VIOXX LITIGATION

On September 30, 2004, Merck & Co., Inc., announced a voluntary worldwide withdrawal of VIOXX (rofecoxib), its arthritis and acute pain medication. Merck said that the decision to pull the drug was based on new, three-year data from a prospective, randomized, placebo-controlled clinical trial--the APPROVe (Adenomatous Polyp Prevention on VIOXX) trial.

Merck's APPROVe trial was designed to evaluate the effectiveness of Vioxx (in 25 mg dosage) in preventing recurrence of colorectal polyps. However, the trial shows that there is an increased risk for heart attack and stroke, beginning after 18 months of treatment in the patients taking Vioxx compared to those taking a placebo.

Merck says that the results for the first 18 months of the APPROVe trial did not show any increased risk of confirmed cardiovascular events. Merck made no comment regarding increased relative risk for patients taking Vioxx in doses higher than 25 mg for periods shorter than 18 months.

An earlier study by Merck--the VIGOR (VIOXX Gastrointestinal Outcomes Research) study--was released in March 2000. The VIGOR study also confirmed a greater number of heart attacks for patients who were taking Vioxx versus naproxen, a similar drug to VIOXX. Specifically, the study shows that patients taking 50 mg of Vioxx for nine months were four to five times more likely to have a heart attack than patients taking naproxen.

Moreover, on September 17, 2001, the Food and Drug Administration (FDA) sent Merck Chief Executive Officer Raymond Gilmartin a warning letter that says Merck engaged "in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed" regarding the VIGOR study. The warning letter continues, "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 heart attacks, compared with patients on naproxen. The letter also says that the Merck press release titled "Merck Confirms Favorable Cardiovascular Safety Profile of Vioxx" was "simply incomprehensible," given the rate of heart attacks and "serious cardiovascular events compared to naproxen." (Read the FDA Warning Letter, by clicking here ).

Vioxx was being used by approximately two million people around the world and accounted for about 10 percent of Merck's annual sales when Merck withdrew the drug. Since its introduction in 1999, 84 million people have used the medication. In the United States alone, 105 million Vioxx prescriptions have been written. Worldwide sales of Vioxx totaled $2.5 billion in 2003.

Vioxx MDL

On February 16, 2005, the Judicial Panel on Multi-District Litigation (MDL) entered a Transfer Order. The order transfers Vioxx cases filed in federal court to Judge Fallon in the Eastern District of Louisiana. You can read the Transfer Order by clicking here. Judge Fallon's Court has set up a website with links to the Court's Orders and various other material regarding the Vioxx MDL. The website is available online at: http://vioxx.laed.uscourts.gov.

Lukins & Annis, P.S., has filed numerous lawsuits in federal court on behalf of people who were injured by Vioxx. These cases have been transferred via the MDL to Judge Fallon in the Eastern District of Louisiana. Discovery and other pretrial matters should be handled by the MDL process. After the MDL process wraps up, the cases should be transferred back to the districts in which the cases were filed, for trial.

The Vioxx team at Lukins & Annis, P.S., stays up to date on the Vioxx MDL and will field any questions you have about the process.

US Food and Drug Administration (FDA) Panel on COX-2 Inhibitors

In February of 2005, an advisory panel to the FDA held hearings on the safety of COX-2 Inhibitors. The panel voted unanimously that all three COX-2 Inhibitors -- Vioxx, Bextra and Celebrex -- carry increased heart risk. Nonetheless, the panel recommended to allow continued use of Pfizer's Celebrex by a vote of 31-1, continued use of Pfizer's painkiller Bextra passed 17-13, with two abstentions, continued use of Merck's Vioxx by a vote of 17-15. Most of the panel members recommended including black box warnings on the labels of all three of the medications to flag the heightened heart risk.

The New York Times then reported that 10 of the 32 scientific experts chosen by the FDA to evaluate these drugs had ties to manufacturers of Vioxx, Bextra and Celebrex. According to a New York Times analysis of the votes, the advisory committee would have voted against Bextra and Vioxx staying on the market had scientists with conflicts of interest been excluded from the vote.

Bextra Withdrawn From the Market

On April 7, 2005, at the request of the U.S. Food and Drug Administration (FDA), Pfizer, Inc, agreed to suspend sales and marketing of Bextra pending further discussions with the FDA. The FDA claimed that Bextra's overall risks outweighed the potential benefits, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program.

Lukins & Annis, P.S., is law firm based in Spokane, Washington, and has successfully advocated for citizens of the Pacific Northwest in similar lawsuits. Regarding Fen-Phen Diet Drug, Lukins & Annis was appointed class counsel in the statewide class action which sought equitable relief on behalf of 125,000 Washington residents exposed to dangerous diet drugs. That action has now achieved settlement under the auspices of a nationwide Multi-District Litigation 1203 settlement. Lukins & Annis continues to pursue claims on behalf of individuals who have suffered serious heart or lung injuries from taking the diet drugs Pondimin and/or Redux. Likewise, Lukins & Annis served as individual personal injury counsel for individuals who received a recalled Sulzer hip implant. Lukins & Annis also represents individuals who suffered injury from ingesting Baycol.

If you or a loved one have suffered from a stroke or heart attack while taking Vioxx, please contact us