Vape industry faces lawsuits & product bans over illnesses and injuries

In September 2019, the Trump administration proposed a temporary nationwide ban on sales of flavored vape cartridges and e-cigarettes in response to an outbreak of a mysterious and deadly respiratory illness. Hundreds of vape users were hospitalized for a severe lung injuries that caused pneumonia-like symptoms, despite testing showing neither bacterial or viral infection.

The CDC issued a warning that vape users should stop using their devices until more was known about their connection to the lung disease. At least 55 people in the United States are known to have died from lung injuries associated with the use of e-cigarettes.

After months of delay, and heavy lobbying from vaping industry advocates and vape users, the Trump administration announced that the FDA will implement a ban of flavored e-cigarettes. The effort is intended to curb teen vaping, which has grown explosively in recent years with the introduction of an increasing variety of flavored vape cartridges. The announcement follows the December 2019 raising of the federal minimum age of purchase of tobacco products to 21.

What is known about the connection between vapes and the lung injuries?

Victims of the lung illness have surged both in number and media attention in recent months as authorities began to link the disease to the use of vapes and e-cigarettes. Over 2,500 people were hospitalized in 2019 from vaping lung illness, and investigators are struggling to determine a precise cause. Vitamin E acetate, a chemical additive found in some vape cartridges, was associated with the disease after laboratory testing.

The Centers for Disease Control and Prevention have determined that some victims of the vaping-related illness are displaying symptoms similar to acute lipoid pneumonia, a form of the disease caused by inhaling aerosolized lipid droplets.

However, not all patients studied have had lipoid pneumonia, instead being diagnosed with other forms of lung damage. This prompted some medical professionals to claim that this may be a new form of lipoid pneumonia.

The vaping industry previously faced a similar public health scare over cases of “popcorn lung.”

In the early 2000s, microwave popcorn factory workers were sickened by diacetyl, a butter-like flavoring additive in their products. When inhaled, diacetyl causes bronchiolitis obliterans, or “popcorn lung.” Victims suffered a massive and irreversible loss of lung capacity. The connection between the chemical and the illness affecting factory workers was made after the home of a popcorn lung-sufferer was discovered to have levels of diacetyl in their kitchen, similar to those found in the air of the popcorn plants.

The chemical was quickly removed from popcorn factories, but eventually found its way into the flavored cartridges used in e-cigarettes. A 2015 study by the Harvard T.H. Chan School of Public Health discovered that 47 types of flavored cartridges and e-cigarettes contained one, two, or all three of the hazardous chemicals acetoin, 2,3-pentanedione, and diacetyl. Of those products, 39 tested positive for diacetyl.

In 2016, the FDA extended regulations for tobacco products to include e-cigarettes, and all other related devices and products. Diacetyl was banned in the EU that same year.

The existence of illicit vape cartridges has become a major concern to authorities.

Two Wisconsin brothers were arrested in Bristol in September 2019, described as ringleaders of an extensive illegal cannabis vaping operation. Upon entering the condominium rented out by the brothers, law enforcement discovered 31,200 vape cartridges with 1 gram of liquid THC, nearly 100,000 empty cartridges, 57 mason jars filled with $6,000 worth of THC, money counting machines, and multiple firearms. Additionally, investigators discovered fake packaging for the cartridges, designed to mimic real brands of candy.

That same month, the New York State Health Department was ordered by Gov. Andrew M. Cuomo to subpoena three companies responsible for the online marketing and sales of thickening agents believed to likely contain vitamin E acetate. These oils are used to thicken vaping liquid in black market THC-based vaping products.  State investigators acted after discovering recently diagnosed victims’ vape cartridges manufactured using the thickening agents contained both THC and vitamin E acetate.

Why is the Trump Administration targeting flavored vape cartridges?

Youth vaping has grown dramatically in recent years. A 2018 study by the National Institutes of Health showed that vaping among high school students rose dramatically, particularly the use of flavored cartridges containing nicotine.

The newly announced ban is not the first time the industry has been targeted by authorities. Michigan became the first state in the US to ban sales of most flavored cartridges and e-cigarettes in September 2019. The city of San Francisco banned the sale and distribution of all e-cigarettes in June 2019, and three years prior the state of California rolled the devices into its existing tobacco laws banning smoking in public places and requiring that purchasers be at least 21 years of age.

