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August 23, 2005

Vioxx Verdict II

Jane Galt notes just how deeply disturbing the $259 million judgment against Merck is. Quoting from the WSJ:

Merck argued that Vioxx couldn't have caused Mr. Ernst's death because, according to his death certificate, he died of an arrhythmia or irregular heartbeat, not a heart attack. While scientific evidence suggests Vioxx can promote blood clots leading to a heart attack, no data have linked the drug with arrhythmias.

Jurors who voted against Merck said much of the science sailed right over their heads. "Whenever Merck was up there, it was like wah, wah, wah," said juror John Ostrom, imitating the sounds Charlie Brown's teacher makes in the television cartoon. "We didn't know what the heck they were talking about."

Jane continues, "jurors were swayed by things that simply shouldn't have been a factor--an irrational belief that the CEO should attend the case (Merck is sued hundreds of times a year; should the CEO stop running the company so the jurors can feel special?), and even more disturbingly, a desire to get on Oprah. You only get on Oprah if you find for the plaintiff." (Yet more proof that Oprah is a blight on American culture.)

It may be hard for the public to grasp just how a quarter-billion dollar verdict hurts them, but it does, both generally by curbing the productivity of industry and particularly by providing a disincentive for pharmaceutical companies to market drugs that make life better. What's more, Radley Balko notes that litigation can cause companies to settle prematurely, before science has caught up to the allegations in a rush of suits.

But the larger issue is that juries simply aren't capable of providing justice in cases where the details require expertise and high intelligence. So long as such questions are put before incompetent juries (and I don't mean to sound nasty), we will have perverse judgments like the one on Vioxx.

Posted by Zach Wendling at August 23, 2005 09:15 AM

Comments

Didn't Merck's lawyers have a say in voir dire?

Blame the ones Merck paid the big bucks for before you blame the ones they chose.

Posted by: Anonymous at August 23, 2005 10:46 AM | permalink

Yes, but the jury did hear testimony from the pathologist who performed the autopsy that the arrhythmia was likely caused by a heart attack.

I consider that fact aside from whether the case was adequately proved and entirely separate from whether such a huge award is moral, ethical or legal.

However, the post makes it appear that no evidence of heart attack was introduced by expert testimony, when it was. I find that very misleading, to say the least.

Posted by: Joel Thomas at August 23, 2005 12:12 PM | permalink

Yes, the pathologist speculated four years after her examination, of which she couldn't recall the specifics, that Mr. Ernst had suffered a heart attack, caused by a blood clot which she didn't find.

Meanwhile, Dr. Craig Pratt, director of research at the Methodist DeBakey Heart Center in Houston, testified that Vioxx was not at fault in the death, and that the arrhythmia was caused by clogged arteries.

If you're a juror, who are you going to believe? Does the pathologist's testimony meet the standard of proof required in a civil trial ("preponderance of the evidence," I believe)?

Posted by: Eric Seymour at August 23, 2005 12:28 PM | permalink

Eric,

I agree but I still think it is misleading to put forward just one side. Both sides can be put up and then just explain why the pathologist's testimony shouldn't carry any weight. It is one thing to argue that the other side's evidence isn't credible. It is quite another to imply that they didn't offer it at all.

Finally, with respect to both sides, expert witnesses were presented who could hardly be called anything close to impartial. That does make a jury's deliberations more complicated.

Posted by: Joel Thomas at August 23, 2005 12:51 PM | permalink

Had Merck merely produced a product that caused heart problems in a small number of people, as appears to be the case with Vioxx, it wouldn't have anything like the problem on its hands it does today.

Merck screwed up in an epic way by ignoring risks of which it was aware, pressuring other researchers to look the other way, and aggressively marketing its product.

Frankly, it strikes me as dishonest to ignore this aspect of the case when complaining about the size of the verdict. Some background:

"Mr. Lanier [plaintiff's attorney] offered jurors a trove of company documents and e-mail messages that revealed how Merck researched Vioxx's heart risks and presented what it knew to doctors and consumers. The documents showed that scientists at Merck were worried about Vioxx's potential cardiovascular risks as early as 1997, two years before Merck began selling the drug.

"The possibility of increased C.V. events is of great concern," Dr. Alise Reicin, a Merck scientist, wrote in a 1997 e-mail message; "C.V. events" is scientific shorthand for cardiovascular problems like strokes or heart attacks. "I just can't wait to be the one to present those results to senior management," Dr. Reicin's message continued.

The documents also revealed that Dr. Edward M. Scolnick, who at the time was Merck's top scientist, said in March 2000 that the largest clinical trial ever conducted of Vioxx confirmed that Vioxx had heart risks, as he had feared. They showed Dr. Scolnick later referring to scientists at the Food and Drug Administration as untrustworthy. And they revealed that Merck had stridently resisted the F.D.A.'s efforts to add warnings to Vioxx's label, and that it eventually complied only in ways that the Texas jury found unacceptably obscure. ("You had to dig three levels to see it," one juror, Lorraine Blas, said of the potential heart problems described in one version of the drug's labeling material.)

