One of the (many) things that made last year’s decision in Barron v. Abbott Laboratories, Inc., ___ S.W.3d ___, 2016 WL 6596091 (Mo. App. Nov. 8, 2016), so hideous that it weighed in at #3 of our worst decisions of the year was that, virtually without discussion, it held that an FDA-approved black box warning was not only inadequate but so poor as to be worthy of punitive damages.  Id. at *7.  Fortunately the Missouri Supreme Court granted a transfer (on January 5, 2017, according to Westlaw) and (we hope) will restore sanity on at least some of the issues in Barron.  However, the mere fact that a boxed warning – the strongest FDCA warning there is – could be utterly disregarded as in Barron got us thinking.

How have courts treated boxed warnings in other inadequate warning cases?

Initially, we’re not dealing in this post with claims that, in order to be adequate, a defendant’s labeling should have included a boxed warning. We’ve dealt with that kind of claim elsewhere, and our position is that, since the FDA must pre-approve all boxed warnings, all “should have added” claims are preempted.  This post deals with prescription medical products that already have boxed warnings.  Preemption becomes an issue in existing black box cases only if the plaintiff claims that the black box should have been changed – since (as discussed in the posts linked to previously) changes to black box warnings require prior FDA approval.

Looking back through our posts, we see we’ve described one decision, Hain v. Johnson & Johnson, No. ATL-L-8568-11 MT, slip op. (N.J. Super. L.D. June 20, 2013), reaching such a result. Hain recognized that “[a] ‘black box’ warning is the strongest warning required by the FDA.”  Id. at 6 (citing 21 C.F.R. §201.57(c)(1).  Regardless of what might be the case with other, similar products:

[B]y mandating each manufacturer include the strongest type of warning possible to warn of [the risk at issue], the FDA ensured each prescriber’s attention would be focused on the risk. . . .  [A] boxed warning required by the FDA existed in the package insert at the time [plaintiff] ingested [the drug].  Courts have previously held prescription warning labels containing a boxed warning, mandated by the FDA, are adequate as a matter of law.

Id. at 7.

In In re Chantix (Varenicline) Products Liability Litigation, 881 F. Supp.2d 1333 (N.D. Ala. 2012), the primary authority cited in Hain, the court determined that under the law of any state in the country, an on-point black box warning was adequate as a matter of law.  Such a warning was “the highest level warning possible, prominently displayed at the beginning of a drug’s official prescribing information.”  881 F. Supp.2d at 1339.  There could be no doubt that such a warning “was sufficient to alert to the possibility of the harm actually suffered.” Id. at 1340.  Plaintiff’s quibbles about when the drug should be used failed because they sought to tell physicians how to practice medicine.  “[T]he decision as to use [of] a medication as a first-line treatment is uniquely up to the prescribing medical professional and based on a decision concerning his or her individual patient.  Id.

Unlike the majority of cases reviewed by this court, the plaintiffs seek to pursue their failure to warn claims post the 2009 black box warning, not for failing to warn of possible complications from [the drug], but for failing to tell physicians when to prescribe it. . . .  [Even] the plaintiffs recognize that a black box warning is “the most serious warning in the FDA’s arsenal”. . . .  For the foregoing reasons, the court finds the 2009 black box warning adequate as a matter of law.

Id. at 1342-43 (citation omitted).  Accord In re Chantix (Varenicline) Products Liability Litigation, 889 F. Supp.2d 1272, 1304 (N.D. Ala. 2012) (“the court finds that [the] black box warning is adequate as a matter of law”).

Similarly, in Christison v. Biogen Idec, Inc., 199 F. Supp.3d 1315 (D. Utah 2016), the court held that a boxed warning of a usually fatal condition was adequate to warn physicians of that risk as a matter of law:

[I]t is undisputed that as a condition of [the drug’s] re-approval . . . the FDA required that the prescribing information contain a “black box” warning about [the risk] which is the strongest warning  required or permitted by FDA.  The black box warning, as the most serious warning available, can be reasonably expected to catch the attention of the consumer. . . .  [T]he intensity of the warning matched the magnitude of the risk.  The black box warning . . . was not qualified or minimized in any way because the magnitude of the risk − death or severe disability − was of the highest possible degree.

