Monday, November 28, 2005

Merck Chief Says Restructuring Coming Soon, Won't Discuss Cuts

Where you can find all the latest breaki
Nov. 27 (Bloomberg) -- Merck & Co. Chief Executive Richard Clark said a statement would come ``soon'' on a restructuring plan he's worked on since taking the job in May, and he wouldn't comment on a report it will include thousands of job cuts.
Clark, in a telephone interview today, declined to comment on a Nov. 26 report in the Wall Street Journal that Merck will cut jobs, close plants and trim research costs. He said he was ``very unhappy'' with the story and wouldn't 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 announcement will be soon,'' he added.
Merck, the No. 3 U.S. drugmaker, faces billions of dollars in liability from 6,400 lawsuits filed against the company over its recalled Vioxx painkiller. The Whitehouse Station, New Jersey-based company is also preparing for sales declines from its Zocor cholesterol drug, which loses patent protection next year, and Fosamax osteoporosis treatment, off patent in 2008.
The Wall Street Journal reported that Merck board members were advised on details of the restructuring on Nov. 22. Earlier in the year, analysts had said the restructuring announcement may come in December.
An unidentified spokesman for the company today would say only that Merck is ``engaged in a worldwide, large-scale review, and are carefully considering a variety of options.'' She declined further comment.
Shares of Merck rose 17 cents, or less than 1 percent, $30.98 on Nov. 25 in New York Stock Exchange composite trading. They had declined 4 percent this year through Nov. 25. The stock has declined 11 percent since May 5 when Clark replaced Raymond Gilmartin, who led the company for 11 years.
Profit
In the third quarter, Merck's profit rose 7 percent on lower marketing and production costs. Sales fell 2.2 percent. The company had costs of $80 million in this year's third quarter related to about 825 job cuts, Clark said on Oct. 24.
Merck is counting on drugs in development to push up earnings. In the third quarter, Merck won U.S. regulatory approval of its Proquad vaccine against measles, mumps, rubella and chickenpox, the first such combination in a single shot. Proquad combines the company's M-M-R II and Varivax vaccines for children 12 months to 12 years old.
Earlier this month, the company said its experimental vaccine prevented cervical cancer caused by two common forms of a sexually transmitted virus, human papillomavirus, which infects more than 5.5 million Americans each year. The medicine, to be sold as Gardasil, prevented 100 percent of cells on the cervix from becoming pre-cancerous and blocked development of a cancer that occurs on the cervix surface.
Sales of Gardasil may reach about $500 million by 2008, according to Scott Henry at Oppenheimer & Co. The total may be higher if the vaccine becomes mandatory, he said Oct. 6.
Vaccine Approvals
The company is also seeking approval for vaccines for the adult form of chickenpox and for rotavirus gastroenteritis.
Recently, the company had a setback when two Cleveland clinic doctors said U.S. regulators should delay approving the Pargluva diabetes pill, which Merck would market with Bristol- Myers Squibb Co., until a new study is conducted to rule out a link to heart attack and strokes.
Bristol-Myers on Oct. 18 said the U.S. Food and Drug Administration wants more information about Pargluva's heart risks before it can be sold. The agency requested more information from trials.
Merck withdrew Vioxx last year in the largest drug recall ever when a study showed it doubled heart injury risks after 18 months of daily use. Merck lost its first Vioxx trial in Texas against the widow of a man who used it for seven months and won a second in New Jersey against a man who used it two months.
Quick Guidance
Merck may get some quick guidance soon on how vulnerable it is in long-term cases. The judge who presided over the New Jersey case is managing 3,500 Vioxx suits and said last week that she wants her next 12 trials to focus on heart attack victims who took the drug for at least 18 months.
Merck has forecast earnings this year of $2.47 to $2.51 a share. That compares with a forecast in July of $2.44 to $2.52 and 2004 earnings of $2.61.
ng news concerning VIOXX

