Vioxx Litigation

The prescription pain drug Vioxx has been withdrawn from the market, because of life-threatening and sometimes fatal risks.

Vioxx can cause:

• Heart attack
• Stroke
• Pulmonary Embolism

What is Vioxx?

It is a prescription pain medicine made by the pharmaceutical company Merck. It's sales in 2003 were $2.5 billion, and millions of Americans took it.

Vioxx is not a steroid or a narcotic. It falls into a broad category of known as nonsteroidal anti-inflammatory drugs, and it is in a subcategory of NSAIDs called Cox-2 inhibitors.

When did it go off the market?

September 30, 2004, both in the United States and worldwide.

Did the FDA require Merck to take Vioxx off the market?

No, but the FDA has never required any prescription drug to be taken off the market, so this doesn't mean much. When it becomes obvious that the risks of a drug outweigh its benefits, the manufacturer withdraws the drug voluntarily to avoid being told it has to do so by the FDA .

What should I do if I am taking Vioxx?

Stop taking it and talk to your doctor about an appropriate substitute.

Do the substitutes have the same risks?

There is no reliable scientific information indicating that other pain relievers in the same class have the cardiovascular risks that Vioxx has. However, all drugs have risks of one kind or another, and selection of the best pain reliever for you is something for you and your doctor to decide.

Why was Vioxx taken off the market?

A recent Vioxx study was stopped early, because it showed an increased risk of serious cardiovascular events, such as heart attacks and strokes. Earlier studies, going back at least to one done at the Cleveland Clinic in 2001, showed the same thing, but the manufacturer disputed the results of the earlier studies and was successful in using the dispute to keep the drug on the market.

Can an existing prescription for Vioxx still be filled at a pharmacy?

No.

What are the serious side effects of Vioxx?

Heart attack (myocardial infarction), stroke (cerebral vascular accident or CVA), and pulmonary embolism (blood clot in a lung). All three can be fatal.

If my case isn't one for one of these three things, will you handle it?

No.

Will my case be put into a class action?

No. However, it almost certainly will be consolidated for some purposes with other Vioxx claims. This type of consolidation benefits claimants, because litigation expenses are spread out over multiple claims.

Am I risking any money by making a claim?

No. If the claim doesn't produce any money, you don't owe us anything.

What do you charge if you win?

40% of the settlement or verdict and reimbursement of expenses.

How and where will my claim be filed?

There are three possibilities. First, suit can be filed in your home state. Second, suit can be filed in New Jersey, where Merck has its headquarters. Third, if Merck will agree to a statute of limitations tolling agreement, suit will not need to be filed. This decision does not need made now, and it is better to wait until we have more information before making it.

Will my doctor be sued?

No. No doctor, hospital, or pharmacy will be sued. Only Merck, the manufacturer.

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The Role that Hill, Peterson, Carper, Bee & Deitzler, PLLC is Playing in the Vioxx Litigation:

We, along with other co-counsel, are representing more than 1,000 people from around the country, who have suffered both fatal and non-fatal heart attacks, strokes, and pulmonary embolisms while on Vioxx.

Hill, Peterson, Carper, Bee & Deitzler, PLLC has participated as both a sponsor and a presenter at Vioxx Litigation Strategy Seminars for lawyers in the following cities:

• Charleston, West Virginia
• Columbus, Ohio
• Indianapolis, Indiana
• Louisville, Kentucky
• Washington, Pennsylvania
• Nashville, Tennessee
• Little Rock, Arkansas

Partner James C. Peterson of Hill, Peterson, Carper, Bee & Deitzler, PLLC is a member of the National Litigation Group formed by the Association of Trial Lawyers of America for Vioxx litigation. Our lawyers have been licensed in the states of Minnesota, Ohio, and West Virginia, and have been permitted to practice in over two dozen other states. In those states in which we are not licensed or permitted to practice by ourselves, we have formed alliances with lawyers who assist us in representing our clients.

1998

Merck submitted an Application to Market a New Drug for Human Use (NDA) for rofecoxib to the United States Food and Drug Administration (FDA) on November 23, 1998, for tablets, at doses of 12.5 mg and 25 mg, for treatment of osteoarthritic pain, acute pain, and menstrual pain. This application is designated as NDA 21-042 by the FDA.

