Disclaimers and Informed Consent in the Medical Marijuana Industry

Because marijuana is still frustratingly and inappropriately listed on Schedule 1 of the Controlled Substance Act (21 U.S.C. Section  321 et seq.) the federal rules applicable to labeling pharmaceuticals do not really apply to medical marijuana. The lack of safe and uniform labeling standards is just another casualty of the federal government’s placement of marijuana on the same schedule as drugs such as heroin, LSD and Ecstasy. Marijuana’s categorization as a Schedule 1 controlled substance has also created challenges for medical marijuana entities seeking to develop informed consent and disclaimers to minimize liabilities arising from any adverse effects experienced by patients. Physicians, grower/processors, and dispensary operators (participants) have therefore made varied attempts to try to properly inform patients of potential risks using labeling and informed consent forms.

There are two broad areas of information that participants need to consider when developing labels, informed consents and other materials related to the use of medical marijuana. But participants still find themselves between a rock and a hard place in their attempts to limit their liabilities for any adverse reactions patients may experience, because of the continuing federal prohibition. Under Pennsylvania law, participants are protected from criminal prosecution since the “growth, processing, manufacturing, acquisition, transportation, sale, dispensing, distribution, possession and consumption of medical marijuana permitted under the Pennsylvania Medical Marijuana Act shall not be deemed to be a violation of the Controlled Substance, Drug, and Cosmetic Act.” In fact, the act goes further to try to protect industry participants from liabilities, stating that patients, caregivers, certifying physicians, grower/processors, and dispensaries will not “be subject to arrest, prosecution, or penalty in any manner or denied any right or privilege, including civil penalty or disciplinary action by a commonwealth licensing board or commission” for lawful use, manufacture, sale, dispensing or other action taken in accordance with the act.