Weekly Mass Torts Bulletin 2023-July-24

Federal regulators have announced a warning label update over Horizon Pharmaceuticals' Tepezza which may cause severe and permanent hearing damage.

The drugmaker faces a growing number of lawsuits over Tepezza, alleging that the organization failed to adequately warn users or the medical community about risks associated with their new-generation thyroid eye disease treatment.

As the first treatment for bulging eyes and double vision brought on by thyroid eye disease, Tepezza was released in January 2020. These diseases, which lead to inflammation of the eye muscles, eyelids, tear glands, and fatty tissues behind the eye, are brought on by hyperthyroidism and are connected to Graves' disease.

Tepezza was first thought of as a niche medicine, but Horizon Therapeutics soon elevated the medication to a blockbuster level when it received approval, generating sales of more than $1 billion annually. However, questions regarding the possibility of Tepezza hearing adverse effects and whether the drug's manufacturer did enough study on their treatment or adequately explain the dangers that patients could have after treatment immediately surfaced.

The U.S. Food and Drug Administration (FDA) recently issued an updated edition of the Tepezza prescription information guide that includes a new section on the risks of severe hearing loss, which might sometimes be irreversible. Additionally, clinicians should check their patients' hearing before, during, and after Tepezza infusions, according to the updated Tepezza cautions about hearing loss.

After several former users filed product liability lawsuits against Horizon, claiming that Tepezza's adverse effects that were not sufficiently reported on the first warning labels had left them with irreparable hearing issues, the warnings update was released. Plaintiffs contend that if Horizon Therapeutics had given them early warnings regarding the need of monitoring their hearing both before and during treatments, they would have been able to prevent irreversible damage to their ears.

A new part of the FDA-approved Tepezza label has been added, and it carries virtually similar cautions to those that plaintiffs contend Horizon Therapeutics should have included when the medication was initially made available.

The new Tepezza label warning states that the medication "may cause severe hearing impairment, including hearing loss, which in some cases may be permanent." Assess the hearing of patients before, during, and after Tepezza therapy, and weigh the benefits and risks of patient care.

Despite the knowledge that Tepezza has been connected to irreversible hearing loss since its clinical trials, according to many lawsuits brought against the maker, Horizon Therapeutics, the business has fought efforts to include a warning about hearing loss on the label.

In recent research, it was shown that over 16% of people who used medication for thyroid eye illness experienced hearing issues, including hearing loss, tinnitus, autophony, and eustachian tube malfunction. This led to the amendment of the warning.

Johnson & Johnson filed a lawsuit against the federal government, making it the latest producer of opioid drugs to try to stop a policy that allows the Medicare government health insurance plan to bargain for cheaper medication pricing.

The pharmaceutical industry claims that President Joe Biden's centerpiece inflation reduction act law's medication price negotiating program would reduce earnings and force drugmakers to halt the development of ground-breaking new therapies.

The Biden administration intends to save $25 billion annually by 2031 by letting Medicare negotiate pricing for some of the most expensive medications used by its beneficiaries, who are 65 and older, despite the fact that Americans spend more on prescription drugs than any other nation.

The first 10 pharmaceuticals to be the subject of talks with new pricing slated to go into effect in 2026 are anticipated to be chosen by the U.S. Centres for Medicare and Medicaid Services (CMS) in September.

We will vehemently defend the President's medication price negotiating bill, which is already assisting in bringing down the cost of medical care for the elderly and those with disabilities, as the Secretary has previously made clear. According to a statement from the U.S. Department of Health and Human Services, the law is on our side.

The complaint was submitted to the District of New Jersey U.S. District Court by the pharmaceutical division of J&J, Janssen. It makes the same claims made in the other cases that are linked to it, claiming that the program is unlawful and amounts to "confiscation of constitutionally protected property."

According to a statement from the firm, the government is pressuring Janssen to provide its cutting-edge, patented medications at costs that are required by law to be much lower than those on the open market.

