Updates are not necessarily a good thing, but we suppose they can be necessary. So here are a couple.
We liked Degelmann for two reasons: (1) it applied express medical device preemption in the context if a Class II device, and (2) it gave preemptive effect to a“device specific” FDA guidance document, which is lower on the regulatory totem pole than a formally adopted regulation appearing in the Code of Federal Regulations. It seemed to us to be a logical application of that court’s pre-Riegel preemption decision, Papike v. Tambrands Inc., 107 F. 3d 737 (9th Cir. 1997), which recognized preemption of failure to warn claims involving a Class II product (tampons) in light of an FDA regulation specifying precisely what warning language this particular device should bear regarding a particular risk.
Degelmann, however, was accepted for en banc review by the Ninth Circuit. Evidently the case settled before briefing was complete, because the other day we saw Degelmann v. Advanced Medical Optics Inc., ___ F.3d ___, 2012 WL 5328277, slip op. (9th Cir. Oct. 30, 2012), dismissing the appeal. Unfortunately, but perhaps inevitably (we haven’t checked the Ninth Circuit’s IOPs), this dismissal order also vacates the earlier panel opinion. So as much as we liked the original Degelmann decision, we won’t be citing it any longer.
Second, we won’t be citing Krumpelbeck v. Breg, Inc., 759 F. Supp.2d 958 (S.D. Ohio 2010) (our post here), any longer either. It’s been reversed by the Sixth Circuit. See Krumpelbeck v. Breg, Inc., ___ Fed. Appx. ___, 2012 WL 3241587 (6th Cir. Aug. 10, 2012). It seems that the Sixth Circuit read the medical literature more leniently than did the district court and found a disputed issue of fact on the state of the art defense. Id. at *4-5.
We’re aware of comments to the blog (we do not take down comments simply because we disagree with them) criticizing us for not mentioning the Krumpelbeck reversal earlier. We have several reactions to that: (1) First and foremost, we’re not neutral. This is a pro-defense blog and we don’t do the other side’s research for them. (2) The reversal was not significant enough to warrant its own post, as (a) it was mostly fact- and state-specific, and (b) the Sixth Circuit’s opinion is nonprecedential and thus not binding on anyone other than the judge in that particular case.
Nevertheless, since Degelmann merits a post, we’ll add Krumpelbeck, since by now everybody involved in the Pain Pump litigation undoubtedly knows about it.