COVID-19 Countermeasures: Liability Immunity Under The PREP Act
On March 17, 2020, the U.S. Department of Health and Human Services (“HHS”) published an administrative Declaration providing broad legal immunity for manufacturers, suppliers, and administrators of certain countermeasures used against COVID-191. Negligence cases regarding covered countermeasures will be barred, limiting an injured party’s possible redress to the Countermeasures Injury Compensation Program (“CICP”).
The authority to issue such declaration arises out of the Public Readiness and Emergency Preparedness Act (the “PREP Act”).2 Congress enacted the PREP Act in 2005 as a response to fears about an avian influenza (H5N1) pandemic.3 Through the issuance of such PREP Act declaration, the Secretary makes a determination that a disease, condition, or other threat to health constitutes a public health emergency and specifies, among others, the category of diseases, health conditions, or threats to health for which the Secretary recommends the administration or use of the covered countermeasure, and the period during which the liability protections are in effect.4
The PREP Act defines “covered countermeasure” by outlining three categories.5 The first consists of “qualified pandemic or epidemic products” and includes products (drugs, biological products, and devices) manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic or to limit the harm such pandemic or epidemic might otherwise cause.6 The second category describes “security countermeasures,” and the final category consists of products subject to emergency use authorizations.7 The PREP Act’s liability protections are extremely broad, essentially covering most manufacture, testing, development, distribution, dispensing, administration, or use of designated covered countermeasures absent willful misconduct.
The PREP Act authorizes the Secretary to establish a program to provide compensation to individuals who have suffered serious physical injuries or death as the direct result of the administration or use of a covered countermeasure, called the Countermeasures Injury Compensation Program (“CICP”).8 Eligible requesters include injured countermeasure recipients, survivors of deceased injured countermeasure recipients who died as a direct result of the administration or use of a covered countermeasure, and executors or administrators on behalf of the estates of deceased injured countermeasure recipients (regardless of their cause of death).9 Requesters will need to prove causation pursuant to CICP’s standard: proof that is based on “compelling, reliable, valid, medical, and scientific evidence.”10 A temporal association between receipt of the countermeasure and onset of the injury is insufficient.
Requesters who successfully demonstrate causation can recover reimbursement for reasonable and necessary medical services and items to diagnose or treat a covered injury or its health complications; lost wages; and death benefit for certain survivors.11 Benefits under CICP will only be paid after the requester has in good faith attempted to obtain available coverage from all third-party payers with an obligation to pay for or provide such benefits, and the requester must provide the information of such payers.12 If a request is denied, the requester can motion the Secretary of HHS to review the determination, but there is a broad statutory prohibition against any further review.13
It is too early to predict the effectiveness of CICP as a route toward remedy for parties injured by covered countermeasures of COVID-19, but compared to traditional tort procedure, it is seemingly unfriendly to requesters. The lack of judicial oversight is cause for concern, with no further appeals available beyond internal review. While traditional tort procedure allows an injured party his day in court, decisions under the CICP are made on an administrative basis. The process for attorneys evaluating a potential case will be to determine the presence of a covered countermeasure and whether the individual or entity that administered it is shielded from tort liability under the Declaration, and to meet the Declaration’s standard for showing causation.
There is a clear need for the development and distribution of life-saving measures to combat the COVID-19 pandemic, and the Declaration helps encourage such innovation. In the pursuit of this goal, is important to consider potential risks and employ reasonable care in the production of such countermeasures.
- Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15198 (Mar. 17, 2020).
- 42 U.S.C. § 247d-6d.
- See Pandemic Planning Update II, Department of Health and Human Services (Nov. 13 2006), available at cdc.gov/flu/pandemic-resources/pdf/panflureport3.pdf.
- See 42 U.S.C. § 247d-6d.
- See 42 U.S.C. § 247d-6d(i)(1).
- Id.
- Id.
- 42 C.F.R. § 110 (Countermeasures Injury Compensation Program).
- Id.
