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Blog Posts in November, 2013

  • Proposed FRCP 37(e); "Perverse Incentives and Sloppy Behavior"

    This is my second post in a series about the pending amendments to the FRCP. I began with commentary on the proposed amendment to FRCP 26(b)(1), which would narrow the scope of discovery. On to FRCP 37(e). First, the text of the amendment. Added text, deleted text. Rule 37. Failure to Make Disclosures or to Cooperate in Discovery; Sanctions (e) Failure to Provide Electronically Stored Information. ...
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  • FDA Proposes Rules Enabling Prompt Updates of Generic Drug Product Labeling

    The U.S. Food and Drug Administration recently issued proposed rules that would allow generic drug manufacturers to independently and promptly revise drug safety information by updating product labeling. Generic drugs are bioequivalent versions of brand name drugs. The former are usually sold at much lower prices once the patent protection for the brand name counterpart has expired. Currently, ...
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  • Judge Approves Janssen Pharmaceuticals' Guilty Plea of Misbranding

    On November 4, 2011, the U.S. Department of Justice (DOJ) announced that Johnson & Johnson (J&J) and some of its subsidiaries will pay over $2.2 billion due to allegations regarding several prescription drugs. On November 7, 2013, as part of this settlement agreement, Janssen Pharmaceuticals Inc. (a J&J subsidiary) pled guilty to a misdemeanor charge for misbranding a drug that was at one time ...
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  • Proposed FRCP Amendments; The Emperor's New Clothes

    “The only thing necessary for the triumph of evil is for good men [and women] to do nothing.” While the origin of the saying is muddled, the message should be clear and familiar. It speaks of our responsibility to bind together in furtherance of justice, and the inevitable consequences of complacency; our duty to make our voices heard, rather than sit idly by while liberty is threatened. It is a ...
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  • Johnson & Johnson Fined Over $2.2 Billion for Criminal and Civil Liability

    The U.S. Department of Justice (DOJ) recently announced that Johnson & Johnson (J&J) and some of its subsidiaries will pay over $2.2 billion due to allegations regarding several prescription drugs. The claims include promotion of the drugs for unapproved uses ("off-label" use), as well as kickback payments to physicians and to Omnicare Inc. - the biggest U.S. long-term care pharmacy provider. The ...
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  • Ford Settles Class-Action Lawsuit Over Diesel Engines

    By Kaiser Gornick LLP posted in Class Action on Monday, November 4, 2013 Ford Motor Co. recently reached a settlement over claims that it sold defective diesel engines. In particular, the settlement affects the now discontinued 6-liter PowerStroke diesel engines installed in 2003-2007 Ford vehicles sold or leased in the Unites States (mostly Super Duty pickups and E-series vans). The components ...
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