Id. at 1343-44 (footnotes omitted).  Accord Amos v. Biogen Idec, Inc., ___ F. Supp.3d ___, 2017 WL 1316968, at *5 (W.D.N.Y. April 10, 2017) (adequacy as a matter of law; the drug’s “label contained this information in a black box warning, the strongest warning available”); Gentile v. Biogen Idec, Inc., 33 Mass. L. Rptr. 607, 2016 WL 4168942, at *6 (Mass. Super. July 28, 2016) (“[t]he black box warning in effect when [the prescriber] first prescribed [the drug] to [plaintiff’s decedent] explicitly warned against the precise risk . . . that [she] ultimately suffered, and fully disclosed the serious consequences of that disease”).

In Aaron v. Wyeth, 2010 WL 653984 (W.D. Pa. Feb. 19, 2010), the product’s black box warning “advised physicians of the specific risks at issue in the instant case,” thus the court found “no evidence that [defendant] breached its duty to exercise reasonable care to inform [the prescriber] and others similarly situated of the risks associated with” taking the drug in question, even though the prescriber testified that he did not remember the warning correctly.  Id. at *10.  In Whiteside v. Johnson & Johnson, 2015 WL 11120989 (Mag. N.D. Tex. Mar. 13, 2015), adopted, 2015 WL 11120990 (N.D. Tex. July 8, 2015), the court dismissed the action with prejudice when the plaintiff abandoned ship in the face of the defendant’s summary judgment motion.  The court noted that the “Plaintiff’s prescription postdat[ing] . . . Defendants’ addition of an adequate ‘black box’ warning about the risks associated with the drug in question . . . would be fatal to Plaintiff’s claims.”  Id. at *1 n.1. See also Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *2-3 (N.D. Tex. Nov. 15, 2007) (black box warning held adequate as a matter of law; Texas presumption unrebutted); Clark v. Hoffman-La Roche, Inc., 2006 WL 1374516, at *7 (N.J. Super. May 2, 2006) (boxed warning “satisfied [defendant’s] burden under either New Jersey or Utah law to provide an adequate warning with respect to the risks” at issue); cf. In re Actos (Pioglitazone) Products Liability Litigation, 2014 WL 4364832, at *34 (W.D. La. Sept. 2, 2014) (characterizing post-prescription boxed warning as “hav[ing] full and adequate warnings”).

In a couple hours of looking we found more than a half-dozen cases where boxed warnings were held adequate as a matter of law.  Thus any court “unaware of any court holding that such a [boxed] warning is per se adequate as a matter of law,” Hutchens v. Abbott Laboratories, Inc., 2016 WL 5661582, at *6 (N.D. Ohio Sept. 30, 2016), either didn’t look very hard, or wasn’t willing to accept what it found.

In our view, the bottom line with boxed warnings is: one, the presence of a boxed warning concerning the relevant risk of a prescription medical product demonstrates that the risk is adequately warned about and sufficiently emphasized, making the warning adequate as a matter of law; and in any event two, since the FDA controls the content of black box warnings, any allegations that existing boxed warnings are inadequate are necessarily preempted.

In the aftermath of Levine, with its generous interpretation of the CBE regulation and its novel “clear evidence” standard, we wondered how long it would be until we saw a court holding that a failure to warn claim with a branded prescription drug was preempted.  Courts were chilled for a while, but eventually the right sort of cases found their way to judges who understood preemption.  Now, we have a pretty big list of decisions finding preemption of such claims, along with decisions exhibiting supportive reasoning.  We are not yet at the point where preemption of failure to warn claims with branded prescription drugs—for a long time, the core claim in the biggest litigations in our bailiwick—is no longer news.  Preemption is still the exception—limited to cases with a strong regulatory history of FDA rejecting the warning plaintiff wanted—rather than the rule, particularly when it comes to favorable appellate decisions.

