Electronic cigarettes and vaping have been heralded by many as a safer alternative to smoking traditional cigarettes. An outbreak of illnesses last fall allegedly related to vaping, however, ignited public hysteria and will almost certainly lead to substantial mass tort litigation aimed at manufacturers of e-cigarette devices and vaping liquids. Similarly, because many e-cigarette and vape manufacturers have placed the blame on THC-containing products, the cannabis industry can expect a rash of lawsuits as well. Manufacturers of these products need to be well prepared to defend against a potential wave of complex product liability litigation.
According to the final update by the Centers for Disease Control and Prevention (CDC) on e-cigarette, or vaping, product use-associated lung injury (EVALI), as of February 25, 2020, 2,807 cases of EVALI and 68 deaths had been linked to vaping. At the onset of the illnesses, many news reports speculated that the use of THC oil was at least partly to blame, and the U.S. Food and Drug Administration (FDA) issued a MedWatch Safety Alert in September 2019 to consumers warning against the continued used of THC-containing vaping products. According to the FDA, early reports indicated that many samples tested by both states and the administration contained THC and vitamin E acetate, a substance used in topical consumer products but on which there is limited data on the effects of inhaling it.
Although the FDA pointed out that more information was needed to understand the relationship between specific products and the reported illnesses, the FDA urged consumers to “avoid buying vaping products from the street” and “to refrain from using THC oil or modifying/adding any substances to product purchased in stores.” In an October 4, 2019, consumer update, the FDA further explained, “No one substance has been identified in all of the samples tested. Importantly, identifying any compounds that are present in the samples will be one piece of the puzzle but will not necessarily answer questions about what is causing these illnesses.” Ultimately, the CDC identified vitamin E acetate as the “primary cause of EVALI,” but this finding alone may not be enough to insulate other manufacturers from allegations of product liability.
Despite the decline in EVALI since last fall, the potential consequences for manufacturers have been worsened by a rise in vaping among teenagers. In 2018, then-FDA Commissioner Scott Gottlieb voiced his commitment to getting vaping products out of teens’ hands, and the FDA imposed regulations restricting the availability of flavored vape products at certain stores. Then, on September 11, 2019, President Trump announced a plan to ban the sale of e-cigarettes in flavors other than tobacco in a more aggressive effort to curtail the rise in vaping among teenagers. Senators Jeff Markley (D-OR) and Mitt Romney (R-UT) responded to the president’s announcement by introducing legislation to the same effect, but no action on that legislation has since been taken. In February of this year, however, H.R. 2339, the Protecting American Lungs and Reversing the Youth Tobacco Epidemic Act of 2020, was passed in the U.S. House of Representatives and sent to the U.S. Senate. Although the Senate has not yet taken up this legislation, it seems unlikely that legislative focus on this issue will altogether disappear.
In many ways, these circumstances produced a perfect storm that has captured the attention of the mainstream media. EVALI involves a “new” product that the public does not fully understand and marijuana, a topic that is politically and socially divisive. A number of implicated manufacturers are based in foreign countries, China in particular. And, moreover, the science may not be sufficiently developed to prove or disprove either side of any allegations. These conditions are ideal for the development of widespread litigation with all types of claims ranging from the credible to the baseless.
The crossroad of vaping and THC-containing products makes this situation particularly appealing for critics and troublesome for manufacturers. Quite simply, because vaping and state-legalized marijuana use are relatively recent developments, the medical community does not have sufficient reliable data regarding the long-term effects of vaping and THC ingestion on the body. Just as it took decades for medicine to understand fully the detrimental effects of traditional smoking, it will likely take years before medical science can sufficiently evaluate allegations of injuries caused by vaping.
Unfortunately, this lag in supporting science has seldom, if ever, stopped the pursuit of mass tort litigation, which can be very effective, based on public opinion alone, if it is not properly managed by experienced defense litigators. One needs to look no further than the explosion of thousands of plaintiffs claiming that the use of talc-containing products led to their cancer. While talc-containing products are still used daily by thousands of consumers worldwide and have been recognized as safe and effective by the scientific community, that has not prevented plaintiffs and their attorneys from naming manufacturers in widespread litigation across the country.
Although EVALI cases have fallen significantly since the startling spike last fall, we anticipate an increase in cases involving a variety of product liability claims against manufacturers throughout the supply chain. Plaintiffs will allege that manufacturers at multiple tiers failed to warn consumers adequately about the risks associated with the use of e-cigarettes, vaping liquids, and other aftermarket or homemade products. It is also likely that plaintiffs will assert claims alleging that defendants’ manufacturing processes are flawed, or their products are designed in a way that caused the plaintiffs’ injuries. Moreover, as would be expected in all mass tort litigation, credentialed experts will not be in short supply to opine on various manufacturing and design defects related either to the e-cigarette devices or the liquid formulations that are turned into an inhalable substance.
While couched as traditional product liability causes of action, potential cases likely to arise from these illnesses are unique because of the intersection of the relatively modern e-cigarette technology and the use of THC-containing products. To minimize the significant exposure presented by these cases, manufacturers of e-cigarettes, THC oils, and other vaping products should act soon to evaluate potential exposure to claims from vaping-related illnesses. To start, these companies should engage skilled mass tort litigators with knowledge of cannabis products and experience in the fast-developing cannabis industry. All parties along the supply chain need to think carefully and critically (and with advice of counsel) about methods of shifting risk exposure. These companies should consider liability-shifting provisions, such as indemnities and appropriate disclaimers related to alterations of a product. In doing so, these companies should be mindful that plaintiffs are nearly certain to allege that any alteration of the products was not only a foreseeable use of the product, but, perhaps, an intended use.
The original article, "Does the Cloud of Vaping-Related Injuries Portend a Storm of Litigation?" appeared in The Voice, Volume 19, Issue 32 on August 12, 2020.