"UNAVOIDABLY UNSAFE"

In 2011 the U.S Supreme Court Ruled Vaccines are "Unavoidably Unsafe." JUST THE FACTS examines this ruling and provides a highlighted summary.


"NCVIA" The National Childhood Vaccine Injury Act of 1986

On Nov 14, 1986 President Reagan signed the NCVIA act establishing a Federal No-Fault system, that eliminates manufacturer liability for vaccines unavoidable, adverse reactions. The act was meant to compensate vaccine-injured children while stabilizing the vaccine market. It also made nearly every aspect of vaccine safety the exclusive responsibility of the Department of Health & Human Services (HHS) 


HISTORY of Bruesewitz vs. Wyeth LLC.

Hannah Bruesewitz was born on October 20, 1991. Her pediatrician administered doses of the DTP vaccine and within 24 hours Hannah started to experience seizures. She suffered over 100 seizures during the next month, and her doctors eventually diagnosed her with “residual seizure disorder” and “developmental delay.” They sued the vaccine manufacturer and lost because of the NCVIA act of 1986


KEY POINTS of Bruesewitz vs. Wyeth LLC

1. In the present state of human knowledge some products (especially drugs) are quit incapable of being made safe

2. As the 1986 Report explains, Congress intended that "unavoidably unsafe products” apply to the vaccines covered in the bill.

3: The FDA has never even spelled out in regulations the criteria it uses to decide whether a vaccine is safe and effective for its intended use.

4. The FDA’s silence on design defects existed long before the Vaccine Act was enacted.

5. Neither the Act nor any other provision of federal law places a legal duty on vaccine manufacturers to improve the design of their vaccines to account for scientific and technological advances. Indeed, the FDA does not condition approval of a vaccine on it being the most optimally designed among reasonably available alternatives, nor does it (or any other federal entity) ensure that licensed vaccines keep pace with technological and scientific advances.

6. The regulation does not authorize the FDA to revoke a biologics license for a manufacturer’s failure to adopt an optimal vaccine design in light of existing science and technology * Neither the United States nor any of the parties, however, has represented that CDC examines whether a safer alternative vaccine could have been designed given practical and scientific limits

7. The normal competitive forces that spur innovation and improvements to existing product lines in other markets thus operate with less force in the vaccine market, particularly for vaccines that have already been released and marketed to the public. * The FDA is perpetually understaffed and underfunded, and the agency has been criticized in the past for its slow response in failing to withdraw or warn about potentially dangerous products.

8. In enacting the Vaccine Act, Congress established a "carefully wrought federal scheme" that balances vaccine-injured persons and vaccine manufacturers.

9. Congress relieved vaccine manufacturers of the burden of compensating victims of vaccine-related injuries in the vast majority of cases - an extremely significant economic benefit that “functionally creates a valuable insurance policy for vaccine-related injuries.”

10. Respondent notes that there are some 5,000 petitions alleging a causal link between certain vaccines and autism spectrum disorders that are currently pending in an omnibus proceeding in the Court of Federal Claims (Vaccine Court). According to respondent, a ruling that does not pre-empt design defect claims could unleash a “crushing wave” of tort litigation that would bankrupt vaccine manufacturers and deplete vaccine supply.

11. As an initial matter, the special masters in the autism cases have thus far uniformly rejected the alleged causal link between vaccines and autism. To be sure, those rulings do not necessarily mean that no such causal link exists * A petitioner to whom the Vaccine Court gives nothing may see no point in trying to overcome tort law’s yet more serious obstacles to recovery

12. Neither the FDA nor any other federal agency, nor state and federal juries—ensures that vaccine manufacturers adequately take account of scientific and technological advancements. This concern is especially acute with respect to vaccines that have already been released and marketed to the public. Manufacturers, given the lack of robust competition in the vaccine market, will often have little or no incentive to improve the designs of vaccines that are already generating significant profit margins. 

https://www.supremecourt.gov/opinions/10pdf/09-152.pdf