Rheinfrank v. Abbott Labs., Inc., __ Fed. Appx. __, 2017 WL 680349 (6th Cir. Feb. 21, 2017), is another favorable appellate decision on preemption.  You may recognize the name—especially if you are a blog aficionado—from our prior posts on the case.  We posted on partial summary judgment being granted as to part of the failure to warn claims being offered—on preemption—and the punitive damages claim—on lack of proof of relevant FDA fraud to meet the exception under the Ohio Product Liability Act provision generally precluding punitives for FDA-approved drugs.  We posted on the expansion of the preemption ruling on motion to reconsider to include design defect.  (These garnered an honorable mention in our list of the best decisions of 2015.)  We even posted on motions in limine rulings.  Even with all of those posts, a brief recap of the facts might help.  The minor plaintiff’s mother took the prescription anti-seizure medication at issue for fifteen years, including through four pregnancies, before she became pregnant with plaintiff.  She kept taking the medication at issue, along with another anti-seizure medication she had been taking, through the birth of plaintiff, who was diagnosed with “physical deformities and cognitive disabilities, including Fetal Valproate Syndrome.”  2017 WL 680349, *1.  The label for the medication at issue had long featured a black box warning and other warnings about birth defects, focusing on neural tube defects like spina bifida and discouraging use during pregnancy unless use of the medications “are clearly shown to be essential in the management of their seizures.” Id. at *2.  Over the course of seven years after plaintiff’s birth, FDA refused the manufacturer’s repeated efforts to revise the label to address developmental delays in offspring based on data from a study that was ultimately published in the New England Journal of Medicine. Id. at **2-4.  A revision of the labeling was ultimately submitted by CBE and accepted by FDA in 2011. Id. at *4.  The prescriber back in 2003 and 2004 testified that she was aware of the black box warning on birth defects, would have relayed it to plaintiff, and would not have relied on other materials outside the label. Id. at *2.

Somehow, on this record, the plaintiff got to trial.  Under the logic of “all’s well that ends well,” we will limit our rant on this point.  After all, we have discussed other birth defect cases that got to trial despite obvious issues, resulted in big verdicts, and got affirmed on appeal. Rheinfrank proceeded to trial under the portion of the strict liability failure to warn claim that was not preempted, a strict liability claim for failure to confirm to representations, the portion of a common law negligent failure to warn claim that was not preempted, and a common law negligent design claim.  Among the reasons why the two failure to warn claims should not have seen a court are that 1) Ohio law requires the allegedly inadequate warning to relate to the injury plaintiff claims, 2) claims relating to developmental delays (including as part of Fetal Valproate Syndrome) were preempted, and 3) the prescriber was aware of black box warnings about really serious birth defects and the recommendation against prescription during pregnancy in most situations.  It is hard to see how plaintiff mustered evidence of proximate cause—that is, that a proposed (non-preempted) alternative warning as to a risk of an injury the plaintiff had (based on evidence that existed when the prescription was written) would have changed the prescriber’s decision to prescribe—to survive summary judgment.  Based on the jury instructions that plaintiff proposed at trial, it seems like a broader discussion of risks and the impact of different warnings about risks was permitted than maybe should have been, which is often a reason why failure to warn claims get past summary judgment.  Given that the prescriber denied reliance on any representations outside the label, it is hard to see how that claim got to the jury.  As for the negligent design claim, it is hard to see how the same reasoning for preempting the strict liability design claim would not have applied or how a design of the drug—without being a different drug—that lacked the same birth defect risk could have been offered.  Anyway, the trial judge may have known what was coming, because the jury listened to the just about the best plaintiff could offer and returned a defense verdict on all counts after two weeks.

Continue Reading Sixth Circuit Affirms Branded Drug Preemption and Trial Win

It wasn’t a complete win, but the summary judgment outcome in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), has to put a spring in the step of the defendants as they approach trial.  What’s left doesn’t strike us as a very good warnings case.  Rheinfrank involved claims that the antiepileptic drug Depakote caused the minor plaintiff’s birth defects.  Make no mistake about it, Depakote has a known association with such injuries.  First approved in 1983, it’s been a Pregnancy Category D drug since 1988, meaning, according to FDA regulations, that:

there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.

21 C.F.R. §201.57(c)(9)(i)(A)(4).  Not only that, since 2003, this drug has carried a black box “teratogenicity” warning, as well as other quite explicit, and all-caps, language to the same effect.  For details, see 2015 WL 4743056, at *2-3.

Plaintiff-mother had used Depakote for years, through four previous uneventful pregnancies.  Id. at *1.  On her fifth pregnancy, even though Depakote came with all these warnings, she continued to take it.  Id.  Her allegations did try to change the subject, however.  In addition to claiming that the black box warning (more about that later) and all the other teratogenicity language were inadequate, she asserted that the defendants failed to warn altogether about “developmental delay.”  Id. at *5.

Continue Reading Preemption (and Other Things) Defanging Depakote Claims

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.