Merck also submitted an NDA for rofecoxib to the FDA on November 23, 1998, for oral suspension, at doses of 12.5 mg/ml and 25 mg/ml, for treatment of osteoarthritic pain, acute pain, and menstrual pain. This application is designated as NDA 21-052 by the FDA.

1999

On May 20, 1999, the FDA approved both NDAs for treatment of osteoarthritic pain, of acute pain, and menstrual pain.

Merck launched an aggressive marketing campaign for Vioxx immediately after its approval in May 1999. This campaign included extensive direct to consumer advertising, and its success would ultimately be demonstrated by sales growth leading to $2.5 billion in sales for the year 2003.

Merck began a study known as the VIGOR (VIOXX GI Outcomes Research) study on January 6, 1999, for the purpose of gathering data to support a gastrointestinal safety claim for Vioxx.

On June 22, 1999, Merck contracted with Peter Holt, M.D., to conduct Vioxx promotional audio conferences, using content provided by Merck, which were to be presented to heath care professionals as educational programs.

By November 18, 1999, the Data and Safety Monitoring Board of the VIGOR study, a committee independent from the Merck, the sponsor, had become concerned over the "excess deaths and cardiovascular events experiences in Group A [Vioxx] compared to Group B [naproxen]."

The FDA sent a letter to Merck dated December 16, 1999, saying that certain Vioxx promotional pieces:

"are false or misleading because they contain misrepresentations of Vioxx's safety profile, unsubstantiated comparative claims, and are lacking in fair balance."

2000

The VIGOR study, which had begun on Janurary 6, 1999, was completed on March 17, 2000. VIGOR is a prospective, randomized, double-blind, study that evaluated approximately 4000 people on Vioxx 50 mg a day (twice the highest approved dose for chronic use) and approximately 4000 patients on the standard dose of naproxen (1000 mg a day), a different type of non-steroidal anti-inflammatory drug. People who were under treatment with low dose aspirin for heart attack prevention were excluded from the study. The study demonstrates that Vioxx is associated with a lower incidence of serious upper gastrointestinal adverse events of major bleeding, perforation and obstruction compared to naproxen. The reduction in risk is over 50 percent in cumulative rates for Vioxx (.52%) compared to naproxen (1.22%). However, the VIGOR study also shows a higher cumulative rate of serious cardiovascular thromboembolic adverse events (such as heart attacks, angina pectoris, and peripheral vascular events) in the Vioxx group (1.8%) compared to the naproxen group (0.6%).

Dr. Peter Holt conducted six Vioxx promotional audio conferences, which were arranged by Merck, presented on behalf of Merck, and moderated by Merck employees: one on June 8, one on June 13, one on June 16, and three on June 21, 2000. Some of the content of these conferences was later found by the FDA to be:

"false or misleading in that they minimized the MI results of the VIGOR study, minimized the Vioxx / Coumadin drug interaction, omitted important risk information, made unsubstantiated superiority claims, and promoted Vioxx for unapproved uses and an unapproved dosing regimen."

A study comparing Vioxx, Celebrex (another cox-2 inhibitor), and aspirin was reported at a June 22, 2000, European League against Rheumatism (EULAR) meeting in Nice, France. This study shows that Vioxx reduces night time osteoarthritic pain more effectively than Celebrex or aspirin. Differences in the incidence of clinical adverse events for the three drugs were not reported in connection with this study.

A second study, a head-to-head safety study comparing Celebrex with Vioxx, was also presented at the EULAR meeting in Nice. This study shows that nearly 60% more patients on Vioxx than on Celebrex experienced significant systolic blood pressure elevations of 20 mmHg or more. This was observed as early as week two of the study and was confirmed at week six.

Andrew Whelton, M.D., who presented the Celebrex vs. Vioxx study, and who is a nephrologist and adjunct professor of medicine at Johns Hopkins, commented:
"For the first time we have a direct safety comparison of these compounds on a level playing field, in the same patient population, which helps us gain a better assessment of safety differences between these two COX-2 inhibitors,"
"This study provides compelling evidence that Celebrex and Vioxx affect hypertensive arthritis patients differently, suggesting that not all COX-2 inhibitors are the same."

