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We’ve written a number of posts on whether, in various jurisdictions across the United States, software and other forms of electronic/magnetic code can be considered to be “products” for purposes of product liability – usually strict liability.  As befits the decentralized product liability litigation landscape in the United States, there is considerable uncertainty, but most decisions, as well as both the Second and Third Restatements of Torts, have determined that incorporeal items composed of electronic bytes are not “products.”…

Continue Reading Software as a Product – The European Union Goes There

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Today we’re updating our readers on new developments this month relating to three of our prior posts.

First, back in March we reported on an “Advocate’s General’s opinion” in a case before the European Court of Justice (“ECJ”).  See the original post for details, but the plaintiff was asserting the radical claim that EU…

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The DDL Blog has paid only sporadic attention to prescription medical product liability in the European Union, with a couple of posts, here and here.  Today, however, we discuss an EU Court of Justice (“E.C.J.”) Advocate General’s opinion concerning medical device product liability, and specifically the extent to which a plaintiff from one of…

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In over eight years, we’ve never before blogged about a European development in prescription medical product liability.  The (relatively) recent decision by the Court of Justice of the European Union (“CJEU”) in Boston Scientific Medizintechnik GmbH v. AOK Sachsen-Anhalt – Die Gesundheitskasse, Nos. C‑503/13, -504/13, slip op. (4th Chamber March 5, 2015) (that’s a mouthful, so we’ll call it “BSMG” for short), causes us to make an exception.

First, a bit about the court.  According to the EU’s website, one of the functions of the CJEU is to “interpret[] EU law to make sure it is applied in the same way in all EU countries.”  So this is essentially the highest EU court for all matters governed by EU legal directives.  Wikipedia adds that the CJEU almost always sits in “chambers” – units of less than the whole – so the “Fourth Chamber” designation is as far as this case is going to go, since it was not assigned to the en banc “Grand Chamber” at the outset.  Thus the BSMG decision is a final, high-court legal interpretation that will apply throughout Europe.

BSMG interpreted “Directive 85/374/EEC,” id. at ¶1, which is the general EU product liability directive enacted back in 1985.  While BSMG involved medical devices, the decision rests entirely on the general product liability directive, and does not even reference the later EU directive for medical devices, Directive 93/42/EEC.  To us, that’s the first takeaway from BSMG – since it is based entirely on the general product liability directive, it could potentially apply to any product:  prescription drugs, or even automobiles, presenting the same sort of acute risks at issue in the decision.

The important facts are these.  BSMG is actually two cases, both brought by European third party payors (“TPPs”) seeking reimbursement of medical costs that they incurred as a result of “defective” medical devices – and not just any medical devices, electronically operated implants, specifically pacemakers and implantable cardioverter defibrillators.  Thus, these devices were both:  (1) life sustaining, and (2) presented life threatening risks should they fail to function properly.  The risk of potential fatal consequences was extremely important to the opinion.…

Continue Reading Bad News from Europe for Makers of Life-Saving Medical Devices

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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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