The FDA has made efforts to strengthen restrictions against flavored vape cartridges and e-cigarettes in the past, and individual states have sought or have enacted tougher restrictions against these products. Even as the Trump administration appealed for a more extensive ban, two cities in California’s Bay Area, Livermore and Richmond, have made efforts to pass legislation banning the sale of e-cigarettes entirely until they are approved by the FDA. They have modeled their proposals after San Francisco’s own suspension of e-cigarettes.

Vape manufacturers have faced lawsuits, warnings from government organizations, and growing public criticism for their marketing of vapes and flavored cartridges towards youths.

The bright colors of these boxes capture attention in a manner some critics feel is deliberately targeting children. (Image credit: Sarah Johnson, “Fruity flavored njoy e-juice.” Licensed via CC BY 2.0.)

Juul Labs, the leading e-cigarette manufacturer in the US, has come under fire for its recent “Make the Switch” campaign of television, print, and radio advertisements. The company also ran advertising campaigns  on Facebook, Instagram, and Twitter. But after the FDA announced a crackdown on youth vaping in September 2018, the company shut down its Facebook and Instagram accounts, limited its Twitter account to non-promotional material, and refocused its YouTube channel to videos on quitting smoking.

Despite these changes, Juul Labs and its parent company Altria Group have been named in a class action lawsuit. The plaintiffs allege that Juul knew the addiction risks their nicotine products posed, but continued to advertise them as a safe alternative to smoking. Some victims claim that they began using the products in their early teens specifically because of the sweet and fruity flavors, while being unaware that they contained nicotine.

Another class action lawsuit was filed in North Carolina against 8 other e-cigarette product manufacturers, alleging that these companies deliberately targeted younger customers through aggressive advertising. They cite marketing materials that pushed sweet flavors while deliberately downplaying or otherwise failing to inform customers of the risks posed by nicotine.

Companies have positioned vapes and e-cigarettes as safe alternatives to regular smoking, but little data exists to support these claims

The vaping industry has claimed that their products represent a safe alternative to traditional smoking products. But these claims have been made without FDA approval, and this lack of oversight is key to both the lawsuits and efforts to ban the products.

On September 9th, 2019, the FDA sent a warning letter to Juul Labs, stating that the company had not received federal approval to sell its products as a safe alternative to smoking or advertise as such. In a second letter, the FDA demanded that the company release all scientific evidence that it had gathered to support its claims that its products are a safe smoking alternative.

E-cigarette cartridges are extremely varied in their ingredients, and studies have revealed that certain hazardous chemicals are used in many products. But despite this, not everything is known about the actual safety of vaporizers, and various health organizations have come to contradictory conclusions on the safety of these devices.

In 2014, the World Health Organization urged caution on e-cigarettes due to the limited scientific understanding of the associated risks. But that same year, the FDA claimed that properly regulated devices could be safer than traditional smoking products, contradicting the WHO’s concerns that hundreds of products and brands had yet to be fully tested.

While vaping has been tied to thousands of severe lung injuries resulting from tainted products, e-cigarettes have been subject to other safety concerns resulting from their reliance on lithium-ion batteries.

In June 2019, a 17-year old Nevada resident was injured when his vape pen exploded while he was smoking. The blast fractured his jaw, knocked out several front teeth, and punched a hole in his chin. The victim claimed that he had been using the device as intended, and could not recall doing anything that would have prompted the vape pen explosion.

Ironically, the victim had not been illicitly smoking. The vape kit had been purchased by his mother, who had hoped that vaping would help her son quit. Instead, the vape pen caused injuries that one of the victim’s surgeons described as looking “like a close-range gunshot wound,” while another surgeon described it as, “an injury we see in high-speed motor vehicle crashes.” The injury was so extensive and unexpected that the case was written up for the New England Journal of Medicine.

Vape pen explosions and burn injuries are believed to be extremely rare, given the millions of people who use them every day. What few accidents have been reported has prompted vape pen manufacturers to argue that the problem lies with the lithium ion batteries (LIBs) used to power them, or the users themselves. Critics argue that a vape pen explosion is a risk inherent to the devices, calling for increased scrutiny and regulations.

