Weekly Mass Torts Bulletin 2022-June-27

U.S. Food and Drug Administration has rejected the authorization of JUUL vaping products' sale by banning the products from the U.S. market, citing the long-term effects of teen vaping addiction.

JUUL introduced the vape pens of various flavors in 2015, which made the products popular in no time among the teens throughout the U.S. The USB-like design of the vape pens allowed the teens to hide them from parents and school officials, which resulted in growing teen addiction.

JUUL marketed the products extensively through social media and other mediums, targeting the prior non-smokers and minors. This led to an increased rate of nicotine addiction among teens throughout the nation, eventually resulting in a ban on the products.

The company denied all the allegations and disagreed with the findings of the F.D.A. The spokesperson for the JUUL said that the company is looking forward to appealing the decision of the product ban.

Currently, the company faces hundreds of lawsuits from families of teens and young adults against vape products. The lawsuits allege that the manufacturer specifically designed the products to lure the children to use the e-cigarettes resulting in lifetime addiction for them. The lawsuits even allege that JUUL failed to warn about nicotine concentrations and potentially harmful chemicals in the vape pens.

There are four types of JUULpods and a JUUL device. The pods manufactured by JUUL include Virginia tobacco-flavored pods and menthol-flavored pods with 5.0% and 3.0% nicotine concentrations.

According to a federal survey, the use of e-cigarettes among teens increased in 2017 and 2018 due to the rise in the popularity of vape products. The usage rate of the products among high school students was 11.7% in 2017, which rose to 27.5% in 2019 and drastically decreased to 11.3% in 2021.

South Carolina has issued a report on how it will spend the hundreds of millions of dollars it receives from the nationwide opioid settlement.

The state would receive more than $360 million from the $26 billion nationwide settlement. Manufacturer, Johnson & Johnson, along with three pharmaceutical drug distributors Amerisource Bergen, Cardinal Health and McKesson, will pay the money to the state over the next 18 years.

As per the deal, South Carolina's 92% share of the settlement would be used to tackle the opioid epidemic in the state. Even the Director of the South Carolina Department of Alcohol and Other Drug Abuse Services said that considering the drug crisis, it is necessary to use the funds wisely by not wasting them on unnecessary things.

South Carolina Department of Alcohol and Other Drug Abuse Services (DAODAS) and the South Carolina Institute of Medicine and Public Health, along with assistance from the Department of Health and Environmental Control, have written a 40-page guide that outlines the list of approved uses of the funds.

The funds would be used to buy approved drugs such as Naloxone and others that would reverse opioid overdoses. It would also be used to implement recovery programmes to prevent the future opioid crisis. Apart from it, the fund would also assist to collect data, execute research and analyze the consequences of opioid use to help the authorities to execute significant strategies to deal with the epidemic.

However, counties, municipalities, hospitals, NGOs, and other organizations are free to choose how they think their funds should be used.

As per the agreement, about two-thirds of the fund's share is reserved for the local governments. South Carolina's Attorney General said that considering the opioid harm metric, a guaranteed amount would be allotted to all 46 counties and more than 40 cities and towns. Larger cities and counties will get larger sums of money compared to the smaller cities.

Hospitals, non-profit organizations and other groups requesting funding would get more than 100 million of the remaining amount to combat the crisis. The approval of the funds' distribution would be done by a new, nine-member board that would include representatives from different regions of the state.

Nearly 4,000 South Carolinians have died from opioid overdoses in the past three years. This number is because of the legal opioids, and the number can go much higher, citing the smuggling of illegal opioids such as fentanyl.

DHEC will offer fentanyl test strips for free to the public through health departments to prevent addiction among the people. People would also receive training on the usage of Narcan, a drug that reverses the effect of overdose.

The national settlement of $26 billion is just one component of the agreement. The drug distributors are even mandated to report suspected opioid orders, and the drug manufacturer J&J is ordered to stop its sale.

A bill to legalize fentanyl test strips has been approved by the Pennsylvania House of Representatives to avert the further opioid crisis in the nation.

The bill was first introduced by a representative of Indiana County in 2019 and reintroduced in 2021. The bill seeks to reduce fentanyl overdoses by making the strips free of legal barriers. Currently, in many parts of the state, the usage and possession of the strips are illegal and might result in penalties.

