E-cigarettes spark legislation

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November 2016 - Annesley H. DeGaris

 

Since hitting the market several years ago, e-cigarettes have rapidly become a popular alternative to cigarettes. But they raise safety questions—from product defects to chemical exposure.
 

E-cigarette use has surged among all age groups, with proponents hailing the devices as a safer alternative to cigarettes. But continuing research raises increasing safety concerns. As more cases alleging product defects and other claims are being filed, it is important to have a basic understanding of ­e-cigarettes and their safety issues.

An e-cigarette is a device that releases vaporized nicotine that is then inhaled—a process known as “vaping.” Typical e-cigarettes include a battery, atomizer, nicotine cartridge, LED light, and sensor. The sensor determines when the consumer starts to inhale and causes the battery to power the atomizer, which heats up the “e-liquid” and turns it into a vapor. The nicotine cartridge holds the e-liquid, a fluid that typically consists of nicotine, a diluent such as propylene glycol or vegetable glycerin, and a flavoring.1

E-liquids come in many flavors, with names targeted to appeal to children, such as “Strawberry Fields” and “Smurfberry.” E-liquid manufacturers also offer tobacco- and menthol-flavored e-liquids to help market the device for smoking cessation.

In 2008, e-cigarette companies raked in $20 million in sales.2 The 2016 e-cigarette­ market is projected to be worth more than $4 billion.3 And experts believe that e-cigarette sales will eclipse cigarette sales within 10 years.4

Between 2010 and 2013, the percentage of adults using e-cigarettes more than doubled.5 Between 2013 and 2014, the percentage of teens in middle school and high school using e-cigarettes tripled.6 One study found that 24.6 percent of high school students surveyed reported current use of a tobacco product, with e-cigarettes being the most common.7

E-cigarettes have become so widespread that the U.S. Department of Housing and Urban Development has considered banning their use in public housing units,8 the U.S. Department of Transportation treats the devices as cigarettes and prohibits vaping on airplanes, and the FDA recently issued new regulations.9

Hazards: Known and Unknown

Several safety hazards have been associated with e-cigarettes, including exploding devices and potential toxic chemical exposure. Although the FDA recognizes some particles in e-vapor as generally safe for ingestion, no studies have determined the particles’ effects when inhaled.10 But reports of adverse health events include hospitalization for pneumonia, congestive heart failure, disorientation­, seizure, hypotension, and nicotine poisoning.11 Early studies suggested that vaping is as safe as breathing normal air,12 but more recent studies show that the cancer risks are similar to those of traditional cigarettes.13

E-cigarettes with variable voltage pose an additional risk. Vaping at a high voltage has an estimated cancer risk five to 15 times as high as the risk associated with long-term cigarette smoking.14 Most variable-voltage e-cigarettes use 3.7 volt batteries, as do standard e-cigarettes. The difference is that a variable-voltage e-cigarette has a circuit that stores and regulates power from the battery, delivering it to the atomizer tank at the voltage the consumer chooses.

The higher the voltage, the greater the nicotine kick—but also a greater exposure to certain chemicals.15 Specifically, the e-cigarette’s battery heats the propylene glycol and glycerin in the e-liquid to the point of decomposition, causing the formation of carcinogens such as formaldehyde.16

Diacetyl is another concerning chemical. It is used to flavor e-cigarettes and has been found in more than 75 percent of the devices and their refill liquids.17 Diacetyl is linked to severe respiratory disease such as bronchiolitis obliterans—also known as “popcorn lung” because of its diagnosis in workers at microwave-popcorn-processing factories who inhaled the chemical, used in artificial butter flavoring.18

Recent research has called attention to other health concerns: e-cigarettes may lead to tumor growth;19 high levels of inhaled nanoparticles can cause inflammation and are linked to asthma, stroke, heart disease, and diabetes;20 and accidentally ingesting the e-liquid may lead to nicotine poisoning. This year, poison control centers have received more than 1,000 reports of potential liquid nicotine poisoning.21 In 2014, more than 50 percent of liquid nicotine poisoning calls involved children under age six.22

Another source of injury is exploding devices. The culprit is the lithium-ion battery. Similar to problems seen in laptops and cellphones, the batteries are prone to overheating. Extreme temperatures can cause the batteries to malfunction.23 When overheated, the cylindrical shape of e-cigarettes may propel the device, contributing to the risk of explosion and fire.24

FDA Regulations

Although e-cigarettes have been on the market for several years, the FDA only introduced regulations earlier this year; they became final on Aug. 8, 2016.25

The regulations already placed on traditional cigarettes—such as disclosing all ingredients, including health warnings on product packages, and requiring that all purchasers (online and in stores) be at least 18—are now applicable to all e-cigarettes.26 As part of the regulations, the agency must approve all tobacco products, which includes e-cigarettes, that were not commercially marketed by Feb. 15, 2007.27

