PolySciFi Blog

Tuesday, August 23, 2005


Fanning the Vioxx flames

An interesting tidbit for the polyscifi Vioxx debate and then another proposal for the legal system.

The particular side effect that got Vioxx pulled from the market was an increase in the number of blood clots that formed in the heart and brain (link):
Vioxx® was withdrawn from the world market because of an increased occurrence of blood clots in heart and brain observed in a long-term study (more than 18 months) of the preparation’s preventive effect on patients with polyps in the colon. Other summaries, which have comprised data from several previous studies, have also proved an increased risk of blood clots when using Vioxx®.
It also appears that any threat of getting such a blood clot eventually goes away (and the problem appears to apply to the entire NSAID class of drugs) and thus does not produce chronic problems:
The risk of developing adverse reactions from the use of Vioxx® disappears within a short period after termination of treatment. For traditional NSAID preparations (arthritis medicine such as ibuprofen, naproxen, etc.), a few studies have shown that there is a slightly higher risk of getting blood clots within the first two months after termination of treatment. It is uncertain whether the same applies to Vioxx®, but if that is the case, the risk is expected to have passed after a maximum of two months.
When the clotting agent is eventually pissed away, the chance of a blood clot returns to normal. For Merck, this means that it's unlikely that there will be any successful suits outside of the ones already filed.

Now here's the nugget to mull over in the $253 million dollar verdict. The man who died - Robert Ernst - didn't have a blood clot:
On Ernst's death certificate, Araneta [the coroner] did not mention a blood clot or a heart attack, only the irregular heartbeat, or arrhythmia....

Last week, expert witnesses for Merck pointed out that Araneta's autopsy had not found a blood clot, even though she said she had carefully examined Ernst's heart and coronary arteries...
On the flip side:
"Expert witnesses called by Lanier [plaintiff's attorney] have offered several potential explanations, including the possibility that a clot had dissolved after Ernst died or that resuscitation efforts had caused it to become dislodged....

[Araneta] said in a deposition played before the jury that a blood clot had probably caused the irregular hearbeat that led to Ernst's death.
If they had found a blood clot, that would've satisfied a preponderance of evidence from my perspective, but based on what's in the papers, it sounds like the personal injury verdict was wrongly decided (as an aside, particularly for technical cases, I think we should have professional juries).

Lots of people have heart arrhythmias for lots of different reasons. I had a friend die of one a few years back, and I'll occasionally have a heart flutter when I drink a shload (that's a metric unit) of caffeine during my up-all-several-nighters (but nowhere enough to kill me from caffeine toxicity), so absent a clot it seems to be a stretch to assume that Ernst's arrhythmia was caused by Vioxx.

This leads me to another point, one that I hope will spark a debate.

Why not separate out punitive civil trials and personal injury civil trials? (Note to trilobite - this is another example of a normative argument, i.e., an argument on how things should be, not an argument on what is legal or what is Constitutional.)

Specifically, I think that any "punishment" that is meted out should be the result of a case brought by the government (whether by the states like in the somewhat recent tobacco cases or by the feds as is done in anti-trust cases).

In addition to the nice intellectual appeal (to me at least), divorcing the two cases should have the following effects which I deem to be positive results:
1. A company or person can be punished for the crime or misdeed without relying on someone to be injured. Like a fine. While I am doubtful that Merck made a major misdeed in this case, others are more certain. But what happens to the punishment when this ruling is overturned as I suspect it will? And more generally what happens to the punitive damages when we agree that there was wrong-doing even if it didn't cause harm to the plaintiff?

2. Any punitive damages would actually go to the state. The aggrieved party would still receive any compensation coming to them, but not the punitive damages. If we want to treat punitive damages like a fine, then I think the government should be the one levying (and receiving) the fines not Robert Ernst nor Jody Neel.

3. There's a reduced incentive to bring the ginormous lawsuits (which most people agree is a problem), but at the same time people would still be compensated for actual injuries and caps may not be needed.


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