Weekly Mass Torts Bulletin 2022-December-12

Pharma Companies Win Critical Zantac Litigation

Pharma firms engaged in the selling of the heartburn medication Zantac have won a critical fight in a lawsuit brought by individuals who say the medicine caused them to develop cancer.

The judgement means that the defendants in the claims, which include GSK and its consumer health spin-off Haleon, Sanofi, Pfizer, and Boehringer Ingelheim, will not have to face thousands of federal court lawsuits, though they will still face many thousands more filed at the state level.

Plaintiffs' attorneys have stated that they would challenge the ruling, calling it a miscarriage of justice. Shares of GSK, Haleon, and Sanofi, who are regarded to be the most vulnerable to the potential of large damages verdicts in the case, all increased following the ruling by US District Judge Florida.

GSK invented Zantac and introduced it to the market in the early 1980s as a prescription and over-the-counter (OTC) medicine for conditions such as heartburn and acid indigestion. Sanofi had the rights to the over-the-counter version of the medicine, which was recalled in 2019 due to probable contamination with the suspected carcinogen N-nitrosodimethylamine (NDMA), with the FDA prohibiting sales the following year.

It was offered in generic form by numerous additional manufacturers, including Boehringer Ingelheim, Pfizer, and Johnson & Johnson, who have also been involved in litigation. All of the corporations have stated that they will strongly defend themselves in the cases, which experts believe might result in billions of dollars in damages if the judgments favour the plaintiffs.

GSK welcomed the verdict, citing information from 12 epidemiological studies that indicate there is no consistent or trustworthy evidence that ranitidine raises the risk of any malignancy. The verdict reflects the status of that science and guaranteed that untrustworthy and litigation-driven science did not reach the federal courts, according to the ruling.

The court rejected all |LS|federal Multi-District Litigation (MDL)|RS| lawsuits claiming the five remaining malignancies in the MDL by eliminating plaintiffs' epidemiological evidence and expert testimony based on their inadequacies and unreliability (liver, bladder, pancreatic, oesophageal, and stomach).

GSK stated that it will continue to forcefully defend itself, including against all state-level accusations.

Juul Agreed To Settle 5,000 Vape Suits In North CA Case

Juul Labs stated that it has agreed to resolve about 5,000 cases in a Northern California court case for an unknown price, putting an end to yet another legal battle over its selling and marketing of e-cigarettes blamed for the teen vaping epidemic.

The planned multidistrict lawsuit settlement would include personal injury, consumer class action, government, and Native American tribal claims in a transaction that the corporation said it had secured funding for.

According to a Juul spokeswoman, these agreements are a significant step in strengthening Juul Labs' operations and securing the company's route ahead in fulfilling its aim of transitioning adult smokers away from combustible cigarettes while combating underage usage.

In September, the business paid $438.5 million to resolve an inquiry by three dozen states. This inquiry focused on the company's early promotion of its goods, particularly the employment of juvenile models and the selling of flavours like mango and crème brûlée, which many said were intentionally directed at underage youths. The conditions of the settlement for Juul's marketing banned the business from targeting young people.

In a statement, a co-lead counsel for the plaintiffs stated that these settlements will provide meaningful compensation to victims and their families, real funds to schools for abatement programmes, and assistance to government and tribal entities in preventing youth e-cigarette use across the United States.

The business is still waiting for the Food and Drug Administration to make a decision on permanent clearance to sell its vaping devices and pods. The FDA dismissed the company's attempt to keep its e-cigarettes on the market in June. Juul was granted a temporary court injunction, and the FDA subsequently put its decision on hold for additional examination, which is still ongoing.

According to Juul, the settlement encompassed about 10,000 claimants, many of whom claimed they were unaware that the product may be more addictive than cigarettes. The plaintiffs, who included school districts, also claimed that the e-cigarettes were excessively harmful due to their appeal to young people. They alleged everything from racketeering to fraud and unjust enrichment.

A co-founder of Parents Against Vaping E-Cigarettes expressed hope that the compensation would be significant enough to recompense millions of American families whose lives had been upended by Juul's teenage vaping pandemic. In this multidistrict action, the organisation is not a plaintiff.

She expressed concern about the lack of details initially released by Juul and expressed hope that the judge overseeing the litigation would order Juul to produce documents proving whether the company had purposefully targeted adolescents.

