Weekly Mass Torts Bulletin 2024-July-30
Modified Vape Kits Pose Risks for Teens: Study
A new report highlights the risks that teens and young adults face when modifying vape kits, altering e-cigarette devices for uses they were never designed for, such as recharging disposable pens or putting cannabis into tanks designed for nicotine and other e-juices.
Federal health officials have long warned that vaping has become a significant health epidemic among U.S. teens, with approximately 10% of high school students reporting e-cigarette use, according to data from the 2023 National Youth Tobacco Survey.
In a study published this month in the medical journal Pediatrics, researchers revealed that about 40% of teens and young adults in the U.S. who vape attempt to modify their e-cigarette devices in ways that may boost nicotine levels or increase the risk of severe burns or lung damage.
Teens and young adults commonly modify e-cigarettes to vape marijuana, according to researchers from the Yale School of Medicine’s Department of Psychiatry. They warn that these modifications are not recommended by manufacturers and may lead to harmful side effects.
Since vape pens emerged as an alternative to tobacco cigarettes, federal health officials have raised concerns about the risk of vape pen explosions from overheating lithium-ion batteries. These incidents have resulted in severe burns, fires, and deaths, often linked to low-quality devices or modified products.
Due to these risks, the U.S. Food and Drug Administration (FDA) has mandated that all new nicotine products must go through premarket tobacco applications (PMTAs). The FDA has also provided guidance to manufacturers on making vapes safer by reducing the risk of battery explosions and preventing toxic nicotine dosing, two side effects that can result from improper modifications.
In this latest study, researchers focused on the habits of modifying e-cigarettes, known as “modding” or “hacking,” among teens and young adults. The study surveyed 1,000 teens and young adults who reported vaping in the past month. Participants answered questions about their awareness and use of vape modifications, including refilling rechargeable pods, recharging disposable pods, refilling disposable pods, rewicking, modifying liquids like changing propylene glycol or nicotine, combining nicotine liquid with cannabis liquid, and putting cannabis liquid into vapes.
Court Upholds Dismissal of Zostavax Shingles Lawsuits
A federal appeals panel has upheld the dismissal of nearly 1,200 Zostavax lawsuits that alleged the vaccine caused the very shingles it was designed to prevent.
The panel agreed with a lower court judge that the plaintiffs failed to provide adequate evidence establishing that the vaccine caused their shingles injuries.
Zostavax was the first shingles vaccine approved in the United States, involving a single-dose injection containing a live version of the virus that causes shingles, aimed at protecting against the painful condition. Despite being promoted for years as safe and effective, thousands of former users filed lawsuits against Merck, claiming that the live virus in the vaccine was not sufficiently weakened, leading to severe autoimmune reactions and persistent shingles outbreaks.
Due to similar questions of fact and law raised in complaints across the federal court system, all Zostavax lawsuits were centralized before a U.S. District Judge in the Eastern District of Pennsylvania in 2018 as part of a federal multidistrict litigation (MDL). Several groups of “bellwether” cases were prepared for trial, involving different categories of injuries.
The judge established two separate bellwether tracks: “Group A,” involving claims that Zostavax caused shingles-related injuries, and “Group B,” involving other autoimmune reactions such as postherpetic neuralgia, acute disseminated encephalomyelitis (ADEM), paralysis, transverse myelitis, meningitis, hemorrhagic strokes, and other injuries.
Before allowing any of the “Group A” cases to proceed to trial, the judge issued a controversial order requiring each plaintiff to provide polymerase chain reaction (PCR) evidence to establish that their shingles were linked to the live strain of the virus contained in the Zostavax vaccine. Since doctors do not typically perform such testing during shingles treatment, and the results cannot be obtained after recovery, this requirement led to the dismissal of all Zostavax shingles lawsuits in December 2022.
The plaintiffs appealed the decision to the U.S. Court of Appeals for the Third Circuit, arguing that the PCR requirement set an impossible standard and that they could provide specific causation without the PCR testing. However, in an opinion issued on July 16, a panel of judges rejected the plaintiffs’ arguments. They found that the dismissal of the claims was valid and that the PCR tests were the only reliable method to distinguish between the live-attenuated and wild-type strains of the virus.
“Plaintiffs knew from the start that they would have to account for and exclude the ‘obvious alternative cause’ of shingles for the Group A cases: the wild-type chickenpox strain of the VSV latent in almost every person over the age of 30,” the appeals court judges wrote. “But even after three years of litigation, plaintiffs had not produced a single piece of medical literature or expert medical opinion explaining how it can be determined that Zostavax, and not chickenpox, caused a person to contract shingles other than through PCR testing.”
