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FDCA

242 published works

  1. Ogletree Deakins Insights

    DOJ Releases Memorandum Supporting Employers’ Right to Mandate Vaccines Approved by the FDA for Emergency Use

    By Publisher, Charles L. Thompson IV, Justin P. Grose

    Growing numbers of private businesses and public entities have announced policies requiring employees and others to be vaccinated against COVID-19 as a condition of employment or as a condition of…

  2. HR Law Watch

    COVID NEWS – DOJ Says Vaccine Mandates Not Prohibited by EUA Law and CDC Updates Mask Guidance for the Vaccinated

    By Tara L. Humma, Gustavo Cardona, Meredith S. Dante

    Below are a number of significant developments related to COVID-19 that impact businesses of all sizes, across industries: DOJ Says Vaccine Mandates Not Prohibited by EUA This week, the Department…

  3. Drug & Device Law

    FDA Reporting and Consumer Protection Issues Certified to Connecticut Supreme Court

    By Bexis

    As we discussed in our recent 50-state survey on failure-to-report claims, plaintiff-side allegations seeking to predicate “warning” liability on a defendant’s allegedly failing to comply with FDCA adverse event reporting…

  4. Drug & Device Law

    Banned on the Run

    By Bexis

    With apologies, this time, to Sir Paul − “The circuit judge, who held a grudge, has put the FDA’s banned on the run. . . .” That’s just about what happened in Judge…

  5. Law and the Workplace

    Federal Court Upholds Employer’s COVID-19 Vaccine Mandate

    By Evandro Gigante, Alex Downie, Rebecca Fishbein

    On June 12, 2021, a federal District Court in Texas in Bridges, et al v. Houston Methodist Hospital et al, Docket No. 4:21-cv-01774 (S.D. Tex. Jun 01, 2021) dismissed a…

  6. Drug & Device Law

    Door Still Shut to Parallel Violation Claims in Florida

    By Michelle Yeary

    This post is from the non-Reed Smith side of the blog. Today’s case – Bernasek v. Gatz, 2021 WL 2152968 (Fla. Cir. May 20, 2021) – doesn’t exactly break new…

  7. Drug & Device Law

    Causation and The Learned-Intermediary Doctrine

    By Andrew Tauber

    Today we report on two cases involving the learned-intermediary doctrine. One holds that the doctrine applies in the context of clinical trials; the other holds that it applies even when…

  8. Drug & Device Law

    We Report on FDA-Based Failure-To-Report Claims – A Fifty-State Survey

    By Bexis

    Not too long ago we discussed the decision in In re Allergan Biocell Textured Breast Implant Products Liability Litigation, 537 F. Supp.3d 679 (D.N.J. 2021) (“TBI”).  TBI addressed quite a…

  9. Drug & Device Law

    Pleading Preemption As A Defense In A Privacy Class Action

    By Eric Alexander

    Critics have been known to accuse us of being too hard on product liability plaintiffs and too forgiving of defendants who develop medical products.  We all have our biases, especially…

  10. Drug & Device Law

    Preemption Again Defeats Breast Implant Claims

    By Bexis

    We praised Brooks v. Mentor Worldwide, LLC, 2019 WL 4628264 (D. Kan. Sept. 23, 2019), when it was first decided, as “checking all the boxes.”  Last week the Tenth Circuit…