Weekly Mass Torts Bulletin 2022-July-18

Allergan and Teva, two manufacturers of opioids, have agreed to pay $54 million in cash and medications to reverse overdoses to settle a federal lawsuit filed by San Francisco that claimed the drug business was responsible for a spike in overdoses and addiction that resulted in a public nuisance.

The statement was made on Tuesday before the last defense arguments against Walgreens, the only surviving defendant, began later in the morning. The drugstore chain is accused in the complaint of over-dosing on opioids without enough monitoring and of failing to recognize and report suspicious orders as required by law.

The number of drug overdose deaths nationwide has increased, including in San Francisco. The Tenderloin district saw the declaration of a state of emergency last year, with officials stating that something needed to be done about the area's high number of drug sellers and users in public places.

According to the city attorney's office, between 2015 and 2020, the number of overdose deaths in San Francisco connected to opioids increased by about 500%, and on an average day, about 25% of visitors to the Zuckerberg San Francisco General Hospital Emergency Department are related to opioids. According to the agreement made public on Tuesday, the two opioid producers would provide $20 million in Narcan and $34 million in cash to San Francisco.

The settlement represents a step toward bringing life-saving therapies to those suffering from opioid addiction, according to Teva Pharmaceuticals, a U.S. subsidiary of Teva Pharmaceutical Industries Ltd., but it is not an admission of culpability or wrongdoing.

The representative for Walgreens failed to reply to a request for comment, and Allergan did not. Only a small number of government lawsuits brought against corporations because of the opioid epidemic have gone to trial thus far, with the San Francisco case being one of them.

Before trials, more cases were resolved. AmerisourceBergen, Cardinal Health, McKesson, and medication manufacturer Johnson & Johnson completed $26 billion in countrywide settlements earlier this year.

A $10 billion arrangement that Purdue Pharma constructed after filing for bankruptcy owing to the numerous lawsuits the manufacturer of OxyContin was facing is currently being reviewed by the court in an effort to get permission.

According to a count by the Associated Press, proposed and final settlements related to the outbreak in the U.S. have cost a combined total of more than $40 billion. The majority of the legal action to far has addressed businesses that manufacture or distribute opioids, although there has also been lawsuit brought against pharmacies.

One drugstore lawsuit has only received a verdict thus far. An Ohio jury determined that CVS, Walgreens, and Walmart supplied opioids carelessly in two counties last year. A judge will decide on their punishment.

Another federal court has rejected Bayer and Monsanto's efforts to block failure to warn allegations made in Roundup lawsuits, ruling that a Georgia man's claims under state law are not preempted by the controversial weedkiller's clearance under the Federal Insecticide, Fungicide, and Rodenticide Act.

The U.S. Court of Appeals for the 11th Circuit revived a Roundup case on Tuesday. The original plaintiff claimed he used the glyphosate-based weedkiller on his lawn for 30 years and as a result, got eye cancer.

A settlement was struck to address the remaining design fault and negligence claims after a District Court earlier rejected the plaintiff's failure to warn and breach of implied warranty allegations. However, the plaintiff challenged the dismissed claims, which Bayer said were barred by federal law since Roundup's registration had been authorized by the U.S. Environmental Protection Agency (EPA).

The Roundup preemption argument seeks to stop plaintiffs from pursuing failure to warn claims based on state law, contending that any additional warnings would have been in conflict with the decision of federal regulators to approve the products without such warnings on the label. Drug and medical device manufacturers have successfully used this defence in the past for specific products that underwent the FDA's pre-market approval process.

The EPA's registration procedure does not have the legal weight to serve as the basis for a preemption claim, according to the Eleventh Circuit, which reversed the lower court's earlier ruling and rejected Bayer's argument.

Nearly 100,000 Roundup lawsuits were filed against Bayer and its Monsanto subsidiary at one point by former weedkiller users who had been diagnosed with non-Hodgkins lymphoma, each of whom claimed that information and warnings regarding the cancer risk associated with the weedkiller had been withheld from consumers and regulators for years.

Bayer has agreed to pay billions in Roundup settlements after multiple plaintiff victories in cases that went to trial in 2018 and 2019. Thousands of cases are still making their way through the court system after claimants refused offers to settle or filed additional claims in response to a recent diagnosis of non-Hodgkins lymphoma. However, it has persisted in pursuing appeals from numerous early rulings.

