300, 300–01 (2012).

7 National Institute on Drug Abuse, Overdose Death Rates, https://www.drugabuse.gov/related-topics/trends-statistics/overdose-death-rates [https://perma.cc/Q9UJ-JX4Z]. In about two-thirds of those cases (47,600), the decedents tested positive for opioids, with about three-quarters related to illicit drugs such as heroin and fentanyl. Of those involving prescription opioids, the vast majority involved multiple substances (legal and illicit) used in combination.

8 Lenny Bernstein, U.S. life expectancy declines again, a dismal trend not seen since World War I, Washington Post (Nov. 29, 2018), https://www.washingtonpost.com/national/health-science/us-life-expectancy-declines-again-a-dismal-trend-not-seen-since-world-war-i/2018/11/28/ae58bc8c-f28c-11e8-bc79-68604ed88993_story.html [https://perma.cc/2TB9-PZV8]. See generally, CDC, Life Expectancy (Mar. 17, 2017), https://www.cdc.gov/nchs/fastats/life-expectancy.htm [https://perma.cc/BMG8-RJ7Z].

9 See National Institute on Drug Abuse, Medications to Treat Opioids Use Disorder (June 2018), https://www.drugabuse.gov/publications/research-reports/medications-to-treat-opioid-addiction/overview [https://perma.cc/P4RA-8FN6].

10 See Department of Health and Human Services, Pain Management Best Practices Interagency Task Force Report (May 2019); National Institutes of Health, National Pain Strategy: A Comprehensive Population Health-Level Strategy for Pain (2016); Institute of Medicine, Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education and Research 1–4 (2011).

11 James Dahlhamer et al., Prevalence of Chronic Pain and High-Impact Chronic Pain Among Adults – United States, 2016, 67 Morbidity Mortality Wkly. Rep. 1001 (2018).

12 The institute for health metrics and evaluation, global burden of disease study, top ten causes of years lived with disability (YLD) (2017); Ehrlich, George E., Low Back Pain, 81 Bull. World Health Org. 671, 671 (2003)Google ScholarPubMed.

13 Rebecca Ahrnsbrak et al., Key Substance Use and Mental Health Indicators in the United States: Results from the 2016 National Survey on Drug Use and Health (Sept. 2017), https://www.samhsa.gov/data/sites/default/files/NSDUH-FFR1-2016/NSDUH-FFR1-2016.htm [https://perma.cc/Q6JW-R5S6].

14 Rosenblum, Andrew et al., Opioids and the Treatment of Chronic Pain: Controversies, Current Status, and Future Directions, 16 Experimental Clinical Psychopharmacology 405, 408 (2008)CrossRefGoogle ScholarPubMed.

15 Deborah Dowell et al., Guidelines for Prescribing Opioids for Chronic Pain—United States, 2016, 65 Morbidity Mortality Wkly. Rep. 1 (2016) (showing a range from 0.7–6%).

16 Nora D. Volkow & A. Thomas McLellan, Opioid Abuse in Chronic Pain — Misconceptions and Mitigation Strategies, 374 N. Eng. J. Med. 1253 (2016).

17 Id.

18 Bonnie, supra note 4, at 24.

19 Volkow, supra note 16, at 1254.

20 See Id. at 1258.

21 National Institute on Drug Abuse, Opioid Overdose Crisis (Feb. 2020), https://www.drugabuse.gov/drugs-abuse/opioids/opioid-overdose-crisis [https://perma.cc/V294-2YZX].

22 See generally, P. Bialas et al., Efficacy and Harms of Long-Term Opioid Therapy in Chronic Non-Cancer Pain, Eur. J. Pain 266, 266 (2019). There are studies showing efficacy for a subset of patients up to one year and others suggesting that opioids are not significantly more efficacious than other medications. See M. Noble et al., Long-Term Opioid Management for Chronic Noncancer Pain, Cochrane Systematic Rev. (2010); see also E.E. Krebs, et al., Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain: The SPACE Randomized Clinical Trial, 319 JAMA 872, 872–82 (2018). It is difficult to assess the efficacy of opioids for long-term pain from available studies because of the variety of conditions causing chronic pain, the fact that FDA drug approval requires only a short time frame for studies, and the ethical problems of designing long, placebo-controlled trials with suffering people.

23 See National Academies of Sciences, Engineering, and Medicine, Framing Opioid Prescribing Guidelines for Acute Pain (2020) (describing how the FDA asked NAESM to develop a framework for new evidence-based guidelines).

