The Defense

In response, Merck counsel Kiernan told the seven-man, five-woman jury that the company meticulously tested the drug, always apprising the FDA and public of all known risks, and that Gilmartin voluntarily pulled the drug in 2004 out of an abundance of caution and against the advice of many doctors who wanted to keep it available. He detailed eight years of testing prior to the drug’s FDA approval and said that while the FDA requires that a new drug be tested on only 1,500 patients, Merck tested Vioxx in studies involving 10,000 patients, of whom 5,400 took Vioxx for periods up to 18 months. Kiernan also stressed a memo issued after conducting extensive hearings by the FDA on April 6, 2005, which said that the reliable evidence still does not show Vioxx to increase cardiovascular risk to any greater degree than any other drugs of its class (like Pfizer’s Celebrex) or even than traditional painkillers like ibuprofen (Advil) or naproxen (Aleve).

Kiernan also emphasized a potentially pivotal aspect of the case: The pathologist who conducted Bob Ernst’s autopsy concluded that he had suffered from longstanding, undiagnosed hardening of the arteries, and that his sudden cardiac death had actually been triggered by an arrhythmia—an irregularity in the heart beat—rather than by a blood clot (thrombosis). All the questions surrounding Vioxx and other drugs of its class have focused on their alleged propensity to promote blood clot-related events—thrombotic heart attacks and strokes—while none have linked it to arrhythmias, Kiernan claimed. About 200,000 Americans each year suffer sudden cardiac death due to arrhythmias, Kiernan said, and hardening of the arteries is what most commonly triggers them. In his own statement, Lanier had glossed over that distinction, insisting that Ernst “died of a textbook Vioxx problem,” and suggesting that Ernst had had a thrombotic heart attack, and that the autopsy pathologist couldn't have detected it using the techniques she used. In an interview, Lanier explains: “Ninety percent of heart attacks have an arrhythmia. The two are not mutually exclusive. We will also show that Merck knew Vioxx increased risks of arrhythmias.”

Kiernan closed by noting that seven of the high-level Merck officers most involved in the case—including the former and current research chiefs, Edward Scolnick and Peter Kim—used Vioxx personally. He asked jurors to consider whether these officers would knowingly conceal serious safety issues with the drug.