MISKIN LAW VIOXX BEXTRA WEB INFO PAGE
wall street journal reported on November 1, 2004: Internal memos of Merck show that they knew of the problems with vioxx 2.5 years before the drug was approved for use. A November 21, 1996 memo noted that if vioxx were put into trial use without aspirin it could be proven that vioxx was gentler on the stomach but "there is a substantial chance that significantly higher rates" of cardiovascular disease would be seen in the vioxx group. A February 25, 1997 email from a Merck official stated that unless vioxx patients also received aspirin "you will get more thrombotic events and kill the drug." Thrombotic events are strokes. The responding email by Alise Reicin now Merck's Vice President of Clinical Research stated that the company is in a "no win situation" because if you give vioxx patients aspirin they would have gastrointestinal problems and if you did not the concern would be one of increased cardiovascular events. It was proposed that persons with high risk of cardiovascular events be kept out of the study so the difference between the vioxx group and the general population "would not be evident". The 1999 VIGOR trial which showed reduced gastrointestinal problems with vioxx excluded people with high risk of heart problems. That study still showed a heart attack rate 4 or 5 times higher than the Naproxen group. Dr. Scolnick the chief researcher of Merck wrote in a March 9, 2000 email commenting on the study that the VIGOR results show cardiovascular events "are clearly there" and that Vioxx's own mechanism was responsible for that. He said it was "mechanism based as we worried it was". Merck in commenting on the increased risk shown in the study attributed the results to alleged positive (heart protective) effects of Naproxen rather than any problem with Vioxx. Research has shown that there is no "heart protection" from Naproxen contrary to Merck's suggestion.
The publication of the above information in an article in the Wall Street Journal was followed by further deep drops in Merck's share price and a cut of Merck's credit rating further to the initial recall of Vioxx. Since then much more is known about the Vioxx situation and the whole story came out at the Ernst trial now successfully completed in Texas. In Atlantic City New Jersey the second Vioxx trial has ended with a victory for Merck. That case of Mike Humeston involved a short term user of Vioxx who suffered from a heart attack and did not recall when he last used Vioxx before the heart attack. Merck shares only rose slightly after that decision. After the Judge found that Merck had withheld evidence at trial a new trial was ordered and Mike Humeston won. Since then Merck has been successful in convincing most juries that other factors may have caused the heart attacks of some victims.
MERCK CLEARLY KNEW AND COVERED UP THE PROBLEM WITH VIOXX RIGHT FROM THE START. VIOXX SALES PEOPLE WERE INSTRUCTED TO DODGE QUESTIONS FROM DOCTORS ABOUT POSSIBLE CARDIOVASCULAR HARM FROM VIOXX.
Merck
denies that the dodge ball effort was seriously intended to mislead doctors.
VIOXX DOSAGE: The danger from vioxx increases with the amount of daily dosage. For a person of average weight the dosage of 12.5 mg per day does not pose much risk but it would for a person with low body weight. For the average weight person 25 mg per day poses a significant risk. Anyone using 50 mg. per day is at high risk even with short term use. Vioxx pills come in 12.5 mg., 25 mg., and 50 mg. sizes. Unless damage is already done the likelihood of vioxx causing a problem goes down quickly once use is stopped. Vioxx can trigger severe heart problems with even short term use but risk increases with longer term use. When contacting us about a claim let us know your pill size, daily dosage and period of use.
An
earlier vioxx poster ad
Over
two billion dollars was spent promoting Vioxx sales
Bextra was
rushed to market by Pfizer after Vioxx and was promoted as more powerful relief
THERE ARE FRAUDULENT ATTEMPTS TO GET MONEY FROM PEOPLE BY OFFERING THEM THAT THEY CAN GET RICH QUICK WITH A VIOXX OR BEXTRA LAWSUIT. DO NOT PAY A LAWYER OR ANYONE ELSE MONEY IF THEY SAY THEY CAN BRING A VIOXX CLAIM FOR YOU. THESE CLAIMS ARE BEING HANDLED ON A CONTINGENCY FEE BASIS AND NO PAYMENT IN ADVANCE SHOULD BE REQUESTED. WE ARE WORKING TO GET OUR CLIENTS WHO ARE MOST SERIOUSLY AFFECTED MAXIMUM COMPENSATION.
Globe and Mail January 25, 2005 report on death toll from Vioxx
Merck, Vioxx and Bextra A Brief History:
A Pharmacy in Germany opened in 1668 and evolved into the company Merck, A Pharmaceutical Giant.
The Merck Manual has been published since 1899.
Since World War One Merck has been an independent US company.
A QUOTE: "We try to remember that medicine is for the patient. We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been." George W. Merck II (1935)
Merck was named America's Most Admired Company by Fortune Magazine for seven years starting in 1986.
Another Quote: "Merck's dedication to fighting disease, relieving suffering, and helping people is a righteous cause." Roy Vagelos, CEO of Merck, 1991
In 1994 Ray Gilmartin, An Electrical Engineer, became CEO of Merck
VIOXX was developed by Merck's Canadian subsidiary in Montreal and by 1996 was known to Merck to carry substantially increased risk of heart trouble for users.
