WEST PALM BEACH, Fla. (CN) – Vaping product manufacturers nationwide are bracing for an onslaught of product liability lawsuits arising from an outbreak of vaporizer-linked respiratory failure, as mystery lingers over what’s causing the illnesses, now blamed for more than 30 deaths.
The first lawsuits over acute respiratory failure – allegedly caused by vaporizer use – have started to flow into courts stretching from California to Florida.
The plaintiffs’ narratives are harrowing. According to a Florida lawsuit, one woman had to undergo a double leg amputation due to medical complications from respiratory failure. The lawsuit claims her lung illness was caused by a flavored cannabidiol (CBD) vaping oil.
In this group of pilot cases, the defendants range from a mid-scale CBD oil manufacturer to Juul, the largest e-cigarette company in the country. None of the lawsuits have pinpointed a vaping fluid ingredient to blame for the injuries.
Tracking the outbreak, the Centers for Disease Control is attributing 34 deaths and more than 1,600 lung injuries to vaporizer use. Cases began spiking dramatically in June.
The CDC says that black-market vaping oils marketed as THC – an intoxicating compound in marijuana – play a “major role in the outbreak.”
Often sourced from street dealers, pop up shops and unlicensed sellers, these illicit vaping oils offer a cheap alternative to buying high-grade THC vaping oils from a legal marijuana dispensary. And in states where marijuana is illegal, they might be the only readily available product for THC oil buyers.
The CDC is stressing that no particular type of vaping liquid, illegal or legal, has been ruled out as having played a part in the outbreak. It has gone so far as to tell consumers to consider ceasing use of all vaping products.
“Case counts continue to increase and new cases are being reported, which makes it more difficult to determine the cause or causes of this outbreak,” the agency said.
Greg Conley, president of the American Vaping Association, said in an interview that reputable producers of vaping products could be unfairly caught up in a litigation onslaught.
Safety-conscious companies’ products may end up being falsely equated with illicit vaping oils that black market sellers fill full of adulterants and diluent chemicals, Conley said.
“There is no advocacy organization that can solve the problem of black markets. These illnesses are going to continue happening until the public is aware and stops purchasing illicit vaping oils, or until drug dealers smarten up and realize that dead people can’t purchase products,” Conley said.
Whatever the source of the outbreak is ultimately found to be, the seal has been broken on the litigation front.
According to Conley, personal injury attorneys “smell blood in the water.”
Virgin Islands plaintiff Erin Gilbert, 35, has suffered injuries that are perhaps the most tragic among claimants in recent lawsuits over vaporizer-linked respiratory collapse.
She had to have both of her legs amputated after developing a respiratory illness so severe that she suffered multiple organ failure and oxygen deprivation, leaving her lower limbs necrotic.
Filed last month in Broward County, Fla., the lawsuit claims the illness was triggered by a mango-flavored CBD vape oil that Gilbert had bought from a local vendor in St. Croix.
Gilbert, a mother of three young kids, had vaporized the oil for only a few days before she developed a severe bout of pneumonia, according to the lawsuit. She went to a St. Croix hospital on Aug. 19, and was later airlifted to Miami.
“Despite antibiotic therapy … Gilbert’s pneumonia swiftly progressed, leading to acute respiratory failure,” the lawsuit states.
When the case was filed, Gilbert was still in critical condition at Jackson Memorial Hospital in Miami.
Just CBD, the vaping oil producer named as a defendant, said it “has sold hundreds of thousands of cartridges and is not aware of a single complaint that even remotely resembles that of the plaintiff.”
“We are saddened to hear about the plaintiff’s alleged medical situation, express our sympathy to her and her family, and wish her a speedy recovery. The company does not believe, however, that there will be any evidence that its product could cause such an injury,” Just CBD said in a statement provided to Courthouse News.
The company sent over a list of ingredients in the product Gilbert purportedly used. It’s made from hemp, CBD, food-grade propylene glycol and food-grade vegetable glycerin, according to the company.
