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No wonder Merck kept Vioxx on the market for four years after a study first disclosed an increased risk of heart attack or stroke in some patients. No wonder Pfizer is determined to keep both Celebrex and Bextra on the market despite similar findings for both drugs.

But why, exactly, is our government allowing that to happen? How many other drugs already are on the market without having been evaluated adequately for safety?

Last week, Sen. Charles Grassley, R-Iowa, chairman of the Senate Finance Committee, called for an independent federal panel, similar to the 9/11 Commission, to investigate drug safety. It was recognition, far too long in coming, that things have gone terribly wrong at the Food and Drug Administration.

If just one or two minor issues had arisen, we might expect Congress to get to the bottom of this mess. But so many serious problems have come to light in recent years that there must be a complete independent review; one that cannot be influenced by millions of dollars in pharmaceutical company campaign contributions.

But not everyone agrees. The Bush administration was quick to reassure Americans over the weekend. White House Chief of Staff Andrew H. Card said that the FDA is doing a "spectacular" job.

"I've got great confidence in the FDA," Card said. The disclosure of safety risks from taking those arthritis drugs "is a testament to the FDA in how they do their job."

It would be, if in fact the FDA had detected those risks and acted upon them. But the FDA played very little role in getting Vioxx off the market, aside from suppressing research showing increased risks of heart attack and stroke.

In fact, the real power that drove Vioxx from the market was personal injury lawyers. If Bush has his way with tort reform, we won't be able to count on pressure from the legal system to police the marketplace.

From contaminated flu vaccine to antidepressants that are useless or worse in young people, the once respected federal drug agency has stumbled badly in recent years. An internal survey of FDA scientists released last week found that two-thirds have doubts about the agency's monitoring of drugs already on the market. A third expressed doubts about the adequacy of safety checks on new drugs.

Earlier this month, the influential Journal of the American Medical Association joined the chorus of voices urging reform. In an editorial for the Dec. 1 edition, the Journal called for creation of an independent agency to monitor the safety of medications already approved. That is an appropriate way to address the problem of monitoring drugs already on the market.

The one advantage in COX-2 inhibitors, their makers always claimed, was that they were less likely to cause serious stomach problem than were the older drugs. But some studies found that as few as one quarter of the drugs' users were at risk for those stomach problems.

In the end, the greatest tragedy about Vioxx, and perhaps Celebrex and Bextra as well, isn't the billions of extra dollars that consumers and their insurance companies have paid for these drugs. Rather, it's that many patients who ended up suffering heart attacks and strokes would have gotten the same relief - without the risk - by simply taking ibuprofen or aspirin.

Winds of litigation swirl around Merck

By LEWIS KRAUSKOPF
STAFF WRITER

PHILADELPHIA - January 23, 2005 - A gathering storm of litigation over the withdrawn drug Vioxx passed through this city last week and could be unleashed as soon as this spring. About 250 lawyers from across the country took part in a litigation conference on the painkiller, which Merck & Co. removed from the market Sept. 30 after a clinical trial showed it doubled the risk of heart problems.

Merck has said 475 personal-injury cases involving Vioxx had been filed against the company as of Nov. 30, but attorneys attending the Philadelphia conference came armed with many more potential plaintiffs. They heard scientific perspectives on Vioxx, strategic advice - and a good portion of outrage expressed at Merck from some of the leading lawyers involved in the litigation. "The liability picture, from a corporate conduct standpoint, we feel, is very, very strong," said Andy Birchfield, one of the chairmen of the Philadelphia conference, told attendees in his opening remarks.

Birchfield, an attorney with the firm Beasley Allen of Montgomery, Ala., may have the first Vioxx case to go to trial, expected to begin as soon as May in Alabama. The conference's other chairman, Christopher Seeger of the New York-based firm Seeger Weiss, said a trial could begin as soon as June in Atlantic County court in New Jersey. Merck has said it would defend itself "vigorously," which was reiterated in a statement handed out by a company representative at the conference. "Merck believes it has strong and meritorious defenses and intends to vigorously defend all of the personal injury cases on an individual basis," the Merck statement said. "We expect to be trying these cases over many years."

The two-day meeting hosted by Mealey's, a division of Lexis-Nexis - which held a similar conference in California in November - offered attorneys a chance to bone up on the pharmacology of Vioxx, theories of liability and issues involving expert witnesses, among other topics that figure to play a role in the evolving litigation.

A smattering of financial analysts and representatives from the insurance industry attended, as did at least one defense attorney uninvolved with Vioxx who simply wanted to learn more about pharmaceutical litigation. But mostly, it was a plaintiffs' party. "When you're handling a large volume of cases ... you want to make sure you're as fully prepared as possible," Michael Galpern, an attorney with the Locks Law Firm in Cherry Hill, said in explaining his attendance.

Another attendee, Roger Orlando, an attorney in Decatur, Ga., said he has been involved with other pharmaceutical-related litigation including withdrawn fen-phen and Baycol drugs, and that Vioxx represented a stronger case compared with most. Orlando's firm opened a New Jersey office in Brick this year so it could file cases in Atlantic County, he said, keeping the litigation in state court where proof levels are not as high as in federal court, and where he likes the jury pool.

The first Vioxx cases will be closely watched as they could build momentum for one side. Birchfield said in an interview that all of the plaintiffs are served by putting the best cases forward. A theme at the conference was the challenge of proving that Vioxx caused the injuries suffered by their clients. A number of risk factors are involved with heart problems - old age, hypertension, high cholesterol and smoking, to name a few.

Several attorneys said they attended the conference to learn how to weed out the clients whose injuries would be most difficult to link to Vioxx. Carlene Rhodes Lewis, a Texas attorney who has been involved in Vioxx litigation since 2001 and may have one the first cases to go to trial, told attendees: "The battlefront in these cases has been general and specific causation. "Merck is placing every plaintiff under the microscope," she said.

Amid the optimism expressed about the case against the drug giant, James Tyrrell, managing partner for the Latham & Watkins in Newark, provided a sobering note. A defense attorney uninvolved in the Vioxx matter, Tyrrell told attendees that they face major hurdles, for example, in showing that their scientific and other evidence is solid enough even to reach a jury.

"These cases are not a lay down," Tyrrell said. "I don't see these cases as being resolved quickly."

E-mail: krauskopf@northjersey.com

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