The FDA Steps In To Fight JUUL & The Vaping Epidemic

The government is finally fighting back against the burgeoning e-cigarette industry as the vaping epidemic ravages teens with addiction and a mysterious lung illness that has hospitalized hundreds and claimed multiple lives. On September 9, federal officials at the Food and Drug Administration issued two warning letters to e-cigarette giant JUUL attacking its claims that its e-cigarette products are a safer alternative to smoking other tobacco products and requesting documents about its marketing practices and nicotine formula. Just two days later, the Trump Administration announced that it was investigating banning all flavored e-cigarettes.

What Did the FDA’s Letters Say?

JUUL markets their e-cigarette products as “modified risk tobacco products,” which means that the products have a lower risk of tobacco-related illnesses or are less harmful than other marketedjuul-e-cigarettes tobacco products. However, in order to advertise a product as a “modified risk tobacco product”, a company must have authorization from the FDA and JUUL has not received this authorization. The FDA reports that, as a result, “JUUL has ignored the law.

In a separate letter, the FDA expressed concern that JUUL’s marketing strategies involved targeting underage users by advertising on social media sites popular among teenagers and using influencers and coupons to entice new customers. The FDA also requested additional information from the company about its use of a special nicotine-salt e-liquid that possibly intensifies the addictiveness of its products.

What Is The Trump Administration’s Position?

On September 11, President Trump announced his administration was taking steps to remove all flavored vaping products from the market, with the exception of tobacco-flavored products. Health and Human Services Secretary Alex Azar shared that the number of teens who say they have vaped increased from 3.6 million in 2018 to 5 million in 2019. These shocking numbers, combined with increasing reports of hospitalizations and deaths linked to vaping-related lung injuries, have increased the Administration’s sense of urgency to place tighter regulations on the e-cigarette industry.

What Happens Next?

According the changes proposed by Azar, manufacturers of any flavored e-cigarette products would have to gain FDA approval to resume sales, which would involve proving that the benefits of the products outweigh the risks. The FDA initially set a deadline of 2021 for the agency to require manufacturers to apply for approval while the agency reviewed the safety of the products. However, a judge recently moved that deadline up to July 2020 and the FDA now says that date could be imminent.

In addition, the FDA demanded that JUUL immediately corrects the modified-risk violations or the company will face tougher enforcement actions such as penalties and possible product seizures.

What Led to the FDA’s Warning Letter?

The FDA reviewed testimony from the House Oversight and Reform subcommittee, which had been investigating JUUL’s marketing and promotional practices. In July hearings, JUUL was accused of “deploying a sophisticated program” targeting children and teenagers, including marketing at schools and summer camps, to become the largest seller of e-cigarettes in the country.

The Dangerous Side-Effects of JUUL & E-Cigarette Products

As of September 12, 2019, the Center for Disease Control and Protection has identified over 380 possible cases from 36 states of lung illnesses tied to the use of e-cigarettes and vaping products. So far there have been six confirmed deaths from lung illnesses associated with e-cigarette use.

What Should I Do If My Child Was Harmed After JUUL E-Cigarette Use?

If you or a loved one has been harmed after the use of a JUUL e-cigarette, contact the attorneys at GoldenbergLaw. With over 30 years of experience fighting corporate negligence, we deliver the Gold standard advocacy you deserve.

Oklahoma Judge Issues $572 Million Verdict in First Opioid Trial

On August 26, 2019 Oklahoma District Court Judge Thad Blakman held healthcare giant Johnson & Johnson responsible for its role in the opioid epidemic in Oklahoma by delivering a $572 million verdict in favor the state. The judge cited the aggressive marketing strategies employed by Johnson & Johnson to increase opioid sales that involved minimizing the risks of addiction and dependence, a sales strategy also known as the “addiction ditch.”

What Happened in Oklahoma?

In the first opioid epidemic case to reach trial, Oklahoma Attorney General Mike Hunter claimed that opioid overdoses killed more than 4,600 people in the state from 2007 through 2017 with thousands more currently battling opioid addiction. The state estimates that it will cost $17.5 billion over 30 years to handle the crisis through opioid use disorder screenings, prevention and treatment, recovery services, medical education, and pain management programs.

What Did Johnson & Johnson Do?

The judge found that Johnson & Johnson engaged in deceptive marketing campaigns aimed at convincing Oklahoma doctors and the public that opioids are safe and effective for long-term use and treatment of chronic pain.

In addition, Johnson & Johnson sales representatives persuaded doctors that patients’ pain symptoms were under-treated and that patients were being harmed as a result. A technique known as “pseudoaddiction” was used to convince doctors that if patients were requesting higher doses they were not necessarily addicted to the opioid, but rather they needed the higher dose to treat their pain.

In trial, the co-director for the Opioid Policy Research Collaborative at Brandeis University, Dr. Andrew Kolodny, testified that Johnson & Johnson and their proxies downplayed the risks of opioid

opioid-pill

use, exaggerated the benefits, and saturated the market with opioids. For instance, Johnson & Johnson minimized the fact that when patients take opioids every day for as few as five days,

physiological dependence begins to set in and it becomes extremely difficult to discontinue opioid use. As a result, there are now more than 2 million opioid-addicted Americans who need treatment.

