As of Nov. 5, the national Centers for Disease Control and Prevention reported 2,051 e-cigarette-related, or "vaping," injuries and 39 deaths, including three in Georgia. E-cigarettes vary widely in design, but all contain the same main components: a battery; a cartridge, which stores the e-liquid; an atomizer, which heats the e-liquid into a vapor; and the mouthpiece. The cartridge may contain flavoring, nicotine, THC, CBD or some combination thereof.

Referred to by the CDC as e-cigarette-or-vaping product use associated lung injury, or EVALI, the CDC is working with both the Food and Drug Administration and the Drug Enforcement Administration to determine the sources of these injuries and remove them from circulation. EVALI's cause is suspected to be a chemical exposure; however, the responsible product, brand or specific substance has not yet been identified. The CDC has named vitamin E acetate as a potential toxin of concern, and there is increasing evidence that the majority of vaping-related injuries and deaths stem from black market or counterfeit products.

FDA first took steps to regulate e-cigarette and vaping products in 2016, when it promulgated a "deeming rule" requiring e-cigarettes and vaping devices to be subject to premarket approval. However, the agency later said it was delaying the provision requiring manufacturers to submit applications for products on the market with a 2022 deadline. In July, a federal judge moved the 2022 deadline to May 12, 2020, for manufacturers to submit a premarket tobacco application for approval. E-cigarette and vape products that fail to win FDA approval will be barred from the market.

Given the precarious nature of the issues surrounding e-cigarette use—including an ever-changing political and regulatory landscape as well as a rapid increase in the number of lawsuits being filed against manufacturers and sellers of e-cigarette and vaping products—companies must consider strategic options to thwart continued problems and minimize risk.

Lawsuits are Varied and Numerous

Across the United States, individual lawsuits and class action lawsuits are being filed at a rapid rate. Many of these lawsuits target Juul Labs Inc., a popular e-cigarette company, and center around the marketing tactics allegedly used to addict people to nicotine. Other lawsuits allege severe personal injury and even wrongful death.

In July 2019, a lawsuit was filed on behalf of Maxwell Berger, a 22-year-old who suffered a hemorrhagic stroke after allegedly becoming addicted to Juul's products (Berger v. Juul Labs, Inc., et al, CGC-19-577444). The lawsuit makes multiple claims, including strict product liability and negligence, and represents the first attempt to hold an e-cigarette maker liable for severe personal injury.

In October 2019, what is believed to be the first wrongful death lawsuit against Juul was filed (Vail v. Juul Labs, Inc., N.D. Cal., No. 3:19-cv-06597). The complaint, which also contained causes of action for strict product liability and negligence, alleges that Juul e-cigarettes and nicotine cartridges were a significant factor in causing the respiratory injury and death of Daniel Wakefield. The complaint alleges that Juul's e-cigarette was defective in design because, among other things, it delivered chemicals harmful to users' airway, throat and lungs. The complaint further alleges that Juul failed to warn of the risks associated with vaping. The complaint also alleges that Juul failed to include instructions regarding product usage, such as how many nicotine cartridges are safe to use in one day.

With the uncertainty surrounding vaping-related injuries, it is important for e-cigarette companies to take necessary steps to avoid becoming part of the onslaught of product liability litigation that is sure to come.

Guarding Against Product Misuse and Misidentification 

Many consumers use cartridges purchased from illegitimate sellers or which are modified from their original form. This is especially prevalent with respect to marijuana cartridges. Data indicates that THC-containing products are linked to most cases of EVALI. Specifically, 76% of the people with lung injuries reported using THC-containing products.

Although THC cannot be legally sold in Georgia for recreational use, manufacturers still must be wary of product misuse. Consequently, companies selling e-cigarettes or vapes—even companies that do not sell THC-based cartridges—can help protect themselves from liability by using adequate warnings. Specific instructions and warnings that only certain approved cartridges may be used with the product, and that using non-approved cartridges could result in serious injury or death, may be added. Further, products should contain disclaimers related to their alteration, remaining mindful of the fact that potential plaintiffs may claim that alteration of the product was foreseeable. Additionally, manufacturers should adequately warn consumers about all known risks associated with the use of their products.

Using informational campaigns and advertising to distinguish their authentic products from knock-offs is another step manufacturers can take to reduce their potential liability. For example, Heavy Hitters, a cannabis vape cartridge producer, uses its website to discuss product authenticity and how to report counterfeit cartridges. The company also hired a former federal prosecutor, Priya Sopori, to assist in developing measures to reduce or eliminate counterfeiting.

It is also beneficial for companies to create updated or new packaging. Loudpack, the holding company for Kingpen—a popular cannabis vape company—invests millions of dollars in redesigning its packaging and product security. Kingpen products now include a six-digit alphanumeric serial number concealed beneath a scratch-off panel, which can be checked on the company's website for authenticity.

To date, vaping-related lawsuits have targeted a wide spectrum of companies, from midscale CBD oil manufacturers to the largest e-cigarette brands. No group is immune. There are concerns that reputable producers of vaping products could be unfairly targeted in the litigation onslaught, as products may be falsely equated with illicit vaping oils from the black market. While it is unknown if the cost of litigation and a new FDA regulatory scheme could reshape the vaping industry, this much is certain: until all the causes behind EVALI are identified, both companies and consumers must remain vigilant to protect themselves.

Shubhra Mashelkar is a partner in the Atlanta office of Weinberg Wheeler Hudgins Gunn & Dial. Her practice focuses on civil litigation with emphasis on product liability, environmental and toxic tort, professional liability and catastrophic injury.

Melissa E. Roque is an associate in the Atlanta office of Weinberg Wheeler Hudgins Gunn & Dial, where she represents clients in civil litigation, including catastrophic injury and product liability litigation.