The legislation aims to raise awareness through the bill by reducing overdoses of opioids rather than penalizing the people experiencing addiction. Even the House Judiciary Committee has approved the bill to deal with the epidemic.

The representative of the state said that Fentanyl, which is a synthetic opioid is one of the major causes of overdose deaths throughout the nation. He even informed that the strip test will only help to control the substance abuse and prevent the next dangerous crisis that would impact the society.

The fentanyl test strips and other testing products are listed under drug paraphernalia, but the bill will get them removed to reduce the number of overdose deaths in the state. The strips are proven to help people assess and reduce their risk of overdose. People should be encouraged to use it to control opioid overdoses. Penalizing the distribution and use of fentanyl strips would only harm society.

Earlier, in May, an attorney general provide a special report that warned fentanyl is the dominant opioid in Pennsylvania. The drug is 50 times more concentrated than heroin and 100 times more concentrated than morphine contributing to a significant rise in overdose deaths. It is also comparatively cheap, making it easily accessible and causing more harm to the communities.

As per the state data, Pennsylvania accounted for 5,224 drug overdose deaths in 2021. The data provided by National Center for Health Statistics log one million overdose deaths throughout the nation since 1999

Mallinckrodt Pharmaceuticals plc will pay at least $6 million to Kansas as per Kansas' Attorney General's order over the company's role in the national opioid crisis.

The approval of the fund distribution was part of Mallinckrodt’s bankruptcy proceedings. Kansas would use the funds to address substance abuse and addiction. The AG's office of Kansas has now recovered nearly $200 million over the lawsuits related to illegal opioid manufacturing, marketing and distribution.

The AG said that he has worked hard to reach the settlement and make the drug manufacturing companies pay for their unlawful business practices, which led to addiction and human suffering. Kansas will receive the payment over the next eight years.

Earlier in February, the AG finalized and approved a $26 billion opioid settlement involving the nation’s three major pharmaceutical distributors and manufacturer Johnson & Johnson. It would clear the way for the states' and local governments' funds to treat and prevent opioid addiction.

Johnson & Johnson and the distributors would pay $35 million and $153 million, respectively, to Kansas and its local government. The AG even reached a settlement with McKinsey & Company in 2021 over its roles in the opioid epidemic, where the firm would pay $4.8 million to Kansas for drug treatment and addiction abatement.

The settlement would be distributed under the Kansas Fights Addiction Act, which focuses on addressing substance abuse and helping ensure addiction services are provided throughout the state. A grant review board has been created by the statute to execute the funding process of addiction treatment and abatement.

The AG's office has recovered more than $1 billion for Kansas consumers and taxpayers since 2011, which is far better than the previous administration.

Bayer has won the fourth consecutive trial as the jury found that the company's Roundup weedkiller did not cause cancer in the Oregon man involved in the lawsuit.

The verdict was announced in the Circuit Court of Jackson County, Oregon, after considering the assessments of expert regulators worldwide. The company even provided reports and scientific studies of over four decades which stated that the Roundup is safe for use and is not carcinogenic.

The spokesperson for the company said that it will continue to defend Roundup by standing firmly with the decision that it is safe for use.

Bayer faces a number of lawsuits against its weedkiller where all the plaintiffs allege that exposure to the product causes cancer due to the presence of Glyphosate, an active ingredient of Roundup. The lawsuits mostly involve residential gardeners who are more exposed to the weedkiller.

Bayer bought Monsanto in 2018, which is the parent manufacturer of Roundup, and the company is facing growing litigation throughout the country. Bayer has already settled 100,000 Roundup cases resulting in penalties worth billions of dollars.

The studies found that glyphosate may cause eye or skin irritation. It is also linked to causing irritation in the nose and throat if a human breathes the spray mist from the products. Increased saliva, burns in the mouth and throat, nausea, vomiting, and diarrhea are other consequences of swallowing glyphosate products.

The weedkiller is also linked to non-Hodgkin's lymphoma, but in the earlier trial, Bayer won the lawsuit due to lack of evidence. It was the third consecutive win for the company.