“E-cigarette docket transferred to USDC ND California”
Mark A. York (October 3, 2019)
See Mass Tort Nexus Briefcase MDL 2913 for the full docket:
(MASS TORT NEXUS MEDIA) The JPML heard Juul arguments on Sept. 26 in Los Angeles, and on October 2, 2019 they issued the MDL 2913 transfer order, consolidating the Juul e-cigarette docket in the U.S. District Court, Northern District of California in front of Judge William Orrick.
In a move to get out in front of plaintiffs, JUUL Labs Inc. filed a motion on Aug. 29 to stay all cases in the litigation and requested the JPML assign the docket to the court in California
JUUL is accused of deceptive marketing practices and failing to warn consumers about the risks of its e-cigarette products. Lawsuits allege JUUL unlawfully marketed its products to teens, and failed to disclose the true amount of nicotine contained in its products.
See Mass Tort Nexus Briefcase MDL 2913 for the full docket
FDA WARNING ISSUED
FDA Warning Letter to JUUL Labs, Inc. (September 9, 2019) https://www.fda.gov/news-events/press-announcements/fda-warns-juul-labs-marketing-unauthorized-modified-risk-tobacco-products-including-outreach-youth
In November 2018, the FDA revealed that vaping had increased nearly 80% among high schoolers and 50% among middle schoolers since a year earlier. Public health experts have said that Juul has largely propelled the rise, commanding about 75% of the e-cigarette market in the United States.
There were communications between FDA officials in mid-October 2018, which detailed allegations of seizures related to Juul use The FDA found “no proof of causality, but at a minimum, an association with Juul,” Mitch Zeller, the director of the FDA’s Center for Tobacco Products, wrote to Scott Gottlieb, the FDA commissioner at the time. In an interview, Zeller said that the FDA had not been able to confirm that Juul use was associated with the seizures in two of the three initially reported cases
Although Juul demands age verification upon navigating to its website and holds a firm stance against minors’ use of Juuls, these vapes are still wildly popular with teens.
Depending on the state, no one under 18 or 21 is supposed to be able to purchase e-cigarettes or any tobacco products. But according to a report from the CDC, e-cigarette use is rising among middle school and high school students, and more than 3.5 million of them used e-cigarettes in 2018.
- Juul delivers massive doses of nicotine, putting youth users at greater risk of addiction
The manufacturer has stated that each Juul “pod” (cartridge of nicotine) delivers as much nicotine as a pack of 20 cigarettes. However, research by Truth Initiativehas found that many young Juul users don’t know the product always contains nicotine.
- Nobody ever disclosed this comparative and now there are thousands of addicted young people who had no clue.
- In addition to the patented formula, juul pods contain a greater amount of benzoic acid, 44.8 mg/mL, compared to other e-cigarette brands, which are in the range of 0.2 to 2 mg/mL.
Advertising is part of the problem. According to the CDC, more than 18 million high school and middle school students combined were exposed to e-cigarette ads in 2014. And Stanford researchers point out that Juul’s marketing hasn’t been congruent with its adults-only stance.
PHILLIP MORRIS SHUTS DOWN JUUL MERGER
What had once looked like a smart pair-up to rejoin the international cigarette giant with its former domestic parent has now crumbled under the weight of doubts about where the regulatory fist would fall. Altria owns a 35% stake in Juul Labs, the leading e-cig maker by far and the primary scapegoat for industry criticism because it is the face of the vaping market.
After careful consideration, Philip Morris CEO Andre Calantzopoulos said in a statement that it and Altria “have agreed to focus on launching IQOS in the U.S. as part of their mutual interest to achieve a smoke-free future.” All that other stuff they were discussing could be forgotten.
Juul said it’s suspending all broadcast, print and digital product advertising in the U.S., and will refrain from lobbying the Trump administration on its draft guidance. The announcement comes after a crackdown on e-cigarettes by the U.S. Food and Drug Administration, that has accelerated following a recent outbreak of severe lung disease that appears to be related to vaping. More than 530 Americans have been diagnosed with the illness and at least eight people have died. Juul is now the subject of a criminal probe in California.
FDA investigators are looking at the use of vitamin E acetate, a compound often used as a cutting agent to allow black market operators to use less pure cannabis oil when filling cartridges. While vitamin E is considered to be safe as a dietary or health supplement ingested in capsule or pill form, it can cause respiratory illness including pneumonia when inhaled.