What are Prescription Opioids and Why are they Dangerous?

Prescription opioids are used for moderate to severe pain relief. To achieve relief, opioid receptors attach to brain cells and release signals to block pain receptors and boost feelings of pleasure. Opioids are intended to be used for a limited time to treat pain that does not respond to standard painkillers such as Aspirin, Ibuprofen, and Paracetamol.

However, opioids are extremely addictive and can be dangerous if abused. The feelings of pleasure resulting from opioids can be addictive. As a result, the patient develops a psychological dependence on the opioids in order to achieve the feelings of pleasure. Additionally, if opioids are consumed at too high of doses, breathing and heart beat are slowed which may lead to death.

A study on opioids conducted by the Center for Disease Control and Prevention revealed the severity of the drugs’ addictiveness. In a sample of opioid naïve, cancer-free adults who received opioid prescriptions, the likelihood of chronic opioid use increased with each additional day of treatment staring with day 3 and the most drastic increase in chronic opioid use occurred after the 5th and 31st day of treatment.

What is the Opioid Epidemic?

The Center for Disease Control and Prevention reported that almost 400,000 overdose deaths in the United States between 1999 and 2017 were tied to opioids.

Startling research from the Center for Disease Control and Prevention in 2006 revealed a stark increase in opioid overdose deaths paralleling a similar increase in opioid prescriptions. Before the opioid epidemic, unintentional drug poisoning mortality rates increased on average 5.3% per year. However, at the beginning of the opioid epidemic (1990-2002), unintentional drug poisoning mortality rates increased by 18.1% per year.

Between 1999 and 2002, the number of opioid-related poisonings listed on death certificates increased by 91.2%. By 2002, opioid-related poisoning was involved in 5,528 more deaths than other addictive drugs such as heroin or cocaine.

What is Happening with Other Opioid Manufacturing Companies?

When Oklahoma initially sued to combat the opioid epidemic plaguing the state, Purdue Pharma and Teva Pharmaceuticals were named as defendants in addition to Johnson & Johnson. However, Purdue Pharma and Israel’s Teva Pharmaceuticals settled with the state prior to trial. Purdue Pharma, the maker of the blockbuster drug OxyContin, agreed to pay $270 million. Teva Pharmaceuticals, one of the world’s leading providers of generic drugs, agreed to pay $85 million.

Since Purdue Pharma did not go to trial, their marketing strategies for OxyContin were not revealed in court; however, the American Public Health Association published an analysis of their manipulative marketing tactics.

Purdue Pharma introduced the opioid OxyContin to the market in 1996 through aggressive marketing and promotion. The high availability of OxyContin correlated with increased abuse, diversion, and addiction. As a result, by 2004 OxyContin became a leading drug of abuse in the United States.

Aggressive and deceptive marketing strategies included creating individual profiles of physicians based on their prescribing patterns and creating a national database to identify the highest and lowest prescribers of particular drugs in a single zip code, county, state, or the country as a whole. After the profiles were compiled, Purdue Pharma targeted physicians who were already the highest prescribers for opioids in the country due to their large numbers of chronic-pain patients.

Purdue Pharma also introduced a lucrative bonus system which incentivized representatives to increase OxyContin sales in their region. The representatives also created a patient coupon program for OxyContin which provided patients with a free, limited-time prescription for 7 to 30 days.

These manipulative marketing tactics disguised the risk of addiction associated with opioids for the treatment of chronic pain. As a result, sales representatives were told to relay the message that the risk of addiction was “less than one percent.”  However, the studies providing these claims proved to be defunct and resulted in Purdue Frederick Company Inc. (an affiliate of Purdue Pharma) pleading guilty to criminal misbranding charges in 2007.

Dangerous Drugs and Deceptive Marketing

The $572 million verdict in Oklahoma against Johnson & Johnson is only the beginning of justice in the opioid epidemic plaguing the country. Companies who fueled the opioid epidemic by predatory marketing techniques increased the presence and availability of dangerous and addictive products. However, cities, states, and municipalities across the United States are fighting to hold those companies responsible for the devastation and predation.

 

 

JUUL E-Cigarettes: Addicting and Injuring Teens With The Help of Social Media

Between June and August of 2019, there have been more than 215 reports of serious lung disease and other health concerns across 25 states tied to e-cigarette use. The first death from severe respiratory illness in connection with e-cigarette use occurred in Illinois in August 2019. As a result, public health officials have begun to further investigate the dangers of “vaping,” specifically the impact it can have on the lungs of adolescents. Many e-cigarette companies aggressively promote their products as a safer alternative to smoking, but an increasing amount of evidence suggests that may not be the case.

e-cig-pod

What are E-Cigarettes?

E-Cigarettes are electronic devices that use a battery to heat a liquid and produce a mix of particles known as an aerosol. The aerosols usually contain nicotine, flavorings, and other chemicals that are then inhaled by the user. The use of e-cigarettes is commonly referred to as ‘vaping.’

