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Note: There is a table in this post that may be easier to view on a phone than on a computer.

Medical device preemption provides powerful protection from litigation involving Class III devices with premarket approval (or “PMA”). 

These devices are a very small subset of FDA-regulated medical devices – around 1% — and they

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Even though lawyers who bill for their time defending product liability cases might favor those cases sticking around and plaintiffs getting many chances before inevitable dismissals with prejudice, we have been clear that we think plaintiffs should not get to re-plead around preemption once courts have defined the preempted path.  There seems to be an

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Two years ago, in Nexus Pharmaceuticals, Inc. v. Central Admixture Pharmacy Services, Inc., 48 F.4th 1040 (9th Cir. 2022), the Ninth Circuit held that the FDCA impliedly preempts private suits brought under state statutes that “rel[y] on the [FDCA], not traditional state tort law theory,” to define state-law requirements. We were so pleased with

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We recently discussed how “failure-to-recall” claims essentially don’t exist – outside of a couple of limited fact patterns that plaintiffs asserting such claims in litigation involving FDA-regulated products can almost never allege.  Today’s post adds the constitutional defense of preemption to good, old-fashioned state-law failure to state a claim.Continue Reading Bartlett Pairs – “Failure To Recall” As a “Stop-Selling” Variant

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A little over two years ago, we wrote a post called What’s In a Name? discussing an attempt by two plaintiffs to hold Pfizer liable for fraud and misrepresentation based on an allegation that it was misleading to call the drug Chantix by its name if it was contaminated.  That case, as we noted in

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Late last Friday, we learned of Hickey v. Hospira, Inc., ___ F.4th ___, 2024 WL 2513487 (5th Cir. May 24, 2024) (thanks, Dick!), becoming the first appellate decision holding that preemption applies to FDA approved prescription drugs that came on the market via the so-called “paper NDA” process.  See 21 U.S.C. §355(b)(2).  Hickey arises out of the Taxotere MDL, which has produced defense-friendly decisions in a number of areas.Continue Reading Preemption and “Paper NDAs” – Perfect Together

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This post is from the non-Reed Smith, non-Dechert , and non-Holland & Knight side of the blog. Everyone else is involved.

The Good, the Bad, and the Ugly is a classic Clint Eastwood spaghetti Western where even the Good may not be all good.  In California state court, a demurrer sustained is a defense win, right?  Although there are some bright spots, In re Ranitidine Cases is one of the ugliest defense wins we have seen in a while, providing leave to amend and a roadmap for further expansion of the Gilead duty-to-innovate.Continue Reading Post-Gilead Heartburn in the California Ranitidine Litigation

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Those of us who took Con Law as first year law students may recall Marbury v. Madison as an early test of the Supreme Court’s place in our nascent republic.  Alliteration being a mnemonic device, some may recall that Madison was Secretary of State James Madison and the decision was written by Chief Justice John