The flavoring is “purchased from a long-tenured and reputable” source, the company claimed.
The company insisted it is committed to product purity. It routinely releases lab testing of its products’ percentage of CBD, a non-intoxicating derivative from marijuana that has gained popularity in recent years as a putative pain and inflammation-reduction aid.
An unrelated class action alleges the company’s labeling overstates the amount of CBD in its products.
The company’s web site maintains: “We believe you have the right to know exactly what is inside your CBD products. Our mission and promise is to never misrepresent the content of our products.”
A company spokesperson said Just CBD has received reports of counterfeit products. She said the company does not directly distribute its brand in the Virgin Islands.
Virgin Islands law enforcement announced in September that they seized thousands of counterfeit cartridges for Juul e-cigarette systems, though no mention of Just CBD products was made.
Gilbert’s lawsuit was filed on the heels of one of the first civil cases nationwide linked to outbreak.
That case alleges a Puyallup-area tribal officer in Washington State was hospitalized with lipoid pneumonia spawned by THC oils that he had been vaporizing. Several licensed vape oil producers are named as defendants in the officer’s case.
In another recent lawsuit, 28-year-old Jason Gluch blames e-cigarette giant Juul for a severe form of pneumonia he developed allegedly from using Juul mango pods for seven months.
Gluch says he started buying the pods as a means to quit smoking in January. He became “powerfully addicted” to the Juul products, using a full pack of Juul pods a week, he says. He found himself “waking up in the middle of the night” to take draws on his e-cigarette, according to the lawsuit.
In July, he started getting persistent chills and night sweats along with blurry vision, he says.
He went to the hospital, suffering from respiratory failure, and was diagnosed with cryptogenic organizing pneumonia. The illness mirrored the symptoms noted in one of the first case studies of vaping-linked respiratory failure, published in the American Journal of Clinical Pathology.
The disease is clinically distinct from lipoid pneumonia, a disease diagnosed in other patients with purported vaping-caused illnesses.
Juul has not responded to a request for comment. A kind of vaporizer product, Juul’s e-cigarettes warm up liquids in a chamber to temperatures that are too low to burn the material, but high enough to volatilize it for inhalation.
The Food and Drug Administration in September admonished the company for advertising its products as a safer than cigarettes without the FDA’s approval of that claim.
Juul for more than a year has been slammed with lawsuits over its alleged use of trendy ads and flavored products to rope youths into using its products. The deceptive trade lawsuits, now being filed in state and federal courts on a daily basis, claim the company concealed the addictiveness of Juul e-cigarettes and under-represented nicotine doses.
The company has publicly denied that it targeted teens in its advertising.
Notwithstanding the long-running cascade of nicotine-addiction lawsuits against Juul, civil cases attempting to link Juul pods to acute respiratory failure and other life-threatening sicknesses are a relatively new phenomenon.
Over the summer, a California federal court complaint attempted to connect plaintiff Maxwell Berger’s stroke to his use of Juul e-cigarettes.
Berger and Gluch’s pleadings both draw heavily from the language and background information in the nicotine-addiction-centered lawsuits against Juul. These plaintiffs say Juul portrayed its products as safe despite evidence that nicotine vaping carries a risk of respiratory and cardiovascular illness.
Conley of the American Vaping Association said smaller vaping liquid producers are ill-equipped to shoulder the legal fees that will come with years of personal injury litigation.
“You can almost never look at the e-cigarette industry as a whole. You can look at it as two divisions,” Conley said. “You have Wall Street-backed companies that have the ability to raise capital, along with Juul, which is more than one-third owned by a big tobacco company with a rich history of defending lawsuits. Then you have the rest of the industry.”
The big tobacco company Conley was referencing is Altria, which recently acquired a multibillion-dollar, 35% stake in Juul. Altria owns Philip Morris USA, maker of Marlboro cigarettes.
Conley said that with financial resources aplenty, the big e-cigarette corporations’ lawyers are free to adopt a strategy of squashing as many personal injury cases as possible with settlement money.
