VIOXX AND ARRHYTHMIAS . . . In the ongoing Vioxx trial in Texas, one of Merck's defenses is to say: "even if Vioxx is unsafe, it did not cause this particular plaintiff's injuries." In today's Wall Street Journal, the defense is explained like this:

Merck has maintained that there is no way Vioxx caused Mr. Ernst's death because his death certificate says he died of an arrhythmia--the interruption of the normal heart-beat rhythm. Merck says there is no link between Vioxx and arrhythmia.

Merck's theory is that Ernst's arrhythmia was caused by Ernst's atherosclerosis. See also Overlawyered. Interestingly, however, while Vioxx argues that there is no direct link between Vioxx and arrhythmia, there is also no direct link between atherosclerosis and arrhythmia. Meanwhile, a doctor not connected with the Vioxx litigation told the Wall Street Journal yesterday that Vioxx and arrhythmia can be related:

"Atherosclerosis by itself doesn't cause an arrhythmia," said Anne Curtis, chief of the division of cardiology at the University of South Florida in Tampa, Fla., and an expert in arrhythmias. Dr. Curtis, who hasn't looked at Mr. Ernst's autopsy report nor any of his medical records, nor is she involved in any of the Vioxx cases, said it is potentially possible that a blood clot caused a heart attack, which then led to an arrhythmia, and ultimately death.

Since Vioxx causes blood clots, this is undoubtedly the direction plaintiff's counsel is heading in Texas. Links to the Wall Street Journal articles are unfortunately not available. My collected Vioxx posts are here.

Comments

[guest]

Wow, there's some lawyer logic for you. The simple fact is that when thousands of patients who took Vioxx were examined, there was no increased risk of arrythmia. End of story. Trying to go back and link them because they share a risk factor (blood clots) is a common but quite flawed technique. Beer doesn't cause one to lose weight. People who drink beer tend to keep high carbohydrate diets. High carbohydrate diets may cause one to lose weight. Beer causes one to lose weight, no? The vioxx jury (as most juries) *didn't* look at the evidence. They played the Kevin Bacon game

[Evan]

I'm a lawyer, but you don't have to disagree with me--I'm just repeating what a doctor who specializes in arrhythmias says. Your speciality appears to be beer. Now, as a specialist in beer, tell me: what long term clinical study was it that was designed to determine whether there was an association between the use of Vioxx and the development of arrhythmias leading to sudden death?

Actually, I'll just answer the question for you--there wasn't one. That being the case, do you have some better data on which to rely besides a study that never happened? And since you seem to know how the jury reached its decision, can you tell us what evidence of case-specific causation was actually presented at the trial--or are you just repeating something you read in a newspaper?

[guest]

Umm, actually, just look at the original New England Journal of Medicine article (March 17 2005)that started all this hub-bub. Of the placebo, 200, and 400 mg patients followed for an average of three years at the Brigham and Women's hospital, absolutely no suggestion of an increased risk of sudden cardiac death due to arrythmia. Oops. I have a very good idea how the jury reached their decision. Awww shucks that folksy sounding trial lawyer just must be telling us the truth...

[Evan]

Thank you for returning to good-naturedly answer my question. That study you are referring to is titled "Cardiovascular Risk Associated with Celecoxib in a Clinical Trial for Colorectal Adenoma Prevention" (NEJM 3/17/05). It was a retrospective study, not a long-term clinical study. More importantly, it dealt with Celebrex, not Vioxx. Celebrex is a different drug with a different chemical structure and a different chemical pathway.

[Jeff]

I'm confused. You state:

"what long term clinical study was it that was designed to determine whether there was an association between the use of Vioxx and the development of arrhythmias leading to sudden death?

Actually, I'll just answer the question for you--there wasn't one."

Does that mean juries are meant to infer that there is
a connection, when no long term clinical study exists to support it?

Also, I'm not a subscriber to NEJM. Can you post the article
to the blog. Thanks in advance.

[Evan]

Jeff: I'd like to post the article for you, but that would be a copyright violation. You can probably get an abstract for free on the NEJM cite.

My point was that the commenter was using a study to prove his point about arrhythmias and Vioxx that didn't exist. When I asked him for one, he pointed me to a Celebrex study. In fact, there has never been a long-term clinical study to assess cardiovascular risks, including arrhythmias, of Vioxx. Merck didn't do one. The studies that *do* exist show an association between the use of Vioxx and the development of clotting events, even though they were not designed to assess the amount of that risk. In specific cases, a jury has to be presented with evidence from a medical doctor who reviews the medical records, rules out other causes, and concludes Vioxx caused or contributed to the event.

