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In a drug or medical device injury case, one of the defense's most potent arguments is often that the product in question underwent FDA approval, so the balance of its safety and efficacy has already been determined. But when a device is approved for sale to the public through the FDA's 510(k) process, the rigorous safety and efficacy analysis required of new and unique medical devices has not been undertaken.
Columns & Departments
Federal Circuit Affirms Finding That Rembrandt's Patent Is Not Infringed by Apple's Accused Products<br>District Court Transfers Case after Federal Circuit Ordered It to Reconsider Party's Venue Objections In Light of <i>TC Heartland</i><brPTAB Decision Invalidating AIP Internet Network Patent Affirmed on Appeal
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Before starting a training program, conduct a needs assessment when performance is inappropriate or inadequate. This means when one or more attorneys or staff are not doing what they should be doing, or they are doing something they should not be doing. Here's how to proceed.
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When you take a catastrophic injury case involving paralysis, it is important to have a thorough understanding of the problems and pitfalls. In this article, the author explores, from personal experience, the different types of future expenses the client can expect to incur.
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<b><i>Better Yet: 'Personal Strategic Plans'</i></b><p> If law firm partners thought of themselves as their own small business and not just a member of their firm, they would embrace the idea of creating a personal strategic vision. No need to hire a consultant; it just takes thought and time to memorialize it.
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<b><i>Part Two of a Two-Part Article</i></b><p>According to the authors, using the holding of recent New Jersey Supreme Court case <i>Bisbing v. Bisbing</i> as a model, the clear and current trend throughout the United States that when a custodial parent is seeking to relocate outside of the state with a child, the best interest of the child standard should apply.
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<b><i>In the First Enforcement Action Initiated By Its New “Cyber Unit,” the SEC Announced It Has Secured a Court Order to Freeze the Assets of Individuals Behind a “Scam” Initial Coin Offering</b></i><p>In the first enforcement action initiated by its new “Cyber Unit,” the Securities and Exchange Commission (SEC) recently announced it has secured a court order to freeze the assets of individuals behind a “scam” initial coin offering, or ICO.
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<b><i>Last Year Saw a Number of Interesting Decisions Concerning the Identity, Rights and Obligations of Non-Equity Owners, Including Partners and Shareholders</b></i><p>2017 saw a number of interesting decisions concerning the identity, rights and obligations of non-equity owners, including partners and shareholders. As more firms utilize non-equity members to play vital roles within their firms, it will become more important for them to take note of these decisions and the guidance they provide.
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Corporations with private fleets in the U.S., as well as for-hire carriers, have begun ordering faster than before. As the economy continues to strengthen, this trend will continue to grow and so will the need to replace aging equipment.
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The challenge for U.S. actors is how to comply with the law in the dynamic world of economic sanctions. This article tries to help by pointing out challenging (or “hot”) current issues and making suggestions about compliance strategies that in-house counsel can leverage to address the most challenging compliance issues.