Drug and Device Blog
www.druganddevicelaw.blogspot.com
Dechert LLP
www.dechert.com
We Don't Recall
Thursday, August 11, 2011
We’ve been around the preemption block a few times – we know what happens when the
mainstay claim in prescription medical product liability litigation, that being inadequate
warnings, gets preempted.
We first saw it in DTP vaccine litigation. We made a little headway with preemption and
plaintiffs responded with “design’ claims based on non-FDA-approved formulations. It took the
Vaccine Act to bury those.
We saw it again in Bone Screw litigation, pre-Lohr. Plaintiffs responded with fraud on the FDA
claims. It took Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), to do those
in.
We saw it yet again in prescription drug litigation, pre-Levine. Plaintiffs responded with all
manner of things – design defect claims with no alternative design at all, failure to test, illegal
promotion, you name it. S ome of these we’re still fighting, but with the preemption threat to
warning claims removed, most of these have receded into the background.
We saw – and see – it a fourth time in PMA medical devices, especially after Riegel v.
Medtronic, Inc., 552 U.S. 312 (2008). The plaintiff’s alternative has been disguised private
FDCA enforcement actions presented as “parallel violation” claims.
And we expect to see it again now that PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), has
knocked out warning claims in generic drug cases. So what’s the non-traditional (a/k/a weird)
claim of choice there going to be? The jury’s still out on that, but judging from the Mensing
reargument petition, which we discussed here, one oddball claim under serious consideration
by the other side is the notion that a defendant can have a common-law obligation simply not
to sell its product at all.
In other words, the flavor du jour in generic cases could be failure to recall, resurrected from
what has to date been extensive and well-deserved judicial repudiation.
While we don’t represent generics (there’s a big legal divide between branded and generic
manufacturers, that we need not go into), we don’t really want them to lose this battle either,
