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Off-Label Marketing of Drugs and Medical Devices
Policing the marketing of drugs and devices was once primarily the preserve of the Food and Drug Administration (FDA), which focused on misleading labels and outright quackery. No longer. Nowadays, many federal investigations, worked jointly by the FDA, Department of Justice (DOJ) and Health and Human Services (HHS), are fueled by the enormous financial recoveries that can be won from manufacturers accused of illegally promoting FDA-approved drugs or devices, bearing an FDA-approved label, for uses not approved by the FDA ('off-label' uses).
For example, Warner-Lambert pleaded guilty, paid $430 million, and entered into a 'Corporate Integrity Agreement' to resolve civil and criminal charges over off-label promotion of the drug Neurontin'. Other reported settlements relate at least in part to off-label allegations: Genentech ($50 million); Lilly ($36 million); Serono ($704 million); Schering-Plough ($435 million); Intermune ($36 million) and, more recently, Purdue Frederick ($470 million).
The Statutory Framework
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Major Differences In UK, U.S. Copyright Laws
This article highlights how copyright law in the United Kingdom differs from U.S. copyright law, and points out differences that may be crucial to entertainment and media businesses familiar with U.S law that are interested in operating in the United Kingdom or under UK law. The article also briefly addresses contrasts in UK and U.S. trademark law.
The Article 8 Opt In
The Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.
Strategy vs. Tactics: Two Sides of a Difficult Coin
With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.
Legal Possession: What Does It Mean?
Possession of real property is a matter of physical fact. Having the right or legal entitlement to possession is not "possession," possession is "the fact of having or holding property in one's power." That power means having physical dominion and control over the property.
The Anti-Assignment Override Provisions
UCC Sections 9406(d) and 9408(a) are one of the most powerful, yet least understood, sections of the Uniform Commercial Code. On their face, they appear to override anti-assignment provisions in agreements that would limit the grant of a security interest. But do these sections really work?