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Statute

FDCA

242 published works

  1. Incontestable Blog

    Supreme Court Holds False Advertising Claims Not Pre-empted by FDCA

    By B. Brett Heavner

    On June 12, 2014, the Supreme Court issued its decision in Pom Wonderful LLC v. Coca-Cola Co., No. 12-761, holding that Lanham Act false-advertising claims are not pre-empted by the…

  2. Drug & Device Law

    Breaking News: No FDCA Preclusion of Lanham Act Food Cases

    By Bexis

    Today the United States Supreme Court ruled in POM Wonderful v. Coca-Cola Co., No. 12-761, slip op. (U.S. June 12, 2014), that at least in food cases – where “the FDA does not preapprove…

  3. Drug & Device Law

    Preemption. Beautiful, Beautiful Preemption

    By John Sullivan

    The test for determining whether a state law claim is impliedly preempted is whether or not the claim would exist in the absence of the FDCA. Rarely do we drug…

  4. Animal Law Update

    Livestock Producers Face Permanent Injunctions

    By Nancy E. Halpern, D.V.M.

    Livestock producers who fail to correct asserted violations of the Food, Drug, & Cosmetic Act face serious repercussions that may result in the permanent or temporary cessation of their operations.…

  5. Drug & Device Law

    With Yet Another One-Two Combination, Claims against Generic and Branded Manufacturers in the Metoclopramide Litigation Go Down

    By John Sullivan

    (This post comes from the non-Dechert side of the blog.) Like the court, we start at the end, with the knockout blow.  Here’s how the court set it up: It…

  6. Drug & Device Law

    A District Court Takes an Exacting Look at Parallel Violation Claims

    By John Sullivan

    We talk a lot about preemption here.  Click on the preemption topic on the side of our webpage (here) and you’ll get pages and pages of posts.  That isn’t surprising.  Preemption can end a…

  7. Drug & Device Law

    Better Late than Never: We Look Back at a 2013 W.D. Okla. Application of TwIqbal to Dismiss a Hip Implant Case Premised on Vague Allegations of FDA Regulatory Violations

    By Stephen McConnell

    Time travel is on our mind today.  We should hasten to add that it is not a topic that usually absorbs us – otherwise we might squander what little credibility…

  8. Drug & Device Law

    Federal Circuit Bats An Eye At FDCA Preemption

    By Steven Boranian

    We don’t get to write much about the Federal Circuit.  It is unique in our federal court system in that it has nationwide jurisdiction over specialized subjects, most notably patent and trademark.  We…

  9. Focus on Regulation

    FDA Calls for Nominations of Difficult to Compound Drugs

    By David Fox, Mike Druckman

    The U.S. Food and Drug Administration (FDA) is required by statute to maintain a list of drug products that cannot be manufactured by pharmaceutical compounding because they are demonstrably difficult…

  10. Drug & Device Law

    Drug/Device Labels are Not Required to Tell Doctors How to Practice Medicine

    By Stephen McConnell

    A few days ago we concluded the litigation strategy class we co-teach at Penn Law School.  This year’s students were the best yet at understanding the importance of reducing any…