Fact Check: Are Pharmaceutical Companies Immune From Covid
As of January 19, about 24 million cases of the coronavirus have been reported in the United States and more than 400,000 Americans have died from COVID-19, according to the New York Times.
USA Today reported that President-elect Joe Biden announced his $1.9 trillion stimulus plan on January 14 and set a goal of providing 100 million doses of the COVID-19 vaccines during the first 100 days of his administration.
The Centers for Disease Control and Prevention’s COVID-19 data tracker shows that 10.5 million people have received at least one vaccine dose and that 1.6 million have received both doses.
According to the Associated Press, “Massive coronavirus vaccine trials involving tens of thousands of participants have so far surfaced no signs of serious side effects, and few unexpected adverse reactions have been reported in the early days of COVID-19 vaccine distribution in the U.S.”
Though millions of people have been vaccinated, some Americans are concerned about the side effects of the vaccines and if pharmaceutical companies such as Moderna and Pfizer could be liable for injuries.
Pharmaceutical companies have no liability for their vaccine products. I ask, if they are so “safe” why can you not seek damages in a court of law if you are harmed by them?There is a special “vaccine court” that they have but it may as well be a kangaroo court.
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Some Companies And Governments Are Pushing Their Staff To Get Vaccinated But Lawyers Say Forcing Employees To Get A Covid Jab Could Be Risky
Dec 15 – Kroger Co will stop some COVID-19 benefits for unvaccinated employees starting next year, as the supermarket chain pushes more workers to get inoculated amid growing concerns over the spread of the Omicron coronavirus variant.
Kroger, among the biggest private employers in the United States, had about 465,000 full and part-time workers as of Jan. 31, according to a regulatory filing.
Meanwhile, all private companies in New York City must order their staff to get COVID-19 vaccines under sweeping new rules announced by mayor Bill de Blasio, as a planned nationwide U.S. mandate on workers remains on hold after running into legal challenges.
As businesses around the world seek to recover from the pandemic’s impact, some firms are imposing rules requiring workers to get a COVID-19 jab while others are letting their staff go unvaccinated.
In some cases, companies are also being ordered by governments to impose vaccine mandates on employees.
“If you’d been asking me six months ago, did I think that mandatory vaccination is something that we’d see, I would have been saying ‘no’,” said Kim Sartin, a London-based partner at international legal firm Baker McKenzie.
“But it’s interesting how things have really evolved.”
Here’s the background and whether your employer can require a jab to work.
The background:
Dozens of countries are offering COVID-19 vaccines for all adults.
What are employers doing?
Have similar vaccine mandates happened before?
What will happen next?
Vaccines Have Improved Lives
To say the least, vaccines have been a game-changer. In fact, some believe them to be the greatest life-saving innovation in the history of medicine.
A great example is the smallpox vaccine. Smallpox used to be a deadly disease. Between 1900 and 1920, it killed around 300 million people. But the development and introduction of a vaccine essentially eliminated the disease.
Vaccines have also worked for other diseases. For example, according to the U.S. Centers for Disease Control and Prevention , the flu vaccine has dramatically reduced the number of flu-related hospitalizations and doctor visits. Other diseases, such as measles, mumps, pertussis, diphtheria, and tetanus, are far less common than they used to be because of widespread childhood vaccination programs.
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Vaccine Adverse Event Reporting System
The NCVIA also mandates that all health care providers must report certain adverse events following vaccination to the Vaccine Adverse Event Reporting System .
The NCVIA also established a committee from the Institute of Medicine to review the existing literature on vaccine adverse events occurring after immunization, regardless of whether there was a direct link between events.
Traditional Route For Vaccine Injury Compensation
Because communicable diseases threaten the entire population, the federal government provides a safety net for those who choose to get recommended vaccines. Under normal circumstances, when someone is injured from a vaccination, the National Vaccine Injury Compensation Program , sometimes called “vaccine court,” provides benefits. The VICP is a no-fault program designed to compensate people injured by somewhat run-of-the-mill vaccines like childhood inoculations.
The purpose of VICP is to ensure an adequate supply of vaccines, stabilize costs, and provide an efficient forum for injury compensation. VICP is an efficient alternative to litigation because it’s less formal than a typical lawsuit and pays attorneys’ fees and expert fees for injured consumers.
Vaccines covered by the VICP are primarily standard-issue inoculations, like the flu shot, recommended for children and pregnant women by the Centers for Disease Control and Prevention. The VICP filing deadline for an injury is within 3 years after symptom onset. For death cases, survivors must file a VICP claim within 2 years of the death and 4 years of symptom onset.
To qualify for VICP benefits, claimants must also meet a certain threshold of injury severity:
- the injury’s effects must have lasted more than 6 months after vaccination, or
- the injury must have resulted in inpatient hospitalization and surgical intervention, or
- the injury must have resulted in death.
