Art De Vany: The VIOXX Trial

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The VIOXX Trial

August 20, 2005 09:34 AM

By now you have heard about the damages awarded by the Texas jury in the death of Robert Ernst, a 59 year old produce manager at WalMart. The amount totaled $253.4 million for loss of income, mental anguish and loss of companionship to his widow, with $229 million in punitive damages.

A juror said "It could have been prevented" implying that had Ernst not taken VIOXX he would not have died. This is clearly wrong. The probabilities are shifted by all the factors in the case. There is nothing that can be done, ever, to turn a probability down to zero. It is looking for guarantees, which juries often do, when there are none

Mr. Ernst was a marathoner and an aerobics instructor in addition to his work. And he had clogged arteries. No information is given regarding his body weight, heart rate complexity, or his marathon participation and training. Nor of his aerobics activities as an instructor. No biomarkers are reported either, such as those you have seen from my post Top Ten Reasons not to Run Marathons are elevated or depressed in marathoners: tHCL, BIL, ALP, HDL and LDL, neutrophils, S100beta, CK, TNF-alpha and so on.

I presume some of these biomarkers were entered into trial evidence, along with cardio data, particularly echocardiograms that show cardiac disfunction. Then again, you never know. Often an expert witness just comes in and renders an opinion. The jury takes it or leaves it. In this case, they accepted an expert's opinion that is being challenged by Merck as unscientific.

I don't and can't know how sound the expert testimony was, but as an expert witness in many trials and as a court-appointed expert to the District Court, I have seen a lot of it come into trials that has been famously labeled "Junk Science" by Peter Huber in his fine book Gallileo's Revenge.

Without trying to reach any conclusion on that point, consider the probability calculation that has to be made here. One has to determine by how much the odds of death for Ernst were shifted by taking VIOXX.

First, it is likely that his marathoning was a factor in his decision to take the drug. Marathoners suffer great injury and repetitive stress and do take pain medication, probably at a higher rate than the general population. But, put that aside. Here is the right way to do the calculation.

Consider the conditional probability of death for Ernst, given his age, biomarkers, existing heart condition and his marathon and aerobics activity. It is clear from the marathon studies I cited that his risk of death was well above the general population of his contemporaries, even of those with similar heart conditions. Now, estimate the shift in the probabilities of death at ages going forward of taking VIOXX, given his condition and activities. Hard to do, but that is the right way.

There is more. Ernst's heart condition, though perhaps preexisting to some degree, was worsened by his marathoning and aerobics activities. Paradoxical I know, but only because of the unfounded opinion that aerobics are good for your heart which the citations I give on my post clearly refute. So, there is some contributory negligence on the part of Ernst for risking his heart with his marathoning and aerobics life style.

The most decisive data, which readers will know from previous posts, would be the complexity measure of Ernst's heart beat, by far the best measure of cardiac function and predictor of impending collapse. I would put Ari Goldberger forth as an expert with these data, they could use past recordings and do the statistics on them. And, a witness who knows the risks of marathoning. Then the jury would be properly informed in reaching its judgement.

I don't know the answers to these hard calculations, but I bet the jury doesn't either.

· Evolutionary Fitness ~ · Uncertainty

Comments

Posted by: Flower Online at September 12, 2006 3:04 AM

A neat idea Dave. I would like to see their medical premiums as another possible indicator. The idea Nassim Taleb and I are working on could be applied to doctors. It would 1. help them finance their training and set up their practice, and 2. it would price their competence through the derivatives market.

Rick: I think we are all wondering. I too was given a presription for the other COX enzyme inhibitor. Took a few and tossed them. They altered my sleep, a sure sign of a problem. Same thing for the other non-steroidal anti-inflammatories. Maybe steriods, the all time best anti-inflammatories are not so bad in comparison.

I have not found Texas juries to be so good in cases there when I testified as an expert. If the quoted juror is any indication, then the jury was badly informed. Or couldn't get it. I don't think the lawyers matter as much as the luck of the draw on the jury myself, but who is going to do that study? I could have gotten OJ off with that jury.

Posted by: Art at August 22, 2005 3:17 PM

I defended the medical profession for 25 years and did some product defense as well. A mega verdict in Ohio would be anything in the range of 5-15 million dollars or so. What is going on in Texas??? A breadwinner making 50k or so a year with twenty years of earnings left would allow the attorney to board about a million of lost future earnings. Loss of the individual to his or her family is a tough intangible but my experience tells me most reasonable juries would come down in the 1 to 3 million dollar range for that component. All that is left is the presumed pain and suffering of the deceased. Another million?? I am being liberal with these assumptions. I am not sympathetic to the purveyors of Vioxx. An orthopod wrote me up for it five years ago warning that if I kept playing tennis he'd see me within five years for a hip replacement surgery. Partial paleo diet, continued exercise (including lots of tennis) and NO vioxx and I feel better now than I did when I went in with the groin pain (classic for hip arthiritis). The vioxx tabs were tiny and I felt that anything that so small but so systemically powerful had to be upsetting to my body's natural defenses and processes. Again, what the hell is going on in Texas?? Rick

Posted by: rick strong at August 20, 2005 4:51 PM

I've wondered why this subject hasn't interested in you in a more formal, academic way. The current system is weighted in favor of the plaintiff. Sure, the plaintiff's attorneys must consider a number of economic factors before going forward, such as opportunity costs.

But the defendants are on the hook for big bucks win or lose. Perhaps the plaintiff's attorneys should be obligated to post some sort of bond before trial guaranteeing some measure of financial recompense for attorney fees should the case go to the jury and they find for the defendant.

Pricing such a bond(which should be public) would give both sides an excellent signal as to what the market thinks of the trial. A high cost would give the plaintiffs pause and give them incentive to settle. A low cost would do the same for the defendant. A public record of these costs over time would be a tremendous help to the public in judging the impact and/or need for various reform proposals.

Prospective clients could use such records to help them figure out which barristers to hire. The general public and their gov't representatives could use such records in assessing the quality of their judges.

Obviously, I'm glossing over a lot of difficulties in implementation. I'm not a lawyer myself. But I'll bet it could be done.

Posted by: dfobare at August 20, 2005 11:36 AM

The VIOXX Trial

August 20, 2005 09:34 AM

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