24 Jason Busse, et al., The Canadian Guideline for Opioid Therapy and Chronic Noncancer Pain, CMAJ (2017); U.S. Deptartment of Veterans Affairs, VA/DoD Clinical Practice Guidelines for Opioid Therapy for Chronic Pain v. 3.0 (2017). See also Dowell et al., supra note 15.

25 Benjamin Djulbegovic, Iztok Hozo & Sander Greenland, Uncertainty in Clinical Medicine, in Philosophy of Medicine 299, 335-36 (Fred Gifford ed., 2011).

26 In the case of treating chronic pain, there is a lack of high-quality evidence on the efficacy of opioids beyond twelve weeks, although that is also the case for most other medications and treatments approved to treat pain. See Baraa Tayeb et al., Durations of Opioid, Nonopioid Drug, and Behavioral Clinical Trials for Chronic Pain: Adequate or Inadequate? 17 Pain Med. 2036, 2042-43 (Nov. 2016). This owes partly to the duration of the FDA approval processes, practical and ethical difficulties of doing long-term, placebo-controlled studies with suffering human beings, and to the fact that chronic pain represents a large umbrella category representing pain of different types and etiologies.

27 See Diane Hoffmann & Anita Tarzian, Achieving the Right Balance in Oversight of Physician Opioid Prescribing for Pain: the Role of State Medical Boards, J. L. Med. Ethics, 21, 21–40 (2003). Commonly-used practices that lean toward surveillance mitigate against uncertainty regarding malingering or drug seeking, including Prescription Drug Monitoring Programs, pain contracts, urine drug testing, and pill counts.

28 One of us has developed the argument for this claim elsewhere. See Hellman, Deborah, Prosecuting Doctors for Trusting Patients, 16 Geo. Mason L. Rev. 701, 711 (2009)Google Scholar.

29 Id.

30 See Daniel Goldberg, Pain, Objectivity and History: Understanding Pain Stigma, 43 Med. Humanities 238–43 (2017).

31 Miranda Fricker, Epistemic Injustice: Power and the Ethics of Knowing 630 (2007). See generally Daniel Z. Buchman, Anita Ho & Daniel S. Goldberg, Investigating Trust, Expertise, and Epistemic Injustice in Chronic Pain, 2017 J. Bioethical Inquiry 31–42 (applying Fricker's concept of testimonial injustice to chronic pain patients as a disbelieved group and arguing clinicians should adopt an attitude of “epistemic humility”).

32 Kimberly Kessler Ferzan, #BelieveWomen and the Presumption of Innocence: Clarifying the Questions for Law and Life, Nomos (forthcoming 2019) (on file with author).

33 See Dahlhamer, et al., supra note 11 (age-adjusted prevalence of both chronic pain and high-impact chronic pain significantly higher among women); Kelly M. Hoffman et al., Racial Bias in Pain Assessment and Treatment Recommendations, and False Beliefs About Biological Differences Between Blacks and Whites, 113 PNAS 4296 (2016) (people of color have their pain disbelieved more often than do white people).

34 Recently, a video posted to Twitter showing a nurse distrusting and mocking patients went viral and elicited an indignant response from people in pain under the hashtag #patientsarenotfaking. See #patientsarenotfaking, Twitter, https://twitter.com/hashtag/patientsarenotfaking?lang=en [https://perma.cc/GAA4-L6K8].

35 Impact of the Opioid Epidemic: Shared Stories, CDC (Sep. 25, 2019), https://www.cdc.gov/injury/features/opioid-epidemic-stories/index.html [https://perma.cc/2FYJ-4VWN].

36 See e.g. Model Rules of Prof'l Conduct r. 1.7 (Am. Bar Ass'n 2018) (“a lawyer shall not represent a client if the representation involves a concurrent conflict of interest”); Am. Med. Ass'n, Code of Med. Ethics Opinion 9.6.2, https://www.ama-assn.org/delivering-care/ethics/gifts-physicians-industry [https://perma.cc/4P8J-RUYH] (“addressing gifts to physicians from pharmaceutical, biotechnology, and medical device companies”).

37 See Eldo E. Frezza, Medical Ethics: A Reference Guide for Guaranteeing Principled Care and Quality 69–70 (2019); Ross, Joseph S. et al., Pharmaceutical Company Payments to Physicians: Early experiences with Disclosure Laws in Vermont and Minnesota, 297 JAMA 1216, 1222 (2007)CrossRefGoogle ScholarPubMed; Howard Brody, The Company We Keep: Why Physicians Should Refuse to See Pharmaceutical Representatives 3 Annals Fam. Med. 82–83 (2005).

38 George J. Agich & Heidi Forster, Conflicts of Interest and Management in Managed Care, 9 Cambridge Q. Healthcare Ethics 189 (2000).

