Monday, May 19, 2008

"Throwing the Baby Out . . ."

On its face, the massive deregulatory policy of the current administration can be considered to be a laudable goal. The thinking is that a free market tends to find its own level of 'comfort' free from governmental restrictions and that this level of comfort will be reached by the give and take of principles that are inherent in our capitalist society. Consider, as an example, the concept of price. If a particular commodity is over-priced, sales fall. The market for that particular commodity must adjust itself by one or more mechanisms. The price can be lowered, or production can be decreased. Alternatively, demand for the commodity can be generated by advertising, model improvement, etc. The give and take of the market place, free of governmental intervention, is the ideal. Were it that simple.

I spent my professional career(s) in one way or another interacting with the pharmaceutical industry. In so doing, I was forced out of necessity to develop an understanding of the relationship between the Food and Drug Administration and the industry. As a trial lawyer, there were many times that my questioning of potential jurors during the voir dire process revealed a basic misunderstanding of the nature of FDA/drug industry interaction that needed to be addressed as part of my trial proofs. The essence of this misunderstanding is the notion that the FDA adequately served to protect the public's interest regarding the safety of the industry's products. People believe that the FDA itself tested drugs for safety. It doesn't. People also believed that because a drug was approved by the FDA it meant that the drug was safe. It doesn't. I can cite chapter and verse in support of these statements regarding the inadequacy of the FDA, but to do so would be beyond the scope of this particular writing. I raise these issues only to point out that long before any deregulatory efforts by various Republican administrations, the basic inadequacy of the FDA had already established a de facto deregulatory status.

The point of all this is to express alarm at the probable outcome of a case currently before the U.S. Supreme Court. Recently that court granted immunity to makers of medical devices on the basic premise that FDA approval means that the product is safe. Safety has become a term of art. If one, seventy (70) or a thousand (1000) people die from a drug reaction, the drug is still safe because safety depends upon a definition that weighs the benefit of the drug to the greater good as opposed to the few who die from its use. The case currently before the court will extend that same protection to drug manufacturers much in the manner that Michigan legislation has established. Since 1995 Michigan has declared that any drug approved by the FDA is, as a matter of law, safe.

I have often used the term "psuedo-conservative" when it comes to addressing the neo-conservative ideas that attempt to bring the country back to basic constitutional values. The question must be asked; Is it not a basic conservative principle that one should be held accountable for one's own actions or misdeeds? As an example, there is a basic lack of Republican forgiveness for the little guy out there who stuck his neck out to invest in real estate and is now faced with potential foreclsoure because of changes in market conditions. The Bear-Sterns-types can be forgiven but the individual is expected to have demonstrated more responsible behavior and is, thus, left to fend on his own as best he can. But I digress. Going back to our constitution I find in the Seventh Amendment the right to trial by jury for civil redress. It is this fundamental right that the potential Supreme Court decision will destroy for the citizens of America when they are killed or damaged by a drug. Shouldn't drug makers be held accountable for unnecessary deaths or injuries when caused by their drugs? What constitutional principle justifies giving an industry blanket amnesty most particularly when the past actions of that industry have revealed a consistent pattern of deceit, fraud and misbehavior that if found among the street people of Detroit would result in long prison sentences?

No comments: