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By Tariq Naeem and Jeff Whitesell, Tucker Ellis LLP
Despite the success of Issue 2 in the November 2023 election, many questions remain as to how Ohio’s recreational marijuana market will be implemented and regulated. These questions come on top of concerns raised by various medical organizations about the long-term health consequences of cannabis use. Despite these uncertainties, one thing is beyond doubt: Ohio’s Product Liability Act (OPLA) will apply to any personal injuries alleged to have arisen from consumption of legal cannabis in Ohio. Businesses seeking to serve the cannabis market in Ohio should be aware of their legal responsibilities under OPLA so they can consider and adopt appropriate risk management practices. In fact, because most states have product liability laws similar to OPLA, cannabis businesses across the country are likely to face similar issues and should take steps now to minimize future risks.
I. IS CANNABIS A PRODUCT UNDER OPLA?
Generally speaking, OPLA governs civil actions seeking damages for death or physical injury to a person from the use of a product. O.R.C. 2307.71(A)(13). 1 As nothing in either Issue 2 or Ohio Revised Code Chapter 3796 (Ohio’s Medical Marijuana Control Program) expressly exempts cannabis from its provisions, OPLA will apply to cannabis businesses if cannabis is considered a “product” for purposes of OPLA:
“Product” means * * * any object, substance, mixture, or raw material that constitutes tangible personal property and that satisfies all of the following:
(i) It is capable of delivery itself, or as an assembled whole in a mixed or combined state, or as a component or ingredient.
(ii) It is produced, manufactured, or supplied for introduction into trade or commerce.
(iii) It is intended for sale or lease to persons for commercial or personal use.
O.R.C. 2307.71(A)(12)(a). Without question, cannabis satisfies the elements necessary to be considered a “product” for purposes of OPLA. It is “tangible personal property” that is “capable of delivery” and is “produced, manufactured, or supplied for introduction into trade or commerce” with intentions to be sold for “personal use.” As such, cannabis businesses are subject to potential liability under OPLA.
While it may not surprise cannabis businesses that OPLA applies to them, what the industry may not appreciate is that all entities involved in the production and sale of cannabis are potential targets for liability under OPLA. As will be discussed below, the causes of action provided by OPLA apply expressly to a product “manufacturer,” which is defined to include those who “design, formulate, produce, create, [or] make … a product or a component of a product.” O.R.C. 2307.71(A)(9). Further, under certain circumstances, a supplier of products also can be held liable for product defects. 2 A “supplier” is anyone who “sells, distributes, leases, prepares, blends, packages, labels, or otherwise participates in the placing of a product in the stream of commerce.” O.R.C. 2307.71(A)(15)(a)(i). Given the breadth of these definitions, cannabis cultivators, processors, and dispensaries are all potential targets of OPLA claims.
II. WHAT IS THE POTENTIAL FOR LIABILITY UNDER OPLA?
Plaintiffs seeking damages under OPLA typically assert one or more of the following causes of action: (1) manufacturing defect; (2) design defect; (3) failure to warn; and/or (4) breach of express warranty. Below is a description of those liability theories and how they might affect cannabis businesses in Ohio.
A. MANUFACTURING DEFECTS
A manufacturing defect arises when a product has “deviated in a material way from the design specifications, formula, or performance standards of the manufacturer, or from otherwise identical units manufactured to the same design specifications, formula, or performance standards.” O.R.C. 2307.74. Under OPLA, it is not a defense to a manufacturing defect claim to say that the manufacturer took all reasonable precautions in bringing a cannabis product to market. Id. In other words, if the product deviates from its manufacturing specifications in any way, the manufacturer can be liable for the injuries that arise from the defect.
With respect to cannabis products, there are many issues described in the public literature or referenced implicitly in cannabis regulations that could give rise to potential manufacturing defect claims. Some of the issues most likely to lead to manufacturing defect claims are THC content higher than listed specifications of a product; adulteration of the product by other drugs; or the presence of contaminants or other undisclosed substances (microbes, mycotoxins, heavy metals, pesticides, fertilizers, solvents). As ample evidence in the literature exists to support the possibility that these or similar issues related to cannabis production can pose potential health risks, manufacturers of cannabis products are reasonably likely to face manufacturing defect claims from consumers of legal cannabis in Ohio.
