Talk about pressure.
On most days, Nancy Santanello, a senior scientist at Merck & Co., pores over research and development data at the giant pharmaceutical company. Today, in a south Texas courtroom, Dr. Santanello will become the human face of Merck to the 12 jurors that will decide the first—and potentially most important—wrongful-death suit to go to trial over the troubled painkiller Vioxx.
Dr. Santanello is expected to be the first witness to take the stand this afternoon—and may be the only Merck executive produced in the case, which began Thursday and may last up to five weeks in Angleton, Texas, about a 44-mile drive south of Houston. Carol Ernst, the widow of Robert Ernst, alleges that Vioxx took her 59-year-old triathlete husband’s life in 2001. Her lawyer, Mark Lanier, told jurors last week that Merck executives coldly plowed ahead with putting Vioxx on the market even though they knew of its potential safety problems. Merck lawyers said that the Whitehouse, N.J., company completed numerous safety tests on Vioxx and that the evidence will show that there is no way Vioxx caused Mr. Ernst’s death.
One focus of the trial will be arrhythmia, or the interruption of the normal heart-beat rhythm—the official cause for Mr. Ernst’s death. Mr. Lanier says that on Monday, he will introduce internal Merck documents that he says link Vioxx to arrhythmia.
In his opening statement, Merck attorney David Kiernan said there was no evidence of such a link.
Dr. Santanello’s testimony could be critical for Merck. Investors and other potential plaintiffs’ attorneys are looking at this first case as a potential predictor of Merck’s ultimate legal liability with Vioxx. A Merck loss in Texas with big damages would encourage more suits, while a Merck win could result in a lower financial liability for Merck over Vioxx. More than 20 million Americans took Vioxx before it was pulled from the market over cardiovascular safety issues, and about 4,000 suits already have been filed. Analysts have projections of Merck liability that range from $4 billion to more than $20 billion.
Merck’s defense team chose Dr. Santanello to be Merck’s corporate representative during the trial, and last week, they told jurors a little something about her. She was the first in her family to go to college, for instance. After college, she taught at an inner-city school for six years. She took Vioxx herself.
Today, however, jurors are likely to hear about a flap involving Merck and Dr. Santanello in the spring of 2004. Back then, Dr. Santanello removed the name of one of her subordinates from the list of authors on a research paper—after the study produced an unflattering portrait of Vioxx.
The study, published in the journal Circulation, was funded by Merck and designed by the company and by Harvard Medical School. The main researchers of the study included one who worked for Dr. Santanello. The study looked at 54,475 patients in a database of Medicare patients in New Jersey and Pennsylvania. The researchers concluded that use of Vioxx was linked to an elevated risk of heart attack compared with people using Pfizer Inc.’s painkiller Celebrex, and with people not taking any prescription painkillers called NSAIDs, or nonsteroidal anti-inflammatory drugs. Researchers said the apparent risk was greater when doses exceeded 25 milligrams of Vioxx, and seemed to be confined to the first 90 days of taking the drug.
In an interview at the time, Dr. Santanello said the subordinates name was removed because there were “serious limitations to the analysis.” Yesterday, a spokesman for Merck said, “Dr. Santanello made the decision that since the company believed the data did not support the conclusions the way the lead author framed them, the appropriate course under both Merck’s policy and the guidelines of the journal was to let the publication go forward without the Merck author’s name.”
Mr. Lanier plans to seize on the topic. “If Merck truly is for full and open disclosure, why did she make a co-author of a paper take her name off?” Mr. Lanier asks in an interview. Mr. Lanier, who has said he plans to keep the jury “entertained,” declined to go into many specifics about what else he will question Dr. Santanello on today for fear his opponent will have too much time to prepare responses.
The researcher, Carolyn Cannuscio, who no longer works for Merck, declined to comment for this story. But she told The Wall Street Journal in an email in May 2004: “While this represented a professional disappointment for me, I also recognized that having the name of a Merck researcher on the paper could have implied, incorrectly, that Merck agreed with the paper in its entirety.”
Last week in court, Mr. Lanier gave a blistering two-and-a-half-hour opening statement that moved quickly through a lot of material in folksy, easy to understand language. He told jurors that they are to be “detectives” in this case. “If we were going to put it into a TV show, this would be ‘CSI Angleton’ because this is your chance,” he said, according to a court transcript. “You’re going to follow the evidence, like any good detective would. You follow the evidence.”
Merck’s attorney, Mr. Kiernan, of the powerhouse defense firm Williams & Connolly, by contrast, kept more of a distance from jurors, according to transcripts and people who were there, and mostly read from his notes as he walked the jury through sometimes dry, complex scientific data about Vioxx.
But while Mr. Lanier is considered a formidable trial attorney, one of his biggest challenges, say plaintiff and defense attorneys alike, is proving “causation”—the legal term for proving that a particular drug actually caused a particular person’s damage.
Causation is viewed as a challenge for plaintiffs in all the Vioxx cases because heart attacks and strokes are so common in the general population, making it hard to prove that any one person’s heart attack was caused by one pill and not a myriad of other problems—such as lack of exercise, smoking, high blood pressure and high cholesterol. Merck has vowed to fight every Vioxx case against it in part because the burden to prove causation in a heart attack or stroke is so high. In some states, however, such as Texas, the plaintiff need prove only that Vioxx contributed, rather than fully caused, a cardiovascular event.
Merck acknowledges that after 18 months of daily usage, Vioxx increases the chance for a heart attack or stroke—a finding Merck made last September that led to the voluntary withdrawal of the drug. Of the millions of users, only a small subset is believed to have taken the drug for that amount of time on a daily basis. Mr. Lanier said Mr. Ernst took Vioxx every day for eight months.
Mr. Lanier has another hurdle in proving Vioxx caused Mr. Ernst’s death. His death certificate reads: “cardiac arrhythmia secondary to coronary atherosclerosis.” Merck says that means he didn’t have a heart attack or stroke and that there is no evidence anywhere to suggest a link between arrhythmia and Vioxx. Merck says Mr. Ernst showed significant atherosclerosis—or narrowing of the arteries by plaque. “Some of the arteries were estimated to be blocked by more than 70 percent,” Merck’s Mr. Kiernan said in his opening statement last week. “What is the most common cause of arrhythmia?” he asked. “Atherosclerosis. And atherosclerosis places someone at substantial risk of an arrhythmia.”
Experts say a definitive conclusion about whether Mr. Ernst had a heart attack in addition to the arrhythmia may not be possible. “Atherosclerosis by itself doesn’t cause an arrhythmia,” said Anne Curtis, chief of the division of cardiology at the University of South Florida in Tampa, Fla., and an expert in arrhythmias. Dr.
Curtis, who hasn’t looked at Mr. Ernst’s autopsy report nor any of his medical records, nor is she involved in any of the Vioxx cases, said it is potentially possible that a blood clot caused a heart attack, which then led to an arrhythmia, and ultimately death. A blood clot, she added, could dissolve by the time an autopsy is done.