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What Do We Know About Australias New Deal
The deal relates to two vaccines the government had previously announced it would supply, should clinical trials prove successful.
These are the University of Oxford vaccine, from AstraZeneca, and the University of Queensland vaccine, from Seqirus .
However, it is not entirely clear what this indemnity deal means in practice. The budget papers say the government will cover: ‘certain liabilities that could result from the use of the vaccine.’
The government considers further details commercial in confidence.
For instance, we dont know how serious or disabling a side-effect would have to be to qualify or whether there is any cap on the amount of compensation.
We also dont know what would happen if there were errors involved, or contaminants introduced, while manufacturing the vaccine. These would still be the companys liability, but it may be hard to determine where boundaries lie.
The Issue Of Punitive Damages
If the Johnson punitive damage verdict is affirmed on appeal, it could significantly affect future vaccine litigation. Prior to the Johnson verdict, punitive damages were not a prominent factor in vaccine cases. Most plaintiffs’ complaints did not even ask for punitive damages . If the verdict is affirmed, claims for punitive damages may become more prevalent.
Affirmation of the punitive damage verdict in Johnson could be interpreted as a determination by a powerful regulatory body that Sabin vaccine should not be administered in the United States unless preceded by an administration of Salk vaccine to unimmunized contacts, and perhaps to the child as well. However, society generally has deemed it desirable to delegate decisions on such health policy issues to specialist groups, such as those advising the FDA and CDCâan approach viewed as appropriate by the committee.
Punitive damage awards would greatly increase the magnitude of financial risk for manufacturers because such damages can be almost unlimited in amount and can be duplicative.
The Johnson verdict again shows that the manner in which courts rule on questions involving a manufacturer’s responsibility is highly unpredictable.
Summary of the Legal Situation
This review demonstrates that the limits of a manufacturer’s responsibilities are unclear. Some decisions appear to suggest that the manufacturer can be held strictly liable in all cases.
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Can I Sue For Vaccine Injury
With all the recent debate over vaccines, theres one point you may have heard from anti-vaccination proponents to back up their decision to not vaccine themselves or children: That you cant sue vaccine manufacturers for vaccine injuries.
In 1986, congress created a separate no-fault court to handle complaints and claims from those who suffered harm due
to vaccines. The National Vaccine Injury Compensation Program is funded by vaccine manufacturers and is administered by the Department of Health and Human Services. When a claim is made against a vaccine manufacturer, the HHS determines if the claim is valid and what its worth. Compensation for valid claims is limited to $250,000.
Prior to 2011, if your vaccine claim was denied by HHS, you were still able to file a personal injury or wrongful death lawsuit and sue the vaccine manufacturer in court. However, after the 2011 Supreme Court ruling in a vaccine injury case against vaccine manufacturer Wyeth, parents are no longer allowed to bring personal injury lawsuits in vaccine injury cases.
The Court decided in a 6-2 decision that the Vaccine Injury Compensation Program was designed to handle all vaccine complaints and protect vaccine manufacturers from claims. In the decision, Justice Antonin Scalia said that when a vaccine is properly prepared and accompanied by proper directions and warnings, lawsuits over side effects are not allowed.
Liability For The Production And Sale Of Vaccines
Potential liability for vaccine-related injuries has received much attention as a deterrent to vaccine manufacturing. A variety of approaches to the issue have been suggested, but there have been few attempts to determine the magnitude of the problem or to analyze basic trends in the interpretation of laws in this area. This chapter provides such an analysis and examines the ways in which the state of the law influences decisions that ultimately affect vaccine availability and innovation.
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Legal Review Of Covid
This article about COVID-19 vaccine liability was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law , who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.
Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.
I have been getting many questions about COVID-19 vaccine manufacturers and liability. Here is a short answer. There are limits to the ability to sue manufacturers for injuries from routine vaccines given to children or pregnant women. They are not absolute and are accompanied by a compensation program that is easier to win in than the regular courts.
There are very strong limits on the ability to sue manufacturers of emergency products not just vaccines. Those are accompanied by a very hard-to-use compensation program, that provides limited compensation.
Ideally, I would like to see COVID-19 vaccine liability moved to the routine compensation program.
Contents
The Countermeasures Injury Compensation Program
If you experience a side effect from the COVID-19 vaccine, your legal situation isn’t hopeless. If you follow the procedural hoops ââ¬â and you will want a lawyer’s help with this ââ¬â you may be able to recover at least some money through CICP.
CICP is an administrative program administered by HHS that is funded by emergency federal appropriations . To be eligible, you must be able to prove that:
- You suffered death or serious physical injury
- Your injuries were directly caused by the use of a covered countermeasure .
If you can prove this, you may be reimbursed for reasonable medical expenses, loss of employment income, and, if you die, survivor benefits.
You only have one year from the date of vaccination in which to bring a CICP claim. If you disagree with the determination, you need to bring it up with HHS you cannot get a judge to review it.
