January 2024

For readers noticing the new byline, let me introduce myself.  I am Susanna Moldoveanu, and I practice with Butler Snow LLP’s Pharmaceutical, Medical Device and Healthcare group.  I am excited to join the Drug & Device Law Blogging Team.  The best group of legal wonks there is.

Today we discuss the Western District of Washington’s recent summary judgment order in Dearinger v. Eli Lilly & Co., 2023 WL 8717570 (W.D. Wash. Dec. 18, 2023).  A prior opinion in this case earned the top spot on the Blog’s Ten Best Prescription Drug/Medical Device Decisions of 2022.  This opinion is short and sweet, but a good one too.Continue Reading W.D. Wash. Nixes Failure to Warn Claim Under Learned Intermediary Doctrine

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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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We’ve noticed a recent uptick in product liability lawsuits brought against over the counter (OTC) and other consumer products. (Shameless plug: we will be on a panel discussing such litigation at ACI in NYC on January 23-24.). These are products that do not require a prescription. Maybe plaintiff lawyers prefer cases without any pesky learned intermediary who