As a result, the dismissal of 1,189 “Group A” cases with prejudice was upheld. This decision emphasizes the critical role of specific and reliable evidence in vaccine-related injury claims and highlights the challenges plaintiffs face in proving causation in complex medical litigation.
Synthetic Opioid 50X Stronger Than Fentanyl Found in Florida
Police in Palm Beach County have discovered N-Desethyl Isotonitazene (ISO), a synthetic opioid up to 50 times more potent than fentanyl.
This is only the second time ISO has been detected in the United States, with the first detection in Philadelphia in December 2022, according to the West Palm Beach Police Department.
The discovery was made by the police's Organized Crime Unit, which seized 20 kilograms of ISO while executing a search warrant on a house and storage unit in Palm Beach County. This seizure, estimated to be worth $1.6 million, resulted from a tip received in February and led to the arrest of one individual, whose identity has not been disclosed. Alongside the drugs, several guns and ammunition were also confiscated.
The arrested trafficker was distributing ISO in forms resembling other narcotics, such as OxyContin and Percocet. Police have highlighted the extreme potency of ISO, which can be 40 to 50 times stronger than pharmacy-grade fentanyl.
This discovery comes amidst a severe fentanyl crisis in the U.S. The Centers for Disease Control and Prevention reported an estimated 107,543 drug overdose deaths last year, with synthetic opioids like fentanyl responsible for 70 percent of these fatalities.
The presence of ISO in Palm Beach County adds a new layer of complexity to the ongoing opioid crisis. The extreme potency and mimicry of other drugs make it particularly dangerous, underscoring the need for heightened awareness and preventive measures to combat this emerging threat.
Over 1,200 Valsartan Cancer Lawsuits Pending in MDL
Attorneys representing plaintiffs in over 1,200 Valsartan lawsuits, along with lawyers for various generic manufacturers accused of selling contaminated versions of the recalled blood pressure medication, are scheduled to meet with a new federal judge this month.
This meeting follows the recent retirement of the judge previously overseeing the case. Valsartan, the generic name for Diovan, became the focus of widespread litigation after several versions of the drug were recalled in late 2018.
This recall was due to contamination with carcinogenic chemicals such as N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), which resulted from changes in the generic drug manufacturing process. The contaminated drugs were distributed widely across the United States, leading to numerous lawsuits, including both class action claims and personal injury cases from former users diagnosed with various cancers, such as stomach, liver, esophageal, prostate, and pancreatic cancers.
Nearly six years after the litigation began, the first Valsartan lawsuit has yet to go to trial. The number of cases continues to grow, as cancers linked to NDMA contamination in Valsartan can take years to develop. Since 2019, all federal Valsartan lawsuits have been centralized in the U.S. District Court for the District of New Jersey for coordinated pretrial proceedings, as they involve common legal and factual questions.
The first trial, initially scheduled for March 2024, was postponed following the unexpected retirement of the presiding judge. In preparation for an upcoming status conference, the parties submitted a joint status report on July 9. This report aims to inform the new judge about past developments in the litigation, key rulings, and ongoing issues left unresolved by the previous judge's retirement.
The report highlights that there are currently more than 1,200 personal injury claims pending, involving plaintiffs who developed cancers after using Valsartan or similar drugs, including losartan and irbesartan. One critical issue addressed in the report is the rescheduling of the first bellwether trial, which was originally set to begin on March 18. Plaintiffs are advocating for the trial to be rescheduled for the fall of this year.
In the upcoming months, the new judge will face several important decisions that could significantly impact the litigation. These include determining the scope of issues to be addressed at trial, decisions regarding depositions, exhibits to be presented, and other procedural matters. These decisions will be crucial in shaping the course of the litigation and how future cases are handled.
Suboxone Dental Claims Info to Be Exchanged in MDL
The U.S. District Judge overseeing the Suboxone tooth decay lawsuits across the federal court system has initiated the process for parties to exchange detailed information about the claims.
This step aims to select a representative sample of cases for further discovery and eventual bellwether trials, potentially guiding future settlement negotiations.
Currently, around 11,000 Suboxone dental claims are pending in a federal multidistrict litigation (MDL). This MDL was established earlier this year to streamline discovery and pretrial proceedings, as each lawsuit shares similar allegations. The plaintiffs claim that the manufacturers of Suboxone, an opioid dependency drug, failed to properly disclose that its sublingual film version could degrade tooth enamel, leading to increased risks of broken or lost teeth.
