In our studies examining the use of Medical Cannabis Therapy (MCT) by Oncologists and Pain Management Specialists[i], we asked physicians what their biggest barrier was to their adoption of medical cannabis. Two-thirds (65%), mention legal concerns. Concern for legal exposure and increased risk of malpractice associated with MCT remains high, given the federal status of cannabis being Schedule I.
To contextualize the degree in which legal concerns have on physicians’ behavior, it is second only to the lack of clinical trials in preventing physicians from recommending MCT to patients. In addition, lack of reliable guidance (from medical associations or colleagues), concern that patients will be punished by their employer, and professional/social stigma of being known as a MCT endorser are also significant barriers to adoption of cannabis into their treatment armamentarium.
However, this raises the question: What are the actual legal risks to physicians if recommending MCT as a treatment for their patients?
Based on federal regulations, if a physician was to prescribe MCT it would constitute aiding and abetting the acquisition of marijuana, which could result in revocation of DEA licensure and even prison time. However, in states where medicinal cannabis is legal, doctors can write a recommendation for the plant, after determining and certifying that the patient suffers from one of the conditions that the state’s law deems to warrant medicinal cannabis. This recommendation “loophole” was upheld by the US Court of Appeals for the Ninth Circuit in Conant v. Walters, which decided that a physician’s discussion of the potential benefits of medicinal cannabis and making such recommendations constitute protected speech under the First Amendment. The court reasoned that doctors should not be held liable for conduct that patients might engage in after leaving the office and that open and unrestricted communication is vital in preserving the patient-doctor relationship and ensuring proper treatment[ii],[iii],[iv].
Amended AMA Policy:
Patients also face legal jeopardy through their employers. Both state and federal courts have upheld firing an employee for medical cannabis use. Employees have been unsuccessful when challenging employee statutes, citing state medical cannabis laws as well as federal and state anti-discrimination laws to justify their MCT. The state medical cannabis laws ordinarily immunize medical cannabis users from the adverse consequences of the law, but do not give them a right that can be used affirmatively against a private entity. The Americans with Disabilities Act (ADA) and similar state anti-discrimination in employment statutes are predicated upon discrimination based on lawful activity and the Controlled Substances Act has consequently proven to be an insurmountable obstacle iIi.
Finally, medical associations within the USA are cautiously developing guidelines for use and monitoring of cannabinoids. Most advocate individualized approach to cannabinoid recommendations/use, with careful monitoring of beneficial and adverse effects. The American Medical Association has been advocating for the re-scheduling of cannabis in order to facilitated large, well-controlled clinical trials of cannabinoids. Yet, they have been slow to modify their published recommendations about MCT.
But, isn’t recommending MCT the same as off-label use of approved pharmaceuticals?
The FDA makes it clear that it does not regulate the practice of medicine and that the federal Food, Drug, and Cosmetic Act of 1938 will not play a role in creating physician liability for off-label drug use [v]. Before using a drug off-label, physicians are trained to ask themselves five questions [vi]:
It is not necessary for a physician to answer in the affirmative to each of these questions in order to prescribe a drug off-label. However, the further they stray, the more legal jeopardy they place themselves into.
So, why not just have a patient sign a consent form to lessen the physician’s liability?