Bayer declared last year that it intends to eliminate the active chemical glyphosate from Roundup weed killers supplied to residential customers in the United States by 2023 in order to reduce its potential responsibility for Roundup. Although a different active component would be used in the products one that has not been connected to a risk of non-lymphoma Hodgkin's would still carry the Roundup label and continue to be sold. However, according to Bayer representatives, glyphosate will still be utilized in goods marketed to farmers and agricultural enterprises as well as goods sold abroad.

Thousands of people pursuing comparable claims asserting that the recalled heartburn medication Zantac, which is turned into a hazardous, cancer-causing substance within the human body will be keenly watching a set of four Zantac cancer cases that a California state court judge has slated for trial in 2023.

Before it was pulled off the market in late 2019, Zantac (ranitidine), a medication used by millions of Americans to treat heartburn and acid reflux, was found to be intrinsically unstable and to create large amounts of the chemical byproduct N-Nitrosodimethylamine (NDMA), a strong human carcinogen.

More than 100,000 product liability claims have been filed against manufacturers, distributors, and retailers of brand-name Zantac or generic ranitidine pills by former users who claim Zantac caused cancer as NDMA moved through the body after years of exposure. These companies include GlaxoSmithKline, Boehringer Ingelheim, Pfizer, Sanofi, and various others.

While many of those cases have been brought in the federal court system, some have also been brought in state courts across the country, including California. In these cases, they have been consolidated before one state judge under what are known as Judicial Council Coordinated Proceedings (JCCP), and the court is coordinating them during pretrial proceedings.

A series of four bellwether trials will be heard in the Alameda branch of the California Superior Court next year, according to a pretrial order that the judge issued late last month. Previously, it was anticipated that the first Zantac trial dates in California would start in October 2022.

A second trial will start on May 1, a third trial will start on August 7, and the fourth bellwether trial will start on October 23, according to the revised timetable. The first bellwether case will commence on February 13, 2023. The order makes no mention of the delay's cause.

The federal court system has implemented a similar "bellwether" procedure, wherein claims filed in U.S. District Courts nationwide are likewise centralised before one judge for coordinated pretrial hearings, and the Court has already said that the first federal Zantac trial will start in 2023.

The results of these early trial dates will not be binding on other plaintiffs, but they are anticipated to have a significant influence on the amounts of any Zantac settlements the manufacturers may offer to prevent the nationwide scheduling of tens of thousands of individual trials in the upcoming years.

In a historic case accusing three large American drug distributors of creating a public health emergency by dispensing 81 million pills over an eight-year period in a West Virginia county where opioid addiction is rampant, a federal court decided in favor of the defendants on Monday.

In the action brought by Cabell County and the city of Huntington against AmerisourceBergen Drug Co., Cardinal Health Inc., and McKesson Corp., the judgment was rendered about a year after closing arguments in a bench trial.

The residents of Cabell County and the City of Huntington have suffered greatly as a result of the opioid crisis. Even while there is a tendency to place blame in these situations, the U.S. District Judge said in the 184-page decision that the case should be determined on the basis of the facts and the law, not on pity. The court determines that a judgement in the defendants' favour should be rendered in light of its findings and recommendations.

The district attorney for Cabell County argued that the distributors should be held accountable for dispersing a "tsunami" of prescription painkillers throughout the neighborhood and that the defendants' actions were irrational, careless, and disregardful of the public's health and safety in a region where opioid addiction is rampant.

The pharmaceutical industry put the blame on an increase in doctor-written prescriptions, poor communication, and pill quotas established by government officials. Although the distributors were accused of causing a public nuisance in the complaint, West Virginia's Supreme Court has only applied the public nuisance statute to activity that interferes with public resources or property.

Plaintiffs did not provide any proof that the defendants delivered controlled drugs to any organisation that was not properly registered with the state board of pharmacy or the Drug Enforcement Agency. The Controlled Substances Act required the defendants to have suspicious monitoring mechanisms in place, which they did. Plaintiffs failed to demonstrate that the defendants' actions were unreasonable in relation to the amount of prescription opioids supplied in Cabell/Huntington.

