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The Legal Aspects of Marijuana as Medicine

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Cannabis in Medicine

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Abstract

This chapter discusses the legal liabilities of those in the medical profession who recommend or distribute marijuana to be used as a medicine. This is commonly known as “medical” marijuana and refers to marijuana that is used for medical purposes under some state laws but has not been approved by the FDA as a medicine. The problem for medical care providers is that most are woefully uninformed or misinformed about marijuana. Botanical marijuana poses many problems for medical care providers. There are legal concerns about vaping and other devices for ingesting or inhaling marijuana. The chapter covers the federal scheduling of marijuana, the federal standard of care and can “medical” marijuana be prescribed and states’ rights and aiding and abetting under federal law. The legal claims against medical care providers that are discussed include:

  • Negligence basics

  • Informed consent

  • Duty to warn

  • Failure to provide proper documentation

  • Labeling of marijuana used as a medicine

  • Apparent authority

  • Failure to conduct a proper examination

  • Third-party endangerment

  • Loss of a chance doctrine

  • Aggravation (exacerbation) of a pre-existing condition

  • Future harm

  • Emotional distress – intentional and unintentional

  • Respondeat superior/vicarious liability

  • Other claims

  • Loss of malpractice insurance

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Notes

  1. 1.

    https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2734632

    Denial of Petition to Initiate Proceedings to Reschedule Marijuana, by the Drug Enforcement Administration (DEA), Department of Justice. 81 FR 53767-01, 2016 WL 4240243 (August 12, 2016)

  2. 2.

    “Medical Marijuana: Clinical Considerations and Concerns,” Richard G. Soper, MD, AZ Medicine, Summer 2011

  3. 3.

    “Medical Marijuana: Clinical Considerations and Concerns,” Ibid

    Marcel O. Bonn-Miller, PhD, et al. “Labeling Accuracy of Cannabidiol Extracts Sold Online,” Research Letter November 7, 2017. JAMA. 2017;318(17):1708–1709.

    §1:20 discussing marijuana contamination. 1 Drug Testing Law Tech. & Prac. Available on Westlaw.

    Food and Drug Administration warning letters from 2015 to 2019. 2016 Test Results for Cannabidiol-Related Products, Food and Drug Administration, www.FDA.gov

  4. 4.

    Information on a 99% THC product available at: https://www.cannabis-mag.com/2017/03/07/hash-THC-a-crystallin/

    Information on marijuana is available at: https://www.drugabuse.gov/publications/drugfacts/marijuana

    §1:17.20. Marijuana use on the rise among adults and children and is causing severe damage; §1:17.40 discussing the rise in THC levels in marijuana; § 1:17.62 discussing effects of concentrates on users; § 1:17.80 discussing marijuana overdoses; §1:18 discussing effects of marijuana use, pharmacological, psychological, mental, physiological, and side effects; §1:18.30 discussing marijuana and employer concerns about driving, job performance, and safety; §1:18.60 discussing marijuana and other drug interactions; §1:18.70 discussing workplace and other violence and marijuana; §1:20 discussing marijuana contamination and employees’ health; § 1:79 discussing safety and side effects; §1:91Discussing Glaucoma; §1:87 discussing damage caused by medical marijuana.1 Drug Testing Law Tech. & Prac. Available on Westlaw

  5. 5.

    The Potential Medical Liability for Physicians Recommending Marijuana as a Medicine, July 2003. Educating Voices, POB 6084, Naperville, IL 60567, www.educatingvoices.org

  6. 6.

    21 U.S.C.A. § 321; 21 C.F.R. § 801.4; 21 C.F.R. § 801.5; 21 C.F.R. § 803.3; 21 C.F.R. § 808.3 (definitions and medical device reporting); 21 C.F.R. § 807.93 (Premarket Notification Procedures); 21 C.F.R. § 860.7 (Determination of safety and effectiveness)

    For a news story on a vaping death see:

    https://www.msn.com/en-us/news/us/oregon-vape-death-patient-used-thc-device-from-dispensary/ar-AAGO1pw

  7. 7.

    “Summary of the Medical Application of Marijuana: a Review of Published Clinical Studies,” U.S. FDA Center for Drug Evaluation and Research, 81 FR 53767-01, 2016 WL 4240243 (August 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, by the Drug Enforcement Administration (DEA), Department of Justice. 81 FR 53767-01, 2016 WL 4240243 (August 12, 2016)

  8. 8.

    Highlights of Prescribing Information, Epidiolex®, www.FDA.gov

    http://www.marinol.com

  9. 9.

    Denial of Petition to Initiate Proceedings to Reschedule Marijuana, by the Drug Enforcement Administration (DEA), Department of Justice. 81 FR 53767-01, 2016 WL 4240243 (August 12, 2016)

    “Summary of the Medical Application of Marijuana: A Review of Published Clinical Studies,” U.S. FDA Center for Drug Evaluation and Research, 81 FR 53767-01, 2016 WL 4240243 (August 12, 2016);

  10. 10.

    Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds. www.fda.gov

  11. 11.

    Adapted from: Eleventh Circuit, Pattern Jury Instructions, (Civil Cases), 2005; 1.3 Negligence Medical Malpractice Claim Against Hospital and Physician Statute of Limitations Defense; Page 468 http://federalevidence.com/pdf/JuryInst/11th_Civ_2005.pdf

  12. 12.

    NJ-JICIV 5.50C, NJ J.I. CIV 5.50C, New Jersey Model Civil Jury Charges Chapter 5 – Negligence Charges Medical Negligence, 5.50C INFORMED CONSENT (Competent Adult and No Emergency)1,2 Approved 10/2000; revised 3/2002

  13. 13.

    “Medical Marijuana: Clinical Considerations and Concerns,” Richard G. Soper, MD, AZ Medicine, Summer 2011

    “Human Performance Drug Fact Sheet, Marijuana,” National Highway Traffic Safety Administration

    Restatement (Third) of Torts: Prod. Liab. § 2 (1998) (10/2017 update) § 2 Categories of Product Defect

  14. 14.

    https://www.colorado.gov/pacific/revenue/search-results?search_api_views_fulltext=MARIJUANA%20PUBLIC%20HEALTH%20AND%20SAFETY%20ADVISORY&f%5B0%5D=og_group_ref%3A98751

    FDA CBD Warning letters

    Available at: https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm484109.htm

  15. 15.

    Evidence on the Carcinogenicity of Marijuana Smoke, August 2009, California Environmental Protection Agency.

  16. 16.

    Pot Smoking Linked to Higher Stroke, Heart Risks: Study,16 Mar 2018 09:55 AM

    https://www.newsmax.com/health/health-news/pot-smoking-higher-stroke/2018/03/15/id/848861

    DeFilippis, E. M. et al. “Cocaine and Marijuana Use among Young Adults Presenting with Myocardial Infarction: The Partners YOUNG-MI Registry.” J Am Coll Cardiol. 2018. https://doi.org/10.1016/j.jacc.2018.02.047.

    Desai, R. et al. “Recreational Marijuana Use and Acute Myocardial Infarction: Insights from Nationwide Inpatient Sample in the United States.” Cureus. 2017;9:e1816. https://doi.org/10.7759/cureus.1816.

    Hackam DG. “Cannabis and Stroke: Systematic Appraisal of Case Reports.” Stroke. 2015 Mar;46(3):852–856. https://doi.org/10.1161/STROKEAHA.115.008680.

    Desbois A, Cacoub P. “Cannabis-Associated Arterial Disease.” Ann Vasc Surg. 2013 Oct;27(7):996–1005. https://doi.org/10.1016/j.avsg.2013.01.002. Epub 2013 Jul 10.

  17. 17.

    Highlights of Prescribing Information, Epidiolex®, www.FDA.gov

  18. 18.

    Galli JA, Sawaya RA, Friedenberg FK. “Cannabinoid Hyperemesis Syndrome.” Curr Drug Abuse Rev. 2011;4(4):241–249.

    Sorensen CJ, DeSanto K, Borgelt L, Phillips KT, Monte AA. “Cannabinoid Hyperemesis Syndrome: Diagnosis, Pathophysiology, and Treatment-A Systematic Review.” J Med Toxicol. 2017;13(1):71–87.

  19. 19.

    1:17.30. Marijuana is addictive, 1 Drug Testing Law Tech. & Prac (available on Westlaw)

    “Health Effects of Cannabis and Cannabinoids: Current State of Evidence and Recommendations for Research” National Academies of Science

    “What is marijuana?” (subchapter “Is marijuana addictive?), National Institute on Drug Abuse, Revised July 2019

    Diagnostic and Statistical Manual of Mental Disorders -5, American Psychiatric Association. Cannabis use can create a strong desire and craving to use more and a need to use more to create the same effect. Page 509. There can be withdrawal just like the withdrawal from other addictive drugs. Page 517.

  20. 20.

    American Psychiatric Association, 2013 “Position Statement on Marijuana as Medicine”

    Health Effects of Cannabis and Cannabinoids: Current State of Evidence and Recommendations for Research. National Academies of Science

    Berenson, Alex, Tell Your Children: The Truth About Marijuana, Mental Illness, and Violence

    U.S. Surgeon General’s Advisory: Marijuana Use and the Developing Brain https://www.hhs.gov/surgeongeneral/reports-and-publications/addiction-and-substance-misuse/advisory-on-marijuana-use-and-developing-brain/index.html

  21. 21.