Our recent post on the outcome of the plaintiffs’ in limine motions in the Guenther Aredia/Zometa case prompted a volcanic retort from one of the plaintiffs’ counsel (who will remain anonymous) that “all was not beer and skittles” (yech – not an appetizing combination) for the defense, specifically listing the court’s rejection of a defense “paper storm” and “preemption based in limines.” Attached to counsel’s emails were an order striking an original set of defense in limines as too darn long and a second order resolving a choice of law dispute in favor of Florida, rather than Georgia, law.  Why a plaintiff would prefer
Florida law in prescription drug product liability litigation case escapes us; some of us remember the excellent Florida law on causation and the learned intermediary rule that led to huge defense wins in the Seroquel litigation.

At about the same time as that email, one of our automatic searches pulled up the opinion on the Guenther defense in limines, which counsel had referenced but did not attach.  See Guenther v. Novartis Pharmaceutical Corp., 2013 WL 4648449 (M.D. Fla. Aug. 29, 2013).  Because (as counsel noted) we are interested in preemption issues – even hard ones for our side, which certainly includes preemption in innovator drug cases post-Wyeth v. Levine, 555 U.S. 555 (2009) –
we took a look.
Hmmmm.
For a post-Levine decision, we actually don’t think the rulings are all that bad.  In fact, since the opinion provides a road map for possible future preemption inroads, we think this Guenther decision is worthy of comment.

Continue Reading More On Aredia/Zometa – Innovator Drug Preemption

We’ve just been informed by a source at Drinker Biddle (Dan Carroll of that firm that won the case) of a brand new decision in the New Jersey Levaquin litigation granting summary judgment and finding that an FDA-mandated black box warning was adequate as a matter of law.  Hain v. Johnson & Johnson, No. ATL-L-8568-11 MT, slip op. (N.J. Super. L.D. June 20, 2013).  The main holdings are:  (1) “by mandating each manufacturer include the strongest type of warning” of a particular risk, “the FDA ensured each prescriber’s attention would be focused on [that] risk.”  Slip op. at 7.  (2) “[P]rescription drug warning labels containing a boxed warning, mandated by the FDA, are adequate as a matter of law.”  Id. at 7.  (3) Where the warning is otherwise adequate, lack of claimed “comparative” risk information (that the product has a “greater” incidence of a warned-about risk than “other” similar products) does not render the warning inadequate.  Id. at 8, 10-11.  (4) Even in the absence of a boxed warning, warnings that provide “specific detailed information on the risks” of a product are adequate as a matter of law.  Id. at 9-10.

Congratulations, and keep those wins coming.

We occasionally blog about motion in limine rulings, but not nearly as often as we read this type of decision.   Let’s face it, as blogging material (as opposed to their impact on a particular case) decisions on motions in limine can be pretty boring.   You can talk about this; you can’t talk about that.   In modern prescription medical product mass tort litigation, the plaintiff usually has about fifteen stock motions, whereas the defendant probably has between 35 and 50.   Motion in limine decisions are usually a matter of checking off this or that from a long list.   We read them – well at least Bexis does, because he has to update the evidentiary chapter for his book – but usually there’s not enough there there for a blogpost

Not so with Hill v Novartis Pharmaceuticals Corp., ___ F. Supp.2d ___, 2013 WL 1953753 (E.D. Cal. May 10, 2013), which decided a number of very interesting issues (including preemption) in the context of motions in limine filed in an Aredia/Zometa case.  In fact, Hill is so interesting that West has decided to publish it, a rarity with motion in limine rulings.

Here’s a rundown of the more important rulings.

(1) A batch of emails were excluded.   Normally this kind of thing is extremely case specific, and thus not of general interest. These emails, however, were between “members of a panel of physicians and oral surgeons” who were editing a document about the drug.   Hill, 2013 WL 1953753, at *1.   These doctors were on an outside “advisory panel” to the defendant manufacturer, but none were employees or otherwise formally affiliated with the defendant. The emails were excluded as hearsay. Id. at *1.   The plaintiffs argued that doctors on a “advisory panel” were “agents” of the company, and thus the emails were admissions by a “party opponent.”   That’s an important issue, since many drug and device company have outside physician advisory groups.  The court rejected the agency argument:
 
Rule 801(d)(2)(D) requires . . . agency. An agency relationship arises when both the principal and the agent must manifest assent to the principal’s right to control the agent. Here, there is, at present, simply no evidence that would permit the Court to conclude that [panel physicians] were agents (or employees) of [defendant], let alone evidence to show that the emails related to matters within the scope of their purported agency. . . . [W]hile it is true . . . that persons serving as “advisors” and “consultants” have sometimes been held to be agents, in none of these cases was it the fact of being an advisor or consultant that alone created the agency relationship. . . . Where an advisor or a consultant is not subject to the control of the party opponent with respect to consultation he or she is hired to give, the consultant cannot be deemed an agent.

