Online: Vioxx Information from Merck Available on the Web
June 27, 2005
For information about Vioxx directly from Merck, visit <i>www.vioxx.com</i>. The site posts the announcement of the withdrawal on Sept. 30, 2004, explaining that the voluntary worldwide withdrawal of VIOXX' (rofecoxib) was based on 3-year data from a prospective, randomized, placebo-controlled clinical trial, called the APPROVe (Adenomatous Polyp Prevention on Vioxx) trial. The trial, which was stopped, was designed to evaluate the efficacy of Vioxx 25 mg in preventing recurrence of colorectal polyps in patients with a history of colorectal adenomas. The announcement explains that in the study, there was an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in the patients taking Vioxx compared with those taking a placebo. According to Merck, the results for the first 18 months of the APPROVe study did not show any increased risk of confirmed cardiovascular events on Vioxx, and in this respect, are similar to the results of two placebo-controlled studies described in the current U.S. labeling for Vioxx.
Top Ten Things Not to Do in Mediation
June 27, 2005
Given the burgeoning use of mediation, it is likely that most litigators, and many legal dealmakers, will find themselves representing clients in this process. It is thus imperative to understand the mediation process, its goals and possibilities, and to be effective in that process, understanding what works and what can abort the process and its positive possibilities. It is just as important to understand what not to do in the mediation process. Here is a non-comprehensive list of 10 choices counsel or parties might make that reduce the likelihood of arriving at a mutually acceptable resolution through mediation.
Legality of an 'Appearance' Policy
June 27, 2005
Employees and job applicants are increasingly filing claims of discrimination based on their appearance or image. The future scope of such claims may hinge on the outcome of a case currently pending in the U.S. Court of Appeals for the Ninth Circuit.
Employers Face Challenges in a Digital World
June 27, 2005
With little or no incremental cost, companies can now store unfathomable amounts of data and information about their business. Documents, e-mails, and financial data all can be sent and retained indefinitely with the simple click of a mouse. As remarkable and efficient as these capabilities are, they create dramatic new challenges for individuals and organizations alike. Employers, in particular, are faced with new challenges involving the retention of electronic records and data. What should be saved? How long is long enough? And what obligations do employers have to preserve electronic records when faced with actual or threatened litigation?
CD: What's It Worth to You? What Legal marketing professionals command for full-time salary.
June 16, 2005
This web audio conference gives marketers and lawyers a glimpse into what the marketing professionals in the legal field command for full-time salary, bonuses and other benefits. Focusing on the results of the highly anticipated LMA Compensation Survey, this event will serve as a snapshot into the strategic position the legal marketing professionals hold, or should hold, in firms.
A Word from the Defense: Is Defending Vioxx a Recipe for Disaster? Take a Careful Look at Who Is Sounding the Alarm
June 14, 2005
The message from our plaintiffs' lawyer colleagues has been steady and direct: "Don't bother defending these cases — you're going to lose and you're going to lose big. Just pay us all lots of money now and save yourself a lot of pain and agony." And what other message would they send? Their goal is to reap the highest reward from the least amount of effort. Litigating every case on every level; financing and staffing hundreds of complex trials, and waiting for final appellate review of every verdict is no way to run a mass tort practice — at least not from the plaintiffs' perspective. Given this author's perspective, it makes sense to examine the options more carefully before deciding that the only way to avoid ruin is to wire massive sums into the trial bar's trust accounts.
Vioxx and the FDA Advisory Committees: Yesterday, Today, and the Search for Tomorrow
June 14, 2005
Amid a cacophony of wailing and gnashing of teeth decrying the Food and Drug Administration's ("FDA's") failure to protect the public from unsafe drugs, the FDA held an emergency advisory committee meeting, which included consultants, to address the safety issues associated with the use of COX-2 selective and non-selective non-steroidal anti-inflammatory drugs ("NAIDs"). The meeting was scheduled and held at warp speed. It provided a transparent dispassionate opportunity to address the safety issues for scientists, affected parties and the public. The decisions of the advisory committee were to some extent, unexpected. This accelerated review process differs from the current advisory committee process of reviewing limited data in a product pre-approval setting. However, this use is a natural extension of the FDA's historic use of advisory committees, <i>ie</i>, analysis of voluminous data on any active ingredient over a period of years and application of the analysis to specific drug products containing the active ingredient.
