Immunity for Them, Not for You (Pt. 4 of What to Consider Before Getting a COVID-19 "Vaccine" or Semi-Annual Revaxx)

NOTE: Below is part 4, the final part, of What to Consider Before Getting a COVID-19 "Vaccine" or Semi-Annual Re-Vaxx. If you haven't read parts 1, 2 and/or 3 yet, you may click the prior-referenced link to read them.

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For the hundreds of thousands of people around the world with reported adverse effects from COVID-19 vaccines to the U.S. Centers for Disease Control and Prevention's (CDC) Vaccine Adverse Event Reporting System (VAERS) [*1], which may be as low as 1% of the actual victims experiencing adverse effects [*2], and others who are experiencing but not reporting such effects, who's going to pay for their lost wages, physical therapy, drugs, and other resulting needs?

For the over-sixteen-thousand with permanent disabilities from the COVID-19 vaccines reported on VAERS, who's going to pay for the lifetime of care required and compensate them for their pain and suffering? For the over-twelve-thousand reported on VAERS as dead from COVID-19 vaccines, who will compensate their loved ones for their losses?

Making those who made drugs that harmed people pay has traditionally been handled under civil law. Most countries' civil legal systems take their cues from the U.S. and U.K.'s "common law" systems, as judges who've heard cases with particular circumstances write "opinions" based on other judges' "opinions" over hundreds of years. Simply put: (1) someone claims another doing X is wrong and caused harm; (2) a judge explains why X is or isn't wrong, and (3) all future judges conclude similar things to X are wrong or not wrong by referencing what the prior judge said, which is now "law."

Countries without a "common law" system will often copy the opinions of these judges through executive/administrative decree or law by legislatures. Hence, laws around the world aren't exactly uniform, but they are fairly similar.

The subset of civil law that applies to drugs injuring people, "product liability," varies somewhat between jurisdictions, but mostly copies an academic publication titled The Second Restatement of Torts at § 402A, which states [*3]:
Special Liability Of Seller Of Product For Physical Harm To User Or Consumer
(1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if
(a) the seller is engaged in the business of selling such a product, and
(b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.

(2) The rule stated in Subsection (1) applies although
(a) the seller has exercised all possible care in the preparation and sale of his product, and
(b) the user or consumer has not bought the product from or entered into any contractual relation with the seller.

A drug company that sells a defective drug, unreasonably dangerous, will pay for any damage its creation causes to the person harmed by it, even if the drug company took the utmost care in creating the drug. Defect can mean the drug could have been designed better but wasn't (defective design), a mistake was made in making the drug by deviating from design (defective manufacture), and/or insufficient safety instructions were provided for the product (defective warning).

To ensure everyone adversely affected by a drug is fairly compensated, victims in most countries can bring claims in "classes," and a drug maker will be forced to pay the entire class. By law, those who might have experienced adverse effects are given notice and an opportunity to "join" a "class action" lawsuit. Thus, one dealing with mildly-irritating side effects who normally wouldn't be bothered to hire a lawyer and sue individually may opt to sign on or be motivated to hire his own lawyer and bring a separate lawsuit. This chain of events from class actions often compounds the amount of money drug-makers would normally pay if class actions weren't allowed.

In the U.S., and other countries, a jury can decide if the drug was defective and, also, how much money to award the injured, which can result in multi-million or even multi-billion-dollar awards that drug makers have to pay. This is why caps on the amount a jury can award are sometimes imposed by legislatures (damage caps), with some controversy [*4].

Imposing damage caps is a priority for makers of drugs that will inherently injure some people. To make a drug that won't injure anyone, (1) all human bodies' reactions to the drug would have to be roughly uniform  (which isn't so) or (2) the drug must be given only to a subset of people who will react appropriately to it. A vaccine is, generally, a one-size-fits-all product, but we are different "sizes" regarding our reactions to it, and no one-size-fit-all truly fits all. Your doctor doesn't usually pick a vaccine tailored to your unique body and medical circumstances; he either recommends it for you or he doesn't.

Alas, some people will almost certainly be injured from a vaccine given to the masses. And try arguing to a judge or jury that those injured should suffer without compensation, because the vaccine was "reasonably dangerous." Thus, if a maker can't escape liability, the next best thing is limiting the amount of money it'd be required to pay out and, perhaps more importantly, to prohibit class actions.