B. DESIGN DEFECTS
A design defect exists when the foreseeable risks of a product’s design or formulation exceed the benefits of that design or formulation. O.R.C. 2307.75. In assessing the risks of a particular design of a cannabis product, various factors might be relevant, including the nature and magnitude of the risks of harm; cannabis users’ awareness of those risks; the likelihood of harm; and any public or private product standards that apply to the design or formulation. O.R.C. 2307.75(B). In assessing potential liability, these risks would be balanced against the benefits of the cannabis product’s design or formulation, including the utility of the product and any advantages associated with that design or formulation; the feasibility of using an alternative design or formulation; and the nature and magnitude of foreseeable risks from the alternative design or formulation. O.R.C. 2307.75(C).
OPLA provides a number of specific defenses to potential design defect claims. In particular, cannabis products would not be considered to be defective in design or formulation if the claim relates to an inherent characteristic of the product that is a generic aspect that cannot be eliminated without substantially compromising the product's usefulness or desirability and that is recognized by an ordinary person with the ordinary knowledge common to the community. O.R.C. 2307.75(E). Thus, for example, it would be difficult for a medical marijuana patient to prove a design defect claim based on the intoxicating effects of cannabis because those effects are inherent to cannabis, cannot be eliminated without compromising its usefulness, and are well known to the community of cannabis users.
Based on the nature of cannabis products and their intended uses, design defect claims are the least likely of those available under OPLA to be faced by cannabis businesses in Ohio. Nevertheless, potential design defect claims against manufacturers of legal cannabis products could include those related to high-potency cannabis products or to the differing risks from various cannabis formulations (flowers, edibles, vapes, beverages, lotions, etc.). For example, some reports associate high-potency cannabis products to increased risks of addiction or psychotic episodes. Additionally, while some studies report that vaping may generate fewer toxic emissions than smoking, cannabis vaping has been associated with several acute and long- term health risks. Further, vaping devices have been reported to catch fire or explode, resulting in burns and other injuries. Each of these examples presents a scenario where cannabis users could argue that the risks of the design or formulation exceeded the benefits and that an alternative design or formulation would have been safer, which would support a potential design defect claim under OPLA. Cannabis businesses can mitigate potential design defect claims by warning about these or similar inherent risks that might not be obvious to the ordinary cannabis consumer.
C. FAILURE TO WARN
Under OPLA, a product is defective due to inadequate warning or instruction if, when it left the control of the manufacturer:
(a) The manufacturer knew or, in the exercise of reasonable care, should have known about a risk that is associated with the product and that allegedly caused harm for which the claimant seeks to recover compensatory damages; and
(b) The manufacturer failed to provide the warning or instruction that a manufacturer exercising reasonable care would have provided concerning that risk, in light of the likelihood that the product would cause harm of the type for which the claimant seeks to recover compensatory damages and in light of the likely seriousness of that harm.
O.R.C. 2307.76(A)(1).
Ohio does not yet have any labeling requirements for recreational marijuana products sold in the state, although – under Ohio’s Medical Marijuana Control Program – medical marijuana products are required to be labeled with certain specific information and warnings. See, e.g., O.A.C. 3796:6-3-09. Regardless of the existence or nature of any state warning requirements, cannabis businesses in Ohio cannot ignore their independent duty under OPLA to warn of any risks they knew about or reasonably should have known about. In this respect, state laws or regulations regarding cannabis warnings would establish only minimum requirements and would not protect cannabis businesses from failure to warn claims.
In complying with OPLA’s duty to warn, cannabis businesses will be “held to the skill of an expert” with “an expert’s knowledge of the arts, materials, and processes involved in the development, production, and marketing” of cannabis. 1 Ohio Jury Instructions CV 451.07. They will have a “duty to remain reasonably current with scientific knowledge, development, research, and discoveries concerning” cannabis, and they will be required to communicate this “superior knowledge” to their customers once the state of the research and knowledge “has reached a level of development that would make a reasonably prudent manufacturer aware of the unreasonable risks of harm” from cannabis. Id.
