Something Sec. Kennedy Can Do That We Should All Be Able To Agree On

Revoke the PREP Act Declarations That Take Away Our Power to Hold Corporations Accountable!

Okay, so we don’t all agree on the best way to prevent or treat disease. Even doctors have different opinions on the safety and efficacy of various pharmaceuticals. But, there’s one thing we can all agree on:

Corporations should be held liable for the deaths and injuries they cause, and people who have been hurt, or have suffered the loss of a loved one, have the right to sue the companies at fault.

Tragically, back in 2005, Congress snuck a last-minute rider into a Defense appropriations bill that gives the Secretary of Health and Human Services the power to take away our right to sue by giving legal immunity to Big Pharma for “medical countermeasures,” no matter how badly the companies screwed up in the “design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use of such countermeasure.”

The only exception would be “willful misconduct,” defined as acting “intentionally to achieve a wrongful purpose; knowingly without legal or factual justification; and in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.” The law set the bar so high that no set of facts could ever meet this burden of proof. Plus, the law forbade any court from reviewing the Secretary’s declarations granting pharmaceutical companies these liability waivers.  

This was unpopular then and no one likes it any better today. It violates our sense of justice, and it’s unconstitutional, but until the lawsuits making that case work their way through the courts, we’re stuck with that 2005 law known as the Public Readiness and Emergency Preparedness Act (PREP Act).

There are several PREP Act declarations issued by previous Health and Human Services Secretaries that Sec. Kennedy should revoke now:

COVID PREP Act Declaration - March 10, 2020 to December 31, 2029

On December 11, 2024, President Biden’s HHS Secretary Xavier Becerra signed the twelfth PREP Act declaration for COVID. The first was issued by President Trump’s Sec. Alex Azar first on March 10, 2020.

The liability waiver covers any antiviral, any drug, any biologic, any diagnostic, any other device, any respiratory protective device, or any vaccine manufactured, used, designed, developed, modified, licensed, or procured, to diagnose, mitigate, prevent, treat, or cure COVID-19, or the transmission of SARS-CoV-2.

One of the craziest things about the COVID PREP Act declaration is that it also covers products used to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by covered countermeasures!

You read that right. If someone gets a serious or life-threatening disease or condition from a dangerous product used to prevent or treat COVID, anything a health care professional gives them to deal with that also has the liability waiver attached to it.

Take this example: Due to the negligence of a pharmaceutical company, you are administered a COVID countermeasure that is unknowingly contaminated with a substance you’re deathly allergic to. Not only will you never be able to sue over that, no matter what happens to you from then on, it’s all covered under the same liability waiver. You won’t be able to sue no matter how flawed or faulty the subsequent treatment is. They could accidently stick you with a used syringe tainted with a deadly disease mislabeled as an EpiPen, and you would have no legal recourse, unless you could prove “willful misconduct.” It’s absurd!

Strangely, the COVID PREP Act declaration doesn’t just cover COVID. It was extended on August 4, 2021, to cover seasonal influenza vaccines, as well.

Pandemic Influenza PREP Act Declaration - December 1, 2006 to December 31, 2027

On the day before Christmas Eve 2022, when no one would be paying any attention, Sec. Becerra sent a great big gift to the pharmaceutical-industrial complex.

It was a PREP Act declaration for pandemic influenza, defined as a flu “for which the majority of the population is immunologically naive.” This was supposedly in reaction to the bird flu, but at the end of 2022, no such virus had been detected in humans. The only “case” at that point had been a prisoner culling a flock of H5N1-positive chickens—who only tested positive because his nasal cavities were contaminated with chicken manure.

A year and a half later, on July 18, 2024, Sec. Becerra issued a Declaration of Emergency for flu. Every effort was made to fly under the radar. There was no news release, nothing was posted on social media, and no news outlet picked up the story. It was a stunning silence for such a significant development in public health policy.

If you didn’t notice that you were living in a pandemic emergency, that’s because it wasn’t an actual emergency, just “a significant potential” for one. Under the law, that counts as an “emergency” just the same. This “potential” for emergency was caused by “pandemic influenza A viruses” but also by “influenza A viruses with pandemic potential.” This emergency didn’t just cover known viruses, it covered “the range of known and emerging influenza A viruses.” So, we were—and still are—experiencing a “potential” public health emergency over known—and unknown—viruses with the “potential” to cause a pandemic.

