The Case Against "The Case Against Merck"

James Hamilton slams the prosecution:

I took a look at one of the studies on which the decision was justified, written by Dr. David Graham and co-authors and published in Lancet in February. This study looked at 8,143 Kaiser Permanente patients who had suffered a heart attack and had also at some point taken a nonsteroidal anti-inflammatory drug (NSAID), of which Vioxx (rofecoxib) is one. Of these patients, 68 were taking rofecoxib while 4,658 were receiving no medication at the time of their heart attack, a ratio of (68/4658) = 1.46%. For comparison, the study looked at 31,496 other patients who had also at some point taken an NSAID, matched for characteristics like age and gender with the first group, but who didn't have a heart attack. The ratio of rofecoxib users to those with no current medication was slightly lower (1.05%) in this second group, which one might summarize as a (1.46/1.05) = 1.39-fold increase risk of heart attack from taking rofecoxib compared to no NSAID. Is that statistically significant, in other words, can you rule out that you'd see a difference of that size just by chance? Yes, the study claimed, but just barely.

On the other hand, this was not a controlled experiment, in which you give the rofecoxib randomly to some patients and not others in order to see what happens. Rather, something about either these patients or their doctors led some of them to be using rofecoxib and others not. Dr. Graham and co-authors looked at a variety of indicators that suggested that the rofecoxib patients already had slightly elevated risk factors for coronary heart disease. Once they controlled for these with a logistic regression, their study found an elevated risk factor of heart attack for rofecoxib takers of 1.34, which was not statistically significantly distinguishable from 1.0.

The strongest evidence from this study was a claimed dose-effect relation. Of these 68 rofecoxib-using heart-attack patients, 10 of them were taking doses above 25 mg per day. Only 8 patients in the much larger control group were taking so high a dose, implying an elevated risk factor of 5 to 1 for high-dose patients. Again observable risk factors could explain some of this, with the conditional logistic regression analysis bringing the implied drug-induced risk down to 3 to 1. According to the study, this elevated risk factor was still statistically significant, even though the inference is based on the experience of just 10 patients.

Sounds compelling...but I wouldn't look towards science and logic to win a case like this.  Especially when you had jurors like these:

"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."

And on the subject of an Autopsy which sowed the patient died from arrhythmia as opposed to a blood clot:

As they assembled around a rectangular wooden table in the jury room, the question of causality -- did Vioxx kill Mr. Ernst? -- caused little trouble for the jurors. The coroner who did the autopsy of Mr. Ernst testified he could have had a blood clot that caused a heart attack but disappeared by the time of the autopsy. That would explain why the death certificate only mentioned arrhythmia.

That speculation about a blood clot was enough for Matthew Pallardy, a 24-year-old juror. "We kind of figured there was one there, but it went away real quick," said Mr. Pallardy. The issue "wasn't a snag. It wasn't a very big debate." Another juror, Derrick Chizer, said as long as the clot existed "for a millisecond" that was enough.

If these jurors are representative of the level of sophistication of jurors around the country, I wonder how Merck will win a single case.

Comments

[nathan steyn]

You can blame Enron, Bernie Ebbers and the widening pay gap between executives and the average worker for this.

The real America is fed up. Big business, which they feel has screwed them in so many ways, is going to be "sent a message."

The surprising thing is that the top brass at Merk, Wall Street and the lawyers didn't see this coming.

Shows how far removed they are from reality.

[william c. owen]

I am plaintiff's lawyer and I am shocked by this verdict. This resulting trend will take Merc down. The only question will be whether reorganization under Ch. 11 can occur quick enough to save the company. Congress needs to prescribe a "clear and convincing" evidentiary standard for every risk factor which was made known to the FDA and presumably weighed and approved by it. A functional tort system can't survive roulette risk assessment of the type illustrated by this verdict.