Of the potential bases for recovery under OPLA, failure to warn claims are likely to be the most common claims faced by cannabis businesses in Ohio for a variety of reasons. 3 One primary reason is the fact that many studies are ongoing regarding the acute and long-term risks of cannabis use, and scientific consensus that cannabis causes a particular risk may take years to develop (if at all). Scientific consensus is not a requirement before updating safety information, however, and cannabis users who claim injury from an undisclosed risk will allege the research was far enough along for cannabis businesses to have known and warned them about the risk.
Thus, cannabis businesses put themselves at risk for liability if they do not diligently assess the science and update safety information where appropriate.
D. BREACH OF EXPRESS WARRANTY
A product is defective if it did not conform, when it left the control of its manufacturer, to a representation made by that manufacturer. O.R.C. 2307.77. A “representation” that can lead to liability under OPLA is one that is “an express representation of a material fact concerning the character, quality, or safety of a product.” O.R.C. 2307.71(A)(14). These types of express warranty claims could arise under innumerable circumstances, most commonly when a customer relies on the advice of a sales associate to select a product suitable for his or her needs. Other common situations that lead to breach of express warranty claims include representations that a product is “all natural” when it is produced using fertilizers or pesticides, that it is “safe” when it has potential side effects, or that it has health benefits that are not proven in the scientific literature.
III. CONCLUSION
While Ohio businesses must remain focused on existing and soon-to-be enacted laws and regulations specific to the cannabis industry, they must not lose sight of how laws of general applicability like Ohio’s Product Liability Act will have substantial impacts on their business operations. Given the ubiquitous nature of product liability litigation in Ohio and across the nation, it is likely impossible to eliminate the risk of future lawsuits from consumers of legal cannabis. Nevertheless, consistent with the above discussion, cannabis businesses can proactively implement practices to anticipate and reduce the risk from product liability claims asserted against them.
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1 Economic loss other than that associated with personal injury or injury to property other than the product at issue is not recoverable under OPLA. O.R.C. 2307.72(C). For example, a cannabis user could not sue to recover his money under OPLA for a cannabis product manufactured with less than the advertised amount of THC.
2 Under O.R.C. 2307.78, a supplier can be liable for its own negligence with respect to selling or marketing the product, which could include the product’s failure to conform to representations made by the supplier. O.R.C. 2307.78(A). Further, under some circumstances, a supplier can be held liable as if it were the manufacturer of the product. Among the most pertinent examples of such circumstances are the insolvency of the manufacturer; common ownership of the manufacturer and supplier; and marketing of the product under the supplier’s own label or trade name. O.R.C. 2307.78(B).
3 Some differences might exist, however, depending on whether the plaintiff is a recreational cannabis user or medical marijuana patient. In particular, analogizing to prescription pharmaceutical cases, the duty to warn in a medical marijuana case would be to the prescribing doctor, not the patient. In a recreational cannabis case, the duty to warn is to the consumer.
About the Authors
Tariq Naeem co-chairs the Tucker Ellis LLP Health & Life Sciences Group. A trial lawyer with a background in the biological sciences, he defends manufacturers of prescription drug and consumer products in all aspects of personal injury cases, particularly those regulated under theFood, Drug, and Cosmetic Act. He works directly with manufacturing, regulatory, clinical, and pharmacovigilance employees to defend clients on such diverse issues as product recalls, design changes, labeling revisions, safety assessments, and FDA investigations. He also advises cannabis businesses on litigation risk management.
Jeffrey Whitesell is counsel at Tucker Ellis LLP, where he defends and advises product manufacturers in the pharmaceutical, medical device, prosthetic, consumer product, industrial equipment, recreational vehicle, automotive, and cannabis industries. He has experience as national coordinating counsel and in multidistrict litigation in jurisdictions across the United States and serves as Ohio and national counsel for product manufacturers in a variety of industries.
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