Friday, December 02, 2005

1st federal Vioxx trial focuses on Fla. man's death

HOUSTON -- A lawyer representing the widow of man who claims that Merck & Co.'s Vioxx caused her husband's death argued yesterday that taking the pain reliever for one month was enough to cause the 53-year-old man's heart attack.
Merck countered in opening statements at the first federal Vioxx trial that its extensive studies of the painkiller before introducing it in 1999 showed no evidence it caused heart attacks with short-term use, and that heart disease, not Vioxx, led to Richard Irvin's death.
Unlike the two previous state-level cases where Merck emerged with a loss and then a win after several weeks, the federal case before US District Judge Eldon Fallon of New Orleans got off to a quick start.
It took less than two hours to pick a jury of five men and four women, three of whom are alternates. Opening statements for the plaintiff -- Irvin's widow, Evelyn Irvin Plunkett -- took less than an hour and Merck's opening didn't take much longer.
The case is in Houston rather than its original venue of New Orleans because of damage from Hurricane Katrina. Jurors will be asked to decide whether Vioxx contributed to the fatal heart attack Irvin suffered in May 2001. Irvin, a manager of a wholesale seafood distributor in St. Augustine, Fla., had been taking the drug for about a month to alleviate back pain when his co-workers found him dead at his desk.

Judging the Jury

Why the tsunami of litigation against drugmaker Merck over the Vioxx recall may hurt consumers more than the corporation allegedly at fault.
Nov. 30, 2005 - Most people supposedly hate attorneys. Indeed, Shakespeare once wrote: "First thing we do, let's kill all the lawyers." Now, I'm not advocating violence in any way, but the reputation of the legal profession hasn't changed all that much over the years. All you have to do is look at any poll and you'll find it at or near rock bottom in the public's opinion (along with, I'm afraid to say, working journalists).
Why then do people continue to side with lawyers who demand huge awards for product-liability lawsuits? I raise this question after reading the latest news about Merck & Co., the third-largest U.S. drug manufacturer. The company recently announced that it's cutting 11 percent of its workforce, around 7,000 jobs, in large part because of a massive, potential liability stemming from its once-popular painkiller Vioxx.
Merck pulled the drug last year after a study showed that Vioxx could increase the risk of heart attacks in some patients. But the company didn't remove the drug fast enough to save Robert Ernst, who died of heart complications after taking the drug. In August, a Texas jury found Merck liable for Ernst's death and awarded his family one of the largest punitive-damage awards in the history of product liability--$253 million. Merck's problems don't end there; the company faces more than 6,000 other Vioxx related lawsuits, and tens of billions of dollars in potential damages once all is said and done.
You might be tempted to say, as apparently the jury did, that Merck got what it deserved. Ernst was a 59-year-old triathlete with no history of heart trouble, at least according to his lawyer Mark Lanier. As Lanier told me while we were both guests on the CNBC business network several weeks ago, Ernst "wasn't one pork chop away from a heart attack."
With facts like those, it's easy to see how jury sided with the plaintiff. I wasn't in the courtroom, but from what I read, Lanier put on quite a show; he was masterful at depicting Merck's alleged negligence, asserting that the company ignored data showing that Vioxx could cause heart attacks in certain people, and when it did disclose the risks, it did so in a way that most people couldn't really understand. Lanier doubles as a Baptist minister (during the trial, he made repeated references to the Bible), and this Bible-belt jury clearly ate up his down-home logic, particularly compared to the robotic performance of Merck's legal team, which never seemed to connect with jurors and may have angered some with its tough cross examination of Ernst's widow.
Well, I'm here to tell you that the Vioxx case is plenty more complicated that Lanier lets on, and unfortunately for all of us, its impact will be felt by far more people than the 7,000 Merck employees who will soon lose their jobs. Start with some of the facts surrounding Robert Ernst, the alleged victim in the first Vioxx case. Ernst may have been a triathlete as his lawyer loves to point out, but he was once a smoker and had clogged arteries. In other words, he probably wasn't a "pork chop away from a heart attack," but he wasn't the picture of health, either.
Several legal experts say for these reasons and others (Texas is supposed to be the home of big jury awards but it also has a cap on punitive damages) the Ernst award will be slashed from $253 million to closer to $25 million. Even so, you won't hear Merck or its employees cheering. It's likely that Merck will have to fight thousands of additional lawsuits from people who say they were harmed one way or another by the drug. And if the fact pattern in the Ernst case can generate such a huge award, there's no telling how much more money Merck will be forced to pay in the coming years.
Some analysts say the company could ultimately shell out between $18 billion to $50 billion in judgments, settlements and legal fees related to Vioxx--more than six times the $5 billion in annual revenue company earned last year. But history also shows those numbers are likely to be low. James Copland, director of the Center for Legal Policy at the Manhattan Institute who has studied the history of jury awards, says the final liability “almost always blows past the initial estimates." In other words: if you think that the loss of 7,000 jobs is messy, that's going to look like a drop in the bucket once those 6,000 lawsuits are finished and the final tab is computed.
To be sure, Merck's problems go beyond Vioxx. The company's patent on another popular drug, Zocor, which reduces cholesterol, is ending next year, leaving it open to competition from generic drug manufacturers. Maybe more problematic: Merck isn't the center of drug innovation; analysts say the company has few promising drugs in its pipeline.
Even so, you can't underestimate the impact such a big liability will have on the company. Developing new drugs is a costly business, and all those legal bills will certainly eat into the firm's R&D budget. Merck, meanwhile, won't lose every case it fights--earlier in the month, a jury in New Jersey found that the company had adequately disclosed the health risks associated with Vioxx, and ruled in its favor. But even if Merck manages to win half of the cases it now faces, analysts say its price tag will still be enormous, forcing even more cost cutting (read: job cuts). Merck's stock has already dropped 70 percent in the last five years. If the company fails to find another miracle drug to improve its bottom line, bankruptcy may not be far away.
Which brings me to my larger point: when are juries going to take into account the economic costs of their action? I'll be the first to admit that sometimes it's easier to hate corporate America even more than all those loathsome lawyers (or for that matter, nerdy journalists). I, for one, have made a career exposing the duplicity and corruption of Wall Street's top firms, and I'll be the first to side with any plaintiff that has a clear-cut case of fraud.
But such black-and-white cases, at least in my experience, have been rare. I've covered some of the biggest Wall Street scams over the past 15 years, and in almost every case, the alleged "victims" allowed themselves to be victimized one way or another. Some were greedy and chose to roll the dice with risky investments peddled by sleazy Wall Street brokers, while others were plain-old stupid, ignoring every warning sign or doing minimal homework before throwing their money away. This is not to say that Robert Ernst's family deserves no money, but given the facts of his particular case, is his $253 million award against Merck justified? And what does that mean for Merck's future given the 6,000 other Vioxx cases that could be decided in the plaintiff's favor with a similar fact pattern?
Maybe the best solution to the problem is to allow all those average Americans who sit on juries hear what these massive jury awards cost other average Americans. The U.S. Chamber of Commerce estimates that each year legal costs drain $230 billion from the economy. It's known as a "dead-weight cost" because it's merely a transfer of wealth from corporate America to plaintiffs, and disproportionately, their attorneys. Then let them hear how outsized awards can destroy a company that employs tens of thousands of people and may someday find a cure for cancer or AIDS. Maybe then they'll start listening less to lawyers.
Editor's note: Charles Gasparino is leaving NEWSWEEK to become an on-air editor for CNBC's financial news program "Squawk Box." However, he will continue writing his Street Fighting column as a contributor to NEWSWEEK.com.

