IN DEFENSE OF THE JURY SYSTEM . . . Last week at the American Enterprise Institute in Washington, I spoke about the $253 million Vioxx verdict in a presentation titled "In Defense of the Jury System, Post-Ernst." Although a video of the presentations by all four panelists is available from the AEI, I'm posting a transcript of my talk here for any interested readers without broadband access.

In another post, I wrote about my impressions of the event and gave brief biographies of the other panelists. All of the presentations were very interesting, especially for anyone involved in the Vioxx litigation or interested in its public policy implications. If you have access to Nexis, you can read a complete transcript of the entire event that was published by the Federal News Service. It also includes all the question-and-answer periods.

My presentation went as follows, although the Powerpoint slides aren't included:

Now that Ted Frank has joined the AEI full time, I’m the only trial lawyer on the panel, which means in general that I’m more fun-loving than the rest. That being the case, I had a joke to get started with today, but I decided on the walk over from the hotel that it wasn’t very funny. So I’m going to dispense with the hilarity and get right to my presentation.

I want to say first, thank you very much for inviting me, Ted, and thanks to the AEI for having me. I think that this is a great event. It’s very interesting to hear you all speak, although I don’t agree with a lot of what you say. I’m glad that you invited me.

Also, before I get started, I should say that although much has been made about my Madison County roots by the organizers of this event, very few of the Vioxx cases I’ve filed with the two other firms I’m working with have been filed in Madison County. As a result, I won’t be addressing Madison County very much in my talk today.    

What I hope to do today is correct some misimpressions about the science that was presented at the Ernst trial. The magazine The Economist had an article that’s on the newsstands right now with a line about the science. In this case, The Economist got it wrong.

It’s there on the slide. The Economist said that Mark Lanier, the plaintiff’s lawyer, won the case despite “the lack of any scientific evidence that Vioxx actually killed Mr. Ernst.”

“The lack of any scientific evidence.” It’s no wonder that some people were angry about the verdict. One example was my brother-in-law—he’s very nice guy, although he’d feel right at home here in Washington under the current administration—and he demanded an explanation from me after reading about the Ernst verdict. “The plaintiff won without presenting any evidence at all!” he told me. The other panelists have echoed much the same claim here today.

If what The Economist said were true, which it’s not, the first person who observers should be outraged at is the trial judge, for letting the case get to a jury in the first place. The trial judge is the gatekeeper of the scientific evidence—he gets to decide what evidence is too speculative or too unscientific for the jury to hear, even before the jury hears it. The judge in Texas determined, even before that jury saw the plaintiff’s evidence, that the plaintiff’s evidence was scientifically valid and wasn’t speculative.  That’s something that’s often overlooked about our jury system. It’s one of the things that make it so resilient: the jury decides the facts, but the judge decides the law. The judge decides what evidence the jury gets to hear. There are many other safeguards built in along the way.  The trial judge can throw out a case based on a defendant’s motion to dismiss, or on a defendant’s motion for summary judgment, or after a trial is half-way through on a defendant’s motion for directed verdict. The trial judge can even throw out a case after the trial is over—after a verdict is reached—on a judgment notwithstanding the verdict.

So why aren’t the very vocal Ernst critics complaining much about Judge Hardin, the gatekeeper of the scientific evidence down in the Texas state court? Back in Madison County, Illinois, where I practice quite a bit, I’ve been hearing plenty about state court judges ever since President Bush came to town last year to make his speech about tort “reform.” When I do this with my fingers, making quotation marks, it’s because when people say they want to “reform” the tort system, often what they want to do is tilt the playing field in favor of big business. I’ve heard since President Bush came to town that the judges are biased, that the judges are unfair, all of which is code, in my opinion, for another message, namely, that what Madison County needs is more Republican judges. That’s what the advocates of tort reform have been saying down in Texas too, only in Texas, they got their Republican judges, including the one, Judge Ben Hardin, who presided over the Ernst trial. That makes it hard for the Ernst critics to blame Judge Hardin for the result. 