- See 42 C.F.R. § 110.20(c) (outlining CICP’s causation requirement).
- See 42 C.F.R. § 110.2 (summarizing available benefits).
- See id.
- See 42 C.F.R. § 110.91 (2018).
Raw Asbestos Imports Quadrupled from January–April 2018 Compared to 2017
Washington, DC—The Asbestos Disease Awareness Organization (ADAO), an independent nonprofit dedicated to preventing asbestos exposure, released new research confirming the increase in raw asbestos imports.
The report detailed that according to the U.S. International Trade Commission, from January to April 2018, the chemical industry brought in nearly 260 tons of asbestos from Russia and Brazil. This represents an increase of nearly 400% of the January–April 2017 imports of 67 tons. The president’s administration and the Environmental Protection Agency, who have close ties to the chemical industry, have defended the ongoing imports and use of this deadly substance.
Asbestos is a known carcinogen and there is no safe or controlled use of asbestos. According to the new “Global Asbestos Disaster” paper, asbestos-related diseases account for nearly 40,000 American deaths each year. This year alone, asbestos has been found in children’s makeup, in schools in Pennsylvania, and in a prison hospital in Georgia.
We believe that asbestos use should be eliminated to protect the public and this trend of increasing the importation of asbestos may possibly expose more individuals to health risks. If you or a close family member have developed mesothelioma or other asbestos-related illnesses, please do not hesitate to contact us for a free consultation.
Case Spotlight: The Auto Mechanic’s Wife
When someone is diagnosed with an asbestos-related disease such as mesothelioma or lung cancer, they are often asked where and how they were exposed to asbestos. For people who did not work in asbestos-related industries or trades, it can be difficult to determine how they were exposed. This is often the case with women who have been diagnosed with an asbestos-related disease and were either housewives or worked in fields that did not have obvious exposures to asbestos-containing products.
When determining where a person (who had little or no direct exposure to asbestos) may have encountered asbestos fibers, attorneys often look to family members who lived with the individual for significant periods of time. Husbands and fathers of the sick individual often worked in trades that involved frequent contact with asbestos-containing products. Asbestos fibers from these products were then brought home on clothing and into the family home and car. Anyone washing the work clothing of individuals who frequently worked with asbestos-containing products was at an increased risk of developing an asbestos-related disease.
Our firm recently represented the family of a woman who never worked directly with any asbestos-containing products, and did not work in any commercial or industrial locations where asbestos products were present. In trying to determine how she may have been exposed, the occupations of her family members were explored. Her husband had worked for a number of years as a truck driver and mechanic and was responsible for performing brake and clutch jobs on the trucks he drove. She was responsible for washing the clothes he wore to work every day, clothes that transported asbestos fibers home and into her lungs.
Brake linings, clutch facings, and a variety of gaskets on automobiles contained asbestos until very recently. Brake linings were one of the last products to have asbestos removed from them, and asbestos-containing brake linings were sold as recently as 2001. When old brake linings and clutch facings were removed and replaced, the brake or clutch was often cleaned out with an air hose or cloth rag. The cleaning created a significant amount of dust, which the worker would breathe in and collect in his hair and on his clothing.
Many people want to ask the obvious question: how is it that the wife or other family member of the worker became sick and not the worker himself? The answer is that not everyone who is exposed to asbestos will develop an asbestos-related disease. Some people work directly with asbestos products every day for years and never get sick, while others develop mesothelioma with only limited exposure to asbestos. Additionally, the latency period for developing asbestos-related disease ranges from approximately 20 to 50 years. This means that most people who develop asbestos-related diseases don’t show any symptoms until decades after they were exposed.
If you or someone you know has an asbestos-related disease and did not work in industries that used asbestos containing products, it’s important to find a firm with extensive experience in investigating such scenarios. Shepard Law has extensive experience reviewing and gathering evidence to help determine the source of asbestos exposure for victims such as these. This experience is crucial because proper documentation and investigation strengthens a client’s case in the legal system. As always, if you suffer from an asbestos-related disease and believe that you have a case, contact us for a confidential consultation.