Merck Dealt Setback as Federal Judge Rules Jury Will View Video Deposition of Leading Cardiologist and Long-Time Vioxx Critic

Merck’s Legal Team Will Have to Confront and Neutralize the Compelling Testimony of a Formidable Medical Expert and One of Vioxx’ Longest-Standing and Harshest Critics if It Hopes to Prevail in First Federal Trial
It really is no secret that Merck will continue to face a mountain of damaging evidence in every Vioxx case it tries. The litigation (now almost 8,000 cases) has already damaged the company’s credibility and financial stability and has hastened a major corporate restructuring that includes massive firings and numerous facility closings.
Although each case is dependent on expert scientific testimony to advocate each side’s medical theories, the underlying categories into which the cases fall are surprisingly few. There are the (1) short-term-use cases (estimated to be about 25% of the total), and (2) long-term-use cases. In each of those categories are; (1) death cases, or (2) cases where the plaintiff survived but suffered serious permanent injuries. Finally, the length of use and extent of injuries can be subdivided one more time into cases where; (1) the plaintiff was suffering from conditions that, in and of themselves or cumulatively, could have caused the cardiovascular event attributed to Vioxx use; or (2) the plaintiff was otherwise heart-healthy and free of complicating medical problems.
As the trials are organized and scheduled by the judges charged with supervising large numbers of cases (N.J. state judge Carol Higbee and U.S. District Judge Eldon E. Fallon) many elements that may have favored Merck has been systematically eliminated.
In New Jersey, Judge Higbee, who controls the progress of some 3,500 Vioxx cases pending in that state, has ordered the next 10 trials involve plaintiffs who took Vioxx for at least 18 months. The judge denied Merck’s motion challenging that decision
That ruling is quite significant in that Merck itself has already acknowledged the existence of an increased risk of heart attacks in long-term Vioxx users and even pulled the drug from the market for that very reason.
Thus, legal analysts see Judge Higbee’s ruling as one that will make it very difficult for Merck to duplicate its recent short-term-use victory in those upcoming “long-term-use” cases.
Merck was therefore pinning its hopes on the short-term-use case now on trial in U.S. District Court in Houston. That apparent advantage vanished, however, when that U.S. District Court Judge Eldon E. Fallon ruled that the plaintiff will be permitted to offer expert testimony that even short-term use of Vioxx carries with it an increased risk of cardiovascular problems including heart attack.
Judge Fallon based his decision on the fact that the very same scientific evidence is being interpreted differently by each side’s highly qualified experts. Thus, there is no basis for the court alone to decide which experts are more credible or whether Merck has eliminated the issue of causation to the point where it should not be submitted to a jury for determination.
Thus, many of the “loose ends” that permitted Merck to boast of its intention to try each case to verdict have been tied up. The “wiggle-room” has been eliminated and all that remains is the evidence with respect to (1) Vioxx as an unsafe drug, and (2) the individual plaintiffs’ medical conditions. While the health of each plaintiff will always remain an attack point for Merck, very few legal analysts see the evidence as being anything but lopsided against Merck on the question of safety and the way in which Vioxx was marketed.
What all of this leads inescapably to is that Merck is in deep trouble if it is forced to confront the ghosts in Vioxx’ past. Those ghosts take the form of: (1) massive scientific evidence placing the cardiovascular safety of COX-2 inhibitors (generally) and Vioxx (specifically) in question; (2) extensive internal documentation from Merck’s own files that cast doubt on both the safety of the drug and Merck’s motives for many of its corporate decisions and marketing strategies involving Vioxx; and (3) long-time critics of the drug who are eminently qualified scientific experts and not simply consumer advocates.
From the beginning of the Vioxx saga the two constants that Merck has feared the most are (1) the paper trail of negative evidence, and (2) Dr. Eric Topol, chairman of cardiovascular medicine at the world-renowned Cleveland Clinic.
Until now, Dr. Topol has been silent, having not been asked to testify at either of the prior state court trials in Texas and New Jersey. As the first federal trial got under way, however, Judge Fallon ruled the jury will be allowed to see a videotaped deposition from Dr. Topol himself.
In that deposition (taken last week), Dr.Topol openly accused Merck of scientific misconduct, misrepresenting facts and endangering patients. He also testified that Merck's former chief executive complained to a top Cleveland Clinic official about his activities.
In order to understand the significance of Dr. Topol’s entry into the litigation, one must consider the earliest evidence that Vioxx was a potentially dangerous drug and how Dr. Topol was immediately concerned about the cardiovascular risks posed by Vioxx and its COX-2 siblings.
Going back as far as 1996, the evidence is clear and consistent when it comes to the potential risks posed by Vioxx and the other COX-2 inhibitors like Bextra and Celebrex.Many critics believe that included withholding critical and damaging data and other information from the FDA and the public.
On Nov. 21, 1996, a Memo by a Merck official shows the company wrestling with the issue of Vioxx' (Rofecoxib) involvement in increased cardiovascular events. At this early date, Merck avoided a trial to prove Vioxx gentler on the stomach than older painkillers because in such a trial, "there is a substantial chance that significantly higher rates" of cardiovascular problems would be seen in the Vioxx group.
On February 25, 1997, an internal Merck e-mail warned that if a proposed Merck trial was carried out "you will get more thrombotic events" - more blood clots - "and kill [the] drug."
In response, Alise Reicin, later a Merck vice president for clinical research said in an e-mail that the company was in a "no-win situation." She went on to propose that people with high risk of cardiovascular problems be kept out of the study so the difference in the rate of cardiovascular problems between the Vioxx patients and the others "would not be evident."
On November 18, 1999 a meeting of the Data and Safety Monitoring Board (DSMB) discussed concerns over the "excess deaths and cardiovascular adverse experiences" that was observed in the group using Vioxx as compared to the patients taking Naproxen.
On March 9, 2000, Merck's research chief, Edward Scolnick, e-mailed colleagues that the cardiovascular events "are clearly there" and stated "it is a shame but it is a low incidence and it is mechanism based as we worried it was."
Worried about the affect on Vioxx, Dr. Scolnick wrote that he wanted other data available before the results were presented publicly, so "it is clear to the world that this" was an effect of the entire Cox-2 class, not just Vioxx.
That same month, however, the company's public statements continued to reject the link between Vioxx and increased intrinsic risk. Merck made no mention that the study found a "mechanism based" connection between Vioxx and the statistically significant increase in cardiovascular events.
The VIGOR study (VIGOR - Vioxx® Gastrointestinal Outcomes Research) sponsored by Merck was submitted to the FDA in June 2000. The study was primarily designed to look at the effects of Vioxx on side effects such as stomach ulcers and bleeding.
While the study showed that patients taking Vioxx had fewer stomach ulcers and bleeding than patients taking another drug, Naproxen, it revealed a statistically significant increase in the number of cardiovascular events (over 100% increase), myocardial infarctions/heart attacks (approx. 400% increase) and strokes in patients who have taken Vioxx compared to those receiving Naproxen.
The VIGOR study was published in the November 2000 issue of the New England Journal of Medicine but did not provide detailed information about other serious cardiovascular complications such as strokes or blood clots.
In February, 2001, a letter by Dr. James Fries, senior professor and medical doctor from Stamford University Medical School to Merck complained about the intimidation by Merck's investigators including the threatening of the loss of funding because of the school's discussion of cardio-vascular events associated with Vioxx.
On February 1, 2001, a Memo by Dr. Shari L. Targum, Medical Officer, Division of Cardio-Renal Drug Products of the FDA documented the serious cardiac events and myocardial infarctions and related deaths for participants in the study who were using Vioxx.
She also discussed the November 18, 1999 meeting of the Data and Safety Monitoring Board (DSMB) where concern was raised over the "excess deaths and cardiovascular adverse experiences" in the group using Vioxx as compared to the patients taking Naproxen.
On February 8, 2001, the FDA Arthritis Advisory Committee Meeting discusses the VIGOR study expressed concern over the unexpected findings of cardiovascular risks and myocardial infarctions associated with the use of Vioxx that was disclosed in the VIGOR study. Merck eventually was required (April, 2002) to add some of the data as to cardiovascular events to their label.
On August 22, 2001, the concerns arising out of the VIGOR study were crystallized by Drs. Debabrata Mukherjee, Steven Nissen, and Eric Topol in Journal of the American Medical Association (JAMA) in their review paper specifically highlighting the cardiovascular side-effect profile of COX-2 inhibitors. The doctors indicated that Vioxx was linked to a 200% increase in blood clots, heart attacks and strokes based on their review of previous clinical trials.
In August of 2002, Dr. Topol and Dr. Falk, a Cleveland Clinic gastroenterologist, published an editorial in The Lancet, encouraging further warnings and labeling regarding the cardiovascular effects of Cox-2 drugs. Even following these warnings, and in the face of mounting evidence for the cardiovascular side-effects of Vioxx, aggressive direct-to-consumer marketing of Vioxx continued unabated.
Immediately after Vioxx was pulled from the market, Dr. Topol, Chief of Cardiovascular Medicine and Chief Academic Officer of the Cleveland Clinic, who was a co-author of the VIGOR Study discussed above told the Washington Post (10/1/04) that Merck’s action was “the right decision about three years too late. This is the sort of thing that Merck should have studied earlier, but they were too busy refuting the warning signs.”
According to The Wall Street Journal, in his deposition, “Dr. Topol countered several crucial aspects of Merck's defense in the Vioxx litigation. Legal observers say it is almost certain that aspects of Dr. Topol's testimony will be used in the wider litigation. A transcript of the sealed deposition was reviewed by The Wall Street Journal.” In addition, “Dr. Topol said that a colleague at the Cleveland Clinic, Richard Rudick, the director of clinical research, told him that Raymond Gilmartin, the former chief executive and chairman of Merck, called a Cleveland Clinic board of trustee member to complain about Dr. Topol. The call came in mid-October 2004, two weeks after Merck withdrew Vioxx from the market and after Dr. Topol published harsh criticisms of Merck over Vioxx in the New York Times and the New England Journal of Medicine.”
Clearly, Dr. Topol is both a formidable expert to reckon with and not just a “hired gun” brought on board by the plaintiff to bolster the case. In fact, he shuns testifying as much as possible.
He was blowing the whistle on Vioxx and the COX-2 inhibitors long before the public and medical community as a whole were even aware of the potential disaster looming ahead. Thus, he cannot be painted as a “Johnny come lately” or as someone with a predisposition against Merck or Vioxx. First and foremost, however, he is a respected expert in his field with impeccable credentials and the very last person Merck wanted to confront in this trial.

