What is Vioxx?
Vioxx was marketed by Merck & Co., before it was pulled from the worldwide market. Vioxx, also known by the generic name of rofecoxib, was voluntarily withdrawn by Merck on September 30, 2004. Merck mounted a very aggressive marketing campaign for Vioxx when it was first introduced to the market, resulting in enormous revenues from the sales of the drug. In 2003, Merck enjoyed Vioxx sales of approximately $2.5 billion. An estimated 84 million people worldwide have used Vioxx since it was introduced, and Vioxx was one of the most frequently prescribed drugs in the United States. Due to the enormous popularity of Vioxx, the recall of Vioxx in 2004 was the largest drug recall in history at the time.
Vioxx is a non-steroidal anti-inflammatory, commonly known as NSAID, cox-2 inhibitor. There are other popular cox-2 inhibitors that have been widely prescribed over the past few years including Celebrex and Bextra. Similarly to Vioxx, Bextra, a cox-2 inhibitor from Pfizer, has also been voluntarily pulled from the pharmaceuticals market because of links to severe cardiovascular side effects such as heart attack and stroke. Celebrex remains on the market for now, however, it contains a black box warning on its label concerning possible links to cardiovascular side effects. Before it was removed, Vioxx was prescribed to treat symptoms of osteoarthritis, rheumatoid arthritis, acute pain, and painful menstrual cycles. These cox-2 inhibitors, Vioxx included, are designed to assist in relieving the pain and inflammation that arthritis patients suffer from, by blocking the cox-2 enzyme that creates prostaglandins in the body. Decreasing these prostaglandins helps the body in reducing pain and inflammation.
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Link Between Vioxx, Heart Attacks and Strokes
Vioxx was pulled from the market after internal studies by Merck & Co. showed that patients who were prescribed Vioxx were more likely to have cardiovascular problems than patients talking a placebo. Vioxx began to come under fire in 2000, when the findings of the "VIGOR" study were reported to the FDA (Vioxx Gastrointestinal Outcomes Research.) This study was designed to see the degree in which Vioxx was safer on the stomach than an alternative painkiller, naproxen, which is sold under the brand name of Aleve. The VIGOR study reported that Vioxx users suffered more cardiovascular problems, including five times as many heart attacks, than did users of the pain medication, naproxen. In September of 2001, the FDA sent Merck a warning letter in regards to their Vioxx advertising campaign, which the FDA believed was minimizing the possible cardiovascular side effects of Vioxx. It was the VIGOR study that prompted the FDA to add a warning to Vioxx concerning the cardiovascular side effects in April of 2002.
Studies linking Vioxx to Heart Attacks and Strokes
The APPROVe study (Adenomatous Polyp Prevention on Vioxx), conducted by Merck in 2001, indicated that Vioxx may pose almost twice the risk of patients suffering a heart attack or stroke, when compared to other patients taking a placebo. The APPROVe study was meant to last for a period of three years, in order to look into the effects of Vioxx on preventing the recurrence of colorectal polyps, as other cox-2 inhibitors like Celebrex have already been prescribed for this reason. The study was halted much earlier than expected, as the study showed that after more than 18 months of treatment with Vioxx, patients developed an increased risk of negative cardiovascular events such as heart attack and stroke.
A study, reported on by the Wall Street Journal, involving patient databases from the health maintenance organization (HMO) Kaiser Permanente, has reported that from 1999 through 2003, approximately 27,785 heart attacks and sudden cardiac deaths may not have occurred had Vioxx not been used. The study indicates that if Celebrex had been used, the cardiovascular problems may have been avoided. The study looked at 1.4 million Kaiser patients, who had taken an NSAID. Included amongst those patients were 26,748 Vioxx users and 40,405 Celebrex users.
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Vioxx Trial Verdict in Favor of Defendant Merck Vacated
The jury verdict rendered in favor of Merck & Co. in the Vioxx-related trial entitled, Humeston v. Merck, has been vacated. After hearing oral argument this morning in the New Jersey Superior Court in Atlantic County, N.J., the Honorable Carol E. Higbee ruled that the November 2005 trial verdict should be vacated on various grounds, including findings by the New England Journal of Medicine that Merck had failed to report material cardiovascular safety data in connection with the publication of its landmark Vioxx clinical study know as Vigor. The judge's ruling nullifies the verdict for all purposes, and will allow plaintiff, Frederick "Mike" Humeston, a new day in court. Seeger Weiss LLP's trial team was led by partners Chistopher A. Seeger and David R. Buchanan, who successfully argued the vacatur motion. In response to Judge Higbee?s decision to vacate the trial verdict, Mr. Seeger stated: "It was difficult for our trial team to hear Merck's witnesses repeatedly distort the truth about the Vigor study results. The judge's ruling today corrects just the latest injustice committed on the entire Humeston family by Merck and ratifies the proper functioning of the judicial process."
Seeger Weiss and Vioxx Litigation
Seeger Weiss is appointed Co-Lead counsel in the federal MDL Vioxx litigation and Co-Liaison counsel in the New Jersey state Vioxx litigation. The Firm further represents hundreds of clients from across the country who suffered life-altering injuries as a result of taking Vioxx, and the firm also represents union health and welfare programs in a class action pending in New Jersey for Merck's over-charging of union welfare funds for Vioxx. Besides seeking reimbursement for their expenditures to make the arthritis and painkiller drug available to their health plan members, the third-party payors would be entitled to triple damages if ultimately successful on their claims, under the New Jersey Consumer Fraud Act. Recently, in a unanimous decision, the New Jersey Appellate Division upheld a trial court's decision certifying a Vioxx-related nationwide class action against Merck, brought on behalf of third-party payors by Seeger Weiss.
"... there is probably no other law firm as knowledgeable about Vioxx." --The Honorable Carol E. Higbee, P.J.Cv.
Questions and Consultations
If you or a family member has used the prescription drug Vioxx and noticed adverse side effects, such as heart attack or stroke, you should contact a physician immediately. If you would like to discuss your rights, are interested in more information on Vioxx litigation, or if you have information about the cases that you would like to share with us, please click here to fill out a short evaluation form, and a member of Seeger Weiss LLP?s experienced staff will call you to discuss your potential rights concerning Vioxx. Attorney consultations incur no obligation on your part and all initial consultations are free of charge and do not create an attorney-client relationship. Seeger Weiss LLP has office locations in both New York and New Jersey and its attorneys practice in courts throughout the country.
Further Reading:
http://www.fda.gov/bbs/topics/news/2004/NEW01122.html
http://www.fda.gov/cder/drug/infopage/COX2/default.htm
Link To Lawyer Seek's Vioxx Content:
<a href='http://www.lawyerseek.com/Practice/Pharmaceutical-Injury-C1/Vioxx-P57/'>Vioxx: Lawyer Seek</a> |
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