To-date, no court has mandated that a physician must disclose, through an informed consent process, the off-label use of a drug. In fact, informed consents may unintentionally bias a patient by 1) unduly frightening patients, and 2) placing a burden on physicians forcing them to constantly review and communicate medication risk and benefit information. This may divert attention away from other more important patient care issues [vii]. Further, a case in 1972, stated: the test for determining whether a particular peril must be divulged is its materiality to the patient’s decision.” A material risk is one in which “a reasonable person, in what the physician knows or should know to be the patient’s position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forego the proposed therapy.[viii]
MCT, while somewhat supported by off-label use practices, remains apart from traditional pharmaceuticals due to its Schedule I status. While opioids account for roughly 25% of drug-related medical malpractice lawsuits in the US[ix], to-date, no court has considered potential malpractice liability for a physician certifying or recommending medical cannabis. Courts may, however, be expected to confront such cases as more states approve the use of MCT and as substantially more patients gain access to cannabis. If wide-spread use begins to uncover serious health risks, there continues to be a lack of evidence supporting the use of MCT for a variety of health conditions, and with less risky FDA approved pharmaceutical cannabinoids continue to enter the market, legal risk of recommending MCT may grow. Douglas Marlowe, JD/PhD[x], former Chief of Science, Law & Policy for the National Association of Drug Courts and Associate Professor of Psychiatry at the University of Pennsylvania Medical School, outlines the process most likely to be taken by the courts when a malpractice suit involving the use of MCT eventually is filed.
First the courts will need to address whether certifying the need for medical cannabis creates a traditional doctor/patient relationship. This carries with it a concomitant duty to render competent professional care. A professional duty of care is created by the virtue of the powers and authority vested in physicians through state licensure and accreditation laws, as well as the reasonable expectations of patients. If a patient is legally obligated to obtain certification for medical cannabis from a physician, and if the patient reasonably believes that the physician will exercise professional judgment and training in making that decision, then a doctor/patient relationship is likely to be recognized. Courts typically find that a doctor/patient relationship has been created where the physician assumed some degree of responsibility for making a diagnostic or treatment decision or saw the patient as part of a formal consultation even if the physician had no further involvement with the patient’s care.
The second issue involves the courts determining whether a physician has breached the duty of care by engaging in substandard medical practice. For example:
Some states employ a custom-based test for determining the standard of carex, requiring the physician to provide the type and level of care that an ordinary and prudent physician with comparable training and experience would have provided under similar circumstances in the same or a similar locality. In these states, expert testimony from physicians who are familiar with the relevant locality and area of practice is usually required to establish the customary standard of care.
In contrast, a growing number of states apply a reasonable physician standardx, which evaluates the physician’s actions against what he or she should have done as opposed to what is customarily done. In these states, expert witnesses may describe the results of
scientific studies to support their conclusions about reasonable care, or on cross-examination, may be called upon to defend their conclusions in the face of conflicting findings.
So how does a conscientious physician recommend MCT while minimizing their legal liability?
Although the number of medical malpractice claims has been dropping since 2001, nearly 8,500 claims were filed against physicians in the US in 2018[xi].
In order to minimize the legal jeopardy of physicians, the Federation of State Medical Boards has provided guidelines for practitioners considering the use of MCT for their patients [xii].
In conclusion, a mindful physician has little to be concerned about regarding the recommendations of MCT to their patients as long as they apply sound medical practices to their use of cannabis. Maintaining accurate and thorough records of the interaction between themselves and patients, provides the physicians with a wide degree of authority by the courts to assess and determine the best therapeutic interventions for the patients. By becoming educated about the latest scientific data and opinions about the benefits, risks, and mechanism of action for medical cannabis, a physician can inoculate themselves against legal issues.
[i]Clinical realities of MMJ for Pain in the USA: Cannalytic Insights, October 2018. https://cannalyticinsights.com/mmjinsights/ and Clinical Realities of MMJ for Cancer in the USA: Cannalytic Insights, October 2018. https://cannalyticinsights.com/mmjinsights/.
[ii]Gregorio, J. Physicians, Medical Marijuana, and the Law. AMA Journal of Ethics. Sept. 2014.
[iii]Garvey, T., Doyle, C. and Carpenter, D.H., Marijuana: Medical and Retail – Selected Legal Issues. Congressional Research Service. April 8, 2015. 7-5700.
[iv]Conant v Walter, 309 F3d 629, 636 (9th Cir 2002)
[v]Bax Global Inc v Brenneman, Ohio 695 (Ohio Ct App 2007).
