Graphic: Vioxx Legal Resources.com

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Graphic: Summary tab
On September 30, 2004, the international prescription drug company Merck announced the worldwide withdrawal of the arthritis medication Rofecoxib, sold in most countries under the brand name Vioxx, because a study showed an increased risk of heart attack and stroke. Patients who have suffered injuries due to Vioxx have filed litigation against Merck for failing to recall the drug when it first learned of Vioxx's dangerous side effects.

To contact in confidence an experienced personal injury attorney at Lieff Cabraser working on the Vioxx lawsuit, click here.


Graphic: International
The painkiller Vioxx was marketed throughout the world, sold in many countries under the name Vioxx and in others as Ceoxx. Lieff Cabraser is working with attorneys and solicitors in:

Argentine flag Argentina
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Flag Canada Canada
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         Kingdom

and other countries to bring litigation against Merck in U.S. courts for patients suffering heart attacks and strokes from Vioxx. If you are visiting this website from outside the U.S., please click here to contact an attorney regarding your experiences with Vioxx or Ceoxx.

 


Press Articles

2005 | 2004 | 2003 | 2002 | 2001 | Timeline
Below are summaries of press articles on the Vioxx case. For a concise review of the Vioxx controversy and how injured Vioxx and Ceoxx users may obtain compensation, please visit our main page.
  
December 3, 2004
Forbes, "Merck's Vioxx Liability Could Reach $38 Billion"
          The legal liability to Merck for the withdrawn arthritis drug Vioxx could be huge, according to Richard Evans, an analyst at Sanford C. Bernstein. If all the patients who had heart attacks as a result of taking Vioxx were to receive an average-sized legal settlement, Evans wrote in a research report, Merck's liability could reach $38 billion. That assumes that 58,000 heart attacks could be linked to the drug, and that the average settlement would be $650,000. At current prices, Evans wrote, the company's share price assumes about $25 billion in risk. Evans, who rates Merck at "market perform," cautions that it's not yet clear whether trial lawyers can win settlements or at jury, but if they do the liability is likely to far exceed his previous estimates.
  
November 18, 2004
The New York Times, "Earlier Merck Study Indicated Risks of Vioxx"
          Nearly a year before Merck received results from the clinical trial that prompted the company to withdraw its painkiller Vioxx from the market, the company received preliminary results from a separate study of patient records that also apparently indicated that the drug posed cardiovascular risks.
          Merck has not publicly disclosed that separate study's results or referred to it in any of its statements about Vioxx's safety record since announcing in late September that it would stop selling the drug. But a company spokeswoman, in response to a reporter's questions yesterday, confirmed the study's existence and said that Merck, which paid for the research, received its preliminary results last November - and was given a final report 10 days before the company announced it would stop selling Vioxx.
          When it withdrew the drug from the market, Merck cited a long-term trial showing that some patients, after taking Vioxx for 18 months, developed serious cardiovascular problems. But Merck's critics continue to say that the company should have heeded signals years earlier that Vioxx might pose dangers. Today in Washington, the company's chief executive, Raymond V. Gilmartin, is expected to be questioned on the matter in a hearing by the Senate Finance Committee, which will also be examining the Food and Drug Administration's handling of Vioxx and other drug safety issues.
          The study report that Merck received on Sept. 20 was an analysis of patient records from the UnitedHealth Group, one of the nation's biggest plans. It compared the relative rates of heart attack and stroke in people taking Vioxx; a similar drug, Celebrex; and traditional over-the-counter painkillers.
  
November 18, 2004
Associated Press, "FDA Called 'Defenseless' Against Bad Drugs"
          The American public is "virtually defenseless" if another medication such as Vioxx proves to be unsafe after it is approved for sale, a government drug safety reviewer told a congressional committee Thursday. "I would argue that the FDA as currently configured is incapable of protecting America against another Vioxx," said David Graham, who warned that the arthritis drug had been linked to an increased risk of heart attack and stroke.
          Raymond V. Gilmartin, the company president, said in prepared testimony that Merck acted within four days of learning about the risk. The Food and Drug Administration has defended its actions regarding Vioxx. In a statement issued late Wednesday, the agency cited its "well-documented and long-standing commitment toess and transparency in its review of marketed drugs." Graham told the committee that research indicated that Vioxx caused up to 160,000 heart attacks and strokes.
  
