VIOXX'S 18-MONTH DANGER THRESHOLD: ONCE A MYTH, ALWAYS A MYTH . . . Since Vioxx was withdrawn from the market in late 2004, there's been talk that Merck's claim of an 18-month danger threshold was more myth than fact. For example, I did a post about it last year: "The 18-Month Vioxx Myth." In that post, I pointed out that a federal judge was allowing expert testimony that Vioxx can increase cardiovascular risks if used even less than 30 days.
Still, however, the 18-month myth persisted. It probably won't any longer. That's because on Monday, the New England Journal of Medicine ran a correction to the study that Merck was relying on for its 18-month defense. The Boston Globe reported the news this way:
In an action that could hamper Merck & Co.'s ability to defend itself against thousands of lawsuits, a prominent journal yesterday published a correction saying that it does not take 18 months of Vioxx use to increase heart risk.
Dr. Gregory D. Curfman , executive editor of the New England Journal of Medicine, said the journal took the unusual step "to make it completely clear to our readers" that suggesting someone needs to take Vioxx at least 18 months before suffering heart risk "is, in fact, a misinterpretation of the data."
What effect will the correction have on the Vioxx litigation? Some say that the news might increase the overall number of lawsuits, but I doubt it. Most Vioxx lawyers were already taking cases in which claimants used Vioxx for less than 18 months. Others say the news will affect the type of evidence that's admissible in a trial. This doesn't seem right either. Even before the correction, there were already many scientists who were rejecting Merck's 18-month defense.
If there are any lasting effects, it will probably be these: (a) the correction adds to Merck's credibility problems, as it appears that Merck's lawyers, who even now are sticking to their 18-month defense, are out of step with the weight of the medical and scientific evidence; and (b) such damage to Merck's credibility adds to the likelihood that treating doctors, who are important witnesses in every trial, will be more sympathetic to the plaintiffs' plight. The same may also be true of the judges who have to make initial determinations about the admissibility of scientific evidence in upcoming Vioxx trials.
There's been a lot of coverage of the NEJM's correction. Here are a few other takes:
- Los Angeles Times: "Journal Runs Correction on Vioxx: Analysis that tied risks only to 18 months or more of use was wrong, the publication says."
- Associated Press: "Lawyers Like Vioxx Correction."
- In the Pipeline: "18 Months to Trouble?"
- The Settlement Channel: "A few months of Vioxx can likely cause cardiac harm."
UPDATE: Ted Frank at Point of Law comments here.