    Suicides in Colorado: Counts

    Colorado Violent Death Reporting Systems https://cohealthviz.dphe.state.co.us/t/HSEBPublic/views/CoVDRS_12_1_17/Story1?:embed=y&:showAppBanner=false&:showShareOptions=true&:display_count=no&:showVizHome=no#4)

  22. 22.

    Shelton, Beatrice, CBD Oil May Worsen Glaucoma, February 5, 2019, American Academy of Ophthalmology 2019

    Marijuana for Glaucoma: Patients Beware! Found at: https://www.glaucomafoundation.org/news_detail.php?id=161

  23. 23.

    “Marijuana Firmly Linked to Infertility,” Scientific American, December 22, 2000

  24. 24.

    “Study shows prenatal cannabis use associated with low birth weights,” Colorado School of Public Health, April 23, 2018

    https://www.cuanschutztoday.org/study-shows-prenatal-cannabis-use-associated-with-low-birth-weights/

  25. 25.

    Volkow ND, Compton WM, Wargo EM. “The Risks of Marijuana Use During Pregnancy.” JAMA. 2017;317(2):129–130.

    “Marijuana Use During Pregnancy and Lactation,” American College of Obstetricians and Gynecologists. https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/Committee-on-Obstetric-Practice/Marijuana-Use-During-Pregnancy-and-Lactation

    U.S. Surgeon General’s Advisory: Marijuana Use and the Developing Brain. https://www.hhs.gov/surgeongeneral/reports-and-publications/addiction-and-substance-misuse/advisory-on-marijuana-use-and-developing-brain/index.html

  26. 26.

    Rheingold, Paul D. “Drug Products Liability and Malpractice Cases,” 17 Am. Jur. Trials 1 August 2019 Update

    http://www.marinol.com

    See also: Highlights of Prescribing Information, Epidiolex®, www.FDA.gov

  27. 27.

    The Potential Medical Liability for Physicians Recommending Marijuana as a Medicine, July 2003. Educating Voices, POB 6084, Naperville, IL 60567, www.educatingvoices.org

  28. 28.

    Vandrey, R. G., et al. “Cannabinoid Dose and Label Accuracy in Edible Medical Cannabis Products.” JAMA. 2015;313(24):2491–2493.

    Freedman DA, Patel AD. “Inadequate Regulation Contributes to Mislabeled Online Cannabidiol Products.” Pediatr Neurol Briefs. 2018;32:3. Published online 2018 Jun 18. https://doi.org/10.15844/pedneurbriefs-32-3.

    FDA “Guidance for Industry, Labelling for Human Prescription Drug and Biological Products - Implementing the PLR Content and Format Requirements

    U.S. v. Lane Labs-USA, Inc., 324 F. Supp. 2d 547 (D.N.J. 2004)

    Strayhorn v. Wyeth Pharmaceuticals, Inc., 882 F. Supp. 2d 1020 (WD TN 2012).

  29. 29.

    NJ-JICIV 5.50, NJ J.I. CIV 5.50, New Jersey Model Civil Jury Charges Chapter 5 - Negligence Charges Medical Negligence, 5.50 Apparent Authority Charge (Approved 6/10)

  30. 30.

    The Potential Medical Liability for Physicians Recommending Marijuana as a Medicine, July 2003. Educating Voices, POB 6084, Naperville, IL 60567, www.educatingvoices.org

  31. 31.

    Ibid.

  32. 32.

    Ibid.

  33. 33.

    Ibid.

  34. 34.

    Ibid.

  35. 35.

    Ibid.

  36. 36.

    Rheingold, Paul D. “Drug Products Liability and Malpractice Cases,” 17 Am. Jur. Trials 1 August 2019 Update

  37. 37.

    The Potential Medical Liability for Physicians Recommending Marijuana as a Medicine, July 2003. Educating Voices, POB 6084, Naperville, IL 60567, www.educatingvoices.org

Disclaimer of Legal Advice

This chapter should not be considered legal advice. This is for informational purposes only. Use of and access to these materials does not in itself create an attorney–client relationship between David G. Evans and CIVEL and the user or reader. Mr. Evans or CIVEL cannot vouch for any study cited herein since they did not do the study. The readers should consult the study and make their own interpretation as to its accuracy. Please also be advised that case law and statutory and regulatory laws cited herein may have been amended or changed by the time you read this. In addition, each state has laws that differ from other states. What may be true in one state may not be true in another. Federal law may also differ from state law. Please consult an attorney licensed in your state for legal advice.

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  1. Cannabis Industry Victims Educating Litigators (CIVEL), Flemington, NJ, USA

    David G. Evans

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Correspondence to David G. Evans .

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  1. Springs Rehabilitation PC, Colorado Springs, CO, USA

    Kenneth Finn

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Evans, D.G. (2020). The Legal Aspects of Marijuana as Medicine. In: Finn, K. (eds) Cannabis in Medicine. Springer, Cham. https://doi.org/10.1007/978-3-030-45968-0_20

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