Celebrex (a different Cox-2 inhibitor) was approved by the US FDA December 31, 1998. Merck attempts in 1998 to get approved quickly and without being required to place stronger warnings than Celebrex for Vioxx. The focus was on ulcers and other gastrointestinal issues not cardiac issues.
May 20, 1999 Vioxx was approved by the US FDA
Upon approval Merck introduced Vioxx with the Jingle: "It's a Beautiful Morning". Olympic skater Nancy Kerrigan appeared in TV commercials. It was marketed as an anti-inflammatory which offered effective relief from pain without causing stomach ulcers and upset which was the main side effect of other Non Steroidal Anti-Inflammatories such as Naproxen. Those earlier drugs inhibited both Cox-2 and Cox-1 which protects the inner lining of the stomach. That inhibition of Cox-1 is thought to be responsible for ulcers and bleeding. Vioxx was promoted by Merck as a Cox-2 only inhibitor which would only work at the sites of inflammation. Unfortunately, Vioxx inhibits Cox-2 throughout the human body and not just at the sites of inflammation and inhibits prostacyclin. Prostacyclin is a product of Cox-2 and plays an important role in vasodilation and inhibiting of blood platelet aggregation. This makes vioxx potentially clot forming.
From the New England Journal of Medicine, reporting on the results of the VIGOR study, November 23, 2000:
"The incidence of myocardial infarction was lower among patients in the naproxen group than among those in the rofecoxib group (0.1 percent vs. 0.4 percent; relative risk, 0.2; 95 percent confidence interval, 0.1 to 0.7)"
The above quote from an Article abstract commented on the VIGOR study which showed there was a four times greater risk of heart attack with vioxx (rofecoxib). That risk was in fact understated because the VIGOR study did not include patients who were considered at risk for heart trouble.
January 16, 2001 Pfizer applies for approval of its new Cox-2 inhibitor Bextra
FDA Reviewer Shari Targum noted in February 2001 vioxx "inhibits the inhibitor" of Platelet Aggregation.
First Heart Attack related lawsuits against Merck for Vioxx issued in California July 2001
September 11, 2001: Terrorist Attack on U.S.A., World Trade Centre and Pentagon hit by hijacked airplanes killing over 3000 Americans
FDA VIOXX WARNING SEPTEMBER 17, 2001 Addressed to Ray Gilmartin CEO of Merck, nobody noticed
November 16, 2001 Bextra approved by FDA
Lawsuits against Merck related to Vioxx causing stroke and heart attack were filed in the United States and those cases are now approaching the trial stage in California and New Jersey Courts. Trial has been delayed due to the large number of new cases and a request to the courts that they manage and co-ordinate all of the claims. Many documents have come forward in the law suits which are subject to confidentiality orders made at the request of Merck.
VIOXX sales were huge at $2.5 Billion US per year.
On February 4, 2004 Ray Gilmartin sold over $30,000,000 worth of vioxx stock.
August 19, 2004 Bextra modifies Bextra label to warn of serious skin reactions approved by FDA September 14, 2004
September 30, 2004 - Vioxx recalled by Merck after being "shocked" by the results of a new study of patients with colon polyps which confirmed the heart and stroke risk. The FDA was surprised by the sudden withdrawal of the drug as the new study showed nothing new or additional to what was known 4 years earlier.
October 1, 2004 Class Action Claims begin in Canada
On October 29, 2004 Merck stated that it acted "reasonably and responsibly" in developing and marketing vioxx. At the same time the FDA asked for further and stricter review of Merck's replacement drug for vioxx before it can be approved.
On November 8, 2004 the U.S. Department of Justice and the Securities and Exchange Commission (SEC) launch investigations of Merck's handling of Vioxx.
On November 19, 2004 a U.S. Senate Committee held hearings in its investigation of Vioxx.
On November 24, 2004 Pfizer was required to place a "Black Box" warning of Bextra
December 2004 Canadian lawyers meet in London Ontario united in Canadian class action steps to be taken on Vioxx only
January 2005 Dr. David Graham allowed to publish his research on extent of harm from Vioxx
January 27, 2005 Court meeting held in Fort Meyers Florida to begin co-ordination of US Federal Court vioxx cases
February 10, 2005 US Senate passes law which restricts class action claims. Passed by Congress and signed by President soon after.
February 16, 2005 Multi District Litigation (MDL) Judges rule that Vioxx cases in US Federal Court will be transferred to Louisiana with Judge Fallon presiding over them.
February 19, 2005 FDA panel rules that all Cox-2 inhibitors will require strong warnings of heart risks and that Vioxx with low dosages may be reintroduced and given to patients who are aware of the high risk and sign waivers. Canada will not necessarily proceed the same way and is reviewing the evidence further.
