CurielKunze988

Doesn't appeal to you, does it?

Would you like to turn more than manage of your wellness 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 assume about it for a tiny while, has extraordinary power over your personal effectively-becoming - could obtain even much more dominance over your destiny. The battle for world 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 choice in Levine v. Wyeth.

Diana Levine, a professional musician, was treated, in April 2000, for a extreme migraine headache and nausea. Staff at the Vermont Wellness Center injected her with Phenergan, a nausea medication. They utilized 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 - even though it complied with FDA needs - was inadequate. Levine won a jury trial and was awarded about $6.8 million.

Wyeth appealed the decision due to the fact 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 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 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 accepted the drug, or medical 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 companies are looking for "a legal shield" against being held accountable.

Why is it that significant corporations, and a lot of of their Republican supporters, are always talking about accountability and responsibility, till it comes to them?

The complete issue 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 handle over our really getting. USA Nowadays published a story - citing an independent panel review of the FDA - which revealed that the agency has about the same size staff as 15 years ago. According to the post, Instead of getting 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 requires away one of the key 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 avert state widespread law claims.

In January 2006, the FDA adopted new regulations, the ultimate purpose was to torpedo efforts to allow personal 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 secure and helpful and that their labeling adequately informs customers of the dangers and positive aspects of the product and is truthful and not misleading." Translation: "if we say it won't kill you, it won't kill you."

And given that when is the FDA in the job of insuring anything? These are the same people who can even inspect imported food to make positive it is safe.

Take all the incredibly technical legal argument out of this and there is nevertheless the aspect of human error, of an understaffed agency monitoring an exponentially developing quantity of pharmaceutical products, and the possible for this agency to slam the door in a citizen's face ought to a medical catastrophe take place.

In May, the Congressional Committee on Oversight and Government Reform held hearings on the pre-emption problem. 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 physique is it anyway? Yours, or the FDA's?

Onward.

Richard Alexander attorney marketing