November 14, 2004
60 Minutes, "Prescription For Trouble"
          When the pharmaceutical giant Merck pulled its blockbuster pain medication Vioxx off the market in late September, it became the largest prescription drug recall in history. The company says it took immediate action after a new study showed that Vioxx doubled the risk of heart attacks and strokes in some patients.
          However, according to internal Merck documents 60 Minutes has seen, and interviews with outside scientists, Merck had concerns that Vioxx could possibly cause cardiovascular risks long before it was pulled off the market. Some 20 million Americans took Vioxx in the five-and-a-half years it was being sold. It may have contributed to thousands of heart attacks and sudden deaths.

To read the complete 60 Minutes Report, click here.
  
November 14, 2004
The New York Times, "In Face of Warnings, Drug Giant Took Long Path to Vioxx Recall"
          In May 2000, executives at Merck, the pharmaceutical giant under siege for its handling of the multibillion-dollar drug Vioxx, made a fateful decision. The company's top research and marketing executives met that month to consider whether to develop a study to directly test a disturbing possibility: that Vioxx, a painkiller, might pose a heart risk. Two months earlier, results from a clinical trial conducted for other reasons had suggested such concerns.
          Merck decided not to conduct a study solely to determine whether Vioxx might cause heart attacks and strokes - the type of study that outside scientists would repeatedly call for as clinical evidence continued to show cardiovascular risks from the drug. Instead, Merck officials decided to monitor clinical trials, already under way or planned, that were to test Vioxx for other uses, to see if any additional signs of cardiovascular problems emerged.
          It was a recurring theme for the company over the next few years - that Vioxx was safe unless proved otherwise. As recently as Friday, in newspaper advertisements, Merck has argued that it took "prompt and decisive action'' as soon as it knew that Vioxx was dangerous. But a detailed reconstruction of Merck's handling of Vioxx, based on interviews and internal company documents, suggests that actions the company took - and did not take - soon after the drug's safety was questioned may have affected the health of potentially thousands of patients, as well as the company's financial health and reputation.
  
November 12, 2004
Forbes, "The Vioxx Safety Study Merck Didn't Do"
          On Sunday, 60 Minutes will run a story asking if Merck knew about the dangers of Vioxx, the arthritis drug that was pulled from the market because it doubled the risk of heart attack and stroke. Did Merck do enough to study Vioxx's effect on the heart?
          At a December 2001 meeting with financial analysts, Merck promised to study the safety of Vioxx and a follow-up drug, Arcoxia. To help prove the heart safety of Arcoxia, Merck announced a 23,542-patient trial called MEDAL in September 2002. Yet no similar study was conducted for Vioxx.
          Certainly, such cancer studies can turn up cardiovascular risk. In fact, it was one of the placebo-controlled studies, begun in 1999, that resulted in Vioxx being pulled from the market. There's only one problem: Cancer studies are not what others heard Merck promise at its meeting with the financial community in 2001. News sources, including Dow Jones and Reuters, reported at the time of the 2001 meeting that big cardiovascular trials were expected for both Vioxx and Arcoxia.
          In a letter to the public published in newspapers this morning, Merck Chief Executive Raymond Gilmartin defended his company's "consistent and rigorous adherence to scientific investigation, transparency and integrity." Moreover, Gilmartin wrote, "When questions arose, we took additional steps, including conducting further prospective, controlled studies to gain more clinical information about the medicine." It's certainly true that Merck studied its drug. But did it really do every study it said it would?
  
November 12, 2004
Crain's New York Business, "Merck CEO defends handling of Vioxx"
          In full-page newspaper ads today, Merck & Co. Chief Executive Raymond Gilmartin defended his company's research on Vioxx as well as its handling of the drug once health concerns emerged. Mr. Gilmartin said in ads that in the weeks since Merck voluntarily recalled the drug because of cardiovascular risks, "incomplete and sometimes inaccurate information has been presented by others about Merck's scientific integrity and [its] commitment to ensuring patient safety."
          Merck has received a subpoena from the U.S. Justice Department requesting information about its research, marketing and selling activities related to Vioxx. The Securities and Exchange Commission has also begun an informal inquiry. The Senate Finance Committee has requested testimony from Mr. Gilmartin at a hearing this month on the Vioxx withdrawal, and lawyers for ex-Vioxx users who are suing Merck are reportedly seeking to depose him.
  