[Ted]

It's certainly "possible" that a blood clot caused a heart attack caused an arrhythmia. It's also possible that Vioxx caused the blood clot, though it's also possible that Ernst's running dislodged plaque in his arteries that then ruptured and caused a heart attack and arrhythmia. And it's possible that Ernst had an arrhythmia without a heart attack at all. From Dr. McCaughey's op-ed in the Wall Street Journal:

Before the trial began, according to the New York Times, Mr. Lanier knew that the autopsy was a problem, and he told his legal team that he was going to "browbeat" the pathologist into supporting his theory linking Vioxx to Ernst's death. How plausible is that theory? "To say that Vioxx did it because a blood clot you didn't find caused a heart attack that left no evidence of heart muscle damage is absolutely speculative," says Dr. Jeffrey Borer, chief of Cardiovascular Pathophysiology at Weill Cornell Medical College. According to an expert on arrhythmia, Dr. John Somberg, professor of Medicine and Pharmacology at Rush Medical College in Chicago. "It is more likely that [Ernst] had a primary arrhythmia" without suffering a heart attack first. Blaming the death on Vioxx, he says, "is very far fetched."

[Evan]

Ted: As you point out, a couple of doctors came forward after the trial and got their names in the Wall Street Journal by doing some Monday-morning-quarterbacking. The portion of the WSJ Op-Ed you cite includes quotes from a cardiologist and a pharmacologist. Neither of those doctors reviewed Ernst's medical records, as did the doctor who testified for the plaintiff at the trial, Dr. Isaac Wiener. Dr. Wiener is board certified in internal medicine, cardiology, and cardiac physiology, the study of irregular heartbeats. He graduated from Harvard Medical School and now teaches at UCLA. He did review Ernst's medical records, and he concluded, after ruling out other possibilities, that Vioxx caused a blood clot that blocked the flow of blood to Ernst's heart and led to his sudden death.

You think it might have been Ernst's running that did him in, but remember, he died in his sleep.

[Ted]

I'm not contesting Dr. Wiener's resume. But expert evidence, even in Texas, is supposed to have a basis beyond "Because I say so." Wiener's definitive answer of "yes" to the question of whether Vioxx was a cause of Ernst's death was not a scientific one. When questioned on the science, he testified that he couldn't say with a "reasonable medical probability" that Ernst had a heart attack—after which his original unsupported opinion should have been tossed from the case. There isn't even a Bayesian basis to argue that Vioxx caused the death.

[Evan]

Ted: That Dr. Wiener wouldn't agree with Mark Lanier, the plaintiff's lawyer, on the question of the heart attack during Lanier's direct examination is a sign that Dr. Wiener was independent and unbiased. Why do you think his answers are unscientific and unsupported? Why do you think that after he presented testimony about the science of blood clots, heart attacks, arrhythmias and sudden death, then tied that science specifically to Ernst's case based on his review of the medical records, ruling out other possible causes along the way, that his opinion should have been "tossed from the case"?

[Ted]

It's called a non sequitur, and it doesn't matter whether it's a Nobel-Prize winner on the stand: if the conclusion doesn't follow scientifically from the evidence presented before it, it's conclusory, it's not "helpful" to the jury, and it's inadmissible. Thousands of people die annually from unexplained sudden cardiac death and primary arrhythmia, so Wiener couldn't possibly have "rul[ed] out [all] other possible causes," if only because he doesn't know the universe of possible causes, as he admitted on cross-examination. "Reasonable probability cannot be created by the mere utterance of magic words by someone designated as an expert."

[Evan]

Ted: You say Wiener's conclusion "doesn't follow scientifically from the evidence presented before it." But you don't say how or why the conclusion doesn't follow, except that in your opinion, Wiener couldn't have ruled out other causes. I don't agree with that. You also make the point that "[t]housands of people die annually from unexplained sudden cardiac death and primary arrhythmia," which I think is an overstatement--the deaths might have been unexpected, but they can be explained. But even if you're right about that, the point doesn't add to the debate about the Ernst science. Dr. Wiener didn't have to explain thousands of unexplained deaths, but only Ernst's. In Wiener's opinion, that death could be explained: it happened as the result of a blood clot that lodged in one of Ernst's already-restricted arteries and cut off the flow of blood to a portion of Ernst's heart, causing the deadly arrhythmia. The best explanation for the blood clot is that it occurred because Ernst was taking Vioxx--even Merck admits an association between the use of Vioxx and the development of blood clots. Despite all this, you still claim Wiener's testimony was too speculative and too unscientific for the jury to hear. As it happened, the trial judge disagreed with your position. Perhaps on appeal, the trial judge will be reversed on these issues and your position will be proven correct. If not, you'll be left to argue that Texas law is too lax on the admission of causation evidence in pharmauetical products-liability cases. Maybe that's the point you've been making all along.

[Aaron]

Being referred here after posting a somewhat off-topic comment to a related discussion, and hoping that somebody is still reading this....