E-Cigarettes come in many shapes, styles, and sizes. Some e-cigarettes are designed to look like traditional cigarettes, while others look like USB flash drives, pens, and other everyday products.

What is JUUL?

JUUL is a Silicon Valley e-cigarette startup recently valued at $15 billion. In recent years, JUUL’s popularity has soared and now amasses 70% of the e-cigarette market. Although the company is partially owned by Altria, the tobacco company behind Marlboro cigarettes, JUUL maintains that their e-cigarette products are intended for adult smokers who want to transition from smoking traditional cigarettes.

What Do JUUL’s E-Cigarettes Look Like?

Similar to most e-cigarettes, JUUL products are battery-powered and heat a nicotine-containing liquid to produce an aerosol. However, stylistically, JUUL products resemble USB flash drives.

What’s Inside the Aerosol in JUUL E-Cigarettes?

JUUL e-cigarettes contain a high level of nicotine. According to the manufacturer, a single JUUL pod contains as much nicotine as a traditional pack of 20 cigarettes.

In addition to the high levels of nicotine, JUUL e-cigarette aerosols contain harmful and potentially harmful substances such as ultrafine particles that can be inhaled deep into the lungs, flavoring chemicals such as diacetyl which is linked to a serious lung disease, volatile organic compounds, cancer-causing chemicals, and heavy metals such as nickel, tin, and lead.

Danger of using JUUL: Nicotine Use in Adolescents

According to the U.S. Surgeon General, there are extensive dangers of adolescents using products that contain nicotine, such as JUUL e-cigarettes. These dangers include:

  • Negative impacts on the developing brain such as disrupting the formation of brain circuits that control attention, learning, and susceptibility to addiction
  • Long-term effects such as mood disorders and lowered impulse control
  • A more activated limbic system which leads to greater risk of addiction
  • High probability of using other tobacco products in the future

Danger of using JUUL: Exposure to Diacetyl

Diacetyl is a flavoring chemical frequently found in e-cigarettes that can cause irreversible conditions such as bronchiolitis obliterans, also known as “popcorn lung.” Exposure to diacetyl may lead lungs-smokingto the chemical seeping into the lung’s smallest airways, the bronchioles, which then become inflamed, damaged, and scarred. The scarred bronchioles block the movement of air in the lungs.

How Common is Exposure to Diacetyl?

In a study conducted by the Environmental Health perspectives, 51 flavors of e-cigarettes were tested and diacetyl was detected in 39 of the aerosols.

How Popular are E-Cigarettes Among Adolescents?

Among adolescents and teenagers, e-cigarettes are more popular than traditional cigarettes. In 2017 and 2018, polls discovered a 78% increase in e-cigarette use among high schoolers and a 48% increase among middle schoolers. Additionally, more than 2/3 of high school users choose e-cigarettes that offer flavors – such as JUUL products – because they seem ‘safer’ than traditional cigarettes. The drastic increase in e-cigarette use among young people has resulted in the Food and Drug Administration calling teen vaping an “epidemic.”

Why are Kids Using JUUL?

Social influence, enticing flavors, and JUUL marketing strategies presenting e-cigarettes as a ‘safer’ alternative for traditional cigarettes appear to have increased JUUL product usage among adolescents.

There is increased concern and public backlash over JUUL’s marketing strategies which appear to be targeting young people. According to Tobacco Control Journal, JUUL stands out from other e-cigarette companies by marketing their devices on social media platforms such as Twitter, YouTube, and Instagram which are especially popular with young people. Researchers claim that the combination of the company’s marketing efforts, their product offerings such as sleek designs mimicking USB flash drives, and candy-like flavors have resulted in more young people becoming hooked on nicotine and using e-cigarettes.

What is JUUL Saying About the Dangers?

JUUL co-founder James Monsees acknowledged the statistics showing “a significant number of underage Americans using e-cigarettes, including JUUL products”.

JUUL CEO Kevin Burns even issued a public apology to parents of teens who are addicted to the company’s vaping products saying, “First of all, I’d tell them that I’m sorry that their child’s using the product.”

Burns also warned nonsmokers against using JUUL products “Don’t vape. Don’t use JUUL” in addition to acknowledging that the long-term effects of vaping are unknown. However, JUUL continues to sell e-cigarettes and market their products on platforms frequented by young people.

How Do I Know if My Loved One has been Harmed by JUUL?

Symptoms of Bronchiolitis Obliterans include:

  • Shortness of breath
  • Fatigue
  • Chest pain
  • Cough
  • Weight loss
  • Nausea
  • Vomiting
  • Fever
  • Trouble doing routine tasks such as washing one’s hair or tying shoes
  • Difficulty breathing

If you or a loved one has experienced these symptoms after using vaping, please contact a healthcare professional.

What Should I Do If My Child Was Harmed After JUUL E-Cigarette Use?

If you or a loved one has been harmed after the use of a JUUL e-cigarette, contact the attorneys at GoldenbergLaw. With over 30 years of experience fighting corporate negligence, we deliver the Gold standard advocacy you deserve.