February 25, 2005 Canadian Health Minister sharply critical of handling of Vioxx by Merck
March 2, 2005 Merck Frosst denied status in Quebec Court of Appeal case Piro which is a challenge of the Quebec class action law
April 7, 2005 Pfizer's drug Bextra no longer allowed to be sold and a Black Box Warning is required for Celebrex
May 2005 Ray Gilmartin "retires" as Merck CEO and is replaced by Richard Clarke a company insider. Company says it will continue to fight every Vioxx claim.
July 7th a Health Canada panel of experts recommends reintroduction of Vioxx on the basis that the benefits outweigh the risks with proper warnings. This recommendation will be considered by the Federal Government when Merck applies to reintroduce the drug. The same panel recommended that Bextra continue to be banned.
July 11, 2005 first Vioxx trial started in Texas. See Ernst trial updates.
August 19, 2005. Huge jury award for the plaintiffs in the Ernst case. Merck announces it will appeal and continue to fight every claim.
August 26, 2005 Merck announces it will considering settling some of the Vioxx claims involving persons who used Vioxx for 18 months or more with no other risk factors who suffered heart attack or stroke. Our office contacted Merck's lawyers in Canada to discuss this.
August 29, 2005 Judge Higbee in New Jersey rejected Merck's argument and ruled that the next Vioxx trial scheduled to begin on September 12 will not be adjourned. Merck had suggested they could not get a fair trial in the wake of the outcome of the Ernst trial and needed a 45 day adjournment. She also ruled that evidence regarding Merck's marketing of Vioxx will not be excluded.
September 12 and 13, 2005 Jury selection began and was completed in the second Vioxx trial of Mike Humeston who suffered a heart attack after short term Vioxx use. The trial is over and Merck won. See our update.
November 7, 2005 Judge Higbee ordered that the next trials in New Jersey will be for Plaintiffs who used Vioxx for over 18 months.
November 28, 2005 The first US federal court Vioxx trial, Irvin, began in Houston for a person who died after short term Vioxx use. It ended in mid-December with a mistrial as the jury could not reach a unanimous verdict. It is only in the US federal court that a majority verdict is not sufficient.
January 24, 2006 Another Texas trial began of Mr. Garza a short term Vioxx user who died of a heart attack. That trial has been adjourned then resumed in mid February and we will report the end result.
February 6, 2006 The retrial of the Irvin case began in New Orleans. It started smoothly with quick jury selection and opening statements. The lawyers were very prepared for this second run and have refined their arguments to make the case more clear from each side's point of view. The trial ended with a victory for Merck which makes clear to us that short term Vioxx use claims are not likely to be successful generally.
March 2006 Two trials together of long term Vioxx users resident in New Jersey are underway. Both suffered non fatal heart attacks. The McDarby case was successful including punitive damages while the Cona case was dismissed by the same jury.
April 21, 2006 Jury returns with a thirty six million dollar award for the plaintiff in the McDarby case.
June 29, 2006 Merck rests its case in the Doherty case in Atlantic City where the first female plaintiff at trial is represented by our associated law firm. The jury found no liability due to other cardiac risk factors but did find Consumer Fraud had been committed by Merck.
August 30, 2006 The Humeston case dismissal was set aside in New Jersey with a new trial ordered.
Subsequent trials have had mixed results. In New Jersey the right of foreign plaintiffs to sue is under consideration by the court.
November 9, 2006 In Quebec the class action has been certified by the court.
November 22, 2006 Judge Fallon rejected certification of a US National class action because the applicable law is different in each state. This was expected and US cases are still expected to proceed individually with no change.
Cases progressed slowly in 2007 while quiet settlement discussions took place. Merck did not want to settle until after the three year time limit for suing in US courts. The Canadian class action was stalled. Finally on November 9. 2007 a settlement was confirmed only for US cases. This set a standard likely to be followed with Canadian and international claims. We expect all of our clients will end up settling through the Canadian process before too long. Early estimates of the amounts likely to be paid and the number of people to be paid have been greatly scaled down. Merck has been effective in fighting every claim and has won 10 out of 15 trials. Compensation will be limited both in dollars and for the scope of injury. The average US claim is being settled for $180,000 inclusive of legal costs and it is restricted to heart and stroke cases where the victim has used Vioxx for a month or more.
Pfizer the
manufacturer of Celebrex and Bextra is a much bigger company than Merck.
To Receive our information package including questionnaire and retainer form please email details of your vioxx and/or bextra use and problems to murray@adrworks.com or miskinlaw@aol.com You may also call our office 905-430-8880 and speak with Anna (extension 18). Our Toronto line is 905-428-8000 and our toll free number is 877-428-8000.
If you have our questionnaire and do not have all information available you may return it with portions incomplete and send us more information later. If you do not understand a question read ahead to the next few questions and come back to it. If you still do not understand call our office.
vioxx
chemical structure
bextra
chemical structure
email us to make a claim: miskinlaw@aol.com or murray@adrworks.com
To learn more about the above mentioned recent events: Visit Our Vioxx Update page