What’s to be done when you can’t blame the trial judge, the gatekeeper of the scientific evidence? You blame the jury. You say the jury was too stupid to understand the science. That’s a claim that’s been made a lot about this case. It’s a claim I don’t happen to agree with.

But  .  . . we’re back to the science. Do you have to take my word for whether the science at the Ernst trial was any good? No, you don’t. That’s because the plaintiff, just like the defendant, presented its evidence through medical experts who know a whole lot more about the science than I do.  Let me tell you about the plaintiffs’ medical experts, and in particular, the plaintiffs’ expert cardiologist. His name was Dr. Isaac Wiener. He graduated from Harvard Medical School and now teaches at UCLA. He’s board certified not only in internal medicine and cardiology, but also in cardiac electrophysiology, which is the study of irregular heartbeats, including arrhythmias—probably the key scientific issue at the trial. Mr. Ernst, remember, suffered an arrhythmia. The issue at trial was what caused that arrhythmia. Dr. Wiener is also the co-director of the Cardiac Arrhythmia Center at the UCLA Medical Center in Los Angeles.  Dr. Wiener saw all the evidence and all the medical reports and read all the studies and he testified about those things to the jury. Here’s the bottom line, in my opinion: no one can claim that Dr. Wiener is a junk scientist.

What was the specific evidence the plaintiff presented? Vioxx has been linked to blood clots and medical problems caused by blood clots—heart problems, strokes, embolisms. The theory presented by Mark Lanier was that it was a blood-clot induced heart attack that led to Ernst’s arrhythmia and sudden death. The blood clot that caused the heart attack, Lanier said in his opening statement, was caused by Vioxx. Dr. Wiener’s medical opinion was a little different--as one of the medical experts, he doesn’t have to agree with everything the lawyers say. In fact, he doesn’t have to agree with any of it. And when questioned by Mark Lanier, Dr. Wiener didn’t agree that Ernst died of a quote “heart attack.” He said people who die suddenly of a cardiac event don’t show evidence of a heart attack.  He preferred to use the term quote “sudden cardiac death.” But whatever the terminology used, Dr. Wiener also testified based on all the medical records in the case, and after ruling out all the  other possible causes, that Vioxx had been a significant contributing factor in Ernst’s sudden cardiac death--as did two other medical experts who testified at the trial, both of them doctors.

I know this is a little technical. But anyone who claims the jury avoided the science—as many have done—has to first have some understanding of the science.  What about some of the other questions that were raised about the Plaintiff’s evidence after the trial was over? At the trial, as I said, the Plaintiff’s experts testified a Vioxx-caused blood clot led to Ernst’s death. Even so, it was impossible after the fact to see the clot with their own eyes. Though much has been made of this in the press, this question of finding the blood clot after Ernst died is a non-issue. It is well-established that when blood clots lead to sudden cardiac death, the clot usually dissolves.  Blood clots are not something you can go hunting for afterward like an Easter egg.  Usually they vanish and leave no trace. That will be true not only in the Ernst trial, but also in many others.

What about Mercks’s evidence of causation? Merck argued that one of Ernst’s arteries was narrowed due to plaque—something called artherosclerosis—and that this caused his arrhythmia and sudden death. According to Merck, Ernst’s use of Vioxx had nothing to do with his death. Both sides agreed about the artherosclerosis, that one of Ernst’s heart arteries was narrowed due to plaque. Yet there was evidence in the trial that this narrowing, by itself, wouldn’t cause an arrhythmia and sudden death. Merck’s experts didn’t really get around this problem, but presented their theory anyway that Ernst’s  artherosclerosis might have caused his sudden death. The biggest problem with this theory was that the narrowing in Ernst’s artery wasn’t severe enough to cause an arrhythmia and sudden death without something more.  That “something more,” according to plaintiff’s evidence, was a Vioxx-caused blood clot, the only thing that could explain why the flow of blood was cut off to Ernst’s heart, leading to the arrhythmia and sudden death.

