Hostname: page-component-848d4c4894-ttngx Total loading time: 0 Render date: 2024-05-10T13:59:50.254Z Has data issue: false hasContentIssue false

Doctors and Pain Patients Avoid “Ruan” in the Supreme Court

Published online by Cambridge University Press:  08 March 2023

Mark A. Rothstein
Affiliation:
LOUIS D. BRANDEIS SCHOOL OF LAW, THE UNIVERSITY OF LOUISVILLE, LOUISVILLE, KY, USA
Mary E. Dyche
Affiliation:
INDEPENDENT SCHOLAR, LOUISVILLE, KY, USA
Julia Irzyk
Affiliation:
INDEPENDENT SCHOLAR, LOS ANGELES, CA, USA

Abstract

Physicians’ fear of criminal prosecution for prescribing opioid analgesics is a major reason why many chronic pain patients are having an increasingly difficult time obtaining medically appropriate pain relief. In Ruan v. United States, 142 S. Ct. 2370 (2022), the Supreme Court unanimously vacated two federal convictions under the Controlled Substances Act. The Court held that the government must prove that the defendant knowingly or intentionally acted in an unauthorized manner.

Type
Columns: Currents in Contemporary Bioethics
Copyright
© 2023 The Author(s)

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Footnotes

About This Column

Mark A. Rothstein serves as the section editor for Currents in Contemporary Bioethics. Professor Rothstein is the Herbert F. Boehl Chair of Law and Medicine Emeritus at the University of Louisville in Kentucky. (mark.rothstein@louisville.edu)