Assisting Families Affected by Mesothelioma: Quick and Meaningful Tips
A diagnosis of mesothelioma is extremely difficult on the whole family. There are so many questions to be answered, so many appointments to keep track of, and so many difficult decisions to be made. However, there are things that you can do to assist a family who is dealing with a diagnosis of mesothelioma:
Set up a meal train.
- Patients with mesothelioma and their families have many appointments to go to and preparing healthy meals after a day filled with doctors’ appointments and/or treatments is easier said than done. Organizing a meal train is a helpful way to make sure the person diagnosed with mesothelioma and his/her caregiver is getting the nutrition they need.
- There are many websites that can help you organize and participate in providing meals to the family in need such as https://www.mealtrain.com/ or https://www.takethemameal.com/.
- Some friends and family may prefer to purchase a gift card rather than cooking a meal. Make a list of eateries that the person being treated for mesothelioma may like a gift certificate from. Good places to suggest are eateries in the area of the hospital and/or treatment facility and take-out places close to home.
Set up a care schedule.
- Between doctor’s visits and treatments, a person diagnosed with mesothelioma has a lot to organize and a lot to consider when choosing where to treat for their disease. In Massachusetts, we are lucky to have some of the best hospitals in the world for the treatment of mesothelioma right in Boston. For many, the choice to be treated at these hospitals brings the stress of traveling into Boston. In some cases, having someone volunteer to drive a person with mesothelioma into Boston would provide great relief.
- A person undergoing treatment will have a variety of needs (a ride to a doctor’s appointment, an appointment to get their glasses fixed, new socks, etc.). A care website will allow the person with mesothelioma to schedule the assistance they need. Friends and family can then volunteer through the site to provide the assistance. One such site is http://lotsahelpinghands.com/.
Providing family meals is a small but meaningful way to help out families.
Spend time.
- Mesothelioma can be a very painful and debilitating disease. Many people who are diagnosed with mesothelioma also struggle with depression as a result of their diagnosis. Spending time with a person diagnosed with mesothelioma is a wonderful way to support them though their diagnosis. Remember, the patient may be suffering and is not there to entertain you. You are there to comfort them and provided some much needed respite for their caregiver.
Take care of technological needs.
Many people who have been diagnosed with mesothelioma are older and not technologically advanced. There are many apps and websites that may benefit them greatly but they may not be aware of. Take some time to help that person:
- Skype with a grandchild who lives far away
- Set up a Netflix queue so when they have difficulty sleeping due to pain, they don’t have to watch infomercials
- Show them how to play Candy Crush so that they have something to pass the time while getting chemotherapy treatments
Support their lawsuit.
- Mesothelioma is caused by exposure to asbestos. Unfortunately, the manufacturers of asbestos-containing products knew of the hazards of exposure to asbestos but continued using asbestos and did not warn persons coming into contact with it to take any precautions. For that reason, many patients diagnosed with mesothelioma choose to pursue a lawsuit against the manufacturers of asbestos-containing products that they came into contact with during their career. Asbestos can take between 15 and 60 years to cause disease in your body. Which means that in order to be successful in a lawsuit, a person with mesothelioma needs to prove the types of asbestos they were exposed to 15 – 60 years earlier. This is no easy feat. Many times, people with mesothelioma must reach out to co-workers to help them remember the products they worked with or the people they worked around. It is easy to brush off those inquiries for fear of being involved in litigation but taking those phone calls could mean a great deal to that family. Supporting the person’s lawsuit can set them up for financial assistance which will greatly help their family when paying for all the medical bills and other costs associated with treatment for mesothelioma.
For a family dealing with the consequences of mesothelioma, doing even just one of the above activities will be a great help to them. Don’t think that your small act of kindness and friendship won’t be appreciated by the family.
Urban Redevelopment and Revitalization: The Next Wave of Asbestos Exposures?
