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November 16, 2006

Merck's Latest Win

A New Orleans federal jury took only 90 minutes yesterday to clear Merck in the latest Vioxx trial. The verdict brings the scorecard ($) to Merck 6, plaintiffs 4. While there are still 24,000 more cases to go, I don't think the record is going to get that much better for the plaintiffs.

Merck's conduct in marketing Vioxx was patently awful, and the drug was demonstrably dangerous. But it's easy to say that Vioxx caused 100,000 deaths a year; it's nearly impossible to identify precisely which ones. Historically, plaintiffs have tanked before juries when their drug-related injuries were also common afflictions among non-drug users. Parlodel is the classic case. The drug company marketed the drug to post-partum women to suppress lactation. There was a lot of evidence that Parlodel can cause strokes, but so does just having a baby. When the cases got in front of juries, the drug company won most of them. (They also kept a lot of the scientific evidence out as well, but that's a different issue.)

One reason fen-phen litigation was so successful was that the diet drug caused a really specific and rare disease, primary pulmonary hypertension, so it was easy to see the causation. But Vioxx causes heart attacks and strokes, the leading cause of death in this country. Nearly 60 percent of all Americans die of something related to cardiovascular disease.

Looking at the profiles of some of the Vioxx plaintiffs, it's easy to see why Merck has chosen to fight them. Charles Mason, the 64-year-old Utah man whose claimed Vioxx caused his heart attack in the latest federal trial, was 5 foot 9 and weighed 228 pounds. Mason was clinically obese, but his lawyer told Bloomberg, "None of his treating physicians ever considered him at high risk for cardiovascular disease.''

It sounds like Mason had a good case--for a malpractice claim. But his Vioxx suit seems pretty weak, given that obesity is a well-known contributor to heart disease and one that the jury was no doubt familiar with. Maybe the plaintiffs' lawyers have a bunch of skinny, 25-year-old stroke victims waiting in the wings, but if they don't, I suspect that in the end, the Vioxx litigation is going to be a pretty big washout.

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"But it's easy to say that Vioxx probably caused 100,000 deaths a year"

Well, it's easy to say it, but only if you don't care that it's an outrageous claim that has no basis in reality. The most exaggerated academic claim yet was David Graham's Lancet piece, which cherry-picked data to come up with a figure of an additional 7000 heart attacks (not heart attack deaths) a year; while that figure was in the text of Graham's paper, Graham's own data showed a figure much lower that wasn't even statistically significant.

Merck has won more than six Vioxx cases, incidentally, even if you don't include Humeston.

Mason's case was especially weak because he wasn't even taking Vioxx. Something that has not been an uncommon fact scenario in the cases brought to trial or almost brought to trial to date.

To correct myself--Graham theorized 22000-35000 excess heart attacks/year in Lancet using cherry-picked data. His original paper for the FDA using his own data (rather than the dataset most favorable to a big number) found 7000 excess heart attacks/year, but the number wasn't statistically significant. Nowhere near the numbers Mencimer posits, and Graham is Vioxx's worst critic.

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