Merck contested the validity of cardiovascular risk findings in the Vioxx vs. Celebrex study in the August 2000 edition of Pharmacy Today, a newspaper published by the American Pharmacists Association.

Results from the VIGOR study were submitted by Merck to the New England Journal of Medicine in the form of an article titled, Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis VIGOR Study Group, which was published in the November 23, 2000, edition of the NEJM. This article had several co-authors, including Alise Reicin, Merck's Vice President of Clinical Research. The lead author, Toronto rheumatologist Claire Bombardier, M.D., had then, and has had since, various relationships with Merck, including being the chief investigator for the VIGOR study.
The Bombardier/Reicin article addresses adverse cardiovascular event data by saying:
"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 overall mortality rate and the rate of death from cardiovascular causes were similar in the two groups."
The conclusions reached in the Bombardier/Reicin article do not mention an increase in cardiovascular risks with Vioxx, saying only:
"CONCLUSIONS: In patients with rheumatoid arthritis, treatment with rofecoxib, a selective inhibitor of cyclooxygenase-2, is associated with significantly fewer clinically important upper gastrointestinal events than treatment with naproxen, a nonselective inhibitor."

The FDA sent a letter to Merck dated December 12, 2000, asking Merck to explain its involvement in, and influence on, the initiation, preparation, development, and publication of the Holt audio conferences conducted in June 2000. This letter also asks Merck to tell the FDA about the nature of its relationship with Dr. Holt.

2001

Merck responded to the FDA's inquiry about Dr. Holt in a January 5, 2001, letter to the FDA, saying:

"Dr. Holt entered into a speaker contract with Merck on June 22, 1999."
…
"Merck has determined that we arranged for Dr. Holt to speak at ten audio conferences in 2000. Merck Business Managers provided him with the topic for the audio conferences and, for two of the audio conferences, asked him to address the safety profiles of Vioxx and other NSAIDs."

An FDA report, written by Shari L. Targum, M.D., a Project Manager for the FDA's Division of Anti-inflammatory Drug Products and dated February 1, 2001, says,

"by November 18, 1999, the Data and Safety Monitoring Board of the VIGOR study, a committee independent from the sponsor, was concerned over the ‘excess deaths and cardiovascular events experiences in Group A [vioxx group] compared to Group B [naproxen] (52 v. 29 respectively).'"

In response to growing public expressions of concern over the cardiovascular safety profile of Vioxx, Merck issued a press release titled "Merck Confirms Favorable Cardiovascular Safety Profile of Vioxx," dated May 22, 2001. This press release says Vioxx has a "favorable cardiovascular safety profile." The FDA would later tell Merck:

"your claim in the press release that Vioxx has a ‘favorable cardiovascular profile is simply incomprehensible, given the rate of MI and serious cardiovascular events compared to naproxen. The implication that Vioxx's cardiovascular profile is superior to other NSAIDs is misleading; in fact, serious cardiovascular events were twice as frequent in the VIOXX treatment group … as in the naproxen treatment group … in the VIGOR study."

An article titled Risk of Cardiovascular Events Associated With Selective COX-2 Inhibitors, written by Drs. Mukherjee, Nissen, and Topol at the Cleveland Clinic, was published in the August 29, 2001, edition of the Journal of the American Medical Association.

These Cleveland Clinic doctors found that the risk of serious cardiovascular adverse events in the studies they analyzed, including VIGOR, is 238% higher for Vioxx than naproxen, and in the subgroup of people for whom aspirin is indicated, the risk is 489% higher for Vioxx than naproxen.

Drs. Mukherjee, Nissen, and Topol conclude their article by saying:
"The available data raise a cautionary flag about the risk of cardiovascular events with COX-2 inhibitors. Further prospective trial evaluation may characterize and determine the magnitude of the risk."
Rxintelligence is a non-profit pharmaceutical research organization founded by the Blue Cross and Blue Shield Association to study the risks, cost, and benefits of new drugs in comparison to older ones. On September 12, 2001, Rxintelligence, in conjunction with Blue Cross Blue Shield of Illinois, released the results of a comprehensive analysis of the Vioxx studies on file with the FDA at that time. This analysis shows a higher incidence of hypertension among those taking Vioxx than in those taking Celebrex.
Thomas W. Abrams, Director of Drug Marketing, Advertising, and Communications at the FDA, issued a Warning Letter dated September 17, 2001, to Merck CEO Raymond V. Gilmartin, relating to "promotional activities and material for the marketing of Vioxx (rofecoxib) tablets."