References

We use the term “licit” to mean that a substance has been approved by the FDA, manufactured in an FDA approved facility, and prescribed by a licensed physician. As further discussed below, some approved and licensed prescribing can violate federal or state laws.Google Scholar
See Rothstein, M.A., “Ethical Responsibilities of Physicians in the Opioid Crisis,” Journal of Law, Medicine & Ethics 45, no. 2 (2017): 682687.CrossRefGoogle Scholar
Even if that were the case in the earlier “pill mill” days of the crisis, abuse of prescription drugs is not the main cause of harm today. See note 6 infra and accompanying text.Google Scholar
Centers for Disease Control and Prevention, Annual Surveillance Report of Drug-Related Risks and Outcomes: United States, 2017, at 9 (2017).Google Scholar
National Center for Health Statistics, Centers for Disease Control and Prevention, Drug Overdose Deaths in US Top 100,000 Annually (Nov. 17, 2021), available at < https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2021/2021117> (last visited November 28, 2022).+(last+visited+November+28,+2022).>Google Scholar
See Aubrey, L. and Carr, B.T., “Overdose, Opioid Treatment Admissions and Prescription Opioid Pain Reliever Relationship: United States,” Frontiers in Pain Research (2022), https://doi.org/10.3389/pain.2022.884674; A. Gertner, “Prescription Opioids Aren’t Driving the Overdose Crisis. Illicitly Manufactured Synthetic Opioids Are,” Garrison Project, February 15, 2022, available at <https://thegarrisonproject.org/prescription-opioids-overdose/> (last visited November 28, 2022).CrossRefGoogle Scholar
Dowell, D., Haegerich, T.M., and Chou, R., “CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016, Morbidity and Mortality Weekly Reports Recommendation Reports 65, no. 1 (2016): 149.Google Scholar
Nadeau, S.E., Wu, J.K., and Lawhern, R.A., “Opioids and Chronic Pain: An Analytical Review of the Clinical Evidence,” Frontiers in Pain Research 2 (2021), art. 721357, doi: 10.3389/fpain.2021.721357.CrossRefGoogle ScholarPubMed
See Rothstein, M.A. and Irzyk, J., “The Opioid Crackdown Leaves Chronic Pain Patients in Limbo,” The Hill, Nov. 29, 2021, available at <https://thehill.com/opinion/healthcare/583332-opiod-crackdown-leaves-chronic-pain-patients-in-limbo>(last visited November 28, 2022).(last+visited+November+28,+2022).>Google Scholar
American Medical Association, Comments on the CDC Guideline for Prescribing Opioids for Chronic Pain (June 16, 2020), available at <https://searchlf.ama-assn.org/finder/letter/searc/opioid/relevant/1/> (last visited November 28, 2022).+(last+visited+November+28,+2022).>Google Scholar
Nadeau, Wu, and Lawhern, supra note 9.Google Scholar
See Sedney, C.L. et al., “’The DEA Would Come in and Destroy You’: A Qualitative Study of Fear and Unintended Consequences among Opioid Prescribers in WV,” Substance Abuse Treatment, Prevention, and Policy 17, no. 19 (2022): doi.org/10.1186/s13011-022-00447-5.CrossRefGoogle Scholar
Dowell, D. et al., “CDC Clinical Practice Guideline for Prescribing Opioids for Pain – United States, 2022,” Morbidity and Mortality Weekly Reports Recommendation Reports 71, no. 1 (2022): 195. See also D. Dowell et al., “Prescribing Opioids for Pain – The New CDC Clinical Practice Guideline,” New England Journal of Medicine 387, no. 22 (2022): 2011-2013.Google ScholarPubMed
See Peachman, R.R., “Will the New CDC Opioid Prescribing Guidelines Help Correct the Course in Pain Care?Journal of the American Medical Association, December 21, 2022, doi:10.10.1001/jama.2022.22284; J. Singer, “CDC Replaces Flawed 2016 Opioid Prescribing Guideline with Flawed 2022 Opioid Prescribing Guideline,” American Council on Science and Health, November 8, 2022, available at <http://www.acsh.org/news/2022/11/08/cdc-replaces-flawed-2016-opioid-prescribing-guideline-flawed-2022-opioid-prescribing-guideline-16654> (last visited December 21, 2022).Google Scholar
142 S. Ct. 2370 (2022).Google Scholar
21 U.S.C. § 841.Google Scholar
21 C.F.R. § 1306.Google Scholar
See Lagisetty, P.A. et al., “Access to Primary Care Clinics for Patients with Chronic Pain Receiving Opioids,” JAMA Network Open 2, no. 7 (2019): e196928, doi: 10.1001/jamanetworkopen.2019.6928.CrossRefGoogle ScholarPubMed
See Larochelle, M.R. et al., “Comparative Effectiveness of Tapering or Abrupt Discontinuation vs. No Dosage Change for Opioid Overdose for Suicide Patients Receiving Stable Long-Term Opioid Therapy,” JAMA Network Open 5, no. 8 (2022): e2226523, doi: 10.1001/jamanetworkopen.2022.26523.CrossRefGoogle ScholarPubMed
See Agnoli, A. et al., “Association of Dose Tapering with Overdose or Mental Health Crisis among Patients Prescribed Long-Term Opioids,” Journal of the American Medical Association 326, no. 5 (2021): 411419.CrossRefGoogle ScholarPubMed