It was recently announced that the L Street power plant in South Boston was being put up for sale by its current owner, Exelon Corp. This news likely has developers around Boston ready to pounce on the property, due to its proximity to the booming commercial real estate market of the Seaport District and the ever-increasing property values in South Boston. It is likely that the property will eventually be re-developed as a mixed-use property, featuring office space, residential condominiums and apartments, as well as commercial space. However, the fact that this property served as an active power plant for over a century may lead to a number of obstacles for potential re-development projects.
The former Boston Edison power plant first went into operation in 1892 as a coal-fired power plant. The plant was later transitioned to an oil-fired and later a natural gas plant, until it was retired in 2007. The property occupies 18 acres off of L Street at the border of South Boston and the burgeoning Seaport District. While the Environmental Protection Agency has been monitoring the property in recent years due to issues including contaminated soil and other environmental hazards, any proposed redevelopment projects are likely to be closely scrutinized by state and federal agencies.
Workers at power plants such as the Boston Edison L Street plant were exposed to a great variety of asbestos-containing products, including:
- Boiler insulation and firebrick
- Turbine insulation
- Gaskets and packing used in industrial pumps and valves
- Steam pipe insulation
As a result of these exposures, a large number of former workers at the L Street plant developed mesothelioma, asbestosis, and other asbestos-related conditions. While power plant workers up until the 1980’s were exposed to these products though directly installing or maintaining equipment in the plant, a new wave of exposures is likely to occur when old power plants and industrial spaces are re-developed or demolished. As urban renewal and gentrification takes place in cities across the country, developers and city officials will need to identify and deal with the issue of in-place asbestos being disturbed as former industrial buildings and power plants are renovated into commercial and residential property. Due to the significant amount of asbestos-containing products used in power plants and other industrial buildings through the 1980’s, the expense of remediation could be significant.
The danger of asbestos fibers being released during any demolition of existing structures on the L Street property may limit the options potential developers have in planning the re-development of the property. If existing buildings are to be renovated to become loft-style housing or office space, asbestos remediation contractors will have to make sure existing asbestos insulation on the property is properly encapsulated and secured. Simply demolishing the existing structures on the property may risk releasing airborne asbestos fibers into a heavily populated area. Regardless of what happens with the former L Street Power Plant, it is clear that the next wave of asbestos-related diseases will be caused by asbestos that is currently in place, and is disturbed and release during the course of renovation and demolition of old buildings.
If you or a loved one is an undergoing treatment for lung cancer or mesothelioma and would like to learn more about your rights please call us for free, confidential consultation (617) 451-9191.
For further information regarding the L Street Power Plant click here.
Taking Care of Our Caregivers
With the holidays quickly approaching, we look forward to celebrating this special time of year with our loved ones but recognize that it is a difficult time of year for many of our clients and their families. A diagnosis of lung cancer or mesothelioma can be devastating to a family and the thought of future holidays without a loved one can certainly make the holiday season very difficult for the families of those who have been diagnosed with lung cancer or mesothelioma.
When someone is diagnosed with an asbestos-related disease their family typically rallies around that person to provide support, comfort and care. Loved ones are so wrapped up in caring for their loved one that they do not always take the time to take care of themselves and deal with their own grief and loss due to the diagnosis. A caregiver spends their time driving their loved one to appointments, making sure that their loved one is taking all of the correct medicines, eating properly and is as comfortable as possible all while maintaining a home, paying bills and educating themselves and their family on their loved ones diagnosis and prognosis. This can be extremely taxing on any one person and caregivers may feel stressed out, alone and depressed. As difficult as it seems, caregivers must take care of themselves!
Tips for Caregivers:
- Take Frequent Breaks: Although it doesn’t seem possible to take breaks away from your loved one that needs your full attention, steal away time when you can. If someone comes to visit your loved one, do not feel that you have to entertain them. Take that time for yourself.