This pandemic emergency existed only on paper, but its magic words were needed for Emergency Dispensing Orders, Emergency Use Instructions, and Emergency Use Authorizations. Those would allow:

• the use of unapproved drugs, uncleared devices, and unlicensed biological products; 

• the unapproved use of approved drugs, cleared devices, and licensed biological products; and 

• extended expiration dates for eligible medical countermeasures.

The CDC waited exactly one day, until July 19, 2024, before issuing Emergency Use Instructions for Tamiflu (Oseltamivir) for the “treatment or post-exposure prophylaxis” of “novel influenza A viruses.” Tamiflu is Gilead’s original run-death-is-near. It can be deadly and cause suicidal ideation. The EUI allows Tamiflu to be used outside the confines of what the Food & Drug Administration considers safe and effective. Sec. Kennedy must revoke this EUI as soon as possible.

Orthopoxviruses PREP Act Declaration - October 10, 2008 to December 31, 2032

Last issued by Sec. Becerra, the PREP Act liability waiver for orthopoxviruses, including smallpox and monkeypox, is very similar to the one for COVID, with the same boilerplate language.

One of the oddities found in nearly all the current PREP Act declarations is this: You don’t have to be a licensed health professional to be covered under the liability waiver. It covers:

Any dentist, advanced or intermediate emergency medical technician, licensed or certified professional midwife, nurse, advanced practice registered nurse, registered nurse, licensed practical nurse, optometrist, paramedic, pharmacist, pharmacy intern, physician, physician assistant, podiatrist, respiratory therapist, or veterinarian who has held an active license or certification under the law of any State within the last five years…

Yikes! You could have any type of previously licensed health professional who let their certification lapse as many as five years ago administering smallpox vaccines–and any mistake they made, as long as it didn’t rise to the level of willful misconduct, would be covered by the PREP Act blanket liability waiver. How’s your confidence in our healthcare system now?

Ebola and Marburg PREP Act Declaration - December 3, 2014 to December 31, 2028

The PREP Act liability waiver for viral hemorrhagic fevers, specifically Ebola and Marburg, is written with the exact same language as those for COVID and orthopoxviruses.

Every PREP Act liability waiver makes a statement regarding how the Secretary came to the conclusion that the PREP Act could be invoked. Here’s Xavier Becerra’s statement for Ebola and Marburg:

I am extending PREP Act Coverage for both Ebolaviruses and Marburgviruses due to the continued national security threat posed by these viruses. Ebolaviruses and Marburgviruses have the potential to cause significant morbidity and mortality during outbreaks. The risk of domestic cases is high due to ongoing outbreaks in other countries over the past decade.

That’s it. Becerra provides no statement of facts to back up these conclusions. Why not? Isn’t he worried that the courts might not agree that Ebola and Marburg pose a national security threat?

One of the most outrageous aspects of the PREP Act is that it states that PREP Act declarations are not subject to judicial review. The PREP Act gives the Secretary dictatorial control over when to give the pharmaceutical companies protection from lawsuits brought on behalf of the people they kill and injure.   

This is awful, and a good reason to repeal the PREP Act, but it does mean that Sec. Kennedy has the power to take PREP Act protections away from the pharmaceutical companies–and that his decision can’t be reviewed by the courts. There’s nothing stopping him. Kennedy is the PREP Act dictator now, and if he wants to restore our right to sue, he can at any time.

Nerve Agents and Organophosphorus Insecticides PREP Act Declaration - April 11, 2017 to December 31, 2027

The statement of the “national security threat” posed by Ebola and Marburg was weak, but at least people had heard of Ebola (maybe not Marburg) when a PREP Act declaration was first issued for it.

Who knew there was a threat that our nation would face a public health emergency in the form of the release of nerve agents or insecticides? Unless the HHS Secretary was concerned with the legal use of agrichemicals?

The first PREP Act declaration for nerve agents and organophosphorus insecticides sheds no light on this question. Issued by President Trump’s HHS Secretary Thomas E. Price, it simply states:

I have determined that there is a credible risk that the release of nerve agents or organophosphorus insecticides and the resulting organophosphorus poisoning or release of carbamate insecticides and the resulting carbamate poisoning may, in the future, constitute a public health emergency.

What the heck?

Zika PREP Act Declaration - August 1, 2016 to December 31, 2027

The PREP Act declaration for Zika is unique in a couple of ways.

