Updates are not necessarily a good thing, but wesuppose they can be necessary. So hereare a couple.
First, some time ago we blogged about Degelmann v. Advanced Medical Optics, 659 F.3d 835 (9th Cir. 2011). The case even made last year’s honorablemention list on our best of the year post.
We liked Degelmann for two reasons: (1) it applied express medical device preemptionin 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 totempole than a formally adopted regulation appearing in the Code of FederalRegulations. It seemed to us to be alogical application of that court’s pre-Riegel preemption decision, Papikev. Tambrands Inc., 107 F. 3d 737 (9th Cir. 1997), which recognizedpreemption of failure to warn claims involving a Class II product (tampons)in light of an FDA regulation specifying precisely what warning language thisparticular device should bear regarding a particular risk.
Degelmann, however, was accepted for en banc review by the NinthCircuit. Evidently the case settledbefore 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 (wehaven’t checked the Ninth Circuit’s IOPs), this dismissal order also vacatesthe earlier panel opinion. So as much aswe liked the original Degelmann decision, we won’t be citing it anylonger.
Second, we won’t be citing Krumpelbeckv. Breg, Inc., 759 F. Supp.2d 958 (S.D. Ohio 2010) (our post here), any longer either. It’s been reversedby the Sixth Circuit. See Krumpelbeckv. Breg, Inc., ___ Fed. Appx. ___, 2012 WL 3241587 (6th Cir. Aug. 10, 2012). It seems that the Sixth Circuit read themedical literature more leniently than did the district court and found adisputed issue of fact on the state of the art defense. Id. at *4-5.
We’re aware of comments to the blog (we do nottake down comments simply because we disagree with them) criticizing us for notmentioning the Krumpelbeck reversal earlier. We have several reactions to that: (1) First and foremost, we’re notneutral. This is a pro-defense blog andwe 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enough to warrant its own post, as(a) it was mostly fact- and state-specific, and (b) the Sixth Circuit’s opinionis nonprecedential and thus not binding on anyone other than the judge in that particularcase.
Nevertheless, since Degelmann merits apost, we’ll add Krumpelbeck, since by now everybody involved in the PainPump litigation undoubtedly knows about it.
Hiç yorum yok:
Yorum Gönder