Mr. Lanier also introduced a marketing videotape that showed Merck sales representatives being trained to view doctors' concerns about Vioxx's heart risks as "obstacles" to be avoided or dismissed. Another marketing document taught representatives to play "Dodgeball" when doctors voiced concerns.

. . .

The $229 million punitive damages figure was not picked at random, but referred to a 2001 Merck estimate of additional profit the company might make if it could delay an F.D.A. warning on Vioxx's heart risk.


Posted by: Doug at August 23, 2005 01:26 PM | permalink

Oops, forgot to give a cite for that quoted material:
It was from yesterday's New York Times.

Posted by: Doug at August 23, 2005 01:27 PM | permalink

And, in retrospect, I was hasty with that "dishonest" remark. I don't have any idea what considerations went into the analysis. As a blogger myself, I should know better than to read anything into things that might not make their way into a post.

Let's just say that I consider any analysis of the Merck verdict unhelpful if it does not include consideration of the role of Merck's actions with respect to prior evidence of heart problems caused by Vioxx.

Posted by: Doug at August 23, 2005 01:46 PM | permalink

Tort lawyers are very adept at presenting information out of context in a way that will prejudice the jury against their target. For instance, anyone who is familiar with the process of testing drugs for safety and efficacy knows that a lot of drugs show signs of dangerous side effects (see Derek Lowe for an insider's perspective on that). The fact that Merck scientists were discussing C.V. risks is a sign of a group of researchers who really are concerned about the safety of their drugs, not sweeping it under the rug.

I haven't seen the "Dodgeball" documents myself, but as I understand it the "dodge" was an element of a game used to train sales reps on discussing sometimes-conflicting study results with doctors. It was a game element that allowed the player to pass on that round, *not* training employees to "dodge" doctors' questions.

Posted by: Eric Seymour at August 23, 2005 01:52 PM | permalink

I might also point out that material such as Doug references was leaked to the media *before* the trial, which is an ethically dubious, if not illegal, tactic.

Posted by: Eric Seymour at August 23, 2005 01:55 PM | permalink

Last night on the NewsHour, one of the suburban white jurors from a Republican district in Texas said their verdict (and $229 million in punitive damages) was actually intended to "send a message" to Merck regarding that company's aggressive marketing of a possibly risky medication.

I suppose we'll be hearing all about "activist juries" now...


Posted by: JohnS at August 23, 2005 02:06 PM | permalink

There is nothing wrong with the analysis done here by Zach. It is not any more one-sided or biased than anything you read from the New York Times. Certainly you are able to read other blogs that fit your particular liberal slant, if you don't like the way Zach opines on the subject.

Posted by: JasonS at August 23, 2005 03:49 PM | permalink

Maybe it's no better or worse, but it's still not useful, imho. It appears clear that the jury hammered Merck specifically because of Merck's response to the information it had. The $229 million came straight from a 2001 Merck estimate of additional profit the company might make if it could delay an F.D.A. warning on Vioxx's heart risk. If you're going to take the jury to task for what wasn't on their mind (the strength of the evidence supporting Vioxx as the actual cause of death, apparently), I think it's necessary to address what was on their mind: Merck's behavior in limiting public awareness of the potential dangers of Vioxx. This wasn't a case where jurors simply pulled a really big number out of thin air because they felt sorry for someone. Apparently they used business estimates to penalize Merck for its business behavior.

Simply critiquing the jury for being too stupid to understand science seems to ignore the possibility that the jury was willing to give the Plaintiff the benefit of the doubt on the science because they found Merck's behavior so reprehensible.

Posted by: Doug at August 23, 2005 04:03 PM | permalink

Why in the world would I only want to read blogs that fit my "particular liberal slant?"

I was attempting to make a point that these jurors appeared to be more interested in the nontrivial " evidence of cover-ups and so on at Merck" than the science. Perhaps they came to a more just conclusion than a jury of experts would have.

But Zach didn't like the verdict, and so would evidently like to consider a reevaluation of the meaning of "jury of your peers," at least regarding Merck. The last thing I would personally like to see is some sort of judicial peer review of industry pros "passing judgement" on their fellows at Merck, or General Motors, or negligent scientists at Los Alamos, for example.

Thanks for letting me share my opinion.


Posted by: JohnS at August 23, 2005 04:29 PM | permalink

a 2001 Merck estimate of additional profit the company might make if it could delay an F.D.A. warning on Vioxx's heart risk.

As I understand it, this information was also presented in an out-of-context and prejudicial fashion. Merck was in discussions with the FDA regarding data from a trial (see #9) that showed both fewer ulcers but more heart attacks versus people taking naproxen. Merck *wanted* this data to be included in the labeling because of the reduced ulcer risk, but also wanted to claim the increased heart attack risk was because naproxen protects the heart (which it does seems to do, because when you compare Vioxx to placebo, the increased heart risk is less than when comparing it to naproxen).

