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The PREP Act is having a moment.  Congress enacted the Public Readiness & Emergency Preparedness Act (“PREP Act”) in 2005 to ensure the availability of effective countermeasures in the event of public health emergencies.  The declaration of COVID-19 as an “emergency” has thus thrust the PREP Act into the limelight.  Heck, when you’re a federal

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Law school exams are usually exercises in issue spotting. Buried within the fact scenarios are various legal issues. The student earns points by identifying those issues and discussing how they should be resolved.  Sequence also matters.  It makes sense to walk through threshold issues, such as jurisdiction, first. 

Goins v. Saint Elizabeth Medical Center, Inc.

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We have no inclination to mess with Texas.  Heck, a state ornery enough to secede from two different countries in order to preserve slavery isn’t likely to care, anyway.  So if Texas wants to run its own power grid, not connect to the rest of us, and freeze in the dark when that system fails, we’re certainly not going to stand in the way.  Conversely, when Texas emphatically adopted the learned intermediary rule in Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012), we hailed it as the best decision of 2012.

But when Texas decides to mess with the rest of us….  Well, that’s different.

So we do have comments on the bizarre complaint that the Texas attorney general recently filed over COVID-19.  The complaint, brought under the Texas consumer protection statute, sued a major manufacturer of COVID-19 vaccine that was used to control the recent pandemic.  That Complaint alleges various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media that have circulated since these vaccines first became available.  The Texas Complaint also claims that, in various ways, the vaccine manufacturer violated certain mandatory FDCA provisions and FDA regulations (¶22), did not follow voluntary FDA guidance (¶¶25-31), supposedly committed fraud on the FDA by submitting misleading data (¶¶47, 117, 120-21), and mostly that it purportedly misled the public and/or the press (¶¶50, 55-91, 154-55, 157-59, 161-63, 165-66, 168-69).Continue Reading A Texas Mess

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Each of these cases is significant enough to merit its own post, but since they came down within a week of each other, we’re discussing both of them here.  They are:  Gahl v. Aurora Health Care, Inc. ___ N.W.2d ___, 2023 Wisc. LEXIS 137 (Wis. May 2, 2023), and M.T. v. Walmart Stores, Inc., ___ P.3d ___, 2023 WL 3135662 (Kan. App. April 28, 2023).Continue Reading Two New Appellate COVID-Related Developments

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This post is from the non-Reed Smith side of the blog.

Federal Rule of Civil Procedure 8(a)(2) requires that a complaint contain “a short and plain statement of the claim, showing that the pleader is entitled to relief.”  TwIqbal requires a complaint contain sufficient facts to make the claim for relief “plausible on its face.” 

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The world order has been restored.  The clouds have parted, and all today is in perfect resonant harmony.  Ok, we are exaggerating.  A lot.  But we are pleased to report that at least one federal district court has correctly interpreted and applied the PREP Act.  We are sure you are as relieved as we are. 

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Last week the Third Circuit became the first federal appellate court to decide the question of whether federal courts have jurisdiction over COVID-related tort litigation.  It concluded they did not.  Maglioli v. Alliance HC Holdings LLC, — F.4th –, 2021 WL 4890189 (3d. Cir. Oct. 20, 2021).  A decision directly at odds with