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Personalized medicine is the wave of the future.  Whether treating disease or prescribing medical devices (or both), medical practitioners are taking individualized patient characteristics into account more and more as they treat their patients.  Cancer therapy can now be targeted at the genetic level, and some medical devices can now be created to match patient

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This is a guest post by Kelly Jones Howell, of Harris Beach and it’s for a good cause.

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DRI’s Drug and Medical Device Committee will hold its annual Seminar on May 3-5, 2023, at the Hilton New Orleans Riverside, in New Orleans, Louisiana.  The Seminar is a preeminent program for practitioners who represent

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Hey, come closer. We’ve got a secret to share with you. We’ll whisper it in your ear. Ready?  Courts hate sealing filings.  It’s an administrative pain.  Plus, parties who claim confidentiality tend to be a bit promiscuous in that regard, labeling far more documents confidential than is warranted.  We’ve been on both sides of confidentiality

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A couple of our recent posts have mentioned the alternative compensation system created by the 1986 National Childhood Vaccine Injury Act (“Vaccine Act”), 42 U.S.C. §§300aa-10, et seq.

This Vaccine Program is the Act’s alternative to tort litigation, which addresses alleged injuries resulting from vaccines covered by the Vaccine Act.  The legal aspects of the

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One aspect of Pietrantoni v. Corcept Therapeutics Inc., ___ F. Supp.3d ___, 2022 WL 16857262 (D. Mass. Nov. 10, 2022), has troubled us ever since we first noticed the opinion.  But we recently noticed that Pietrantoni had been selected for publication, so we decided the issue was important enough to examine in depth.

Continue Reading The Problem with Pietrantoni – Unraveling Undertaking Liability

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The first thing you learn as an appellate clerk is the importance of the standard of review.  If the review is de novo – purely legal issues – your judge will not defer at all to what happened below.  It’s a whole new (hence, de novo) ballgame. If the review is for abuse of discretion

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We call ourselves the Drug and Device Law Blog, but sometimes we cover cases outside the drug and device field because such cases can sometimes be helpful or inspiring. Perhaps it is an example of thinking outside of the box.  

Jackson-Mau v. Walgreen, Inc., 2023 U.S. Dist. LEXIS12057 (EDNY Jan. 24, 2023), is

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If we had forgotten that there continue to be abundant U.S. cases of COVID-19, then there was plenty around us to remind us.  Public mask usage seems to have increased.  We heard how the “tripledemic” of viruses had made hospital beds scarce.  We have had colleagues out of commission instead of completing our assignments.  The

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In the podcast called Know Your Enemy, political progressives take a probing look at the history of American conservative political thought.  The podcast is somewhat unusual because it takes opponents’ opinions seriously.  There is much more analysis than name-calling.  The podcast considers the views of intelligent conservative theorists and writers (e.g., Leo Strauss, Garry Wills