“They eventually may just try to settle, pay everything out and make people go away for low amounts of money,” Conley said. “If they actually fight [in court], I don’t believe these lung illness cases will be shown to be caused by nicotine vaping products.”
He said the cost of litigation, combined with a new FDA regulatory scheme, could reshape the vaporizer industry and put many of the smaller vaporizer companies out of business in the next few years.
The FDA asserted dominion over the regulation of e-cigarette producers and vape shops in 2016 when it deemed e-cigarettes to be tobacco products under the Family Smoking Prevention and Tobacco Control Act.
A deadline for submitting e-cigarette product applications to the FDA has been extended until 2022, giving small-scale nicotine cartridge producers a sigh of relief. The application process involves extensive safety reviews meant to show the FDA that a given product will be marketed in a manner that protects public health.
The FDA meanwhile is considering a regulation to prohibit the use of fruity flavorings in e-cigarette liquids.
Industry advocates have warned that a flavor ban — combined with new regulatory roadblocks to selling modular vaporizer devices — could create a large black market for nicotine vaping items, similar to what’s going on in the THC oil arena.
“Grey and black markets just create consumer safety issues. And we know prohibition in this country does not work. There are 14 million people who vape. You can’t put this genie back in the bottle,” Conley said.
States and cities across the nation have moved fast to ban fruit flavored e-cigarettes on the grounds that they appeal to teens.
Michigan was the first state to institute a flavor ban. But after vape shops sued, a judge issued a preliminary injunction blocking the state from enforcing it. New York State’s flavored e-cigarette ban was likewise temporarily blocked in court.
Massachusetts has instituted a four-month ban on all vaping product sales. A judge in Suffolk County on Monday allowed the ban to remain in place, provided that the governor’s office submits a formal emergency regulation.
Meanwhile San Francisco, where Juul maintains its headquarters, has an upcoming moratorium on all vaping products sales pending FDA review.
Juul for its part has announced that it will no longer sell fruit-flavored products anywhere in the U.S.
As for contaminants in the THC vaping oil market — the list of suspect substances is long.
Dr. Ruth Lynfield of the Minnesota Health Department said in an interview that Vitamin E, used to thicken THC vaping oil, is being investigated as a possible contributor to the wave of vaping-linked lung illnesses.
Health officials are focusing on vitamin E oil in part because it has become one of the most widely used diluting agents in THC vape liquids, especially in illegal products. And its inhalation safety profile is not well-developed.
Other substances, including pesticides, thermal decomposition products of propylene glycol, heavy metals from heating elements, and various solvents have been suggested as possible contributors to the outbreak.
There have been isolated hospitalization reports indicating that some black market vaping oils contained powerful research chemicals, synthetic cannabinoids, in place of naturally derived THC.
Lynfield said it “paints a pretty frightening picture” when droves of previously healthy vaporizer users in their 20s and 30s fall ill and end up in hospitals on mechanical ventilation. She said what is happening appears to be a true large-scale outbreak, not some statistical fluke or mass misattribution of infectious illness to vaping habits.
CDC data, which includes “confirmed and probable” cases of vaping-related lung injury, indicates that nearly 80% of patients are under the age of 35.
Confounding efforts to make the THC oil distribution chain safe, empty counterfeit vaporizer cartridges can be readily purchased online and in retail shops in California. Unscrupulous profiteers buy the cartridges, fill them with potentially unsafe diluents and distribute them on a mass scale.
According to Conley, high state taxes on vaping and THC products are creating a breeding ground for illicit products.
“When you put big taxes on legitimate vaping cartridges, and you combine that with a lackadaisical attitude towards black market sales, we end up with people avoiding high prices by buying something from the guy down the street. And the packaging looks like it came from a dispensary,” he said. “A consumer thinks, ‘Well maybe it just fell off the back of a truck.’ And that’s why he’s getting a THC oil for $30 instead of $60.'”