39 States have their own laws governing what doctors must report. See e.g. Cal. Penal Code § 11166 (Deering 2019) (requiring mandated reporters, which includes doctors and nurses, to report child abuse within 36 hours of “receiving information concerning the incident”); N.Y. Penal Law § 265.25 (McKinney 2000) (physicians must report “every case of a bullet wound, gunshot wound … or any other injury arising from or caused by the discharge of a gun or firearm, and every case of a wound which is likely to or may result in death … inflicted by a knife”).

40 Mary Anne Bobinski et al., Bioethics and Public Health Law 266 (3d ed. 2013).

41 See, e.g., Maia Szalavitz, What the Media Gets Wrong about Opioids, Columbia J. Rev. (Aug. 15, 2018) https://www.cjr.org/covering_the_health_care_fight/what-the-media-gets-wrong-about-opioids.php, [https://perma.cc/WNA6-3AHC].

42 Id.

43 See Rosenblum, supra note 14.

44 See generally, Frederick Schauer, Playing by the Rules: A Philosophical Examination of Rule-Based Decision-Making in Law and in Life 13, 104 (1991).

45 Schauer, Frederick, The Generality of Law, 107 W.Va. L. Rev. 217, 220-22 (2004)Google Scholar.

46 Dowell et al., supra note 15.

47 Id. at 16.

48 See Kate M. Nicholson, Diane E. Hoffman & Chad D. Kollas, Overzealous use of the CDC's opioid prescribing guideline is harming pain patients, STAT (Dec. 6, 2018), https://www.statnews.com/2018/12/06/overzealous-use-cdc-opioid-prescribing-guideline [https://perma.cc/8LCS-KXN6].

49 Id.

50 See Opioid prescription limits and policies by state, Ballotpedia (Oct. 4, 2019), https://ballotpedia.org/Opioid_prescription_limits_and_policies_by_state#Alaska [https://perma.cc/P3Y5-YREH].

51 See Kroenke, Kurt et al., Challenges with Implementing the Centers for Disease Control and Prevention Opioid Guideline: A Consensus Panel Report, 20 Pain Med. 724, 726 (2019)CrossRefGoogle ScholarPubMed.

52 See Nicholson, Hoffman & Kollas, supra note 48.

53 See Kelly K. Dineen, Definitions Matter: A Taxonomy of Inappropriate Prescribing to Shape Effective Opioid Policy and Reduce Patient Harm, 67 U. Kan. L Rev. 961, 962–67 (2019) (arguing that the lack of a definition of improper prescribing makes reliance on proxies like dosage more likely); see also Jessica Schneider, Justice Department reveals its number crunching methods to catch over-prescribers, CNN (Sept. 24, 2019), https://www.cnn.com/2019/09/24/politics/opioid-doctors-arrests/index.html [https://perma.cc/S8SN-667R] (noting factor of doctor's prescribing above the dosages recommended by the CDC).

54 See Human Rights Watch, Not Allowed to be Compassionate, 65 (2018).

55 See Deborah Dowell, Haegerich, Tamara & Chou, Roger, No Shortcuts to Safer Opioid Prescribing, 380 New Eng. J. Med. 2285, 2287 (2019)Google Scholar

56 See Id. at 2285–86. In its guideline, the CDC had rated the quality of the evidence it used for each recommendation. These two provisions that were translated into law and mandates were based on poor and low-quality evidence.

57 FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering, U.S. Food and Drug Administration (Apr. 9, 2019), https://www.fda.gov/drugs/drug-safety-and-availability/fda-identifies-harm-reported-sudden-discontinuation-opioid-pain-medicines-and-requires-label-changes [https://perma.cc/T87C-KBNU].

58 See Nicholson, Hoffman & Kollas, supra 48.

59 See Kroenke et al., supra note 51, at 725; Ramin Mojtabai, National Trends in Long-term Use of Prescription Opioids, 27 Pharmacoepidemiology and Drug Safety (2018) (finding 5.4% of adults in the United States had long-term opioid prescriptions in 2013–2014).

60 See Ajay Manhapra et al., The Conundrum of Opioid Tapering in Long-Term Opioid Therapy for Chronic Pain: A Commentary, Substance Abuse 153, 157 (2018) (includes case studies of patients on opioid for long duration); see generally, Judith Parsells et al., Prevalence and characteristics of opioid use in the US adult population, Pain 507, 511 (2008).

