Weekly Mass Torts Bulletin 2022-May-16

A trial has begun in federal court in Cleveland, where a judge will decide the amount of penalty the two Ohio counties will get from CVS, Walgreens and Walmart pharmacies over the companies' alleged role in the opioid crisis.

In November's trial of opioids, a jury discovered that pharmacy chains are responsible for the massive amount of pain pills distributed in Lake and Trumbull counties. It is the first case in the U.S. where the pharmacies are held responsible for the opioid epidemic.

The plaintiff's attorneys said that the pharmacies need to pay $1 billion each to both the counties for the damage caused due to the surge of pills, which eventually resulted in hundreds of overdose deaths.

From 2012 to 2016, 61 million pills were distributed in Lake County, which accounted for 265 pills for each resident. On the other hand, Trumbull County received 80 million prescription painkillers accounting for 400 for every county resident.

As per the estimates provided by an epidemiologist from Columbia University, in 2019, Lake County and Trumbull County reported that 6,000 and 7,600 people, respectively, suffered from opioid use disorder and addiction. The epidemiologist even testified that thousands of children from the two counties suffered from learning problems, mental illness and other issues, including PTSD as their parents used illicit opioids. The attorneys representing the pharmacies questioned the estimates provided by the epidemiologist.

The counties are expected to argue by presenting testimonies from doctors to elaborate on the damage suffered by the communities because of the opioid crisis, which impacted child welfare, other county agencies and an abatement plan for the counties.

Since 2015, drug overdose deaths have increased in the two counties because of synthetic opioids like fentanyl. The drug problems began after the users became addicted to prescription opioids initially. Even the children of the parents who use opioids are vulnerable to addiction.

The federal juries across the U.S. have resolved many opioid lawsuits in recent years by providing relevant verdicts and settlements. A total settlement amount of over $40 billion has been agreed upon by the drug makers, distributors and pharmacies until now.

According to the data provided by the U.S. Centers for Disease Control, the country reported nearly 500,000 deaths from 2000 to 2019 due to legal and illegal opioids.

The Biden administration has asked the U.S. Supreme Court to reject Bayer AG's appeal to dismiss the Roundup claims alleging that the weedkiller causes cancer.

Roundup is the top-selling product of Bayer, which is currently facing several lawsuits that would potentially cost billions of dollars for the company. All the lawsuits against the company allege that the use of weedkillers results in cancer.

One of the plaintiffs from California alleges that decades of Roundup exposure resulted in causing his non-Hodgkin’s lymphoma. The case will ultimately be useful to settle tens of thousands of claims. The victory for Bayer in this Supreme Court case will save $3 billion from the $16 billion set aside by the company to deal with the weedkiller claims.

As per the lawsuit, the plaintiff used Roundup from the 1980s to 2012 on his plot of land in Sonoma County, located about 60 miles north of San Francisco. In 2015, he got diagnosed with lymphoma. He sued Monsanto under California law by claiming that the company failed to warn the risk of using Roundup, which caused his illness. He was awarded more than $80 million initially, but the trial judge reduced the settlement to $25 million, and the appeals court upheld the award.

Bayer argued in the Supreme Court that as per the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the company is immune to liability. FIFRA law says that states may not impose packaging or labeling requirements that are different from federal law. The company even argued that a speculative testimony was allowed by the trial judge, which was improper.

The lawyers for the plaintiff urged the Supreme Court to not hear the case as the award is relevant as per the 2005 Supreme Court ruling where the state lawsuits were allowed if the FIFRA and state warning requirements comply.

The U.S. District Judge who is overseeing all the Elmiron lawsuits has selected three cases that will be prepared for a series of bellwether trials beginning on the first half of 2023.

As per the complaints filed by the Elmiron users, the manufacturers of the drug failed to warn the users and the doctors about the importance of monitoring for vision changes and provided misleading information resulting in blurry or distorted vision, as well as blindness.

The first case from the selected three cases was filed by a Georgia couple who alleged that the Elmiron usage from 2008 through 2014 resulted in injury to both eyes of the lady. The couple revealed that they were not aware of the side effects of the drug as the manufacturers did not provide any warnings.

The second case was filed in January 2021 by a lady from Broussard, Louisiana. The woman alleges that she suffered vision loss and macular degeneration due to years of Elmiron usage.

