Photo of Bexis

We saw the 360 blurb this morning on In re
Darvocet, Darvon & Propoxyphene Products Liability Litigation
Docket No. 2226, slip op.
(E.D. Ky. Oct. 10, 2012), and we thought we’d be content just adding it to our
branded-in-generic (that is to say Conte) scorecard.  After all – we’re pleased to say – there have
been a lot of similar decisions lately.

But there’s more to this Darvocet opinion –
which we’ll henceforth call “AAIPharma” because there are now so many Darvocets
− than meets 360’s eye (at least until you get to the 12th paragraph).  Specifically, we found an application of the
implied preemption rationale in PLIVA v. Mensing, 131 S. Ct. 2567
(2011), to a branded manufacturer.  That’s worthy of a post.

Here’s what happened.  Only one of 50 cases in AAIPharma survived
the product identification requirements of state law, involving a plaintiff Lopez.  As to that case, the court found a sufficient
TwIqbal allegation of product identification, specifically:

The plaintiffs in Lopez, however, do specifically
allege the ingestion of a . . . product manufactured by the AAI
Defendants.  [They] assert[] that Plaintiff
Mark Lopez ingested “[t]hree prescriptions for Darvocet N-100 from Olden
Pharmacy, which lists the manufacturers as AAI Pharma, LLC . . . from
August 2005 to October 2006.”  These
alleged ingestion dates occurred after the AAI Defendants transferred the New
Drug Application (“NDA”) for Darvocet to Xanodyne Pharmaceuticals.

Slip op. at 5 (record citations omitted).  The court held that this was enough, at the
judgment on the pleadings stage, to avoid dismissal.

However, the court did not stop there.  It went on to consider preemption under MensingSlip op. at 5.  That’s notable because the opinion specifies that the defendants in
question are branded manufacturers.  See
Id. at 3 n.2 (identifying moving defendants as “Brand defendants”).  We consider the application of Mensing
implied preemption to branded manufacturers as one of the frontiers of
preemption at the moment.
So where does Mensing
leave off and the benighted domain of Wyeth v. Levine, 555 U.S. 555
(2009), begin?  The court in AAIPharma
fixed the boundary at the point where the branded manufacturer lost the ability
to do what the Levine decision turned upon – unilaterally change its
warnings.  As mentioned in the block
quote above, the plaintiff in Lopez only ingested that particular
branded product after the
defendant had sold its NDA to somebody else. 
At that point, because it was no longer the NDA holder, the defendant
could no longer file a unilateral CBE label change to its warnings:

Because the AAI Defendants did not have the power to
change the label after May 2005, Lopez’s failure-to-warn claims against the AAI
Defendants are preempted under [Mensing].

Slip op. at 5. 
Thus, the Lopez plaintiffs’ warning claims were preempted.  The court did not preempt design-related
claims because at the time of manufacture the defendant was still the NDA
holder, and thus not subject to any such limitations.  Id. at 5-6.
So it’s a warning-only decision, but then in most prescription drug
cases warnings are the major battleground.

Thus, the important point in AAIPharma remains:  Mensing’s impossibility preemption
applies, and bars warning-related claims, whenever the facts support it.  Those facts are the distinction that the Mensing
court drew against Levine – the ability of the defendant to
change/strengthen its warnings unilaterally, without needing the prior
involvement of the FDA.  Thus, while Levine
and its “clear evidence” of likely FDA rejection standard eliminated a lot of
preemption in litigation involving branded drugs (clear evidence being found
only in a handful of cases), it did not eliminate all of it.  As AAIPharma demonstrates, there are
certain situations (transfer of the NDA) as well as certain types of defendants
(non-NDA holders that can’t use the CBE process at all) where the implied
preemption defense can succeed even where the product in question is a branded

While Mensing is by no means an antidote to the
execrable Levine decision, it’s something to remember if you happen to
be representing a branded defendant in one of these peculiar situations.