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Texan sues VIOXX®

VIOXX-lawsuit

Burleson Resident Sues VIOXX® After Suffering Stroke

DALLAS, TX – (October 8, 2004) – Miller Weisbrod, LLP, a Texas law firm that specializes in medical malpractice and drug product litigation, today filed a lawsuit in the 160th State District Court of Dallas against Merck & Co., Inc., alleging that its now withdrawn arthritis medication caused a major stroke that paralyzed a 64-year-old Burleson, Texas man who took it for two years.


In 2002, Jack Register was enjoying a healthy life with his wife, four children and four grandchildren. A manager a Lockheed Martin for 25 years, he spent his free time jogging, running and lifting weights. His doctor prescribed Vioxx® for an annoying neck pain that Mr. Register had complained about.


In March 2004, he suffered a series of small strokes and then was felled by a major stroke in April of this year. Mr. Register was given no reason for his strokes and his doctors were puzzled as to the cause. He remained on Vioxx® through the stroke instances. The damage caused by the major stroke left him fully paralyzed on his right side with speech impediments. Through intensive rehabilitation, Mr. Register has been able to regain use of his right side although it remains weak. As a result, he was unable to return to work at Lockheed and had to retire early.


Merck on Sept. 30 withdrew from worldwide markets its widely advertised Vioxx® brand of arthritis painkiller after a three-year study of 2,600 people showed patients taking the drug were more likely to suffer a heart attack or stroke than others who took a placebo. The study was being conducted among patients at risk of developing recurrent colon polyps.


Vioxx® was sold in more than 80 countries and 2003 sales of the drug were $2.5 billion, according to Merck.


Three separate committees in Congress are investigating the U.S. Food and Drug Administration, the federal agency charged with assuring the safety and effectiveness of drugs sold in this country, over its handling of a previous Vioxx® warning as well as its actions on other drugs. The head of the Senate Finance Committee, Iowa Republican Sen. Charles Grassley, has accused the FDA of muzzling critics of Vioxx®, a charge the agency denies. Another Republican, House Government Reform Committee Chairman Rep. Tom Davis, has questioned the FDA’s ability to do its job after the agency learned in 2000 of another study indicating elevated heart attack risk from Vioxx®, but waited until 2002 to ask Merck only to add information about that result in the drug’s instructions.


Eric J. Topol, chairman of the department of cardiovascular medicine at the Cleveland Clinic, recently wrote in The New York Times on October 2, 2004:


"In 2001, I was part of a team from the Cleveland Clinic that published a paper demonstrating the significant heart attack risk of Vioxx®. The research, published in The Journal of the American Medical Association, found that compared to naproxen, a commonly used over-the-counter anti-inflammatory drug with similar benefits, Vioxx® has a five times greater heart attack risk. In response, Merck claimed that early conclusions about the risk were flawed, and attributed the comparatively high heart attack rates to an unproven protective effect of naproxen. Our study was followed by several others demonstrating Vioxx®'s dangers. Each time Merck had a similar reply: the study was "flawed."

Merck finally had to acknowledge the truth, but only by accident. The company undertook a large, randomized trial of 2,600 patients with colon polyps in hopes of proving that Vioxx® could help their condition. In the process, though, Merck discovered that 3.5 percent of patients taking Vioxx® suffered heart attacks or strokes as against 1.9 percent taking a placebo. Merck at last did the right thing by voluntarily and abruptly taking Vioxx® off the market.

There are two important issues to consider here. First, the risk of heart attack or stroke found in the Merck study, at 15 cases per 1,000 patients, may be greatly underestimated. Merck's trial did not include anyone with known heart disease - patients who might be expected to have the highest risk."