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Off-Label Promotion and Product Liability
The pharmaceutical industry has recently felt empowered and emboldened by one final court decision and another pending case that would seemingly allow companies to distribute, proactively, information about unapproved uses, i.e. , off-label, so long as the information is truthful and not misleading. However, companies must, nevertheless, consider potential product liability ramifications. There is no indication that, because firms may now be allowed certain latitude in one area, they are immune from product liability exposure.
Amarin Pharma v. FDA
With Amarin Pharma, Inc. v. United States Food and Drug Administration, No. 15 Civ. 3588 (PAE) (S.D. N.Y. Aug. 5, 2015), the U.S. Food and Drug Administration (FDA) lost yet another court decision challenging its ability to restrict a company's commercial free speech rights. There, the U.S. District Court for the Southern District of New York granted Amarin's preliminary injunction to prohibit the FDA from taking enforcement action against the company's distribution of information about an unapproved use of its FDA-approved fish oil, triglyceride-lowering prescription drug product, Vascepa' (icosapent ethyl).
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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?