Nearly four years ago, Mike Humeston tripped and strained his knee. To ease the pain, the postal worker took Vioxx, which at the time was a new and popular medicine touted as a super-aspirin.
The drug provided some relief, but two months later, Humeston developed a different problem: He suffered a heart attack.
Since then, he can no longer hike in the high desert near his Boise, Idaho, home or go duck hunting with his son. He tires easily, takes blood-pressure medication daily and worries health insurance will be difficult to obtain when he retires.
“I’m very resentful. I was always active,” said Humeston, 60, a former Marine who served in Vietnam. “I would never have traded a risk of a heart attack for a shorter period of time with a knee strain. But there was no warning on the product.”
As a result, Humeston has filed a lawsuit against Merck, which withdrew Vioxx last fall over links to heart attacks and strokes, feeding a growing controversy over the safety of prescription medicines and the ability of federal regulators to monitor drug makers.
More than 2,000 other Vioxx patients or their families have also filed lawsuits in federal and state courts around the country, prompting Wall Street to estimate the Whitehouse Station drug maker’s liability will run anywhere from $4 billion to as much as $30 billion.
Humeston’s lawsuit is scheduled to go to trial on Aug. 1 in Atlantic City, making it only the second Vioxx case nationwide to reach this point. For this reason, his case is expected to be closely watched, as will a trial that’s slated for July in Houston.
For Merck, the stakes are high.
“These first few cases will, essentially, establish the setting for all the litigation that follows,” Gregory Mark, a professor of corporate law at Rutgers Law School, said. “The outcomes will influence the tactics used in future trials by lawyers on both sides.”
Since the Sept. 30, 2004, withdrawal of Vioxx, the drug maker has taken a drubbing. A long-standing reputation for innovation has been eclipsed by charges—some made at congressional hearings—the company was more interested in profits than patients.
Merck has insisted it had no evidence of Vioxx’s risks until last fall. Yesterday, Ted Meyer, a lawyer for Merck, issued a statement saying Vioxx was “carefully studied,” both before and after regulators approved the drug, and all test results were disclosed.
In addition, “Merck will present evidence showing Vioxx did not cause or contribute in any way to Humeston’s heart attack,” the lawyer, who works for Hughes Hubbard & Reed in New York, said.
The controversy surrounding Vioxx originally surfaced in 2000, when a Merck study revealed a possible link to heart problems. The study was meant to show Vioxx prevented stomach problems better than older painkillers, such as naproxen. Merck viewed this as a crucial marketing advantage.
But the results also highlighted the possibility Vioxx could cause heart attacks and strokes. Merck contended there was no scientific explanation. Instead, the company said the results indicated naproxen, which was given to other patients, protected the heart.
The allegations against Merck hinge, in part, on internal documents—including several e-mail messages between top scientists—that suggest the drug maker for years downplayed the risks associated with Vioxx, according to various lawsuits.
Some of the evidence already has been well-publicized, such as memos instructing sales reps not to discuss the 2000 study, and an “Obstacle Response Guide” that was designed to help sales reps deflect concerns doctors may have about Vioxx.
But Chris Seeger, Humeston’s attorney, promised fresh details will emerge.
“People have heard bits and pieces, but nobody has really been told the entire story from beginning to end,” said Seeger, who also co-heads a steering committee for lawyers in New Orleans, where Vioxx lawsuits filed in federal courts are being consolidated.
Among those who may testify is Ray Gilmartin, Merck’s embattled chief executive until he retired abruptly last month, and Ed Scolnick, Merck’s top scientist from 1985 through 2002. If they don’t appear in court, taped testimony will be shown, said Seeger.
Some on Wall Street, however, seem to be in a show-me mood.
So much potentially damaging information has already been disclosed that one analyst said the outcome of the first few trials may not have much effect on investors and Merck’s slumping stock price—unless damning evidence is introduced.
“This is going to be a marathon,” Barbara Ryan of Deutsche Banc Securities, who tracks drug makers, said. “So I’m not sure the first couple of cases will be terribly relevant to the overall litigation, unless some new evidence surfaces.”
Nonetheless, Robert Rabin, a product-liability expert at Stanford University Law School, predicted juries that harshly penalize Merck in these early cases may encourage still more former Vioxx patients to file lawsuits.
And the damage is about more than money.
“Remember, the biggest impact litigation like this has will be on Merck’s reputation for making safe and effective drugs,” Mark, the Rutgers law professor, said. “It’s very unlikely a single lawsuit would destroy it, but if there are lot of (verdicts against Merck) and they implicate the company, Merck could be harmed by a thousand cuts.”