Merck to slash jobs in wake of Vioxx debacle

Where you can find all the latesMerck, the US pharmaceuticals giant, is poised to announce a major restructuring plan that could lead to large-scale job cuts and plant closures.
An announcement could be made as early as this week. The plan would be the first major move by Richard Clark, who took over as chief executive in May.
The move follows a period of upheaval at Merck, which has been under pressure since it had to withdraw Vioxx, its best-selling painkiller, from the market after it was linked to an increased risk of heart attacks and strokes.
Merck faces thousands of lawsuits from former patients over the Vioxx debacle, including several hundred from British patients. A number of cases have been filed in US courts. More than 20m people worldwide had taken the drug, including some 400,000 in the UK. The episode led to the departure of Merck's chairman and chief executive, Raymond Gilmartin.
"We are carefully considering a variety of options to help improve our core business," said a Merck spokeswoman.t breaking news concerning VIOXX

Merck Facing No-Nonsense Federal Judge in Next Vioxx Trial

Where you can find all Judge Hands Merck a Clear Setback by Ruling Plaintiff May Introduce Expert Testimony that Even Short-Term Use of Vioxx Can Pose Serious Cardiovascular Risks
Although Merck had some reason to be optimistic following its recent victory in New Jersey state court in the second Vioxx trial, that optimism was more the result of weaknesses in the plaintiff’s case rather than a preponderance of the evidence in favor of Merck.
In the recent New Jersey case, there were a number of factors which favored Merck including: the plaintiff only took Vioxx for two months before his heart attack; he survived his injuries and actually appeared to be in surprisingly good health at trial; plaintiff had a number of serious (non-Vioxx) risk factors that could have caused his heart attack; the case was tried in Merck’s “home state;” and Merck’s trial attorney took every opportunity to make it appear as if the trial judge was being unfair to the drugmaker with her rulings. The jury also was not enthralled by plaintiff’s trial attorney.
In determining which cases will be tried next in New Jersey, Judge Carol 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 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 victory in those upcoming “long-term-use” cases.
Thus, it was to Merck’s advantage to try another “short-term-use” case on the heels of its victory since a second straight win could significantly change the dynamics of the ongoing litigation in favor of Merck.
That apparent advantage has vanished, however, now that U.S. District Court Judge Eldon E. Fallon has 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.
The trial that is scheduled to start Tuesday in Houston, Texas, involves the death of a 53-year-old man, Richard Irvin Plunkett, who took Vioxx intermittently for less than a month before he suffered a fatal heart attack. (The trial was moved from New Orleans due to the widespread damage caused by Hurricane Katrina).
The weaknesses that would have favored Merck have now been virtually eliminated. In addition to the admission of expert testimony regarding the risks associated with short-term Vioxx use, are these additional problems for Merck:
the trial will be held in Texas where the first jury returned a $253 million verdict against Merck
the decedent did not have the serious health problems the plaintiff in the last trial had
this is a wrongful death case, which is far more serious in the eyes of a jury
Judge Fallon presided over very similar MDL (multidistrict litigation) involving the Johnson & Johnson drug, Propulsid, and thus has particular expertise in this type of complex pharmaceutical case
Fallon is regarded as a stern, no-nonsense judge who has already made it quite clear that he will not tolerate the carnival atmosphere that prevailed in the last trial in New Jersey.
Judge Fallon has already instructed the attorneys during pretrial hearings that he didn't "need 'War and Peace' " from them, and discouraged unnecessary statements. He threatened to hold sessions in the evenings and on weekends to keep on schedule. He also cautioned both sides that he didn't "want to hear from the defense how motherly or fatherly Merck is," or from the plaintiff that the company "was trying to make a buck."
It is Judge Fallon’s plan to try four representative cases he has chosen and to have those trials completed by April when he hopes to sit down with both sides to discuss a possible settlement of the MDL.
Since Judge Fallon has eliminated the “short-term-use” advantage Merck thought it enjoyed as well as the possibility that Merck’s attorneys will turn the trial into a theatrical production, the upcoming federal trials will likely be tried on the evidence alone.
In that case, many legal analysts believe Merck will be hard pressed to convince the four upcoming juries in Texas of the safety of a drug it was forced to pull from the market in September 2004 for the very reasons it is now being sued.the latest breaking news concerning VIOXX

News Analysis: Can Merck bounce back from Vioxx?

