A Stitch in Haste

Sunday was not a good day for Merck, as it got a one-two punch from the New York Times and 60 Minutes, both of which smelled blood in the water and had major reports on the Vioxx recall, about which I have blogged previously.

No full-blown fisking here; I just want to focus on one dangerous meme in both reports:

NYT: "A heart attack in exchange for an ulcer is a poor treatment," said Dr. Ray, who is now consulting with lawyers suing Merck.

60M: "to have a medicine that's causing heart attacks and strokes is something that can't be tolerated," says [Dr. Eric] Topol.

Hogwash.

Of course, the sleight-of-hand behind these two quotes is the failure to put the risks from Vioxx (or any other pharmaceutical) into a probabilistic context.

We like to use the shorthand that a drug "causes" side effects. But in reality, the most that can typically be said is that a drug may increase the likelihood of a side effect. And the probabilities are often miniscule. If taking Vioxx increases your risk of suffering a heart attack from 1 in 10,000 to 3 in 10,000, then yes it "triples" the risk, but the risk remains extremely small.

So is the drug worth the risk or isn't it? The answer is, of course, "it depends."

Let's say you have a patient with severe rheumatoid arthritis who also has a history of serious gastro-intestinal illness but has no risk factors for heart attack or stroke. It would be totally inappropriate, both medically and legally, to say it is automatically and inarguably wrong to give that patient Vioxx.

I have blogged before about the law regarding defective drugs, but to review: A product is only "defective" for one of three reasons: defective manufacture (think "flu vaccine"), defective design or defective labeling (i.e., failure to warn).

In the case of pharmaceuticals, "defective design" has an extremely narrow meaning: "no reasonable health care professional would prescribe the drug for any class of patient under any circumstances."

Notice how the Vioxx opponents are trying to steer the debate in that direction by claiming that any increase in cardiovascular risk automatically makes a drug "unsafe" or "dangerous." That has never been the standard for product liability in pharmaceuticals, nor should it be.

Let me be excruciatingly clear on this: at first glance at least, it does look like Merck may be liable for Vioxx under the third prong of pharmaceutical liability (failure to warn / improper labeling). And perhaps liability will be found on other legal theories, especially fraud. But the plaintiff's bar must not be allowed to rewrite the law regarding defective design by parading a string of biased physicians who engage in hyperbole and histrionics by misstating the nature of pharmaceutical risk.

If Merck turns out to be liable under traditional legal theories, then yes, hang the company out to dry (I'm more concerned about hanging the plaintiffs out to dry -- see my previous post). But Vioxx's critics must be held to the same standard of intellectual honesty that they now claim Merck failed to maintain.

POST SCRIPT: Speaking of "blood in the water," check out this post from Overlawyered.com on the plaintiff bar's festive celebrations of, and preparations for, the pending Vioxx litigation.

UPDATE #1: The Wall Street Journal agrees with me...and welcome Point of Law Forum readers!

UPDATE #2: So do Reason Magazine and Jonathan Wilde of Catallarchy.

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Will Cell Phones Be the Next Product Liability Disaster?
Flu versus Bad Vaccine: Let the Public Decide