61 Jane Ballantyne & Jianren Mao, Opioid therapy for chronic pain, New Eng. J. Med. 1943, 1944-45 (2003).

62 See Pain Management Best Practices, supra note 10 at 26.

63 See U.S. Food and Drug Administration, supra note 57; Human Rights Watch, supra note 54, at 3–4.

64 See Human Rights Watch, supra note 54, at 39.

65 See generally id. (reporting on eighty-six interviews with chronic pain patients, healthcare providers, and officials to highlight the struggles of these patients).

66 See id. at 39, 48.

67 Tami L. Mark & William Parish, Opioid Medication Discontinuation and Risk of Adverse Opioid-Related Health Care Events, 103 J. Substance Abuse Treatment 58, 60–61 (2019). Anyone who has taken opioids long-term is likely to develop physical dependence, requiring that opioids be tapered slowly to avoid side effects. Dependence is distinct from addiction, because it lacks the behavioral component that characterizes a use disorder. See e.g., National Institute on Drug Abuse, Media Guide: The Science of Drug Use and Addiction 3 (2018), https://www.drugabuse.gov/publications/media-guide/science-drug-use-addiction-basics [https://perma.cc/35D7-8BTZ].

68 Jason M. Glanz et al., Association Between Opioid Dose Variability and Opioid Overdose Among Adults Prescribed Long-term Opioid Therapy, 2 JAMA Network Open (2019); see also James, Jocelyn R. et al., Mortality after Discontinuation of Primary Care–Based Chronic Opioid Therapy for Pain: A Retrospective Cohort Study, 34 J. Gen. Internal Med. 2749, 2755 (2019)CrossRefGoogle ScholarPubMed (increased mortality risk).

69 Perez, Hector R. et al., Opioid Taper Is Associated with Subsequent Termination of Care: A Retrospective Cohort Study, 35 J. Gen. Internal Med. 36, 40 (2019)Google ScholarPubMed.

70 Joshua J. Fenton et al., Trends and Rapidity of Dose Tapering Among Patients Prescribed Long-Term Opioid Therapy, 2008–2017, 2 JAMA Network Open (2019).

71 Pooja A. Lagisetty et al., Access to Primary Care Clinics for Patients With Chronic Pain Receiving Opioids, JAMA Network Open, July 2019.

72 Jay Wohlgemuth et al., Quest Diagnostics, Health Trends: Drug Misuse in America 2019, at 6 (2019).

73 See id. at 9.

74 See 2 Dan B. Dobbs et al., The Law of Torts § 312 (2d ed. 2019).

75 See Henry S. Richardson, Moral Entanglements: The Ancillary-Care Obligations of Medical Researchers (2012) (adopting a nuanced view regarding when ancillary care obligations are incurred that begins with the moral entanglement of the researcher and research subject).

76 See Helen Leask, 1 in 3 Survivors Still in Pain Years After Cancer Treatment, Medscape (June 24, 2019), https://www.medscape.com/viewarticle/914817.

77 See CDC, Guideline for Prescribing Opioids for Chronic Pain, https://www.cdc.gov/drugoverdose/pdf/prescribing/Guidelines_Factsheet-a.pdf [https://perma.cc/8D3RJHGB]. The complication arises because once the disease is in remission, it becomes a much harder to come up with a principled distinction between this pain and chronic non-cancer pain.

78 See Department of Health and Human Services, HHS Guide for Clinicians on the Appropriate Dose Reduction or Discontinuation of Long-Term Opioid Analgesics (2019) (underscoring the risks of rapid taper in providing guidance on when tapering is and is not appropriate and how taper appropriately affects patients).

79 See American Medical Association, Code of Medical Ethics Opinions, Chapter 1: Opinions on Patient-Physician Relationships (discussing ethical obligation not to decline patients whom they've accepted into care); Lippman, Helen & Davenport, John, Patient Dismissal: The Right Way to Do It, 60 J. Fam. Prac. 135, 136 (2011)Google Scholar (discussing legal obligation against abandonment).

80 Physicians have these responsibilities under Title III of the Americans with Disabilities Act of 1990, 42 U.S.C. § 12181-9, 28 C.F.R. pt. 36 (title III); see Bragdon v. Abbott, 524 U.S. 624 (1998) (refusal of dentist to treat patient on the basis of HIV disease violates ADA).

81 Press Release, U.S. Dep't of Justice, Justice Department Reaches Settlement with Selma Medical Associates Inc. to Resolve ADA Violations (Jan. 31, 2019), https://www.justice.gov/opa/pr/justice-department-reaches-settlement-selma-medical-associates-inc-resolve-ada-violations [https://perma.cc/66G6-PEWB] (resolving violations of the ADA related to the refusal to accept a prospective new patient on the basis that he takes Suboxone).