[vi]Committee on Drugs, American Academy of Pediatrics Uses of drugs not described in the package insert (off-label uses) Pediatrics. 2002;110(1):181–183.
[vii]Wilkes M., Johns M. Informed consent and shared decision-making: a requirement to disclose to patients off-label prescriptions. PLoS Med. 2008;5(11):1553–1556.
[viii]Canterbury v Spence, 464 F2d 772 (DC Cir 1972).
[ix]Opioid epidemic leads to increase in medical malpractice claims, civil lawsuits. Spangenberg, Shibley & Liber, LLP.
[x]Marlowe, D.B. Malpractice Liability and Medical Marijuana. The Health Lawyer. American Bar Association Health Law Section. Vol. 29; Num. 2. Dec. 2016.
[xi]Beck, D., MD. The True Cost of Health-care: Malpractice Statistics. http://truecostofhealthcare.org/malpractice_statistics/
[xii]Model Guidelines for the Recommendation of Marijuana in Patient Care. Report of the FSMB Workgroup on Marijuana and Medical Regulation. Adopted as policy by the Federation of State Medical Boards. April 2016
John Taenzler, Ph.D. Partner & Chief of Research
Dr. Taenzler earned his doctorate in experimental neuropsychology from Clark University in 1995, where he served as an associate professor and departmental statistical consultant for various universities in the Boston area. He has worked as a research consultant in the pharmaceutical and biotechnology industry for more than 20 years, including Executive Vice President in a large, global marketing research company (GfK) and Founder/Principal in two custom research organizations (Evolution Consulting & Research and Jaunty Consulting).
Dr. Taenzler has conducted global pharma/biotech research in over 30 countries and is well-versed in the healthcare regulatory issues and government agencies that provide and oversee healthcare services. Dr. Taenzler has conducted research in nearly every area of healthcare including:
• Pharmaceuticals (most notably in the therapeutic areas of auto-immune disease, oncology, respiratory disease, pain-related syndromes, gastrointestinal disorders, psychiatric disorders)
• Hospitals/long-term care facilities (including disease management, robotics, pharmacy operations)
• Healthcare professionals (including physicians, nurses, pharmacists, laboratory technicians)
• Patients (including caregivers)
• Supply chain organizations (including specialty pharmacy, retail and hospital pharmacies, pharmaceutical distributors)
• Medical Appliance/Drug Delivery Devices (including inhalers, transdermal systems, injection devices, human factors testing and mitigation strategies)
• Payors/Managed care (including P&T committee composition, sales force targeting, disease/case management, coverage issues).
Your email address will not be published. Required fields are marked *
Save my name, email, and website in this browser for the next time I comment.
Notify me of follow-up comments by email.
Notify me of new posts by email.
NEWLY-proposed ‘safety’ levels of THC in European hemp and CBD food products have been condemned as ‘unacceptable, unnecessarily low, and not supported by scientific evidence’. In 2015, the European Food Safety Authority (EFSA) stipulated a minuscule maximum THC daily intake of 1μg (microgram) per kilogram of bodyweight (bw) in foodstuffs. While Member States and the…
More than 90 percent of Maine towns and cities still don’t allow recreational marijuana stores, even as sales in the industry have steadily grown since they started nearly a year ago. While Brewer and Orono are both on track to allow recreational cannabis stores sometime soon, they’ll join only three other Penobscot County communities that allow such shops — Bangor,…
In the recent competition for cannabis business licenses in Illinois, Ambrose Jackson’s team struck gold. They won rights to both grow and sell their own cannabis. Jackson is quitting his health care management job to commit full time to becoming a legal marijuana business owner. But he’s anxious about it, because now the hard part…
The state Cannabis Regulatory Commission will not begin accepting new applications for business licenses by this weekend, thereby missing a statutory deadline intended to keep development of the legal weed marketplace on track. But the commission at its meeting Tuesday evening did approve a new licensing platform to help it process applications when the time…