First federal Vioxx trial gets under way with opening statements

First federal Vioxx trial gets under way with opening statementsTHERESA AGOVINOAssociated Press
HOUSTON - A lawyer representing the widow of man who claims that Merck & Co.'s Vioxx caused her husband's death argued on Tuesday that taking the pain reliever for one month was enough to cause the 53-year old man's heart attack.
But Merck countered in opening statements at the first federal Vioxx trial that its extensive studies of the painkiller before introducing it in 1999 showed no evidence it caused heart attacks with short-term use, and that heart disease, not Vioxx, led to Richard "Dicky" Irvin's death.
Unlike the two previous state-level cases where Merck emerged with a loss and then a win after several weeks, the federal case before U.S. District Judge Eldon Fallon of New Orleans appeared to rush along at a headlong pace.
It took less than two hours to pick a jury of five men and four women, three of whom are alternates. Opening statements for the plaintiff - Irvin's widow, Evelyn Irvin Plunkett - took less than an hour and Merck's opening didn't take much longer. Testimony was expected to begin as well.
The case is in Houston rather than its original venue of New Orleans because of damage wrought by Hurricane Katrina.
Jurors will be asked to decide whether Vioxx contributed to the fatal heart attack Irvin suffered in May 2001. The 53-year-old manager of a wholesale seafood distributor in St. Augustine, Fla. had been taking the drug for about a month to alleviate back pain when his co-workers found him dead at his desk.
"There was nothing that would have triggered a fatal heart attack except for Vioxx," Plunkett's attorney Andy Birchfield told jurors.
This is the third trial Merck is facing over Vioxx's safety. It lost the first state trial in Texas last August, but scored a victory in its home state of New Jersey earlier this month.
Whitehouse Station, N.J.-based Merck withdrew Vioxx from the market in September 2004 after a long-term study showed the drug doubled risk of heart attack or stroke if taken for 18 months or longer. By then, more than 20 million Americans had used Vioxx.
Birchfield told jurors that Merck likes to cherry pick the 18-month hallmark to demonstrate that the drug could not have caused problems in patients who took it for a shorter time. But he told jurors a study showed Vioxx can cause problems after just seven days.
He said that Merck knew about Vioxx's safety problems before it was launched. Birchfield quoted from internal e-mails, including some from Merck scientists who raised warning flags about its cardiovascular risks, to support his assertions.
Merck made a "premeditated, financial decision" not to warn patients about the drug's risks because it wanted the revenue the former $2.5 billion seller would generate, and longed to beat Pfizer Inc.'s competing drug Celebrex in the marketplace, Birchfield said.
Merck's lawyer, Phil Beck, told jurors that Vioxx didn't trigger Irvin's heart attack and that the company acted responsibly at all times in its development and marketing of the drug.
"There is no evidence of short term use (of Vioxx) causing heart attacks," Beck said.
He spent the better part of his allotted hour for opening statements explaining to jurors how pain relievers work, and how Vioxx was a major advance because it was gentler on the stomach that other treatments such as aspirin.
"Mr. Irvin's problem was not that he took Vioxx, it was that he had coronary heart disease," Beck said.
Beck said coronary heart disease is common in men like Irvin - in their 50s and slightly overweight. He told the jury that in the sixty minutes he would talk, 60 people would die from clogged arteries. Beck added that Irvin had a particular type of plaque that was prone to rupture and to cause blood clots.
Birchfield had said during his opening that Irvin had 60 percent blockage in an artery, but that wouldn't have been enough to cause a heart attack.
Irvin's health status is expected to be a crucial factor in the trial.
In court filings, his widow says he was in "very good health" when he began taking Vioxx. Merck has noted that he received a Vioxx prescription from his son-in-law - an emergency room physician - without a checkup.
Also, Irvin's autopsy said he had moderate to severe clogged arteries, and a blood clot in a major coronary artery caused an irregular heartbeat and death.
Merck claims the clot formed when some of that plaque ruptured with no help from Vioxx. Plunkett alleges Vioxx - which inhibits an enzyme that promotes inflammation and thins the blood - led to the clot formation.
The company faces about 7,000 state and federal lawsuits and analysts have estimated its liability could reach $50 billion.

