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First U.S. Vioxx trial begins
ANGLETON, Texas -- Merck & Co. traded its mission of healing and treating sickness for relentless marketing and pursuit of profits, a plaintiff's lawyer in the nation's first Vioxx-related lawsuit to go to trial told jurors Thursday.
Mark Lanier, representing widow Carol Ernst, displayed the phrase "Merck-y ethics" on a large screen and promised to skewer the judgment of a company he said knew the popular painkiller could be dangerous years before a study showed it could double risk of heart attack or stroke. That study prompted Merck to voluntarily remove it from the market last year.
In a much more subdued presentation, Merck lawyer David Kiernan, who is also a surgeon, urged jurors to keep an open mind as Merck seeks to show the company didn't rush a lucrative drug to market and slip shoddy science past the U.S. Food and Drug Administration to pump up profits.
"That charge could not be more false," he said.
Ernst's husband, Robert, a personal trainer, died in his sleep four years ago of an arrhythmia, or irregular heartbeat. He had been taking Vioxx for about eight months to ease pain in his hands.
Lawyers from throughout the country associated with other Vioxx lawsuits packed the courtroom for hours of opening statements -- more than two hours afforded each side.
Kiernan said Vioxx has been in development since 1991 and cut in half the potentially lethal stomach bleeding that some patients got from traditional pain relievers like aspirin.
Vioxx was tested in 58 clinical trials involving 10,000 patients before it went on the market, he said, far surpassing FDA testing recommendations
Buffeted by photos, graphics and documents shown on a large screen behind him, Lanier targeted former Merck CEO Ray Gilmartin. He described Gilmartin as the first non-doctor or non-scientist -- "a Harvard-trained businessman" -- to run Merck, starting in 1994.
Lanier said Gilmartin aimed to turn Merck into "an ATM machine that's spitting out money" by beefing up sales with glitzy television ads for various drugs -- including Vioxx, which came on the market in 1999.
Vioxx was critical to Merck, Lanier alleged, because patents on other lucrative drugs ran out in 2000 and 2001 and "if Vioxx doesn't fill up the ATM machine for us, we're running dry. It's Vioxx or bust."
He said the company downplayed studies that raised concerns about Vioxx's safety and pushed the painkiller to a growing market of arthritis sufferers and their doctors to keep the bottom line robust.
"You watch what happens to their studies. It will make you sick," Lanier said.
He said Merck wined and dined Robert Ernst's doctor, Brent Wallace, and targeted him and many other doctors in a plan to push them to prescribe Vioxx. He said the company paid doctors to let Merck sales representatives watch them write those prescriptions.
The case in Angleton, a town about 40 miles south of Houston, is the first of more than 3,800 state and federal lawsuits pending against New Jersey-based Merck.
Merck claims the company responsibly researched Vioxx's safety in numerous clinical trials before the U.S. Food and Drug Administration approved it, and monitored the drug after it went on the market in 1999.
Lanier said he plans to torpedo Merck's expected defense of how the company says no studies link Vioxx to arrhythmia, so the drug couldn't have caused Robert Ernst's death. He said he aims to show a heart attack causes arrhythmia, and Ernst's sudden death left no time for any heart damage to show.
The trial is expected to last five weeks.
About 20 million people took the anti-inflammatory drug prescribed for arthritis and acute pain since it came on the market in 1999. In 2000, a study found that some Vioxx users suffered five times as many heart attacks as users of the older painkiller naproxen, sold under the brand name Aleve.
In 2002, the FDA added warnings to Vioxx's label. Continued research showed Vioxx doubled the risk of heart attack or stroke if taken for 18 months or longer, which prompted Merck to pull the drug.
Lanier complained that some Angleton residents had received phone calls from pollsters claiming to be Merck representatives asking if they had heard of the case and whether Carol Ernst deserved any money.
"The hypocrisy of this makes me want to puke," Lanier told reporters.
Jonathan Skidmore, a Merck attorney, said Merck wasn't involved in any polling and wanted to find out what happened as much as Lanier.