- Accept Offers of Help: When friends and family offer to help they mean it! It is difficult to know how to help in situations where someone has been diagnosed with a serious disease so don’t be afraid to tell trusted friends and family what they can do to help out. Whether it is asking them to bring over a meal, to drive your loved one to an appointment or to come over and make you laugh, they will appreciate knowing how to help you and you will have some much needed help.
- Exercise: Taking time to do something for yourself is important. Take a walk around the block to clear your head or take a class that you enjoy.
Create a Way to Get Information Out: Taking care of a loved one is a full time job and as much as you may appreciate the constant calls asking for updates it can be exhausting trying to keep everyone informed. Create a way to update your friends and family without having to continually call each and every one of them. Options include:- Private group on Facebook: You could set up a private group which would allow you to send private information to only those who you would like to have that information
- Create a blog: A blog would allow you to communicate with anyone that wanted information on you and your loved one. They are easy and free to set up using the WordPress website – https://wordpress.com/.
- Start a telephone tree: Give each person in your group a person to call when there is news. Call the first person on your list and ask that they call their contact person to share the news and contact the next person in line.
- Join a Support Group: There are many local support groups for caregivers which allow a caregiver to get the support that they need to continue on with their very difficult support role. Check with your local hospitals or see the list below:
At Shepard Law we are fortunate to meet many wonderful clients and their supportive caregivers. We recognize that a diagnosis of mesothelioma does not only affect the person being diagnosed with the disease. During this holiday season we wanted to take the time to thank the tireless caregivers that show such amazing strength, resilience, and compassion while taking care of their loved who have been diagnosed with lung cancer or mesothelioma.
If you or a loved one is an undergoing treatment for lung cancer or mesothelioma and would like to learn more about your rights please call us for free, confidential consultation (617) 451-9191.
This Veterans Day, We Should Also Honor Those Who Were Injured by Asbestos
Each year in November we get the chance to pay tribute to the brave men and women who have served in the armed forces. While all veterans should be honored and thanked 365 days a year, Veterans Day provides us with a special opportunity to thank those who have served our country.
Many of our firm’s clients are veterans who are suffering from asbestos-related diseases, such as mesothelioma and lung cancer. Because of this, I have had the opportunity to work with those who have served in virtually every branch of the military. I always enjoy hearing stories about the things our clients encountered while defending our country, some clients even share old photo albums from their military service. While it is an honor to help these veterans and their families work through the process of litigating asbestos claims, it is also disheartening to know that because of their dedication and service, many veterans will continue to develop asbestos-related diseases every year.
Veteran’s Exposure to Asbestos
Asbestos was commonly used in various roles by the armed forces for many years. Asbestos was found in the equipment in the engine and boiler rooms on Naval vessels, as well as in the brakes and engines of Air Force and Naval aircraft, and in many other products. These products had to be maintained and repaired on a regular basis. That maintenance and repair work released asbestos fibers into the atmosphere, which could have been breathed in by anyone working in the nearby area.
Earlier this year, several attorneys from our firm took a trip to Battleship Cove in Fall River, MA (http://www.battleshipcove.org). We were treated to a tour of the USS Massachusetts and the USS Joseph P. Kennedy, Jr. During this remarkable experience we explored every aspect of these vessels, including the engine and boiler rooms – which have remained largely intact from when the ships were operational. It was a particularly poignant experience since many of our clients worked in these engine and boiler rooms as either:
- Machinist Mates
- Boiler Technicians
- Electricians
- Firemen
- Engineers
In fact, asbestos was so prevalent among these positions that the military website miltary.com reported that:
‘Virtually every ship commissioned by the United States Navy between 1930 and about 1970 contained several tons of asbestos insulation in the engine room, along the miles of pipe aboard ship and in the walls and doors that required fireproofing.’
