At the crux of the nation’s first Vioxx-related civil trial under way is whether Merck & Co.’s once lucrative painkiller caused a Texas man’s 2001 death from arrhythmia.
While the New Jersey pharmaceutical giant pulled the drug from the market last year after a study showed it doubled the risk of heart attack or stroke if taken for 18 months or more, the company claims no studies link Vioxx to arrhythmia, or an irregular heartbeat.
Last week, Merck’s lawyers presented evidence that the company studied whether Vioxx caused arrhythmias in nine clinical trials before the drug went on the market in May 1999 and found “no clinically meaningful differences” in patients who took the painkiller compared to those who took sugar pills or other anti-inflammatory pain relievers.
But Mark Lanier, the Houston lawyer representing Carol Ernst, the plaintiff in the case, contends her husband, Robert, died too quickly for his heart to show damage. He also points to Merck’s medical manual used by doctors across the country, which says arrhythmia in some form occurs in more than 90 percent of heart attack patients.
On Monday Lanier’s next expected witness was Dr. Isaac Wiener, a cardiologist and co-director of the Cardiac Arrhythmia Center at UCLA Medical Center in Los Angeles.
Robert Ernst, a produce manager at a Wal-Mart near Fort Worth who ran marathons and worked as a personal trainer, took Vioxx for eight months to alleviate pain in his hands until he died in his sleep. The trial in Angleton is the first of more than 4,200 state and federal lawsuits across the country to go before a jury.
Lanier alleges that Merck knew Vioxx could be dangerous years before the company pulled the drug but downplayed those concerns in favor of aggressive marketing for a multibillion-dollar seller. Merck’s lawyers say the company acted responsibly, disclosed studies on Vioxx and believed it to be safe until results from the long-term study last year prompted pulling the drug.
About 20 million people took Vioxx after its launch in 1999. Controversy emerged 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 difference to naproxen’s heart-friendly qualities rather than a defect in Vioxx, garnering a rebuke from the Food and Drug Administration for making that assertion without scientific proof.
After two years of wrangling with the FDA, in 2002 Merck added warnings about cardiovascular risks to Vioxx’s label.