Vioxx, rofecoxib, is a non-steroidal anti-inflammatory drug (NSAID) manufactured by Merck & Co. for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of painful menstrual symptoms. Vioxx was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children. Vioxx is included in the group of NSAIDs known as COX-2 inhibitors (cyclooxygenase-2) because it selectively blocks the enzyme cox-2. This class of medications also includes the drugs Celebrex and Bextra.

Known Side Effects of Vioxx

Serious problems from stomach ulcers, such as bleeding, are well-known side effects or complications in people treated with NSAIDs. Similar problems have occurred in people treated with Vioxx. Other adverse reactions can include liver damage. Some of the warning signs of liver damage can be nausea, vomiting, fatigue, loss of appetite, itching, yellow coloring of skin or eyes (jaundice), "flu like" symptoms, and dark urine.

Vioxx and the VIGOR Clinical Trial

In 2000, a study was completed by Merck known as the "VIGOR" (Vioxx Gastrointestinal Outcomes Research) clinical trial. This clinical trial was a prospective, randomized, double-blind, one-year study evaluating approximately 4000 patients on Vioxx 50 milligrams a day and approximately 4000 patients on the standard dose of Naproxen (1000 milligrams a day), another non steroidal anti-inflammatory drug. In this trial, approximately 8,000 patients with arthritis were prescribed Vioxx, Naproxen, or other traditional pain killers. The VIGOR study found a significant four-fold increased risk of serious cardiovascular thromboembolic adverse events -- such as acute heart attacks, strokes, angina pectoris, and peripheral vascular events -- in patients taking Vioxx compared to patients taking Naproxen. The higher cumulative rate of serious cardiovascular events was 1.8% for patients prescribed Vioxx and 0.6% for patients prescribed Naproxen. Adjudicated serious cardiovascular events (confirmed by a blinded adjudication committee) included the following: sudden death; myocardial infarction; unstable angina; ischemic stroke; transient ischemic attack; peripheral venous; and arterial thromboses.

The Food and Drug Administration (FDA) reviewed the findings of the VIGOR clinical trial and other controlled clinical trials. The FDA agreed with the Arthritis Advisory Committee recommendations of February 8, 2001 that the label for Vioxx should include the cardiovascular information. The Vioxx label already warned about gastrointestinal side effects, advising patients and their doctors about the risks of gastrointestinal ulcers, bleeding, and perforation. In addition, the Committee advised that the NSAID class warning regarding gastrointestinal adverse events should be modified, but not removed from the Vioxx label.

Merck Withdraws Vioxx from the Market

In September 2004, Merck announced the withdrawal of Vioxx from all markets in the U.S. and worldwide after a long-term study was halted because of an increased risk of serious cardiovascular events including heart attack, stroke, blood clots and other cardiovascular complications among study patients taking the drug Vioxx. Over two million people were prescribed Vioxx at that time. On September 30, 2004, the FDA acknowledged Merck's voluntary withdrawal of Vioxx. The FDA also issued a Public Health Advisory directed at patients who were prescribed Vioxx of Merck's voluntary withdrawal of Vioxx and advising patients to consult a health care professional about alternative medications.

Merck was fully aware of the health risks of its Cox-2 inhibitor anti-inflammatory drug, Vioxx, as early as March 2000. There was a concerted effort to bury negative evidence and even distort the drug trials by excluding heart patients from the Vioxx studies so that the rate of cardiovascular problems for Vioxx patients would not be obvious. This large pharmaceutical company reportedly put profit making before its consumers' health. Because millions of Americans have taken the drug Vioxx, the Food and Drug Administration estimates that more than 27,000 patients have suffered heart attacks or have died as a result of using Vioxx.

Vioxx and Litigation

On August 19, 2005, a Texas jury awarded Carol Ernst $253.4 million in damages as a result of the death of her husband from a heart attack after he took Vioxx . The jury found Merck liable for lost pay, mental anguish, loss of companionship, and punitive damages. This very large award was subsequently reduced to approximately $26 million under a Texas law capping punitive damages.

A number of the claims against Merck for the injuries caused by Vioxx has been consolidated into multidistrict litigation or MDL. MDL occurs when there are common fact questions underlying all of the cases. The individual civil actions pending in different districts are temporarily transferred to a single district so that pretrial proceedings can be coordinated. Then the individual cases are returned to their original districts for trial. Multidistrict litigation is different than a class action lawsuit. In a class action there is only one lawsuit, only one case -- all the plaintiffs represented by a single person or a small group of people against the defendant or defendants.

The Vioxx MDL is assigned to the Eastern District of Louisiana. The hurricanes in that area did delay some proceedings; however, the New Orleans courthouse re-opened on November 1, 2005. The court's post-Katrina order suspending deadlines remains in effect until November 25, 2005.

On November 3, 2005, a jury in Atlantic County, New Jersey ruled in Merck's favor in the second Vioxx trial which was brought by a postal worker who suffered a heart attack after using Vioxx for less than six months. While losing a trial is never good for the plaintiff involved in the case, we are not at all discouraged by the result. We have spoken extensively with the plaintiff's lawyer in that case and based on our conversations we do not believe that the jury's verdict diminishes the strength of Vioxx cases generally. Litigation of this magnitude must be compared to a heavyweight boxing match in the sense that it is a 12-round bout. An early victory in any single case in front of any single jury cannot be considered an early knock-out.

Thus, we are not discouraged by the New Jersey verdict, nor do we take the Texas verdict to mean that all Vioxx cases are worth hundreds of millions of dollars. There are several more trials scheduled across the country, including more trials in New Jersey during the first half of 2006. The outcomes of these trials will be important to all involved parties.

The third federal Vioxx lawsuit ended in a mistrial in December 2005 when the jury was unable to reach a unanimous verdict after three days of deliberations. Originally filed in Louisiana, the case was tried in Houston, Texas, due to damage from Hurricane Katrina, but will be re-tried in 2006 in Louisiana.

The Plaintiffs' Steering Committee (PSC) -- the group which represents the plaintiffs in pretrial proceedings in the Vioxx MDL -- continues to work through discovery disputes with the Defendants' Steering Committee (DSC). The State Liaison Committee (SLC) is coordinating the state and federal Vioxx litigation.

If you or a loved one took Vioxx and suffered injuries such as a heart attack or stroke, you may have a legal case. If you would like to speak to a lawyer, please click the Find Attorney button at the top of the page.