In the index to this blog, we list 39 posts about the
Aredia-Zometa litigation.  After today it will be 40.  And
counting.  That might actually be understating our coverage.  (We’re
not always so punctilious at affixing topical labels to our posts.) 
Sometimes it seems as if one could understand all of recent drug and device
law, from A to Z, just by looking at developments in the Aredia-Zometa litigation.  
Maybe that is so because so many of the Aredia-Zometa cases have gone so far
through the litigation gristmill, including trials, and have thereby produced
so many judicial opinions on so many different areas, such as design defect,
warning causation, learned intermediary, bankruptcy estoppel, abatement,
ghostwriting, loss of consortium, etc..  

In fact, just one of the Aredia-Zometa cases, Dopson-Troutt,
has been like a mini-industry churning out drug and device law rulings. 
We have blogged about that case on topics such as choice of law, punitive
damages, comment k, warranty claims, and Daubert (including Parisian).
  Just a couple of days ago, Dopson-Troutt maintained its status as
the A-Z gift that keeps on giving. In the pretrial order we discussed last
week, the court went the right way in rejecting non-mutual, offensive
collateral estoppel. 

This week’s Dopson-Troutt ruling heaves in some lumps of
coal amidst some shiny baubles.  The defendant filed an omnibus motion
in limine.  The court’s opinion in Dopson-Troutt v. Novartis
Pharmaceuticals Corp.
, 2013 U.S. Dist. LEXIS 135834 (Sept. 23, 2013),
characteristically, covers a lot of ground.  (Maybe the “omnibus” term
should have been a clue.)  Some of the terrain is lovely. Some of it is
rocky.  First, the court correctly holds that Pennsylvania law does not
recognize the heeding presumption in cases involving prescription
products.  The court had little difficulty distinguishing the asbestos and
OTC cases relied upon by the plaintiffs.  Dopson-Troutt, 2013 U.S. Dist.
LEXIS 135834 at *10-11.  We like this ruling, but we are not exactly going
to applaud when a court manages to get something right that should be perfectly
clear and obvious.  And we are definitely not going to applaud when the
court proceeds to mangle the ruling by saying that testimony by nonprescribing
doctors “could be relevant” to a jury’s determination of whether warnings would
affect a “reasonable doctor.”  Id. at *12-13.   The court did
not want to rule in a vacuum.  It wanted to see what testimony would be
excluded.  Maybe the court will ultimately get this issue right and
exclude a lot of speculative drivel.  But now we’re the ones who are
speculating, aren’t we?  

  

We love preemption.  We wish we could sprinkle a little
preemption in our coffee in the morning and on our ice cream at night.  We
try to sprinkle preemption in just about every case we have.  Sadly, not
all courts share our taste for preemption.  In fact, we are starting to
get the idea that some courts don’t like it at all. They make a face and spit
it out whenever possible.  For some judges, preemption is ipecac. 
(And we are emetophobes.)  In Dopson-Troutt, the defendant mounted a
fairly aggressive preemption defense against the failure to warn claim. 
The defendant argued that “a label change requiring prior FDA approval is
preempted.”  Id. at *19.  Not surprisingly, the plaintiffs relied
upon Levine.  The defendant tried to read Bartlett and Mensing as opening
up new preemption ground, even for brand manufacturers.  We agree that
Bartlett and Mensing have implications for brand preemption, and we have said
as much before.  But it will take some guts for a court to reread Levine
in light of Mensing/Bartlett.  Frankly, it would amount to a pleasant
surprise.  A court that treats preemption as a red-headed stepchild simply
isn’t going to go our way.  Let’s just say that the Dopson-Troutt court
did not surprise us.  It discounted Bartlett and Mensing, saw the Levine
decision as the colossus still bestriding brand manufacturer preemption law,
and denied the defendant’s effort to cabin Levine.

   

The defendant sought to prevent the plaintiffs from arguing
that the Zometa label should have disclosed that Aredia was safer.  The
FDA requires certain types of evidence to justify comparative claims. The
Dopson-Troutt court denied the defense motion but it seemed to be animated more
by caution than logic.  The denial of the defense motion was without
prejudice:  “Without knowing what comparisons and supporting studies are
at issue, the Court lacks sufficient information to make a
determination.”  Id. at **23-24. Maybe we are cockeyed optimists, but we
bet that when the plaintiffs are forced to put up or shut up as to whether
studies would have proved the claimed comparison, they will be forced to shut
up. 

  

The defendant fared much better on the plaintiffs’ claim
that there should have been a black box warning.  FDA regulations clearly
prohibit manufacturers from unilaterally adding a black box warning.  See,
e.g., 21 CFR section 201.57(3); 44 Fed. Reg. 37434, 37448 (June 26,
1979).  The plaintiffs had no response save a rather silly one – that
there is no instance of the FDA striking a black box warning used by a
pharmaceutical company.  Id. at *25.  Yeah, but still.  And by “still,”
we mean that the regulations still say what they say.  That, at least, is
how the Dopson-Troutt court saw the issue, and it granted the defense motion to
exclude the black box argument. 

  

The plaintiffs challenged the form, as well as the
content, of the Zometa label.  The quarrels over form included placement,
bolding, and font size.  It is hard to believe that this sort of thing is
not wholly entrusted to the judgment of the regulatory body.  The
defendant cited the Pom Wonderful case in arguing that the plaintiffs’ desire
to fly-speck the format of the label threatened the FDA’s primary
jurisdiction.   Wonderful or not, the Dopson-Troutt court concluded
that Pom Wonderful was inapplicable because it was a food, not drug, label case.
 The court denied most of the defendant’s motion, which strikes us as an
invitation to plaintiffs to come forward and propose all sorts of dopey format
changes.   Nevertheless, to the extent the plaintiffs insisted that
the label use an FDA disapproved font, that claim was deleted.  Id. at
**27-28.  Perhaps one should be grateful for small favors. 

Finally, the defendant sought to exclude evidence of any
corporate conduct post-dating the plaintiff’s tooth extraction (which plays a
major role in determining onset of an A-Z plaintiff’s injury).  The court
would not at this point agree to that exclusion ex ante, because there was the
possibility that after-the-fact documents or actions might be somehow relevant,
such as for showing prior knowledge.  Id. at *28.  This is a court
that views in limine motions with almost as much trepidation and suspicion as
preemption.  Even so, reserving judgment is better than indulging in bad
judgment.  If the court wants to hold off on categorical rulings, so be
it.  It’s all good so long as the court ends up making the right ruling,
and does so before the plaintiffs manage to poison the jury well. 

  

In other words, there is every reason to believe there will
more rulings in the future.  We will hear from Dopson-Troutt again.