Jury Chosen In First Federal Vioxx Trial

HOUSTON -- The first federal trial over the painkiller Vioxx is under way.
A jury was chosen Tuesday in Houston in a trial that will determine whether the drug caused the death of a 53-year-old man.
The case centers on the May 2001 death of Richard "Dicky" Irvin Jr., a Florida man who had a fatal heart attack a month after he started taking Vioxx to alleviate back pain. His wife, Evelyn Irvin Plunkett, claims in her lawsuit that her husband was in "very good health" when he started taking the once-popular painkiller, reported KPRC-TV in Houston.
Merck, the maker of the drug, maintains that Vioxx didn't cause Irvin's death because he was taking it for such a short time.
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Merck, based in Whitehouse Station, N.J., pulled Vioxx from the market in September 2004 after a study showed it could double the risk of heart attack or stroke if taken for 18 months or longer. The drug, prescribed to relieve acute pain and arthritis while cutting the risk of stomach bleeding, went on the market in 1999 and reached peak sales of $2.5 billion a year.
In the first two Vioxx cases to go to trial on the state level, the company lost one case in Texas, but successfully defended itself in a New Jersey trial.
This trial, which is expected to last two weeks, is being heard in Houston instead of in its original venue of New Orleans because of the damage from Hurricane Katrina.
Four women and five men were chosen for the jury. Three are alternates.
Merck faces about 7,000 state and federal lawsuits and billions of dollars in potential payouts for judgments, settlements and legal fees.
Merck has vowed to fight most of litigation, though the company has said it will consider settling lawsuits that involve long-term Vioxx usage.

First federal Vioxx trial begins

HOUSTON, Texas (AP) -- The first federal Vioxx trial began Tuesday as a jury was chosen in a case that would determine if Merck & Co.'s once-popular painkiller caused the death of a 53-year-old man.
The court took less than two hours to choose a four-woman, five-man jury -- three of whom are alternates.
The case before U.S. District Judge Eldon Fallon of New Orleans is in Houston rather than its original venue of New Orleans because of damage by Hurricane Katrina.
The case pits the widow of Richard "Dicky" Irvin, who took Vioxx for about a month to alleviate back pain, against Merck, which has scored a loss in Texas and a win in its home turf of New Jersey in the first two state-level Vioxx cases. (Read)
Lawyers representing widow Evelyn Irvin Plunkett aim to prove that Merck's former blockbuster painkiller led to his death in May 2001. Plunkett says her husband, the manager of a wholesale seafood distributor of St. Augustine, Florida, was in "very good health" when he began taking Vioxx.
The company's court filings indicate Merck's defense will center on whether Vioxx could be responsible for Irvin's death when he took the painkiller for such a short time.
The plaintiffs allege some of the 58 clinical trials involving 10,000 patients that Merck conducted before Vioxx went on the market in 1999 show adverse cardiovascular effects after use as short as six weeks.
Merck, based in Whitehouse Station, New Jersey, pulled Vioxx from the market in September 2004 after a study showed the drug doubled risk of heart attack or stroke if taken for 18 months or longer.
By then, more than 20 million Americans had used Vioxx.
The company faces about 7,000 state and federal lawsuits and billions of dollars in potential payouts for judgments, settlements and legal fees.

Merck Suffers Vioxx Lawsuits Setback

A U.S. district judge's pretrial ruling against drug maker Merck and Co. means a tougher fight for the company in thousands of lawsuits involving its withdrawn painkiller Vioxx.
The Nov. 16 ruling affects the first federal trial of Vioxx, scheduled to begin Tuesday in Houston. U.S. District Judge Eldon Fallon ruled that plaintiff lawyers in the case may present evidence that brief use of Vioxx may trigger heart attacks and strokes, the Associated Press reported.
The judge rejected Merck's motion to throw out the case due to insufficient evidence. The case involves a 53-year-old Florida man who died of a heart attack after being on Vioxx for about a month.
This ruling blocks Merck's attempt to avoid having to fight thousands of federal lawsuits involving short-term use of Vioxx, legal experts said.
"It leaves Merck stuck with every dad-gum one of those cases," Houston lawyer Mark Lanier told the AP. In August, Lanier won a $253.4 million verdict for the widow of man who was a short-term user of Vioxx.
Merck has vowed to fight thousands of Vioxx liability lawsuits one by one. More lawsuits are being filed against the company. There were at least 7,875 as of last Wednesday, the AP reported.
Merck, meanwhile, announced Monday that it planned to slash 7,000 jobs, 11 percent of its workforce, and close or sell five factories worldwide in an effort to cut production costs and reduce the time it takes to get new products on the market, the Los Angeles Times reported.

