“Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages.”
— Judge Benjamin Cardozo, Schloendorff v. Society of New York Hospital (1914)
In the immediate aftermath of World War II, the Allied forces convened a series of military tribunals in Nuremberg to prosecute Nazi war criminals. These included 23 physicians and administrators who conducted horrific and inhumane experiments on nonconsenting concentration camp prisoners. These procedures included injecting unwilling subjects with experimental drugs and vaccines. (RELATED: The Wages of COVID — Part One)
The so-called Doctors’ Trial (United States of America v. Karl Brandt, et al) made manifest the need for ethical standards in medical research and led to the Nuremberg Code, a set of 10 principles to protect human subjects of experimentation. The Code’s first and foremost principle requires the informed consent of subjects who voluntarily agree to participate in medical experiments only after understanding their nature, risk, and purpose.
Today, the Nuremberg Code is a cornerstone of medical ethics. Moreover, its doctrine of informed consent is one of the seminal bases for the products liability laws that apply to the pharmaceutical industry.
In order to satisfy the requirement of informed consent, pharmaceutical manufacturers have a legal obligation to warn patients, physicians, and pharmacists about the known or reasonably knowable risks and side effects associated with their drugs.
The duty extends to risks and side effects that the manufacturer knew or should have known through premarket testing, post-market surveillance, or scientific research.
In most jurisdictions, manufacturers can meet their duty to warn by adequately informing prescribing physicians — so-called “learned intermediaries” — who then are expected to communicate the risks to patients.
Informed consent requires patients to be fully aware of a drug’s potential risks in order to make educated treatment decisions. A failure to warn can vitiate informed consent and result in legal liability if the lack of warning causes injury. In that regard, a product is considered to be defective if it lacks adequate warnings about nonobvious risks.
To succeed in a failure-to-warn claim, plaintiffs must typically prove the following:
- The manufacturer had a duty to warn
- The warning was absent or inadequate
- The missing or inadequate warning proximately caused the plaintiff’s injury
Such claims can be pursued under negligence standards (where the manufacturer’s conduct was unreasonable) or under strict liability (where the focus is on the drug’s missing or inadequate warnings, regardless of the manufacturer’s care).
Informed Consent and COVID Vaccines
All of which brings us to May 2020, when the federal government tasked the pharmaceutical industry with producing COVID vaccines through the appropriately named Operation Warp Speed. The Department of Health and Human Services (HHS), the Defense Department, and other agencies provided “regulatory support” and billions of dollars for research. The goal was to deliver 300 million vaccine doses by early 2021.
Because of the public health emergency presented by the calamitous COVID pandemic, the Food and Drug Administration (FDA) dispensed with its usual thorough and 6 to 11-year testing regimen. Instead, the vaccines underwent accelerated and comparatively limited clinical trials before the FDA issued Emergency Use Authorizations to the drug companies that would manufacture and distribute them. In fact, from concept to deployment of the vaccines, the FDA’s streamlined approval process took approximately 1 year, an unprecedentedly short period of time. (RELATED: Had COVID, Not Getting Vaccinated)
Consequently, as will be seen, this hurried approval process resulted in the manufacture and distribution of vaccines with materially incomplete safety profiles and, concomitantly, inadequate product warnings. In short, under the tenets of product liability law, the vaccines could credibly be declared defective due to a lack of adequate warnings.
Now you might reasonably think that, given these circumstances, the inoculation of millions with the COVID vaccines posed an increased risk of harm to the public and exposure to massive legal liability for the drug manufacturers. But, in 2005, Congress passed the Public Readiness and Emergency Preparedness (PREP) Act, which provides broad immunity to drug manufacturers against claims for losses arising during a declared medical emergency from the manufacture, distribution, administration, or use of epidemic or pandemic “countermeasures” such as vaccines. This legal immunity applies unless the manufacturer engaged in willful misconduct causing death or serious bodily injury.
In February 2020, HHS Secretary Alex Azar officially declared the pandemic to be a medical emergency and invoked the PREP Act to protect the drug companies participating in Operation Warp Speed. Consequently, individuals injured by COVID vaccines were and are precluded from suing manufacturers in federal and state courts. Instead, they must seek compensation through the Countermeasures Injury Compensation Program (CICP), which is administered by HHS.
Claims submitted to the CICP are subject to a one-year statute of limitations and a high burden of proof of causation requiring “compelling, reliable, valid, medical, and scientific evidence.” Even if this burden is met, compensation is limited to medical expenses, lost wages, and survivor benefits.
In fact, the CICP, which is wholly funded by taxpayers, has proven to be a legal dead end. So far, out of the 700 million doses administered, only 11 COVID vaccine-related claims have been paid for a grand total of $419,000.
Thus protected from legal liability, in 2020, Pfizer-BioNTech and Moderna marketed mRNA COVID vaccines. In return, from 2020 through 2023, sales of the Pfizer-BioNTech vaccine yielded revenues of approximately $85 billion, while Moderna’s sales generated estimated revenues of $41 billion.
Once the vaccines became available, a locked-down public clamored to be inoculated in the hope of being protected from COVID and to escape the onerous public health restrictions aimed at controlling the spread of the virus.
Recall that in most states, unvaccinated people were restricted from entering almost all public venues such as restaurants, bars, gyms, theaters, churches, sports arenas, and places of employment.
In 2021 and 2022, the Biden regime mandated vaccination or regular COVID testing for all federal employees and contractors. Unvaccinated employees risked termination. The Labor Department’s Occupational Safety and Health Administration required vaccination for companies with more than 100 employees. And unvaccinated healthcare workers at facilities receiving Medicare/Medicaid funding faced suspension or being fired. As for the military, members who refused the vaccine were disciplined and discharged.
In late 2020 to early 2021, during the vaccine rollout, federal and state public health officials and the media spread optimistic claims that vaccination would prevent infection and transmission of COVID.
For example, in December 2020, the CDC advised that the vaccines were highly effective and a critical tool to help stop the pandemic. Similarly, in early 2021, the CDC and Dr. Anthony Fauci stated that vaccinated individuals were far less likely to spread the virus. And the CDC advised that vaccinated individuals could gather indoors without wearing masks. (RELATED: Dr. Fauci Doubles Down)
Simultaneously, legacy media like CNN and the New York Times reported the vaccines had high efficacy against COVID infection and claimed vaccination would be a game-changer to end the pandemic. In short, the public health establishment and the media touted vaccination as a way to protect oneself, halt the spread of the virus, and return to normal.
So it was that, in order to reclaim their lives and livelihoods, millions of Americans dutifully and hopefully lined up for the COVID jab.
The irony here, of course, is that the rosy claims that the vaccines would prevent infection and transmission of the virus proved to be untrue. In fact, as the Biden regime and public health officials ultimately had to concede, while the vaccines reduced the risk of infection and transmission, they did not eliminate it.
This concession was but the first hint that the government, its associated medical authorities, and the media had oversold and misrepresented the efficacy of the COVID vaccines.
If only the story had ended there.
But, as will be seen in the next installment of this series, in addition to questionable efficacy, the vaccines proved to have dangerous side effects, which the Biden regime and its media adjunct did their best to hide.
So stay tuned.
George Parry is a former federal and state prosecutor. He blogs at knowledgeisgood.net.
READ MORE from George Parry:
