We Can Help

The costs of mesothelioma can be overwhelming. They can include income loss, expensive treatments that may not be covered by health insurance, plus pain and suffering for you and for your family. Because the disease is preventable – and because it is usually caused by someone else’s negligence – legal options may be available to help regain these costs. Asbestos lawyers focus their practice on knowledgeably and effectively bringing to justice companies that exposed employees and the public to asbestos products. A mesothelioma attorney can help you consider your options and file a claim against the company responsible for your asbestos-related illness. More than one company may be responsible. A mesothelioma attorney identifies all companies at fault. Mesothelioma lawsuits have helped thousands of people receive financial assistance. A lawsuit can result in much-needed money to help reduce financial hardships during an illness and can also provide a more stable future for your loved ones. A lawyer specializing in asbestos litigation can help you seek compensation for expenses related to illness caused by asbestos exposure.

EPA Proposes Stricter Asbestos Reporting

The United States Environmental Protection Agency has proposed a new rule that would require much stricter reporting and record keeping for all uses of asbestos throughout the past four years.

The rule would require companies that manufacture or process asbestos-containing products to report all types of use, quantities of use and exposure-related information, much of which is not currently required.

It also includes articles containing unintended impurities, such as talc products contaminated with asbestos fibers.

According to the EPA, the data obtained will be used to more accurately guide the agency in future actions. It also will be used in Part II of the ongoing Asbestos Risk Evaluation looking at legacy asbestos and the growing issue of contaminated talc, particularly in cosmetics.

“Getting a more comprehensive and complete set of data on how and where this chemical is used is part of EPA’s broader effort to evaluate the health risks from asbestos and, when needed, put protections in place,” said Michal Freedhoff, assistant administrator for the EPA’s Office of Chemical Safety and Pollution Prevention, in a press release announcing the proposal.

Banning Chrysotile Asbestos

In April, the EPA proposed a new rule that would ban the ongoing use of all chrysotile asbestos, the only known form of raw asbestos currently being imported into the U.S. This proposal stemmed from the earlier Part 1 of the Risk Evaluation.

The chloralkali industry is the only known user of imported raw chrysotile asbestos, but this form of asbestos is still prevalent in products such as automotive brakes and linings, sheet gaskets, diaphragms, oil-field brake blocks and several other vehicle frictions products.

These proposals were the first ever risk-management rules issued under the new process for evaluating the safety of existing chemicals for the Toxic Substances Control Act, which was amended in 2016.

Both proposals are currently undergoing public comments. The EPA will review the comments and incorporate any changes necessary before publishing the final rules in the Federal Register.

An EPA spokesperson told The Mesothelioma Center at Asbestos.com this latest data collection rule will be finalized by December 2022. The Risk Management Rule leading to the ban of chrysotile asbestos should be finalized by December 2023.

EPA Stepping Up Asbestos Action

The rules stem from the EPA’s growing interest in asbestos and its risks to public health, much of it prompted from legal prodding by advocacy groups.

The inhalation or ingestion of microscopic asbestos fibers can cause a variety of serious diseases, including malignant mesothelioma and lung cancer.

Although asbestos has been heavily regulated in the U.S. for decades, the push for a total ban and more comprehensive reporting has intensified in recent years.

“Strong data and the best available science are the foundation of our work to protect communities from hazardous chemicals like asbestos,” Freedhoff said.

Asbestos Regulation Will Intensify for Many

This latest proposal summarized the required reporting as “asbestos in bulk form, in an article, or as an impurity, or as a component of a fixture.”

From the North American Industry Classification System, the EPA also identified nine industries expected to be most affected by the new rule. They are:

  • Oil and Gas Extraction
  • Mining
  • Chemical Manufacturing
  • Nonmetallic Mineral Product Manufacturing
  • Fabricated Metal Product Manufacturing
  • Transportation Equipment Manufacturing
  • Gasoline Stations
  • Repair and Maintenance groups
  • Miscellaneous Manufacturing

In addition to identifying the asbestos being used, companies will also be required to file information regarding the manner or method of disposal, along with environmental and health effects of the substance or mixture.

They will be asked the number of individuals exposed, along with estimates of who also will be exposed to the product in the future, along with the duration of exposure.

These latest proposals come in the wake the EPA’s ongoing Risk Evaluation. Part I of the Asbestos Risk Evaluation, which was released in December of 2020, focused mostly on chrysotile asbestos and current uses, determining unreasonable risk of injury to health.

Part 2 of the Risk Evaluation, which expands the focus considerably, will be released in 2024 and will rely heavily on the more comprehensive data being required.

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New Mesothelioma Immunotherapy Clinical Trial Opens at MD Anderson

The acclaimed MD Anderson Cancer Center in Houston is opening a phase II clinical trial involving a new immunotherapy drug aimed specifically at advanced, rare cancers, including both pleural and peritoneal mesothelioma.

This single-institution clinical trial will be measuring the safety and effectiveness of vudalimab, also known as XmAb20717, which was designed by the California-based biopharmaceutical company Xencor.

Vudalimab’s uniqueness stems from its ability to block the activation of cell surface proteins PD-1 and CTLA-4. These proteins stop the immune system from working properly and promote T-cell activation that targets tumors.

“The hope [with this trial] is that we can show better efficacy, improved response rate and a more durable response for patients than what we see now,” medical oncologist Dr. Arvind Dasari, clinical trial principal investigator, told The Mesothelioma Center at Asbestos.com. “We want to build on what is already out there with immunotherapy and make it better.”

Vudalimab Could Be More Versatile than Opdivo/Yervoy

Researchers believe vudalimab may be able to duplicate the methodology and improve upon the effectiveness of the immunotherapy combination of Opdivo and Yervoy, but with fewer side effects as a single agent. The U.S. Food and Drug Administration approved the Opdivo/Yervoy combination in 2020 as a first-line treatment for unresectable pleural mesothelioma.

As immune checkpoint inhibitors, Opdivo targets the PD-1 cell surface protein and Yervoy targets CTLA-4. Vudalimab alone has shown an ability to target both as a dual blockade agent, the first of its type being touted for mesothelioma treatment.

“The idea is benefiting patients, controlling their cancer and making sure to not adversely affect quality of life with more toxicities,” Dasari said. “For so long there have been only limited options for patients with mesothelioma. We are finally making progress now.”

The earlier phase I clinical trial of vudalimab was spread across a dozen different locations and focused on finding the optimal dosage level, along with ensuring the safety and tolerability for future patients.

“Preliminary data was associated with complete and partial responses in multiple tumor types and was generally well tolerated,” wrote the authors of the phase I trial in Journal for ImmunoTherapy of Cancer. “These findings support further development of vudalimab in advanced solid tumors.”

