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.
Despite Pennsylvania’s broad protections for participants however, medical marijuana is still illegal under federal law, so does this negate the benefits of informed consents when it comes to protecting participants?
Fortunately, it does not. Participants can protect themselves under traditional laws that govern business practices, and medical activities. The first thing that participants should do on the path to liability protection is to review any protections provided under their state law for participating in the medical marijuana industry. Next, a participant should thoroughly review and follow the requirements they must meet under state law in order to avail themselves of these protections. For example, here in Pennsylvania, growers must only sell to other permitted medical marijuana entities located within the commonwealth. Additionally, certifying physicians, defined as “practitioners” under the act, may not have a direct or financial interest in any medical marijuana grower/processor or a dispensary. And a patient must obtain a medical marijuana identification card issued by the state in order to enter a dispensary and purchase medical marijuana products. Additionally, participants must provide accurate, complete information on the medical marijuana labels and informed consent for medical marijuana’s use.
In Pennsylvania, the Department of Health has issued regulations governing the labeling of medical marijuana. Under these regulations, labels must be easily readable; made of weather-resistant and tamper-resistant materials; conspicuously placed on the package; and include the following:
- Percentage of THC or CBD and species of marijuana
- Name, address and permit number of the grower/processor
- Form, quantity and weight of medical marijuana
- Unique identifier for harvest, batch and lot
- Packaging and expiration date
- Employee identification number of individual processor
- Name and address of dispensary where sold
- Instructions for proper storage
The labels must also contain the following warnings: Product must be kept in its original container, unauthorized use is unlawful and will subject the purchaser to criminal penalties, this product might impair the ability to drive or operate heavy machinery, and keep out of reach of children.
Also, the product is for medicinal use only. Women should not consume during pregnancy or while breast feeding except on the advice of the practitioner who issued the certification and in the case of breastfeeding, the infant’s pediatrician.
In addition to required label warnings, some certifying physicians and dispensaries will ask patients to sign a written statement containing certain disclaimers. While the contents of the statement may vary, these patient-disclaimer statements often focus on two issues: potential adverse health effects; and medical marijuana’s illegality under federal law.
As with other medicines, a disclaimer regarding the appropriate authorized use, prohibitions, and possible side effects helps protect a dispensary or physician from legal liability resulting from adverse effects from, or misuse of, their products or the prescription of treatments. But with medical marijuana there is the additional disclaimer advising the patient of marijuana’s status as an illegal substance under federal. In this area, practitioners are under a different legal rubric than other participants, since unlike grower/processors or dispensaries, physicians will not be selling or dispensing, or even touching, the medical marijuana. Practitioners are not “prescribing” the medical marijuana in the same way they would approved pharmaceuticals, but rather they are “recommending” it, see Conant v. Walters, 309 F.3d 629, 638 (9th Cir. 2002). In Conant, the U.S. Court of Appeals for the Ninth Circuit reasoned, based partially on a U.S. Supreme Court case out of Pennsylvania, Planned Parenthood of Southeast Pennsylvania v. Casey, 112 S.Ct. 2791, 2800 (1992), that a physician’s recommendation of medical marijuana is protected by the First Amendment’s right to free speech. Although this Ninth Circuit decision is non-precedential in Pennsylvania, the federal government has not challenged a physician’s right to recommend medical marijuana since the Conant case was decided in 2002. Physicians, informed consent forms should focus on the traditional disclaimers of side effects, but should still state that medical marijuana remains illegal under federal law.
Given the unique role that dispensaries play in a patient’s medical marijuana treatment, with dispensaries in Pennsylvania also serving the role of recommending dosages, forms, and methods, many dispensaries seek to document patient’s “informed consent” through written patient disclaimers in addition to the required label warnings. In fact, some dispensaries also document the patients’ awareness of the patients’ obligations and rights under applicable state law, along with the potential penalties under federal law for the consumption of medical marijuana by requiring patients to sign a statement acknowledging these risks.
While Pennsylvania’s labeling laws are fairly comprehensive, dispensaries and grower/processors should still seek legal advice regarding the appropriate language to use on an informed consent/limited liability form in order to have additional protections ensuring that the medical marijuana patients are informed about, and consent to, treatment, while providing additional liability protection for themselves and their business
Judith D. Cassel of Cannabis Law PA, in Harrisburg, is a partner in the firm. She works in cannabis regulatory and commercial law assisting clients in application drafting, administrative litigation, appeals, and commercial transactions. Contact her at firstname.lastname@example.org.
Melissa A. Chapaska works in regulatory matters involving medical marijuana applications, investigations, litigation, and appeals before state courts and administrative agencies. Contact her at email@example.com.