Additionally, the complaint claims that the legislation forbids the corporation from making claims it seems to be false and deceptive, such as that the costs associated with the program are reasonable, in violation of the First Amendment's protection of free expression in the U.S. Constitution.

The business Johnson & Johnson has increased its criticism of scientific findings by suing four doctors who published papers indicating ties between talc-based personal care products and cancer.

LTL Management, a J&J subsidiary that took on the company's talc liability in a contentious 2021 spinoff, last week filed a lawsuit in New Jersey federal court, asking the court to order three researchers to "retract and/or issue a correction" of a study that claimed patients occasionally developed mesothelioma after using consumer talc products containing asbestos.

One of the scientists refrained from commenting. Inquiries about the other two did not receive a response. Lawyers who previously defended the three researchers in a related lawsuit declined to comment.

More than 38,000 lawsuits have been filed against J&J on the grounds that the company's talc products, particularly its Baby Powder, contained asbestos and contributed to the development of malignancies, including ovarian and mesothelioma. J&J is making a $8.9 billion settlement offer in bankruptcy court to settle those cases, as well as any further talc litigation. According to J&J, its talc products are risk free and asbestos-free.

Due to an increase in litigation and "misinformation" regarding the safety of the talc product, J&J has discontinued distributing talc-based Baby Powder in favor of cornstarch-based goods.

The claims had a mixed record at trial, including some defense wins, but also a $2.1 billion decision handed to 22 women who claimed that the asbestos in the business's talc products caused their ovarian cancer. The corporation started looking for bankruptcy as a potential resolution to the litigation in 2021. The expenses of J&J's talc-related judgments, settlements, and legal fees have reportedly totaled roughly $4.5 billion, according to bankruptcy court files made in April.

The lawsuit filed last week by LTL against two pathologists associated with Peninsula Pathology Associates in Newport News, Virginia, and a pulmonologist who practiced at the Massachusetts General Hospital Cancer Center before his retirement follows a similar complaint that LTL filed against a different physician in Great Neck, New York's Northwell Health, in late May.

The doctor studied 33 individuals whose only exposure to asbestos, according to them, came from talc goods in a 2019 report, and pathologists followed up with a 2020 analysis of 75 comparable patients.

According to the allegations, all four physicians have testified as experts in litigation brought against J&J and their work has been used where they have not. LTL claimed that the researchers hid the information that some or all of the study participants had already been exposed to asbestos from unrelated sources.

Additionally, the corporation is requesting that the researchers be ordered by the court to provide the names of the patients. Fraud and other offenses are among the accusations made in the cases.

According to a lecturer at the University of Southern California Gould School of Law, businesses hardly ever bring legal action because of opposing studies. For product disparagement claims in New Jersey, LTL will find it very challenging to demonstrate that the researchers intended to hurt J&J's brand; nonetheless, the business may use the lawsuits as an opportunity to deter future researchers or recover the narrative around talc safety.

A statement from the researchers was not immediately available. Similar lawsuits were brought by LTL against the researchers in December 2022, but these were dropped in April along with the remainder of the bankruptcy since they were connected to LTL's initial bankruptcy filing.

The U.S. Food and Drug Administration has revised its guidelines to assist patients in making knowledgeable choices on the use of surgical mesh in hernia repair.

The FDA examined 45 research articles published in the previous 11 years and 22 years' worth of adverse event reports in response to concerns regarding the safety of hernia mesh devices.

The adverse event reports list issues including discomfort, harm, and impairment, and the papers offer estimates of how frequently typical complications occur. The FDA has already taken a different kind of mesh off the market, but it is still keeping an eye on the safety of hernia devices.

In 2019, the FDA prohibited the marketing of mesh devices used for transvaginal pelvic organ prolapse repair. Mesh technologies have a longer history and a superior safety track record when it comes to abdominal hernia repairs.

But there are issues with the hernia devices. A man who received treatment with Ventralex hernia mesh from C.R. Bard, a Becton Dickinson affiliate, last year was awarded $4.8 million by a jury. More than 33,000 product liability lawsuits have been filed against BD over their range of hernia repair tools. For the autumn, more experiments are planned.

