For more than eight months, Vioxx eased the pain and stiffness in Robert Ernst’s hands. But eight days after Ernst, a 59-year-old personal trainer, clocked 62 miles on a bike, he died in his sleep from arrhythmia, or an irregular heartbeat.
Believing Vioxx caused her husband’s death, Carol Ernst will take on pharmaceutical giant Merck & Co. in a Texas court in July. After the delay of a similar case in Alabama, it will be the first of 2,400 Vioxx lawsuits filed nationwide to go to trial.
Merck removed Vioxx from the market in September 2004 after an in-house study showed that taking Vioxx doubled the risk of heart attack and stroke for patients who took it for 18 months or more.
Merck, the world’s third-biggest drug maker, said 20 million people took Vioxx after it first went on sale with great fanfare in 1999. The anti-inflammatory drug was prescribed for arthritis, acute pain and disorders such as carpal tunnel syndrome. Researchers also were studying whether it could prevent some forms of cancer.
Mark Lanier, the Houston litigator representing Carol Ernst, hopes to portray Merck as a relentless profit machine with pushy sales people. He also said he will demonstrate that Merck threatened to pull research funding from skeptical doctors. And he says he will use internal documents and e-mails to suggest the company minimized the drug’s potential health risks until the in-house study was so overwhelming that Merck decided to pull the drug.
“It’s like Saddam Hussein wanting credit for coming out with his hands up,” Lanier said of Merck’s voluntary removal of Vioxx from the market.
Merck attorney Jim Fitzpatrick wasn’t amused at Lanier’s analogy.
“The comment itself isn’t only inappropriate, it couldn’t be farther from the truth,” he said.
Merck says the company, based in Whitehouse Station, N.J., believed Vioxx was safe. Merck Vice President Dennis Erb told Congress in May that the company quickly disclosed studies that first raised the possibility of heart repercussions, including the one that led to the drug’s withdrawal.
“We believed wholeheartedly in the safety of Vioxx and that Vioxx was an important treatment option,” Erb said, noting that his father took the drug.
Merck also plans to argue that because Ernst died of arrhythmia, not of a heart attack, Vioxx could not be to blame.
Lanier has nabbed multi-million-dollar verdicts in asbestos and contract battles but the Vioxx case is his first foray against the pharmaceutical industry. He has a growing reputation for charming jurors while skewering adversaries.
Lanier said he’ll present jurors with science as well as testimony about corporate greed intended to raise the ire of jurors in Brazoria County, a Houston suburb of semi-rural and industrial neighborhoods where the trial will take place in Texas district court.
Carol Ernst lives in north Texas, but the trial is to be held in the more plaintiff-friendly Texas Gulf Coast because Lanier initially included as co-defendant a medical clinic in Brazoria County that was dismissed from the case.
Lanier will face veteran defenders of pharmaceutical companies.
Gerry Lowry represented Bayer Corp. in the first Baycol trial more than two years ago, where Bayer was cleared of ignoring research linking the cholesterol-lowering drug to dozens of deaths.
Lanier said he’ll tell jurors that former Merck CEO Ray Gilmartin led an all-out marketing effort for Vioxx in the hopes of surpassing Pfizer’s Celebrex in sales, despite safety concerns.
“Vioxx was their biggest moneymaker,” Lanier said. “They had to sell the dog out of this thing.”
Lanier said he’ll also tell the jury that Merck knew as early as 2001 that Vioxx users suffered twice as many heart attacks and other cardiovascular problems as users of the older painkiller naproxen, sold under the brand name Aleve.
In 2002, the FDA added warnings to Vioxx’s label, and Merck’s own follow-up research led to the company’s decision to pull the drug.
Merck’s strategy will be to tread lightly with the soft-spoken widow and focus instead on science. Unlike hundreds of other pending cases, the first to reach a jury doesn’t involve a classic heart attack. An autopsy said Robert Ernst died of arrhythmia secondary to cardiac atherosclerosis, plaque buildup in his arteries.
“In the context of a sudden death, there is no reliable scientific evidence that Vioxx causes arrhythmia. This is not a heart attack or a stroke case,” said Jonathan Skidmore, a member of the Merck defense team.
“It’s obviously no doubt a tragedy for Mrs. Ernst, and one we don’t take lightly,” Skidmore said. “But the company will have to deliver its evidence too at the courthouse.”
Whether Gilmartin or other current and former top Merck executives testify remains to be seen. Texas law prevents litigants from issuing subpoenas for anyone who lives outside a 100-mile radius of the courthouse.
Skidmore declined to say whether Merck intends to invite its executives to Texas.
The absence of proof that Vioxx risks don’t go hand in hand with arrhythmia is not enough to make this an impossible case, said Fordham University law professor Benjamin Zipursky. He said if Merck focuses solely on that argument, a victory might not carry to the next case if it involves a classic heart attack.
If the company argues that there is no solid proof that Vioxx causes heart attacks or strokes—just that it may increase such vulnerability in already weakened patients—a win will cast much more of a shadow on other cases, Zipursky said.
Carol Ernst said all she wants are some answers to the cause of her husband’s death. She heard his last raspy breaths on a pillow next to hers.
“The more time goes by, the more intensely I know how much I really lost,” she said. “There’s that steel core inside me that says, ‘OK, I’m ready for you to give me some answers. See me in person and tell me you’re interested in patient safety.’ ”