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Does not appeal to you, does it?

Would you like to turn over manage of your health and viability - possibly your really 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 even though, has extraordinary energy over your private well-being - may obtain even much more dominance more than your destiny. The battle for globe domination of your body will take place this fall in the august chambers of the U.S. Supreme Court.

The foundation of the legal fight is the Vermont Supreme Court selection in Levine v. Wyeth.

Diana Levine, a specialist 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 used her arm to administer the injection and the outcome was very disastrous: she lost her correct 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 - though it complied with FDA specifications - was inadequate. Levine won a jury trial and was awarded about $6.8 million.

Wyeth appealed the choice since it desires 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 should be revised.

The Politics of Pre-Emption

At the heart of the upcoming U.S. Supreme Court battle is the notion 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 accepted the drug, or medical device, and the label, then drug producers 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 organizations are hunting for "a legal shield" against becoming held accountable.

Why is it that key corporations, and several of their Republican supporters, are constantly speaking about accountability and responsibility, until it comes to them?

The whole point is scary.

Here is an agency - the FDA - which is understaffed and not keeping up with technologies - faced with the possibility of assuming even a lot more handle over our very being. 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 article, Rather of being proactive, the agency (FDA) is frequently in "fire-fighting" mode.

If the U.S. Supreme Court guidelines in favor of Wyeth, upholding the pre-emption rule, it requires away one particular of the major legal treatments the average 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 frequent law claims.

In January 2006, the FDA adopted new regulations, the ultimate purpose was to torpedo efforts to permit private injury claims to be heard by state court juries.

The FDA said "it is the specialist federal public agency charged by Congress with insuring that drugs are secure and helpful and that their labeling adequately informs users of the dangers and positive aspects of the product and is truthful and not misleading." Translation: "if we say it will not kill you, it will not kill you."

And given that when is the FDA in the job of insuring anything at all? These are the exact same folks who can even inspect imported food to make certain it is protected.

Take all the really technical legal argument out of this and there is nevertheless the aspect of human error, of an understaffed agency monitoring an exponentially expanding number of pharmaceutical items, and the prospective for this agency to slam the door in a citizen's face should a healthcare catastrophe happen.

In Might, the Congressional Committee on Oversight and Government Reform held hearings on the pre-emption concern. Chairman, Rep. Henry Waxman, stated in his statement, that if the pharmaceutical managers, the FDA and the Bush Administration have their way in court, "...one particular of the most effective incentives for safety, the threat of liability, would vanish."

Whose body is it anyway? Yours, or the FDA's?

Onward.

Richard Alexander [ We're Listening To You]

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