Search results for: 3d printing

This post is from the non-Butler Snow side of the blog.

When you represent medical device manufacturers in product liability litigation, you will deal with allegations that a device broke or failed because of what it was made from, and you will encounter both experts and “experts” (scare quotes intended) in materials science. 

Materials science…

We have blogged several times about the somewhat esoteric issue of whether intangible items – chiefly computer software, website algorithms, and other electronic information – is treated as a “product” for purposes of imposing strict liability on their creators.  It’s an interesting topic; Eric recently wrote a paper on it, and Bexis is putting together a “white paper” for the Product Liability Advisory Council on the same subject.  From these exercises we concluded that a 50-state survey on intangibles as “products” for product liability purposes would be both doable and useful.Continue Reading How the Fifty States View Electronic Data as a “Product”

Arbitration, if done right, is an effective, speedy, and low-cost alternative to civil litigation of all kinds, which is why the other side (or at least the lawyers representing them) hates it.  Unfortunately, with prescription medical products − and their necessary learned intermediary physicians – arbitration doesn’t come up very often in our line of work, although nothing inherent in personal injury litigation precludes mandatory arbitration.

But it might happen more, in the future.  In a think piece we published a couple of years ago, on software liability, we identified arbitration as one of the consequences in litigation where intermediaries (“learned” or otherwise) were out of the picture.  “In direct-to-consumer contexts, providers routinely seek to use contracts such as click-wrap licenses to allocate software-related liability including limitations on liability, forum selection clauses, compulsory arbitration and similar protective measures.”

But our clients might, at least in certain situations, be able to enjoy both the learned intermediary rule as well as mandatory arbitration.Continue Reading Oye Cómo Va?  To Arbitration.

Personalized medicine is the wave of the future.  Whether treating disease or prescribing medical devices (or both), medical practitioners are taking individualized patient characteristics into account more and more as they treat their patients.  Cancer therapy can now be targeted at the genetic level, and some medical devices can now be created to match patient…

As regular readers know, we bloggers have been following the issue of whether software of various sorts – electronic bytes – is a “product” for product liability purposes.  It’s a longstanding issue, since the current Restatements of Torts specifically defines a “product” as something “tangible,” which arrays of electrons are not.  “A product is tangible…

We’ve blogged several times about the Biomaterials Access Assurance Act of 1998, 21 U.S.C. §§1601-06.  In a nutshell, the BAAA provides suppliers of “raw materials and component parts” used in the manufacture of medical devices with a “Get Out of Litigation Free” card in most situations.  It allows manufacturers of “biomaterials” – defined as “a…

Drug & Device Resources

Bexis’ Book

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.
Learn More About This Book