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How Unusual Is This
This deal is not entirely new or unexpected. The government has provided some indemnity to pharmaceutical companies that make vaccines against smallpox and influenza.
The governments of many other countries have also agreed to indemnify COVID-19 vaccine manufacturers, including governments in the UK, US and theEuropean Union.
The manufacturers believe that as the use of their vaccine is for the benefit of society, they should not be held financially accountable for any consequences from a vaccine reaction.
Side Effects Of Covid
The FDA has approved three COVID-19 vaccines in the United States for emergency use. Pfizer, Moderna, and Janssen/Johnson & Johnson make them.
COVID-19 vaccines have been associated with certain, mostly mild, side effects. They include:
- Fever
- Easy bruising
- Red spots on the skin beyond the injection site.
There have also been rare reports of people developing a nerve disorder or severe blood clotting after getting the Janssen/Johnson & Johnson vaccine. We discuss these reports and possible legal relief here.
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Injured Party Files A Petition
The first step in filing a claim with the Vaccine Injury Compensation Program is to file a petition with the U.S. Court of Federal Claims, the court that handles vaccine injury claims. The court then notifies the Department of Health and Human Services and Department of Justice , which represents HHS in the vaccine court process.
Risk & Liability: Who Is Accountable For Adverse Effects Of The Covid Vaccine
Get Vaccinated to Offset Risk?
Since the release of COVID-19 vaccines, weve seen a rush to get as many people vaccinated as quickly as possible. As with almost any medical treatment, the side effects can vary in degree, depending on the personand as we now seeon the vaccine manufacturer.
After receiving the vaccine, individuals may experience anything from minor fatigue and pain to swelling, and now, potentially fatal blood clots are on the list, as a few patients have experienced from the Johnson & Johnson vaccine.
Real Risks of Vaccination
In a joint statement from The Centers for Disease Control and the Federal Drug Administration, there have been six reported U.S. cases of severe and rare blood clots due to the J& J vaccine, which has since been pulled from clinics nationwide and paused in production. Of the six U.S. women who developed the severe blood clots stemming from initial side effects of fever, aches, and chills, one has died while the other five require hospitalization.
Deemed rare by the CDC, these real risks of vaccinations have stirred up even more discussions around who should be held accountable for doses that dont work out as planned.
What is The PREP Act?
Is the FDA Liable?
What is Being Done Now?
Amendments have been requested and made to the PREP Act since the start of COVID spreading. For now, individuals adversely affected after a failed vaccination will need to file a claim with the U.S. Department of Health and Human Services.
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Qubecs Vaccine Injury Compensation Program
The following description comes from the Québec Ministry of Health website . In 1979, a five-year-old girl, Nathalie Lapierre, developed viral encephalitis shortly after being vaccinated for measles, and was left severely disabled. Her parents brought an action against the Government of Québec for damages, including those relating to tutoring. In Québec vs. LapierreFootnote 9, the Québec Court of Appeal held that, while there was a causal link between the vaccination and the injury, there was no fault on the part of the Province , and there was no obligation under Québec law to compensate in the absence of fault. In dismissing Lapierres appeal, both the Court of Appeal and the Supreme Court of Canada observed that an obligation independent of any fault in circumstances such as those of the case at bar would be an excellent thing, but it does not exist in our law at present. In the result, perhaps for political reasons, or in recognition of the demands of social justice, the Government of Québec provided some support to the family in this case. Subsequently, in 1985, it introduced its VIC Program, which was statutorily grounded in a new division of the Public Health Protection Act. A regulation specific to this program was adopted in November 1987, and the first claims for compensation were filed the following year.
Is Anyone Liable
Remember, vaccine manufacturers aren’t the ones approving their product for mass distribution. That is the job of the FDA.
Which begs the question, can you sue the U.S. government if you have an extraordinarily bad reaction to a vaccine?
Again, the answer is no.
“You can’t sue the FDA for approving or disapproving a drug,” said Dorit Reiss, a professor at the University of California Hastings College of Law. “That’s part of its sovereign immunity.”
Sovereign immunity came from the king, explains Dunn, referring to British law before the American Revolution. “You couldn’t sue the king. So, America has sovereign immunity, and even each state has sovereign immunity.”
There are limited exceptions, but Dunn said he doesn’t think they provide a viable legal path to hold the federal government responsible for a Covid vaccine injury.
Bringing workers back to the office in a post-Covid world also carries with it a heightened fear of liability for employers. Lawyers across the country say their corporate clients are reaching out to them to ask whether they can require employees to get immunized.
Dunn’s clients who run businesses serving customers in person or on site are most interested in mandating a Covid vaccine for staff.
“They view it as a selling point,” Dunn said. “It’s particularly important for restaurants, bars, gyms and salons. My clients in that segment of the service industry are looking hard at making it mandatory, as a sales point to their customers.”
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