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FDA and CDC Investigate Outbreak of Lung Disease Caused by Vaping

In August of 2019, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) released a joint statement announcing an investigation in response to an outbreak of “distressing incidents of severe respiratory disease” among e-cigarette users. (1) At the time of their statement, the outbreak consisted of 215 potential cases, including one death, in 25 states. (2) (3)

A week later the number of potential cases surged to 450, in 33 states, though later this number was revised to 380 cases in 36 states after investigations were completed. (4) Federal health officials reported at least six deaths. (5)

Since then, the number of reported potential cases has climbed to over 500 cases, with the numbers increasing every day, with no particular manufacturer or kind of use identified as the cause of the outbreak.

According to a preliminary report published in The New England Journal of Medicine of cases reported in Illinois and Wisconsin, 94% of patients with vaping-related lung injuries required hospitalization and nearly a third were put on a mechanical ventilator. (6) These patients ranged in age from their teens to their fifties, with a median age of 19. (7)

On August 30, the CDC published a health advisory recommending people consider refraining from using e-cigarettes until the investigation determines the cause of the outbreak. (8) An editorial in The New England Journal of Medicine calls this “an epidemic that begs for an urgent response.” (9)

FDA Reports Potential Risk of Seizures

In April of 2019, the FDA released a statement notifying the public about reports of seizures occurring after e-cigarette use, particularly among young adult users. (10)

The FDA identified 35 cases of seizures in e-cigarette users reported to the FDA and poison control centers over nine years. (11) The agency believes these cases “warrant scientific investigation into whether there is in fact a connection.” (12) Most of the reports involved youth and young adults. (13)

The agency also noted that because reporting is voluntary, other instances may have gone unreported. The FDA statement urges healthcare providers and consumers to become aware of vaping and seizures, and to report any adverse experiences to the Safety Reporting Portal (SRP). (14)

Vape pen

What Is an E-Cigarette?

Electronic cigarettes, also known as e-cigarettes or e-cigs, are handheld devices that produce “vapors” for users to inhale. The vapors are formed by heating a liquid that typically contains nicotine, artificial flavorings, and other chemicals. (15) (16)

Initially designed to simulate the experience of smoking a cigarette, “vaping” is now a popular habit among people, especially adolescents, who have never been smokers. (17) (18) Some e-cigarettes resemble tobacco products such as cigarettes and cigars, while other designs look more like pens or USB sticks.

Common nicknames for e-cigarettes include:

  • E-cigs.
  • Vapes.
  • Vape pens.
  • Vaporizers.
  • Electronic nicotine delivery systems (ENDS).

Popular e-cigarette brands include:

  • JUUL.
  • blu.
  • Logic.
  • MarkTen.
  • Vuse.

The liquid in e-cigarettes, known as “e-liquid” or “e-juice,” is typically sold in cartridges or “pods.” The ingredients and composition of e-liquid varies greatly across brands. There are more than 7,000 different flavors available on the market. (19) Nicotine concentrations and additives vary widely across products. (20) (21) (22)

Nicotine is extremely addictive. Some e-cigarette products deliver higher doses of nicotine than traditional cigarettes. Many of the other chemicals found in e-liquid are unstudied, and the long-term health consequences of vaping are unknown. (23)

Vaping Industry Under Fire for Aggressively Marketing to Youth

Fueled by misleading safety claims, aggressive marketing, youth-tempting flavors, and one of the most addictive substances known to humans, e-cigarettes have hooked a new generation of young people on nicotine.

E-cigarettes are increasingly popular with children and young adults. In 2018, one in five high school students and one in twenty middle school students used e-cigarettes. (24)

The most popular brand of e-cigarette is JUUL, which accounted for 70% of the e-cigarette market share in 2019. (25) The JUUL is a device shaped like a USB flash drive and charge using a USB port. “JUULpods” come in flavors like “mango” and “creme.”

E-cigarette companies claim their products are intended as a safer alternative to cigarettes for people who already smoke. But the industry uses marketing tactics that seemingly target adolescents, even though very few are smokers. Aggressive social media campaigns, music festivals sponsorships, candy- or other food-like flavors, and youth-oriented packaging have lured millions of youth into tobacco addiction. (26) (27)

FDA Notifications to JUUL

In May of 2018, the FDA sent official requests to JUUL and three other e-cigarette manufacturers “requiring them to submit important documents to better understand the youth appeal of these products.” According to FDA Commissioner Scott Gottlieb, the agency is “taking a hard look at whether certain design features and product marketing practices are fueling the youth use” of e-cigarettes. (28) In response, some e-cigarette manufacturers produced a plan to curb underage vaping. But in early 2019, the FDA accused e-cigarette manufacturers of backtracking on their promises “to restrict their products in a way that will decrease access to kids.” (29)