Thousands of severe injuries, as well as several fatalities, have been attributed to vape pen explosions.

Depending on where the pen is when it explodes, they can cause very severe burn and blast injuries, with the lithium batteries fueling very hot fires. These incidents have occurred worldwide, across a broad range of vape pen models from various manufacturers. The e-cigarette website has compiled an extensive list of vape pen explosions and battery explosions, showing a mixture of fires and personal injuries they have caused. In addition, a study published in BMJ Journals found that between 2015 and 2017, more than 2,000 Americans went to the emergency room with injuries caused by e-cigarette burns and/or explosions.

  • In March 2013, a woman and her husband were driving to an airport when her e-cigarette battery, plugged into a car charger, exploded shortly after liquid began to leak from the casing. Burning chemicals sprayed throughout the car, starting fires that gave the victim second degree burns on her legs and one of her hands. She successfully sued the e-cigarette distributor, the wholesaler, and the store where she bought the device for $1.9 million in 2015.
  • In 2016, a 15-year-old Windsor, CA boy lost a half dozen teeth and suffered extensive injuries to his mouth when his allegedly modified vape pen exploded while in use. Firefighters reporting to the scene claim that shrapnel from the pen was still hot when they arrived.
  • A 26-year old Orange County, CA resident suffered second and third-degree burns after an e-cigarette battery exploded in his pants pocket. Requiring multiple surgeries for the burns, the man went on to sue the two vape shops where he brought the device and its charger.

Exploding vape pens have been blamed for at least two deaths in the United States:

  • In May 2018, a 38-year-old Florida man was killed when his vape pen exploded, launching a projectile that penetrated his skull, and starting a fire that caused burns to more than 80% of his body. The Philippines-based manufacturer of the vape pen stated that their products “do not explode,” and blamed the explosion on a faulty atomizer or battery.
  • In January 2019, a 24-year-old Texas man started to smoke a vape pen outside the store where he had just bought it. The pen exploded, showering his face and neck with metal shrapnel. He died in the hospital two days later. His cause of death was listed by the Tarrant County medical examiner as a stroke resulting from his carotid artery being severed by “penetrating trauma from exploding vaporizer pen.”

Lithium ion batteries are a recurring factor in vape explosion incidents, but are not the only cause for concern.

Lithium ion batteries are ubiquitous in consumer electronics today due to their energy efficiency and small size. But they are inherently dangerous. Within each LIB is strip of polypropylene that keeps the electrodes inside from making contact. But should that strip be damaged or breached, allowing the electrodes to make contact, the battery will heat up, expand, and inevitably explode in a spray of flammable electrolyte.

These batteries have made headlines due to malfunctions in other consumer devices. The Samsung Galaxy Note 7 was notably banned from all airliners going to and from the US after a number of battery ignition incidents. And in 2017, a woman flying from Beijing to Melbourne was awakened when the battery in her headphones exploded. But while LIBs are the common factor in many vape explosion stories, there are others to consider.

Vape manufacturers may still play a role in these accidents due to design flaws with their devices: Like many other popular electronic devices, vapes are often designed to be small and easily pocketable. A number of these incidents involve devices and batteries that were in a shirt or pants pocket. Some vape designs do not feature recessed buttons, which can be easily depressed by accident, activating the device heat element and leading to a potential explosion.

Poorly made and incompatible battery charger accessories have caused vape explosions: Many modern vape pens can be plugged into a charger via a USB cable. Some users opt to use a cheap, universal charger for their vapes. Alternatively, some users choose to carry spare batteries to plug into their vape pens when a charger isn’t readily accessible.

Unfortunately, some of these accessories do not necessarily conform to the same safety standards that the vape manufacturers adhere to. Alternatively, these third-party accessories may meet the voltage requirements for some devices, but not others.

User error and inaccurate reporting has only helped to muddy public understanding of the risks posed by vape pens: Critics have been quick to point to the vape pens themselves as the common factor in these accidents. But proponents for the devices have argued that in many of these cases, the point of failure has been the users themselves, citing cases where the wrong charger was used, or a non-standard modification was made to a device that exploded.