The regulations apply to all manufacturers, distributors, sellers, and anyone else involved with the e-cigarette industry. Manufacturers will have to register with the FDA and provide a list of ingredients that the agency will review for approval. Manufacturers have argued that only those few businesses that can afford to comply will survive.28 At least one manufacturer lawsuit has been filed against the FDA seeking to have the rules vacated and declared unlawful.29

Emerging Litigation

E-cigarette litigation is varied and still in the early stages. Plaintiffs have brought cases alleging false advertising, lack of health warnings, and personal injuries—including lung disease, nicotine poisoning, and combustion of devices and batteries that caused severe burns.

Some causes of action, such as consumer fraud and deceptive trade practices, depend on the vagaries of state law, with some states—such as California—being more advanced in the nature and range of applicable consumer protection statutes. Products liability actions include claims for defective design and inadequate warnings.30

The first e-cigarette explosion lawsuit was tried in September 2015. The jury awarded the plaintiff nearly $1.9 million after the device exploded in her car, causing second-degree burns.31 Other cases involve an e-cigarette exploding in the plaintiff’s mouth, requiring doctors to surgically repair the plaintiff’s tongue and amputate a finger;32 and an e-cigarette that exploded and set a room on fire, creating a large hole in the plaintiff’s cheek.33

Several class actions also have been filed, including one in California alleging dangerous levels of diacetyl and other chemicals34 and lack of warning labels about the known links to popcorn lung, emphysema, and chronic obstructive pulmonary disease.35 Other class actions have alleged false advertising and marketing claims about e-cigarettes’ ability to help users quit smoking, failure to warn or inform consumers of associated health risks, and misleading consumers about e-liquid ingredients and their safety.36

Although litigation is still developing, when screening a potential case, plaintiff attorneys should consider issues that are common to products liability cases. Preservation of the device—including the battery and charger, which are sometimes sold separately from the device—and establishing a proper chain of custody in an explosion case, for instance, must be scrupulous. The early and careful gathering of all of a plaintiff’s medical records will be key, regardless of whether the plaintiff was injured by an exploding device or from exposure to chemicals.

As in any case, client screening is crucial. Ask potential clients about any modifications they made to the device. Selecting causation experts will require careful research—especially in exposure cases given the emerging science of e-cigarette toxins and the strictures of Daubert. Although device manufacturers are obvious defendants, many are located outside the United States. You should look into bringing defective design and inadequate warning claims against local retailers and distributors.

The e-cigarette is a nicotine-delivery device, and its growing popularity has revealed major products liability issues. Although FDA regulation of these devices should be applauded, history shows that the civil justice system often can create the necessary change faster than government regulation. With this device, both are needed.


Annesley H. DeGaris is a partner at DeGaris & Rogers in Birmingham, Ala. He can be reached at adegaris@degarislaw.com.