2013 WL 1953753, at *3 (citations and quotation marks omitted). Here, the emails themselves refuted agency, as they “criticized” what was being drafted (precisely why plaintiff wanted to use the emails).   Id.   That the physician advisors “could criticize the [document] and propose changes to it suggests that their role was to provide an independent assessment and that [defendant] did not have the right to control them.”   Id. at *4.

Thus, if fighting claims that your client’s physician-advisors have somehow become “agents” of your client, Hill is definitely a decision of interest.

(2) The court threw out allegations of “ghostwriting.”  This seems to be one of the other side’s flavors du jour, as we see it asserted here, there, and everywhere.  We say, “big whoop” – as if it should surprise anybody that initial drafts of articles (or lawyers’ briefs) weren’t actually written by the ultimate author.  Lawyers do this all the time, as do other busy professionals.  As long as the information that’s presented is correct, we don’t see a problem.  It’s irrelevant to the merits of anything . . . and that’s more or less what the court found:
 
[T]he Court was concerned that Parisian’s [ghostwriting] opinion lacked a proper foundation. [Plaintiff] also represented to the Court . . . that Parisian would not be questioned about this issue. [Since] the only expert who offered an opinion . . . about ghostwriting and company-funded publications was Parisian, this prong of [defendant’s] omnibus motion is granted.

   Hill, 2013 WL 1953753, at *5. A Parisian opinion lacking proper foundation? No surprise there. And without the opinion – well, plainly, ghostwriting is of no inherent relevance to anything.

(3) The court allowed plaintiffs to argue that the duty to warn was not limited to the prescribing physician.  Before the A-Z litigation started, we’d thought, and Bexis had even written in his book, that limiting the duty to warn in this way was a loser.  But the defense has done a lot better than we thought on this issue, and has won it outright in several cases.   Not in Hill, however – although the ruling is phrased in a rather odd way:
 
[Plaintiff] would not be precluded under the learned intermediary doctrine from introducing such [inadequacy of warning] evidence and from arguing that [defendant’s] duty to warn ran to individuals other than her prescribing physicians. While [defendant] would then be entitled to a jury instruction directing the jury not to consider such a duty where the jury found that the warnings to the physician were inadequate, it could not preclude [plaintiff’s] counsel from introducing evidence and argument to the contrary.


Hill, 2013 WL 1953753, at *7. That’s not bad for a denial.   Instead of simply holding that non-prescribing treaters (usually dentists in A-Z) must be provided with adequate warnings, and leaving it at that, the court found that those physicians were part of the population against which the adequacy of warnings is to be judged.   Still the defendant was entitled to a jury instruction “not to consider such a duty” with respect to inadequate warnings, id., so it’s hardly a total loss.

(4) Several of the evidentiary rulings were grounded in preemption.   A-Z involves prescription drugs, so after Wyeth v. Levine, 555 U.S. 555 (2009), preemption arguments are swimming upstream.   The first motion concerned “black box” warnings, where (as we discussed here) a very good preemption argument exists because the FDA reserves to itself the decision whether to include boxed warnings and what they say. As is often the case with such allegations, the plaintiff backed down. Hill, 2013 WL 1953753, at *7 (plaintiff “represents she will not offer argument or evidence on black box warnings”). Too bad; that one’s a winner.

 
One that wasn’t a winner was defendant’s attempt to extend Mensing preemption to prescription drugs.   Not that PLIVA v. Mensing, 131 S. Ct. 2567 (2011), an implied preemption case, shouldn’t apply across the board, but because this particular aspect of the plaintiff’s warning claim – involving “a different dosing regimen” – unfortunately appears to fall on the bad side of the “changes being effected” (“CBE”) divide that marks the boundary between the domains of Levine and Mensing:
 
Among other things, this “changes being effected” (CBE) regulation provides that if a manufacturer is changing a label to add or strengthen a contraindication, warning, precaution, or adverse reaction or to add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product, it may make the label change upon filing its supplemental application with the FDA; it need not wait for FDA approval.


Hill, 2013 WL 1953753, at *9 (citations and quotation marks omitted) (emphasis added). With “dosage” within the general scope of the CBE reg, the court wasn’t about to find preemption.

