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In updating chapter three of his book, on non-informational causes of action, Bexis had the opportunity to add the last several years of “alternative design” opinions.  Quite a few states, as well as the Third Restatement of Torts, require plaintiffs alleging design defects to identify a “feasible” alternative design for the product as a prerequisite for asserting a design defect claim.  Even where an alternative product design is not mandatory, plaintiffs frequently offer such evidence. In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.”

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed.  Thus, as a matter of logic and semantics, “feasibility” would seem to demand that any proposed “alternative” to the existing design of a product subject to FDA scrutiny must likewise have passed the same level of FDA scrutiny.  For several decades – starting with plaintiffs’ pre-Vaccine Act attacks on vaccine designs – courts have addressed FDA approval as a component of “feasibility” in states that impose this limitation on design defect claims.

Continue Reading The FDA and Feasible Alternative Designs

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Back in the antediluvian era of the Bone Screw Litigation some 25 years ago, Bexis was responsible for crafting (and sometimes outright inventing, see fraud on the FDA) defenses for that then-unusual medical device-related mass tort.  One of the first post-MDL-remand Bone Screw cases involved a Louisiana statute, La. Stat. Rev. §9:2800.56, requiring that, for a product to be “unreasonably dangerous in design,” the plaintiff must establish that “[t]here existed an alternative design for the product that was capable of preventing the claimant’s damage” based on the statute’s risk/utility test.

Continue Reading A Primer on Alternative Design

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

Defendants in Pizzitola v. Ethicon, Inc., filed motions to exclude two of plaintiff’s experts and both decisions (two orders issued) heavily favored the defense, rejecting recurrent design defect arguments by plaintiffs.

The product at issue is synthetic pelvic mesh.  Plaintiff’s first challenged expert was a gynecologic surgeon.  While is area of practice may overlap with issues in the case, his report went well beyond both relevant issues and his area of expertise.  Namely, plaintiff’s expert wanted to opine that lots of things were alternative designs that in fact were not.  Starting with a different medical procedure altogether.  “It is not an alternative design of any product.  In fact, it is not a product at all.”  Pizzitola I, 2022 U.S. Dist. LEXIS 184352, *6 (S.D. Tex. Oct. 7, 2022).  Plaintiff argued the testimony was relevant to a risk/utility analysis but showing that a different medical procedure may be safer, “does not affect whether a product has utility and/or risks.”  Id. at *7.  The decision to perform a different medical procedure lies within the medical judgment of the treating surgeon and has no bearing on the design of the device at issue.  Id. 

Continue Reading Two Strikes Against Plaintiff’s Experts in Texas Pelvic Mesh Case

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If the pelvic mesh litigation ever ends, the tongue of history will tell a tale of specious plaintiff theories that hoodwinked judges and juries into condemning good products. Plaintiffs extracted millions of dollars and erased product lines by cobbling together irrelevant workplace material handling sheets, counterfactual stories in which the FDA does not exist, and

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The complaint in Robinson v. Ethicon Inc., Action No. H-20-3760 (S.D. Tex.) was filed in 2013.  To put that in perspective, Amazon’s first Alexa-enabled device, the Echo, wasn’t on the market.   There’s a good chance you weren’t running your phone on 4G yet.  And, if you were using earbuds with your phone, you were

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We’ve used the term one-two punch to refer to a couple different situations – Daubert wins followed by the grant of summary judgment; Mensing preemption for generic manufacturers and no innovator liability for brand manufacturers.  And we’re going to dust it off again today to refer to Couturier v. Bard Peripheral Vascular, Inc., —