In September of 2019, the FDA sent a warning letter to JUUL. (30) The FDA found JUUL had violated multiple regulations, including marketing its productive as a “safer” alternative to smoking without regulatory approval. The FDA was particularly concerned with comments JUUL representatives made to students, including calling the product “totally safe.” (31)

Teen girl vaping

Dangers of Vaping

There are many dangers inherent to vaping, especially among youth and young adults. E-cigarette use has been found to predict the use of combustible cigarettes and other tobacco products. Adolescents who had “no intention of smoking” when they start vaping were found to be more likely to become combustible cigarette smokers than adolescents who have never used e-cigarettes. (32)

Nicotine exposure can harm adolescent brain development, affecting attention, memory, and cognition. (33) Using nicotine products may “prime the adolescent brain for addiction to other drugs.” (34)

Beyond nicotine, the flavorings found in e-cigarettes, which significantly contribute to their popularity with youth, are another source of health risks. (35) According to the Surgeon General, “Some chemicals in e-cigarettes, although approved for ingestion, have established adverse health effects when inhaled.” (36) For example, chemicals used to produce vanilla, cinnamon, and chocolate flavors have demonstrated cellular toxicity. (37) (38) (39) Also, mixing flavors together, as young people often do in social settings, may increase toxicity. (40)

The relationship between vaping and seizures is another cause for concern for young e-cigarette users. Developing brains are more susceptible to seizures than adult brains. (41)

These websites contain more information about the dangers of e-cigarettes, particularly for teens and young adults:

E-Cigarettes, Pulmonary Disease and Respiratory Failure

A recent surge in cases of severe vaping-related lung injury has alarmed doctors and public health officials. Users of e-cigarettes have been hospitalized with a range of respiratory issues, including difficulty breathing and abnormal lung morphology, as seen on chest radiographic imaging. (42) Patients may require time in the intensive care unit or may spend time, up to weeks, on a ventilator. (43)

In many of these cases, the patient appears to be suffering from pneumonia but has no bacterial or viral infection. (44) “Pulmonary infiltrates” and “ground-glass” opacities may appear on the chest radiographs of some of these patients. (45)

Some e-cigarette users have been diagnosed with acute eosinophilic pneumonia (AEP). (46) (47) AEP occurs when the lungs are exposed to irritants that trigger an immune response. This results in the rapid accumulation of a type of white blood cells called eosinophils. (48)

Other e-cigarette users have received diagnoses of acute exogenous lipoid pneumonia. (49) (50) (51) Lipoid pneumonia occurs from inhaling vaporized oil or fat molecules. (52) When the oil droplets cool, they deposit in the lungs. This can spur an inflammatory response that can be fatal. (53)

E-cigarette liquids may contain a variety of lipid sources. (54) Vape liquid samples in New York State recently tested positive for vitamin E oils. (55) Another common lipid found in vape fluids is vegetable glycerin. (56)

E-Cigarettes and Bronchiolitis Obliterans Organizing Pneumonia

Bronchiolitis obliterans organizing pneumonia (BOOP), also often referred to as cryptogenic organizing pneumonia (COP), is a rare lung disease characterized by inflammation that manifests as swirls of fibrous tissue filling the bronchioles and alveoli in the lungs. (57) (58) There are at least two published case studies of e-cigarette users developing BOOP, both of which required hospitalization, intubation, and mechanical ventilation. (59) (60)

E-Cigarettes and Strokes

Support for the link between e-cigarettes and strokes is provided by a 2017 study on the pulmonary effects of e-cigarettes. The study examined healthy young adults after 30 minutes of vaping and found “a significant increase in heart rate and blood pressure in the volunteers who were exposed to e-cigarettes containing nicotine.” (61) High blood pressure is a significant risk factor for strokes. (62)

A significant increase in heart rate and blood pressure in the volunteers who were exposed to e-cigarettes containing nicotine.”

E-Cigarettes and Heart Attacks

Smoking has long been known to increase the risk of heart attack (also called myocardial infarction). New research suggests vaping may carry similar risks.

An analysis of National Health Interview Surveys showed that daily e-cigarette use was associated with increased odds of heart attack. (63)

Nicotine adversely affects the cardiovascular system in numerous ways. (64) New generation e-cigarettes deliver high doses of nicotine. (65) Using these devices produces heart-rate acceleration, increased blood pressure, and increased heart contractility. (66)

Endothelial damage is one of the primary mechanisms of smoking-induced cardiovascular disease. (67) Endothelial cells line the entire cardiovascular system, including the heart and blood vessels. A recently published study found that rats exposed to e-cigarettes had comparable impairment to endothelial function as rats exposed to combustible cigarette smoke. (68) 

Symptoms of Pulmonary Disease and Respiratory Failure

Patients suffering from vaping-related lung injuries, including respiratory failure, have experienced the following symptoms: (69) (70) (71)

  • Difficulty breathing.
  • Shortness of breath (dyspnea).
  • Cough.
  • Chest pain.
  • Low oxygen concentration in the blood (hypoxemia).
  • Fatigue.
  • Fever.
  • Weight loss.
  • Nausea, vomiting and/or diarrhea.