Third Vioxx case begins, Merck wins in UK

Nov. 29 (UPI) -- The first federal court case based on Merck's withdrawn painkiller Vioxx --and the second in Texas -- begins Tuesday.
The plaintiff in Merck's third Vioxx showdown is the widow of a Vioxx user who claims the drug caused the 2001 death of her husband, who reportedly had taken the pain reliever for about one month.
Federal suits based on Vioxx have been consolidated and are based in a Houston federal court, moving there from New Orleans in the wake of Hurricane Katrina.
Merck is fresh off a victory against another short-term Vioxx user in an Atlantic City, N.J.-based state court last month.
In that case, the plaintiff --who had taken the drug for about two weeks -- was unable to convince the jury that Vioxx had caused his heart attack.
But Merck saw its first Vioxx-related legal defeat last August in a Texas state court, when the White House Station, N.J.-based firm was ordered to pay $253 million in damages to the widow of a longterm Vioxx user.
Meanwhile, Merck saw a legal win in Britain this week, when more than 200 Vioxx plaintiffs lost their legal aid appeal, according to a BBC report issued Tuesday.
The ruling means many U.K. plaintiffs will no longer be able to mount compensation claims in British courts, the report said.
The British court overseeing the Vioxx cases also denied the insurance needed to pursue a claim on a no-win, no-fee basis, BBC said.
"The fact that we have not been able to achieve any sort of funding package to allow these cases to go ahead spells the end of drug litigation in this country," said Martyn Day, of London-based Leigh Day & Co Solicitors, who represented the plaintiffs.

First federal Vioxx trial gets under way with opening statements

HOUSTON - A lawyer representing the widow of man who claims that Merck & Co.'s Vioxx caused her husband's death argued on Tuesday that taking the pain reliever for one month was enough to cause the 53-year-old man's heart attack.
But Merck countered in opening statements at the first federal Vioxx trial that its extensive studies of the painkiller before introducing it in 1999 showed no evidence it caused heart attacks with short-term use, and that heart disease, not Vioxx, led to Richard "Dicky" Irvin's death.
Unlike the two previous state-level cases where Merck emerged with a loss and then a win after several weeks, the federal case before U.S. District Judge Eldon Fallon of New Orleans appeared to rush along at a headlong pace.
It took less than two hours to pick a jury of five men and four women, three of whom are alternates. Opening statements for the plaintiff - Irvin's widow, Evelyn Irvin Plunkett - took less than an hour and Merck's opening didn't take much longer. Testimony was expected to begin as well.
The case is in Houston rather than its original venue of New Orleans because of damage wrought by Hurricane Katrina.
Jurors will be asked to decide whether Vioxx contributed to the fatal heart attack Irvin suffered in May 2001. The manager of a wholesale seafood distributor in St. Augustine, Fla., had been taking the drug for about a month to alleviate back pain when his co-workers found him dead at his desk.
"There was nothing that would have triggered a fatal heart attack except for Vioxx," Plunkett's attorney Andy Birchfield told jurors.
This is the third trial Merck is facing over Vioxx's safety. It lost the first state trial in Texas last August, but scored a victory in its home state of New Jersey earlier this month.
Whitehouse Station, N.J.-based Merck withdrew Vioxx from the market in September 2004 after a long-term study showed the drug doubled risk of heart attack or stroke if taken for 18 months or longer. By then, more than 20 million Americans had used Vioxx.
Birchfield told jurors that Merck likes to cherry pick the 18-month hallmark to demonstrate that the drug could not have caused problems in patients who took it for a shorter time. But he told jurors a study showed Vioxx can cause problems after just seven days.
He said that Merck knew about Vioxx's safety problems before it was launched. Birchfield quoted from internal e-mails, including some from Merck scientists who raised warning flags about its cardiovascular risks, to support his assertions.
Merck made a "premeditated, financial decision" not to warn patients about the drug's risks because it wanted the revenue the former $2.5 billion seller would generate, and longed to beat Pfizer Inc.'s competing drug Celebrex in the marketplace, Birchfield said.
Merck's lawyer, Phil Beck, told jurors that Vioxx didn't trigger Irvin's heart attack and that the company acted responsibly at all times in its development and marketing of the drug.
"There is no evidence of short-term use (of Vioxx) causing heart attacks," Beck said.
He spent the better part of his allotted hour for opening statements explaining to jurors how pain relievers work, and how Vioxx was a major advance because it was gentler on the stomach that other treatments such as aspirin.
"Mr. Irvin's problem was not that he took Vioxx, it was that he had coronary heart disease," Beck said.
Beck said coronary heart disease is common in men like Irvin - in their 50s and slightly overweight. He told the jury that in the sixty minutes he would talk, 60 people would die from clogged arteries. Beck added that Irvin had a particular type of plaque that was prone to rupture and to cause blood clots.
Birchfield had said during his opening that Irvin had 60 percent blockage in an artery, but that wouldn't have been enough to cause a heart attack.
Irvin's health status is expected to be a crucial factor in the trial.
In court filings, his widow says he was in "very good health" when he began taking Vioxx. Merck has noted that he received a Vioxx prescription from his son-in-law - an emergency room physician - without a checkup.
Also, Irvin's autopsy said he had moderate to severe clogged arteries, and a blood clot in a major coronary artery caused an irregular heartbeat and death.
Merck claims the clot formed when some of that plaque ruptured with no help from Vioxx. Plunkett alleges Vioxx - which inhibits an enzyme that promotes inflammation and thins the blood - led to the clot formation.
The company faces about 7,000 state and federal lawsuits and analysts have estimated its liability could reach $50 billion.