November 7, 2004
Newhouse News Service, "Vioxx recall may cost $18 billion"
          A Wall Street analysis suggests the Vioxx recall may cost the pharmaceutical firm Merck as much as $18 billion over the next decade. The staggering sum reflects the possibility that more than 50,000 Vioxx users suffered heart attacks or strokes, and that each patient will file a successful lawsuit against the beleaguered drug maker, according to the report by Merrill Lynch.
          The popular painkiller was withdrawn Sept. 30 after being linked to cardiovascular problems. Since then, anxious investors have driven Merck shares down about 40 percent over fears that litigation costs will skyrocket. Those fears rose further after recent reports suggested Merck attempted to downplay the cardiovascular risks before Vioxx was launched in 1999, and continued to do so even after researchers and physicians questioned the drug's safety.
          About 300 lawsuits have been filed against Merck and hundreds more are expected. Some lawsuits seek damages, while others want the company to pay for medical monitoring in the event a heart attack or stroke occurs later. Merck spokeswoman Anita Larsen said the Whitehouse Station, N.J., company will vigorously defend against the lawsuits but can't predict the outcome or reasonably estimate the possible loss.
  
November 5, 2004
The New York Times, "Merck lawsuits on tap? Attorneys representing people alleging harm from Vioxx set meetings to fix game plan"
          Drugmaker Merck & Co., which pulled its blockbuster painkiller Vioxx from shelves in September, is about to become the target of hundreds of lawsuits, according to a published report Friday. Attorneys, representing people who claim injury or death because of the use of Vioxx, plan to meet next week to lay the foundations for a nationwide blitz against Merck.
          Merck (Research) has been buffeted since the company pulled Vioxx after it was shown to increase the risk of heart attack and strokes.
          The specter of litigation against Merck has increased since the recall was issued in late September. On Thursday, Swiss scientists writing in a report for British medical journal The Lancet said that the company should have pulled Vioxx four years ago because of data showing an elevated risk of a cardivascular event.
  
November 5, 2004
The New York Times, "Lawyers Organizing for Mass Suits Over Vioxx"
          Hundreds of plaintiffs' lawyers who claim that people were injured or killed by the painkiller Vioxx plan to meet next week to lay the groundwork for a nationwide legal assault against the drug's maker, Merck.
          The lawyers expect the discussions to begin informally on Tuesday in Pasadena, Calif., in the hallways of a conference on Vioxx litigation that will also beto defense lawyers.
  
November 5, 2004
The New York Times, "Study Says Drug's Dangers Were Apparent Years Ago"
          Merck and federal officials should have withdrawn the painkiller Vioxx from the market as early as 2000 because studies of the drug had clearly shown that it doubled the risk of heart attacks among users, according to a study released yesterday by The Lancet, a British medical journal.
          Authors of the study pooled data from 25,273 patients who participated in 18 clinical trials conducted before 2001. They found that patients given Vioxx had 2.3 times the risk of heart attacks as those given placebos or other pain medications. Merck withdrew Vioxx on Sept. 30 of this year after a company-sponsored trial found a doubling of the risks for heart attack or stroke among those who took the medicine for 18 months or more.
          An editorial accompanying the study criticized both Merck and the Food and Drug Administration, and described Vioxx's approval and its popularity as "public health catastrophes" that led to over 27,000 heart attacks and sudden deaths.
          "For with Vioxx, Merck and the F.D.A. acted out of ruthless, short-sighted and irresponsible self-interest," wrote Richard Horton, editor of The Lancet.
  
November 1, 2004
MSNBC.com, "Report: Merck tried to bury Vioxx concerns; E-mails suggest drug firm knew of problems for years"
          Internal e-mails and other documents from Merck & Co. show the company fought for years to keep safety concerns from undermining the drug's commercial prospects, the Wall Street Journal reported on Monday [November 1, 2004].
          Vioxx, a drug known as a COX-2 inhibitor, was withdrawn from the market after it was shown to double the risk of heart attack and stroke in patients who had been taking it for at least 18 months. Vioxx generated some $2.5 billion in annual sales, and its withdrawal pummeled Merck's shares.
          On Monday [November 1, 2004], the Journal reported that an e-mail dated March 9, 2000, suggested Merck recognized that something in Vioxx was linked to increased heart risk.
          Edward Scolnick, Merck research chief at the time, wrote in the e-mail that cardiovascular events "are clearly there" and called it a "shame."
          Although Scolnick compared Vioxx with other drugs with known side effects and wrote, "there is always a hazard," the company's public statements continued to reject the link between Vioxx and increased intrinsic risk.
  
October 22, 2004
New Jersey Star-Ledger, "Vioxx recall continues to shake Merck"
          The fallout from the Vioxx recall became crystal clear yesterday as Merck reported third-quarter earnings plunged 29 percent, more cost-cutting is planned and hundreds of additional lawsuits have been filed by health plans and consumers. The profit picture for next year appeared equally sobering: The Whitehouse Station-based drug maker estimated 2005 earnings will drop as much as 11 percent thanks to lost Vioxx revenue and costs associated with the Sept. 30 product withdrawal.
          The difficulties created by Vioxx are only beginning. As of Oct. 15, Merck faces about 300 lawsuits filed by health plans and individuals alleging consumer fraud. Other lawsuits seek class-action status and allege personal injury, such as gastrointestinal bleeding and heart attacks. Some demand medical monitoring.
          The episode may resemble the diet-pill litigation. Since Wyeth withdrew two drugs in 1997, the company has taken $16.6 billion in charges and reached settlements with thousands of consumers. Nonetheless, lawsuits remain outstanding and more charges are expected. At last count, about 20 million Americans have taken Vioxx since it was launched in the United States in 1999, with about 105 million prescriptions written. The number of patients outside the United States who have taken Vioxx is not known, according to Merck.
  
October 18, 2004
The Washington Post, "Painful Withdrawal for Makers of Vioxx; Pulling of Arthritis Drug Raises Questions on Marketing, Safety Risks"
          Backed by a $195 million ad campaign, featuring testimonials from former skater Dorothy Hamill and music by the Rascals to appeal to aging baby boomers, Merck had sold Vioxx to more than 20 million Americans since its approval in 1999 and millions more worldwide.
          An examination of how and why Merck reacted offers an unusual look at how safety issues are handled in clinical trials once a drug is on the market and the complex business of weighing risks against benefits.With Vioxx, researchers had been warning about the drug's possible cardiovascular risks since 2000, only a year after it was approved by the FDA. Data from a company study found then that users had four times as many heart attacks and strokes as those who used another painkiller.
          When the recall occurred, it came about because of a major clinical study sponsored by Merck that tracked 2,600 patients for almost three years to find out if Vioxx helped prevent colon polyps. Merck launched the effort hoping to create new markets for Vioxx, while also laying to rest questions about the drug's connection to heart attacks and strokes.
          Far from it, the trial confirmed the predictions of Merck's harshest critics, who had long complained that the New Jersey manufacturer was closing its eyes to Vioxx's problems and improperly pushing a dangerous drug onto consumers with aggressive ads. Vioxx and other Cox-2 inhibitors like Celebrex had been promoted as wonder drugs, since they provided pain relief to arthritis sufferers without causing stomach problems, but now Vioxx is off the market and the others are under a cloud.
          Cleveland Clinic cardiologist Eric J. Topol, an early critic of the drug, estimates Vioxx may have caused 30,000 to 100,000 heart attacks and strokes, many of them "preventable" because patients could have taken other drugs.
  