About 55 lawsuits brought against Juul across the country were among the matters before the JPML panel at the hearing.
Recently, Juul announced that CEO Kevin Burns would step down immediately and the company would suspend all advertisements of its products. The new CEO, K.C. Crosthwaite, comes from Philip Morris USA parent corporation Altria Group Inc., which has a 35% stake in Juul.
Recent developments include stores like Walmart have stopped selling e-cigarettes and vaping products and cities and states have banned the products. Juul also faces mounting regulatory pressure from the U.S. Food and Drug Administration, which is investigating Juul’s marketing claims to children, as have many state attorneys general.
JPML panel chairwoman Sarah Vance, who sits on the Eastern District of Louisiana, started by announcing this would be her last hearing as head of the MDL panel. U.S. District Judge Karen Caldwell of the Eastern District of Kentucky a current panelist, will be the new chairwoman.
Juul counsel, Austin Schwing, a partner at Gibson, Dunn & Crutcher in San Francisco, argued for the cases go to a court near his client’s headquarters in San Francisco before U.S. District Judge William Orrick of the Northern District of California, but was also open to U.S. District Judge Brian Martinotti of the District of New Jersey, while some plaintiffs counsel also supported Orrick.
In briefs before the panel, there was an initial request for two MDL’s to be created, with plaintiff’s counsel initially advocating for Orrick to oversee the Juul litigation related to misleading marketing that failed to disclose the nicotine in its products. While also requesting that Judge Martinotti hear the personal injury cases whose claims focused on pulmonary disease, seizures and other serious health problems.
Judge Vance clarified the denial quickly in the hearing, stating the cases were too massive and complex to be divided. “Events in the past few minutes have overtaken me,” she said.
Andy Birchfield, of Beasley Allen, also changed his mind about dividing the cases, said “we need an experienced hand” as a judge. He initially supported Martinotti, a judges who had overseen dockets New Jersey state court’s Multicounty Litigation Center before his appointment to the federal bench.
MDL No. 2913 – IN RE: Juul Labs, Inc., Marketing, Sales Practices, and Products Liability Litigation JPML Initial Transfer Order
Judge Orrick entered Pretrial Order No. 1 on the same day the JPML designated his court as the home of MDL 2913.
See Mass Tort Nexus Briefcase MDL 2913 for the full docket
JUUL Changed Nicotine Disclosures
Juul measures nicotine content by weight, which is different from most brands, which usually measure by volume. Juul originally only sold pods with 5% nicotine by weight, but started offering 3% pods in August 2018.
According to an older version of Juul’s FAQ page, one 5% pod contains roughly the same amount of nicotine as one pack of cigarettes, or about 200 puffs. However, this information is no longer available on Juul’s website, and there’s no precise information about 3% pods, either. However, an article in the New England Journal of Medicine says that the 5% pods contain a concentration of 59 milligrams of nicotine per milliliter of liquid.
In contrast, prior to the Juul frenzy most vapes contained roughly 1 to 3% nicotine by volume. A study in the journal Tobacco Control notes that the new average seems to be rising to that 5% mark. Juul’s creators increased the nicotine because they felt other vapes on the market couldn’t compare to the sensations delivered by regular cigarettes.
In the FDA warning letter to JUUL Labs, Inc. of September 9, 2019 the following “unauthorized marketing claims” were cited:
The warning letter identifies several statements, including statements discussed in testimony from a July 2019 Congressional hearing on JUUL. According to that testimony, a JUUL representative speaking with students at his presentation in a school stated that:
JUUL “was much safer than cigarettes” and that “FDA would approve it any day.”
JUUL was “totally safe.”
A student “…should mention JUUL to his [nicotine-addicted] friend…because that’s a safer alternative than smoking cigarettes, and it would be better for the kid to use.”
“FDA was about to come out and say it [JUUL] was 99% safer than cigarettes…and that…would happen very soon….”
Additionally, a “Letter from the CEO” that appeared on JUUL’s website, and also in an email that JUUL sent to a parent in response to her complaint that the company sold JUUL products to her child, states: “[JUUL’s] simple and convenient system incorporates temperature regulation to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and the harm associated with it.”