In 2005, David Graham, the FDA Whistleblower, was asked, “What are your thoughts on former President Bush’s attempt to pass tort reform, which would protect most pharmaceutical companies from lawsuits except in the most egregious cases?” In response to that question, some of David Graham’s comments were:
I think it's dangerous and wrong for the following reasons:
We already have an FDA that’s been neutralized by industry and sees industry as its client.
The Center for Drug Evaluation and The Office of New Drugs dominates drug safety so that the drug safety is not independent.
Government now isn’t going to protect the average citizen from the consequences of unsafe drugs.
The only alternative [the public has] left is the legal system - the tort system...All that’s left to people now is the courts. That’s the only way we have of getting companies to change their behavior.
Recognizing David Graham’s words and warning, his statement needs to be explained further, because what he warns should never happen, has already happened with vaccines. Vaccines are classified differently than pharmaceutical drugs, and as a result of 1986 US legislation, the legal system, the final consumer safety measure, was removed for vaccines completely. Today, the American public cannot sue vaccine manufacturers, no matter what - no matter the injury a person experiences, no matter how reckless a manufacturer behaves by NOT following production protocol, no matter how reckless a manufacturer behaves by NOT conducting adequate testing to determine the safety (or lack there of) of their product. The manufacturers cannot be sued, period.
1986 in the US - How this legislation came to be
In the early 1980’s (when vaccine manufacturers could still be sued) parents of vaccine injured children were suing, to receive compensation for the vaccine injuries their children had sustained, and the parents were winning their cases. The result was that pharmaceutical companies were paying out large settlements, and were going bankrupt. Several vaccine makers were forced out of business completely. The financial impact on the vaccine manufacturers was so significant that many companies decided to stop manufacturing vaccines completely. That of course created a problem. With fewer vaccine makers, and with the remaining vaccine makers threatening to stop producing vaccines all together if they weren’t protected from lawsuits, the US Government was essentially blackmailed into making pharma immune from vaccine lawsuits.
As a result, legislation was established in 1986, to protect pharma. I imagine the 1984 instruction given by the US Department of Health and Human Services was in direct response to this situation. Remember that 1984 Government instruction was "any possible doubts, whether or not well founded, about the safety of the vaccine cannot be allowed to exist in view of the need to assure that the vaccine will continue to be used to the maximum extent consistent with the nation’s public health objectives.”
With the passing of the 1986 legislation to protect pharma, the National Vaccine Injury Compensation Program was created. On the US Government webpage, it states, "[This program] was created in the 1980s, after lawsuits against vaccine companies and health care providers threatened to cause vaccine shortages and reduce U.S. vaccination rates." (Link Here)
When vaccine makers were made immune to lawsuit, a different process had to be put in its place. This process is an administrative procedure, where a parent submits request to the Government for financial compensation for their child's injury. Applications that don't perfectly match the current injury criteria, have to go through an assessment process which has become named, "vaccine court." Don't be deceived by the name, vaccine court does not at all follow standard court proceeding process, and, pharmaceutical companies are not required to participate at all, nor are they held ethically or financially responsible. In the previous article, I explained Robert F Kennedy Jr's statement, that in vaccine court there is no deposition or discovery.
In that article I provided definition for those as follows:
Deposition – is where witnesses provide sworn out-of-court testimony. Deposition is used to gather information as part of the legal discovery process and, in limited circumstances, may be used at trial.
Discovery - which is a pre-trial procedure in a lawsuit in which each party, through the law of civil procedure, can obtain evidence from the other party or parties by means of discovery devices such as a request for answers to interrogatories, request for production of documents, request for admissions and depositions. Discovery can be obtained from non-parties using subpoenas. When a discovery request is objected to, the requesting party may seek the assistance of the court by filing a motion to compel discovery.
In that article, I quoted Robert F Kennedy Jr from an interview he gave for episode three of the documentary Vaccines Revealed. He said :
...not only do [manufacturers] avoid the liability but they also avoid the discovery, the depositions, the documents searches, all those things that would explore and scrutinize the decision making that are taking place in that vaccine company.
...you want to see how these same companies, these pharmaceutical companies are behaving when they have this big defense bar looking over their shoulders, and suing them and getting $100 million and billion dollar settlements year after year after year or judgements year after year for their pharmaceutical products. Why would that same company behave any differently when it comes to vaccines? Of course the answer is, they don't.