MD Anderson Specializes in Mesothelioma

MD Anderson, selected to move the drug into phase II, has been ranked the No. 1 Cancer Hospital in America for the past seven years by U.S. News and World Report.

Dasari will be working closely with the center’s mesothelioma specialists, Dr. Anne Tsao and Dr. Raghav Kanwal.

MD Anderson currently has six different phase II clinical trials involving immunotherapy that are available to patients with mesothelioma. One of them is measuring the feasibility of Opdivo and Yervoy injections for patients in combination with mesothelioma surgery.

This latest clinical trial is hoping to enroll 140 patients, including 20 with peritoneal mesothelioma and 20 with pleural mesothelioma, and hopes to establish the efficacy of vudalimab.

“Immunotherapy is one of the keys for improving treatment of mesothelioma, and dual checkpoint inhibition may be part of that,” Dasari said. “Recent data has really shown a compelling need for immunotherapy, and we are building on that.”

Both previously treated and untreated patients with mesothelioma disease are being accepted into the clinical trial. Also being accepted are select patients with small cell lung cancer, Hodgkin lymphoma, cervical carcinoma, neuroendocrine carcinomas and microsatellite high cancers.

Patient will receive the drug intravenously on days one and 15 of each cycle of treatment. Blood and tissue samples will be collected to help determine exactly what works, and why.

“This is a first step. We’ll see how big, or how small, that step is. And it’s not the last step, by any stretch. We’ll improve on what we’ve done, and what we’re doing now,” Dasari said. “We’ll learn from every single patient in the trial and learn what we can do better. We have a vision for the future. This is part of that vision.”

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Johnson & Johnson To Continue Global Sale of Talc-Based Baby Powder

Johnson & Johnson will continue selling its iconic talc-based baby powder outside the United States and Canada after shareholders rejected a proposal that would have ended its worldwide production and distribution.

The proposal failed to receive the majority vote needed at J&J’s annual meeting of stockholders last month, which was held virtually due to the COVID-19 pandemic. Ending global sales was one of 14 issues – and the most controversial – listed in the company’s proxy statement.

J&J discontinued selling Johnson’s Baby Powder throughout the U.S. and Canada in 2020 after being flooded with lawsuits claiming long-term use of its product was causing serious health issues stemming from talc contaminated by asbestos fibers.

The most serious issues involved ovarian and mesothelioma cancer. An estimated 40,000 talc lawsuits have been filed.

J&J Shareholders Have Their Say

The litigation stemming from those lawsuits already has cost Johnson & Johnson close to $1 billion in legal fees and $3.5 billion in settlements and verdicts, according to the company. At least 25,000 cases are still outstanding today.

Along with the ballot, the shareholder proposal included lengthy statements from management encouraging rejection of worldwide talc sales, and statements from proposal authors urging its passage.

“J&J remains vulnerable to further erosion of its reputation as a trusted purveyor of health-related products by continuing to sell and market its talc-based baby powder to the rest of the world,” wrote proposal author Antoine Argouges, CEO of Tulipshare Ltd. “The use of talc in personal care products is a public health concern.”

The U.S. Food and Drug Administration discovered small traces of asbestos in baby powder samples taken in 2019, which prompted a partial recall. Less than a year later, Johnson & Johnson suspended sales of the talc-based product in the U.S. and Canada.

“This is no longer a political, or legal, or consumer problem,” Argouges wrote. “This is a shareholder problem.”

Johnson & Johnson Says Talc Baby Powder Is Safe

Johnson & Johnson has continued to insist its product is safe, attributing the stoppage of sales to exaggerated reports of contamination, legal ramifications and lagging interest in the product. It insists that its regular testing of talc has proven there is no asbestos contamination.

Talc, a naturally occurring mineral, is often mined near asbestos deposits close to the Earth’s surface, increasing the risk of asbestos contamination.

“The company continues to use cosmetic talc in Johnson’s Baby Powder because decades of science have reaffirmed its safety,” management wrote in its opposition to the proxy proposal. “Decades of independent scientific testing has confirmed that JBP [Johnson’s Baby Powder] is safe and is not contaminated with asbestos.”

Johnson & Johnson, one of America’s richest companies, has a market share estimated at $450 billion. A major reason for its desire to continue marketing its talc-based baby powder was its recent ability to create a new subsidiary to separate assets from liabilities.

The newly created entity, called LTL Management LLC, immediately filed for bankruptcy protection. A federal judge in New Jersey approved the Chapter 11 bankruptcy plan in February. J&J will now avoid a much more costly and drawn-out route of litigating individual lawsuits.

Although details of the bankruptcy filing are still ongoing, LTL Management has listed its net worth at $10 billion, along with $10 billion in liabilities. Johnson & Johnson has set aside an additional $2 billion to be distributed through the pending bankruptcy trust.

“These actions are not a concession of liability, but rather a means to achieve an equitable and efficient resolution of the claims raised in the talc litigation,” management wrote in the proxy. “The claims are premised on the allegation that talc causes ovarian cancer and mesothelioma, a position that has been rejected by independent experts.”

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Heated Intrathoracic Chemotherapy Could Extend Mesothelioma Survival

Patients with pleural mesothelioma undergoing aggressive surgery should consider combining it with controversial hyperthermic intrathoracic chemotherapy to extend survival, according to a recent study.

Although the procedure, also known as HITHOC, has yet to be proven effective in a randomized clinical trial – and still is being debated by mesothelioma specialists – the report has elevated its status as a potentially useful adjuvant.

“We concluded that the heated chemotherapy, delivered in a specialty center, has shown benefit,” researcher Alan G. Dawson told The Mesothelioma Center at Asbestos.com. “It should have a place in the multimodality approach to treatment.”

Dawson studies malignant pleural mesothelioma with the Thoracic Oncology Research Group at the University of Leicester, United Kingdom.

Annals of Surgical Oncology published this latest retrospective review in April, drawing from 598 patients in 15 different studies covering eight countries.

Pleural Mesothelioma Survival Times Rise Significantly

The results showed significant improvement for those undergoing the combination treatment as compared to those receiving the surgery and traditional systemic chemotherapy.

“I was actually quite surprised at the findings,” Dawson said. “Going in, there was a lot of skepticism. Most thought there would be no difference in survival, or not much in the way of difference. The numbers, though, show that there is.”

Overall survival of those receiving the novel combination ranged from 11 to 75 months, compared with a 5- to 36-month range for those having surgery without HITHOC. The disease-free interval ranged from 7.2 to 57 months for the combination group, compared with 12.1 to 21 months for those bypassing HITHOC.

HITHOC involves circulating a heated, high-concentration chemotherapy solution throughout the chest cavity for 60-90 minutes immediately following aggressive surgery.

