A Stitch in Haste

The first Vioxx judgment against Merck is in, and it's ugly: (WSJ - $)

The jury awarded awarded the man's widow $24 million in actual damages, plus $229 million in "exemplary," or punitive damages, for a total of about $253 million.

A jury of seven men and five women ruled against Merck on each of three key questions. They found Merck failed to warn doctors of the Vioxx's danger, that the drug was improperly designed, and that Merck's negligence caused Robert Ernst's death.

The first question, failure to warn, is a perfectly valid allegation to make against a pharmaceutical company or any other manufacturer. See Restatement of Torts (Third), Section 10.

The second question, defective design, is almost totally untenable in the pharmaceutical context and certainly not applicable to Vioxx or the other COX-2 inhibitors.

I discussed this issue on November 15, 2004, in a blogpost titled, COX-2: "Heart Attack for an Ulcer." I am reposting it below.

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Merck 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 minuscule. 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.

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I think Merck will be subject to enough liability just for the failure to warn claims (there are already something like 4,000 Vioxx lawsuits, and undoubtedly countless more will be filed once personal injury lawyers start airing "Have you or a loved one..." commercials with "$253 million" in a huge font across the screen.

So be it. But let's not bankrupt the company, as some lawyers will undoubtedly seek to do, by adding on frivolous "defective design" actions. Vioxx may have been defectively labeled, but it was not, and could not possible have been, "defectively designed."

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Meanwhile, Point of Law Forum discusses the nature of the damages award.