Anti Swine Flu Vaccine Legaltainment

[zerospeaks]

and remember.... this is only some of the things the judge will consider before he even considers to officially "hear" this case.

It is an uphill battle. Like suing the IRS for wrongfully enforcing taxes.

 

[jsfisher]

Back to the radar analogy....

Unlike the case of with the radar, where we need to hear from the officer that he did follow the tuning procedures and is properly trained to use the radar, the process the FDA followed in approving the vaccine is a matter of public record.

The petition compares and contrasts that public record of what the FDA did with what the law says it should have done. A one-sided debate, for sure, and it will be interesting to see the government's response, but the allegations are not empty. That doesn't mean the allegations have merit, however; and I was hoping someone could comment on the merit of the legal argument in the petition for injunction.

 

[jsfisher]

We can argue how well it does it's job, but the FDA has minimum standards of acceptability for such a thing as this vax. The judge would need evidence that the vax does not meet these standards and THEN that the FDA did not examine those standards, (or did examine them and just said "argh matey! We be rebels!).

I don't know why rebels sound like pirates.

Not true at all. The challenge is not whether the vaccine meets any standards for safety or effectiveness. It is all about whether the FDA followed the legally required steps it needs to follow to approve the vaccine.

The petition is not about science; it is about process, and that's what the judge would be reviewing.

 

[zerospeaks]

Well I haven't read the filing. So it was just me speculating.

 

[jsfisher]

Well I haven't read the filing. So it was just me speculating.

Understood.

This link taken from the opening post gets you the basic filing. Much of it made my eyes glaze over, but it is not too hard to get the gist.

 

[jsfisher]

By the way, a New York State Supreme Court^* justice has granted a temporary injunction against the state mandate for seasonal and H1N1 flu vaccinations for health-care workers. The argument is completely different at the state level from the federal, but it is the same basic cast of characters involved.

http://www.timesunion.com/AspStories/story.asp?storyID=853738&category=STATE





^*The State Supreme Court is something of a misnomer. It is not the highest state court.

 

[Dr. Imago]

Normally you would be right that the burden of proof lies on the FDA, only the FDA has a track record of showing in court that it does indeed do it's job.

Not quite (and not to start a semantics argument)...

The FDA actually acts more like a court. The "burden of proof" is actually on the manufacturer. The FDA simply "adjudicates" and hands down a "verdict" on the arguments offered by the manufacturer as to why the new therapy should be approved. They may ask for more "evidence" before making a final ruling, but they are not attempting to "prove" anything.

The ultimate goal, for the FDA, is simply to determine whether or not the benefit of a new therapy outweighs its risk to the population. They weigh what's presented to them, determine whether or not that is adequate to make that determination, and then either give a "yeah" or "nay" vote as to whether or not that manufacturer can effectively have a "license" market that new therapy.

That's all the FDA really is: a licensing agency. Nothing more.

And, then after approval and the commencement of marketing by the manufacturer, DDMAC continues to actively monitor the ongoing "license" during the post-marketing period. In other words, this is a dynamic process (which is what many people don't realize).

~Dr. Imago