Negligence Per Se

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Recently, within the course of a couple of weeks, two different courts reached the same conclusion – that a plaintiff’s negligence per se claims, largely based on purported violations of the Food, Drug & Cosmetic Act (“FDCA”), failed to state a claim.  See Disarro v. Ezricare, LLC, 2023 WL 6619445 (M.D. Fla. Oct. 11, 2023), and Alcozar v. Orthopedic & Sports Medical Center, ___ N.E.3d ___, 2023 WL 6302337 (Ind. App. Sept. 28, 2023).  Another thing that these two opinions share is that neither of them relied on federal preemption in disposing of the FDCA-related negligence per se claims.Continue Reading Beating FDCA-Based Negligence Per Se Claims on Non-Preemption Grounds

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Back in 2008, the United States Supreme Court held, in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted.  After all, PMA “is in no sense an exemption from federal safety review − it is federal safety review.”  Id. at 323.  Thus, by a 7-2 margin the Court held, per Justice Scalia, that all state-law liability claims before it – “strict liability; breach of implied warranty; and negligence in the [product’s] design, testing, inspection, distribution, labeling, marketing, and sale,” id. at 320 – were expressly preempted:Continue Reading PMA Preemption Decision Slides to the Bottom of the “Parallel Claim” Slippery Slope

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Bexis has just submitted revisions and updates to Chapter 4 of his treatise, Drug and Medical Device Product Liability Deskbook.  Chapter 4 is “The Federal Framework,” and one of the topics it covers is the use of claimed FDCA violations as the basis for state-law claims, including, most prominently, negligence per se.  Bexis addresses in depth a number of non-FDCA-based common-law defenses to negligence per se: (1) consistency with legislative intent; (2) the force-of-law requirement; (3) prohibition on creation of novel tort duties; (4) inapplicability of licensing statutes; (5) requirement of a specific standard; and (6) causation issues.  That means Bexis has been reading a lot (hundreds) of recent non-FDCA negligence per se cases, involving everything from traffic accidents to firearms to data breaches.Continue Reading On Pleading Negligence Per Se

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Summary judgment was affirmed in Vesoulis v. ReShape LifeSciences, Inc., 2022 WL 989465 (5th Cir. April 1, 2022), although the recent troubling trend towards non-precedential defense wins but precedential defense losses continues.  Vesoulis was a one-off suit under Louisiana law against the manufacturer of a pre-market (“PMA”)-approved medical device and the implanting – or, more properly, explanting – surgeon.  Plaintiff allegedly suffered an injury that, according to the informed consent form he signed, was a one in 10,000 possibility.  Id. at *1.

The device being PMA approved, one might think that the chief defense was express preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  It wasn’t.  Rather, plaintiff’s central warning claim fell under the Louisiana product liability statute (“LPLA”) because the surgeon was “experienced.”  Id. at *2.  Instead the case turned on implied preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). 

Continue Reading FDCA-Based Negligence Per Se & Informed Consent Don’t Mix

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Under Fed. R. Evid. 9(b), “[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.”  In our sphere, federal courts are quite variable in how they apply this standard when deciding 12(b)(6) motions.  In particular, MDLs seem to have an unfortunate habit of allowing general allegations to support…

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Ever since our Bone Screw days, when we used the strategy to great effect, we’ve rooted for defendants undertaking to beat post-MDL remand plaintiffs in guerrilla litigation in numerous courts across the country.  The way to do it is twofold:  On the one hand the defendant creates litigation uncertainty by hemming the other side in…

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Only five days after our recent post highlighting the possible no-private-right-of-action implications of the (to us, anyway) obscure Astra USA, Inc. v. Santa Clara County, California, 563 U.S. 110 (2011), case, the Fourth Circuit applied it along the lines we had speculated could be helpful to defendants.  Bauer v. Elrich, ___ F.4th ___,…

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Today’s post discusses a recent implied-preemption decision that is relevant beyond the generic-drug context in which it arose.

A bit of background first.

In Buckman Company v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), the Supreme Court held that 21 U.S.C. § 337(a)—which declares that all actions to enforce the FDCA “shall be by…

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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