News Analysis: Can Merck bounce back from Vioxx?
(PR Week)As the first federal case over withdrawn painkiller Vioxx goes to trial in the US, David Quainton looks at Merck's fall from grace and the implications for the pharma trade.US pharma leviathan Merck & Co was once well loved, a bastion of sound science and a reliable company in which to invest. In September 2004 this all changed. Vioxx, its now-notorious blockbuster arthritis drug, was found to double the risk of heart attack and stroke. What was worse, people believed Merck already knew about it.
Within days a quarter of Merck's share value was wiped away. pounds 1.4bn in yearly sales dwindled. And there were widespread calls for the resignation of popular CEO Raymond Gilmartin, who eventually stepped down in May.Over a year later, Merck is still reeling from the loss of its all-American 'apple pie' image - and the first US federal Vioxx trial is set to kick off next week.Merck, Sharp & Dohme, the company's UK subsidiary, is also feeling the heat. Some of the 400,000 UK users of Vioxx - part of the Cox-2 inhibitor class - have threatened legal action in the US, and there are 103 suspected Vioxx-related deaths officially registered in the UK.So far Merck's record in US courts is lost one, won one. And it has insisted that it plans to fight every Vioxx case against it 'over many years'.But can the company's reputation, and that of the pharmaceutical industry, recover from the episode?Fall from grace'Merck was routinely admired as one of the most respected companies in the US,' says Christopher Bowe, who has reported for the Financial Times on the Vioxx saga from New York.'You can't underestimate how far the company has fallen.'In an apparent effort to win back some lost ground, Merck has brought in Burson-Marsteller to rebuild its reputation (PRWeek, 19 August).B-M declines to comment on the relationship, but Merck insists the corporate campaign had been in development long before the Vioxx fallout. Merck itself now has a five-strong press team in New Jersey dedicated to handling Vioxx enquiries.'It took a hefty knock and its reputation is still suffering,' Kent GP Dr Julian Spinks tells PRWeek. 'For a company that was once so trusted it's difficult.We read in the newspapers that Vioxx was being recalled before being told about it - it was a shock.'According to Spinks there has been no tangible wooing of doctors to get them back on side. And patients, he says, do not need to be addressed: 'For patients it doesn't matter - they don't know who makes their drugs I think GPs will continue to use Merck products.' But he adds: 'Merck and the pharma industry in general are less trusted now.'Any attempt to curry favour with GPs such as Spinks could be stymied by the revised code of practice from the Association of the British Pharmaceutical Industry (ABPI), unveiled last week. Under the more stringent regulations, GPs can only be taken to two-star hotels and flown economy class - an attempt to help the industry shed its shady image.According to Bowe, the US has had similarly strict rules in place for a long time. So what can Merck do?At the moment, Bowe says, Merck is taking a 'business-as-usual' approach - the company hopes a string of successful new drugs will help interested parties move on from the Vioxx debacle.'There's always been safety crises, ever since snake-oil salesmen,' says London-based FT pharma correspondent Andrew Jack. 'So Merck will recover - but it might need to do things a little differently.' He insists the traditional model of blockbuster drugs will have to change: selling drugs to millions of people (in Vioxx's case more than 20 million worldwide) makes it very difficult to monitor patient reactions.'In terms of PR the pharma industry in general does not do enough to enhance its image,' Jack argues. 'If Merck was known for programmes in the developing world and broader campaigns promoting a healthy lifestyle, it would have found it easier to recover.'Bad medicine?One of the charges levied at Merck was a lack of openness around its clinical trials. Whispers of cover-ups and a document called 'Dodge Ball Vioxx', intended to help sales people avoid health questions surrounding the drug, did the company few favours.Merck spokesman Guy Bizzoco says the firm is committed to being more open. 'Merck has had a long-standing commitment to sharing scientific information with the public,' he says.The firm is now registering all hypothesis-testing clinical trials that it sponsors and conducts on ClinicalTrials.gov, a US government-sponsored venture designed to encourage greater pharma transparency.New York-based Ketchum global healthcare practice chief Mark Cater says: 'The Vioxx situation is no longer just Merck's problem - it has spilled over to become an industry issue. The pharma industry is now a lot more cautious about its brand comms, but Vioxx's effect will be to change the way the industry communicates for good.'The general feeling from PROs, GPs and journalists is that people will continue to use Merck drugs, however much its corporate name has suffered - but the company will never fully get away from Vioxx.'We can't speculate for how long the shadow of Vioxx will be cast (over Merck),' says Bizzoco. 'But Merck is prepared for the long haul.'Bowe suggests the effect of Vioxx is that Merck will no longer be seen as everybody's favourite pharma firm.'It's down in the murky waters with everyone else now. It's just as bad as all the other pharma companies,' he says. 'In that respect, for Merck it won't be happily ever after.'VIOXX: RISE AND FALL OF A BLOCKBUSTER- November 1998: Merck submits new drug application to the US Food and Drug Administration (FDA)- May 1999: Vioxx approved by FDA- May 2001: Merck issues press release saying Vioxx has a 'favourable cardiovascular safety profile'- September 2001: FDA issues warning letter to Merck claiming May's press release to be false- October 2003: Merck study finds 39 per cent increased risk of heart attack within first 90 days of taking Vioxx when compared with Pfizer's Celebrex- September 2004: Vioxx withdrawn- February 2005: Federal inquiry of Cox-2 inhibitors opened by the FDA- August 2005: First Vioxx lawsuit settled in favour of plaintiff - jury awards widow nearly pounds 150m in damages- November 2005: Merck wins second Vioxx case. test breaking news concerning VIOXX

