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Vioxx suits won't equal easy money for patients

By GRAHAM BRINK
Published October 18, 2004

TAMPA - Flip through many major newspapers these days and you'll see ads with similar pitches.

"Attention Vioxx Patients: You may have a valuable claim," or "Vioxx Victims: Fight Back!"

Lawyers across the country have begun signing up patients who believe they were injured after taking Vioxx, a popular painkiller. The onslaught of ads began soon after New Jersey-based drugmaker Merck recalled Vioxx on Sept. 30.

Merck's announcement is expected to spark hundreds of lawsuits in Florida and thousands across the country. The company could lose billions of dollars.

"The phone is ringing off the hook," said lawyer James Hooper, who has offices in Tampa and Orlando. "And we aren't even advertising."

Vioxx, often prescribed to arthritis sufferers, burst onto the market in 1999. Along with similar drugs, it was lauded as a breakthrough in pain relief, since it did not cause the stomach ailments associated with some other painkillers.

Merck aggressively marketed Vioxx, earning $2.5-billion in worldwide sales in 2003. About 20-million patients took the drug in the United States, with 1.3-million still taking it last month, the company said. It was the largest voluntary drug recall in history.

The study that forced Merck to act showed that people who took the drug for more than 18 months had nearly two times the chance of experiencing serious cardiovascular problems as those on placebo pills.

It's unclear at this point exactly how many Vioxx users fall into that category.

Hooper and several other lawyers said research suggests the number could be in the 25,000 to 30,000 range.

The study in question was commissioned to look at the effectiveness of Vioxx in preventing the recurrence of colorectal polyps. Only incidentally did it unearth the increased risk of heart attacks and stroke.

For that reason, it's unclear right now whether other Vioxx patients, say those who used it for six months, might also have been at risk, said Pinellas Park lawyer Joseph H. Saunders. Merck might even argue that the data is suspect since the study did not specifically focus on strokes or heart attacks, Saunders said.

"Both sides will pull together more studies to see if conclusions can be drawn," Saunders said. "Then we will have a better idea of how many people could be affected."

Vioxx usage and cardiovascular problems aren't necessarily a slam dunk case.

Asbestos cases, for instance, had a signature injury, a form of cancer rarely diagnosed in anyone not exposed to asbestos. In the case of Baycol, a recalled cholesterol-lowering drug, injured users suffered from a rare muscle-wasting condition.

But heart attacks and strokes are also common in people who didn't take Vioxx. Pre-existing conditions will work against Vioxx users. Smokers, diabetics and the obese, for instance, could have a difficult time convincing Merck or a jury that Vioxx caused their injuries.

"The heavy lifting in cases like this comes in figuring out who has really suffered debilitating problems because they took the drug," Hooper said. "Some cases will be clear-cut, like a 40-year-old nonsmoker in good health who takes the drug and then has a heart attack. Others aren't so easy."

Merck officials have already indicated that they will use the voluntary recall to show that they acted responsibly.

They stressed that they knew of no deaths that could be attributed to the drug.

Janet Skidmore, a Merck spokeswoman, said the company took immediate action upon finding out the results of the study.

She said the company had many "meritorious defenses," though she would not elaborate.

"Merck has always acted in the best interest of its patients," Skidmore said.

The recall, though, was not a complete surprise to some industry observers.

Vioxx users reported serious problems with the drug early on. In 2002, the Food and Drug Administration required Merck to add additional warnings to Vioxx labels. Earlier this year, the agency received an overview of a study that linked Vioxx to increased risk of stroke and heart attacks. And before the recall, about 200 patients filed lawsuits that claimed Vioxx had caused them injuries.

Tampa lawyer John Newcomer, who has signed up Vioxx patients, said the company knew about problems with the drug for years and only just now acted to do anything about it.

"It's an incident of greed trumping science," he said.

The first few cases will likely go to trial, Newcomer said. After that, Merck will decide which cases are defensible and which they should settle. If enough cases get filed, much of the litigation could be consolidated under one federal judge. The consolidation cuts down on costs and hastens resolution.

The company could then decide to offer a mass settlement.

Litigants can opt in and take their share of the money, normally based in part on the level of disability, or they can opt out and pursue their cases.

Drugmaker Bayer AG, for instance, has paid nearly $1.1-billion to settle more than 2,800 cases related to the 2001 withdrawal of Baycol. The company recalled the drug after studies linked it to a muscle-wasting syndrome and about 100 deaths. About 7,500 Baycol suits are still pending, according to the company.

And Wyeth, another drugmaker, has already paid nearly $17-billion in litigation and settlement costs since the recall of its once popular diet drug fen-phen.

More people took Vioxx than Baycol or fen-phen. But the hurdles in linking Vioxx use to heart attacks or strokes could limit the number of cases, Saunders said.

"I think this will be hotly contested litigation," Saunders said.

-- Times news researcher Cathy Wos contributed to this report. Graham Brink can be reached at brink@sptimes.com or 813 226-3365.

[Last modified October 18, 2004, 02:10:34]


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