Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.
In recent large-scale pharmaceutical litigation, plaintiffs' counsel have concentrated significant resources seeking the details of how individual patients in pre- and post-marketing company clinical trials were assessed, characterized, and reported to the Food and Drug Administration ('FDA'). The reason is clear: They are seeking to develop (in the author's opinion unfairly) a story that the pharmaceutical company hid risks and overstated benefits. The efficacy and safety data generated by industry-sponsored studies, and the manner in which the data are analyzed and reported, have therefore become the focus of large-scale pharmaceutical litigation.
Recent events in the Vioxx' litigation show that plaintiffs' counsel are now expanding this approach to industry-sponsored studies submitted to medical journals, with apparent success. The editors of the New England Journal of Medicine ('NEJM') claim that they recently obtained information revealing inaccuracies in the data reported in the VIGOR (Vioxx Gastrointestinal Outcomes Research) study that calls into question some of the study's conclusions. (Curfman GD, Drazen JM, Morissey S. Expression of concern: Bombardier et al., Comparison of upper gastrointestinal toxicity of rofexicib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000; 343: 1520-8. N Engl J Med 2005; 353: 2813-14.) Although the VIGOR study was designed to compare gastrointestinal events in patients with rheumatoid arthritis treated with either rofecoxib (Vioxx) or naproxen (Naprosyn'), data on cardiovascular events were also monitored. According to the editors, three myocardial infarctions (heart attacks) in Vioxx patients were incorrectly omitted from the data submitted to the NEJM. The editors concluded that the omission of the three additional heart attacks ' which raised the total number of heart attacks in Vioxx patients from 17 to 20, as opposed to 4 in Naprosyn patients ' rendered certain calculations and conclusions in the VIGOR article 'incorrect' and 'misleading.'
ENJOY UNLIMITED ACCESS TO THE SINGLE SOURCE OF OBJECTIVE LEGAL ANALYSIS, PRACTICAL INSIGHTS, AND NEWS IN ENTERTAINMENT LAW.
Already a have an account? Sign In Now Log In Now
For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.
A federal district court in Miami, FL, has ruled that former National Basketball Association star Shaquille O'Neal will have to face a lawsuit over his promotion of unregistered securities in the form of cryptocurrency tokens and that he was a "seller" of these unregistered securities.
Why is it that those who are best skilled at advocating for others are ill-equipped at advocating for their own skills and what to do about it?
Blockchain domain names offer decentralized alternatives to traditional DNS-based domain names, promising enhanced security, privacy and censorship resistance. However, these benefits come with significant challenges, particularly for brand owners seeking to protect their trademarks in these new digital spaces.
In recent years, there has been a growing number of dry cleaners claiming to be "organic," "green," or "eco-friendly." While that may be true with respect to some, many dry cleaners continue to use a cleaning method involving the use of a solvent called perchloroethylene, commonly known as perc. And, there seems to be an increasing number of lawsuits stemming from environmental problems associated with historic dry cleaning operations utilizing this chemical.