Next: What about the question of “speculation” that some have raised since the trial ended?  Well it’s not speculation when you have well-credentialed experts testifying about causation based on their review of all the medical records, as happened in this case. But here again, you don’t have to take my word for it. Those safeguards I said are built into the jury system? If Merck thinks the evidence was too speculative, it has an opportunity to raise this issue with the trial judge even after the trial is over, as well as on appeal—not once, but twice, since there are two levels of appeal in Texas. That’s another reason why I can say that the Ernst trial is evidence that the jury system is working.

One final point about the science of the Ernst trial. Some are asking, “Hey, I thought Vioxx was fine as long as you took it for less than 18 months. Ernst took it for only 8.” That 18-month number is from Merck’s VIGOR and APPROVe studies. Neither—and this is important--neither VIGOR nor APPROVe was designed to assess the cardiovascular risk of Vioxx.  The VIGOR study, for example, specifically excluded from the study group most people thought to be at risk for heart problems. Had people at risk for CV events been included, the results of VIGOR study would have been different.

The VIGOR and APPROVe studies were not designed to assess cardiovascular risk. That’s why the VIGOR and APPROVe studies are of limited use in saying Vioxx definitely didn’t cause a bad event. What they do show is an association between the use of Vioxx and the development of blood clots in general, even though not designed to test the amount of risk. Causation in specific cases as they come to trial will have to be decided on a case-by-case basis by having qualified doctors rule out other alternative causes, which is exactly what went on in the Ernst trial. And, I should also point out, it’s exactly the way real doctors treat real patients and make real-life life-or-death decisions, by ruling out other alternative causes and reaching a clinical diagnosis.

What about the other studies that are cited by Merck supporters? Every study that’s out there is of limited utility on the risk issue because none was designed to assess that risk. Instead, they were done to test new uses and new markets for Vioxx. That’s a problem for Merck. It suggests Merck was ignoring the risk, despite evidence that its scientists knew about and appreciated the dangers of Vioxx before it came on the market. 

Mr. Calfee talked about an active research program. My question is, if the research program was so active, why didn't Merck study the one thing that was thought to be the biggest problem, which is cardiovascular risk?

Just recently, it has come to light that Merck did design a study to assess the cardiovascular risk of Vioxx.  It was the VALOR study, a large-scale cardiovascular risk study that Merck had in place to start in 2002. But just days before Merck was to submit the study’s outline to the FDA for approval, Merck halted the study. The reason it was halted hasn’t been explained.

A final important Merck study is the VICTOR study, which came up in Texas and will probably come up again at the upcoming trial in New Jersey. The VICTOR study, even though it also wasn’t designed to test for cardiovascoular risk, showed an almost immediate difference in cardiovascular events between subjects on Vioxx as compared to those taking a placebo. Merck hasn’t yet published the results of the VICTOR study.  I don't know if they plan to, but there will probably be more information about the study results in upcoming months. The study wasn't completed. It was halted when Vioxx was taken off the market, but nonetheless there exists a lot of data.

So, that’s the science behind the Ernst verdict. Does the jury’s original $253 million verdict tell us anything about problems with the jury system?

First of all, I think it’s a mistake to confuse the verdict with the final result. But no matter what happens to the Ernst verdict—already, the $229 million punitive award will be reduced to only $1.6 million—the verdict does demonstrate, in my mind, that the jury system works. Just looking at the science alone, here’s what happened at the trial: Merck’s explanation for Ernst’s death, presented through its experts, didn’t hold up in comparison to the Plaintiff’s explanation—in the collective opinion of 10 of the 12 jurors who heard all the evidence.  Like the Wall Street Journal article that someone else mentioned—and it was a fascinating article—the Wall Street Journal said that the jurors only took an hour to decide about causation, but what that fails to take into account is that they listened to the evidence for five weeks. They had five weeks plus an hour to decide about causation.

It’s easy to second-guess a jury. But I’d still be defending the Ernst jury even if the result had gone the other way. You can ask any trial lawyer—plaintiff’s lawyers or defense lawyers—Ted said it himself just a minute ago—or you can ask any judge, state or federal, about whether they respect the ability of lay juries to sift through the evidence and reach a just result. They will almost universally say yes. I have some data about that on the slide. If Merck wins the next trial, and the next, I might have some questions about what evidence was presented. I might have some questions about the way that evidence was presented—exactly the sort of questions some have been raising about the Ernst trial. But if juries do decide for Merck from here on out, I won’t be questioning the jury’s competence or intelligence to reach a just result based on the evidence that was presented to it.

