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Ending the Myth That Branded Drug Companies Cannot Benefit from Preemption
A myth has surfaced over the past few years that federal drug law preempts product liability suits against generic drug companies, but not brand-name manufacturers. This myth stems from an over-simplification of three U.S. Supreme Court cases. Put simply, preemption applies when it would be impossible for a prescription drug manufacturer to comply with both the FDA's requirements and what a plaintiff's lawyer alleges as its duty under tort law, here changing a drug's warnings or design to address a finding of defect in a given case. It does not matter whether the defendant made a generic or brand-name drug.
In December 2015, the United States Court of Appeals for the Sixth Circuit directly pierced this myth in Yates v. Ortho-McNeil-Janssen, No.15-31049 (6th Cir. Dec 11, 2015). The court issued a well-reasoned opinion applying the Supreme Court's doctrine of impossibility preemption to a design defect claim that the brand-name drug manufacturer should have changed the dosage of its drug's active ingredient. The Sixth Circuit held that impossibility preemption blocks any such design liability claim. The brand-name drug manufacturer could not abide by both FDA's approval for the specific design of that drug and sell an altered version of that drug.
The U.S. Supreme Court's Trilogy of Drug Preemption Cases
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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?