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Friday, April 28th 2006

Complex Case

I’ve been arguing a lot of late about complex case exemptions to the 7th amendment. I will be honest, while I support caps on punitive awards in medical malpractice cases they make me uneasy. Let the injured collect what they deserve. I just don’t think the current system does a very good job of actually identifying those who actually deserve per physician negligence. While information on actual jury verdicts is scarce, there is plenty of evidence to imply that for any number of reasons the current system simply doesn’t compensate the right people.

Looks at healthcare claims in New York and then in Utah/Colorado both turned up statistics that showed 90+ percent of patients who suffer negligence never get compensated, either because they never seek to or because they fail in their claims. Meanwhile in the Utah/Colorado study 77% of those who collected on claims did so absent of negligence. It doesn’t distinguish if the insurance companies settled in these cases (highly likely) or the amount was won by verdict at trial. I contend it is outrageous, no matter if the insurance company paid them off or not.

Part, albeit not of the all problem, is that juries are incapable of deciphering complex medical or pharmaceutical suits for the technical nature of them. The unreliability of the system to seek out true negligence forces insurance companies to settle non-negligent cases at a higher rate than they otherwise would. I think the single greatest thing that can be done to solve this problem isn’t caps on awards but healthcare courts.

On the issue of jury compentency I appreciate John Calfee’s New York Sun piece. It comments on the recent Vioxx jury award for the 77-year-old diabetic.

Essentially, the jury had to decide three things. One was whether Vioxx was a substantially contributing factor to the heart attack suffered by an elderly ex-smoker with diabetes and coronary artery disease. Unfortunately, science can’t give us a good answer. Mr. McDarby was clearly at great risk for a heart attack. But there is no way to know which of a multitude of precipitating factors tipped the balance on that terrible day. We don’t even have reliable data indicating an extra probability of a heart attack in the relevant circumstances.

The jury simply had no way to determine whether the plaintiff would have had a heart attack if he had used a different pain reliever. Relying on an unpredictable mix of intuition and emotion, the jury simply guessed.

The second issue was failure-to-warn. The plaintiff argued that in addition to complying with all FDA regulations about warnings, Merck should have specifically warned the doctor not to prescribe Vioxx to this patient. What warning, we should ask, and to what effect? Here, the jury had even less foundation than when deciding causation. The most important data about Vioxx and heart attacks had long since been published and widely discussed in medical circles. Moreover, Vioxx was a lifesaver for patients with a propensity toward fatal ulcers, which every year kill thousands of patients taking older drugs that Vioxx replaced. Whether more warnings would have pushed the patient toward more safety or just rearranged Mr. McDarby’s numerous various risk factors was something the jury could not possibly discern. No scientifically based warning could have said something like “there is a so-and-so percent extra chance of a heart attack.” A warning would presumably have said something like “don’t prescribe this to patients with a high risk of heart attack,” but what good would that have done in the absence of information about whether the obvious alternative treatments were better?

Again, the jury had to guess. And again, there is no reason to think its guess would have been better than the FDA’s own expert assessment.

The third question was whether to award punitive damages, something never before done to a pharmaceutical manufacturer liability case in New Jersey. Under New Jersey law, the jury had to find that Merck had withheld information from the FDA in a “wanton and willful” manner. Again, a problem for the jury was the FDA itself. As a former FDA staffer testified, the FDA was satisfied that Merck had turned over all the information it needed. How did the jury reach a conclusion so different from the FDA’s own? Here lies one of the most unsettling parts of this trial. Merck, like all responsible manufacturers, massaged the Vioxx data as it arrived, trying to get a fix on the true heart-attack risk and other matters in a diverse mix of patients. The FDA has to know that firms do that kind of analysis all the time. The jury said Merck should have shared its own preliminary assessment of the data with the FDA even though the FDA famously makes up its own mind about such things and the underlying data had in fact already been given to the FDA. Had Merck not undertaken its analysis, there would have been nothing to keep from the FDA.

Indeed, I agree that the decision on the punitive award was most troubling. The data had been turned over for the FDA to do their own analysis. Such was the final word. As well, the data was from studies unrelated to the heart risks of Vioxx. And yet, the fact that the analysis, which Merck was under no obligation to do, was slow in being turned over to the FDA (because it was preliminary) they were found against.

Ridiculous, you can’t win. Either you refuse to perform your own analysis (which certainly wasn’t required of Merck as the FDA had all the data) and the jury hears how you should have. Or you do, and the jury hears how it is evidence you knew your drug was dangerous and maybe even covered it up. How is the FDA not the final authority on this?

Healthcare courts would put decisions in the hands or jurists with medical training. Not necessarily biased physicians but not the mechanic down the street either.

I would not trust myself to come to a fair conclusion on the issue of a manufacturer’s fault during a plane crash. I don’t trust an engineer to come to a fair conclusion on the issue of my medical competence.