First Vioxx federal trial to focus on length of use

Where you can find all the latest breaking neHOUSTON - In April of 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 of 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, 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 its home turf of 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.
Whitehouse Station, N.J.-based Merck pulled 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.
The company faces about 7,000 state and federal lawsuits and billions in potential payouts for judgments, settlements and legal fees.
The Texas jury in August punched Merck with $253 million after finding the drug maker liable for the death of 59-year-old marathon runner Robert Ernst. The amount will fall to no more than $26.1 million under Texas caps on punitive damages, and Merck will appeal.
Earlier this month, the New Jersey jury absolved Merck of liability and left the plaintiff — 60-year-old Vietnam veteran 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 said in court papers that under Florida law, jurors cannot award punitive damages if the company loses because such damages were already awarded in the Ernst case, which alleged similar misconduct.
That doesn’t mean the Texas punitive award precludes punitives in the Irvin case, said Jim Rossi, professor and associate dean for research at Florida State University College of Law.
He said Fallon can allow punitives if he determines those in the Ernst case insufficiently punished Merck. Texas caps require that jury’s punitive damage award of $229 million to be cut to $1.6 million.
“There will be an issue with the limitation in the Florida statute, but it is hardly an across-the-board barrier to the recovery of punitives in a later case,” Rossi said.
Florida law also caps punitive damages, Rossi added. If awarded, punitives are limited to $500,000 or three times the amount awarded for compensatory damages, whichever is greater. Compensatory damages are economic, such as lost income, and non-economic, such as pain and suffering.
However, if jurors find Vioxx to be “unreasonably dangerous” and that Merck was motivated by unreasonable financial gain, punitives can rise to $2 million or four times compensatory damages, Rossi said.ws concerning VIOXX
Merck lawyers declined to discuss the case, citing Fallon’s request that lawyers eschew public comments until a verdict is reached. 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.
Ernst took Vioxx for eight months. Humeston took it intermittently for two months. Irvin took the drug for about a month, and Merck claims no studies show Vioxx can be lethal after such short-term use.
Plunkett counters that some of the 58 clinical trials involving 10,000 patients conducted before Vioxx went on the market in 1999 revealed it could trigger cardiovascular problems after a few weeks’ use.
Those studies were among several presented to jurors in the Ernst case. But Merck executives — several of whom are on Merck’s potential witness list for the Irvin case — testified that data from all the trials, evaluated in their entirety, showed the drug was safe and it won U.S. Food and Drug Administration approval.
Fallon ruled earlier this month that the six-member jury will slog through the scientific arguments.
Irvin’s health status will be a factor. His widow says he was in “very good health” when he began taking Vioxx, but Merck notes 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 trial will be the first of four overseen by Fallon. The next cases are slated for February, March and April, though the specific cases or trial dates have yet to be selected. Fallon told attorneys last month that when the fourth trial concludes, he will meet with them to explore a global settlement for all federal Vioxx litigation.

What's in an MDL? Vioxx.

