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FDCA

242 published works

  1. Drug & Device Law

    No Claim for Conspiracy to Violate the FDCA

    By Bexis

    We just spotted Placencia v. I-Flow Corp., 2011 WL 1361562 (D. Ariz. April 11, 2011), a pain pump case, in which the court threw out the plaintiff's latest attempt to…

  2. Drug & Device Law

    Yesterday’s Santa Clara Decision and Its Implications for the FDCA

    By Bexis

    We fingered Astra v. Santa Clara County as a potentially interesting case from the moment that the Supreme Court granted cert.  Here's how we described the case on four days after…

  3. Drug & Device Law

    Will The Supreme Court Tackle a Plaintiff End-Run Around No Private Right of Action?

    By Stephen McConnell

    Okay, that's a klutzy title. The football obsession doesn't leave us until the morning after the Super Bowl. But the Iggles have been ignominiously bounced from the NFL playoffs, so…

  4. The Appellate Strategist

    Justice Kagan and the Future of Generic Drug Preemption

    By Kelly Savage

    US Supreme Court Will Decide Fate of Preemption Defense for Generic Companies this Term Since the decision of the Supreme Court in Wyeth v. Levine, 129 S.Ct. 1187 (2009), the…

  5. Drug & Device Law

    TwIqbal & PMA Preemption, Perfect Together

    By Bexis

    We’ve blogged repeatedly about preemption in PMA medical device cases.  We’ve also had a lot to say about using TwIqbal (that is Ashcroft v. Iqbal, 129 S.Ct. 1937 (2009), and…

  6. Drug & Device Law

    Preemption, Pleading & Rule 11

    By Bexis

    One way that some plaintiffs seem to be responding to TwIqbal is simply to make up the facts needed to plead a plausible claim.  That happened in Cornwell v. Stryker…

  7. Dangerous Drugs & Medical Devices

    Solicitor General Files Brief in Pliva v. Mensing, Rejects Preemption

    By Justinian Lane

    A little late, but better than never.  Especially since the Solicitor General agrees that failure to warn lawsuits against generic manufacturers are not preempted by the FDCA: The court of…

  8. Drug & Device Law

    Food for Thought

    By Stephen McConnell

    When it comes to food, we're more often like the kids singing "Food, Glorious Food" in the beginning of the musical Oliver! than like the serious legal mavens we pretend…

  9. Life Sciences Legal Update

    Ninth Circuit Court of Appeals Holds that the FDCA Precludes Plaintiff’s Claim Under the Lanham Act

    By Lisa Baird

    The Ninth Circuit recently confronted an issue of first impression: whether a plaintiff could maintain an action under the false advertising prong of the Lanham Act, where a determination of…

  10. Drug & Device Law

    The Un-Dead on “Parallel Requirements,” Preemption, and Punitive Damages

    By Bexis

    He may be gone - dead in the blogging sense - but Herrmann continues to provide scholarly commentary about issues we care about from beyond the cyber-grave.  Dave Alden, Mark's…