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Mistrial for Merck

December 12, 2005 at 12:00 AM EDT
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MARGARET WARNER: Jury deliberations had resumed for just 20 minutes this morning when a judge declared a mistrial in the latest liability case involving the former blockbuster painkiller drug, VIOXX.

The jury had been deadlocked for three days in this first federal trial on whether VIOXX caused heart attacks and strokes, and whether its manufacturer, MERCK, failed to disclose the risks to the public.

The mistrial comes in the wake of an editorial by the New England Journal of Medicine last week. That editorial accused MERCK of omitting key data from a report on a VIOXX clinical trial that the Journal published in 2000.

For more on all this, I’m joined by our health correspondent, Susan Dentzer.

Susan, first of all, the judge wasn’t talking and the jurors I don’t think are talking — but why do the attorneys think the judge declared a mistrial after what was I just think 18 hours of deliberation?

SUSAN DENTZER: Well, Margaret, in a federal case like this, the jury must reach a unanimous verdict. And the jurors had signaled, having started deliberating on Friday, the jurors had signaled to the judge as early as Saturday morning that they were deadlocked.

So the judge apparently let the deliberations continue Saturday and Sunday but concluded this morning that letting them deliberate any longer was not likely to produce any convergence among the jurors. If it was, it was going to be for a reason like everybody wanted to knock it off and go home and do their Christmas shopping and wasn’t going to be for a substantive reason that they had really bridged their differences so the judge concluded a reasonable amount of time had passed and it was time to declare a mistrial.

MARGARET WARNER: Now this does come on the heels of this very widely publicized New England Journal editorial, which criticized VIOXX and VIOXX researchers. Do the attorneys think it’s related in any way to the judge’s concerns perhaps about the publicity that that editorial which came out late last week received?

SUSAN DENTZER: It does not appear to be the case. The attorneys for the plaintiffs asked the judge to dismiss the case, to declare a mistrial on Friday because of the editorial that had appeared on Thursday.

The judge, however, did not do that and then waited until today to declare a mistrial so it seems to be unrelated.

MARGARET WARNER: Tell us a little more about the New England Journal editorial. I mean, were they accusing MERCK of essentially cooking the results of this study?

SUSAN DENTZER: This is very murky but the language of the editorial does seem to do that.

In effect, this all goes back to a trial that took place in 1999 and the results were published in 2000. The trial weighed the results of taking VIOXX against another group that was also in the trial that was taking another painkiller, naproxen, commonly sold in brands like Aleve.

Essentially what the trial results showed at least in the published version that made it into the New England Journal is that there was a four times greater risk of heart attack and stroke among the patients taking the VIOXX versus the patients taking naproxen.

What the Journal editorial last week said was that the MERCK authors had omitted from those results three additional heart attacks which included in the trial sample would have knocked that rate to five times the number of heart attacks and strokes.

Now what the Journal article said was that MERCK researchers had deleted some of this data from the diskette that was sent to the Journal for the publication.

MERCK has said that, no, in fact what happened was the MERCK authors were leaving out the additional heart attacks that occurred after a preset window that was going to bear on the publication. They then though went on to report those three additional heart attacks to the FDA so that by the time the Journal article was out in November of 2000, the FDA knew about these additional heart attacks and those results became broadly public in 2001.

MARGARET WARNER: How unusual is it for a prestigious journal like the New England Journal to go back and critique a study they printed now, they published five years ago?

SUSAN DENTZER: It’s unusual but it’s becoming increasingly common in this environment that has grown up the last several years as we’ve had several very profile — high-profile instances of drug safety issues like this.

And I suspect it will become more common in the future as people understand increasingly that a lot is riding on the publication results reported in these various journals about drug trials.

MARGARET WARNER: Because, again, they get a lot of publicity and then patients start asking the doctors for them.

Now we know, of course, that the companies developing the new drug, they pay for the study because nobody else even has the drug. But then if it goes to something like the New England Journal, how much independent or outside review, vetting, is there before they publish the study?

SUSAN DENTZER: There’s a lot of outside review. All of these journals are so-called “peer review journals” so that other researchers in the same field will scrutinize the data.

But on the other hand they can’t redo the trial so a lot is riding on the trust that is placed in the original investigators that they’ve collected — that they’ve first of all designed the study accurately, they’ve collected the data accurately and so forth and so on.

So there’s no completely foolproof way to keep misconduct from occurring in these publications but nonetheless I think they are scrutinized pretty heavily.

MARGARET WARNER: Now back to the MERCK — the trial involving VIOXX that was declared a mistrial today. As Jim announced in the News Summary there’s 7,000 of these lawsuits. Only two have been decided so far in state courts. Are all the plaintiffs essentially alleging the same thing?

SUSAN DENTZER: Well, they all allege that VIOXX caused the heart attacks and strokes in either the plaintiffs themselves if they’re still alive, or their loved one if the loved ones have deceased after — allegedly after taking VIOXX.

But there also are additional allegations in many of the suits: For one allegation that MERCK knew about the dangers of VIOXX and failed to warn the public until 2002 when the risks about VIOXX were included in the so-called “drug label,” the information that goes to doctors. Anybody who was taking VIOXX before that could argue and has argued certainly in these cases that they were not adequately warned about the risks. And other cases have alleged misconduct on the part of MERCK, that MERCK hid the data, misinformed doctors about the risk, and so on.

MARGARET WARNER: So what’s ahead for this particular case?

SUSAN DENTZER: This case is clearly going to be retried and there will be a conference with the judge and the attorneys for the plaintiffs and the defendants later this week to decide when. MERCK counsel said today they were very hopeful that that would happen as soon as February when more federal litigation is supposed to take place.

The bigger question though is: What’s coming down the line in terms of other cases that are going to be litigated particularly at the state court level? One very important distinction among the cases is: How long were the plaintiffs taking the drug? This is important because when the drug trials were announced in September of 2004 that caused MERCK to pull the drug off the market, essentially those results only emerged after patients had been taking the drug for 18 months.

So MERCK has in essence played that up and said, see, the risks occur, the doubling of the risks of heart attack and stroke occur after you have been on the drug for 18 months.

Well, in this case in which the mistrial was just declared, the plaintiff –

MARGARET WARNER: One month.

SUSAN DENTZER: — was only taking it about three weeks.

So in January we will see the first of these cases at the state court level where a plaintiff genuinely had been taking the drug for more than 18 months. This will go right to the heart of MERCK’s defense in this case and will be a very serious — if in fact the jury decides in favor of the plaintiff and not MERCK, it will be a very serious setback for MERCK.

MARGARET WARNER: Susan, thank you.

SUSAN DENTZER: Thanks, Margaret.