HOUSTON -- Of the 7,000 state and federal lawsuits pending against Vioxx maker Merck & Co., one-fourth or more get little if any hometown advantage. The 1,800 or so federal cases are piled together before a single judge in what is known as multidistrict litigation. That provides consistency where the rest can be chaotic _ often to the delight of plaintiff's lawyers _ for a defendant insistent upon fighting most one by one.
In multidistrict litigation, or MDL, federal lawsuits are not combined into one mass lawsuit. They are put in the same corral where one judge coordinates all pretrial matters to avoid duplication of depositions of witnesses and document collection. "Generally, it's the defendant who wants to be in an MDL. It lets them conserve resources and do everything at one time," said Dawn Barrios, a New Orleans attorney who leads the committee of attorneys acting as state liaisons to the Vioxx MDL. "It can make a defendant crazy when they have cases going on in state courts, defeating the MDL purpose." Whitehouse Station, N.J.-based Merck withdrew Vioxx from the market in September 2004 when a study showed it could double the risk of heart attack or stroke after 18 months' use. Analysts speculate that litigation stemming from the one-time $2.5 billion seller could cost Merck billions in settlements, judgments and legal fees. The first of four federal Vioxx trials is slated to begin Tuesday in Houston before U.S. District Judge Eldon Fallon of New Orleans. Congress in 1968 enacted a law allowing for lawsuits with similar allegations to be transferred to a single federal judicial district for pretrial coordination, said Carl Tobias, a professor at the University of Richmond School of Law. "It's quite natural for mass tort cases to proceed under multidistrict litigation," Tobias said, noting past MDLs include lawsuits over breast implants, diet drugs and latex gloves. The Vioxx MDL is among more than 1,600 MDLs that emerged after the law passed. Once an MDL is created, state lawsuits scattered across the country can be pulled into the MDL at the defendant's request, Barrios said. Then it's up to plaintiffs to persuade the judge to send them back to state court. Fallon, who oversees the Vioxx MDL created in February this year, has yet to rule on any such plaintiff requests. But state lawsuits filed where the defendant is based allow plaintiffs to avoid being pulled into the MDL. More than half of the state lawsuits pending against Merck are in New Jersey before the same judge. Also, the defendant can agree not to request that other state cases be added to the MDL. Regarding Vioxx, Merck agreed to let Texas cases filed in four counties remain in state court, said Tommy Fibich, a Houston plaintiff's lawyer. Those loopholes allow plaintiffs' lawyers to avoid an MDL, where federal courts are generally seen as more business friendly than state courts. "Plaintiffs want to exert as much pressure on the defendants as possible and scatter (lawsuits) in as many jurisdictions as possible. The MDL is counter to that philosophy," Barrios said. Mark Lanier, the Houston litigator who won a $253 million verdict against Merck last August in the first state Vioxx trial in the nation, and others have assembled a team of law firms and lawyers to push all future Vioxx lawsuits into state courts. Lanier said the team aims to "resolve cases fairly," but he expects the legal teams to run state trials nearly continuously and tie up Merck's resources outside the MDL. Without mentioning Lanier, Fallon in a hearing last month called such an effort "counterproductive" to his desire to eventually settle all Vioxx claims. But folding state cases into an MDL puts them in control of lawyers on plaintiffs' and defendants' steering committees who do the bulk of the pretrial work _ and earn the bulk of the fees. Lanier said he is focusing on his state efforts _ largely in New Jersey suits _ because he's not on the plaintiffs' committee in the MDL. "I cannot entrust my clients to them," Lanier said. "So I hope the MDL works well. I want to run alongside it and not frustrate it. But I also want to work my clients' cases. I can do that in state court." ing news concerning VIOXX

Will Texas be kinder to Merck this time?Merck returning to Lone Star state for round three of Vioxx fight.

November 23, 2005: 3:52 PM EST By Aaron Smith, CNNMoney.com staff writer
NEW YORK (CNNMoney.com) - Merck is returning to Texas next week, where it lost its first Vioxx lawsuit in a state court, to fight its third case - now in a federal court - a legal battleground that could be more receptive to the company, say legal experts.
Kevin Duckworth, an attorney for Jenner & Block who has defended drug companies but is not involved in the Vioxx trials, said that Merck should be "excited" about fighting the next battle in federal district court. "Oftentimes state court judges are not listening to them."
Jury selection begins under Judge Eldon Fallon in the wrongful death case of plaintiff Evelyn Irvin Plunkett, in federal district court in Houston on Nov. 29. Plunkett's husband Richard Irvin died in 2001 from a fatal heart attack after taking Vioxx for about one month, according to plaintiff attorneys Jere Beasley and Andy Birchfield. Plunkett of St. Augustine, Fl. blames Vioxx for her husband's death, though Merck has insisted all along that Vioxx did not kill anybody.

