Weekly Mass Torts Bulletin 2023-November-13

A divided federal appeals court has ruled that California cannot mandate businesses to warn consumers about the potential dangers of glyphosate, an ingredient in the Roundup weedkiller linked to cancer.

The 9th U.S. Circuit Court of Appeals in San Francisco, upholding a permanent injunction, declared it unconstitutional to compel Bayer's Monsanto unit, the maker of Roundup, and other agricultural businesses to provide the proposed carcinogen warnings under California's Proposition 65.

In a 2-1 majority decision, the Circuit Judge stated that turning producers into a "billboard" for California's "at best, disputed" message on the alleged unsafety of glyphosate violated their First Amendment commercial speech rights, despite the state's significant interest in its citizens' health.

The judge argued that forcing sellers to warn consumers of a potential 'risk' not confirmed by any regulatory body or not 'known' to more than a small scientific subset does not directly serve the state's interest.

Bayer praised the decision as a "strong blow against compelled warnings for Roundup that are not supported by science" and deemed it crucial for the company's ongoing personal injury litigation.

Initially linking glyphosate to cancer, California's original warnings were revised last year, citing the International Agency for Research on Cancer's findings that glyphosate was "probably carcinogenic" to humans.

Rejecting all warnings, the judge noted that they required Bayer and other objectors to convey a "controversial, fiercely contested message that they fundamentally disagree with."

The ruling upheld a June 2020 injunction by a U.S. District Judge in California. The office of the California Attorney General expressed disappointment, declining to disclose plans for another appeal. Lawyers for 13 agriculture and business trade groups opposing the warnings did not immediately respond.

Bayer has faced extensive Roundup litigation, with three trial losses last month, since acquiring Monsanto for $63 billion in 2018. Although settling most Roundup claims for $10.9 billion in 2020, the company still faced about 45,000 claims by early this year.

After substantial efforts to combat the teen vaping epidemic in the U.S. over the past decade, a recent federal survey indicates a significant reduction in tobacco use among teens this year.

The U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) report a decline in vaping from 14% to 10% across all middle and high school students compared to the previous year.

The findings, published in the CDC's Morbidity and Mortality Weekly Report on November 2, are based on data from the 2023 National Youth Tobacco Survey (NYTS) conducted from March to June 2023.

Overall, 2.8 million teens reported using any tobacco product this year, marking a decrease from 17% in 2022 to 13% in 2023. The primary factor behind this decline was a reduction in e-cigarette use, which dropped from 14% to 10%, resulting in 580,000 fewer high school students reporting current e-cigarette use in 2023.

However, middle schoolers experienced an overall increase in tobacco use, rising from 4.5% to 6.6%, along with an increase in the concurrent use of multiple tobacco products, which increased from 1.5% to 2.5%.

The survey revealed that the use of any specific tobacco product among middle schoolers, including e-cigarettes, did not change significantly. Among teens who reported using e-cigarettes, 25% stated they vaped every day. Popular e-cigarette brands included Elf Bar (used by nearly 60% of students), Esco Bars (22%), Vuse (21%), JUUL (17%), and Mr. Fog (14%).

Notably, disposables were the most common type of e-cigarette used by teens compared to cartridge-based products. Additionally, teens reported reduced use of cigars and traditional tobacco cigarettes, reaching an all-time low.

For the first time, the survey included questions about the use of flavors with the terms "ice" or "iced" in the name, as well as flavors implying but not explicitly indicating a specific taste, such as "island bash." Nearly 90% of teens who reported using e-cigarettes stated they used flavored products, with popular flavors including fruit, candy, mint, and menthol.

Research suggests that teens using nontraditional e-cigarette flavors are more likely to vape frequently and continue use. Flavored vapes may contribute to addiction and an increased risk of heart disease, as indicated by previous studies.

While the decrease in vaping is viewed positively, health officials remain concerned about the persistent popularity of e-cigarettes among youth, driven largely by advertising and social media influence. Despite the decline, e-cigarettes remain the most commonly used tobacco product among high school and middle school students for the tenth consecutive year.

In 2021, the FDA implemented measures such as rejecting vape product approval applications and issuing bans on 55,000 e-cigarette products.

The FDA continues enforcement actions against illegal e-cigarettes, including Elf Bar, with plans for additional measures against unauthorized manufacturers and distributors.

Drogueria Betances, LLC, one of Puerto Rico's major pharmaceutical drug distributors, has been ordered to pay $12 million following allegations of failing to report numerous suspicious orders for controlled substances, as stated by the U.S. Justice Department.

The accusations against the company include not reporting a minimum of 655 orders for fentanyl and at least 113 orders for oxycodone from 2016 through June 2019. These orders were flagged as suspicious due to their frequency and volume, according to the department.

Moreover, Drogueria Betances is also charged with numerous violations related to record-keeping and failing to submit distribution transaction reports to the U.S. Drug Enforcement Administration, particularly concerning opioids, spanning from May 2017 to July 2018.

As part of the settlement, the company has been mandated to enhance its compliance program and promptly report any suspicious orders to the DEA, among other requirements. While Drogueria Betances has agreed to pay the fine and strengthen its reporting system for the distribution of controlled substances, the company has disputed allegations of an inefficient system for monitoring suspicious orders.

In a statement, the company's president highlighted their significant investments in technology and external guidance over the years to ensure strict adherence to the laws and regulations governing controlled medications. The president also clarified that Drogueria Betances has never been accused of diverting controlled products to unauthorized individuals or entities.

This legal action by the U.S. government follows a notable increase in opioid-related fatal overdoses in the U.S. territory of Puerto Rico, with figures rising from 19 deaths in 2017 to 521 in 2021, as per the latest available statistics.