TCS Daily


What the Texas Jury Did to Patients

By John E. Calfee - September 8, 2005 12:00 AM

After a Texas jury awarded a quarter of a billion dollars to the widow of a man who died after taking the pain reliever Vioxx, jury members told the press they wanted to send the drug industry a message. Exactly what message did they send? Frankly, it's a little alarming.

Let's look at what happened. This litigation began with a drug that's very good but not perfect. It relieves pain. It prevents a lot of the ulcers that other pain relievers cause, ulcers that kill some ten to twenty thousand people a year. But every so often, this drug may cause heart attacks, although we don't know that for sure. And there is the crucial fact that these pills were mainly taken by the elderly, many of whom will have heart attacks anyway.

Next comes a plaintiff lawyer looking to make money suing pharmaceutical companies. He takes on a case involving someone who died not from a heart attack but from heart arrhythmia, which is a very different thing. Vioxx probably had nothing to do with that death because clinical trials found no connection between arrhythmia and Vioxx. So his first task was to convince a jury that a heart attack could have caused that arrhythmia. He succeeded because there were experts on both sides and under Texas law the jury was allowed to reach a conclusion even if they thought there was only a 51 percent chance they were right.

But even if there had been a heart attack, Vioxx probably didn't cause it. The FDA and its outside experts are persuaded that all of the standard anti-inflammatory pain relievers, including Advil and many prescription drugs, and not just Vioxx, may slightly increase heart attack risk. The causes of most heart attacks remain a mystery. But again, with a battle of experts in the courtroom, the plaintiff lawyers persuaded the jury that there was a 51 percent chance that Vioxx caused this heart attack, assuming there was in fact a heart attack in the first place. No matter that six months ago, an FDA expert panel voted in favor of bringing Vioxx back on to the market, and just last month, a Canadian expert panel voted by eleven to one to resurrect Vioxx.

So in this case, a smart lawyer was able to persuade a jury that a heart attack could have caused a death that was probably caused by something else, and that Vioxx could have caused this heart attack even though most heart attacks in Vioxx patients are probably not caused by Vioxx.

Then the jury hit the manufacturer with quarter of a billion dollars in damages. After judicial appeals, this first Vioxx case may end up with damages of only about five to ten million dollars. A string of similar verdicts would be enough to force the drug industry out of the business of creating some very useful drugs. The people who develop drugs know that in the end, all they can offer are reasonable trade-offs: we can stop your pain but we can't rule out a slightly higher risk of your getting hit by something serious that may happen anyway, like a heart attack or stroke. You can decide what you want to do, but such trade-offs cannot be avoided if you are to have drugs to treat your pain. No one will ever know everything about the risks.

So the jury in Angleton, Texas, certainly sent a signal to the pharmaceutical industry last week. That signal said that making reasonable trade-offs can put the industry out of business. If the manufacturer of a new pain medication -- or an Alzheimer's preventative or an osteoporosis treatment -- gets blamed for half the heart attacks its customers suffer, or even 10 percent of them, that drug cannot survive. Being held liable for a thousand heart-related deaths at ten million per death requires ten billion dollars a year just for liability reserves. Almost no one can afford to pay for a drug that carries that kind of burden, even though many patients would probably love to use the drug if they could buy it at a reasonable cost. The Texas Vioxx award stakes out a path toward similar verdicts that could end up denying valuable new drugs to patients.

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