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Fran Miller, professor at Boston University's schools of health and management, said that federal court is preferable to state court for Merck because "Merck would like to divorce itself from any possibility that there's a home court advantage for the plaintiff."
Anti-corporate sentiment in the Angleton, Texas jury pool may have contributed to Merck's loss in the first case, where the plaintiff was successfully represented by Houston-based attorney Mark Lanier in a wrongful death suit in August. Merck (up $0.30 to $30.81, Research), the second-largest American drug maker, could face its nemesis Lanier in a state court once again. Lanier said he is taking on Merck in its home state of New Jersey, where Merck has already won a case and where about half of the approximately 7,000 Vioxx lawsuits have been filed. Lanier is representing Tom Cona, a former Vioxx patient, a heart attack survivor and one of seven possible plaintiffs selected by Judge Carol Higbee for the case.
Lawyers representing Merck and Plunkett in the federal case are under gag order and said they could not comment.
Federal vs. State
Merck pulled its arthritis painkiller Vioxx off the market on Sept. 30, 2004 after a clinical study suggested an increased risk of heart attacks and strokes in patients who took the drug for at least 18 months. However, Merck says the study did not establish any increase in risk of death from Vioxx. Nevertheless, approximately 7,000 lawsuits against Merck have been filed since the withdrawal. The first three cases involve patients who took Vioxx for less than 18 months.
Merck lost its first case, in Superior Court in Angleton to plaintiff Carol Ernst. The plaintiff's husband Robert Ernst was a Vioxx patient when he died in 2001 from a heart attack. Ernst, a mother of four adult children who blamed Vioxx for her husband's heart attack, was awarded $253 million by the jury, though state law capped her damages at $26 million plus interest, said Lanier.
But Merck won its second case, in Superior Court in Atlantic City, N.J. on Nov. 3, against Frederick Humeston, a 60-year-old Vietnam veteran and postal carrier who blamed Vioxx for his non-fatal heart attack in 2001.
In the Angleton case, Lanier successfully portrayed Merck to the jurors as a shady company that deliberately concealed negative information about Vioxx. In the Atlantic City case, Chris Seeger, who represented Humeston, failed to convince jurors that Merck had engaged in wrongdoing, but Merck lawyers managed to pick apart Humeston's integrity, weakening his case.
Lanier, a part-time preacher with five children, appealed to the anti-corporate attitude of the Angleton jury pool. But that attitude is more representative of Angleton than Houston, said experts, who described the Houston jury pool as better educated and more urbane than Angleton, a town of 19,000 located just 30 miles south.
"Houston has some sophisticated people who could readily understand the kind of causation issues that Merck has out there," said Sheila Birnbaum, a lawyer with Skadden Arps who has defended drug companies but not Merck. "They're not the same jurors in both places, Angleton and Houston, even though they are all Texans."
Also, Judge Fallon's federal-level interpretation of the law could be more sophisticated, and therefore more conducive to Merck's legal strategy, which relies heavily on scientific data to suggest that Vioxx is free of blame.
"Most large publicly traded corporations would much rather be before a federal judge, versus being before a state judge, for what appear to be obvious reasons: federal judges have a tendency to read more, be more up to speed on the law, and interpret the law in a more sophisticated manner," said Duckworth, the attorney with Jenner & Block.
Lanier in New Jersey
Lanier, the lawyer who defeated Merck in Angleton, is part of a legal "dream team" that is representing a consortium of some 20,000 plaintiffs. Lanier and other attorneys are trying to file all their cases in state court, and are resisting Judge Fallon's attempts to consolidate state cases in federal court.
Lanier is getting ready to take on the drug giant in Atlantic City on Jan. 30, 2006, where Merck won the second Vioxx case. Lanier's plaintiff, 59-year-old Cona from Cherry Hill, N.J., was one of seven possible plaintiffs selected by Higbee for the next case in New Jersey Superior Court. All the plaintiffs have one thing in common: they took Vioxx for more than 18 months, a crucial detail in the ongoing litigation. In previous cases, Merck has based much of its defense on the fact that the plaintiffs took Vioxx for less than 18 months, because the study that prompted the withdrawal showed that risks emerged after that time.
"This case will stop Merck from parroting out the false 18-month drivel," said Lanier, whose client had a heart attack after two years of taking Vioxx.
To read about a recent study on health risks associated with Vioxx, click here.

