E-Cigarette Expert Witness Teams Will be Key as Litigation Increases: Do E-Cigarettes Cause BOOP, Strokes and Seizures?

Posted by on July 31, 2019

E-Cigarette Expert Witness Teams Will be Key as Litigation Increases

E-cigarettes and other reduced risk nicotine products (such as smokeless tobacco, heated tobacco, and tobacco-free nicotine products) have generated enormous interest across a spectrum of stakeholders, including smokers who have reportedly quit smoking using one or more of these new (potentially) reduced risk products.

Regulators and plaintiff’s attorneys are also paying close attention to this booming industry. For instance, in response to a ruling by Judge Paul W. Grimm of the U.S. District Court for the District of Maryland, the FDA announced that it had moved up the date for PMTAs (premarket tobacco applications) for makers and importers of e-cigarettes and other electronic nicotine delivery systems (ENDS) and certain other tobacco products like cigars, pipe tobacco and hookah to submit applications for their currently marketed products to the agency within 10 months (instead of the previous 2022 deadline). The deadline has now passed and it remains to be seen which applications will be successful. Needless to say, many companies  scrambled to meet this aggressive deadline and there was also a request to further push the deadline due to the COVID-19 pandemic, although the extension was not permitted.

Further, last year, the House Oversight Subcommittee on Economic and Consumer Policy held a 2-day hearing to assess whether Juul Labs has played a role in alleged youth nicotine addiction “epidemic.”

Rep. Krishnamoorthi’s opening statement can viewed below:

Notably, Rep. Krishnamoorthi also recently introduced new legislation aimed at capping the amount of nicotine in e-cigarettes.

With regards to litigation, the landscape is evolving very fast. In a recent post we outlined some of the types of legal cases and claims being filed against e-cigarette manufacturers, including a recent personal injury suit against Juul Labs where a man is alleging that his addiction to the company’s product caused him to suffer a massive stroke, several school districts suing JUUL alleging it endangered the lives of its students, and multiple suits have been filed by the Beasley Allen Firm, and by a State Prosecutor in an Illinois county. According to one source, the Beasley firm currently “represents more than 200 clients injured by vaping, of whom only eight have filed lawsuits” and “fully expect that there will be hundreds if not thousands of individual cases filed.” As of September 2020, lawsuits are continuing to accumulate, such as this one involving multiple counties in Maryland.

A racketeering suit was also filed against Juul in August 2019 and Juul is scheduled to respond to in September 2020. Many plaintiff law firms now have dedicated websites for recruitment of plaintiffs. Some of these firms cite to reports that allege an association between e-cigarettes and seizures (i.e., FDA’s Statement from April 2019 and the FDA’s Update on this issue from August 2019 indicating 127 cases of seizures), e-cigarettes and bronchiolitis obliterans organizing pneumonia (BOOP) [also called cryptogenic organizing pneumonia], and e-cigarettes and hemorrhagic stroke (one of the sites indicates that heart rate and blood pressure can increase after using a nicotine-containing e-cigarette, and they then make the extension that high blood pressure is a risk factor for strokes). In the summer of 2019, it was reported that 14 teens and young adults were hospitalized in Wisconsin and Illinois for breathing problems potentially linked to vaping (nicotine and/or THC), according to health officials in those states. The CDC later indicated that it was investigating more than 1,000 cases of “severe pulmonary disease” across many states. Laboratory tests commissioned by the New York State Department of Health showed that “very high levels of vitamin E acetate” were detected in in nearly all illicit THC-containing samples analyzed and WAS NOT found in the nicotine-based products that were tested. Ultimately, the FDA and CDC have concluded that “Vitamin E acetate is strongly linked to the EVALI outbreak.”

A Strong E-Cigarette Expert Witness Team is Key

As the e-cigarette (and other reduced risk product) lawsuits wind their way through the courts, attorneys will have to recruit a strong expert witness team to review the available evidence and mount an effective response to the opponent’s allegations. While each case will have nuances that will require a unique cadre of experts, here are some of the e-cigarette expert witness disciplines that will certainly come into play in e-cigarette litigation:

Addiction Expert Witness (Adult and/or Adolescent/Youth)

Public Health Expert Witness

Nicotine Expert Witness

Physical Chemistry Expert Witness

Chemistry/Formulation Expert Witness

Epidemiology Expert Witness

Ex-FDA Regulatory Expert Witness

Various Medical Expert Witnesses (Neurovascular, Neurology, Pulmonology, Pathology, Medical Toxicology among others)

Statistical Expert Witness

Materials Science Expert Witness (lithium batteries)

Marketing and/or Advertising Expert Witness

Patent and Design Expert Witnesses

Maintaining an Awareness of the Scientific Literature is Also Key

As we have indicated previously, there is a huge volume of new scientific information on e-cigarettes and other reduced risk products released every single week. The current volume of new science is staggering—an average of ~40 articles relevant to e-cigarettes alone are being published weekly.

As new scientific information continues to emerge and expand, attorneys on both sides will have to adjust their strategies to adapt to new information which will inform about new risks and aid in developing better defenses.

As the e-cigarette litigation landscape continues to shift, it is important not to be caught off-guard by failing to keep up on the fast-moving science. There are technologies that can help with your scientific literature search strategy, and we would be happy to discuss your needs so you can avoid missing important e-cigarette literature.

To learn more about how we can help with your expert requirements or scientific litigation strategy, get in touch using the form below.


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