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'Duty to warn' at heart of Vioxx suits




Litigators are circling like alligators around the quivering drug company Merck. Estimates of what Merck ultimately might have to pay people who used its pain pill, Vioxx, rise every day: $50 billion is the highest bid so far. Two weeks ago, in the first case to come to trial, a Texas jury awarded Carol Ernst $253 million over the death of her husband. She might get a mere tenth of that. But there are nearly 5,000 Vioxx lawsuits. Just type "Vioxx" into your favorite Internet search engine to see why that number could rise to 20,000.

Merck has set aside $675 million just to cover its legal expenses. But the lawyers collect from both sides. If Carol Ernst gets $25 million, about $8 million of that -- the traditional one-third -- will go to her lawyer, Mark Lanier. Lanier says that after he pays off the law firm that turned the case over to him, plus other expenses, he'll be "lucky to get 10 percent." Shucks.

You might be under the impression that Merck did something terribly wrong in putting Vioxx on the market. But the Vioxx cases don't generally claim that.

Instead, they are based on the last refuge of the tort lawyer: the "duty to warn." Any product carries some risk. If you slice up a beach ball, saute it and eat it, the consequences could be dire. But even the world's greatest lawyer would hesitate to argue that this is the fault of the beach ball manufacturer. That doesn't mean the lawyer won't take your case. He or she will take it and argue that the manufacturer should have warned purchasers that beach balls are not edible, cooked or raw.


The duty to warn is one of the law's great celebrations of hindsight. When something actually has gone wrong, it is hard to argue (especially to a jury) that this development is too unlikely to worry about. And it is nearly impossible to argue that consumers shouldn't be given information to decide for themselves.

Speaking for myself, I set aside one day a month exclusively for reading all the warning labels on products I have bought, such as beach balls. Then I assess whether the risk I am undertaking exceeds the benefit I hope to gain. But I wonder how many of my fellow citizens are so scrupulous.

I wonder, in particular, how likely it is that Carol Ernst's husband would even have noticed such a warning on the side of the box or bottle or speed-mumbled during one of those eerily atmospheric TV commercials for prescription drugs.

Or, if he noticed it, would he have acted? It might have saved his life, but only in the way that deciding to take a later flight has saved your life when the earlier plane crashes. There is no actual connection. The studies Merck is accused of ignoring suggest a small increased risk of a heart attack among people using Vioxx for more than 18 months. Robert Ernst had used Vioxx for only eight months, and he didn't die of a heart attack. He died of a different heart ailment known as arrhythmia. Lanier convinced the jury that the arrhythmia could have been caused by an earlier heart attack that left no trace.

The absurdities pile on. Everyone but a few extreme libertarians can agree that the government has a legitimate role to play in protecting us from dangerous prescription drugs.

But in our system, the government plays two conflicting roles. The Food and Drug Administration approves or disapproves a new pharmaceutical, weighing the trade-off between risk and benefit. And then the court system comes along and sees that trade-off differently. The fact that Vioxx was approved by the FDA carries little authority in Tort World, where thousands of juries in hundreds of courts of the 50 states will draw the line in other places.

Unnecessary product

Vioxx was a nearly unnecessary product. It came on the market in 1999 as an expensive alternative painkiller for people whose stomachs couldn't handle cheap pills such as ibuprofen. Merck's real offense was selling Vioxx to millions of people who didn't need the stuff. It did so by abusing the power of advertising, the reality of insurance and our national penchant for shortcuts in the pursuit of happiness. But the entire pharmaceutical industry is guilty on those charges, which apply to safe drugs as well as dangerous ones.

Then there is justice. Foreigners look with amazement on a society that gives Carol Ernst $17 million or so in trade for her 59-year-old husband -- more than he's worth to anyone else and yet almost insultingly inadequate to her -- and gives tens of millions to a few lawyers like Lanier, and is about to institute a transparently phony plan to provide prescription drugs that do work to people who need them, but with no money to pay for them.

X Kinsley is the Editorial and Opinion editor of the Times.




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