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From Gameresource
Does not appeal to you, does it?
Would you like to turn more than handle of your health and viability - possibly your very longevity - to an understaffed, underfunded government bureaucracy?
Does not appeal to you, does it?
The FDA (U.S. Food & Drug Administration), which if you believe about it for a small while, has extraordinary energy over your personal nicely-becoming - may possibly achieve even more dominance over your destiny. The battle for globe domination of your body will happen this fall in the august chambers of the U.S. Supreme Court.
The foundation of the legal fight is the Vermont Supreme Court decision in Levine v. Wyeth.
Diana Levine, a skilled musician, was treated, in April 2000, for a severe migraine headache and nausea. Staff at the Vermont Health Center injected her with Phenergan, a nausea medication. They utilized her arm to administer the injection and the outcome was really disastrous: she lost her right arm below the elbow, and left the hospital an amputee.
Levine sued Wyeth, which sells Phenergan, on the basis that the warning label on Phenergan - even though it complied with FDA specifications - was inadequate. Levine won a jury trial and was awarded about $6.8 million.
Wyeth appealed the decision simply because it wants to hide behind the FDA. The situation went to the Vermont Supreme Court which ruled against Wyeth, saying, in essence, the drug manufacturer had a duty beneath state law to strengthen the warning label on the drug, regardless of the FDA's confusing, and sometime conflicting, regulations on when, or if, warning labels really should be revised.
The Politics of Pre-Emption
At the heart of the upcoming U.S. Supreme Court battle is the concept of pre-emption: that federal law pre-empts the right of victims such as Diana Levine to sue for the damages inflicted upon them in state courts.
The [supposed] logic is this: if the FDA has approved the drug, or healthcare device, and the label, then drug suppliers want only to comply with the FDA's needs to be granted sweeping immunity against private injury law suits filed in state court for damages based for failure to warn. Or as the New York Instances stated the drug businesses are seeking for "a legal shield" against becoming held accountable.
Why is it that main corporations, and several of their Republican supporters, are always speaking about accountability and responsibility, until it comes to them?
The complete issue is scary.
Here is an agency - the FDA - which is understaffed and not maintaining up with technologies - faced with the possibility of assuming even far more control over our extremely getting. USA Today published a story - citing an independent panel critique of the FDA - which revealed that the agency has about the very same size staff as 15 years ago. According to the report, Rather of being proactive, the agency (FDA) is often in "fire-fighting" mode.
If the U.S. Supreme Court rules in favor of Wyeth, upholding the pre-emption rule, it takes away 1 of the key legal treatments the typical U.S. citizen has when events such as Diana Levine's nightmare happens.
And yes, politics, notably the Bush administration, is solidly evident. The Bush Administration has moved stealthily to stop state common law claims.
In January 2006, the FDA adopted new regulations, the ultimate purpose was to torpedo efforts to let individual injury claims to be heard by state court juries.
The FDA mentioned "it is the professional federal public agency charged by Congress with insuring that drugs are safe and successful and that their labeling adequately informs customers of the dangers and benefits of the item and is truthful and not misleading." Translation: "if we say it won't kill you, it won't kill you."
And since when is the FDA in the job of insuring anything? These are the exact same folks who can even inspect imported food to make confident it is secure.
Take all the incredibly technical legal argument out of this and there is still the element of human error, of an understaffed agency monitoring an exponentially growing quantity of pharmaceutical goods, and the prospective for this agency to slam the door in a citizen's face must a medical catastrophe happen.
In May, the Congressional Committee on Oversight and Government Reform held hearings on the pre-emption issue. Chairman, Rep. Henry Waxman, said in his statement, that if the pharmaceutical managers, the FDA and the Bush Administration have their way in court, "...1 of the most potent incentives for safety, the threat of liability, would vanish."
Whose physique is it anyway? Yours, or the FDA's?
Onward.
Richard Alexander [ We're Listening To You]