The belief is that the heated chemotherapy will kill any tumor cells that evaded the surgeon, which will slow the potential cancer recurrence.

Therapy Proven with Peritoneal Mesothelioma

While HIPEC, a similar procedure used effectively for peritoneal mesothelioma in the abdominal cavity, has proven to be a huge treatment benefit, HITHOC is used in a much smaller percentage of patients alongside surgery.

Specialty centers throughout the United Kingdom all have opted against using it, although this latest report could change things. Some thoracic surgeons in the U.S. have been using it, but others have opted against it.

Very few published guidelines for treatment of pleural mesothelioma include HITHOC. The National Comprehensive Cancer Network guideline does not. The latest American Society of Clinical Oncology guideline recently addressed it, but with considerable caution.

The recommendation is that “intracavity therapies may be delivered safely in experienced centers of excellence, but that their role in improving outcome is indeterminate.”

HITHOC Comes with Risks

Dosage levels made a considerable difference in the effectiveness of the HITHOC, according to the report. The higher dosage levels led to almost double the median overall survival times. Direct application in the thoracic cavity allows for a much higher local concentration, in contrast to typical systemic therapy.

As the report illustrates, though, the HITHOC procedure is not without risks. Morbidity rates can rise with the combination treatment.

According to the report, 12 of the 15 studies included data on morbidity. Atrial fibrillation was the most common morbidity at 20.4%. Renal complications were reported in 16.8% of the patients.

Selection of Mesothelioma Patients Is Key

The report also emphasizes the importance of proper selection of patients in receiving the aggressive surgery and HITHOC combination.

The heated chemotherapy regimen adds another 90 minutes to an aggressive surgery that already can take anywhere from four to 8 hours, a reason some surgeons opt against using it.

Traditionally, multimodal therapy consisting of surgery, radiation and systemic chemotherapy has been used to obtain extended survival, but recent years have included these smaller studies with HITHOC.

Two-year survival rates in this report ranged from 25% to 67%, while three-year survival rates ranged from 17% to 42%.

“It’s never been proven in a randomized trial, but evidence suggests there are benefits,” Dawson said. “If you are well enough to be considered for aggressive surgery, I would say you should consider the heated chemotherapy that can kill the tumor cells left behind.”

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United Kingdom Proposes 40-Year Asbestos Removal Deadline

The United Kingdom’s Work and Pensions Committee has proposed a 40-year timeline to complete the regulated removal of all long-standing legacy asbestos from public and commercial buildings, potentially setting a new standard for other nations to follow.

Its proposal was recently delivered to the House of Commons with a recommendation that the government and Health and Safety Executive incorporate the findings into their approach to asbestos management.

The U.K. already is one of more than 60 nations in the world to have banned asbestos, but none have passed this type of regulation for legacy asbestos, which has been killing people worldwide for decades.

This latest directive could be groundbreaking.

“Asbestos is one of the great workplace tragedies of modern times,” Stephen Timms, a member of the British Parliament and chair of the Work and Pensions Committee, said about the proposal. “While the extreme exposures of the late 20th century are now behind us, the risk from asbestos remains real.”

Britain Aims for ‘Net-Zero’ Asbestos Levels

Asbestos is a naturally occurring mineral that was once used in many industries due to its ability to resist heat and strengthen most anything with which it was mixed.

Unfortunately, it is also toxic. Asbestos becomes a health threat if the microscopic fibers are inhaled or ingested, causing a variety of serious problems that can include asbestosis, lung cancer and malignant mesothelioma.

According to the recent report, there are an estimated 300,000 nondomestic buildings in the U.K. that contain some level of asbestos. The report estimated that 5,000 people died in Britain from asbestos exposure in 2019.

The goal, according to the report, is a “net-zero” level of asbestos in the U.K., obtained through its total removal in a safer, strictly regulated and more manageable process.

UK Plan Outlines Path to Eradicating Asbestos

Asbestos was first banned in the U.K. in 1999, and subsequent legislation through the Control of Asbestos Regulations Act there helped improve safety measures surrounding legacy asbestos.

Among the directives within this recent proposal are:

  • Sponsor improvements in how information on asbestos in buildings is used and communicated.
  • Develop a framework for the measurement of current asbestos exposure in nondomestic buildings.
  • Work with local government agencies to review and share evidence related to routine environmental air monitoring of asbestos in those buildings.
  • Improve inspection and enforcement activity targeting compliance with the Control of Asbestos Regulations governmental agency.
  • Require accredited and licensed asbestos removal contractors, adhering to strict protocol, to be used for all projects.
  • Develop a strategic plan that adheres to the 40-year window in which asbestos is removed from all buildings to achieve the net-zero result.

“Setting a clear deadline of 40 years for the removal of asbestos from nondomestic buildings will help to focus minds,” Timms said. “This is no time for laissez-faire.”

Nonoccupational Asbestos Exposure Rates Rising

Levels of asbestos exposure attributed to certain occupations, such as construction, shipbuilding and mining, have continued to drop significantly. However, the nonoccupational level of exposure is rising as commercial construction with asbestos from decades ago deteriorates with age and requires significant renovation or demolition.

The Work and Pensions Committee’s report calls for a “cross government and system-wide strategy for the long-term removal of asbestos.”

It also calls for stricter enforcement of current asbestos removal procedures, which often are done by individual businesses not adhering to standards.

“The drive towards retrofitting of buildings to meet net-zero aspirations means the risk of asbestos exposure will only escalate in the coming decades,” Timms said. “Falling back on regulations which devolve responsibility to individual building owners and maintenance managers will not be sufficient to protect people’s health.”

US Lags Behind UK on Asbestos Ban

Asbestos legislation has been enacted in the United States to regulate the mineral closely, but the U.S. has yet to legislate a total ban on asbestos and has made no formal attempt to address the presence of long-standing asbestos throughout the country.

The U.S. Environmental Protection Agency recently proposed a ban on chrysotile asbestos, the only known type of asbestos still being imported into the country.

Its proposal would prohibit the ongoing importation of raw chrysotile asbestos along with the manufacturing, processing, distribution and commercial use of any product containing that type of asbestos. The proposal would be part of the Toxic Substances Control Act.

The EPA is still evaluating the risks of legacy asbestos and other similar minerals. It is not expected to finalize its evaluation until the end of 2024.

With this latest proposal, Britain is taking more of a leadership role in putting an end to a very serious problem.

“The importation, supply and use of asbestos was banned in the U.K. over 20 years ago, but its legacy lives on,” the report concludes. “A policy of waiting for materials containing asbestos to deteriorate before removing them is not sustainable in the long term. We need a system-wide strategy. This is becoming a more urgent task.”