October 10, 2004
Forbes, "Top Doctor Calls For Vioxx Investigation"

          The New England Journal of Medicine issued two editorials today calling for renewed scrutiny into the entire class of arthritis drugs to see if other drugs in the category also cause heart problems. In one editorial, Cleveland Clinic cardiologist Eric Topol, who was the first to raise the alarm about Vioxx three years ago, calls for a formal government investigation into how Merck and the U.S. Food and Drug Administration left Vioxx on the market for so long after concerns about its possible heart risks had been raised. He blasts them for not doing bigger, better studies that might have teased out Vioxx's effect on the arteries.
          Merck pulled Vioxx last week after a big study found long-term use of the drug nearly doubled the risk of heart attacks and strokes. The second editorial, by University of Pennsylvania cardiovascular researcher Garret FitzGerald, warns that it is very possible that other similar drugs, such as Pfizer's Celebrex and Bextra, may also increase the risk of heart problems. He says the burden of proof is now on Pfizer and Novartis -- and other drugmakers that sell or hope to sell so-called cox-2 inhibitors -- to prove that their drugs are safe on the heart.

  
October 6, 2004
MSNBC.com, "Vioxx linked to thousands of deaths; Newspaper cites government study on recalled pain drug"
          Merck & Co.’s arthritis drug Vioxx may have led to more than 27,000 heart attacks and sudden cardiac deaths before it was pulled from the market last week, the Wall Street Journal reported Wednesday, citing an unreleased study by government regulators.
          Last week, Merck abruptly recalled Vioxx, an arthritis treatment and one of the company’s top-selling drugs, after an internal study showed that patients taking the drug were more likely to suffer a cardiac event than those taking a placebo.
          The Journal’s report, citing a study by the Food and Drug Administration, said that from Vioxx’s approval in 1999 through 2003, an estimated 27,785 heart attacks and sudden cardiac deaths would have been avoided if Celebrex, a competing drug made by Pfizer Inc., had been used instead of Vioxx.
  
October 5, 2004
Irish Times, "Arthritis Drug Concerns Raised Some Time Ago"
          The potential for cardiac side-effects with the arthritis drug Rofecoxib, which was withdrawn from use last week, has been known for some time, it was claimed yesterday.
          A number of doctors have contacted The Irish Times to express their concern that the drug, which is marketed here as Vioxx, was not withdrawn earlier. They said they have been concerned about its safety and that of other Cox II inhibitors for some time.
          Vioxx was withdrawn from use last Thursday after research had shown that taking the drug long-term could increase the risk of heart attack or stroke between three and fourfold compared to patients taking a dummy pill. The drug is one of the latest generation of non-steroidal anti-inflammatory drugs.
  
October 2, 2004
Washington Post, "Lawsuits for Vioxx use begin to emerge"
          The abrupt withdrawal last week of the best-selling painkiller Vioxx is an event rich in ironies and lessons that may ultimately lead to a rethinking of the way drug safety is evaluated in the United States.
          Drugs whose stated advantage is that they are safer than their competitors -- which was Vioxx's claim -- are likely to get much closer scrutiny. The Food and Drug Administration in the future may force companies to run new, definitive clinical studies specifically to address safety issues even after a drug is on the market and in widespread use.
          Vioxx, taken by 1.3 million Americans, was removed from sale worldwide on Thursday because it raised the risk of cardiovascular disease, the nation's leading cause of death. Proof of that hazard did not come until five years after the drug was licensed and three years after the first hints of a problem.
  
October 1, 2004
The Wall Street Journal, " Merck Pulls Vioxx From Market After Link To Heart Problems"
          On the morning of Sept. 24, Raymond Gilmartin, chief executive of Merck & Co., got the call every pharmaceutical executive dreads. Peter Kim, Merck's research chief, told him an outside panel overseeing a clinical trial of the company's painkiller Vioxx had urged Merck the night before to halt the trial and immediately stop patients from taking the drug.
          The reason: Patients on the drug were twice as likely to have a heart attack or stroke as those on a placebo.
          Six days after that call, Merck announced that it is withdrawing Vioxx from the world-wide market.
          The drug had global sales of $2.5 billion in 2003 and more than 100 million prescriptions have been written for it since it went on the market in 1999, according to Merck. But it had been dogged for several years by suggestions that it led to heart problems. Until yesterday, Merck vehemently denied there was a connection.
  
