Skip to main content

Statute

FDCA

242 published works

  1. Antitrust Law Blog

    Beginning to Close the POM Circle? – <i>POM Wonderful</i> and Drug Advertising: <i>JHP Pharmaceuticals</i>

    By Sheppard Mullin

    Earlier this year, in POM Wonderful LLC v. Coca-Cola Co.,[1] the Supreme Court examined the interaction between the Lanham Act’s prohibition against false advertising and the FDCA’s prohibition against food,…

  2. Drug & Device Law

    The Scylla and Charybdis of PMA Preemption

    By Michelle Yeary

    This post is from the non-Reed Smith side of the blog only. It’s been a while since we’ve seen a legal reference to Scylla and Charybdis, the sea monsters of Greek myth…

  3. Drug & Device Law

    Buckman Preempts Adverse Event Fishing Expedition

    By Bexis

    We’ve always been of the opinion that the rationale for preemption in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), concerning:  (1) the FDA’s exclusive enforcement power, and (2) the adverse…

  4. Drug & Device Law

    Negligence Per Se and Fraud Claims Dismissed in Risperdal Litigation

    By John Sullivan

    The Middle District of Florida in Gallant v. Ortho-McNeil-Jannsen Pharmaceuticals, Inc., 2014 U.S. Dist. LEXIS 131769 (M.D. Fla. Sept. 29, 2014), recently addressed a plaintiff’s negligence per se and fraud…

  5. Defense Litigation Insider

    What’s in a name? That which we call a rose by any other name would smell as sweet;

    By Jonathan F. Tabasky, Anna Baitchenko

    Plaintiffs, when faced with a legal bar to traditional negligence claims, frequently try to cloak them in new theories of liability. This tactic is reminiscent of dialogue in William Shakespeare's…

  6. Drug & Device Law

    Testing the Limits of Prescription Drug Preemption

    By Steven Boranian

    Just how far can a state go in regulating prescription drugs?  The simple answer is that states can go nowhere and that FDA is king in this field under the FDCA and…

  7. Drug & Device Law

    Preemption Made Easy

    By John Sullivan

    The reason that the court’s decision in Wagner v. Pfizer, 2014 U.S. Dist. LEXIS 94281 (W. D. Wisc. July 11, 2014), is useful is not because it dismisses state-law claims against generic…

  8. Drug & Device Law

    Hey, Jude! Making It Good on Preemption

    By Bexis

    Taking a sad song and making it better, St. Jude Medical recently scored double-barreled preemption victories in implantable cardioverter defibrillator (“ICD”) lead litigation.  On consecutive days, federal courts in Minnesota, Pinsonneault v. St.…

  9. Drug & Device Law

    Interesting Case On A Couple Of Issues

    By Bexis

    While most of the buzz late last week concerned the Darvocet affirmance, we also recommend that defense counsel check out this case:  Amos v. Biogen Idec, Inc., 2014 WL 2882104 (W.D.N.Y. June…

  10. IP Intelligence

    Lanham Act Claims for Misleading Product Description Can Coexist with FDCA Labeling Regulations, Court Finds

    By Lesley Grossberg

    A unanimous Supreme Court (8-0, Justice Breyer recusing) ruled on June 12, 2014 in POM Wonderful v. Coca-Cola that one competitor may sue another for unfair competition under the Lanham…