Vioxx faces first federal trial next week

NEW ORLEANS (AP) - A judge has ruled on the scope of arguments in the first federal lawsuit over the painkiller Vioxx.
The judge says the widow of a Florida man may argue that Vioxx can be lethal if taken for weeks. But the judge also ruled that Merck and Company may argue it takes 18 months to create any danger.
Each side had tried to get the judge to rule out its opponent's key argument on how long someone must take Vioxx before it increases the risk of heart attacks.
The trial beginning next week in Houston involves a man who died after a month on the drug.
Merck won a case this month in its home state of New Jersey but lost a case in Texas three months ago.

Judge rules on scope of Vioxx arguments in first federal lawsuit

Judge rules on scope of Vioxx arguments in first federal lawsuit
11/21/2005, 4:49 p.m. CT
By JANET McCONNAUGHEY The Associated Press

NEW ORLEANS (AP) — Lawyers for a woman whose husband died of a heart attack after a month on Vioxx may argue that the once popular painkiller can be lethal if taken for weeks, and Merck & Co. may argue that it takes 18 months to create any danger, a federal judge has ruled.

Each side had tried to get the judge to rule out its opponent's key argument — how long someone must take Vioxx before it increases the risk of heart attacks — for the first federal Vioxx trial.
"In essence, both the Plaintiff and Merck rely on the same material," U.S. District Judge Eldon Fallon wrote in a 57-page ruling. "They simply interpret it differently and reach contrary conclusions. The Court's role as gate-keeper is to scrutinize the methodology, not the conclusions."
The trial begins Nov. 29 in Houston, where it was moved after Hurricane Katrina hit New Orleans, and those contentions are the keys.
Merck is 1-1 before state juries. It won a case this month in its home state, New Jersey, and lost a $253 million verdict in Texas three months ago, though Texas law will cut it to $26.1 million.
Merck's attorneys may also bring up evidence about whether Evelyn Irvin Plunkett and her husband, Richard "Dicky" Irvin, were separated when he died at the age of 53, Fallon wrote. That may be relevant to arguments about whether Plunkett should be awarded damages for loss of her husband's love and companionship, the judge wrote.
This case is among 1,800 for which Fallon is supervising pretrial matters. Plunkett contends Vioxx caused the blood clot that killed her husband, manager of a wholesale seafood distributor in St. Augustine, Fla.
Fallon has asked attorneys in the case not to talk to reporters. He has not issued a written order. But a note made public Monday said Plunkett's attorneys, who had contended that they could talk to reporters until the trial started, and Merck's, who had complied immediately, had agreed Thursday on terms for the order.
Fallon's 57-page ruling, which was dated Friday, also covered expert witnesses. Fallon said all 13 expert witnesses may testify, though he said some of the testimony might be redundant. He also limited testimony by one professor.
The separation question was among rulings on dozens of motions added to the record Monday. In each case, the motions are described briefly on the left half of the page, and Fallon's decision hand-written on the right.
The judge noted that he would wait until trial to decide about several of them, including whether the U.S. Food and Drug Administration has found that all nonsteroidal anti-inflammatory drugs increase the risk of strokes and heart attacks. Plunkett's attorneys claim that is false and prejudicial.
Merck stopped selling Vioxx in September 2004, when a study showed it could double risk of heart attack or stroke if taken for 18 months or longer. The company says no studies prove such a risk for shorter periods, and that it believed Vioxx to be safe until the 2004 study.
Plunkett claims Merck knew it could be dangerous years before it went on the market.