October 1, 2004
Newsday, "Concerns over Vioxx raised in '01"
          In February 2001, Dr. Steven Nissen of the Cleveland Clinic was part of an advisory panel put together by the Food and Drug Administration to address mounting evidence suggesting the popular COX-2 inhibitor Vioxx could increase risk of heart disease and stroke.
          The drug had been approved two years earlier and millions throughout the world were taking daily pills to reduce the pain and inflammation of arthritis and other conditions.
          Nissen told his colleague and chairman of cardiovascular medicine, Dr. Eric Topol, that he was not satisfied with the explanation put forth by Merck officials, who said Vioxx wasn't harmful to the cardiovascular system. According to Merck, comparison studies of Vioxx versus naproxen, sold as Aleve, were actually picking up on Aleve's protective effects on the heart, rather than alleged harmful effects from Vioxx.
  
October 1, 2004
CNN.com, "Merck faces lawsuit after Vioxx pulled"
          An Oklahoma lawsuit filed on Thursday charges that Merck & Co. misled patients about the safety of its arthritis drug. The case may signal many more such lawsuits against the drugmaker, following its withdrawal of Vioxx, legal experts said.
          The company said earlier on Thursday that the drug, used by 2 million people worldwide, doubled the risk of heart attack and stroke in a recent clinical trial.
          The suit, filed on behalf of an Oklahoma County resident but likely to become a class-action effort, alleges Vioxx raises the risk of heart attack, blood clots and other serious cardiovascular events, which can lead to injuries and death.
  
October 1, 2004
San Francisco Chronicle, "Arthritis drug Vioxx yanked off market"
          Pharmaceutical giant Merck & Co. abruptly ordered a worldwide recall of its premier arthritis drug Vioxx on Thursday after a company-run study confirmed that long-term use of the pills increased risk of heart attack and stroke.
          Vioxx is taken by more than 2 million arthritis patients around the world for the treatment of joint pain. It's one of a new family of anti-inflammatory drugs known as COX-2 inhibitors, which grew in popularity because they cause fewer stomach problems than competing nonprescription medicines such as naproxen or ibuprofen.
          The reason Vioxx causes a higher risk of heart problems remains a mystery. However, one theory holds that such drugs can disable a protective mechanism that keeps blood cells from clumping together. A number of smaller clinical studies have also detected increased rates of high blood pressure among patients taking Vioxx compared to those on Celebrex.
  
October 1, 2004
Forbes, "Merck's Legal Nightmare"
          Merck's recall of its popular painkiller Vioxx after a big study found it increased the risk of heart attacks and strokes could set off the next big class-action feeding frenzy.
          Virtually every time a drug has been recalled because of side-effect problems in recent years, the companies have faced legal liability. The question for Merck and its investors now is, How big will its legal bill be? The answer is unknown but could potentially be huge, because Vioxx was a popular drug used by millions of consumers. Overall, 84 million people worldwide have taken Vioxx worldwide since it was approved in 1999.
          "This is going to be a nightmare of unbelievable proportions in terms of legal liability" for Merck, says independent analyst Hemant Shah of Warren, N.J., who was one of the first to predict that Wyeth would face enormous legal liability from its recall of the diet drugs fenfluramine (part of the fen-phen combo) and Redux in 1997.
  
October 1, 2004
Associated Press, "Merck Raises Vioxx Prescription Estimate"
          Merck & Co. on Friday raised its estimate of the number of prescriptions written in the United States for its recently recalled heart disease treatment Vioxx.
          Merck said about 105 million U.S. prescriptions were written for the drug from May 1999 through August 2004. The drug giant said it has not determined the number of prescriptions written outside of the United States.
          Previously, Merck said the drug had been prescribed about 84 million times since 1999. Merck recalled Vioxx Thursday after a study showed it doubled the risk of heart attacks and strokes.
  
October 1, 2004
Atlanta Journal-Constitution, "Vioxx Users Can Find Safe Alternatives"
          A day after one of the largest drug recalls in history, America's two million Vioxx users are left wondering what's next in terms of relieving their arthritis pain.
          Fortunately, a wide range of safe, effective treatment alternatives are waiting on drugstore shelves, experts say.
          "There are several anti-inflammatory medicines that have the same effect as Vioxx, and several in the same class of cox-2 inhibitors," said Dr. Michael Fleming, president of the American Academy of Family Physicians.
  
