Here’s another guest post from Reed Smith’s Eric Alexander, who is inching (being hauled) towards full blogger status, but who isn’t there yet – so we’re posting this for him.

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We warn our readers that there will be a neck-snapping
segue later in this post.  You might want
to stretch before reading.  The segue was
in no way necessitated by our sloth in posting on the second case discussed
here, which had already received enough press (sometimes not too accurate press)
before we might have posted on it solo.  Instead,
we are presenting a two-fer because cases that mostly deny summary judgment do
not usually merit individualized attention here.  So, with more advance disclaimers than you
get with winning “free” stuff on the internet, here goes.

            The case
leading to the opinion in Cross v. Amtec
Med., Inc.
, No. 3:09-CV-00168-HTW-LRA, 2012 U.S. Dist. LEXIS 141508 (S.D.
Miss. Sept. 30, 2012), seems like what we imagine is a typical pain pump
product liability case.  The plaintiff
has a complicated medical history, decides to sue fairly late in the game after
trolling the internet—gee, maybe some lawyer websites popped up—sues a mix of
pump distributors and manufacturers (but not drug manufacturers), and asserts a
range of theories, including that the pump allegedly at issue was marketed
off-label in violation of the FDCA. 
After some discovery, the defendants moved for summary judgment and
partial summary judgment.  They contended
that Mississippi’s three year statute of limitations with statutory discovery
rule was not met when plaintiff waited almost nine years after the post-surgery
use of the product allegedly at issue to sue, with complaints of shoulder
pain—roughly the injury in the suit—and medical care for it throughout much of
the pre-suit period.  Well, some of her
providers said her shoulder was normal and some said she had regular tendinitis
or arthritis (a four-syllable word in parts of the country) so there were
genuine issues of material fact as to whether she should have known the cause
of her injury within three years of when she sued.  Not too remarkable, but she also had something
lacking for many plaintiffs who sue over an injury they say they have had for a
while before they sued:  an actual
pre-lawyer, new medical diagnosis.  So, summary
judgment  on the statute of limitations denied.

            Next up
was product ID.  Plaintiff’s evidence on
which pain pump she used nine years before she sued was pretty sparse—”[n]one
of [the] evidence presented by the parties provides a contemporaneous
identification of the pain pump brand.” 
(Hey, sparse evidence on stale cases is one of the justifications for
having statutes of limitations and repose, in the first place.)  But the plaintiff had two documents relating
to billing—one over a year after the alleged use—that the court said created a
genuine issue.  So, no summary judgment
on product identification.

            On to
partial summary judgment.  The defendants
tried to knock out the warnings claims by arguing there was no proof of
inadequate warnings back when the product was allegedly used in 2000 and there
is no post-sale duty to warn under Mississippi law.  This one ended like the first two, with the
court finding genuine issues of material fact precluding summary judgment, but
we are confused by the result.  While the
court said plaintiff came up with “numerous studies in existence prior to 2000
that linked joint cartilage toxicity with exposure to foreign substance,” none
of them involved the pump or medication at issue here.  (The opinion does not say they involved medications
at all, let alone pain medications delivered into the intra-articular space of
the shoulder.)  There was also no
indication that the plaintiff had an expert offering an opinion that these
pre-sale studies required a warning not given with the product.  And there was no discussion at all of whether
there was any evidence that any such hypothetical warning would have mattered
at all to the surgeon who prescribed/placed the plain pump.  This is not just our usual call for attention
to proximate cause.  In this case, the surgeon
in this case was the lead author
of a study published in 2000 that noted no complications with pain pumps
delivering pain medication into shoulders after shoulder surgery.  If the surgeon knew about these “foreign
substance” studies or likely would have said “so what” if warned about
them—either of which seems plausible here—then the plaintiff cannot make out a
prima facie for failure to warn.  But the
opinion did not go into this issue and just denied partial summary judgment on
warnings.

            After these
three denials, the defendants’ win—wait for it—may seem a little like the BlackKnight getting his blood on King Arthur after sustaining a few flesh wounds,
but partial summary judgment was granted. 
The plaintiff apparently based part of her failure to warn claims on the
argument that her use of the pain pump was beyond the indication for the
product as cleared by FDA and that the defendants had promoted such off-label
use in violation of 21 C.F.R. §  801.  She apparently, however, did not assert a
freestanding claim for violating regulations or otherwise defrauding FDA.  That may be why the court granted partial
summary judgment “on the plaintiff’s off-label use claim” without mentioning
preemption or Buckman.  It is nice to get the straightforward
analysis, like we used to urge when moving on per se negligence claims based on alleged regulatory violations,
that “plaintiff is barred from seeking redress for violations of the FDCA
because that Act has not provided for a private right of action,” leaving
enforcement up to the government.  Given
its analysis, the court was able to duck the harder question of whether there
was any off-label promotion given the regulatory history and absence of
evidence on promotion to the surgeon in the case.  (The latter point being that proximate cause
issue completely ignored in denying summary judgment on the broader warnings
claims.)  Without belaboring the
regulatory history on the scope of the approved indication for the pain pump
here, suffice it to say that how the court viewed FDA’s authority and
competence and the deference shown different FDA decisions would likely have
played a role if the court had to decide whether there was off-label
promotion.  More generally, the idea that
courts (or their civil juries) should stay out of certain issues in drug and
device products cases involves at least a legislative deference to FDA’s
competence and authority.

