We Americans expect accountability of manufacturers and practitioners in the medical field, even during emergencies.However, the almost twenty pharmaceutical companies working to develop a vaccine at warp speed in response to the COVID virus, and persons prescribing, administering, or dispensing countermeasures to the virus, will have no liability exposure. This includes no liability for vaccine injuries that may occur from new vaccines.
The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act. (Federal Register / Vol. 85, No. 52 / Tuesday, March 17, 2020 / Notices)
The PREP Act creates a shield against liability lawsuits against the pharmaceutical companies, and many “qualified persons.” It would provide a shield from liability for the use of an emergency “countermeasure,” which could include, for example, the use of a ventilator that caused a death, or the use of a mask that caused a person to experience lethal hypoxia (low oxygen levels). The shield of liability for multibillion-dollar corporations notably helps secure the financial future of powerful, well-connected corporations, while ordinary families and small and medium sized businesses struggle to survive in the aftermath of governmental orders to isolate and shut down during an emergency.
If a new COVID vaccine comes on the market to address the declared emergency, if people are injured or killed by the vaccine, they will not be able to sue the manufacturer. Companies will not be penalized. If you are so unfortunate as to be hurt by a new vaccine or any of the existing declared pandemic countermeasures, the PREP act tells you where you can and can’t go. You cannot go to a regular court because the responsible parties will now have immunity from your lawsuit due to the emergency. You need to go to the newly created CICP court, (Countermeasure Injury Compensation Program Court). There you will be required to provide “compelling, reliable, valid, medical and scientific evidence” of any injury. In order to win your case, the burden of proof will be on you, not the government, and in fact, you will be in an adversarial contest with the government, its lawyers and experts.
The causal connection between the countermeasure and the serious physical injury must be supported by compelling, reliable, valid, medical and scientific evidence in order for the individual to be considered for compensation. (Federal Register / Vol. 85, No. 52 / Tuesday, March 17, 2020 / Notices)
A similar liability shield for vaccine manufacturers is already in existence and deals with vaccine injuries, thus, vaccine manufacturers have long enjoyed freedom from liability when their vaccines cause injury or death. Claims are addressed in the “Vaccine court,” aka the VICP court. The VICP court, established under the National Vaccine Injury Compensation Program, works to provide compensation for vaccine injury from vaccines on the recommended school vaccine schedule. However, although the Vaccine court has awarded now over $4 billion dollars in compensation for deaths and injuries from childhood vaccines, critics have described it as being riddled with bias and ineffectiveness, and for victim Plaintiff families seeking compensation, it is a long, arduous, expensive ordeal, over a period of many years. The government’s lawyers aggressively fight against the victims on causation issues. So, few victims win and all too many lose.
Even during a crisis, we must be sensitive to the needs of individuals who have been injured and are suffering. We need to call for accountability of those who have injured others by the manufacturing of defective and dangerous products while rushing to reap profits from a captive and fearful public. And also hold accountable those who are prescribing, administering, or dispensing these products without notification to consumers of the harm they may cause. The broad liability shield for pandemic countermeasures seems to be worrisome, troubling and, in our view, an abridgment of basic rights.
This Declarationbecame effective as of February 4 th, 2020. President Trump declared the national emergency March 13 th and HHS Secretary’s Azur’s important declaration was noted in the Federal Register March 17, 2020, with little notice or discussion from the media.
Authored by: Leo Cashman, Executive Director, DAMS, Dental Amalgam Mercury Solutions and board member of NHFC, and Diane Miller, JD, Director or Law and Public Policy, National Health Freedom Coalition (NHFC) and National Health Freedom Action (NHFA)
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