The National Childhood Vaccine Injury Act of 1986 (NCVIA), in the U.S., did just that. Ostensibly, drug makers were pulling out of the vaccine market, because the cost of liability insurance was too high for vaccines to be profitable. Congress feared a vaccine shortage and barred the public from suing drug companies over adverse effects from vaccines. It, instead, set up a compensation system through the Federal Court of Claims (colloquially referred to as "Vaccine Court"), a non-jury administrative system that does not allow class actions.

An excise tax is placed of, currently, $0.75 [*5] on each vaccine, and for each disease its designed for, to fund a pool of money to award the injured. Those seeking compensation aren't suing the drug makers but, instead, the U.S. government. Presently, damages are capped at a max of $250,000 (for death). Awards focus on the cost of managing the condition of the injured, ensuring they have funds to pay for their care.

An administrative-law judge (ALJ) in Vaccine Court decides if the vaccine given caused side effects on an "injury table" within a certain period of time. Rather than require mounds of independent medical evidence (which doctors often charge $1,000+/hour to produce), the burden of proof is lower.

The injury table for the seasonal influenza vaccine was last updated in 2017 [*6]. 



The middle box shows the adverse effects the ALJ will consider. The far-right box shows the time-frame the ALJ must find the adverse effects to have materialized within in order to award compensation. For example, did a person develop Guillain-Barré Syndrome ("a rare neurological disorder in which the body's immune system mistakenly attacks part of its peripheral nervous system") [*7] no sooner than three days and no later than 42 days after getting a seasonal influenza vaccine? If so, the ALJ can give an award if a claim in Vaccine Court is filed.

An ALJ can decide if a non-boxed side-effect caused harm, but this would require additional evidence to persuade him. If the ALJ denies a claim, that's it. Design defects are barred from being heard by a jury in the traditional U.S. court system.

This scheme was challenged in the U.S. Supreme Court Case Bruesetwitz v. Wyeth, 562 U.S. 223 (2011) [*8]. The opinion is twenty-eight pages of debate and a ruling in regards to what the following paragraph in the NCVIA means:

No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.

Note "properly prepared" refers to defective manufacture and "accompanied by proper directions and warnings" refers to defective warning, two of three aspects of product liability mentioned earlier. Does the phrase "unavoidable" refer to the third aspect, defective design? If so, then the NCVIA wouldn't bar any claims in regular court.

The majority reasoned that defective design claims must be barred, because drug makers wouldn't get anything in exchange for the public having access to what the majority referred to as a "generous" liability and payment scheme in Vaccine Court. Ostensibly, drug makers are "paying" for their immunity from $250,000+ jury awards and class actions via Congress imposing a $0.75 tax on their products that might cut into profits by raising the prices of their vaccines.

In reality, drug makers get two benefits and zero cost from the NCVIA. First, they get immunity from liability in the traditional court system. Second, they avoid defending themselves in Vaccine Court (as the U.S. government handles the claims for injury) and defer any compensation to the injured through a, currently, $0.75 tax on each vaccine given.

This liability scheme was designed to encourage drug makers to produce vaccines so there won't be shortages. Legislatures and administrative agencies can't create medical remedies for novel disease out of thin air; they rely on the private sector to produce remedies for the public. The U.S. Congress, and others around the world, thought ahead: what if a medical emergency necessitated rapid distribution of a medical remedy?

Thus, in 2005, a new U.S. law, the Public Readiness and Emergency Preparedness Act (PREP Act), which authorizes the Department of Health and Human Services (HHS) to declare even more immunity from liability for any claims related to "emergency countermeasure" vaccines and any other countermeasures (like drugs and medical devices) "against diseases or other threats of public health emergencies" [*9], was enacted, inspiring governments around the world to mirror it.

Law can put people in jail. It can tax people. But it can't produce a remedy for a public-health emergency. Normally, makers of remedies could be sued under product-liability laws if they try to remedy a health emergency and wind up harming people, meaning their failure could bankrupt them in legal fees, insurance costs, and judgment-awards they'd owe. But, if vaccine makers were given an additional boost in legal immunity, beyond the NVCVIA, perhaps their ingenuity could be stimulated to produce remedies to public-health emergencies.

First, a "countermeasure," like a vaccine, is approved by the jurisdiction's regulatory agency for "emergency use." Normally, regulatory agencies like, in the U.S., the Food and Drug Administration (FDA), require many months of testing of long-term health risks for vaccines before approving them for general use. But, the regulatory demands for testing are severely truncated for what are redeemed as "emergency countermeasures" by the HHS. This truncated "testing," in the U.S., for COVID-19 vaccines as an emergency countermeasure was thoroughly discussed in part 2 (of 4) of this piece that you can read here [*10].