            Which
brings us to PREVOR v. FDA, No.
11-1187 (RMC), 2012 U.S. Dist. LEXIS 136569 (D.D.C. Sept. 25, 2012).  (We urged stretching of necks in the first
paragraph.  Do not make some sort of inadequate
typeface argument; that would be preempted.) 
That is the recent case where a federal court concluded on summary
judgment that “FDA acted arbitrarily and capriciously” (even accepting FDA’s
evidence as true and giving FDA the benefit of all justifiable inferences) and
directed FDA to reverse its prior decisions. 
In part because of the amici, Washington
Legal Foundation and big manufacturers who can’t wait and are resourceful by
nature, this was a heavyweight battle over what may seem at first blush like a
fairly narrow issue:  the regulatory
pathway FDA selected for something called Diphoterine Skin Wash (DSW—not the
place for cheap shoes) used to prevent/minimize chemical burns when there is no
running water handy.  You would expect
more litigation over the effects of industrial chemicals getting on eyes or skin
than on whether a canistered liquid propelled by pressured gas—like a fire
extinguisher, we suppose—is a drug, device, a combo product that is mostly a
drug, or a combo product that is mostly a device.  That is what FDA’s Office of Combination
Products (OCP) and then Office of Special Medial Programs (OSMP) decided,
leading to a challenge under the Administrative Procedures Act (APA) by DSW’s
manufacturer.  (To add to the alphabet
soup frenzy, PREVOR seems to like its nom
in all caps.)  PREVOR wanted DSW to be
regulated as a device, as it apparently is in other countries, and FDA said
would be regulated as drug-device combo assigned to CDER—the drug Center, as
opposed to CDRH, the device Center—because the product works “primarily” as a
drug.

            While the
fight centered on how FDA interpreted the word “primary” and got into its Latin
derivations, it is the dynamic of how FDA decisions play out in litigation that
really interested us.  (Okay, we really
did wonder why the court did not realize that “primary” is like the feminine
genitive plural form for “first” in Latin, which would have gone a long way in
the case and why courts get “de minimis” wrong.)  As an initial matter, the ability for
regulated entities to challenge the regulating body’s rules or (draft) guidelines
issued to interpret its regulations promulgated pursuant to statutes enacted by
Congress touches on all sorts of funky issues we do not normally see directly
in litigating drug and device products cases. 
We do see, on the back end, how early decisions from FDA on whether
medical products have to be approved as drugs, approved as PMA devices, cleared
as 510(k) devices, or something else can affect, well, just about
everything.  We will resist the Bexian
urge to elaborate on the divergent treatment of federal preemption based on a medical
product’s regulatory pathway and history.

            Now, we do
not see how the PREVOR decision
itself comes into evidence or would filter into the jury’s thinking about FDA,
which is more likely to be influenced by news about E. coli in spinach.  But
judges are also sensitive to perceptions about FDA and not just from the usual
plaintiff repetitions of criticisms from IOM, GAO, and Sid Wolfe.  In PREVOR,
it was a manufacturer (with its amici)
pushing to have FDA’s decisions labeled as “arbitrary, capricious, and
unsupported by law,” which sounds worse than “the product of understaffing and
tight deadlines” we sometimes hear from the products plaintiffs.  Other than just urging your judge that the
regulatory process worked like it was supposed to work for the drug or device
whose manufacturer you are defending a product case, we think that a little
deeper dive into the impact of FDA’s goal of promoting public health may help.

            In PREVOR, FDA never explained why it took
a position on interpreting the word “primary” that would increase the chances
that a medical product would be treated as a “drug” or a combination product
over which the drug Center (CDER) would have principal purview.  It seems obvious that the interpretation
policy was in fact driven by the result rather than simply making it easier for
OCP to handle Requests for Determination of how a medical product would be
classified.   In general, drugs are
harder to get approved than devices, certainly new drugs are harder to get
approved than non-PMA devices. 
Drug-device combo products assigned to CDER have a harder path than
drug-device combo products assigned to CDRH. 
It so happens that CDER has more medical professionals on staff than
CDRH and probably more review staff overall. 
In terms of public criticisms of approval/clearance staffing and
performance, CDRH has gotten hammered even more than CDER.  (On complaints about post-marketing
surveillance, CDER is clearly the favorite target.)  So, from a resources and public relations
perspective, FDA management may want to make as many products—particularly the
burgeoning number of combo products—go through CDER to get to market as
possible.  It probably increases total
user fees to pay for more reviewers. 
Maybe that even furthers public health. 
Maybe the FDA erring on the side of promoting public health is
consistent with why pain pump plaintiffs should be “barred from seeking redress
for violations of the FDCA” or why FDA decisions on approvals and labeling
should lead to federal preemption or at least useful presumptions under some
state product liability acts.  Maybe.  It is certainly more palatable than trying to
argue to a judge that the products plaintiff should not be able to pursue some
of all of her claims because of FDA actions that could very well have been
arbitrary and capricious.