Thursday, July 28, 2005
Plaintiffs’ Expert Testifies That Vioxx Caused Death
Merck’s Studies Found Cardiovascular Risk
Lanier questioned Dr. Egilman about how Merck may have manipulated its study data to hide Vioxx’s cardiovascular risks. In one of Merck’s preclincal studies, completed in 1996, patients taking Vioxx experienced a higher rate of cardiovascular events than patients taking placebo. This study “signaled” to Merck that Vioxx might be associated with an increased risk of cardiovascular events and should have prompted Merck to perform further cardiovascular studies, according to Egilman. But instead of studying cardiovascular risks, Merck simply omitted that study data from its future analyses of Vioxx’s cardiovascular risks.
Dr. Egilman reviewed several of Merck’s studies with the jury and described whether they showed an increased cardiovascular risk. Several of those studies, which were designed to assess Vioxx’s effectiveness for new indications such as the treatment of Alzheimer’s, found that patients taking Vioxx experienced more cardiovascular events than patients taking other drugs or placebo. Merck’s only study that was designed specifically to evaluate cardiovascular risks in humans, the VALOR study, was never completed, despite a year of research.
Merck Failed to Warn About Risks
Dr. Egilman explained how drug companies’ warn doctors about the risks of their drugs. Companies provide doctors with “package inserts” with their drugs. The package insert lists information about a drug’s risks in various sections of the insert and with varying degrees of importance. Those sections include a warnings section, which doctors pay the most attention to according to Dr. Egilman, a precautions section, and a section that lists adverse events experienced by patients taking the drug. Dr. Egilman was careful to point out that the adverse events section specifically states that there is no causal link between the drug and the listed adverse events.
Lanier asked Dr. Egilman to explain where in the Vioxx package insert Merck warned about cardiovascular risks. Dr. Egilman explained that Vioxx’s package insert does not warn doctors about those risks. Instead, the package insert issued in 2000, when Bob Ernst died while taking Vioxx, merely acknowledged cardiovascular adverse events in its adverse events section. Accordingly, Dr. Egilman opined that Merck’s package insert failed to adequately warn doctors about Vioxx’s cardiovascular risks.
Vioxx Caused Bob Ernst’s Death
Dr. Egilman linked Vioxx to Bob Ernst’s death. Vioxx lowers levels of prostacyclin in the body, which is a chemical in the blood that prevents clotting. Vioxx was present in Mr. Ernst’s blood when he died, which means that Vioxx may have reduced Mr. Ernst's ability to prevent clotting. Mr. Ernst showed evidence of arteriosclerosis or plaque build up in his arteries, which increased the likelihood of a blockage that, because of Vioxx, his body could not correct. Dr. Egilman also testified that the records show that Mr. Ernst suffered an arrhythmia. According to Merck’s own physicians’ desk reference, arrhymias are associated with heart attacks 90% of the time. Accordingly, Dr. Egilman concluded that Vioxx caused or contributed to Mr. Ernst’s death.
Plaintiffs’ argument about arteriosclerosis rides a fine line. Dr. Egilman testified that Bob Ernst was at greater risk for a heart attack while on Vioxx because he had arteriosclerosis. Merck argues, however, that Mr. Ernst’s arteriosclerosis along with his arrhythmia caused Mr. Ernst’s death, not Vioxx. Almost admitting that Mr. Ernst’s arteriosclerosis played a role in his death, plaintiffs have used Merck’s alternative cause to make Mr. Ernst an eggshell plaintiff. Consequently, Merck’s failure to warn put Mr. Ernst at greater risk because he suffered from arteriosclerosis.
Merck Cross-Examines Dr. Egilman
On cross-examination, Merck’s counsel, David Kiernan, established that Dr. Egilman has spent much of his career testifying as an expert against corporations. Dr. Egilman acknowledged that he has testified in approximately 300 depositions and at 150 trials. And much of that testimony was against corporate defendants in asbestos litigation.
Kiernan asked Dr. Egilman a series of questions about his experience with clinical trials. Dr. Egilman conceded that he had virtually no experience whatsoever coordinating clinical trials, but he explained that his testimony is instead based on his experience analyzing clinical trial data as a practitioner and medical investigator.
Similar to his opening statement, Kiernan appeared to be reading from a prepared list of questions. Several of Dr. Egilman’s responses left room for potentially damaging follow-up questions, but most of the time Kiernan simply moved to the next question. It is not clear whether Kiernan is confined to a script, approved and directed by Merck, or he is intentionally avoiding the pitfalls of an open discussion with Dr. Egilman. But much of his cross-examination appears too fixed to convey his points to the jury.
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