Once approved as an emergency countermeasure, an absurd level of liability protection is afforded. This is where the rabbit-hole we're about to enter begets a truly wild ride. Note the HHS's enactment and interpretation of liability protection for COVID-19 vaccines as an emergency countermeasure [*11]. 



Absent "willful misconduct," meaning the vaccine maker intentionally tried to injure people or acted with reckless disregard for whether they would or wouldn't injure people, no claims can be brought in the regular, judicial, U.S. court system.

Immunity from litigation extends not only to the COVID-19 vaccine makers, but any person or entity participating in the distribution of the product. As long as someone is injured in an event with "a direct connection to [a] countermeasure's administration or use," he/she or it is immune from litigation. Thus, immunity from liability goes far beyond mere design defects.

If a vaccine delivery truck runs over and kills people on its vaccination-site delivery path, the victims, according to the HHS, aren't allowed to sue. If, in the course of injecting one with the vaccine, someone slips and falls, the injured have no right to sue, since the slip and fall resulted from the attempt to give a "covered countermeasure."

Can victims, nonetheless, bring claims in Vaccine Court? Ostensibly, yes. But, good luck proving your claim [*12].



Claims against those giving an HHS-approved countermeasure (like the COVID-19 vaccines) must be "supported by compelling, reliable, valid, medical and scientific evidence." In law, "compelling" means beyond the normal suing-people standard of "preponderance of the evidence." Further, the word "and" is critical here. Scientific evidence requires long-term studies into the side effects. Emergency-use authorization negates such studies. So, how is one to prove with "scientific evidence" that his/her injury is related to a COVID-19 vaccine?

As long as COVID-19 vaccines remain under "emergency use" provisions of the PREP Act, or under similar schemes in other countries, it is effectively impossible to bring a successful claim without additional studies.

Hopefully, future studies on the harmful effects of the COVID-19 vaccines, as discussed in part 3 (of 4) of this series here [*13], will allow such claims to be brought.

Eventually, I believe such evidence will come to light. Then, a tsunami of claims will be brought. Thus, lawyers might want to research and practice their skills in this area to assist if and when the time for justice is ripe.

---
FOOTNOTES
[*1] https://wonder.cdc.gov/vaers.html
[*2] https://digital.ahrq.gov/sites/default/files/docs/publication/r18hs017045-lazarus-final-report-2011.pdf
[*3] The Second Restatement of Torts, § 402A https://h2o.law.harvard.edu/text_blocks/134
[*4] The Seventh Amendment of the U.S. Constitution states: "In suits at common law, where the value in controversy shall exceed twenty dollars, the right of trial by jury shall be preserved, and no fact tried by a jury, shall be otherwise reexamined in any court of the United States, than according to the rules of the common law." https://www.law.cornell.edu/constitution/seventh_amendment Argument ensues as to whether a "fact tried by the jury" can also be the award in dollars that would exceed a damage cap imposed by a legislature. Common law is law made by judges, not legislatures. Thus, arguably, only a judge could change a jury award, and damage caps are "unconstitutional."
[*5] The Health Resources and Services Administration in the U.S. states:

Funded by a $.75 excise tax on vaccines recommended by the Centers for Disease Control and Prevention for routine administration to children, the excise tax is imposed on each dose (i.e., disease that is prevented) of a vaccine. Trivalent influenza vaccine for example, is taxed $.75 because it prevents one disease; measles-mumps-rubella vaccine, which prevents three diseases, is taxed $2.25.
https://www.hrsa.gov/vaccine-compensation/about/index.html
[*6] https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/d/injury-table.pdf
[*7] https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Guillain-Barr%C3%A9-Syndrome-Fact-Sheet
[*8] https://www.supremecourt.gov/opinions/10pdf/09-152.pdf
[*9] https://www.hrsa.gov/vaccine-compensation/about/index.html
[*10] https://stratagemsoftheright.blogspot.com/2021/06/false-efficacy-difference-between.html
[*11] https://www.federalregister.gov/documents/2020/03/17/2020-05484/declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical-countermeasures
[*12] https://www.hrsa.gov/cicp/
[*13] https://stratagemsoftheright.blogspot.com/2021/07/adverse-effects-seen-and-unseen-pt-3-of.html

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