Medical cannabis and potential product liability implications
Awareness around the use of medical cannabis has increased, as has legal availability across many jurisdictions. Countries in Europe and North America have responded to the demand, and with it the revenue from associated sales (Canada estimates up to CAD$1.79 billion in 2019 alone). As the UK slowly enters this market, we consider the potential product liability implications that may follow.
In June 2018, the Home Office initiated a review into cannabis-based medicinal products. This was in response to the concerns raised by parents of children with severe epilepsy about being denied access to the products’ therapeutic benefits.
Post review recommendations resulted in The Misuse of Drugs (Amendments) (Cannabis and Licence Fees) (England, Wales and Scotland Regulations) 2018 (the 2018 Regulations), which amend the Misuse of Drugs Regulations 2001 (the 2001 Regulations).
The changes to the 2001 Regulations (which came into force on 1 November 2018) mean that the prescription of cannabis-based products for medicinal use (with the exception of synthetic cannabinoids) is now permitted. However, this is only permitted by clinicians listed on the Specialist Register of the General Medical Council, where there is an unmet clinical need. This is because of the unlicensed nature of the vast majority of the products.
NHS England has advised that such products should only be prescribed where there is clear published evidence of benefit, or clinical need which cannot be met by licensed medicine and where established treatment options have been exhausted.
The Medicines and Healthcare Products Regulatory Agency published guidance on the 2018 Regulations on 31 October 2018. Clinical guidance from the National Institute for Health and Care Excellence (NICE) is currently expected to be published by October 2019 and we will be monitoring developments.
What is medical cannabis?
What constitutes a cannabis-based product for medicinal use in humans is set out in the 2018 Regulations. It is a preparation for use as an ingredient of or another product which:
“is or contains cannabis, cannabis resin, cannabinol or a cannabinol derivative (not being dronabinol or its stereoisomers)”.
It must also be produced for medicinal use in humans and is either:
“a medicinal product, or a substance or preparation for use as an ingredient of, or in the production of an ingredient of, a medicinal product.”
Cannabidiol (CBD) and tetrahydrocannabinol (THC) are two natural compounds found in plants of the Cannabis genus. CBD is primarily found in extractions from the hemp plant. THC is the main psychoactive compound that gives a high sensation e.g. when smoking marijuana. Both CBD and THC release neurotransmitters in the user’s brain, which provide messages between cells and can affect for example our immune systems, stress and pain thresholds.
Although CBD and THC have similar chemical structures they do not have the same psychoactive effects. CBD is a non-psychoactive compound whereas THC provides a sense of euphoria. CBD is used to treat a variety of medical conditions such as depression and anxiety, mental disorders, nausea, severe headaches, IBS, pain and inflammation. THC is used to help with medical conditions such as anxiety, nausea, lack of appetite, pain, sleeping disorders and muscle control problems.
Potential product liability implications
As the availability and use of medical cannabis in different parts of the world looks set to continue to rise, one likely consequence is an increase in product liability claims, and product recall involving potential multiple defendants in the supply chain.
Some examples of potential defective product claims (including failure to warn claims) that could arise are:
- A harmful pesticide in the unprocessed cannabis contaminates the final edible product with toxic chemicals.
- Inaccurate testing of the concentrations of THC and other active components in an edible product resulting in an excess of THC consumption.
- A product when delivered to the patient may have already expired. The recommended prescription dosage under the current guidelines is just a month, but the current prescription and delivery process takes about eight to ten weeks.
- A product is incorrectly labelled with a lower THC concentration and the patient suffers as a result.
- The patient has depression and is not warned to take the product under psychiatric monitoring.
- The instructions and warnings may not list and/or adequately describe all of the known potential side effects of the product to the patient.
- Inadequate instructions are not provided for contraindications to cannabis use e.g. when THC is combined with alcohol, opioids, barbiturates, benzodiazepines, antihistamines, and others, which may result in complications such as angina.
- The instructions and warnings may not clearly set out the symptoms of an overdose to the patient.
- The packaging may not be sufficiently child resistant.
In the future, medical cannabis manufacturers and their insurers will need to ensure that they focus on developing and marketing safe products with adequate instructions/warnings and proper labelling and packaging to increase the optimal safety of therapeutic use of their products and to assist in mitigating any potential liabilities.
Related item: Insuring the emerging cannabis industry