Mark Lanier, who represents the widow of a Texas man who died in May 2001 after taking Vioxx for eight months, told jurors about the results of 1999 clinical trials of Vioxx on osteoarthritis patients.
The so-called "CV cards," intended to show cardiovascular effects of Vioxx, indicated little difference between Vioxx and sugar pill groups. Dr. Nancy Santanello, head of Merck's epidemiology department, has repeatedly said that such trials conducted before Vioxx went on the market in 1999 consistently showed little difference in effects on patients.
Lanier alleged Wednesday that Merck's math didn't add up. He handed Santanello a calculator, and she came up with a lower rate of cardiovascular problems in the 783 patients on sugar pills than noted on the card that the company sent to doctors.
Lanier alleged the wider difference was correct, but Merck pumped up the sugar pill rate to be closer to that of Vioxx to make the painkiller appear safer.
Santanello said the calculation she came up with in court was skewed because it didn't account for the actual number of days patients took the sugar pills during the trials. Osteoarthritis patients can't do without their regular pain medication for an entire six-week or six-month trial, she said, and her in-court calculation assumed they took only sugar pills throughout the entire trials.
Lanier said the lower rates were based on information Merck provided the U.S. Food and Drug Administration.
"It may be murky math on your part," Santanello told Lanier.
"With all due respect, ma'am, you did the math," Lanier retorted.
The case centers on the death of Robert Ernst, a marathon runner and personal trainer who worked as a produce manager at a Wal-Mart near Fort Worth. He died in his sleep next to his widow, Carol, who is suing Merck.
Lanier alleges Ernst died of an arrhythmia brought on by a heart attack caused by Vioxx. He also alleges Merck aggressively marketed the drug knowing it could be dangerous years before Merck pulled the painkiller from the market last year when a study showed Vioxx could double risk of heart attack or stroke if taken for 18 months or longer.
Merck contends the company acted responsibly, disclosed studies and possible risks and believed Vioxx was safe until the study last year showed otherwise.
The case on trial in Angleton, about 40 miles south of Houston, is the first of more than 4,200 state and federal lawsuits filed across the country to go before a jury.