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Peritoneal Mesothelioma HIPEC Program Comes to Alabama

Patients in Alabama diagnosed with peritoneal mesothelioma cancer no longer need to leave the state in pursuit of optimal care and long-term survival. The best possible mesothelioma treatment is now closer to home.

The O’Neal Comprehensive Cancer Center at the University of Alabama at Birmingham recently launched a complex treatment program for several abdominal malignancies that combines extensive cytoreductive surgery with hyperthermic intraperitoneal chemotherapy, also known as HIPEC.

This combination, used only at select specialty centers throughout the U.S., has been especially effective for peritoneal mesothelioma, a rare cancer caused primarily by asbestos exposure.

“We’re excited to bring it here and get this program rolling,” surgical oncologist Dr. Salila Hashmi told The Mesothelioma Center at Asbestos.com. “Peritoneal mesothelioma is such a unique disease. We want the best for our patients.”

Specialty Treatment Benefits Alabama Mesothelioma Patients

Hashmi joined the specialists at the cancer center in 2021 and played a major role in the launch of the only mesothelioma program of its kind in the state. She was specially trained in the treatment.

In the past, patients with peritoneal mesothelioma who lived in Alabama needed to travel to New Orleans, Atlanta or North Carolina to find this survival-extending combination. Unfortunately, many stayed closer to home and received less-effective treatment.

The difference in survival can be significant. Studies have shown that patients receiving only standard systemic chemotherapy have a median survival of just 12-14 months. Those receiving the cytoreductive surgery and HIPEC have a better than 50% chance of living five years or longer.

There are peritoneal patients throughout the country today who received the combination and have lived more than 10 years afterward, some of whom underwent a treatment repeat after tumor recurrence.

A recent retrospective study at Wake Forest Baptist Medical Center, one of the first in America to use the combination, demonstrated an almost seven-year median survival for peritoneal mesothelioma patients who repeated the treatment more than once.

Aggressive Cytoreductive Surgery Includes HIPEC

The cytoreductive surgery is a lengthy and aggressive procedure designed to remove all visible tumor cells from the abdominal cavity. It can include removing parts or all of the spleen, pancreas, liver, gallbladder and intestinal tract.

HIPEC, which is used immediately following surgery, involves circulating heated chemotherapy throughout the abdominal cavity to kill any tumor cells that may have evaded the surgeon. After up to 90 minutes of circulation, the heated chemotherapy is removed.

The HIPEC procedure is considered a more targeted way of delivering high-dose chemotherapy. Because the chemotherapy solution is removed, HIPEC typically has fewer side effects than systemic chemotherapy.

This combination also is being used with appendix, colorectal and gastric cancers.

Mesothelioma Specialty Centers Are Critical

Although the cytoreductive surgery and HIPEC combination has been recognized as a more effective treatment, less than half of those diagnosed with peritoneal mesothelioma nationally receive it. Some patients don’t qualify for various reasons, and others are discouraged by their oncologists who rarely encounter mesothelioma. They often treat the disease only with systemic chemotherapy.

“You need someone with the knowledge and insight to even realize this is an option for you,” Hashmi said. “Not everyone will qualify, but everyone at least deserves the chance to be evaluated.”

Hashmi also said sometimes a patient who doesn’t qualify initially can qualify after undergoing other treatments such as immunotherapy or systemic chemotherapy.

O’Neal Comprehensive Cancer Center, which carries the respected NCI designation for maintaining the highest standards of care, has been treating the more common pleural mesothelioma cancer for more than a decade and often is hailed for its wide array of medical programs.

The addition of this latest program for peritoneal diseases is particularly significant.

“Patients no longer have to travel further away from home,” Hashmi said. “We can serve them here now. We can give them the best possible care.”

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Johnson & Johnson Bankruptcy Plan Won’t Halt Industrial Talc Lawsuit

Johnson & Johnson may have used a controversial bankruptcy spinoff to avoid almost 40,000 cosmetic talc lawsuits, but it now must face plaintiffs harmed by industrial talcum powder decades ago.

U.S. federal Judge Michael Kaplan ruled earlier this month that the recent bankruptcy plan halting the majority of cases would not apply to this latest class-action lawsuit.

The ruling in a New Jersey Superior Court stems from a complaint first brought in 1986. A man claimed his lung disease was caused by asbestos exposure linked to contaminated talc at his job at Windsor Minerals, a mine in Vermont owned by Johnson & Johnson.

J&J sold the mine in 1989. The man died in 1994, but his family has reopened the case. They claim new evidence has shown the company was withholding test results and falsifying records, which led to the case being dropped.

Through the 1980s, more than a thousand others filed lawsuits against J&J that met similar ends. The recent ruling is expected to gather many of them in a class-action suit.

Ruling Reopens Talc Legal Claims

Kaplan, who approved J&J’s Chapter 11 bankruptcy filing in February, ruled that the proposed lawsuit was different enough from the cosmetic talc cases that it can move forward.

J&J has long maintained that the talc in its products, both cosmetic and industrial, is free from asbestos, a toxic mineral that can cause serious illnesses, including mesothelioma and ovarian cancers.

Most everyone agrees that talc, one of the world’s softest minerals, is safe by itself but it often is mined near asbestos and can become contaminated.

“We stand by the safety of the talc sold by Windsor Minerals, which was once a Johnson & Johnson subsidiary,” the company said in an emailed statement. “Johnson & Johnson denies the claims being brought forth in this suit, and will defend the case if it proceeds.”

Product testing, which varies widely, has been inconclusive through the years. The U.S. Food and Drug Administration performed a review of cosmetic talc products in 2020 and found traces of asbestos in nine of 52 products.

Separating Cosmetic and Industrial Talc Lawsuits

In recent years, Johnson & Johnson, which is one of America’s richest companies, has both won and lost legal cases brought against it involving asbestos-contaminated talc.

The majority of talc cases involve women and cosmetic powders, including the iconic Johnson’s Baby Powder. The use of talc in the baby powder was discontinued in the U.S. and Canada in 2020.

Settlements and verdicts from Johnson & Johnson lawsuits have cost the company an estimated $4.5 billion over the last several years. It first explored the bankruptcy strategy after the U.S. Supreme Court refused to review a $2.1 billion judgement in Missouri that went to 20 women who claimed their ovarian cancer had been caused by various talc products.

Prompted by the tens of thousands of lawsuits, J&J created a new entity called LTL Management LLC, which was designed solely to absorb its talc liabilities. That company immediately filed for bankruptcy, putting a hold on all lawsuits.

J&J Saving Big with Talc Bankruptcy Spinoff

J&J is the largest pharmaceutical company in the world, leading to outrage from plaintiffs at its ability to declare bankruptcy under a Texas law aimed at protecting corporate interests.

