Today, Reed Smith is hosting a client roundtable in London, “Identifying and Mitigating Risk in a Changing Global Economy,” for life sciences clients. In light of that, we thought it would be a good idea to have a blogpost that’s relevant to what’s hot in the UK. Well, there’s nothing hotter on that side of
Today we feature another guest post from our European correspondents, Reed Smith partner Marilyn Moberg and associate Kathryn Bond. There has been another significant decision from the Court of Justice (its description, not ours) of the European Union, and once again it is bad news for manufacturers of life-saving prescription products – this time vaccines.
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.