This Warning Letter says:

"[Merck] engaged in a promotional campaign for Vioxx that minimized the potentially serious cardiovascular findings that were observed in the Vioxx Gastrointestinal Outcomes Research (VIGOR) study, and thus, misrepresents the safety profile for Vioxx.
….
Specifically, your promotional campaign discounts the fact that in the VIGOR study, patients on Vioxx were observed to have a four to five fold increase in myocardial infarctions (MIs) compared to patients on the comparator non-steroidal anti-inflammatory drug (NSAID), Naprosyn (naproxen)
…
The promotional activities and materials described above minimize the potentially serious Cardiovascular findings that were observed in the VIGOR study, minimized the VIOXX / Coumadin drug interaction, omit crucial risk information associated with Vioxx therapy, contain unsubstantiated comparative claims, and promote unapproved uses. On December 16, 1999, we also objected to your dissemination of promotional materials for Vioxx that misrepresented Vioxx's safety profile, contained unsubstantiated comparative claims, and lacked fair balance.

Due to the seriousness of these violations, and the fact that your violative promotion of Vioxx has continued despite our prior written notification regarding similar violations, we request that you provide a detailed response to the issues raised in this Warning Letter on or before October 1, 2001.

This response should contain an action plan that included a comprehensive plan to disseminate corrective messages about the issues discussed in this letter to the audiences that received these misleading messages. This corrective action plan should also include:

Immediately ceasing all violative promotional activities, and the dissemination of violative promotional materials for Vioxx.

Issuing a ‘Dear Healthcare provider' letter to correct false or misleading impressions and information. This proposed letter should be submitted to us for review prior to its release. After agreement is reached on the content and audience, the letter should be disseminated by direct mail to all healthcare providers who were, or may have been exposed to the violative promotion.

A written statement of your intent to comply with ‘1' and ‘2' above."

Merck's Vice President of Clinical Research, Dr. Alise Reicin, and others authored an article in defense of Vioxx's cardiovascular risk profile titled Cardiovascular thrombotic events in controlled, clinical trials of rofecoxib, which was published in the November 6, 2001, edition of the journal Circulation. Dr. Reicin and her companion authors summarize their assessment of Vioxx as follows:
"This analysis provides no evidence for an excess of CV [cardiovascular] events for rofecoxib [Vioxx] relative to either placebo or the non-naproxen NSAIDs that were studied. Differences observed between rofecoxib and naproxen are likely the result of the antiplatelet effects of the latter agent."

2002

An article titled Non-Steroidal Anti-Inflammatory Drugs and Risk of Serious Coronary Heart Disease: An Observational Cohort Study, authored by Vanderbilt University researchers headed by Wayne Ray, was published in the January 12, 2002, edition of the Lancet. This article posits an explanation of how Cox-2 inhibitors promote thromboembolic events.
A work sponsored by Merck and conducted and written by Merck employees led by Alise Reicin, Merck's Vice President of Clinical Research, titled Comparison of cardiovascular thrombotic events in patients with osteoarthritis treated with Rofecoxib versus nonselective, nonsteroidal anti-inflammatory drugs (Ibuprofen, Diclofenac, and Nabumetone), was published in the January 15, 2002, edition of the American Journal of Cardiology. The Merck authors, seeking to defend Vioxx, conclude:
"…an analysis from the rofecoxib osteoarthritis development program found no difference between rofecoxib, comparator nonselective NSAIDs, and placebo in the risks of cardiovascular thrombotic events.."
An article titled Why Do Cyclooxygenase-2 Inhibitors Cause Cardiovascular Events? Authored by Drs. Bing, Lomnicka and others at the Department of Experimental Cardiology at the Huntington Medical Research Institutes was published in the journal Pharmacology on February 6, 2002. The authors explain that a selective Cox-2 inhibitor, such as Vioxx, can promote adverse cardiovascular events by tipping the balance of prostacyclin and thromboxane in favor of thromboxane. This imbalance promotes both platelet aggregation and vasoconstriction, which can lead to catastrophic cardiovascular events, including stroke, heart attack, and pulmonary embolism.

