Merck & Co.’s top epidemiologist faces the potential for a tough week when testimony begins in the nation’s first Vioxx-related lawsuit to go to trial.
Nancy Santanello, executive director and head of Merck’s department of epidemiology, attended opening statements in the case last week and was expected to return to the courtroom Monday.
If so, the plaintiff’s lawyer, Mark Lanier, aims to make her his first witness.
“It’s my intention to really go after her,” Lanier said Sunday.
Lanier tried to get Santanello in the witness chair last week after jurors listened to hours of opening statements from him and Merck lawyer David Kiernan. But state District Judge Ben Hardin ended the day’s proceedings and said testimony would commence Monday.
Kiernan ended his opening statement by mentioning Santanello along with a string of other current and retired Merck executives as having taken Vioxx before the company pulled the popular painkiller from the market last year.
The trial centers on the May 2001 death of Robert Ernst, a 59-year-old produce manager at a Wal-Mart in Cleburne, near Fort Worth. Ernst also ran marathons and worked as a personal trainer. According to the plaintiffs, he took Vioxx for about eight months to relieve pain in his hands, and died in his sleep next to his wife, Carol, one month shy of their first wedding anniversary.
His autopsy report says he died of an arrhythmia, or irregular heartbeat, secondary to plaque buildup in two major arteries.
Whitehouse Station, N.J.-based Merck argues that no studies link Vioxx to arrhythmia, so the drug couldn’t have caused Ernst’s death. Lanier’s legal team argues that arrhythmia is most often caused by heart attack, but Ernst died too fast for his heart to show damage.
About 20 million people took Vioxx since it was launched in 1999. But controversy over the drug started soon after its introduction when a 2000 study found that some Vioxx users suffered five times as many heart attacks as people who used the older pain reliever naproxen. At the time, Merck attributed the disparity to naproxen’s cardioprotective qualities, not a defect in Vioxx.
But after two years of wrangling with the Food and Drug Administration, Merck added warnings about cardiovascular risks to Vioxx’s label in 2002. Merck removed Vioxx from the worldwide market last year after a study showed the drug doubled patients’ risk of heart attack or stroke if taken for 18 months or longer.