September 30, 2004
Bloomberg.com, "Merck to Withdraw Vioxx Because of Heart Risks"
          Merck & Co. withdrew its Vioxx painkiller, which generated $2.5 billion in sales last year, because of a link to heart attacks and strokes. The company's shares slid as much as 28 percent, wiping out $28 billion in market value.
          New three-year data from Merck suggested that patients taking Vioxx for more than 18 months faced twice the risk of a heart attack compared with those taking a placebo. The Whitehouse Station, New Jersey-based company retracted its third-quarter profit forecast and cut its full-year estimate by 50 cents to 60 cents a share, spokesman Tony Plohoros said.
          The U.S. Food and Drug Administration issued an advisory, urging Vioxx users to consult with a doctor about alternative medications.
September 25, 2001
USA Today, "FDA sends warning letter to Vioxx maker"
           The Food and Drug Administration has ordered Merck, maker of the blockbuster painkiller Vioxx, to issue a letter to doctors "to correct false or misleading impressions and information" stemming from the drug's promotional campaign.
           Merck's marketing efforts, aimed mainly at doctors, have minimized Vioxx's known and potential cardiovascular risks, the FDA wrote in an eight-page "warning letter" faxed Sept. 17 to Raymond Gil- martin, president and chief executive officer. The letter, signed by Thomas Abrams, head of the FDA's Division of Drug Marketing, Advertising and Communications, was posted Friday on the FDA Web site.
          So far this year, the FDA has sent drug companies fewer than a dozen warning letters, which the agency reserves for activities that raise significant public health concerns.
          According to the Sept. 17 warning letter, a doctor under contract with Merck to present talks to other physicians, company sales representatives and a press release have minimized the possibility that Vioxx could increase users' risk of heart attacks or strokes.
  
September 3, 2004
Atlanta Journal-Constitution, "FDA Nod Won't Guarantee Drug Safety"
          A 60-year-old woman with degenerative disk disease recently came into Dr. Allen Lebovits' Manhattan office with a complaint. This time, the grievance wasn't about the pain but about news reports linking Vioxx, her pain reliever, with an increased risk of heart attacks and sudden cardiac deaths.
          Lebovits expects to see more reactions just like this in the wake of new reports that heart attack rates and sudden cardiac deaths were tripled in patients taking Vioxx vs. those taking a similar drug, Celebrex. Both are in the class of medications known as cox-2 inhibitors.
          But Vioxx was not the only drug to get bad press this week. A study released early from the Sept. 15 issue of the Journal of the American Medical Association reported that people who took a high dose (80 milligrams daily) of Zocor, a cholesterol-lowering statin, had an increased risk of muscle-related complications without any increased benefit.
          Both Vioxx and Zocor are U.S. Food and Drug Admininstration-approved blockbuster drugs.
  
August 27, 2004
Forbes, "Vioxx Safety Debate Renewed After FDA Report"
          A new study linking high doses of Vioxx to an increased risk of heart attacks and sudden cardiac deaths has re-ignited a running debate about the safety of the arthritis drug.
          The study of 40,500 people enrolled in Kaiser Permanente, the nation's largest health management organization, found that heart attack rates and sudden cardiac deaths were tripled in patients taking Vioxx in doses higher than 25 milligrams a day compared to those taking a competing drug, Celebrex.
          The study was done by personnel at the U.S. Food and Drug Administration, who said that "this and other studies cast serious doubt on the safety" of Vioxx and that Celebrex "may be safer."
          Merck & Co., which markets Vioxx, "strongly disagrees" with the findings of the new study, according to a statement by Peter S. Kim, president of Merck Research Laboratories. He faulted the study as being merely observational, looking back at medical records, rather than a randomized, controlled clinical trial, "the gold standard to evaluate safety and efficacy."
  
August 27, 2004
San Jose Mercury News, "Arthritis drug linked to higher heart risks"
          California health care giant Kaiser Permanente is likely to advise its doctors not to prescribe the popular arthritis drug Vioxx after a medical study of Kaiser members found the medicine may increase the risk of life-threatening heart problems.
          The study, led by the federal Food and Drug Administration, found that people taking higher doses of Vioxx had more than triple the risk of heart attack or sudden cardiac death when compared with people who had not recently used the prescription medicine or similar painkillers.
          Some researchers have questioned the safety of Vioxx before, but the findings from this new study are likely to broaden those concerns. Given the study's size -- almost 1.4 million Kaiser patients in California, with more than 26,700 taking Vioxx -- other insurers are likely to join Kaiser in reconsidering their position of the drug. Doctors and federal regulators said they might re-examine the drug.
  
