Jury selection begins today in Angleton, Texas in the first personal injury/wrongful death trial against Merck & Co. for alleged non-disclosure of the risks of taking the pain relieving drug Vioxx. Angleton is a small town in a plaintiff-friendly county about an hour south of downtown Houston. Talented Houston-based personal injury trial lawyer Mark Lanier has been receiving quite a bit of free publicity about the upcoming trial (here is the NY Times article and an earlier WSJ ($) article is here), and here are several previous posts on Merck and Vioxx.
Mr. Lanier’s effectiveness as a trial lawyer is in no small part attributable to the fact that he is a devout Christian who regularly teaches a Bible Study class at his church in Houston. Such familiarity with the Bible typically resonates with jurors in small Texas towns, who often rationalize tenuous liability and damage issues through Biblical associations.
Curiously, as Professor Ribstein has pointed out, Mr. Lanier’s case against Merck is based largely on the very un-Biblical concept of resentment and not the truth. Merck pulled Vioxx from the market in October, 2004 after a study showed that it increased the risk of heart attack or stoke, but not necessarily the risk of death. That move prompted Cleveland Clinic cardiologist Eric Topol to go postal over Merck’s handling of the drug, contending that Vioxx resulted in 15 cases of heart attack or stroke per 1,000 patients.

Unfortunately, what Dr. Topol failed to mention is that the foregoing number of cases relating to Vioxx was precisely seven more cases of heart attack or stroke per 1,000 patients taking the similar medication, Naprosyn. Moreover, as MedPundit points out, Dr. Topol neglected to mention that aspirin — which is regularly prescribed without controversy for heart attack and stroke prevention — results in a clinically significant case of bleeding in every 3 out of 1,000 patients. Thankfully, aspirin has not been pulled from the market, at least yet.
Moreover, the statistical bungling got even worse. David Graham, the associate director for science in FDA’s office of drug safety, took the results of these studies and without any sub-group analysis calculated that 27,785 heart attacks may have occurred between 1999 and 2003 as a result of Vioxx use based on the number of Vioxx prescriptions. That was music to the ears of the plaintiffs personal injury bar, but the music was a bit tinny given that his conclusion was not based on the number of Vioxx users who truly should have been counted. Rather, it is based on the the number of patients who were on Vioxx continuously for more than 18 months as indicated in the studies that showed an increased risk of cardiovascular problems. Thus, the statistical evidence is quite shaky that short-term or periodic use of Vioxx contributes to an increase risk of cardiovascular problems. Not surprisingly, the initial trials of Vioxx were all shorter than 18 months and they did not find any meaningful evidence of increased risk.
As my late father often observed, the truth is that medicines are toxins that have side effects that sometimes kill people. Vioxx was developed to address the problem of patients who regularly die as a result of the use of non-steroidal anti-inflammatory medications for chronic pain. Studies reflect that about 16,500 patients die and another 100,000 are hospitalized annually as a result gastrointestinal bleeding from the use of these NSAID medications for chronic pain. The number of people who have suffered heart attacks and strokes as a result of the long-term use of Vioxx pale in comparison to these numbers.
The foregoing is not meant to be a defense of Merck or other drug companies. It’s simply to point out that Vioxx is not unusual — most medications have potentially serious side effects. Perhaps there should be more rigorous FDA approval process for new drugs and maybe the FDA should be given the power to require drug companies to fund research to evaluate possible side effects that emerge after a drug is approved and large numbers of patients begin using it. However, those moves are more likely to result in a longer approval process for new drugs and even higher cost for most medications than better patient safety. Moreover, increased regulation raises the sticky issue of establishing parameters to decide if and when a certain side effect in a new drug would require pulling that drug from the market. Stated another way, just when do the risks of a medication outweigh the benefits of the drug in treating a certain disease or medical condition?
Thus, these are the issues that we need to be discussing in regard to medications such as Vioxx. However, the reality is that analysis of such issues is unlikely to be anywhere near as appealing to the jury in Angleton as Mr. Lanier’s morality play. Where is the Biblical justification for that?