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If we have said it once, we have said it a hundred times:  medical product manufacturers are not insurers of their products.  Almost as frequently uttered would be that strict liability is not the same thing as absolute liability.  In the show position might be that the temporal relationship between a new medical condition and

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More than once have we taken note of the current plaintiff lawyer infatuation with enlisting “independent” (ha ha ha) laboratories that will manage to detect contaminants in any drug, cosmetic, or puddle of unicorn tears.  For example, see our coverage of the Zantac MDL magnum opus ruling where the court was less than impressed by

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Second chances, sure.  Two bites at the apple, we see it all the time.  Three strikes before you are out, fairly common.  But a fourth amended complaint to cure basic pleading deficiencies?  That seems overly generous by any standards.  Well, almost any standards because that is what plaintiff got in Greenwood v. Arthrex, Inc.

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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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As much as we liked those parts of In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, 888 F.3d 753 (5th Cir. 2018) (applying Texas law), that overturned a half-billion dollar verdict caused by a combination of attorney misconduct and judicial lassitude, we also recognized the problematic effects of certain other Fifth Circuit rulings in that decision.  While the good parts of Pinnacle Hip were good enough to win that decision a spot in our 2018 top ten cases, that decision’s adverse aspects were bad enough that it also landed on our list of 2018’s worst ten decisions.  Specifically we observed:

The most serious error the court made was refusing to apply established Texas law that comment k precludes strict liability across the board.  Pinnacle Hip ignored – really ignored − a half dozen prior decisions (including one of its own) on this issue.  Even if there wasn’t any precedent (which there was), expanding state-law liability where the state courts have not is not the job of a federal court sitting in diversity.

Continue Reading Comment K, Presumptions, and Medical Device Design Defects Under Texas Law

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For many years, the “one-two punch” was our affectionate label for post-Mensing cases that prevent innovator liability and preempt generic liability.  But it’s been several years since we’ve used the expression this way because it was so effective in knocking out those cases, we just aren’t seeing them like we used to.