Not so, however, with respect to that aspect of a warning claim alleging that the defendant “should have formatted the [drug] labeling differently.” Id. at *10.  The formatting of drug labels is minutely governed by the FDA’s regulations, and is not governed by CBE standards.   In what may be a ruling of first impression, Hill held that warning claims attacking how the warnings were formatted were preempted:
 
FDA regulations for prescription drug labeling extend not only to content but to formatting. While the case law is clear that manufacturers may modify the contents of a brand-name drug label without FDA approval by adding to or strengthening the warnings, [plaintiff] has provided no authority − and the Court’s research reveals no authority − to suggest manufacturers may do the same with the label’s formatting. Accordingly, [defendant’s] motion is hereby granted to the extent it seeks to preclude [defendant] from arguing that the [drug] labeling should have been formatted differently.

2013 WL 1953753, at *11. While the formatting claim is only a minor part of the A-Z litigation, we’ve seen warning claims based on allegations in other cases that this or that risk was insufficiently highlighted to make it stand out.  Preemption of formatting claims would kill off such claims.  To us, the finding of what we’ll call “formatting preemption” from here on out may well be the most important of all the Hill rulings. Defense counsel – make a note of it.

(5) Also of general interest is the ruling in Hill precluding the plaintiff from pursuing a “lost chance” case. “Lost chance” is a medical malpractice concept arising from failure-to-diagnose situations where a pre-existing disease (usually cancer) gets worse in the interim.   The theory seeks to recover for the “increased risk” that the plaintiff will die of the belatedly diagnosed condition, and utilizes negligent services sections of the Restatement (Restatement (Second) §§321 & 323) that excuse plaintiffs from having to prove “but for” causation.   In short, it’s not a product liability theory – since in product liability the product is alleged to be the cause of whatever injury is asserted

We’ve opposed plaintiffs trying to infiltrate “lost chance”/”increased risk” theories into product liability litigation in Pennsylvania:
 
The doctrine of increased risk of harm is inapplicable absent the undertaking of a service either gratuitously or for consideration. Appellants’ allegations of negligence did not assert that [defendant] undertook to “render services” to [plaintiff], therefore a charge on increased risk of harm was not appropriate. Additionally, the doctrine presupposes an outside injury or source of negligence not concurrent with any alleged negligence by a defendant.





 

Ettinger v. Triangle-Pacific Corp., 799 A.2d 95, 107-08 (Pa. Super. 2002).   Accord Steamfitters Local Union No. 420 Welfare Fund v. Philip Morris, Inc., 171 F.3d 912, 936 (3d Cir. 1999) (“Converting a company’s marketing into a special undertaking . . . would subject every manufacturer that advertises its products to liability for a ‘special duty’ created by such marketing. . . .  We are unwilling to so dramatically extend the scope of liability for a state-law cause of action”); Lempke v. Osmose Utilities Services, 2012 WL 94497, at *4 (W.D. Pa. Jan. 11, 2012) (courts “have invoked Section 323 in a variety of factual settings, but never in the context of a negligence-based products liability case”); Lobianco v. Eckerd Corp., 2004 WL 3009005, at *4 n.23 (E.D. Pa. Dec. 29, 2004) (increased risk “theory is limited to medical malpractice cases [and] is inapplicable to this [product liability] case”).

Thankfully, the court in Hill also rejected this misplaced theory:
 
[T]he lost chance doctrine, even when recognized, has been limited to medical malpractice cases. . . .  [Plaintiff] has provided no authority − and the Court’s research reveals no authority − to suggest that the doctrine could conceivably apply in a products liability case where, as here, the plaintiff alleges that a pharmaceutical manufacturer’s failure to warn of risks associated with a prescription drug caused the plaintiff to develop a condition she would not otherwise have developed had she not taken the drug.

2013 WL 1953753, at *13.   Thus, while ostensibly deciding a motion in limine, the ruling in Hill is a significant substantive legal decision with respect to the “lost chance”/”increased risk” issue.

(6) The defendant in Hill also sought to have everything that happened after the plaintiff last used the drug excluded, mostly as subsequent remedial measures.  The defendant lost – but won.  The most significant subsequent events – label changes – were excluded:
 
Evidence that a manufacturer changed a product’s warning label after a plaintiff was allegedly injured by the product is not admissible in a failure-to-warn case because such evidence could lead a jury to infer the manufacturer added the warning because it believed the product was unsafe without it.  This is precisely the type of inference that Rule 407 [pertaining to subsequent remedial measures] forecloses in order to avoid discouraging the taking of remedial measures.  [Plaintiff] argues that the changes [defendant] made to the [drug’s] label . . . involved nothing more than the inclusion of intentionally misleading [information] . . . and were therefore not subsequent remedial measures. . . .   [A] manufacturers motive for making the change is irrelevant.

