DrusieSoper275
Does not appeal to you, does it?
Would you like to turn over handle of your health and viability - possibly your extremely 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 little while, has extraordinary power over your private nicely-getting - may acquire even much more dominance over your destiny. The battle for planet domination of your physique 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 skilled musician, was treated, in April 2000, for a severe migraine headache and nausea. Staff at the Vermont Wellness Center injected her with Phenergan, a nausea medication. They utilised her arm to administer the injection and the outcome was extremely disastrous: she lost her proper 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 - although it complied with FDA requirements - 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 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 must 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 proper 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 manufacturers need to have only to comply with the FDA's requirements 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 businesses are searching for "a legal shield" against being held accountable.
Why is it that major corporations, and a lot of of their Republican supporters, are often speaking about accountability and responsibility, until it comes to them?
The whole factor 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 a lot more manage more than our extremely getting. USA Today published a story - citing an independent panel evaluation of the FDA - which revealed that the agency has about the identical size staff as 15 years ago. According to the report, As an alternative of becoming proactive, the agency (FDA) is usually in "fire-fighting" mode.
If the U.S. Supreme Court guidelines in favor of Wyeth, upholding the pre-emption rule, it requires away 1 of the main legal remedies 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 common law claims.
In January 2006, the FDA adopted new regulations, the ultimate objective was to torpedo efforts to let individual injury claims to be heard by state court juries.
The FDA stated "it is the specialist federal public agency charged by Congress with insuring that drugs are protected and efficient and that their labeling adequately informs users of the risks and rewards of the product and is truthful and not misleading." Translation: "if we say it will not kill you, it won't kill you."
And since when is the FDA in the job of insuring anything at all? These are the identical people who can even inspect imported food to make sure it is safe.
Take all the very technical legal argument out of this and there is nevertheless the element of human error, of an understaffed agency monitoring an exponentially expanding quantity of pharmaceutical products, and the prospective for this agency to slam the door in a citizen's face really should a medical catastrophe take place.
In May, the Congressional Committee on Oversight and Government Reform held hearings on the pre-emption issue. Chairman, Rep. Henry Waxman, stated in his statement, that if the pharmaceutical managers, the FDA and the Bush Administration have their way in court, "...1 of the most powerful incentives for safety, the threat of liability, would vanish."
Whose physique is it anyway? Yours, or the FDA's?
Onward.
Richard Alexander supreme court health care decision