It is the only PREP Act declaration issued by an acting Secretary who was a career civil servant rather than a presidential appointee. Norris Cochran has been Deputy Assistant Secretary of Budget and Director of the HHS Office of Budget, a Senior Executive Service position, since March 2009. He served as acting HHS Secretary in the first months of both President Trump (2017) and President Biden (2021).

The Zika declaration is limited to vaccines. Interestingly, when Cochran created the liability waiver for Zika vaccines in 2017, he listed a number of different platforms that we’re familiar with now, but weren’t on the market at the time, including mRNA vaccines, DNA vaccines, and nanoparticle vaccines.

Cochran’s PREP Act declaration for Zika was signed on February 6, 2017, in the first days of the Trump Administration, but the effective date for the liability waiver was listed as August 1, 2016, when Barack Obama was still President.

When Sec. Kennedy revokes all the current PREP Act liability waivers, he should make the effective date of his declaration match the effective date of the liability waivers he is nullifying. Nothing in the PREP Act prevents that, and his use of his PREP Act power can’t be judicially reviewed.

Anthrax PREP Act Declaration - October 1, 2008 to December 31, 2027

The anthrax PREP Act declaration, most recently extended by Sec. Becerra, is the most transparently ironic. As justification, it invokes “the deliberate exposure of citizens in the United States to Bacillus anthracis (B. anthracis) spores in 2001,” but it was issued right after the FBI determined that the anthrax attacks were not an act of foreign terrorists, but had been traced back to the Pentagon’s premier bioweapons laboratories at Ft. Detrick.

The anthrax PREP Act declaration refers to an earlier liability waiver from 1984, Public Law 85-804, which allows the government to indemnify contractors “against unusually hazardous or nuclear risks,” and it notes that BioPort/Emergent Biosolutions and Emergent Biodefense Operations were already being indemnified by the Department of Defense for the production of anthrax vaccines as military contractors.

This raises two points. First, that the government considered the anthrax vaccines to be “unusually hazardous,” and second, that the PREP Act was a choice to not just indemnify contractors who were requested by the government to produce specific medical countermeasures, but to create a free-for-all where anyone in the pharmaceutical industry could produce any product and, no matter how useless or dangerous, it would be covered by a blanket liability waiver.

Acute Radiation Syndrome PREP Act Declaration - October 10, 2008 to December 31, 2027

The PREP Act declaration for Acute Radiation Syndrome provides a blanket liability waiver to medical countermeasures for “an unintentional radioactive release, a deliberate detonation of a nuclear device, or other radiological/nuclear events.”

It appears targeted at one particular countermeasure, listed in the first Acute Radiation Syndrome PREP Act declaration from 2008: Amgen’s Neupogen—which doesn’t even improve Acute Radiation Syndrome survival rates, according to a non-human primate study.

Neupogen isn’t just being warehoused in case there’s a nuclear war or some other “radiation emergency.” It’s routinely given to cancer patients who receive radiation therapy in the course of their treatment, marketed as a white blood cell booster. Increasingly, Neupogen is utilized for other conditions including the treatment of recurrent miscarriage in women with autoimmune disorder or PCOS. It isn’t yet approved for this use, but the theory is that an increased amount of white blood cells suppresses the immune system and keeps it from attacking the embryo. 

And, it can be deadly. FDA-required warnings for Neupogen include death by spleen rupture or sickle cell crisis, among other life-threatening complications, and it has been identified as the cause of death in a patient with asthma.

Would the PREP Act liability waiver give Amgen a defense against lawsuits in these cases?

This question has not been litigated, but the case could be made. The Prep Act declaration for Acute Radiation Syndrome is limited to persons treated in the event of “an unintentional radioactive release, a deliberate detonation of a nuclear device, or other radiological or nuclear incident,” but it also says, “Liability immunity is afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population.”

Botulism PREP Act Declaration - October 10, 2008 to December 31, 2027

Botulism is a rare bacteria disease, impacting about 200 people in the U.S. per year. The botulism PREP Act declaration gives blanket liability protections to botulism antitoxins. The side effects of these drugs are numerous and there is no data on their safety or efficacy for pediatric populations, even though most botulism cases are in infants.

These PREP Act declarations take away our power to hold corporations accountable! The PREP Act is unconstitutional and should be repealed, but until the courts or Congress act, Sec. Kennedy must restore our right to sue the pharmaceutical companies for the deaths and injuries they cause by revoking each of these PREP Act declarations.