Many here join Vioxx fight

(November 21, 2005) — Paul Crowell says he hates "sue-happy" people.But after a blood clot and a heart attack put Crowell in a 10-day coma and crippled his left leg, he believed he deserved some payback.
Crowell blames those problems on Vioxx, the now-infamous pain reliever that he used to treat a bad back, so the 49-year-old Rochester man is exploring his legal options.
"I feel like if I win something and get something out of it, fantastic," he said. "It wasn't a happy point in my life."Crowell is one of 96 people from Monroe County who have filed claims in state Supreme Court against the maker of Vioxx, Merck & Co., which stopped selling the drug last year after finding it increased the risk of heart attack and stroke. The local cases are among 6,500 filed nationwide by people who say the drug caused ailments.
The first lawsuit against Vioxx, in Texas, resulted in a $253.4 million award to the widow of a man who died of a heart attack after he used the drug for eight months. That award will likely be cut significantly because of Texas' caps on punitive damages.
However, a New Jersey jury sided with Merck earlier this month in rejecting an Idaho man's claim that he deserved restitution for a heart attack he suffered after taking Vioxx for two months.
So what might happen with the lawsuits filed here?Despite Merck's promise to fight each case individually, many lawyers say the company will eventually have no choice but to settle, and will then devise criteria for whom it thinks deserves a settlement. The process will likely take years.
But because of Merck's victory in New Jersey, many plaintiffs might get shut out of a settlement if they didn't take the drug for long, weren't taking it at the time of the heart attack or stroke, or had other health problems, said Peter Catalano, a personal injury lawyer in Rochester and Syracuse with Alexander & Catalano. "The New Jersey verdict has made all lawyers who represent Vioxx victims look more closely at their cases," he said. "They're not all automatically a slam-dunk."
Lawsuits inevitableLegal experts expect thousands of suits to be filed, considering Vioxx, a popular drug for arthritis, back pain and other ills, was prescribed to 20 million Americans between 1999 and 2004. The case is comparable to the one faced by fen-phen, a diet drug pulled off the market in 1997 after concerns that it caused heart valve damage and lung disease. Fen-phen's makers agreed to pay upward of $3 billion to claimants. Lawsuits against Merck were inevitable once it pulled Vioxx off the shelves in September 2004. The company decided to discontinue the product after a study it sponsored revealed that heart attacks and strokes doubled in Vioxx users compared with those taking a placebo.
Previous studies also had revealed the drug's impact on cardiovascular health, which resulted in Merck putting a warning label on the package in 2002.
But the civil cases against Merck claim the company knew much more about the drug's impact on the heart and blood vessels and did nothing to warn doctors or protect consumers.
The local people suing Merck are represented by the Buffalo-based Barnes Firm. Shortly after the recall, Barnes inundated the media with advertisements looking for clients who claimed to be injured by Vioxx.
Greece resident Robert Coene, 70, is part of the local lawsuits. He won't divulge all the details of his case because of the pending suit, but he said he had a heart attack in 2004 after taking Vioxx for four years.
The plaintiffs are lumped into 16 different lawsuits, most filed in late October, which include Barnes lawyers' arguments concerning Merck's alleged wrongdoings. However, the lawsuits provide no details about the claimants' injuries.
There is one plaintiff who is suing on behalf of someone who is deceased. Brian A. Goldstein, the Barnes lawyer who filed the suits, did not return calls seeking comment.
The Barnes Firm is the only law firm to file claims against Vioxx in state Supreme Court in Rochester. There are likely other local residents involved in cases elsewhere. Local lawyers are referring clients to lawyers outside the area who specialize in large medical lawsuits.
Paul Rheingold, a Manhattan-based lawyer, has received referrals from 13 law firms in the Rochester area concerning clients who want to sue over Vioxx. However, none of the cases has been strong enough for him to take, Rheingold said.
"We have screened 2,200 cases (from across the country) to come up with less than 100," Rheingold said. A person would have "had to take (Vioxx) for three or four months, the heart attack has to be due to a blood clot, and they can't have many risk factors."
Had been off VioxxCrowell, a salesman for a company called Prepaid Legal Services, had been off Vioxx for at least a couple of years before he had his heart attack in April 2004. He also suffers from emphysema after years of smoking.
But he said he never had high blood pressure until he started taking Vioxx. Also, Crowell had his heart checked before the heart attack, and there were no signs of blockage, he said.
Doctors surmised that a blood clot went through his heart and lodged in his groin. As a result of the surgery to remove the clot, Crowell will likely always need a leg brace to stand and walk.
"If I don't recover anything, I gave it a shot. I'm not going to pitch a fit," said Crowell. "But on the other hand, because of what I went through, I'm interested in getting something. My leg is ruined for the rest of my life."