Roundup Leads To Antibiotic Resistance In P. aeruginosa

According to the researchers, glyphosate in Roundup may lead to hazardous germs growing resistant to existing antibiotics, resulting in serious damage or death.

The study comes amid ongoing worries about the long-term consequences of Roundup and glyphosate, which are both ingredients in the commonly used weedkiller and have previously been linked to an increased risk of non-Hodgkin's lymphoma.

The World Health Organization's International Agency for Research on Cancer (IARC) decided in 2015 to classify glyphosate in Roundup as a probable carcinogen, and the manufacturer has been accused of concealing information about the risk of non-Hodgkin's lymphoma for decades in order to avoid any negative impact on sales.

Tens of thousands of Roundup lawsuits have been filed in recent years as a result of Monsanto's failure to disclose the risk associated with their widely marketed weed killer, which uncovered internal documents highlighting how the company has covered up negative findings associated with glyphosate for decades, and manipulated study results involving the widely used weed killer.

While most recent research has focused on the cancer dangers of glyphosate, the key component in Roundup, there have long been worries about its impact on the environment, pollinators such as bees, and microbes.

Low-dose exposure to glyphosate acid (GLY) and glyphosate-based herbicides (GBHs), such as Roundup, appears to boost the antibiotic resistance qualities of Pseudomonas aeruginosa, which can cause severe infections and pneumonia, according to researchers from Hungary.

The gram-negative bacterium Pseudomonas aeruginosa (P. aeruginosa) is commonly found in soil and water. However, it is frequently transferred in hospital settings via contaminated surfaces, people, and equipment, and it can frequently acquire antibiotic resistance.

P. aeruginosa infections can be fatal, causing pneumonia, fevers and chills, breathing difficulties, chest discomfort, tiredness, and coughing. It has a mortality rate that ranges from 18% to 61%.

FDA Approves Narcan As An Opioid-reversal Spray

Emergent BioSolutions Inc., the developer of Narcan, a nasal spray form of naloxone, said that the US Food and Drug Administration has approved an application for an over-the-counter version of its popular opioid-reversal nasal spray.

The business stated that it has been working on the app for several months. According to Emergent, the FDA's priority review gives the medicine a projected approval date of March 29, 2023, putting it ahead of competitors that have indicated their plans to enter the market.

The FDA has pushed pharmaceutical firms to seek permission for over-the-counter versions of overdose-reversal drugs like Narcan in order to combat a growing overdose epidemic caused by fentanyl-laced heroin.

Last week, FDA Commissioner stated that naloxone, which binds to opioid receptors to counteract the effects of opioids, should be as widely available as defibrillators.

Emergent was forced to transition to over-the-counter because to pressure from new potential rivals and the FDA. The FDA informed prescription drugmakers in November that once it has sufficient data to support approval of a nonprescription naloxone product, any naloxone products marketed as prescription-only that do not differ clinically from non-prescription products will be considered misbranded.

Emergent is not modifying the formulation of Narcan in its application to transition to over-the-counter status. The FDA merely requested that Emergent examine whether anyone seeking to use the medicine could read the packing instructions and administer the drug without the assistance of a doctor.

Emergent's CEO stated that the company has not yet determined the price of the over-the-counter drug. According to GoodRx, the average cash price of a box of prescription-only Narcan in November was $152, compared to around $137 for generic competitors in the market.

Two additional businesses pursuing over-the-counter versions of naloxone are expected to push costs even down since they have said that their objective is to reduce pricing to allow for more access.

Pocket Naloxone Corp. and Harm Reduction Therapeutics Inc., a charity funded by the now-defunct Purdue Pharma LP, both claim to want to make the medicine affordable and widely available.

Last year, overdose deaths surpassed 108,000, fueled by illicit fentanyl, which is also making its way into other drugs, such as cocaine and counterfeit pills, killing people who unknowingly consumed opioids.

The recent introduction of generic competition into the $287 million opioid-overdose reversal market has weighed on Emergent's stock, which is down 73% year to date. Naloxone accounts for around 24% of the company's sales.

According to IQVIA Holdings Inc., which gathers medication sales data, sales of Narcan nasal spray increased to $224 million in 2020, or 78% of naloxone sales in monetary terms, up from 15% or $56 million in 2017. In 2020, these dosages accounted for around 48% of naloxone kits, up from 21% in 2017.