Vioxx - An Overview

In May 1999, the US Food and Drug Administration approved the drug Vioxx (generic name, rofecoxib) for the treatment of osteoarthritis, menstrual pain and the management of acute pain in adults. Vioxx is a non-steroidal anti-inflammatory drug (NSAID), which reduces inflammation and relieves pain. Vioxx does not actually cure arthritis or other diseases that cause acute pain, but helps to alleviate their symptoms. In September 2004, Merck & Co., Inc. (Merck), the manufacturer of Vioxx, voluntarily withdrew Vioxx from the market citing an increased risk of cardiovascular problems, including heart attack and stroke, in individuals who took the drug. If you took Vioxx and experienced adverse side effects, talk to your doctor as soon as possible. In addition, contact an attorney who has experience with product liability litigation.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

NSAIDs reduce inflammation and relieve pain. They are a good alternative to steroids, which, while considered safe for brief use to reduce inflammation, can cause serious side effects when taken for longer periods. Such serious side effects include weight gain, fluid retention often visible in the face, sudden mood swings, muscle weakness, blurry vision, increased body hair, osteoporosis (bone weakening), high blood pressure, stomach irritation and/or glaucoma. NSAIDs work by inhibiting an enzyme called cyclooxygenase (COX). In the early 1990s, it was determined that there were actually two such enzymes, COX-1 and COX-2. Researchers believed that only COX-2 actually caused pain and inflammation, and manufacturers began to develop drugs that would inhibit only COX-2, which would also avoid the gastric problems, including ulcer, perforation and bleeding, usually associated with NSAIDs.

Vioxx, like the drugs Celebrex and Bextra, is a COX-2 inhibitor. COX-2 inhibitors prevent inflammatory prostaglandins from forming. Inflammatory prostaglandins are produced by COX-2, and it is thought that these compounds cause pain and inflammation and prohibit blood cells from sticking together. Vioxx is different from other NSAIDs in that it does not block COX-1. COX-1 maintains stomach tissue. Because Vioxx does not interfere with the stomach tissue and lining, it was promoted as a drug that could relieve pain and lessen inflammation without causing gastric problems such as ulcers and gastrointestinal bleeding.

Vioxx Studies

In November 2000, the Vioxx Gastrointestinal Outcomes Research (VIGOR) study was published in the New England Journal of Medicine. The study compared approximately 4000 patients on 50 mg of Vioxx per day (twice the highest approved dose) to approximately 4000 patients on the standard dose of Naprosyn (naproxen), al older NSAID. VIGOR was a one-year. double-blind study, meaning that neither the patients nor the researchers knew who was receiving which drug. According to study results, Vioxx had a much lower incidence of digestive tract punctures, bleeding and/or blockages than naproxen.

However, another finding in the VIGOR study was that there was a higher incidence of cardiovascular problems in the Vioxx group than the naproxen group. The report concluded that the relationship between cardiovascular distress and the use of Vioxx was still unknown. This outcome surprised many heart experts, who then wanted more research done to assess the cardiac risk Vioxx posed.

An August 2001 study published in the Journal of the American Medical Association by researchers from The Cleveland Clinic linked Vioxx to an increase in the risk of blood clots, heart attacks and strokes. This study reviewed and analyzed previous clinical trials. Additional studies and articles regarding Vioxx's effect on the heart continued to appear in medical journals.

Vioxx Litigation

Litigation involving prescription drugs like Vioxx falls under the umbrella of pharmaceutical liability litigation, which is in turn a subset of product liability cases. Litigation against Merck began in 2001, and then really took off after Merck recalled Vioxx in 2004. To date, almost 27,000 cases have been filed against Merck. Consolidated cases were established in a number of jurisdictions, including New Jersey state court and federal multidistrict litigation in the Eastern District of New Jersey. Merck's strategy was to defend each case and not settle. About twenty-one cases proceeded to trial, with Merck obtaining defense verdicts or hung juries in fifteen.

On November 9, 2007, Merck announced that it had entered into a settlement agreement with the law firms of the executive committee of the Plaintiffs' Steering Committee in the federal multidistrict litigation and representatives of plaintiffs in state coordinated proceedings to resolve the state and federal myocardial infarction and ischemic stroke claims already filed against Merck. Under the terms of the agreement, Merck agreed to pay $4.85 billion into a settlement fund for qualifying claims.

If you have questions about Vioxx litigation, contact a pharmaceutical liability lawyer.

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