From what I have read, the "tort reform" focus on the Vioxx trial has been focused largely on the jury - essentially, "What a silly jury, that didn't even know that Vioxx can't cause arrythmias." Leaving aside for the moment Evan's response to that contention, I am curious as to what motions the defense brought in relation to the plaintiff's testimony, or in an effort to obtain summary disposition in the case, and how the judge ruled on those motions. (Obviously, the testimony was presented and the case went to trial, so in terms of the judge's ruling I am interested not in the obvious, but in the factual and legal grounds the judge recited as a basis for his rulings.)

[Jeff]

If the search is for the "truth", why not empanel jurors that have more training in science, statistics or medicine? That would seemingly minimize the importance of court room theatrics (like Lanier's Oprah appeal), and provide credibility to the outcome.

[Aaron]

Why are you assuming that "theatrics" play a significant role in jury decisions?

The Oprah example is pretty weak - you don't think lawyers will get to know the personalities and preferences of more specialized juries? You think that training in medicine, science, or statistics will make jurors humorless, such that they won't laugh at jokes?

[Matt]

"The Oprah example is pretty weak - you don't think lawyers will get to know the personalities and preferences of more specialized juries? You think that training in medicine, science, or statistics will make jurors humorless, such that they won't laugh at jokes?"

I thought only representing insurance companies could do that.

[Ted]

The problem with the Oprah reference wasn't that it was a joke, it was that it was dead serious.

[Evan]

Ted: As I understand the Oprah reference, Mark Lanier told the jury during his closing that they should send a message and that people were listening, but "I can't promise it will get you on Oprah." As he said the Oprah line, he smiled at the juror who'd mentioned watching Oprah on her jury questionnaire.

Some people would call that a joke. The people who probably wouldn't call it a joke are the deadly-serious Merck lawyers who were also in the courtroom at the time. They were too busy fuming about how that damned plaintiff's lawyer had just made a juror smile again.

[Evan]

Ted: I looked it up. According to press reports, Lanier said, "I can't promise Oprah." I don't agree with the previous commenters that that line was "an appeal" or constituted "theatrics."

[Jeff]

Evan-I would appreciate your opinion...

If both sides need to approve the selection, why would anyone be against some minimal scientific, medical, or statistics training to serve on a Vioxx jury? Or even economics training, to help decide damages.

[Evan]

Jeff: I don't think that any lawyer would be "against" educated jurors. But if you are saying that our democracy should prohibit certain voters from sitting on juries, there you would get some disagreement.

At the Ernst trial, both sides had lawyers and expert witnesses to explain their respective positions to the jury. I disagree with the notion that any of the jurors were too uneducated to understand, or that a jury of 12 college professors would have necessarily reached a different result.

[Jeff]

Thanks for your answer. That is an experiment I'd love to see run.

Has any legal scholar attempted to run a double blind study, contesting the same case with all variables controlled (counsel/judge/...) except the the education and training of the jury?

Or maybe looking at outcomes (verdict, damages) and the R squared attributable to jury background? Admittedly, correlation is not causation but it would be fascinating to see if education correlates with the verdict and size of damages.

[Ted]

I know what Lanier said about Oprah, and you know that I know, because I quoted it at the panel. I also know what jury consultant Lisa Blue told Lanier about Oprah, which is what led him to use the remark: "This jury believes they're going to get on Oprah. They only get on Oprah if they vote for the plaintiff."

It's effective spin on your part to characterize this solely as a joke, but it isn't accurate to say that. If it's funny, it's funny because it's true: Lanier was offering the jurors fame in exchange for a big-number vote, and, sure enough, Lanier was right when the media gave every juror who wanted it extensive television time. That's an impermissible argument in any courtroom I'm running, and just shy of jury tampering.

[Evan]

Ted: "Just shy of jury tampering"? That's a bit of an overstatement. I wonder if Merck's lawyers even bothered to object. I'm sure they didn't notify any prosecutors or file any bar complaints.

As for Lisa Blue, with all due respect to her, there was no way for her to know whether or not the jurors wanted to appear on Oprah. Only one juror mentioned Oprah in the jury questionnaire. Blue was making an educated guess. Not only that, but she was speaking metaphorically. Since then, her comment has been blown out way out of proportion. I think many people are under the impression that all the jurors said they wanted to be on Oprah. That's not what happened.

Merck will get it's turn in New Jersey. I read commentary by someone or another who pointed out that in the next trial, the only way to get on Oprah will be to rule in favor of Merck. I'll watch to see if Merck's lawyers engage in any "jury tampering" in their next closing argument.

Also, for the record, I hope one day to get on Oprah.

[Aaron]

Ask about substantive issues, such as pretrial motions and how the judge ruled, and the defense attorneys and tort reform advocates provide... the sound of silence.

But gosh, one little comment about Oprah to the jury and they'll seemingly expound until the end of time about how it ruined the defendant's chance at a fair trial.