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After a pharmaceutical or medical device manufacturer initiates a recall, its duties pursuant to FDA laws and guidelines do not end there. The FDA has set out certain responsibilities and steps that a manufacturer must or should follow after initiating a recall. Pharmaceutical and medical device manufacturers, however, can effectively combine their post-recall duties and responsibilities with a proactive preparation of a defense of potential litigation.
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When should an attorney confess his mistakes to those he fights for? The answer is not always easy, and a lawyer's inclination to admit wrongdoings might depend on how he perceives a client.
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The article herein takes the discussion of alternative billing a step further with information from Association of Corporate Counsel (ACC). How does a law firm or in-house counsel do it and what steps can taken to create a competitive advantage with alternative billing?
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In-house counsel and their outside counterparts routinely struggle with the problem of when and how to issue legal hold notices. When is litigation reasonably anticipated? Who should get the notice? Should the notice be tailored to the case or based on a rigid template? One question that should have a consistent answer is whether the notice should be in writing.
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The ongoing recession has led lawmakers and the SEC alike to focus on limiting perceived excessive risk-taking and improving the accountability of boards of directors to shareholders. This focus has yielded a range of ideas, although none more controversial than the SEC's recently proposed rules to permit shareholders to include their director nominees in a company's proxy statement.
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In private rulings, the IRS has sanctioned several ways in which a prime lease to a tenant that subleases to others can structure a gross receipts formula for rent that will not result in the rental payments being characterized as based in whole or in part on profits.
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This article takes a brief look at a few of the more commonly applicable laws: the federal Stark law, the federal Anti-Kickback Statute and regulatory performance standards mandating certain space-sharing restrictions for Independent Diagnostic Testing Facilities.
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Twenty years ago, a defense attorney might have sighed with relief to hear an Assistant U.S. Attorney (AUSA) say that a client was only a "witness," or would not be prosecuted, or would be immunized in return for truthful cooperation in the government's investigation. These days, not so fast.
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The first part of this article summarized the law of inadvertent waiver of privilege and the evolution of courts' approaches to this problem. The conclusion offers a roadmap for the product liability practitioner to navigate the opportunities and challenges presented by Rule 502, and illustrates how to protect a client's privileged communications in a cost-conscious way.
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Two recent court opinions challenge the growing consensus that 11 U.S.C. ' 365(d)(3) (the "Statute," or "Section 365(d)(3)") does not require the timely payment of stub rent, which is "the rent for the interim period between the day the order for relief was entered in the bankruptcy case and the end of that month." This article offers an analysis.