The thing is that nobody it looking at them and nobody is allowed to look at them, and not only that but the congress not only made them immune from any liability, but they also made it very easy to bring a vaccine to market. So you don't have all these kind of burdens, hoops, and impediments and testing. You don't have for example double blind placebo testing of big populations.
Because of the 1986 legislation, vaccine manufacturers can do whatever they want behind closed doors, without anyone ever knowing - save for whistleblowers who choose to take great personal risk and speak out. One example of this occurred in 2010, when two Merck virologists came forward with allegations that Merck has been fraudulently manipulating vaccine test results, to make it appear their vaccine is effective when it isn't. These whistleblowers have brought forward a lawsuit against Merck on behalf of the US Government. The case is ongoing in the US court system. You can learn more about this situation from a previous article, Safety & Efficacy Part 8
In vaccine court, because the vaccine manufacturers are not involved at all, it is actually the Government who instead steps in to take the manufacturer's place as the defendant. As a result, in vaccine court, Government appointed attorneys represent the Government (acting as the defendant). And, a Government appointed Master (the judge) determines the final ruling in the case (if it gets that far). If the parent wins their case or if the Government offers a settlement, those "awards" are paid from a Government fund, created and grown from tax payer dollars.
At its inception, vaccine court was intended to be an easy and fast system, to provide prompt support and compensation to those who were vaccine injured. Unfortunately, the reality of how vaccine court actually plays out and operates today is far different from how it was envisioned in its creation stages. The vaccine court process can take years. For some cases, a decision isn’t made for a decade.
Another incredible nuance about this "court," is that one ruling in one case does not establish precedent for future similar cases. This was the reality for the autism cases. The autism omnibus trial grouped 5000 autism cases together, reviewing them together in three separate categories. The 2007 ruling of that omnibus trial was that vaccines don't cause autism, and all 5000 requests for compensation were denied. What's interesting about that though, is that previous trials did award compensation for brain injuries which caused autism in the child. And one of the cases that was originally within the omnibus trial was that of Hannah Poling. At some point, Hannah's case was removed from the omnibus proceedings. Despite that omnibus conclusion that "vaccines don't cause autism," in Hannah's case, the vaccine court later conceded that her severe autism was the result of the vaccine induced brain injury that she sustained. Her case was supposed to be sealed, so that the public would never know this, but somehow documents were leaked. After documents were leaked, Sanjay Gupta interviewed Hannah's father, Dr. Jon Poling, who is a neurologist. His 5 minute interview is incredible and is a must watch for everyone.
Hannah Poling is not an isolated case. Sarah Bridges is a psychologist and mother to Porter Bridges. Sarah also won her case for her son, and Porter now receives financial compensation. He is severely autistic as a result of the vaccine caused brain injury he sustained in infancy. Sarah explains this in a 20 minute interview, and she also explains how gruelling the vaccine court process is.
Mary Holland is the Director of Graduate Legal Skills at NYU, and in 2011 she published a legal review which explains that 83 similar cases have received financial compensation through the vaccine court, for the child's vaccine caused brain injury. In all 83 cases the child was subsequently left autistic or with autistic like symptoms.
So, in essence, following application requesting assistance from the parent, the Government then represents and defends the Government, against the parent, and the Government makes the final decision on whether or not to pay for the injury. And remember, this is the same Government that has officially stated, "any possible doubts, whether or not well founded, about the safety of the vaccine cannot be allowed to exist”...If the Government actually rules in favour of the applicant, the court sometimes then insists those cases be sealed so that the public can never learn about the situation, and cases are also never used as precedent for future similar claims. Recognizing all that, vaccine court is basically set up as a battle between David and Goliath, and the Government actually views this procedure as a reasonable process for parents.
MUST WATCH (Here): Neurologist and Father, explaining their vaccine court ruling – the Government conceded that his daughter’s autism resulted from her vaccine injury.
Bio for Dr. Jon Poling Here
MUST WATCH (Here): Psychologist and mom, explaining their vaccine court ruling - her son is being compensated for his medical problems, which include autism, which resulted from his vaccine injury. She describes the grueling vaccine court process.
Bio for Dr. Sarah Bridges Here
Mary Holland - 83 Cases where autistic children received financial compensation through the vaccine court Here
A short video that explains how the US Vaccine Court process works (Here)
National Vaccine Injury Compensation Program – the Government Website (Link Here) Explains that the program was established because vaccine makers were being sued
A short video where Barbara Loe Fischer explains the consequences of the 1986 US Legislation Here
Bio for Barbara Loe Fishcher Here
Continue to the next post here: Safety & Efficacy - Part 25