Presto: A new Vioxx Liability Estimate

NEWS: ANALYSIS & COMMENTARY Presto: A New Vioxx Liability Estimate! Why analysts' reports shift wildly with every twist in litigation against Merck Fifty billion dollars is a pretty eye-catching number. So it got plenty of notice in August when stock analyst David Moskowitz issued a report saying that's what Merck & Co. (MRK ) ultimately may have to pay in the thousands of Vioxx personal-injury lawsuits it faces. A Texas jury had just handed the drugmaker a stinging defeat in the first lawsuit to go to trial involving the now-withdrawn blockbuster painkiller. Merck faced up to $26 million in liability for that case alone.
On Nov. 3 in New Jersey, Merck prevailed in its second Vioxx trial, and Moskowitz, with Friedman, Billings, Ramsey Group Inc. in Arlington, Va., issued his next report. Merck's Vioxx-related exposure, he now estimated, was about $12 billion, "down from our previous $18 billion estimate."Readers of Moskowitz's reports could be forgiven for wondering: "What $18 billion estimate?" While the original $50 billion figure, quickly picked up and propagated in the media, got two mentions in Moskowitz's August report, the $18 billion number is nowhere to be found. In an interview with BusinessWeek, Moskowitz said the $18 billion estimate was "implicit" in his August report's target stock price for Merck of $25. He called the $50 billion "a high-end" figure, based on his view that Merck's liability "could fathomably" reach that level. But, he insists, "it was never our estimate."Pity the investor trying to make sense of this. But perhaps reserve a dollop of sympathy for analysts like Moskowitz. They thought they'd be using their expertise in fields such as finance and pharmaceuticals to evaluate stocks -- but now must try to factor in the arcane machinations of complex litigation. They have no choice. In recent years, Altria (MO ), Ford Motor (F ), Firestone, Halliburton (HAL ), Microsoft (MSFT ), and Research In Motion (RIMM ) have all faced bet-the-company litigation that Wall Street can hardly afford to ignore.Vioxx is just the latest in a parade of mass torts to march through the pharma sector. Merck voluntarily pulled the drug from the market on Sept. 30, 2004, after one of its clinical trials suggested that it could increase the risk of heart attack and stroke for certain people. On Nov. 29, the third trial involving the painkiller is set to get under way in federal court in Houston. Close to 7,000 Vioxx suits are on the docket and more are sure to follow.CHOCK FULL OF INTANGIBLES The specter of Merck facing such massive potential liability sent many drug-industry watchers scrambling to project the potential tab. As quantitative beings, analysts are hard-wired to look for "metrics" that they can plug into economic models and have a vision of the future pop out. They are used to projecting a company's future earnings, for instance, by assembling reams of data on its revenues, costs, and taxes. With litigation, they try the same approach, crunching variables such as the number of possible claimants and the likely size of a typical settlement or court award to produce sophisticated-looking reports packed with calculations and charts.But a close look at these estimates reveals that they are often based on numbers that are flawed, simplistic, or random to the point of absurdity. Analysts also seem prone to making dramatic adjustments to their calculations based on incremental or inconsequential developments -- such as the results of a single trial. And no spreadsheet can capture the myriad intangibles that are so critical to the outcome of litigation, such as the evidentiary rulings of a judge, the deliberations of a jury, or the strategies and resolve of the opposing parties. That's a big reason why the estimates in the past year have variously projected Merck's liability at $5 billion, $10 billion, $12 billion, $18 billion, and $30 billion, not to mention Moskowitz's chart-topper.Two reports issued by Credit Suisse First Boston (CSR ) analyst Catherine J. Arnold in February illustrate how arbitrary and accordion-like investment houses' approaches to litigation analysis can be. On Feb. 15, Arnold wrote that Merck's pretax Vioxx liability "could approximate $19 billion," a number based on 96,000 claimants winning settlements or court awards averaging $200,000. One week later, Arnold slashed her estimate to $4.75 billion. Her reason: a vote by a U.S. Food & Drug Administration advisory panel that supported Vioxx's return to the market. (The FDA has yet to act on the recommendations, and Vioxx remains off the market.)SLIPPERY BOUNDARIES While the 17-15 vote was a narrow victory for Merck, the panel also suggested that the FDA consider limiting the direct-to-consumer advertising of Vioxx, that it be prescribed to a restricted patient population and only at lower doses, and that it carry a so-called black box warning -- a prominent billboarding of potential hazards. The panel also agreed unanimously that data showed Vioxx significantly increased cardiovascular risk.Sanford C. Bernstein & Co. (AC ) analyst Richard T. Evans concluded that the panel's actions left Merck's legal exposure unchanged, and, if anything, might help plaintiffs prove their case. But Credit Suisse analyst Arnold decided that the advisory body's deliberations highlighted evidence that would favor Merck and discourage litigants. She thus changed her estimated percentage of potential claimants who would actually file suit from 100% to 25%. Most recently, Arnold has raised that number back up to 50%, resulting in her latest liability projection of about $10 billion.In an interview, Arnold acknowledges that the huge swings in her numbers might raise some eyebrows. "From a distance, it does seem peculiar to see these estimates go from one place to another." But, she adds, "we're in the early days of a very fluid situation and we're trying our best to put boundaries around it."And both she and Moskowitz say they have no choice about trying to come up with estimates. "I don't think our job allows us the option of saying 'I don't know,"' Arnold says. But not everyone sees it that way. Deutsche Bank Securities Inc.'s (DB ) Barbara Ryan, who has covered pharma stocks since 1982, says she has refused to offer an estimate for Merck's exposure because "it's a futile exercise." If you look at past estimates for litigation involving other products, she says, "they've all been off the mark."

Patients lose Vioxx legal appeal

Over 200 people who had heart attacks or strokes while taking the painkiller Vioxx have lost a legal aid appeal.
The ruling will mean many will no longer be able to mount compensation claims in British courts.
The insurance needed to pursue a claim on a no-win, no-fee basis has also been denied, said solicitor Martyn Day who acts for the 200 claimants.
Some UK claimants are trying to sue in the US, but Mr Day said these could be thrown out by the manufacturer Merck.
Heart attacks and strokes
Merck withdrew Vioxx last year after a study it carried out said the drug could double the risk of heart attack or stroke.
Mr Day, of Leigh Day & Co Solicitors in London, said he was bitterly disappointed by the appeal ruling.
"This was as good a case as we have seen for a long, long time."
He said the claims were supported by "gold standard" scientific studies showing a significant risk of adverse effects compared with similar drugs.
"The fact that we have not been able to achieve any sort of funding package to allow these cases to go ahead spells the end of drug litigation in this country.
"Here is a very good case to test the system and the system is found terribly wanting."
I'm very worried there will be no recourse to justice for these people
Martyn Day
He said the cost of mounting a compensation claim in instances such as this could be in the order of £10 - £15m.
He said this meant that legal aid authorities say they are unable to afford it and insurers are not prepared to take the risk.
"We were looking for a £5m cover, but even then the insurers were saying there is no way we can take on that sort of a risk," Mr Day explained.
"We are left trying to go to the US.
"I'm very worried there will be no recourse to justice for these people. They are very likely to be left in limbo land."
Merck said in a statement that it believed it had meritorious defences and intended to vigorously defend individual Vioxx cases one by one.
A spokeswoman said: "We believe we did the right thing every step of the way, including withdrawing Vioxx."
The firm is facing thousands of lawsuits from Vioxx users claiming its use led to heart attacks and strokes.
US courts
Earlier this month, Merck won a high-profile court case in New Jersey relating to Vioxx.
An Atlantic City jury found it gave doctors adequate warning about possible health risks and did not commit consumer fraud in marketing the drug.
Over 70 UK are set to see whether they might be able to bring their case in the US.
UK health law firm Alexander Harris have issued 24 cases in the US state of New Jersey and have a further 50 waiting.
Ann Alexander from the firm said: "We may not be able to pursue the claims to conclusion if we fail on what is known as the forum argument. This decides whether you are allowed to bring a case in a different country to your own. It will be a decision for the Judge as to whether non us residents will be allowed to pursue their claims in the US court.
"Our clients will not be prejudiced in any way by following this course of action and will still be able to pursue a claim in the UK, should we not succeed. We felt it was important to pursue this avenue first."

