Tuesday, August 16, 2005

Law suits and adverse drug outcomes

Here is something to watch for in coming weeks. What happens when a drug, approved by the FDA, suddenly has some unexpected deaths associated with its use? Think of Vioxx. This is an antiinflammatory drug taken by persons with painful arthritis and in a few cases patients had heart attacks and died. What happened next is being acted out in a court room where Merck is being sued by trial lawyers for humongous damages on behalf of "victims" and others who took the drug but did not die and are also going to be included in law suits to come.
Now we have a situation where 4 women who took RU-486 out of 400,000 who have taken the drug since 2000 have died of infections which are very closely attributable to having taken the drug. RU-486 has a controversial history since it is well-known as the "morning-after" pill which blocks pregnancy if taken soon after intercourse. The anti-abortion position was that the drug would be misused and was dangerous to women who took it. In fairness, however, they also opposed it on moral grounds as being an abortion pill. Since this was the anti-abortion position, the liberals defended it and got it approved by the FDA. The pro-abortion crowd is now fighting to get it approved as an over the counter drug.
Here is what we need to watch for. Will the trial lawyers yield to their liberal instincts and leave the drug alone or will they yield to their greedy instincts and sue to have the drug be withdrawn and the manufacturer pay through the news?

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