Updates are not necessarily a good thing, but we
suppose they can be necessary.  So here
are 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 honorable
mention list on our best of the year post.

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is nonprecedential and thus not binding on anyone other than the judge in that particular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.