In light of this, the FDA has disclosed its current assessment of the available data about the safety of surgical mesh in hernia repairs. The organization provided information from two sections of its safety monitoring program, outlining the most frequent adverse occurrences in its 55,000 reports and outlining the findings of its research of the scholarly literature.

The FDA reports most commonly cite pain, damage, disability, infection, inflammation, and nausea as adverse effects. The literature and this coincide to some extent. The FDA discovered incidence ranges of 0.3% to 68% for pain and 0% to 21% for surgical site infection in the literature. Up to 3.8% of the time, pain has a major negative influence on quality of life.

The deadly synthetic opioid fentanyl, which has been responsible for thousands of deaths in Texas over the past several years, has been tracked by the state of Texas using an internet program.

The governor made the announcement as part of his office's "One Pill Kills" fentanyl awareness campaign. The dashboard is run by the Department of State Health Services. The dashboard shows state-wide averages for Fentanyl poisoning fatalities, along with how they stack up against all other drug-related poisoning fatalities.

The statement emphasized that Texas continues to step up its efforts to address the spreading fentanyl problem afflicting our state and the country and that more than five Texans die every day from lethal fentanyl. The information posted on this website will assist Texans in taking the lead in the battle against this dangerous substance. Texans must band together to increase awareness of this deadly opiate among families, friends, and communities.

According to the website, the state defines a fentanyl-poisoning death as one in which "fentanyl is indicated in the cause of death description", and it is found that the fatality was inadvertent or accidental.

The U.S. Drug Enforcement Administration claims that opioid has effects comparable to morphine despite being 100 times stronger. The DEA stated in a fact sheet that "two milligrams of fentanyl can be lethal depending on a person's body size, tolerance, and past usage."

According to Texas data, more than 2,160 people died in 2022 as a result of fentanyl intoxication. Of the 4,844 drug-related deaths in the state that year, that represents nearly 44%. This is an increase from the 891 and 1,645 fatalities attributed to fentanyl in 2020 and 2021, respectively. Fentanyl-related fatalities have been linked to 540 deaths as of June 2023 (the website notes that data from the previous three years is provisional and subject to change). Additionally, the data is separated by age, gender, and race or ethnicity.

The program also offers statistics for the entire county, including the overall number of fatalities and the fatality rate per 100,000 inhabitants. Since 2014, the data has been available for yearly tracking. Unsurprisingly, the opioid crisis has been most severe in the state's major metropolitan counties. In Harris County, there were more than 500 fatal poisonings from fentanyl in 2022. Following that are 74 in El Paso, 194 in Travis County, 181 in Bexar, and 199 in Dallas County.

Travis County had the highest mortality rate per 100,000 people in 2022, at 14.45, compared to Harris County's rate of 9.72, although having fewer fatalities overall than Harris County. Montgomery County had a rate of 9.66 and 63 fentanyl-related fatalities in 2022. El Paso County's rate was 8.32, followed by Bexar County's 8.32.

The launch of the online tool comes after a legislative session in Austin during which lawmakers enacted multiple bills to prevent the use of the synthetic drug in Texas, including a House bill that establishes a state charge of murder in the event that selling the drug leads to death. The legislature also approved a bill to increase access to Narcan, often known as Naloxone, in colleges and institutions. If used in time, the medication can save a life as it immediately reverses the effects of opioids.

The governor of Texas, Greg Abbott, is furious with the Biden administration because of the state's opioid epidemic and claims that the illegal drug trade is encouraged by the White House's so-called "open border" policy. Abbott started Operation Lone Star, a government-run and taxpayer-funded border security initiative, more than two years ago. In the recently approved state budget, which covers the fiscal years 2024 and 2025, border security operations got more than $5 billion, including billions allocated for continuing the work.

Critics of the operation point out that rather than between the ports of entry, the majority of the fentanyl enters through the ports that link the United States and Mexico. More than 90% of the fentanyl collected since the start of the federal government's 2023 fiscal year in October, according to a study from the Washington Office on Latin America, has entered the country through ports of entry.