Unfortunately, reporting of these accidents is sometimes confusing or misleading, which proponents claim is giving vape pens a bad reputation. A New York man was severely burned in January 2019 when a spare e-cigarette battery in his pocket exploded, but the story’s headline reported it as the device itself exploding. The text of the article did clarify that it was a spare battery, but many readers may not have noted this detail.

Competition among vape pen and lithium ion battery manufacturers may be resulting in unsafe products being rushed to market.

As with most consumer electronics, new model vape pens are released regularly, as are new LIBs with increased capacities and smaller physical sizes. The rush to meet consumer demands means that companies want to get new products to market faster than ever, and they seek ways to cut costs wherever possible.

A vape manufacturer may use cheaper safety elements in their devices, a decision that saves cents per device, but could save millions on a large-scale production run. Or they could go with a cheaper battery, risking the possibility that the safety features within may be less robust. The choice to go with device elements that are “good enough” in order to get product out in an extremely competitive market not only potentially puts end users at risk, but can also put companies themselves in peril.

E-cigarette manufacturer Puresmoker went out of business in 2013 after one of their devices exploded in the face of a user a year prior. It was determined that the victim was powering the device with an Enercell battery purchased from a Radio Shack. While the vape pen itself may not have been the primary factor, the cost of litigation potentially forced the company to close its doors.

Industry insiders and advocates argue that vape pens are no more dangerous than other consumer electronics with lithium ion batteries. While this is true for most users, a danger does exist, one that is potentially flying under the radar. Manufacturers have been asked to improve their customer education efforts in hopes of limiting these incidents. But a lack of understanding about the devices remains, as has a lack of oversight, which has not only allowed potentially unsafe use of vape pens to propagate, but may also have allowed companies like Juul to advertise their products as safe alternatives to traditional smoking.

A ban of flavored vape cartridges may have unintended consequences for those using the devices to quit smoking.

The Trump administration’s push for a more comprehensive ban of flavored vape cartridges follows efforts at the state and federal level to engage in further regulation of the industry. But there are signs that a ban could have long-term side effects that actually endanger the public.

A 2018 study from the Harm Reduction Journal claimed that e-cigarette flavorings play a key role in attracting users of all age groups to the devices. The study found that users often transitioned from tobacco and menthol flavors to sweeter or fruity flavors. In addition, many users who switched from traditional smoking to vapes or e-cigarettes often chose a sweet flavor for their first device.

The study further suggests that sweeter flavors appear to be desirable to individuals who have switched to vapes to quit smoking altogether. The change in flavors from tobacco and menthol to sweeter alternatives guides users further away from their previous smoking habits. Vaping industry advocates have argued against restrictions of flavored vape cartridges, citing their ability to help smokers quit. But the FDA currently does not approve e-cigarettes as a means to help with quitting, saying that there is limited evidence to support such claims.

Because flavored vape cartridges provide an altogether different experience compared to traditional cigarettes, vape users may be less inclined to return to traditional cigarettes. On the opposite end of the spectrum, people who start with flavored vaping may be discouraged from picking up smoking due to the difference in taste.

The study concluded with a warning that a ban on flavored cartridges would potentially steer smokers away from the devices altogether, and at worse encourage users to justify continuing to use traditional smoking products.

The US has recognized the draw of flavored tobacco in the past, and in an effort to discourage smoking in minors and young adults, enacted the Family Smoking Prevention and Tobacco Control Act in 2009. The act bans flavored cigarettes outside of tobacco and menthol, in addition to restrictions on advertising, and requiring tobacco companies to go through the FDA for all product approvals.

A ban on flavored vape cartridges represents a severe setback to a burgeoning industry, affecting the thousands of vape shops that have opened in response to growing consumer demand. But such a ban would also potentially represent a massive setback in efforts to combat smoking around the world.

Over 7 million people die worldwide each year from medical complications resulting from tobacco use, with just under 500,000 of those deaths occurring in the US alone. Banning flavored cartridges and restricting sales of e-cigs may start to address the growing numbers of vaping youth, but it is also clear that it would be addressing only one part of a greater challenge.

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