Suboxone, a combination of buprenorphine and naloxone, was initially approved in a tablet form in 2002. About ten years later, a sublingual film version was introduced, meant to be placed under the tongue or inside the cheek. The lawsuits allege that this film version was developed to delay generic competition rather than provide a better treatment option, and it lacked essential warnings about potential dental damage.
It was not until June 17, 2022, that the U.S. Food and Drug Administration (FDA) required an update to the warning label to include the risk of tooth decay associated with Suboxone. The update followed the identification of hundreds of complaints about dental problems from users. Plaintiffs argue that earlier warnings and instructions could have prevented permanent damage and costly dental treatments.
Since February 2024, the Suboxone tooth decay lawsuit MDL has been centralized before a U.S. District Judge in the Northern District of Ohio. A status conference was recently held, where the Judge instructed the parties to start gathering and exchanging specific information from claimants. This process is crucial for identifying a smaller set of cases that will proceed to early bellwether trials. These trials are intended to help both sides understand how juries might react to key evidence and testimonies, potentially influencing settlement discussions.
The Judge's order, issued on July 19, directed the parties to negotiate a protocol for this information exchange. The goal is to determine the best way to collect data that will lead to a selection of cases for further discovery and trial. Both sides are required to submit their proposals to the court by August 27. These proposals should outline the specific information they believe will help identify cases representative of the broader litigation and aid in resolving the cases.
While the outcomes of these early bellwether trials will not directly bind the remaining claims, they are expected to influence the average settlement amounts for Suboxone tooth decay lawsuits. This influence could help establish a framework for the drug maker's potential payouts to avoid taking each individual case to trial.
The next status conference is scheduled for September 4, with the parties expected to submit a joint agenda for the meeting by August 29.
SC Rejects Sackler Family’s $6B Opioid Settlement
The U.S. Supreme Court recently overturned a contentious settlement that would have allocated billions of dollars to treatment programs and victims of the opioid epidemic.
This decision, which blocks the Sackler family from receiving protection against future lawsuits, highlights ongoing legal and ethical debates surrounding the family's role in the crisis.
Justice wrote the majority opinion for the 5-4 decision, stating that the Sacklers were seeking more extensive relief than what is typically granted in bankruptcy cases. He noted that the family hoped to eliminate claims related to wrongful death and fraud without contributing a significant portion of their assets. "Describe the relief the Sacklers seek how you will, nothing in the bankruptcy code contemplates (much less authorizes) it," he wrote.
In contrast, another justice who dissented warned that the court's ruling would have a "devastating" effect on the thousands of victims affected by the opioid epidemic. She emphasized that these victims would be deprived of the substantial monetary recovery they had fought for over years of litigation. Chief Justice and the court's liberal justices joined in dissent.
She urged Congress to amend U.S. bankruptcy law to address the repercussions of the court's decision, which she predicted would lead to significant harm. She stressed that the issue should be carefully examined by lawmakers to prevent further chaos.
The justice pointed out that the bankruptcy law does not explicitly grant courts the authority to allow third parties, like the Sacklers, to evade future liability. While acknowledging that this decision might disrupt Purdue Pharma's current reorganization plan, he suggested that increased legal exposure for the Sacklers could result in better terms in future negotiations. He referenced an argument from the Justice Department, noting that "if past is prologue," there could be a more favorable deal on the horizon.
The case revolves around Purdue Pharma and its executives, who were instrumental in the production and promotion of OxyContin, a highly addictive opioid. This drug played a significant role in the opioid crisis, which has claimed hundreds of thousands of lives in the United States and caused widespread devastation.
As part of a proposed settlement, the Sackler family had agreed to pay $6 billion to affected families and states. In return, they sought immunity from future civil liability claims. Purdue Pharma had marketed OxyContin as a safer, less addictive painkiller, promoting its use for extended periods and for more common injuries. This strategy contributed to the Sacklers' wealth and their reputation for philanthropy.
However, lawsuits and media reports revealed that the Sackler family continued to push OxyContin even after becoming aware of its addictive potential. This led not only to widespread addiction but also to many individuals turning to heroin and other opioids when they could no longer access the prescription drug. According to the Centers for Disease Control and Prevention, nearly 645,000 people died from opioid overdoses between 1999 and 2021.
In concluding his opinion, the justice acknowledged the complex policy issues at play but emphasized that it is not the court's role to resolve them. He argued that Congress should determine whether third parties can be shielded from future lawsuits, underscoring that the court's responsibility is to interpret and apply the law as it stands. He concluded, "nothing in present law authorizes the Sackler discharge," reaffirming the court's decision to reject the settlement that would have protected the Sacklers from future legal claims.