LTL Management listed its worth at $10 billion, along with $10 billion in liabilities, according to recent court records. Johnson & Johnson said the subsidiary will have $2 billion set aside to settle all talc claims.

The bankruptcy filing is designed to pressure claimants to accept lower settlements and avoid any excessive payouts. It also would speed up the process of compensating those who were injured.

In the most recent court proceedings, J&J contended that the allegations within the latest class-action suit were much like those in the cosmetic talc cases and should be lumped into the bankruptcy proceeding.

By contrast, the recent lawsuit brings claims of fraudulent legal testimony on behalf of J&J and little mention about consumer talc, which was a major reason the cases will be allowed to proceed.

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Study Finds Benefits to Second Peritoneal Mesothelioma Surgery

Patients with peritoneal mesothelioma cancer can survive considerably longer if they are willing and able to undergo a second aggressive surgery following tumor recurrence.

History has proven that an incentive for a repeat surgery is there.

A recent 30-year retrospective review at Wake Forest Baptist Medical Center has shown how beneficial the combination of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy, or HIPEC, can be for several cancers with peritoneal metastasis.

“People often think it’s a one-and-done procedure,” Wake Forest Baptist surgical oncologist Dr. Edward Levine told The Mesothelioma Center at Asbestos.com. “But it’s not always that way. For some, a repeat surgery can be a real life-extending event.”

Annals of Surgical Oncology published the review in March. It was co-authored by members of Wake Forest’s surgical oncology and biostatistics and data science departments.

Wake Forest Baptist Medical Center is one of the world’s most acclaimed facilities for the treatment of peritoneal malignancies. It was among the first to establish a HIPEC program, in 1991.

Mesothelioma Surgery with HIPEC Extends Survival

Cytoreductive surgery is an aggressive and lengthy procedure designed to remove all visible tumor cells from the abdomen. It can include removing parts or all of the gallbladder, liver, pancreas, spleen and intestinal tract.

HIPEC, used immediately after the surgery, involves circulating heated chemotherapy throughout the abdominal cavity in hopes of killing any microscopic tumor cells left behind by the surgeon.

The recent single-center study involved 156 patients from 1991-2021 who received the cytoreductive surgery and HIPEC combination at least twice.

During that period, 1,547 patients were treated with the combination at least once for a peritoneal malignancy, mostly for appendix, colorectal or mesothelioma cancers.

Of the 156 repeat-surgery patients, 17 had peritoneal mesothelioma. Appendix cancer dominated the repeat-surgery group with 102.

The 156 patients who received the combination multiple times had a median survival of 10.7 years, compared to just 2.5 years for those having it only once. Seventeen patients underwent the procedure three times and one patient was treated with it four times.

Peritoneal mesothelioma patients receiving the treatment at least twice had a median survival of 67.7 months, more than double the estimated median survival for patients receiving it only once.

The mesothelioma patients in the review also had a median survival of 32.2 months after the second surgery, compared to 40.1 months for those with colorectal cancer.

Surgery Remains Best Treatment for Recurrence

“Historically, I think this has shown if there is a recurrence, another surgery is still the best treatment when it comes to survival,” Dr. Perry Shen, a Wake Forest Baptist surgical oncologist and study co-author, told The Mesothelioma Center. “Tolerating multiple major operations can be done ­– with the right patients.”

Peritoneal mesothelioma is a rare cancer most often caused by an exposure to asbestos and diagnosed in fewer than 500 people annually in the U.S. Both Levine and Shen emphasized the importance of patients being treated at a specialty center with considerable experience in selecting patients for surgery.

Although the combination of cytoreductive surgery and HIPEC is considered the most effective treatment for mesothelioma, fewer than half of those diagnosed receive it. Most oncologists rarely see the disease and treat it only with standard chemotherapy, leading to an average survival of less than one year.

Peritoneal Mesothelioma Surgery Underutilized

One recent study, conducted by researchers at Inova Fairfax Medical Campus in Virginia, found that a large percentage of patients who could have been helped by cytoreductive surgery and HIPEC – and had their survival extended significantly – were not having the surgery for various reasons.

Although some patients are denied surgery because of age, overall health reasons or disease progression, those are not the majority with peritoneal mesothelioma.

One reason for the lack of surgery is its association with the tougher-to-treat and more prevalent pleural mesothelioma, which develops in the thoracic cavity and has a much shorter survival time.

Only an estimated one-fourth of the patients with pleural mesothelioma even qualify for aggressive surgery.

This most recent review at Wake Forest also showed little difference in complication rates between the first surgery and second, for both the overall group and the peritoneal mesothelioma group.

For the 17 mesothelioma patients undergoing repeat surgery, only two had serious complications after the first surgery and just three had complications after the second surgery.

“When you looked at the data, it was a pleasant surprise. The complication rates were comparable,” Shen said. “Part of that is, we’re selecting patients who we think can do well with it. It’s another reason patients should go to a high-volume center with experience. The procedure can extend survival.”

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EPA Proposes Ban on Chrysotile Asbestos

The U.S. Environmental Protection Agency proposed a potentially historic ban April 5 that would prohibit all current uses of chrysotile asbestos.

Chrysotile is the only known type of asbestos still being imported into the country today.

The rule would prohibit the ongoing importation of raw asbestos along with the manufacturing, processing, distribution and commercial use of products containing chrysotile asbestos. It is being proposed under the Toxic Substances Control Act, which was amended in 2016 and designed to address the safety of existing chemicals.

Asbestos is still used in the U.S. today in products such as diaphragms, sheet gaskets, oil-field brake blocks, aftermarket automotive brakes and linings, and other vehicle friction products.

“We’re taking an important step forward to protect public health and finally put an end to the use of dangerous asbestos in the United States,” said Michael Regan, EPA administrator.

Ban Would Impact Chloralkali Industry

All raw asbestos imported by the U.S. today – an estimated 300 metric tons in 2020 – is used by the chloralkali industry, which will be hurt the most financially by the proposal. It uses asbestos in the manufacturing of semipermeable diaphragms for making chlorine.

The American Chemistry Council, a lobbying group for the chemical industry, blasted the EPA’s proposed ban of asbestos in a statement this week, insisting it would reduce the domestic supply of chlorine, potentially disrupting the drinking water supply.

“If enacted, the EPA’s proposed rule would ban the manufacture of nearly one-third of the chlorine and sodium hydroxide chemicals and have significant adverse effects on the supply of the nation’s drinking water,” the statement said.

According to the EPA, there are only 10 chloralkali factories still using asbestos diaphragms in the U.S. and that use is declining. Other plants are already using alternatives to asbestos.

