Monday, November 3, 2008

Big Supreme Court Case Today

The Washington Post is reporting that the future of drug regulations may change today.

At the crux of the case is when the FDA approves a drug, does it relieve the drug maker of liability from tort cases within the state courts.

Traditionally, the tort cases in state courts have provided a strong incentive for drug makers to actively improve their labeling upon discovery of new information. Facing multi million dollar liabilities is a very strong incentive for drug companies to actively work to make their drugs, and the labeling of their drugs, as safe as possible.

Traditionally, the FDA label approval is considered a minimum, or floor. That is to say, that so long as the approved labeling is in place, the drug maker could add additional labeling to clarify appropriate usage of the drug, e.g., warnings for how the drug should be administered.

Even though the drug labeling is approved, the drug companies are still liable for their products. Should they be found to be negligent in their labeling, or in any other way that can be successfully argued to hurt individuals, the company would face expensive tort cases. I think this is a nice additional check to the FDA's approval. Every other consumer products maker faces the same liability.

If you make a product that is dangerous and fail to provide adequate warning, you are accountable for the damage that it causes people. Please let me clarify that I'm talking about real dangers, not frivolous inconveniences. If you were to find out that the television set that you purchased was emitting x-rays and one of your children develops a brain tumor, I think you have a case against that television manufacturer. I think the same is true with drug companies.

The Bush administration, however, is interpreting the FDA regulations much differently. They are saying that once the approval is in place that the drug makers are absolved from any further responsibility to update the labeling on their drugs despite any new information that may become known.

The drug companies love this interpretation, without having to worry about being held accountable for their products, they need not continue updating the labeling information of their products--which is very expensive.

If the supreme court were to decide that drug companies are immune from state tort cases I believe that it would be a tremendous blow to public safety.

In my opinion, and I'm not any sort of lawyer so take that for what it's worth, this shouldn't even be up for argument. In my opinion, the justices are far too conservative. I fear that if one more Scalia or Alito were to be appointed that the interests of big businesses would take precedence over the rights and safety of individuals.

EDIT: Here is a brief of the arguments from the Wall Street Journal's legal blog.

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