Addressing the Conflict: FDA vs. Torts
Our legal system supports two regulators of the safety of prescription drugs ' the U.S. Food and Drug Administration and courts applying the tort liability regime. The FDA's mission, while narrowly circumscribed in its early years, grew dramatically over the last half of the twentieth century. Today, the FDA administers the most comprehensive drug regulatory system in the world.
The Off-Label Divide
Is it ever appropriate for a drug manufacturer to disseminate information about an off-label use of a drug? If so, when is it inappropriate? Is the dissemination of such information commercial speech protected by the First Amendment that cannot be proscribed by the FDA? Can manufacturers be held accountable for this speech by the FDA or in a products liability action?
IP News
Highlights of the latest intellectual property news and cases from around the country.
Fact or Fiction: Trial Counsel Should Author Patent Opinions
When patent issues arise, clients often need both trial counsel and opinions of counsel. Opinions are primarily needed for: 1) advice on how to avoid infringement; 2) assessment of liability risks and potential outcomes of infringement lawsuits; and 3) protection against a finding that any infringement was willful. Trial counsel are needed when a patent infringement suit is threatened, imminent, or instituted. This article discusses the advantages of employing the same attorney or law firm as both opinion counsel and trial counsel. It explains why disqualification of counsel is not as much of a concern as some commentators emphasize. Finally, it analyzes the issues surrounding attorney-client privilege and work-product protection and concludes that the dangers are minimal with experienced trial counsel.
E-mail and Records Management in the Legal Environment
Law firms have historically recognized the need to keep all legal matters in some kind of permanent file. Therefore, the position of "record manager" is well known. However, the definition of a "record" has expanded in scope to encompass all computer-generated documents. Importantly, that now includes e-mail and e-mail attachments. This article will explore the differences between records and documents, the unique challenge e-mail represents and issues to be aware of when setting up a cutting edge records management system.
Viewpoint: Class Actions, Reform, and the Impact on Franchisors
Since the 1960s, consumer advocates have used the tool of the class action to shepherd and win redress for those who have relatively small claims, but don't have the practical means to pursue their own individual lawsuits. The honorable intention is to notify and help vulnerable or unsophisticated plaintiffs who may not even realize they have been swindled. Class actions have won significant refunds for HMO customers, credit card and utility customers, and, of course, aided victims negligently exposed to toxic substances.
Case Briefs
Highlights of the latest insurance cases from around the country.
