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Does not appeal to you, does it?

Would you like to turn more than handle of your well being and viability - possibly your quite longevity - to an understaffed, underfunded government bureaucracy?

Does not appeal to you, does it?

The FDA (U.S. Food & Drug Administration), which if you assume about it for a small even though, has extraordinary energy more than your individual nicely-being - may possibly gain even far more dominance over your destiny. The battle for planet domination of your body will occur 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 specialist musician, was treated, in April 2000, for a serious migraine headache and nausea. Staff at the Vermont Well being Center injected her with Phenergan, a nausea medication. They utilised her arm to administer the injection and the outcome was really disastrous: she lost her appropriate arm beneath 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 needs - was inadequate. Levine won a jury trial and was awarded about $6.8 million.

Wyeth appealed the decision since it wants to hide behind the FDA. The case 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 ought to 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 appropriate 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 medical device, and the label, then drug manufacturers need only to comply with the FDA's specifications to be granted sweeping immunity against personal 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 looking for "a legal shield" against becoming held accountable.

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

The whole issue is scary.

Right here is an agency - the FDA - which is understaffed and not keeping up with technology - faced with the possibility of assuming even far more control more than our very being. USA Right now 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 post, As an alternative of being proactive, the agency (FDA) is typically 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 main legal treatments the average U.S. citizen has when events such as Diana Levine's nightmare occurs.

And yes, politics, notably the Bush administration, is solidly evident. The Bush Administration has moved stealthily to stop state typical law claims.

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

The FDA mentioned "it is the specialist federal public agency charged by Congress with insuring that drugs are safe and effective and that their labeling adequately informs customers of the dangers and advantages of the product and is truthful and not misleading." Translation: "if we say it won't kill you, it will not kill you."

And considering that when is the FDA in the job of insuring anything? These are the same folks who can even inspect imported food to make confident it is secure.

Take all the very technical legal argument out of this and there is still the element of human error, of an understaffed agency monitoring an exponentially growing number of pharmaceutical products, and the prospective for this agency to slam the door in a citizen's face should a medical catastrophe happen.

In Might, the Congressional Committee on Oversight and Government Reform held hearings on the pre-emption problem. Chairman, Rep. Henry Waxman, said in his statement, that if the pharmaceutical managers, the FDA and the Bush Administration have their way in court, "...one particular 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 bankruptcy attorney marketing