2013 WL 1953753, at *14 (citations and quotation marks omitted).   As to everything else, the court in Hill was unwilling to enter a “blanket” exclusion order against evidence based on one point in time.   Id. at *14-15. Defendant will have to “offer individualized objections to the introduction of [such] evidence at trial.” Id. at *15.  Again, for a loss, that’s not bad – not bad at all.

(7) Finally, the defense came away with a win with respect to “evidence of medical expenses that were not actually paid” – that is, nominal charges for medical costs that far exceeded what the plaintiff (or her insurer) actually paid for the services.   This is another recurring issue, as so-called “chargemaster” prices for medical services bear no resemblance to reality, and are routinely reduced to pennies on the dollar by insurers (and the government).   We’ve seen this in Pennsylvania as well, where the rule is that the reasonable value of medical services cannot exceed the sum that a plaintiff’s medical care providers accepted as payment in full.   Moorhead v. Crozer Chester Medical Center, 765 A.2d 786, 789-90 (Pa. 2001).

That’s the majority rule, and Hill followed it:
 
The Court concludes that because evidence of any amounts billed above the amounts paid are not of consequence in determining plaintiff’s damages claim . . ., and because such evidence would be of only modest probative value for other purposes, such evidence would have extremely limited relevance under Rule 401 and its introduction would likely confuse and mislead the jury into considering collateral payments within their damages calculation if introduced at trial.  Consequently, the prejudice of introducing such evidence substantially outweighs its probative value.

2013 WL 1953753, at *17.

There are a number of other rulings in Hill – some that the defense won and others that it lost – but these are the ones that aren’t so fact-bound as to be of little interest outside of the A-Z litigation.  With preemption, lost chance, agency, post-sale warning changes, actually-paid medical costs, and ghostwriting on the table, this was an extraordinarily meaty set of in limine rulings.

Here’s an interesting case, Ray v. Allergan, Inc., ___ F. Supp.2d ___, 2012 WL 1979226 (E.D. Va. June 1, 2012), sent to us by Gary Spahn, of Troutman Sanders (who helped brief the case).  In Ray the court overturned a plaintiff’s verdict of over $12 million − notable in itself (way to go, Gary).  In some small way, we returned the favor by recommending to West that Ray be published.  You scratch our backs, we’ll scratch yours.

 

Briefly, Ray involved Botox (short for “botulism toxin”).  Obviously, a product with variant of “toxin” right in the name carries significant risks, particularly if misused.  A major dispute (no surprise) was the warnings that accompanied Botox concerning those risks.  Plaintiff ultimately lost the verdict because his counsel engaged in trial tactics that were too cute by a half.

 

But what makes Ray particularly interesting to us is that it’s really a preemption case, although the opinion goes out of its way to hide it.  The claim that the plaintiff wanted to pursue was that the drug (technically, a “biologic”) should have had “black box” warning.  However, the plaintiff faced the same obstacle that proved fatal to the generic drug plaintiffs in PLIVA v. Mensing, 131 S. Ct. 2567 (2011) − black box warnings required prior FDA approval.  “[T]he Court, at trial, concluded that, under the applicable FDA regulations, [defendant] could not have used a black box warning without prior approval of the FDA.”  Ray, 2012 WL 1979226, at *3.  As Ray restated the situation:

 

During the comment period in 1979, the FDA was asked whether a manufacturer could include a boxed warning without first securing approval of the FDA. . . . The FDA responded that to ensure the significance of boxed warnings in drug labeling, they are permitted in labeling only when specifically required by the FDA. . . . [T]he Final Rule and the regulations state that if a boxed warning is required, its location will be specified by the Food and Drug Administration.

Id. at *5 (internal quotes to FDA statements omitted).

 

We’ve discussed the basis for black box preemption in detail before, and Ray summarizes them just fine, so we’re not going to go through the details again.  Suffice it to say that, in Ray the judge agreed that the black box claim was preempted (even if it wasn’t described in those terms in the opinion) and told the plaintiffs not to pursue that claim.

