Ohio Vioxx® Lawyers

VIOXX® INFORMATION

The prescription pain drug Vioxx® has been withdrawn from the market, because of life-threatening and sometimes fatal risks.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

Vioxx® Questions & Answers

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.

Vioxx® Facts & Timeline

Vioxx® is the brand name of rofecoxib, a prescription drug in the class of nonsteroidal inflammatory drugs known as Cox-2 inhibitors.

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.

If you or someone you know has suffered serious side effects such as a heart attack or stroke from the use of Vioxx®, call or e-mail the experienced Ohio Vioxx® attorneys at Clark, Perdue, Arnold & Scott today.

Schedule a consultation or ask us a free legal question