The third case was filed in October 2020 by a woman in Louisiana with allegations that she suffered from retinal pigmentary changes, including macular degeneration, after using the drug from 2012 to 2014.

Elmiron (pentosan polysulfate sodium) is a medication used to treat interstitial cystitis or painful bladder syndrome. The lawsuits filed against the medication allege that the usage of the drug results in the users suffering from permanent vision problems, including a form of retinal damage known as pigmentary maculopathy.

The jury established a bellwether process to deal with the Elmiron settlement negotiations. A case could be identified as a bellwether trial case only if the plaintiff has developed either pigmentary maculopathy or suffered exacerbation of an underlying retinal disorder after consuming the Elmiron. Another clause mandates that the drug should have been ingested on or before November 7, 2021.

The U.S. District Judge Brian R. Martinotti is overseeing all the Elmiron lawsuits, which are consolidated in litigation in the District of New Jersey. The litigation was formed in December 2020 for coordinated discovery and pretrial proceedings.

A Sauk County woman who got diagnosed with terminal cancer has sued the CPAP maker by joining the lawsuit that alleges the sleep apnea treatment machine causes cancer.

As per the lawsuit, the woman went through different models of the continuous positive airway pressure (CPAP) machine known as the DreamStation since 2008. She even used one of the voluntarily recalled devices by Philips Respironics. The woman stated that she regularly used the machine due to her bad sleep apnea.

The woman suffered from breathing problems that began in August 2016 post which she got diagnosed with asthma. In July 2020, she got diagnosed with cholangiocarcinoma, or bile duct cancer which is now in the fourth stage of severeness for which she is undergoing chemotherapy treatment.

Citing the problems with the machines, the company has considered recalling the machines. 20 kinds of CPAP, BiPAP and ventilator devices made between 2009 and last year were recalled from the market. The company even informed that it recalled 2.6 million devices in the U.S.

The U.S. Food and Drug Administration (FDA) recorded more than 1,200 complaints and more than 100 injuries because of the machines as of the July 2021 report. The issues have been classified as the most serious ones by labeling them as a Class 1 recall citing the serious injuries and deaths caused by the machines.

As per the data provided by FDA, there are potential health risks associated with the machines caused due to a foam (called PE-PUR, or polyester-based polyurethane foam). The foam is supposed to reduce sound and vibration, but FDA reports state that it could break down entering the device's air tubes and get swallowed.

FDA stated that inhaling or swallowing the pieces of the foam can result in irritation to the skin, eyes, nose and respiratory tract (airway) along with other damages, including inflammatory response, headache and asthma. It can even result in toxic or cancer-causing effects on the kidneys and liver. The foam might even release certain dangerous chemicals.

A Texas-based law firm has created litigation against the machines where roughly 800 claimants have signed suing Philips for the health risks associated with the recalled products.

A spokesperson for Philips informed that the company has shipped more than 650,000 replacement devices to U.S. customers who were affected or faced problems due to the products.

Nearly 300,000 US service members and veterans are suing 3M alleging that the company's earplugs are faulty, which resulted in hearing loss and tinnitus for the users.

One of the service members from Newton, North Carolina, is among the 300,000 plaintiffs who are suing 3M, alleging that the company's Combat Arms earplugs are defective. The plaintiff served the U.S. army by completing two rounds of duty in the US military as a field artillery specialist in Iraq and Afghanistan. He is a decorated service member for training Afghan soldiers on how to operate artillery. The plaintiff accuses that he has been diagnosed with tinnitus, a persistent ringing in his ears due to the use of earplugs during his service tenure. 

As per the lawsuit filed by the plaintiff, the defective earplugs resulted in low ringing in the ears after the combat. He even said that he feels agitated when he wakes up in the middle of the night as it is difficult to get rid of the ringing.

3M has been battling lawsuits over its earplugs since 2018. The company argues that the earplugs efficiently serve their purpose if used properly and do not cause hearing damage. Until now, 3M has won six earplug lawsuits and lost 12.

So far, the total amount of the settlements to be paid by the company accounts for $220 million, including the punitive damages. 3M has not paid the amount yet and has appealed to reconsider the decisions in the court.

Even the government argued that 3M failed to inform the users about the design defects in the earplugs that could harm them. 3M denies all the wrongdoings and said that the products comply with the safety protocols. The company faces one of the largest multi-district litigation in the history of the U.S. over the earplugs.