According to a statement from Cardinal Health, the judge's decision acknowledges what we proved in court: We do not produce, market, or prescribe prescription drugs. Instead, we only act as a secure channel for manufacturers to deliver drugs of all kinds to our thousands of hospital and pharmacy clients, who then dispense them to their patients in accordance with doctor-ordered prescriptions. We are dedicated to being a part of the solution to the opioid epidemic, and we are working to prevent controlled drug diversion by maintaining our small but crucial position in the pharmaceutical supply chain.

The plaintiffs' counsel expressed their "great disappointment" with the decision. We believed that the information gleaned through witness accounts, business records, and enormous datasets demonstrated that these defendants were in charge of setting up and managing the infrastructure that allowed opioids to flood West Virginia. Regardless of the outcome, we want to express our gratitude to the first responders, public servants, medical experts, researchers, and many more people who shared their testimonies to reveal the truth.

The COVID-19 pandemic exacerbated the addiction epidemic in the United States, with drug overdose fatalities exceeding 100,000 in the year ending in April 2021, according to the Centers for Disease Control and Prevention. That year saw the most overdose fatalities ever reported. In all, state and local governments, Native American tribes, unions, hospitals, and other institutions have filed more than 3,000 cases in state and federal courts over the harm caused by opioids. Most claim that in a problem connected to the deaths of 500,000 Americans over the previous 20 years, drug manufacturers, distributors, or pharmacies created a public nuisance.

The state of West Virginia settled with McKesson in a separate, related action for $37 million in 2019, Cardinal Health for $20 million, and AmerisourceBergen for $16 million in 2017.

The acceptance of a $3.5 million settlement from drugstore chain Rite Aid as part of a multi-jurisdictional action against opioid dealers and manufacturers would be decided by the Cobb County commissioners' vote.

The settlement is worth $10.5 million and is divided between Durham County in North Carolina and Cobb County in Ohio, with a third of the total amount going to each local government. As municipal and state governments throughout the country started suing manufacturers like Purdue Pharma, which makes OxyContin, for losses brought on by the opioid crisis, Cobb initially joined the lawsuit in 2018.

The lawsuit claimed Rite Aid failed to properly monitor and report suspicious orders of prescription opioids from its retail stores and failed to put measures in place to prevent the diversion of prescription opioids, which led to an increase in opioid addictions, overdoses, and fatalities. Rite Aid says these failures were due to a lack of effective monitoring and reporting.

Rite Aid accepts the money without admitting any wrongdoing. Rite Aid will be required to advance the county's $1.25 million each if the insurers are unable to pay the $10.5 million total as soon as possible, despite the company's efforts to persuade them to do so. A federal judge chose Cobb's claim as one of many "bellwethers," or test cases, from a much broader body of litigation.

According to county attorneys, there were 1,430 plaintiffs participating in the lawsuit as of 2018. According to a document from the County Attorney, the case was scheduled to go to trial in 2019.

A committee has been formed by the county manager in the meantime to offer suggestions on how the cash should be distributed. The parties to the litigation are prohibited from discussing the settlement with the public or members of the media under the terms of the agreement.

The Rite Aid action, however, seems to be unrelated to another opioid deal the county entered into with a number of the biggest drug distributors in the country, as well as Johnson & Johnson, in November.

The state's consent to engage in the settlement was a requirement for Cobb's involvement. Attorney General made the announcement in January that Georgia will join the settlement, which would pay Georgia and its local governments $636 million and amounts to a $26 billion national settlement.

The Rite Aid deal comes as Cobb continues to have triple-digit drug overdose deaths each year. 180 individuals died of unintentional drug overdoses in 2020, more than in any of the five years before, according to the county medical examiner's most recent annual report, which is only available for the previous year.

Other opioids contributed to 93 deaths in total, 88 of which involved fentanyl. A considerable number of deaths in Cobb County are still caused by acute accidental drug intoxication. Nearly a quarter of the fatalities the (office) investigates are drug-related according to the medical examiner's findings.

According to the Centers for Disease Control, there were over 92,000 overdose fatalities nationwide in 2020. Roughly 56,000 deaths involved synthetic opioids, particularly fentanyl, accounting for over 61 percent of all fatalities. The deal will be put to a vote by the Cobb commissioners at their meeting on Tuesday at 9 a.m. at 100 Cherokee Street in Marietta.