VIOXX In The News

Bisnar | Chase, Vioxx Attorneys, represent the victims of all drug related illness and injuries, wrongful death, and dangerous drug errors. Our skilled dangerous drug lawyers and Vioxx attorneys have an outstanding track record of impressive recoveries on behalf of our clients. We are dedicated legal professionals who care about our clients, and have been exclusively representing cases of serious injury and wrongful death since 1978. The firm is based in Orange County, California, but represents clients throughout the world. If you or a loved one has suffered as the result of the pharmaceutical drug Vioxx, contact Bisnar | Chase today for a free consultation.

Journal Runs Correction on Vioxx

By Denise Gellene, Times Staff Writer
June 27, 2006

The withdrawn painkiller Vioxx could cause heart problems for patients taking it for less than 18 months, according to a correction in the New England Journal of Medicine that disputes the company's contention that the drug was safe when taken for a short time.

The journal said the original statistical analysis of a March 2005 study was incorrect and it was uncertain how long the drug could be safely taken before patients incurred an increased risk of stroke and heart attack.

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Click here to read the report by the New England Journal of Medicine.

Cardiologist says Vioxx still a risk after stopping

By Bill Berkrot
Fri May 12, 2006

NEW YORK (Reuters) - A leading cardiologist on Friday disputed Merck & Co's interpretation on the safety of patients once they stop taking Vioxx, saying they remained at high risk of heart attacks or strokes for some time afterward.

Dr Steven Nissen, interim chairman of cardiology at the prestigious Cleveland Clinic, said Merck misrepresented an analysis of data from a follow-up review of patients involved in the trial that led to the pain medication being pulled from the market.

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Jury Awards Widow $253.4M in Vioxx Trial

By KRISTEN HAYS and THERESA AGOVINO
AP Business Writer

ANGLETON, Texas (AP) -- A Texas jury found pharmaceutical giant Merck & Co. liable Friday for the death of a man who took the once-popular painkiller Vioxx, awarding his widow $253.4 million in damages in the first of thousands of lawsuits pending across the country.

A seven-man, five-woman jury deliberated for 10 1/2 hours over two days before returning the verdict in a 10-2 vote. But the damage award is likely to be drastically cut to no more than $26.1 million because Texas law caps the punitive damages that made up the bulk of the total.

Plaintiff Carol Ernst began to cry when the verdict was read while her attorneys jumped up and shouted, "Amen!"

Jurors in the semi-rural county rejected Merck's argument that Robert Ernst, 59, died of clogged arteries rather than a Vioxx-induced heart attack that led to his fatal arrhythmia. Ernst, a produce manager at a Wal-Mart store, ran marathons and taught aerobics classes on the side.

The case drew national attention from pharmaceutical companies, lawyers, consumers, stock analysts and arbitrageurs as a signal of what lies ahead for Merck, which has vowed to fight the more than 4,200 state and federal Vioxx-related lawsuits pending across the country. Merck said it plans to appeal.

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FDA Public Health Advisory - Non-Steroidal Anti-Inflammatory Drug Products (NSAIDS)

FDA/Center for Drug Evaluation and Research - December 23, 2004

The FDA is issuing a public health advisory concerning use of non-steroidal anti-inflammatory drug products (NSAIDS) including those known as COX-2 selective agents.

Recently released data from controlled clinical trials showing that the COX-2 selective agents (Vioxx, Celebrex, and Bextra) may be associated with an increased risk of serious cardiovascular events (heart attack and stroke) especially when they are used for long periods of time or in very high risk settings (immediately after heart surgery).

Click here to read the entire advisory.

FDA Issues Public Health Advisory Recommending Limited Use of Cox-2 Inhibitors - Agency Requires Evaluation of Prevention Studies Involving Cox-2 Selective Agents

FDA Talk Paper - December 23, 2004

The Food and Drug Administration (FDA) today issued a Public Health Advisory summarizing the agency's recent recommendations concerning the use of non-steroidal anti-inflammatory drug products (NSAIDs), including those known as COX-2 selective agents. The public health advisory is an interim measure, pending further review of data that continue to be collected.

In addition, FDA today announced that it is requiring evaluation of all prevention studies that involve the Cox-2 selective agents Celebrex (celecoxib) and Bextra (valdecoxib) to ensure that adequate precautions are implemented in the studies and that local Institutional Review Boards reevaluate them in light of the new evidence that these drugs may increase the risk of heart attack and stroke. A prevention trial is one in which healthy people are given medicine to prevent a disease or condition (such as colon polyps or Alzheimer's disease).

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Statement of Sandra Kweder, M.D., Deputy Director, Office of New Drugs at the Center for Drug Evaluation and Research, FDA

Before Committee on Finance, United States Senate - November 18, 2004

Modern drugs provide unmistakable and significant health benefits. It is well recognized that FDA's drug review is a gold standard. Indeed, we believe that FDA maintains the highest worldwide standards for drug approval. FDA grants approval to drugs after a sponsor demonstrates that they are safe and effective. Experience has shown that the full magnitude of some potential risks do not always emerge during the mandatory clinical trials conducted before approval to evaluate these products for safety and effectiveness. Occasionally, serious adverse effects are identified after approval either in post-marketing clinical trials or through spontaneous reporting of adverse events. That is why Congress has supported and FDA has created a strong post-market drug safety program designed to assess adverse events identified after approval for all of the medical products it regulates as a complement to the pre-market safety reviews required for approval of prescription drugs in the United States. Monitoring the drug safety of marketed products requires close collaboration between our clinical reviewers and drug safety staff to evaluate and respond to adverse events identified in ongoing clinical trials or reported to us by physicians and their patients. The most recent actions concerning the drug Vioxx (rofecoxib) illustrates the vital importance of the ongoing assessment of the safety of a product once it is in widespread use.

Click here to read the entire statement.

Study Says Merck Should Have Pulled Vioxx in 2000

By Tom Armitage, Reuters - November 5, 2004

BERNE (Nov. 5) - Drug giant Merck & Co. Inc. should have pulled its Vioxx painkiller from the market four years ago because data showing it raised the risk of heart attacks has existed since 2000, Swiss scientists said on Friday.

In a report for British medical journal The Lancet, researchers at the University of Berne said there was substantial evidence of the dangerous side effects of the drug by the end of 2000, but the mounting data was not analyzed properly.

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Merck halts Vioxx sales

By Rita Rubin - USA Today - October 1, 2004

The maker of blockbuster pain reliever Vioxx said Thursday that it is voluntarily withdrawing the drug because of new data showing it increases the risk of heart attacks and strokes.

This is one of the largest - ever withdrawals of a drug, says the Food and Drug Administration’s Steven Galson.

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Merck Pulls Arthritis Drug Vioxx from Market

All Things Considered - NPR - September 30, 2004

Pharmaceutical giant Merck & Co. is pulling its arthritis drug Vioxx from the market after a study confirmed earlier concerns that it raises the risk of heart problems, including heart attacks and stroke. Vioxx is currently used by 2 million people worldwide and has been used by more than 84 million people around the world, according to Merck.

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Coping Without Vioxx

By Linda A. Johnson - staff reporter - The Wall Street Journal - September 30, 2004

Merck & Co.'s abrupt decision to pull the blockbuster drug Vioxx from the market will force millions of patients to find alternative options to alleviate pain from arthritis and other maladies.

There are plenty of other treatments available, but figuring out which ones are right for which patients will depend on a variety of factors -- most notably heart-disease risk and history of ulcers.

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