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The cornerstone of many FDA enforcement actions against pharmaceuticals manufacturers in recent years has been the charge that they have "misbranded" their pharmaceutical products by promoting them for uses not approved by the FDA. Now, the Second Circuit has thrown the concept of criminal liability for misbranding by means of off-label-use promotion into turmoil.
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While it is natural for same-sex marriage supporters to want to ride the current wave of ballot box victories for marriage equality, that instinct should be resisted because popular-vote referenda are simply not the appropriate vehicle for determining fundamental individual rights, like the right to marry.
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In a law firm environment, great leaders are necessary to provide client service, build client relationships, develop more junior lawyers, and generally ensure the profitable use of firm resources. This requires everyone's best thinking. How does a leader harness the group's best thinking? The most effective leaders use coaching skills. In other words, all they do is ask the right questions.
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In 2012, the U.S. Court of Appeals for the Eighth Circuit issued what was only the second federal appellate ruling on statutory damages against an infringing file sharer. The Eighth Circuit reinstated statutory damages of more than $220,000 against a woman who illegally file-shared two dozen songs, finding the damages to be constitutional.
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Businesses that want to use data analytics and comply with privacy rules have an additional burden when the data in question become or could become part of discoverable information in litigation. Then, businesses must make choices about how to handle PII data, which of it to produce and the justifications to support those decisions. Balancing these data-driven issues requires an understanding of the ever evolving landscape of each competing concern.
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While used less frequently than security deposits and personal guarantees, granting the landlord a security interest in its personal property can enhance a tenant's credit. This device may be more effective when conferred by certain types of tenants than by others, but nevertheless, it may provide the landlord with a potent default remedy, particularly in a fragile market.
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An immense wave of Dodd-Frank litigation will sweep the federal courts this year, following two years of desultory rule-making by the relevant federal agencies.
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The new Guidance raises the question of how much, if any, knowledge and control of a subsidiary's bribery, as opposed to its actions generally, the government believes is necessary for a parent to be held liable under the FCPA's anti-bribery provisions ' and whether the answer is different for the DOJ than for the SEC.
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Opening the door to a potentially historic step in the nation's gay rights movement, the U.S. Supreme Court on Nov. 7 agreed to decide two constitutional challenges involving same-sex marriage.
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Creating a brand name that is trademark-worthy and can be defended in the market requires a thoughtful strategy. The standards of the USPTO for trademark registration are nuanced, and the wrong choice of words can make it challenging to obtain a defensible registered mark.