Manufacturers Have 2 Years to Comply

Although asbestos is heavily regulated today, and its use has dropped dramatically in recent decades, the push for an asbestos ban has intensified in recent years. More than 60 countries worldwide already have instituted some degree of a ban.

The EPA blocked most uses of asbestos in 1989 under the TSCA, but a federal appeals court overturned much of the ban in 1991 after considerable lobbying by the industry.

If passed, the prohibitions banning asbestos diaphragms and sheet gaskets would take effect in two years. Prohibitions related to many of the other products would begin in 180 days.

This latest proposal comes in the wake of the EPA’s recent Risk Evaluation for Asbestos Part 1, which found unreasonable risk to human health for all ongoing uses of chrysotile asbestos.

The EPA is currently in the midst of Part 2 of its risk evaluation, which is scheduled to be completed by 2024. It will include other types of asbestos, the use of asbestos in talc products and legacy asbestos left behind after decades of unbridled use.

Landmark Proposal Coincides with Awareness Week

Asbestos was once a coveted, versatile ingredient, valued for its ability to resist heat and strengthen anything with which it was mixed. It was widely used in construction and thousands of consumer products. Unfortunately, the microscopic fibers are toxic when inhaled, causing a wide range of illnesses, including lung cancer and mesothelioma.

Legislative efforts to ban asbestos have been building in Congress. Earlier this month, the U.S. Senate unanimously passed its annual National Asbestos Awareness Week resolution.

The resolution urges the Office of the Surgeon General to warn and better educate citizens about the public health issues associated with asbestos exposure.

Regan signed the latest proposed rule document April 5 and submitted it for publication in the Federal Register. The EPA will be accepting comments on the proposal for 60 days.

“This is a landmark step forward,’’ said Linda Reinstein, co-founder and president of the nonprofit Asbestos Disease Awareness Organization. “The reality is, now we have part one. We still need Congress to step up.”

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Senate Passes Asbestos Awareness Resolution, Inches Closer to Ban

The U.S. Senate unanimously passed its annual National Asbestos Awareness Week resolution, inching closer to long-awaited, much-anticipated legislation to ban the toxic substance.

The bipartisan resolution urged the Office of the Surgeon General to warn and better educate citizens about the public health issues of asbestos exposure, the primary cause of mesothelioma cancer.

Advocates welcomed the resolution designating April 1-7 as the official Awareness Week, believing more widespread education will increase the likelihood of a legislative ban in the future.

“I think the resolution shows unanimous understanding of the facts. There is no safe level of exposure,” said Linda Reinstein, president and founder of Asbestos Disease Awareness Organization. “Are we any closer to a ban now? Yes, I think the more people learn about the dangers of asbestos, how prevention is the cure, the closer we get to a ban.”

Montana Senators Take the Lead

The Senate resolution was passed March 29. Montana Senators Jon Tester and Steve Daines co-sponsored the resolution.

Libby, Montana is home to an infamous vermiculite/asbestos mine, where thousands have been sickened through the years and almost 700 have died as a result of its presence.

The mine was closed in 1990 and the U.S. Environmental Protection Agency placed Libby on its Superfund National Priorities List in 2002 to begin decontamination efforts. Those efforts only recently concluded.

“Asbestos has a long, troubling history in Montana, and too many families continue to suffer from exposure to this toxic substance,” Tester said. “It’s past time we outlaw the use of asbestos. It’s critical that we arm folks with the most up to date information possible so that we keep people safe, and make asbestos exposure a thing of the past.”

Although asbestos is heavily regulated in the U.S. today – and consumption has dramatically dropped in recent decades – there is no outright ban of the product. There is, however, no mining of asbestos today in the country.

Legacy Asbestos Remains Big Problem

An estimated 300 metric tons of raw asbestos were imported in 2020 – the second smallest amount in 50 years – but all of it was used by the chloralkali industry.

A small but unknown amount of asbestos within manufactured products, such as brake blocks used in the oil industry, friction products and rubber sheets for gaskets, are also still being imported.

One of the biggest threats to people today is legacy asbestos, stemming from decades of unbridled used of the product. The EPA is scheduled to finish Part 2 of its Final Risk Evaluation in 2024, which will include legacy asbestos.

The closest the U.S. came to a ban was in 1989 when the EPA issued the Asbestos Ban and Phase-Out Rule, but it was overturned in court two years later.

Close to a Ban in 2020

In recent years, both the House of Representatives and the Senate showed bipartisan support for a legislative ban, but the measure failed to receive a vote.

The Alan Reinstein Ban Asbestos Act Now of 2020 – named after Linda Reinstein’s husband who died of mesothelioma more than a decade ago – was suddenly dropped from consideration by the House of Representatives after last-minute provisions were added to the bill that went beyond what had been negotiated..

New drafts of the legislation are currently being explored for the next Congressional session.

World-Wide Awareness Week

The U.S. Senate Resolution mirrors the same April 1-7 dates of the Global Asbestos Awareness Week, which is orchestrated by the nonprofit ADAO.

Its program – entitled Asbestos: One Word, One Week, One World – involves videos, stories and educational resources presented by leading experts and organizations throughout the world.

Most of the materials will be translated into five different languages.

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Study shows critical protein may play a role in origin of mesothelioma

Researchers have discovered that a protein critical in the embryonic stages of life is reactivated in certain cases of mesothelioma, offering clues into the origin of this aggressive cancer.

Past Asbestos Testing on Inmates Could Affect J&J Talc Lawsuits

Johnson & Johnson funded a study more than 50 years ago at a Philadelphia prison that injected asbestos fibers into a small number of inmates to measure the short-term reaction to the toxic mineral when mixed with talc.

Details of Johnson & Johnson’s involvement in that study were unsealed for the first time at a trial in 2021, illustrating the company’s long-ago concern over potential problems with asbestos-contaminated talc in several of its products.

Bloomberg News first reported the story earlier this month. Legal experts believe the recently uncovered documents could potentially be powerful evidence in future cases against J&J.

Johnson & Johnson is the world’s largest health care company. It has been defending itself in court since 2013 from plaintiffs alleging that its talc products have caused cancer, including mesothelioma, primarily because of the asbestos contamination.

The asbestos study was done by University of Pennsylvania dermatologist Albert Kligman, who conducted dozens of similar experiments for almost two decades at the Holmesburg Prison in Philadelphia.

J&J Had Asbestos Concerns Long Ago

Although the inmate-based studies were documented many years ago in newspapers and books, J&J’s involvement in the talc and asbestos testing had never come to light. Earlier reports mentioned only the federal government and Dow Chemical as study sponsors.

Inmates were paid anywhere from $10 to $300 to participate. According to the recent report, Kligman recruited 10 inmates for the asbestos study. Each received an asbestos injection in his lower back, along with an injection of talc.