See Rothstein, M.A. and Irzyk, J., “Physician Liability for Suicide after Negligent Tapering of Opioids,” Journal of Law, Medicine & Ethics 50, no. 1 (2022): 184189.CrossRefGoogle ScholarPubMed
United States v. Ruan, 966 F.3d 1101 (11th Cir. 2020), vacated and remanded, 142 S. Ct. 2370 (2022).Google Scholar
United States v. Khan, 989 F.3d 806 (10th Cir. 2021), vacated and remanded, 142 S. Ct. 2370 (2022).Google Scholar
21 U.S.C. § 841.Google Scholar
21 C.F.R. § 1306.04(a).Google Scholar
Ruan, 966 F.3d at 1123.Google Scholar
Id. at 1130.Google Scholar
Id. at 1165.Google Scholar
Kahn, 989 F.3d at 821.Google Scholar
21 C.F.R. § 1306.4(a).Google Scholar
Kahn, 989 F.3d at 826.Google Scholar
Brief for the United States at 24.Google Scholar
Id. at 16.Google Scholar
Brief for Petitioner, Dr. Shakeel Khan, at 52.Google Scholar
Brief for Petitioner, Dr. Xiulu Ruan, at 40.Google Scholar
Id. at 47.Google Scholar
Brief for Amicus Curiae Association of American Physicians and Surgeons and Jeffrey A. Singer, M.D., in Support of Petitioner at 2.Google Scholar
Brief for Amicus Curiae National Pain Advocacy Center in Support of Petitioners.Google Scholar
Brief of Amici Curiae Professors of Health Law and Policy in Support of Petitioner.Google Scholar
Ruan v. United States, 142 S. Ct, 2370, 2373 (2022).Google Scholar
Id. at 2378.Google Scholar
Id. at 2373.Google Scholar
Id. at 2382 (Alito, J., concurring in the judgment).Google Scholar
Linder v. United States, 268 U.S. 5, 17-18 (1925).Google Scholar
“[A] doctor acts “in the course of professional practice” in issuing a prescription under the CSA if — but only if — he or she believes in good faith that the prescription is a valid means of pursuing a medical purpose. A doctor who knows that he or she is acting for a purpose foreign to medicine — such as facilitating addiction or recreational drug abuse — is not protected by the CSA’s authorization to distribute controlled substances by prescription.” Ruan,142 S. Ct. at 2389 (Alito, J., concurring in the judgement).Google Scholar
National Conference of State Legislatures, Prescribing Policies: States Confront Opioid Overdose Epidemic, June 30, 2019, available at < https://www.ncsl.org/research/health/prescribing-policies-states-confront-opioid-overdose-epidemic.aspx> (last visited November 28, 2022).+(last+visited+November+28,+2022).>Google Scholar
The Network for Public Health Law, Laws Limiting the Prescribing or Dispensing of Opioids, December 31, 2019, available at < https://www.thedoctorpatientforum.com/images/50-State-Survey-Laws-Limiting-the-Prescribing-or-Dispensing-of-Opioidspf-CSD_FINAL.pdf> (last visited November 28, 2022).+(last+visited+November+28,+2022).>Google Scholar
National Conference of State Legislatures, supra note 48.Google Scholar
Enzinger, A.C. et al., “US Trends in Opioid Access among Patients with Poor Prognosis Cancer Near the End-of-Life,” Journal of Clinical Oncology 39, no. 26 (2021): 29482958.CrossRefGoogle ScholarPubMed
Centers for Disease Control and Prevention, Prescription Drug Monitoring Programs (PDMPs), available at < https://www.cdc.gov/opioids/providers/pdmps.html> (last visited November 28, 2022).+(last+visited+November+28,+2022).>Google Scholar
Kim, B., “Must-Access Prescription Drug Monitoring Programs and Opioid Overdose Exposure: The Unintended Consequences,” Journal of Health Economics 75 (2021): 102408, doi.org/10.1016/j.healco.2020.102408.CrossRefGoogle Scholar
For example, Dr. Andrew Kolodny, Executive Director of Physicians for Responsible Opioid Prescribing, stated: “I can’t point to data, but I believe that for the vast majority of people who become stuck on opioids, their prescriptions began because of injury or surgery.” J. Keilman, “Hospitals Cut Back on Opioids to Battle Addiction Epidemic,” Chicago Tribune, January 23, 2018, available at <https://www.chicagotribune.com/news/ct-met-hospital-opioids-20180116-story.html> (last visited November 28, 2022). For a refutation of this assumption based on data, see Aubrey and Carr, supra note 6.+(last+visited+November+28,+2022).+For+a+refutation+of+this+assumption+based+on+data,+see+Aubrey+and+Carr,+supra+note+6.>Google Scholar
Jamison, R.N. et al., “Attributes of Primary Care Practitioners in Managing Chronic Pain Patients Prescribed Opioids for Pain: A Prospective Longitudinal Controlled Trial,” Pain Medicine 17, no. 1 (2016): 99113.Google Scholar
Slat, S. et al., “Opioid Policy and Chronic Pain Treatment Access Experiences: A Multi-Stakeholder Qualitative Analysis and Conceptual Model,” Journal of Pain Research 14 (2021): 11611169, doi: 10.2147/JPR.S282228.CrossRefGoogle ScholarPubMed
See A. Agnoli et al., supra note 20.Google Scholar