Lawyer Blames Vioxx for Man's Heart Attack

HOUSTON (AP) - A lawyer representing the widow of man who claims that Merck & Co.'s Vioxx caused her husband's death argued on Tuesday that taking the pain reliever for one month was enough to cause the 53-year old man's heart attack.
But Merck countered in opening statements at the first federal Vioxx trial that its extensive studies of the painkiller, introduced in 1999, showed no evidence it caused heart attacks with short-term use, and that heart disease had led to Richard "Dicky" Irvin's death.
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Unlike the two previous state-level cases where Merck emerged with a loss and then a win after several weeks, the federal case before U.S. District Judge Eldon Fallon of New Orleans appeared to rush along at a headlong pace.
It took about two hours to pick a jury of five men and four women, three of whom are alternates. Opening statements for the plaintiff -- Irvin's widow, Evelyn Irvin Plunkett -- took about an hour and Merck's opening took about the same time.
The case is in Houston rather than its original venue of New Orleans because of damage wrought by Hurricane Katrina.
Jurors will be asked to decide whether Vioxx contributed to the fatal heart attack Irvin suffered in May 2001. The 53-year-old manager of a wholesale seafood distributor in St. Augustine, Fla. had been taking the drug for about a month to alleviate back pain when his co-workers found him dead at his desk.
"There was nothing that would have triggered a fatal heart attack except for Vioxx," Plunkett's attorney Andy Birchfield told jurors.
This is the third trial Merck is facing over Vioxx's safety. It lost the first state trial in Texas last August, but scored a victory in its home state of New Jersey earlier this month.
Whitehouse Station, N.J.-based Merck withdrew Vioxx from the market in September 2004 after a long-term study showed the drug doubled risk of heart attack or stroke if taken for 18 months or longer. By then, more than 20 million Americans had used Vioxx.
Birchfield told jurors that Merck likes to cherry pick the 18-month hallmark to demonstrate that the drug could not have caused problems in patients who took it for a shorter time. But he told jurors a study showed Vioxx can cause problems after just seven days.
He said that Merck knew about Vioxx's safety problems before it was launched. Birchfield quoted from internal e-mails, including some from Merck scientists who raised warning flags about its cardiovascular risks, to support his assertions.
Merck made a "premeditated, financial decision" not to warn patients about the drug's risks because it wanted the revenue the former $2.5 billion seller would generate, and longed to beat Pfizer Inc.'s competing drug Celebrex in the marketplace, Birchfield said.
Merck's lawyer, Phil Beck, told jurors that Vioxx didn't cause Irvin's heart attack and that the company acted responsibly at all times in its development and marketing of the drug.
"There is no evidence of short term use (of Vioxx) causing heart attacks," Beck said.
He spent the better part of his allotted hour for opening statements explaining to jurors how pain relievers work, and how Vioxx was a major advance because it was gentler on the stomach that other treatments such as aspirin.
"Mr. Irvin's problem was not that he took Vioxx, it was that he had coronary heart disease," Beck said.
Beck said coronary heart disease is common in men like Irvin -- in their 50s and slightly overweight. He told the jury that in the sixty minutes he would talk, 60 people would die from clogged arteries. Beck added that Irvin had a particular type of plaque that was prone to rupture and cause blood clots.
Birchfield had said during his opening that Irvin had 60 percent blockage in an artery, but that wouldn't have been enough to cause a heart attack.
Dr. Benedict Lucchesi, a cardiac research from the University of Michigan called by the plaintiff's side, told jurors that Vioxx raises the risk of heart attacks because it blocks production of a substance called prostacyclin, which keeps the blood from clotting.
Vioxx relieves pain by blocking an enzyme known as Cox-2. In doing so, Vioxx also inhibits prostacyclin production, upsetting the balance with another substance, thromboxane, a clotting agent, leading to heart attacks, according to Lucchesi. He testified that he thought Vioxx could cause a heart attack in patients taking it for less than 30 days in some circumstances.
"I think it is highly likely that Vioxx contributed to Mr. Irvin's heart attack," said Lucchesi, who testified at the two other Vioxx trials.
But under cross examination, Lucchesi conceded that he never looked at the slides of Irvin's blocked artery and acknowledged the debate in the scientific community about whether an imbalance of prostacyclin and thromboxane leads to heart attacks.
Lucchesi also said his convictions about what caused Irvin's death differed from two other plaintiff experts -- a pathologist who believes, as does Merck, that ruptured plaque triggered the heart attack, and another pathologist who was noncommittal.
Lucchesi answered yes when Merck's lawyer asked if a plaque rupture could cause sudden death.
Merck faces about 7,000 state and federal lawsuits and analysts have estimated its liability could reach $50 billion.

Shakers: Merck chief is mum on reports of job cuts ws concerning VIOXX

BOSTON Merck chief is mum on reports of job cuts
The chief executive of Merck, Richard Clark, said Sunday that a statement would come soon on a restructuring plan he has worked on since taking the job in May, but he would not comment on a report that it would include thousands of job cuts.
Clark declined to comment on a report Saturday in The Wall Street Journal that Merck would cut jobs, close plants and trim research costs. He said he was "very unhappy" with the story and would not discuss it as "a matter of principle."
"The problem with an article like that is that we haven't had time to talk to employees," Clark said. "We're very unhappy. We want to tell our employees first."
The drug maker faces billions of dollars in liability from 6,400 lawsuits filed against it over its recalled Vioxx painkiller. The company, based in Whitehouse Station, New Jersey, is also preparing for declining sales of its Zocor cholesterol drug, which will lose patent protection next year, and Fosamax osteoporosis treatment, which has a patent that expires in 2008.
The Wall Street Journal reported that Merck board members were advised on details of the restructuring on Tuesday. Analysts had expected a restructuring announcement to come in December.
A company spokeswoman said Sunday that Merck was "engaged in a worldwide, large-scale review," and that it was "carefully considering a variety of options." She declined to comment further.
Merck's shares have declined 11 percent since May 5, when Clark replaced Raymond Gilmartin, who had led the company for 11 years
Jacobs will vacate Adecco's top jobs
ZURICH: The billionaire Klaus Jacobs plans to find a new chairman and chief executive for Adecco, the world's largest provider of temporary workers, after taking over the running of the company last week.
Jacobs will yield the chairmanship at the annual shareholders' meeting in 2007, Adecco's spokesman, Axel Schafmeister, said by telephone Sunday. And the company will have a new CEO when the "right person" is identified, he said.
Adecco is thinking about listing its shares in the United States. It is looking at the "advantages and disadvantages" and has not yet reached a decision, Jacobs has said.
Adecco, based in Glattbrugg, Switzerland, said last week that Jacobs had tightened his grip on the company, buying a $1 billion stake from the co-founder, Philippe Foriel-Destezet, and removing the chief executive, Jérôme Caille.
Jacobs will increase his holding to 29 percent from 16 percent as well as take the dual role of chief executive and chairman. Jacobs was co-chairman of the board from August 1996 to April 2002. He rejoined the board as co-chairman in 2004, Schafmeister said.
Born in the German city of Bremen, though now a Swiss citizen, Jacobs made his fortune from chocolate. In 1982, he merged his company with Interfood, gaining the Toblerone brand. In 1998 he led the initial public offering of Barry Callebaut, now the world's largest supplier of bulk chocolate.