Notes

  1. E-liquid Help & Support, Totally Wicked, www.totallywicked-eliquid.com/e-liquid-help-support.
  2. Ben Radding, E-cigarettes: A Chance to Kick the Habit or a Health Crisis in the Making?, Men’s Fitness, www.mensfitness.com/life/e-cigarettes-chance-kick-habit-or-health-crises-making.
  3. Richard Craver, E-cig Sales Experience Rebound as MarkTen Styles Gain Traction, Winston-Salem Journal (June 1, 2016), http://tinyurl.com/hmflnkl.
  4. Yanzhong Huang, E-cigarettes: China’s Next Growth Industry, Forbes (May 27, 2014), www.forbes.com/sites/yanzhonghuang/2014/05/27/e-cigarettes-chinas-next-growth-industry/#f0af6b967b4c.
  5. Ctrs. for Disease Control & Prevention, Key Findings: Trends in Awareness and Use of Electronic Cigarettes Among U.S. Adults, 2010–2013 (Sept. 23, 2014), www.cdc.gov/tobacco/basic_information/e-cigarettes/adult-trends/index.htm.
  6. Rob Stein, Use of E-cigarettes Triples Among U.S. Teens, NPR (Apr. 16, 2015), www.npr.org/sections/health-shots/2015/04/16/400144741/use-of-e-cigarettes-triples-among-u-s-teens.
  7. Ctrs. for Disease Control & Prevention, Morbidity and Mortality Weekly Report (MMWR), Tobacco Product Use Among Middle and High School Students—United States, 2011 and 2012 (Nov. 15, 2013), www.cdc.gov/mmwr/preview/mmwrhtml/mm6245a2.htm.
  8. Steven Nelson, Public Housing Ban on Smoking May Include E-cigarettes, U.S. News & World Rep. (Nov. 12, 2015), www.usnews.com/news/articles/2015/11/12/ e-cigarette-use-may-be-banned-alongside-smoking-in-public-housing.
  9. U.S. Dep’t of Transp., DOT Bans E-cigarettes From Checked Baggage (May 18, 2016), www.transportation.gov/briefing-room/dot-bans-e-cigarettes-checked-baggage.
  10. Janet Raloff, Health Risks of E-cigarettes Emerge, ScienceNews (June 3, 2014), www.sciencenews.org/article/health-risks-e-cigarettes-emerge.
  11. Ii-Lun Chen, FDA Summary of Adverse Events on Electronic Cigarettes, 15 Nicotine & Tobacco Research 615 (2013).
  12. Sham Shivaie, Study Finds Conclusive Evidence Vaping is Safe, Vape About It (Mar. 30, 2015), vapeaboutit.com/study-finds-conclusive-evidence-vapor-is-safe/.
  13. See R. Paul Jensen et al., Letters, Hidden Formaldehyde in E-cigarette Aerosols, 372 New Eng. J. Med. 392 (2015).
  14. Id.
  15. Toni Clarke, Ramping Up E-cigarette Voltage Produces More Dangerous Formaldehyde, Sci. Am., www.scientificamerican.com/article ramping-up-e-cigarette-voltage-produces-more-dangerous-formaldehyde/.
  16. Julie Chao, All E-cigarettes Emit Harmful Chemicals, but Some Emit More Than Others, Berkeley Lab (July 27, 2016), newscenter.lbl.gov/2016/07/27/e-cigarettes-emit-harmful-chemicals-emit-others/.
  17. Amy Roeder, Chemical Flavorings Found in E-cigarettes Linked to Lung Disease, HarvardGazette (Dec. 8, 2015), news.harvard.edu/gazette/story/2015/12/popcorn-lung-seen-in-e-cigarette-smokers/.
  18. Id.
  19. U.S. Dep’t of Veterans Aff., Office of Research & Dev., Cell Harm Seen in Lab Tests of E-cigarettes (Dec. 28, 2015), www.research.va.gov/currents/1215-8.cfm.
  20. Raloff, supra note 10.
  21. E-cigarettes and Liquid Nicotine, Am. Ass’n of Poison Control Ctrs., www.aapcc.org/alerts/e-cigarettes/.
  22. Id.
  23. Herb Weisbaum, What’s Causing Some E-cigarette Batteries to Explode?, NBC News (Mar. 8, 2016), www.nbcnews.com/business/consumer/what-s-causing-some-e-cigarette-batteries-explode-n533516.
  24. Id.
  25. The FDA claims the authority to regulate and control the “parts and components” of tobacco, which include e-liquids, atomizers, and certain batteries. Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, 81 Fed. Reg. 28,974 (May 10, 2016).
  26. Id.
  27. Id.
  28. Michael Murray, FDA Lawsuits: The Battle Against Strict E-cig Laws, White Cloud Electronic Cigarettes (July 6, 2016), www.whitecloudelectroniccigarettes.com/blog/fda-lawsuits-the-battle-against-strict-e-cig-laws/.
  29. Nicopure Labs, LLC v. Food & Drug Admin., No. 1:16-cv-00878-ABJ (D.D.C. filed May 10, 2016).
  30. Ed Schottenstein, The Alarming Dangers of E-cigarettes, Schottenstein Law Offices (Dec. 16, 2015), www.edschottenstein.com/personal-injury/dangers-of-e-cigarettes/.
  31. Ries v. VapCigs, No. RIC 1306769 (Calif. Super. Ct. Riverside Cnty. filed June 10, 2013).
  32. Hailey Branson-Potts, E-cigarette Explosions Prompt Three Lawsuits in California, L.A. Times (Nov. 19, 2015), www.latimes.com/local/lanow/la-me-e-cigarette-lawsuits-20151119-story.html.
  33. Id.
  34. Cox v. Cuttwood LLC, No. 8:15-cv-01961 (filed C.D. Cal. Nov. 23, 2015) (case dismissed without prejudice on Feb. 23, 2016).
  35. Sheppard v. Fumizer LLC, No. BC558408 (Calif. Super. Ct. Los Angeles Cnty. filed Sept. 22, 2014).
  36. Kaleigh Rogers, Lawsuit Claims Vape Company Lied About the Chemicals It Puts in E-juice (Nov. 16, 2015), motherboard.vice.com/read/lawsuit-claims-vape-company-lied-about-the-chemicals-it-puts-in-e-juice; Whitney v. ITG Brands LLC, No. 3:15-cv-04003 (N.D. Calif. filed Sept. 1, 2015); Greene v. Five Pawns, Inc., No. 8:15-cv-01859 (C.D. Calif. filed Nov. 11, 2015).