Vioxx-type danger and legal frivolity
Last week, a Texas jury found Merck was liable for the death of a man, Robert Ernst, who took Vioxx, the company’s painkiller. While the company will appeal an award of over $250 million to the Ernst widow, claiming that the jury did not find that Vioxx caused his death, the jury punished Merck for failing to change its marketing practice after its own study identified a small group of patients that had more heart problems after taking Vioxx. It’s message was, in the word of the words of one juror: “Stop doing the minimum to put your drugs on the market.”
Vioxx likely did not cause Mr. Ernst’s death. But the jury made it clear that causation is not the issue. Rather it believed that Merck was irresponsible for not doing a better job in making people aware of the real risks and benefits of Vioxx. While Merck may ultimately win its appeal on the merits, the fact is, if it has determined who would benefit from Vioxx and who is at risk, Merck could have avoided its current problems.
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Better science, not big damage awards, are the way to safer and more effective drugs. Litigation will discourage companies from pursuing research on drugs for incurable illnesses that, even with genetic testing, will have serious side effects. The only way out of this mess is for companies to personalize the development and prescribing of drugs. Merck’s learned the lesson of not targeting treatments the hard way. Let’s hope other companies are more proactive. Personalized medicine will make Vioxx-type lawsuits a rare effect of our legal system instead of the disease it is today.
Goldberg makes some interesting points. I agree that the damage award is nonsensical – see Jane Galt’s excellent analysis – Who decides–and how? What I like about Goldberg’s analysis is that he goes beyond the obvious and suggests a path for better evaluation. While I am not convinced that our science is currently sophisticated enough to meet his objectives, we can certainly start to approximate his objectives.
Until we have a better funded FDA with a broader mandate, we will continue to see such stories. During my 30 years since graduation numerous drugs have had post-release difficulties. That will happen, because you cannot learn everything about a drug prior to release. We must give higher precedence to science than marketing. I fear that the pharmaceutical companies have not understood that concept. This judgement (even when lowered) should get their attention. Hopefully the companies will develop some risk aversion. Our patients deserve that.
