TullHelman950
Doesn't appeal to you, does it?
Would you like to turn over handle 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 feel about it for a small whilst, has extraordinary power over your personal properly-being - might achieve even far more dominance more than 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 choice in Levine v. Wyeth.
Diana Levine, a skilled musician, was treated, in April 2000, for a extreme migraine headache and nausea. Staff at the Vermont Health Center injected her with Phenergan, a nausea medication. They employed her arm to administer the injection and the outcome was extremely 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 - although it complied with FDA needs - was inadequate. Levine won a jury trial and was awarded about $6.8 million.
Wyeth appealed the selection due to the fact it desires 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 below 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 idea of pre-emption: that federal law pre-empts the correct 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 authorized the drug, or healthcare device, and the label, then drug producers require 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 Occasions stated the drug companies are looking for "a legal shield" against becoming held accountable.
Why is it that significant corporations, and a lot of of their Republican supporters, are often talking about accountability and responsibility, until it comes to them?
The entire point is scary.
Right here is an agency - the FDA - which is understaffed and not maintaining up with technology - faced with the possibility of assuming even far more control more than our extremely being. USA These days published a story - citing an independent panel assessment of the FDA - which revealed that the agency has about the exact same size staff as 15 years ago. According to the article, As an alternative of getting proactive, the agency (FDA) is frequently in "fire-fighting" mode.
If the U.S. Supreme Court rules in favor of Wyeth, upholding the pre-emption rule, it requires away one of the significant legal remedies 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 prevent state typical law claims.
In January 2006, the FDA adopted new regulations, the ultimate objective was to torpedo efforts to permit individual injury claims to be heard by state court juries.
The FDA stated "it is the professional federal public agency charged by Congress with insuring that drugs are safe and successful and that their labeling adequately informs users of the risks and rewards of the item and is truthful and not misleading." Translation: "if we say it will not kill you, it won't kill you."
And because when is the FDA in the job of insuring anything? These are the same folks who can even inspect imported food to make sure it is protected.
Take all the very technical legal argument out of this and there is still the factor of human error, of an understaffed agency monitoring an exponentially growing number of pharmaceutical goods, and the potential for this agency to slam the door in a citizen's face should a medical catastrophe take place.
In Could, the Congressional Committee on Oversight and Government Reform held hearings on the pre-emption situation. Chairman, Rep. Henry Waxman, said in his statement, that if the pharmaceutical managers, the FDA and the Bush Administration have their way in court, "...a single of the most strong incentives for safety, the threat of liability, would vanish."
Whose physique is it anyway? Yours, or the FDA's?
Onward.
Richard Alexander attorney marketing