According to Kligman’s report to J&J, the short-term effect of the asbestos was on the inmates’ skin, causing granulomas, a clumping of cells due to inflammation. It was believed this was an indication of potential lung disease.

In the 2021 California trial in which jurors first heard about the Holmesburg study, a woman was awarded more than $26 million, much of it in punitive damages.

A spokeswoman for J&J told Bloomberg earlier this month that the company regrets its earlier involvement with Kligman and his studies, but said it was typical of research standards at the time.

“We deeply regret the conditions under which these studies were conducted, and in no way do they reflect the values or practices we employ today,” she said. “Our transparent, diligent approach to bioethics is at the heart of all we promise our customers and society.”

Kligman died in 2010. The University of Pennsylvania issued an official apology for his work in 2021 when the J&J involvement first became public.

J&J Moves Forward with Bankruptcy Plan

J&J has maintained that its talc products have never been contaminated by asbestos, which often is found near the Earth’s surface where talc is mined.

In the midst of more than 35,000 talc-related pending lawsuits, though, J&J stopped selling its iconic Johnson’s Baby Powder in the United States and Canada in 2020, citing a drop in interest among consumers.

Shortly after its involvement with the Holmesburg study was used in the California lawsuit, J&J moved forward with its controversial bankruptcy plan, hoping to split its liabilities from its assets. Jury verdicts and settlements already have cost J&J an estimated $3.5 billion.

Johnson & Johnson created an entity called LTL Management LLC, which immediately filed for bankruptcy protection and put all talc litigation on hold.

Based on that plan, which was approved by a federal judge in New Jersey last month, most of the lawsuits will be settled with LTL Management, which listed its worth at $10 billion along with $10 billion in liabilities.

J&J, one of America’s richest companies, has a market share of close to $450 billion. The company expects to save billions, forcing most of the lawsuits to work through the bankruptcy protection process.

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$36.5 Million Verdict Could Change Asbestos Litigation in Libby, Montana

A Montana District Court jury recently delivered a $36.5 million verdict in a bellwether case that is expected to significantly change the landscape of future litigation involving vermiculite mining and asbestos exposure in Libby, Montana.

The jury in Great Falls, Montana, awarded laborer Ralph Hutt $6.5 million in compensatory damages and $30 million in punitive damages in February, dwarfing awards plaintiffs have typically received in the past.

Based on a recent Montana Supreme Court decision, the insurance carrier once overseeing the occupational safety program at W.R. Grace & Company, which operated an asbestos-contaminated mine in Libby, is no longer protected by the company’s 2001 bankruptcy filing.

District Court Judge Amy Eddy had chosen Hutt’s case as the first of almost 900 cases pending against Maryland Casualty Company, which provided the safety program and workers’ compensation insurance for W.R. Grace & Company. Eddy oversees Montana’s special asbestos claims court, which was formed in 2017.

Eddy said in pretrial hearings that she wanted this case to establish the parameters and framework for future trials involving similar claims. One of the issues was the statute of limitations, which was decided in favor of the plaintiff.

The court also ruled that safety and medical professionals at Maryland Casualty had the duty to protect workers’ health, yet they failed to warn them of the hazards of the job and the risks of airborne asbestos. They also did not report early signs of lung problems among workers.

According to evidence presented at the recent trial, doctors at Maryland Casualty withheld information from affected workers after annual X-rays showed early lung scarring caused by asbestos exposure, long before any diagnosis was made.

Maryland Casualty Company is now owned by Zurich Insurance Group, a worldwide insurance leader with clients in more than 100 countries.

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Libby Mine Contaminated Entire Region

Libby is home to the longest-running manmade environmental disaster in U.S. history. Vermiculite, often mixed with toxic asbestos, was mined there for more than 70 years. It contaminated the entire area, affecting the health of miners and unsuspecting residents.

W.R. Grace & Company operated the mine from 1963 until it closed in 1990. Serious health issues still are emerging today due to the lengthy latency period between exposure and diagnosis of asbestos diseases such as mesothelioma cancer.

The devastation caused by the mining of asbestos received little attention until 2002, when the U.S. Environmental Protection Agency placed Libby on its Superfund National Priorities List and began decontamination efforts.

Asbestos was once a coveted and much-used natural mineral known for its ability to strengthen and fireproof almost anything with which it was mixed. Its toxicity, though, has led to strict regulations and very limited uses.

Health Issues in Libby Will Continue

In the small town of Libby, at least 400 deaths from asbestos-related causes have been documented. Almost 3,000 people have been diagnosed with asbestos-related diseases at the Center for Asbestos Related Disease, a clinic that was established more than a decade ago.

Hutt worked in the Libby mine for just 18 months in the late 1960s. He was first diagnosed with asbestosis, a lung disease caused by asbestos exposure, in 2002.

He spends much of his days struggling to breath on his own and tethered to an oxygen tank. Hutt provided a video deposition for the trial from his home in Roseburg, Oregon.

Until now, legal options have been limited for victims of asbestos exposure in Libby. The first lawsuits were filed in the mid-1990s against W.R. Grace & Company, but after paying out several million dollars in claims, it filed for bankruptcy.

The bankruptcy trust fund limited settlements to smaller amounts and provided minimal compensation for victims. A district court judge, for example, approved a $43 million settlement spread across 1,300 plaintiffs in 2012. Another settlement in 2017 involved $25 million and 1,000 plaintiffs.

This bellwether case – sparked by the Montana Supreme Court ruling – has changed the landscape by holding Maryland Casualty Company responsible.

“It’s been a long road,” said attorney Allan McGarvey, who represents Hutt and many others with similar cases. “The wheels of justice may grind slowly, but in the end, justice is done.”

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Johnson & Johnson’s Talc Bankruptcy Plan Approved

Much to the ire of plaintiff attorneys across the country, a federal judge in New Jersey granted approval for Johnson & Johnson to move forward with its controversial bankruptcy plan involving thousands of talc-related lawsuits.

This strategy will allow Johnson & Johnson to split its assets from its liabilities, putting more than 38,000 claims on a newly created entity called LTL Management LLC, which filed for Chapter 11 bankruptcy protection.

The lawsuits center around asbestos-contaminated talc and include those for mesothelioma cancer. The majority involve ovarian cancer.

United States Bankruptcy Judge Michael B. Kaplan approved the plan Feb. 25, rejecting an appeal by a committee of personal injury attorneys who had asked the court to disallow the filing of the J&J subsidiary.

“We disagree with the court’s decisions,” said a spokesperson for the mesothelioma claimants committee, which was part of the bankruptcy objection argument in New Jersey. “We remain concerned that victims have been forced into bankruptcy while J&J has been shielded from answering for their independent and separate talc products liability.”

