Weekly Mass Torts Bulletin 2024-January-1

2023 may go down in history as the year the United States fully grasped the severity of the fentanyl crisis, a crisis that is ravaging communities and deepening societal divisions over how to address it.

For the first time, the nation saw overdose deaths surpass 112,000, disproportionately affecting young individuals and communities of color. This crisis now overshadows past drug epidemics, including those of the 1980s and the prescription opioid surge in the 2000s, according to drug policy experts and those affected by addiction.

A North Carolina harm reduction advocate, who admits to occasional use of street opioids including fentanyl, described the devastation: "Our entire community has been decimated. Fentanyl is dangerous, and xylazine is outright poison," she explained. "So many people I know have died, including my daughter, and our mentors. The danger level is unprecedented."

Health professionals point to fentanyl, a synthetic opioid far stronger than heroin, as the primary culprit in these deaths. However, the illegal drug market has become increasingly hazardous, offering a lethal mix of substances including fentanyl, methamphetamines, and a constantly evolving array of new chemicals.

Recent dangers include xylazine, a horse sedative causing severe flesh wounds in users, and nitazenes, a class of synthetic opioids potentially more lethal than fentanyl. Mexican cartels are known to press these substances into pills, deceptively designed to mimic legitimate medication for depression, pain, and ADHD.

Drug overdoses are now among the leading causes of death for Americans aged 18-45, and there's been a notable increase in overdose deaths among pregnant women. The fentanyl issue has sparked intense political debate. Several Republican politicians have criticized the Biden administration for its perceived failure to curb fentanyl smuggling.

A former South Carolina governor, now a GOP presidential hopeful, highlighted the crisis's magnitude during a New Hampshire speech on December 14, noting that fentanyl has caused more American deaths than the combined fatalities of the Iraq, Afghanistan, and Vietnam wars.

Drug fatalities in the United States began to escalate dramatically in early 2020, rising from an already alarming annual figure of 65,000 to what many policymakers now fear is a new norm exceeding 110,000 deaths per year. Initially, public health experts attributed this surge to the Covid-19 pandemic, as lockdowns disrupted addiction treatment services and increased feelings of isolation.

However, the expectation that this surge in overdose deaths would diminish with the return to normalcy in American life has not materialized. The director of the National Institute on Drug Abuse, the premier agency for drug policy and addiction research in the U.S., expressed concern: "The numbers keep increasing. I had been hopeful that post-Covid, we would see a decline. While the rate of increase isn't as steep, the numbers are still on the rise."

By 2023, the overdose death toll reached a record high of over 112,000 within a 12-month period, as reported by the Centers for Disease Control and Prevention.

Seattle Public Schools is set to receive a total of $1.75 million by 2027, as a result of settlements concluded after a prolonged four-year legal dispute with the e-cigarette manufacturer JUUL Labs.

The settlement terms dictate that the district will net around $1.3 million after deducting litigation expenses and attorney’s fees, which account for 15% of the total amount. The initial payment of $750,000 is scheduled for this month, followed by annual payments of approximately $150,000 each January from 2024 to 2027.

The legal action against JUUL Labs was initiated by Seattle Public Schools in November 2019. The lawsuit, filed in the United States District Court for the Western District of Washington, accused JUUL Labs and other involved parties in the production, distribution, and marketing of vaping products, of deliberately targeting minors. This alleged targeting was claimed to have led to a significant rise in vaping and nicotine addiction among young people.

The lawsuit’s intent was not just financial compensation; it also sought a judicial order to halt the defendants from marketing their products to minors, alongside seeking funds for programs within the district to address addiction and to educate students about the risks of addictive substances, including nicotine. The school district's general counsel mentioned that certain aspects of the case were addressed through regulatory actions by the Food and Drug Administration.

Seattle Public Schools was one of the 1,500 government entities involved in this lawsuit. The settlements were agreed upon in September, but only became official following court approval as part of a broader class-action settlement.

The Seattle Public Schools Board of Directors endorsed the acceptance of the settlement funds during their meeting on December 13. Following this, the district’s counsel highlighted the need to assemble a team, involving members from School Health, to determine the most effective utilization of these funds in addressing issues arising from JUUL’s marketing practices.

Furthermore, the district finalized a separate settlement with Altria, another defendant in the case, in July. This agreement will result in Seattle Public Schools receiving an additional approximate amount of $400,000, expected to be paid in April 2024.

The FDA has granted approval for the AvertD test, the first DNA-based test designed to assess an individual's genetic predisposition and heightened risk of developing opioid use disorder (OUD) after initial exposure to prescription painkillers.

Developed by AutoGenomics and sponsored by SOLVD Health, the approval comes with specific conditions: the test is restricted to consenting adult patients with no prior history of oral opioids, intended for use before receiving a multi-day regimen for acute pain treatment, such as pre-surgery.

The FDA acknowledges potential risks associated with the test, emphasizing that over-reliance could lead to false negatives, providing a misleading sense of security to patients at increased risk of OUD. Conversely, false positives might result in inadequate pain management by avoiding opioids entirely. Importantly, the AvertD test is not intended for patients undergoing chronic pain treatment.

Under premarket approval, AutoGenomics is required to train healthcare providers on the test's appropriate use and conduct a substantial study on its real-world performance, with findings reported to the FDA.

Despite uncertainties surrounding benefits and risks during premarket decision-making, the FDA recognizes the urgent need for devices addressing the opioid crisis. The AvertD test, by assessing the risk of OUD, was deemed to provide reasonable assurance of safety and effectiveness, considering available alternatives, patient perspectives, public health needs, and the ability to address uncertainty through post-market data collection.

The prescription-only test employs a cheek swab to analyze DNA, searching for 15 genetic variants associated with an increased risk of OUD.

An earlier version of the AvertD test faced scrutiny in October 2022 when an FDA panel reviewed it for de novo clearance. The committee voted 11-to-2 against the test, citing concerns about study design, potential misinterpretation of results by clinicians, uncertainty in algorithm accuracy, and applicability to a diverse real-world population.

Following the advisory committee's feedback, the FDA collaborated with AutoGenomics to enhance the test and subjected it to a more rigorous premarket review. The FDA's decision reflects a balanced consideration of benefits, risks, and the urgent need to address the opioid crisis.

The opioid crisis remains a significant public health challenge in the United States, necessitating innovative approaches for prevention, diagnosis, and treatment of opioid use disorder, including risk assessment measures. The approval of the AvertD test represents a step towards personalized interventions in combating the complex issues surrounding opioid addiction.