Required reading

Culp and Berry. 2007. Merck and the Vioxx debacle: Deadly loyalty. 22 STJJLC 1. Read only the "Introduction," "I. The litigation---picking the winning hand," and "II. What did the company know, and when did they know it?" (parts A, B and C only).

Johnson, C. 2008. Merck to pay $650 million in medicaid settlement. Washington Post, 8 February 2008.

Merck. 2007. Merck agrees to resolve U.S. Vioxx product liability.

Settlement Agreement Read only Articles 2 and 3

Supplementary Reading

Description of the Settlement Agreement This may be helpful.

Questions for class discussion

1. Merck frequently defends itself by arguing that there is no good evidence that Vioxx causes heart attacks when used for short periods of time (e.g. one month, or less than 18 months). Critique this argument from a scientific viewpoint. Even if there is no statistically significant demonstration that Vioxx causes heart attacks when used only for a month, does this mean that Vioxx does not cause heart attacks when used only for a month?

2. Merck sometimes defends itself by arguing that the plaintiff has many other risk factors for heart attacks (e.g. Doherty, Barnett or Smith cases). Critique this defense scientifically. As a start for this critique, think about why scientists oftentimes conduct toxicological studies in animals at much higher doses than what humans are typically exposed to. In addition, scientists sometimes investigate whether a chemical is a carcinogen by testing it on mice that are genetically predisposed to getting cancer. What is the relevance of these observations to Merck's defense?

3. There is good scientific evidence that Vioxx causes heart attacks. Importantly however, although Vioxx does cause heart attacks, at low doses, the increased risk is not dramatically higher than background. How should Merck exploit this to defend itself? What can plaintiffs do in response?

4. Culp and Berry state that "Merck's has argued that the company had no reliable scientific evidence that Vioxx increased the risk of cardiovascular events until September 2004 when a clinical trial, designed to see if Vioxx could prevent colon polyps, showed an increased risk of heart attack and stroke among patients taking Vioxx for eighteen-months as compared to those who took placebos." Do the scientific papers on Vioxx we have discussed this semester support Merck's contention?

5. Was it ethical for Merck to not undertake studies that could have earlier shown that Vioxx causes heart attacks? Why did not Merck undertake these studies?