Symptoms of Bronchiolitis Obliterans Organizing Pneumonia

Patients suffering from bronchiolitis obliterans organizing pneumonia may experience a flu-like illness, cough, shortness of breath, severe respiratory distress, and crackling or rattling sounds in the lungs (known as crackles or rales, respectively). Diagnosis of bronchiolitis obliterans organizing pneumonia is usually confirmed by evaluation of clinical symptoms, a chest x-ray or high-resolution chest computed tomography (CT), and a lung biopsy. (72)

Symptoms of Seizures

Symptoms of different types of seizures may include: (73)

  • Muscle spasms.
  • Loss of consciousness or awareness.
  • Uncontrollable jerking of your limbs.
  • Perceptual disturbances.
  • Confusion.
  • Staring spells.
  • Body stiffening and shaking.
  • Loss of bladder or bowel control.

Several of the seizures described in the incident reports released by the FDA describe grand mal or tonic-clonic seizures, (74) characterized by the dramatic convulsions people often associate with seizures. But there are many types of seizures, and some have subtler, more mild symptoms. (75) Mild seizures are probably less likely to be reported.

Symptoms of Strokes

The National Stroke Association recommends the acronym FAST to identify the warning signs of a stroke: (76)

  • Face: does one side of your face droop when smiling?
  • Arms: when you raise your arms, does one arm drift down?
  • Speech: is speech slurred or odd?
  • Time: is of the essence. Call 911 immediately if you witness or experience any of these symptoms.

Additional symptoms of strokes include: (77)

  • Sudden severe headache.
  • Sudden numbness or weakness in face or limb, especially on one side of the body.
  • Sudden confusion or trouble speaking.
  • Sudden vision problems, in one or both eyes.
  • Sudden loss of balance or coordination, dizziness, or trouble walking.

Symptoms of Heart Attacks

According to the American Heart Association, warning signs of heart attack include:(78)

  • Chest pain or discomfort.
  • Nausea, vomiting, or light-headedness.
  • Pain in jaw, neck, or back.
  • Arm or shoulder pain or discomfort.
  • Shortness of breath.

Potential Lawsuit Claims

E-cigarette users, especially teenagers and young adults, have been lured into a highly addictive habit without being informed of the risks. Many vape just for the flavor. They are unaware they are inhaling a dangerous drug. According to the Surgeon General, “It is questionable whether youth know what nicotine is, let alone whether it is contained in the e-cigarette products that they are using.” (79)

Even e-cigarette users who are aware of the risks of nicotine may be coaxed into a false sense of safety. Featuring high-tech designs and free of messy smoke, vapes seemingly offer precise control over what goes into your body.

But e-liquid labels often state an inaccurate nicotine content. A study of e-liquids for sale in North Dakota vape stores found more than half the products sampled listed nicotine concentrations that were off by 10% or more. One sample contained “172% more than the labeled quantity.” (80)

E-liquid also contains many other chemicals, including solvents, flavorings, and other additives. Often these substances are not all listed in the ingredients, and very little study has been done to see the effects of inhaling the mixture of these different chemicals all at once.

E-cigarette manufacturers have made unfounded and misleading safety claims about their products. The long-term health effects of inhaling cocktails of chemical vapors are unknown. Companies are using consumers, in particular teens and young adults, as guinea pigs while they profit.

People harmed by vaping products may be entitled to compensation. Weitz & Luxenberg is currently taking cases on behalf of JUUL e-cigarette users who experienced:

  • Pulmonary disease and/or respiratory failure, without infection.
  • Seizure.
  • Hemorrhagic stroke (intracerebral hemorrhage).
  • Ischemic stroke.
  • Bronchiolitis obliterans organizing pneumonia (also called cryptogenic organizing pneumonia).
  • Heart attack (myocardial infarction).
  • Death due to any of these.
  • Addiction that began while a teenager and before 2019.

Weitz & Luxenberg is one of the law firms appointed by the court to serve as co-lead counsel for the JUUL e-cigarette multidistrict litigation (MDL).

W&L’s attorneys have decades of experience helping people harmed by dangerous products obtain justice from the corporations responsible for their injuries. Some of our recent successes include billions of dollars in settlement funds for dangerous metal-on-metal hip implants and a $9 billion jury verdict for a client who developed cancer after taking the drug Actos.*