Although the engine and boiler rooms we saw were clean of asbestos, this was not the case when these vessels were operational and it was easy enough to image what the working conditions would have actually been like aboard a Naval vessel during the mid-20th century. At that time, those engine and boiler rooms would have been packed with servicemen, whose work on the equipment would have created a dusty and dirty atmosphere. It was that dust, inhaled by unsuspecting men and women which decades later has caused so many veterans to suffer from asbestos-related illnesses.
Protecting Your Legal Rights
Our office has represented hundreds of veterans in asbestos cases over the years so we understand how and where asbestos was used in military applications. Often, our clients were not even aware that they had come into contact with asbestos until they received a diagnosis of mesothelioma. If you or a loved one is a veteran that has been diagnosed with mesothelioma, you may qualify for additional benefits. Please call us for free, confidential consultation (617) 451-9191.
What You May Not Know About Lung Cancer
November is lung cancer awareness month and with good reason. According to the American Lung Association, “Lung cancer causes more deaths than colorectal, breast and prostate cancers combined. An estimated 158,040 Americans are expected to die from lung cancer in 2015, accounting for approximately 27 percent of all cancer deaths.”
What causes lung cancer?
Most people know that smoking is a major cause of lung cancer and if you’re a man the risk is even higher. In a recent study conducted by the US Surgeon General, it was reported that that male smokers are twenty-five times more likely to develop lung cancer than non-smoking males. Many of us also know that occupational exposure to asbestos is another risk factor that increases your chances of developing lung cancer. However, the general public is not as aware of the synergetic effect that occurs when smoking and exposure to asbestos are combined. For these individual, the risk of developing lung cancer doesn’t just increase – it multiples.
Combining smoking and asbestos exposure multiplies risk
For reasons that are not yet completely understood, asbestos poses a greater risk for lung cancer in individuals who smoke cigarettes. It is generally accepted that smoking and asbestos exposure have a synergistic effect. This means that smoking and asbestos combines in the lungs in a way that multiplies the risks that either would have on its own, although studies differ as to the extent of the multiplying effect.
This multiplying of risks is of great significance because the vast majority of individuals who worked with or around asbestos-containing products were also smokers. Consider the occupations that are most often associated with asbestos exposure:
- Shipyard workers
- Navy veterans, particular those who worked in the engine and boiler rooms
- Insulators, pipecoverers and laggers
- Pipefitters and plumbers
- Boilermakers
- Machinists and millwrights
- Plasterers and drywall installers
- Auto mechanics
Men who worked in these occupations were extremely likely to have smoked. In over twenty years of representing victims of asbestos exposure, I can count on two hands the number of lung cancer cases where my client was a lifelong non-smoker and we can understand why. These trades occurred in environments where smoking was not only allowed, it was socially encouraged. Most construction crews were given smoking breaks during the day.
“I have had clients tell me that they weren’t really interested in smoking, but they started doing it because they didn’t want to be left out of the smoking breaks that their buddies were allowed to take.”
—Mike Shepard
US military veterans were practically told to smoke – until 1975 cigarettes were included in K-rations and C-rations. A machinist mate in the United States Navy worked in an engine room that was loaded with asbestos insulation, gaskets and packing, while regularly smoking cigarettes. It is no wonder that so many of my clients are former Navy firemen, machinist mates, electricians and the like. They spent their working hours in a windowless compartment surrounded by boilers, turbines, pumps, valves and a multitude of other equipment that incorporated asbestos insulation, gaskets and packing. That equipment was in constant need of service and repair, creating daily exposures to asbestos. All the while, these veterans were smoking cigarettes as a way to deal with the stress and monotony of life on board a Navy ship. Now, decades later, those two carcinogens have combined in their lungs to cause cancer.
What can you do?
Throughout this month please join us – advocates, survivors, caregivers and family members – as we show support for the lung cancer community and recognize the toll that both smoking and exposure to asbestos has taken, and continues to take, on the men and women who built this country and the service men and women who have protected it.
We want you to know your rights. If you or a loved one suffers from Mesothelioma or lung cancer, call for information on how we can help. Time is of the essence, so call us today (617) 451-9191.