August 27, 2004
NBC 10 (Philadelphia, Pennsylvania), "Vioxx Linked To Increased Cardiac Deaths"
          A new study shows that the prescription drug Vioxx can drastically increase a person's risk of sudden cardiac death, and that risk is greater if you take a higher dose, or if you take it for a long time.
          The Food and Drug Administration funded the study. The study looked at medical records of 1.4 million people.
          People taking low doses of Vioxx, less than 25 milligrams daily, had a 50 percent higher risk of heart attack and sudden cardiac death, compared to those taking Celebrex. Both drugs are COX-2 inhibitors, which reduce inflammation in arthritic joints.
          "All medications are poisons, and they should be taken for the shortest period of time that you can," said Dr. Vincent Zarro, a rheumatologist at Drexel University College of Medicine.
Zarro says elderly patients, especially those taking diuretics or anti-hypertensive medication, are at the highest risk.
          "At this point, I would advise my patients to avoid taking Vioxx or other nonsteroidal anti-inflammatory drugs," Zarro said.
  
July 14, 2004
WebMD News, "Painkiller Vioxx Often Taken at Too High Dose"
          Evidence continues to grow that the popular pain reliever Vioxx may cause high blood pressure, swelling, and other health problems. And with the latest study, there's a new concern: High rates of misuse of the popular arthritis remedy, with many patients taking daily doses at twice the usual recommended level.
          And it's not that they are necessarily "doubling up" their prescribed doses for better pain relief. Researchers at Vanderbilt University Medical Center say that patients are often being prescribed the highest 50 milligram dose by their doctors for daily pain relief.

Lieff Cabraser: Experienced Product Liability Lawyers
          Founded in 1972, Lieff Cabraser Heimann & Bernstein, LLP is a nearly sixty attorney law firm with offices in San Francisco, New York, Washington, D.C., Beverly Hills, and Nashville. In 2003 and 2004, the National Law Journal recognized Lieff Cabraser as one of the top 20 plaintiffs’ law firms in America.
          For our personal injury cases, we bring a team of experienced lawyers. Each client is assigned a partner and an associate. In addition, we have on staff multiple nurses, legal assistants, scientific analysts and case clerks to assist the attorneys.
          We have represented thousands of patients who ingested prescription drugs with dangerous undisclosed side effects, and patients who received defective medical devices in personal injury lawsuits across America, including residents of Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming.
          We look forward to communicating with you and answering any questions you may have. To learn more about the competitive advantages our firm offers clients in personal injury and products liability cases, click here.

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Lieff Cabraser Heimann & Bernstein, LLP
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Trademark Notice
          "Vioxx" is a registered trademark of Merck. Lieff Cabraser Heimann & Bernstein, LLP is in no way affiliated with Merck, and the Vioxx trademark is used solely for informational purposes.

Copyright © 2004-2005 Lieff Cabraser Heimann & Bernstein, LLP

Graphic: Latest News
"Researcher says 139,000 harmed by Vioxx," Reuters, Jan. 3, 2005
 
Just weeks after Forbes announced Merck's Vioxx liability could reach US$38 billion, the U.S. drug safety officer who warned months ago about risks from Merck & Co. Inc.’s painkiller Vioxx has won clearance to publish a study arguing the now-recalled drug may have caused up to 139,000 excess cases of heart attacks and strokes. More...
  
To read more press articles on the Vioxx recall and Vioxx class action lawsuit, click here.


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Lieff Cabraser has participated in twenty-three $100 million-plus settlements and verdicts. To read a summary, click here.


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News
Click here to read recent press articles on the Vioxx recall and Vioxx lawsuits.


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Timeline
Read about key events in the Vioxx recall and Vioxx lawsuit by clicking here.



Vioxx Recall Lawsuits and Vioxx Side Effects: 2004 Update News

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