Wednesday, August 10, 2005
Merck’s CEO Says Company Needed Vioxx to Grow
Merck’s Expert Pathologist Says No Evidence of Heart Attack
Merck’s expert pathologist, Dr. Wheeler, testified on redirect that a heart attack cannot be diagnosed without any evidence as the plaintiffs contend. Plaintiffs have presented no evidence to suggest that Bob Ernst died of a heart attack; they have presented no evidence of characteristic symptoms, EKG, or enzyme levels indicative of a heart attack, or gross or microscopic evidence of a clot that could have caused a heart attack. He opined that a heart attack could not be diagnosed by process of elimination, as plaintiffs suggest.
On Monday, plaintiffs’ chief trial counsel, Mark Lanier, cross-examined Dr. Wheeler about a textbook, which he uses to teach medical students at Baylor University. It effectively corroborates the plaintiffs’ argument that Mr. Ernst died of a heart attack even though his body showed no evidence of a clot leading to a heart attack. In response, Dr. Wheeler testified on Tuesday that he would never use a textbook to diagnose a patient. Strangely, Merck’s attorney continued to cite the textbook as authority in support for Merck’s argument that Mr. Ernst died of an arrhythmia and not a heart attack.
Using the flip chart that has served him so well in this trial, Lanier listed the doctors with whom Dr. Wheeler disagreed. They included: (1) the coroner who examined Mr. Ernst, Dr. Araneta, who testified that Mr. Ernst likely died of a heart attack; (2) Dr. Wiener, plaintiffs’ expert cardiologist, who testified that Vioxx caused Mr. Ernst to suffer a heart attack; (3) Dr. Lucchesi, a pharmacologist, who testified about the enzymes in Mr. Ernst’s blood that may have dissolved the clot that caused his heart attack before it could be seen by the coroner; and (4) the emergency room doctor who wrote that Mr. Ernst suffered a heart attack. Dr. Wheeler reaffirmed that he disagrees with the opinions of each of these doctors.
Lanier and Dr. Wheeler sparred about how severely Mr. Ernst’s heart arteries must have been blocked to cause him to suffer arrhythmia-induced sudden cardiac death without a clot—Merck’s theory about Mr. Ernst’s death (Plaintiffs’ contend Mr. Ernst suffered a heart attack as a result of a clot, which blocked a heart artery causing him to suffer a heart attack). Mr. Ernst suffered from arteriosclerosis, which is a plaque build up in his arteries. The coroner confirmed that his heart arteries were 75% blocked by plaque in some places. According to sources cited by Lanier, to suffer arrhythmia-induced sudden cardiac death without blockage by a clot, Mr. Ernst’s heart arteries must have been blocked by 90%. Lanier asked Dr. Wheeler what made up for the difference between Mr. Ernst’s existing 75% blockage and the 90% blockage required to cause his death. Dr. Wheeler testified that a 75% blockage alone could lead to an arrhythmia-induced death, but he could not cite a single study to support his opinion.
Former Merck CEO Defends Merck’s Actions
In video excerpts from the deposition of Ray Gilmartin, Merck’s former CEO, he explained the events leading up to the withdrawal of Vioxx. He testified that Vioxx’s cardiovascular risks first became apparent after Merck completed its APROVE study. That study was designed to evaluate the effectiveness of Vioxx on colon polyps and showed that patients taking Vioxx experienced cardiovascular adverse events at a much greater rate than patients taking placebo. Merck assembled scientists to evaluate the results, some of which recommended that Vioxx be withdrawn from the market. Mr. Gilmartin testified that Merck opted to do what was best for patient safety and voluntarily withdrew the drug.
Plaintiffs showed the jury excerpts from Mr. Gilmartin’s deposition in which he talked about Merck’s economic goals. He acknowledged that Merck was in the “middle of the pack” when he began as CEO in 1994. Merck needed a drug to become a more profitable company. And Vioxx, according to Mr. Gilmartin, was intended to help Merck achieve that goal. He testified that Merck “would’ve been a very different company had it not sold Vioxx and sold it well.”
On redirect, he explained that new information about the entire class of cox-2 drugs, including Pfizer’s competing drug, Celebrex, had come to light. Consequently, Merck spoke with the FDA about bringing Vioxx back to the market, but no decision had been made as of the time of his testimony.
Continue to log onto www.firstvioxxtrial.blogspot.com for daily updates about the nation’s first Vioxx trial.