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FDCA

242 published works

  1. Sentencing Law and Policy

    Mixed DC Circuit ruling in suit against FDA allowing execution drug importation

    By Douglas Berman

    Main July 23, 2013Mixed DC Circuit ruling in suit against FDA allowing execution drug importation As reported in this AP piece, the DC Circuit "ruled Tuesday that the Food and…

  2. Drug & Device Law

    Revisiting Publisher (Non)Liability

    By Bexis

    We were perusing the recent GAO report on electronic drug labeling in our spare time (we’re weird like that).  We found a number of interesting points − such as what…

  3. Drug & Device Law

    A Walk Around Primary Jurisdiction

    By Stephen McConnell

    Sunday was a pretty good day. It was both Father’s Day and Bloomsday.  June 16 is called Bloomsday because that is the day that Leopold Bloom and Stephen Daedalus wandered around Dublin…

  4. Drug & Device Law

    Reinforcing The Learned Intermediary In Wisconsin

    By Bexis

    One of the few states where there is any doubt about the applicability of the learned intermediary rule is Wisconsin.  That’s primarily because the rule has never been addressed (one way or…

  5. Drug & Device Law

    Lacognata Affirmed

    By Bexis

    Remember that weird case where the plaintiff was suing because the defendant removed a drug he liked from the market?  Well, it was affirmed the other day, by the Eleventh…

  6. Drug & Device Law

    Plaintiff’s Second Try Still Preempted

    By Michelle Yeary

    This one's from the Dechert side only. We talk about a lot of motions to dismiss on this blog and being a defense blog, the overwhelming majority are successful.  Motions…

  7. Drug & Device Law

    Polett To Be Reargued En Banc

    By Bexis

    We previously blogged about the Pennsylvania Superior Court vacating an 8-figure in Polett v. Zimmer and remanding for a new trial due to multiple reversible errors committed at the first…

  8. Drug & Device Law

    When Is Off-Label Use Not Off Label?

    By Bexis

    We've read Phelps v. Wyeth Inc., No. 09-6168, slip op. (D.Or. April 2, 2013) (also at 2013 WL 1403060).  In general, Phelps is another rather dismal Fulgenzi-type decision holding involving metoclopramide and holding…

  9. Drug & Device Law

    Bartlett Oral Argument – The Supreme Court Encounters Tort Marxism

    By Bexis

    No, we didn’t attend the Bartlett oral argument, but the Supreme Court has become wonderfully efficient at providing argument transcripts.  So we’ve read through the argument.  Our strongest impression is, boy, is Bartlett a…

  10. Drug & Device Law

    Oklahoma Supreme Court OKs Federal Takeover of State Tort Law

    By Bexis

    We were planning to write about the Bartlett oral argument today (we still might) when we learned about Howard v. Zimmer, Inc., ___ P.3d ___, 2013 WL 1130759 (Okla. March 19, 2013),…