Sometimes we take routine things for granted. We don’t appreciate the taste of our morning coffee, it’s just always there. We don’t appreciate the softness of our favorite college sweatshirt, it’s just always been that way. We don’t appreciate that while watching an episode of The Walking Dead and seeing a familiar face we can IMDB and find out we recognize the actor from a 3-episode storyline on Law & Order from the late 1990s. That last one hasn’t always been available, but it’s getting harder to recall what it was like to not have that answer until it woke you from a sound sleep at three in the morning.
In the legal world we take things for granted too. We talk about things like breach, duty, causation, and on this blog, preemption, so routinely, we do start to gloss over them a bit. TwIqbal, Daubert, Buckman. Routine, routine, routine. And for sure, learned intermediary fits into this category of things we know about, we like, but maybe take a bit for granted. For many of us, it’s been part of drug and device law our whole careers given that the term was first coined in 1966 by the Eighth Circuit in Sterling Drug Inc. v. Cornish, 370 F.2d 82, 85 (8th Cir. 1966). So sometimes, it’s good to be reminded just how important it is.
That is what today’s case is all about. In Bock v. Novartis Pharmaceuticals Corp., 2016 U.S. App. LEXIS 18042 at *1 (3d Cir. Oct. 5, 2016), decedent’s family alleged that the defendant failed to adequately warn decedent’s doctors that its drugs Aredia and Zometa contribute to the risk of developing osteonecrosis of the jaw (“ONJ”), which decedent developed following multiple tooth extractions and other dental procedures. The court’s decision starts out with a recitation of the warnings that accompanied the drugs as well as additional warnings distributed by the defendant via “Dear Doctor” letters. Those warnings, which pre-dated decedent’s prescription and use of the drugs, included information such as that ONJ had been reported in patients using the drugs, mostly associated with dental procedures like tooth extractions and that invasive dental procedures should be avoided. Id. at *2-3. We know we come at this from the skewed perspective of drug and device defense counsel, but the warning seems fairly clear to us.