Did you know that vaccine manufacturers cannot be sued in state courts for damages as a result of design-defects in their products?
That’s what the U.S. Supreme Court ruled 6-2 in Bruesewitz v. Wyeth — that the National Childhood Vaccine Injury Act protects vaccine manufacturers from design-defect claims.
Congress had passed the National Childhood Vaccine Injury Act (NCVIA) in 1986 in response to a massive increase in litigation against vaccine manufacturers, which drove two of the largest domestic manufacturers out of business and led to a shortage of vaccines. Congress created the new law to shield vaccine manufactures from tort litigation and, in so doing, alleviate the growing shortage of vaccines. (Homeland Security News Wire)
In place of lawsuits against vaccine manufacturers, the National Childhood Vaccine Injury Act created a system of federal government oversight of vaccine safety:
- All health care providers must report adverse vaccination events and possible side effects to a post-marketing surveillance program — the Vaccine Adverse Event Reporting System (VAERS), co-managed by the CDC (Centers for Disease Control and Prevention) and the FDA (Food and Drug Administration). The CDC and FDA are agencies within the federal government’s Department of Health & Human Services (HHS).
- To coordinate vaccine-related activities of the CDC, FDA and other HHS agencies, the NCVIA created the National Vaccine Program — an office within the HHS which is required under Title 42, United States Code, 300aa-27(c), to report every two years to Congress about vaccine safety, adverse reactions, and other aspects of vaccinations.
Indeed, the Supreme Court’s majority opinion in Bruesewitz v. Wyeth by Justice Antonin Scalia concluded (p. 55 of Bruesewitz v. Wyeth) that by passing the NCVIA, Congress had struck a “careful balance between providing adequate compensation for vaccine-injured children and conferring substantial benefits on vaccine manufacturers to ensure a stable and predictable childhood vaccine supply.” Nevertheless, the Supreme Court’s “majority’s decision today disturbs that careful balance based on a bare policy preference that it is better ‘to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries.’”
Informed Consent Action Network (ICAN) is a non-profit founded by Del Bigtree to investigate “the safety of medical procedures, pharmaceutical drugs, and vaccines while advocating for people’s right to ‘informed consent’.”
On August 25, 2017, ICAN filed a Freedom of Information Act (FOIA) lawsuit for those bi-annual vaccine reports that the HHS is required to send Congress, pursuant to 42 U.S.C. SS300aa-27(c).
HHS stonewalled ICAN’s FOIA request for eight months.
On April 12, 2018, ICAN filed another lawsuit, “Informed Consent Action Network v. U.S. Department of Health and Human Services” in U.S. District Court, Southern District of New York, demanding an answer to their FOIA filing.
On July 6, 2018, ICAN finally received a response — an admission in federal court by the U.S. Department of Health and Human Services, the federal agency mandated by Congress under 42 U.S.C. SS300aa-27(c) to track vaccine safety, that they had never done it:
Although the HHS’ National Vaccine Program Office is required to report every two years to Congress on their monitoring of vaccines, the HHS has no such records — not even one in the 31 years since 1987. That means the National Vaccine Program had never monitored vaccine manufacturers for vaccine safety and side effects.
Here is a screenshot of the “Stipulation” or court order in ICAN v. HHS, in which HHS made that stunning admission:
As ICAN observes:
The 1986 [National Childhood Vaccine Injury] Act created a system in which vaccines are licensed, recommended, encouraged, subsidized, and defended by HHS. The 1986 Act’s scheme thus places HHS in charge of two competing duties. On one hand, HHS is responsible for vaccine safety. On the other hand, HHS is required to promote vaccine uptake and defend against any claim they cause any harm.
Regrettably, it appears that HHS has chosen to focus almost entirely on its vaccine promotion and defense function to such a degree that it has essentially abandoned its vaccine safety function.
- Congress passed a law in 1986 protecting vaccine manufacturers from being sued in state courts.
- At the same time, Congress created an agency within HHS, charged with the job of monitoring vaccine safety.
- That agency, National Vaccine Program Office, is supposed to report to Congress every two years.
- As a result of two lawsuits by the non-profit Informed Consent Action Network, HHS finally admitted in federal court that it doesn’t have any reports from the National Vaccine Program Office.
- This means HHS had never monitored vaccine safety, although it is required by law to do so.
- Neither has Congress done its job. Why hasn’t Congress held HHS to account for failing to submit vaccine safety reports?
- This means the American people really have no reason, other than what vaccine manufacturers say, to think vaccines are safe.
- And yet the media demonize vaccine skeptics as “conspiracy theory” crazies.
Did you know that generic drug manufacturers cannot be sued for manufacturing and selling a defective drug? – even if:
- The drug causes horrific injuries;
- The generic company knew the drug was causing horrific injuries and did nothing to warn patients or doctors about the dangers of the drug.
That’s because the Supreme Court ruled in PLIVA v. Mensing (2011) and Mutual Pharma. V. Bartlett (2013) that while brand-name companies are allowed to add new warnings to their drug labels without getting prior permission from the FDA, generic companies are not. If a generic drug company discovers a new side effect of one of its drugs, it is not permitted to tell patients or doctors about this new information. It must first contact the FDA and request that the brand-name label be changed. Only after the brand-name label is changed is the generic company allowed to change its label. In essence, generic manufacturers are prohibited from giving any warnings to doctors or to the public that have not already been given by the brand-name manufacturer. (Spangenberg Shibley & Liber Trial Lawyers)
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