In the context of this, it is the sales and marketing department's job to forecast what the impact on sales would be under various scenarios. That is the context of the 2001 estimate, which has not been reported. It was not a case of Merck officials saying "Gee, we hope we can hide this information for a few more months and make more money."

Posted by: Eric Seymour at August 23, 2005 05:42 PM | permalink

One more thing. Derek Lowe has three good posts from August 19 and 21 regarding Merck and Vioxx.

Posted by: Eric Seymour at August 23, 2005 05:45 PM | permalink

It's so hard to feel bad when a corporation -- whose very purpose for existing is to comfortably shield powerful, rich people from liabilty -- for once may have gotten a raw deal.

A corporate trial costs the government and taxpayers massive amounts of money to administer, as it's dragged through years of litigious stalling and wrangling. All to find justice for an entity that isn't even human. Compare that to the resources spent on the average indigent criminal trial. Compare possible product liability verdict injustice to the racial imbalance of death penalty verdicts in America, and the amount of print spent on each. There's no contest -- large corporations get ten times the justice of most human beings in the court system in this country.

Further, it's incredibly expensive to even attempt to bring a legal challenge to a large corporation's misdeeds, because of the massive legal guns they have loaded and ready to fire at the slightest threat. Many meritorious claims against corporations by people with few resources die pathetic deaths, smothered by corporate litigation tricks and strategies.

The fact that once in a long while a corporation might have failed to get complete justice, considering what wonderful protection our legal system provides rich property owners (who corporations exist solely to protect, anyway) just doesn't get my sense of injustice fired up. Sorry.

But of course, I'm a liberal -- I care about people, and don't shed tears for corporations corporations. That's always kinda made me an oddball around hear. I now return you to your regularly scheduled programming of weeping for these imaginary citizens.

Posted by: Phil at August 23, 2005 08:19 PM | permalink

Phil, there's a reason the arguments against such verdicts is usually framed much morein terms of negative consequences for society (fewer drugs, etc.) than in terms of justice for the company.

As for the testimony about the causation, I haven't seen anything yet that really shows that no reasonable & well-informed jury couldn't have weighed the different testimonies presented & decide that preponderance lay in the plaintiff's favor. Second-guessing their judgments is not the same as showing those judgments to be unreasonable.

Posted by: philosopher at August 24, 2005 03:04 AM | permalink

Well, Phil, this particular case was brought by a private citizen (and her multimillionaire trial lawyer), so the costs to the government were overall probably less than the average trial of a person accused of a felony (no need to pay the DA and public defender's salaries).

And as for corporations, they are no more or less than the combined investment interests of a large number of people. Some of them are wealthy, but some are regular people who have investments in stock (either directly or through mutual funds). When Merck's stock dropped 8% on Friday, a lot of senior citizens who worked hard throughout their lifetime saw a measurable drop in the value of their retirement portfolios.

And then there's the people who work for corporations. If you take down a corporation, lots of good people are suddenly out of jobs. So you really can't say that you care about people but you hate corporations. Because corporations are made of people, they have the same attributes people do. Some are good citizens, and some are not. I believe they deserve to be judged on an individual basis.

Posted by: Eric Seymour at August 24, 2005 09:01 AM | permalink

Before you go crazy on the harm such a verdict does to the drug industry and through them the larger society, you may want to take a peak at the Economist's article on the verdict, touting it as a potential cure to the drug industries woes.

In the end, this jury which took more time than any of us will to examine the case may have made a better judgement of judging thid individual company's actions in this individual case than any of us can from reading an article here or there. In my world, the jury's $229 million dollar settlement is cause for far less consternation than the estimate for additional profits garnered by delaying FDA action kicking around Merck. If we expect companies to be good citizens on an individual basis, defending them in the name of poor pensioners, than we need to hold them to higher standards than valuing profits far beyond the value they place on human life.

Posted by: Peter at August 24, 2005 10:29 AM | permalink

"And as for corporations, they are no more or less than the combined investment interests of a large number of people.

. . .

Because corporations are made of people, they have the same attributes people do."

One of the primary functions of a corporation is to shield individuals from personal responsibility. Corporations are also potentially immortal. And, on the flip side, they can be dissolved when the going gets tough and the individuals who own them can set up a new corporation and go back to doing what they were doing. Finally, corporations have no physical manifestations that can be thrown in jail.

All of these things make corporations, and dealing with malfeasance by individuals working for corporations, different than the same actions performed by individuals working in combination but without a corporate shield from personal responsibility.

Posted by: Doug at August 24, 2005 02:32 PM | permalink

Bear in mind that Merck is the Gold Standard for that whole industry. No drug company does it better.

Posted by: Anonymous at August 24, 2005 06:29 PM | permalink

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