SPECIAL ALERT!  Vioxx Withdrawn From the Worldwide Market

On September 30, 2004, Merck & Co., Inc. voluntarily withdrew its arthritis drug, Vioxx, from the worldwide market after new data from a clinical trial found a much higher risk of heart attacks and strokes was attributed to Vioxx use.  The subject clinical trial, referred to as APPROVe (Adenomatous Polyp Prevention on Vioxx), was a three-year study aimed at showing that Vioxx at a 25mg dosage prevented the recurrence of colon polyps.  However, physicians who were overseeing the clinical trial, referred to as the data safety monitoring board, recommended the study to be halted because of the increased risk of cardiovascular events including heart attacks and strokes.  Merck, as well as the Food and Drug Administration (FDA), recommend patients who are currently taking Vioxx to discuss alternative treatments with their health care providers.

The FDA first approved Vioxx in May 1999 for the reduction of pain and inflammation caused by osteoarthritis, as well as for acute pain in adults and for the treatment of menstrual pain.  Vioxx was the second of a new type of non-steroidal anti-inflammatory drug (NSAID) called a Cox-2 inhibitor, (Pharmacia's Celebrex was the first).  At the time that Vioxx was approved, the hope was that it would lower the risk of gastrointestinal ulcers and bleeds as compared with standard pain relievers such as aspirin or ibuprofen.  However, the FDA mandated that the label for Vioxx include the standard gastrointestinal warning, which aspirin, ibuprofen and other pain relievers are required to use.

In order to apply to the FDA for removal of the gastrointestinal warning, Merck engaged in a study called VIGOR (Vioxx Gastrointestinal Outcomes Research), which compared Vioxx to Naproxen, another common pain reliever.  Merck was hoping that the study would show that Vioxx did not have the gastrointestinal side effects of Naproxen.  However, when analyzing results of the VIGOR study, Merck found that Vioxx had a four-fold increased risk of cardiovascular events, including heart attacks and strokes, in those patients who took Vioxx instead of Naproxen.  These findings were reported to the FDA in June 2000.  Given the VIGOR results, the FDA implemented labeling changes to Vioxx to include information about the increased risk of cardiovascular events.

Studies following the VIGOR trial also demonstrated that those patients taking Vioxx are at an increased risk for heart attacks and strokes, including a Merck sponsored trial from Brigham & Women's Hospital in Boston as well as a Kaiser Permanente analysis.  The FDA was in the process of reviewing these latest studies to determine what actions to take with regard to Vioxx when Merck's withdrawal announcement was made on Friday, September 30th, based upon the APPROVe trial.

The law firm of Anapol Schwartz has closely monitored the link between Vioxx and heart attacks and strokes since the VIGOR results were first made public.  Since that time, our firm has reviewed over 1,000 cases on behalf of individuals who alleged injury from their use of Vioxx.  When an individual contacts Anapol Schwartz or a case is referred to our office where it is alleged that Vioxx caused the injury, we immediately begin investigation of the claim.  We ask the client to provide a series of information, including the identity of current physicians, Vioxx use and the injury claimed.  A client's medical records are ordered from those medical providers identified.  Once those records are obtained, our attorneys, along with professionally trained staff and, if necessary, outside experts and consultants, review those records to determine if a link can be made between Vioxx usage and the injury alleged.

Our firm has filed lawsuits against Merck & Co., Inc. on behalf of 86 individuals who were injured from their use of Vioxx.  These cases have been filed in New Jersey state court, where we are actively pursuing recovery on behalf of our clients.  Members of our firm are taking an active role in the litigation and one member, David Jacoby, was selected as Plaintiff's co-liaison counsel.  Presently, we are engaged in the discovery phase of the Vioxx litigation, which means we are reviewing millions of pages of documents, which Merck was compelled to produce to use.  We are also deposing Merck's scientists, marketers and other relevant witnesses.  We hope that these trials will be scheduled shortly in these cases.

In light of these current developments, we are accepting and reviewing new Vioxx cases.  If you or someone you know believes that Vioxx has caused them injury, you are urged to contact our firm.  You may fill out a free electronic case evaluation on our website at www.anapolschwartz.com.  We will review your intake form and contact you to discuss the claim.  You may also contact our attorneys directly.  They are Sol Weiss (215.735.1130 or sweiss@anapolschwartz.com), David Jacoby (856.488.5484 or djacoby@anapolschwartz.com), Greg Spizer (215.735.1130 or gspizer@anapolschwartz.com) or Tracy Finken (215.735.1130 or tfinken@anapolschwartz.com).