From TCSDaily: "The Battle Over Drug Safety and Preemption: Coming Soon to a Congress Near You"
(Feb. 02, 2009). Excerpt:
[N]o one can possibly believe that mass litigation in state courts is a good way to settle anything. Professor Lester Brickman and Judge Janis Jack
have documented the astounding shenanigans and fraud in the asbestos
and silicosis cases, and to think a higher standard prevails in drug
litigation would be naïve.
And:
[W]e don't like to think of it this way, but releasing a drug for
general use is in itself a clinical trial. While large-scale effects
can be found in the small-scale trials required before FDA approval, it
is inevitable that mass use will sometimes find results that are less
common, more subtle, or prevalent in particular sub-populations.
The medical community knows this, and devotes considerable resources to tracking post-release experience with drugs to get feedback on any problems. Patients need to accept that using a new drug has risks and that is an unavoidable part of the price that must be paid if there are to be any drugs at all.
Perhaps there should be a fund for people harmed by such effects, paid for as part of the system, but drug makers should not be accused of negligence for a problem that is not a failure of evaluation procedures but a law of nature and statistics. The litigation approach introduces confusion that is moral as well as economic.
The medical community knows this, and devotes considerable resources to tracking post-release experience with drugs to get feedback on any problems. Patients need to accept that using a new drug has risks and that is an unavoidable part of the price that must be paid if there are to be any drugs at all.
Perhaps there should be a fund for people harmed by such effects, paid for as part of the system, but drug makers should not be accused of negligence for a problem that is not a failure of evaluation procedures but a law of nature and statistics. The litigation approach introduces confusion that is moral as well as economic.
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