Doesn't appeal to you, does it?



The FDA (U.S. Food & Drug Administration), which if you think about it for a little while, has extraordinary power over your personal well-being - may gain even 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 decision in Levine v. Wyeth.

Diana Levine, a professional 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 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 requirements - was inadequate. Levine won a jury trial and was awarded about $6.8 million.

Wyeth appealed the decision 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 under 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 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 approved the drug, or medical device, and the label, then drug manufacturers need only to comply with the FDA's requirements 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 Times stated the drug companies are looking for "a legal shield" against being held accountable.

Why is it that major corporations, and many of their Republican supporters, are always talking about accountability and responsibility, until it comes to them?

The whole thing is scary.

Here is an agency - the FDA - which is understaffed and not keeping up with technology - faced with the possibility of assuming even more control over our very being. USA Today 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 article, Instead of being proactive, the agency (FDA) is often in "fire-fighting" mode.

If the U.S. Supreme Court rules in favor of Wyeth, upholding the pre-emption rule, it takes away one of the major 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 prevent state common 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 said "it is the expert federal public agency charged by Congress with insuring that drugs are safe and effective and that their labeling adequately informs users of the risks and benefits of the product and is truthful and not misleading." Translation: "if we say it won't kill you, it won't kill you."

And since 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 safe.

Take all the extremely 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 products, and the potential for this agency to slam the door in a citizen's face should a medical catastrophe occur.

In May, the Congressional Committee on Oversight and Government Reform held hearings on the pre-emption issue. 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 of the most powerful incentives for safety, the threat of liability, would vanish."

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

Onward.

Richard Alexander