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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?
In the wake of the preemption analysis of Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001), and the First Amendment analysis of Washington Legal Foundation v. Henney, 202 F.3d 331 (2000), the dissemination of information about off-label uses of prescription drugs and medical devices is enigmatic legal territory. In the eyes of many commentators, these cases address entirely different issues. The two fight for the same territory, however, and both confuse the already foggy legal backdrop against which drug manufacturers' communications with doctors take place.
The Off-Label World
Yachts, Jets, Horses & Hooch: Specialized Commercial Leasing Models
Defining commercial real estate asset class is essentially a property explaining how it identifies — not necessarily what its original intention was or what others think it ought to be. This article discusses, from a general issue-spot and contextual analysis perspective, how lawyers ought to think about specialized leasing formats and the regulatory backdrops that may inform what the documentation needs to contain for compliance purposes.
Hyperlinked Documents: The Latest e-Discovery Challenge
As courts and discovery experts debate whether hyperlinked content should be treated the same as traditional attachments, legal practitioners are grappling with the technical and legal complexities of collecting, analyzing and reviewing these documents in real-world cases.
Identifying Your Practice's Differentiator
How to Convey Your Merits In a Way That Earns Trust, Clients and Distinctions Just as no two individuals have the exact same face, no two lawyers practice in their respective fields or serve clients in the exact same way. Think of this as a "Unique Value Proposition." Internal consideration about what you uniquely bring to your clients, colleagues, firm and industry can provide untold benefits for your law practice.
Risks and Ad Fraud Protection In Digital Advertising
The ever-evolving digital marketing landscape, coupled with the industry-wide adoption of programmatic advertising, poses a significant threat to the effectiveness and integrity of digital advertising campaigns. This article explores various risks to digital advertising from pixel stuffing and ad stacking to domain spoofing and bots. It will also explore what should be done to ensure ad fraud protection and improve effectiveness.
Turning Business Development Plans Into Reality
This article offers practical insights and best practices to navigate the path from roadmap to rainmaking, ensuring your business development efforts are not just sporadic bursts of activity, but an integrated part of your daily success.