Now . . . despite my views, some are willing to draw conclusions about the Ernst verdict, so let me address a few of those, then I’ll wrap up:

First, the question of punitive damages. Sure, the $229 million punitive award was reduced, but aren’t punitive damages a bad idea in the first place? It’s important to keep in mind that  punitive damages are not awarded very often.  When they are awarded, they are meant to punish—to act as a reminder that outrageously reckless conduct shouldn’t happen again. In the Ernst case, the conduct being punished included failing to appropriately warn about a likely clotting risk of Vioxx though such a risk was known to Merck, and marketing Vioxx in a misleading way to the very people who were most likely to be affected by such a risk. The specifics of these failures have been well-documented by the New York Times, the Wall Street Journal, and other newspapers, as well as by a Congressional Committee that issued a report on May 5, 2005. If you want further details about the specifics of Merck’s conduct, those are good places to start.

What about the effect of the Ernst verdict on the development of new drugs? Despite other pharmaceutical mass torts, drug companies continue to do very well financially. Drug companies continue to develop new drugs. Take Wyeth, for example. That’s a company that recently paid $21 billion in settlements for the diet drug litigation. It still has a healthy pipeline of new drugs. But let’s set examples like that aside. Why would anyone even consider granting favors to the pharmaceutical industry like tort immunity when the fix is so simple: first, warn appropriately about known risks, and second, market the drugs to the most appropriate users, those for whom the benefits of the drugs are most likely to exceed the risks.

That’s all consumers are asking. Drug companies should fully disclose risks about which they know and study the ones they suspect so that doctors and consumers can make informed choices. No one wants to keep drug companies from developing new drugs. No one wants to keep drug companies from making money. No one expects prescription drugs to be free of all risks.  All drug companies have to do is fully inform consumers of the known risks.

In my opinion, that’s something that Merck didn’t do with respect to Vioxx. It’s unfortunate, because had Merck been forthright about the clotting problems and done a clinical study to assess the risk, Vioxx might still be available to people who might benefit from it. Who are those people? Not a group of people large enough to create a blockbuster drug. I mean a smaller group of people without heart problems who are in serious pain and need a painkiller that won’t give them the gastrointestinal problems other painkillers might.

That was the promise of Vioxx, but it wasn’t to be. And now, as a result, a very small minority of commentators are calling for tort immunity for drug companies and discussing reforms to the jury system that would benefit drug companies. I think these ideas are radical and unnecessary. The tort system and the jury system may not be perfect, but they are certainly better than any of the alternatives, especially those involving granting favors to drug companies that might lead to even greater health risks.

People say jury system reform, people talk about tort reform. If anything needs to be reformed, it’s the business practices of a few—but only a very few—drug companies that are willing to put consumer’s lives at risk in a search for greater profits.

Again, thanks to the AEI for having me.

My collected Vioxx posts are here. If you are (a) someone who was harmed by Vioxx or (b) a lawyer who wants to refer your Vioxx cases to a highly-competent team of mass-tort lawyers, look here.

 

 

Comments

[Ted]

The full transcripts, including the question-answer session, should be up shortly; there have been a lot of conferences, and they're backed up, but the files are with the right people for proofing.

I meant to ask on the walk back what your joke was, Evan, but we got distracted by Reverend Phelps's buffoons.

[Evan]

Ted: Since I knew I'd be going third, I had a couple of different openings prepared that I could choose from depending on the tone of what had come before. One of the openings I abandoned included something I called a "joke" but which was really more of an anecdote. It probably wouldn't have worked. Repeating it here wouldn't improve it.

[Beldar]

I've got a whole set of anecdotes that are only funny after a third beer.

[Katherine]

I'm glad you posted the transcript; very informative. :-)

[Eh Nonymous]

Beldar: do you have any that are funny after the _first_ beer? Because it is, after all, a Monday at 10:30 a.m.