An article by FitzGerald, Cheng, and others at the University of Pennsylvania titled Role of Prostacyclin in the Cardiovascular Response to Thromboxane A2, published in the April 19, 2002, Journal of Science, explains:

"…PGI2 modulates platelet-vascular interactions in vivo and specifically limits the response to TxA2. This interplay may help explain the adverse cardiovascular effects associated with selective COX-2 inhibitors, which, unlike aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs), inhibit PGI2 but not TxA2."

2003

Dr. Reicin continued her defense of Vioxx in an article titled Selective COX-2 inhibition and cardiovascular effects: a review of the rofecoxib development program, which was published in the October 1, 2003, edition of the American Heart Journal. Dr. Reicin and her colleagues say in this publication:
"Rofecoxib [Vioxx] was not associated with excess CV [cardiovascular] thrombotic events compared with either placebo or nonnaproxen NSAIDs. Again, naproxen appeared to be the outlier, suggesting a cardioprotective benefit of naproxen."
"The totality of data is not consistent with an increased CV [cardiovascular] risk among patients taking rofecoxib [Vioxx]."

2004

An article by Solomon and others at the Harvard Medical School, titled Relationship Between Selective Cyclooxygenase-2 Inhibitors and Acute Myocardial Infarction in Older Adults, was published in the April 2004 edition of the journal Circulation. The Harvard authors conclude from their study:
"…rofecoxib [Vioxx] use was associated with an elevated relative risk of AMI [acute myocardial infarction] compared with celecoxib [Celebrex] use and no NSAID use. Dosages of rofecoxib [greater than] 25 mg were associated with a higher risk than dosages [less than or equal to] 25 mg."

An article by H.K.Choi in the May 1, 2004, edition of the American Journal of Medicine, titled Effects of rofecoxib and naproxen on life expectancy among patients with rheumatoid arthritis: a decision analysis
concludes:

"Our analysis suggests a longer life expectancy with naproxen than rofecoxib [Vioxx] … except in those at low risk of myocardial infarction or at high risk of upper gastrointestinal toxicity."
David Graham, M.D., made a poster presentation titled "Risk of Acute Myocardial Infarction and Sudden Cardiac Death with Use of COX-2 Selective and Non-Selective NSAIDS" at the 20th International Conference on Pharmacoepidemiology and Therapeutic Risk Management, held from August 22-25, 2004, in Bordeaux, France. The data for the presentation was taken from a study done by Kaiser Permanente under a contract funded by the FDA.
Vioxx taken at more than 25 mg per day increased the risk of heart attack and sudden cardiac death by 300% in those enrolled in the Kaiser Permanente study.
On August 26, 2004, Peter Kim, President of Merck Research Laboratories, issued a press release saying:
"Merck strongly disagrees with the conclusions of an observational analysis by Graham et al, presented at an international medical meeting this week…"
"Merck stands behind the efficacy and safety, including cardiovascular safety, of VIOXX,"
On September 27, 2004, Merck informed the FDA that the Data Safety Monitoring Board for an ongoing long-term study of Vioxx, known as the APPROVe study, had recommended that the study be stopped early for safety reasons.
The APPROVe study was not intended to be a cardiovascular risk assessment study. It was commissioned by Merck to look at the effect of Vioxx in people at risk for developing recurrent colon polyps.
The APPROVe study demonstrates an increased risk of cardiovascular adverse events, including heart attacks and strokes, for the Vioxx population relative to the placebo population in the study, particularly for people taking Vioxx for more than 18 months.
Merck representatives informed the FDA in a September 28, 2004, meeting that Merck would withdraw Vioxx from the United States market.
On September 29, 2004, Merck sales representatives were visiting doctors' offices across the country, urging the doctors to prescribe Vioxx for their patients, and denying an increased cardiovascular risk for the drug.
Merck and the FDA each announced the withdrawal of Vioxx from the United States market on September 30, 2004. Merck also announced worldwide withdrawal the same day.
An FDA analysis, based on data from the Kaiser Permanente study, projects that 27,785 heart attacks and sudden cardiac deaths "would have been avoided" had Celebrex been used instead of Vioxx.
Approximately 20 million people in the United States took Vioxx between its introduction in 1999 and its withdrawal in 2004.