Johnson & Johnson Will Save Billions

Kaplan rejected the argument of the plaintiffs, allowing J&J to avoid a much more costly and drawn-out route of litigating individual lawsuits. He said bankruptcy offers a faster and fairer alternative.

“This Chapter 11 is being used, not to escape liability, but to bring about accountability and certainty,” Kaplan wrote. “There is nothing to fear in the migration of tort litigation out of the tort system and into the bankruptcy system.”

Officials from Johnson & Johnson testified in court that they first explored this bankruptcy strategy seriously in June 2021 after the U.S. Supreme Court refused to review a $2.1 billion judgement in Missouri for 20 women who claimed their ovarian cancer had been caused by J&J’s talc products.

Johnson & Johnson is one of America’s richest companies, with a market share of more than $450 billion. Jury verdicts and settlements already have cost J&J an estimated $4.5 billion, but the initial bankruptcy filing in October halted talc lawsuits in federal and state courts.

By comparison, the newly created subsidiary, LTL Management LLC, listed its worth at $10 billion, along with $10 billion in liabilities, according to court documents.

Johnson & Johnson is expected to save billions of dollars long term. Its stock closed Friday – the day Kaplan announced his decision – up 5%, its biggest one-day gain since spring 2020.

“I am surprised and disappointed that Judge Kaplan is allowing their bankruptcy to go forward,” Daniel Wasserberg, a New York City attorney who specializes in talc litigation, told The Mesothelioma Center at Asbestos.com. “When one of the richest companies on Earth is allowed to shed its liabilities by throwing them into a judicially sanctioned dumpster, there can be no justice for the people they killed or their loved ones.”

Recent Court Ruling Was Unexpected

Kaplan’s ruling was somewhat surprising, based on his position as a U.S. bankruptcy judge for the District of New Jersey.

The hearing was originally scheduled for North Carolina, a jurisdiction considered more favorable to this bankruptcy strategy, which was why LTL Management was opened there. A federal judge, though, said he was “obligated” to have the case heard in New Jersey where J&J is headquartered. It is a district considered less favorable to bankruptcy filings, according to past cases.

When the move was announced, attorneys throughout the country with cases against J&J applauded the move to New Jersey, expecting the petition for bankruptcy protection to be denied.

Bankruptcy Strategy Could Be Blueprint for Other Companies

J&J has continued to insist its talc products are safe, but it has stopped selling many of them in the U.S. and Canada as the number of injury lawsuits grew. J&J attributed the stoppage to misinformation.

Details of the bankruptcy filing will continue to be negotiated. Johnson & Johnson said it has set aside $2 billion to settle talc claims, but that number could change considerably in the coming weeks.

The bankruptcy filing is expected to pressure claimants to accept lower settlements than they would have before and avoid any excessive payouts.

“It’s very disappointing when huge corporations with massive profits can abuse the bankruptcy system to avoid liability for harming Americans with dangerous products like asbestos,” said attorney Joe Lahav, on-site legal advisor at The Mesothelioma Center. “All this latest decision does is allow corporate fat cats to keep even more money in their pockets and out of the hands of the innocent people they’ve harmed.”

Attorneys worry now that this latest ruling could become a blueprint for profitable companies in the future to benefit from Chapter 11 and protect valuable business assets.

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Mesothelioma Clinical Trial Matches Treatment to Genetic Profiles

Scientists at the University of Leicester in the United Kingdom recently published phase 2 clinical trial results involving abemaciclib, a new genetic therapy for malignant pleural mesothelioma.

Researchers designed the trial to match mesothelioma treatment to a patient’s specific genetic profile. The early study results are promising for mesothelioma patients who have previously received first-line chemotherapy with pemetrexed and either cisplatin or carboplatin.

Restoring Gene Function Promotes Tumor Destruction

Abemaciclib, available under the brand names Verzenio and Ramiven, is approved by the U.S. Food and Drug Administration for breast cancer patients with specific genetic biomarkers. The drug blocks the CDK4 and CDK6 enzymes, which inhibit tumor cells from reaching apoptosis, a form of cell death.

Researchers leading the mesothelioma clinical trial, termed MiST2, believe that finding the proper treatment for each person is key to developing a cure.

They noted that mesothelioma tumors without the chromosome locus 9p21.3, which is responsible for expressing a protein called CDKN2A-MAP, led to shorter overall survival in patients. The researchers used abemaciclib to restore the associated tumor suppressor, p16ink4A, and improve mesothelioma survival.

Study Results Promising for Mesothelioma Patients

The MiST2 study enrolled 26 mesothelioma patients between 2019 and 2020. Each patient tested negative for the tumor suppressor gene, indicating they might benefit from abemaciclib.

Study authors administered abemaciclib as second-line therapy. All the patients in the study had previous treatment with mesothelioma chemotherapy, including pemetrexed (Alimta) and either cisplatin or carboplatin.

Trial participants received 200 mg of abemaciclib twice daily over 12 weeks while researchers monitored patients for drug safety and effectiveness.

The study found that abemaciclib achieved disease control in 54% of mesothelioma patients after 12 weeks. Three patients had a partial response to the gene therapy, and 11 patients had stable disease after the same timeframe.

At the study’s primary endpoint, the median progression-free survival had reached over 18 weeks with a median overall survival of 31 weeks.

Side Effects Common, Predominantly Mild

The most common side effects in the study were diarrhea and fatigue, affecting 92% of study participants.

Only three of the 26 patients in the study, 12%, experienced treatment-related adverse events that study authors classified as Grade 3. These side effects included diarrhea, shortness of breath, low blood platelets, vomiting and pulmonary embolism.

About 23% of participants experienced severe adverse events causing one patient to discontinue treatment. One patient had an extreme adverse event related to diarrhea, and a single patient died due to neutropenic sepsis.

Promising Results Lead to Further Study

Study authors summarized the current data by noting that the trial has helped scientists understand how mesothelioma patients respond to gene therapy.

“This study met its primary endpoint, showing promising clinical activity of abemaciclib in patients with p16ink4A-negative mesothelioma who were previously treated with chemotherapy,” the authors concluded. “[This therapy] warrants further investigation in a randomized study as targeted stratified therapy.”

Some patients may have genes that allow a particular response to a drug, such as abemaciclib, but there is still potential to find targets beneficial to other patients.

The researchers are interested in adding additional therapy options for patients as the clinical trial continues. Depending on their genetic profile, patients may also receive rucaparib, an FDA-approved drug for certain types of ovarian cancer, or a combination of immunotherapy drugs.

Contingent on the trial’s success in the future, it may expand to more mesothelioma cancer treatment centers across the U.K. Identifying additional biomarkers that can treat a broader range of patients is key to developing treatment plans tailored to each patient’s disease.

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