Wipro chief considers increasing dividend
NEW DELHI: Azim Premji, chief executive of Wipro, said Sunday that the Indian software services company was considering quadrupling its dividend payouts by using some of its $1 billion in cash.
Premji said his company, based in Bangalore, India, also would invite shareholders to offer stock for conversion into American depositary receipts, and that it would set up a software center in Romania.
"The dividend payouts will be more generous than in the past two years and will be broadly in line with what we told investors in the last quarter," said Premji, who owns 81 percent of the company.
Wipro and its rivals, Tata Consultancy Services and Infosys Technologies, are getting bigger orders from U.S. and European companies as Indian software makers expand services to include computer network management and software testing. Global software orders to outsourcing centers like India will rise 30 percent annually over the next three years, according to a report by Bernstein Research and Everest Research Institute.
Wipro will pay shareholders 10 percent to 15 percent of its free cash flow in the form of dividends, up from 3 percent to 4 percent previously, Premji said.

Merck braces for Vioxx trial No. 3

Merck & Co. Inc. is preparing for its third Vioxx trial, this one from a Florida woman whose husband died of a heart attack.
Jury selection was to begin Tuesday in Houston, the Chronicle reported Monday.
New Jersey-based Merck lost the first Vioxx trial and was hit with a $253 million verdict. It won the second trial.
The pharmaceutical company, which Monday announced massive layoffs and numerous factory closures, pulled its blockbuster painkiller off the market in September 2004 after researchers said it doubled the risk of heart attacks and strokes in patients who took it for 18 months or longer.
Merck is believed to face an estimated legal liability of some $20 billion in about 6,500 Vioxx cases nationwide. e latest breaking news concerning VIOXX

First Federal Trial Over Merck's Vioxx to Begin

Where you can find all the latest breaking news conIn April 2001, Richard "Dicky" Irvin was among millions of people who found relief from nagging pain in Vioxx, then a popular painkiller often praised as a wonder drug that worked when others failed.
But back-pain relief was fleeting for the 53-year-old manager of a wholesale seafood distributor in St. Augustine, Fla. In May that year he went to work and told his boss he didn't feel well. A little later his co-workers found him dead at his desk. Whether Merck & Co.'s once-lucrative drug led to his death lies at the center of the third Vioxx-related case in the nation to face a jury, and the first to do so in federal court. "It's going to be interesting. Merck is pretty cocky, which is fine," said Jere Beasley, a former Alabama lieutenant governor who will lead his Montgomery, Ala., law firm's team representing Irvin's widow, Evelyn Irvin Plunkett. Merck enters its third court battle with a split record in state courts — a loss in Texas and a win in New Jersey. The federal face-off, to begin Tuesday with jury selection and opening statements, will be in Houston rather than its original venue of New Orleans because of damage wrought by Hurricane Katrina. Merck, based in Whitehouse Station, N.J., pulled Vioxx from the market in September 2004 after a long-term study showed that the drug doubled the risk of heart attack or stroke if taken for 18 months or longer. By then, more than 20 million Americans had used Vioxx. The company faces about 7,000 state and federal lawsuits. The Texas jury in August found Merck liable for the death of 59-year-old marathon runner Robert Ernst and awarded his widow $253.4 million in damages. The amount will fall to no more than $26.1 million under Texas caps on punitive damages, and Merck will appeal. This month the New Jersey jury absolved Merck of liability and left the plaintiff — 60-year-old Frederick "Mike" Humeston of Idaho, who survived what he claimed was a Vioxx-induced heart attack — with nothing. Any damages awarded if Plunkett wins will be governed by Florida law because the lawsuit was filed in Florida before it and all other federal Vioxx litigation came under the watch of U.S. District Judge Eldon Fallon of New Orleans to streamline trial preparations. Merck lawyers declined to discuss the case, citing Fallon's request that lawyers refrain from public comment until a verdict was reached. The company's court filings indicate that Merck's defense will center on whether Vioxx could be responsible for Irvin's death when he took the painkiller for such a short time. Ernst took Vioxx for eight months. Humeston took it intermittently for two months. Irvin took the drug for about a month. The trial will be the first of four overseen by Fallon. The next cases are slated to be heard in February, March and April; the specific cases have yet to be selected. Fallon told attorneys last month that when the fourth trial concluded, he would meet with them to explore a global settlement for all federal Vioxx litigation. cerning VIOXX

Vioxx producer to cut 7,000 jobs

WThe manufacturer of controversial drug Vioxx has revealed plans to cut 7,000 jobs on the eve of the first federal trial relating to the drug's use.
US pharmaceutical firm Merck said it planned to close five production plants as part of a big restructuring.
The firm will cut its workforce by 11% by 2008 with the aim of saving as much as $4bn (£2.3bn) by 2010.
Merck is due in a Texas court to fight allegations that Vioxx contributed to the death of 53-year old Richard Irvin.
The firm is facing thousands of lawsuits from Vioxx users claiming its use led to heart attacks and strokes.
Different verdicts
The company withdrew Vioxx last year after its own research showed prolonged use of the drug could double the chance of suffering a heart attack or a stroke.

The actions we are announcing today are an important step in positioning Merck to meet the challenges the company faces now and in the future
Richard Clark, Merck chief executive
Earlier this year Merck was found liable for failing to provide sufficient warning about Vioxx's risks in the first state trial and told to pay damages of more than $250m.
However, a second similar lawsuit was thrown out.
The federal case is being brought by the relatives of Mr Irvin who suffered a fatal heart attack in 2001.
At the time of his death, he had been taking Vioxx for a month.
Outstanding lawsuits
Shares in Merck, the world's fifth largest drugmaker, have nearly halved in value since it voluntarily withdrew Vioxx from sale last year.
Merck has denied that it was negligent in its handling of the drug and has pledged to fight all lawsuits, more than 7,800 of which are outstanding.
Half of the jobs being cut will be in the US, the remainder in Merck's other markets.
"The actions we are announcing today are an important step in positioning Merck to meet the challenges the company faces now and in the future," said chief executive Richard Clark.
"We are engaged in an ongoing effort to enhance efficiencies throughout the company and improve the way we discover, develop, manufacture and market our medicines and vaccines."
Merck's shares fell 3% after it announced the restructuring. here you can find all the latest breaking news concerning VIOXX