 

But the plaintiff was allowed to argue, based on the general CBE-based non-preemption principles of Wyeth v. Levine, 555 U.S. 555 (2009), that the defendant could have “strengthened” the labeling by making the label “more prominent” generally.  Ray, 2012 WL 1979226, at *7.  Given that inch, plaintiff’s counsel took a mile in closing − arguing repeatedly to the jury about “big, bold” letters, and putting the warning “right up front.”  Id. at *4 (listing four different examples of such argument).

 

Even then, counsel might have gotten away with it, except….  It turns out, counsel also engaged in pantomime − hidden from the judge − that blatantly violated the judge’s ruling about not arguing for a black box warning:

 

While these points were being made, [plaintiff’s] counsel repeatedly made hand gestures that, according to [defendant], described a box.  [Defendant] objected at the time, but not having seen the gestures, the Court overruled the objection and gave the jury no instruction limiting the text of the argument to the prominence of the warning or dispelling any suggestion that a black box warning could have been issued unilaterally by [defendant].  A review of the courtroom security videotape . . . teaches that such an instruction should have been given because, in the context of the words used by [plaintiff’s] counsel, the jury could have concluded that counsel was arguing that a black box warning should have been given without having the jury also informed that such a warning would have required prior FDA approval.

Ray, 2012 WL 1979226, at *8 (emphasis added).  The court’s Levine-based jury instruction only “exacerbated the confusion over the propriety of a black box warning,” due to counsel’s surreptitious hand gestures.  Id. at 9.  The gestures, the argument, and the lack of a curative instruction, left the jury with the impression, they could impose liability on failure to include a black box.  Id.  Reversible error.  So bye-bye big verdict.

 

Oh, and congratulations to defense counsel for their resourcefulness in accessing the courtroom security videotapes to catch opposing counsel in the act.

 

There’s more though − but there isn’t.  The court states that “as will be explained elsewhere,” Mensing, which was evidently argued by the defendants, “d[id] not alter” the result.  Ray, 2012 WL 1979226, at *7.

 

Why’s that?

 

We look “elsewhere” and find out.  It’s because the Mensing argument is an argument for judgment as a matter of law rather than for a new trial, and the defendant only moved for a new trial.  Ray, 2012 WL 1979226, at *13-14 (“if [defendant] is correct, the Plaintiff’s claim would fail entirely and, in that event a new trial would not be appropriate.  Thus, the issue of preemption is not one to be resolved in [defendant’s] motion for a new trial”).

 

From the Ray opinion, however, we can figure out what the defense Mensing argument probably was − and we think it’s a good one.  What’s more, it’s a good argument for extending Mensing beyond generic drugs.  Specifically, we pluck out the following statements from Ray that describe certain informal steps that the plaintiff argued that the defendant could have taken to engage the FDA.

 
  • “[T]he Court also concluded, over [defendant’s] objection, that [defendant] was free to approach the FDA to request permission to use a black box warning.  Thus, [plaintiff’s] counsel was allowed to question some [defense] witnesses respecting whether [it] could have approached the FDA about placing a black box warning on the . . . package inserts.  Ray, 2012 WL 1979226, at *3 (emphasis added).
  • “[T]hat argument is rejected because no FDA regulation would have kept [defendant] from approaching the FDA and asking to use a black box warning.”  Id. at *3 n.2 (emphasis added).
  • “[E]ven for those [older] products, conforming labeling could be submitted to the FDA for approval at any time.”  Id. at *5 (emphasis added).
  • “[T]here is nothing in the statute or the regulations that prevents a manufacturer from submitting proposed labeling before the date by which it must be submitted.”  Id. at *6 (emphasis added).
  • “[N]othing in the regulations prohibited [defendant] from approaching the FDA to suggest use of a boxed warning.”  Id. at *6 (emphasis added).

These “take steps” claims − that the defendant could have approached the FDA informally and outside of established channels and sought help to do this or that, when it could not do those things independently − are precisely what the Supreme Court flatly rejected in Mensing as a “Mouse trap game.”  As stated in Mensing:

 

[Plaintiffs] argue that if the Manufacturers had asked the FDA for help in changing the corresponding brand-name label, they might eventually have been able to accomplish under federal law what state law requires.  That is true enough. . . .  If [defendants] had done so, and if the FDA decided there was sufficient supporting information, and if the FDA undertook negotiations with the brand-name manufacturer, and if adequate label changes were decided on and implemented, then the Manufacturers would have started a Mouse Trap game that eventually led to a better label. . . .

 

This raises the novel question whether conflict pre-emption should take into account these possible actions by the FDA and the brand-name manufacturer.  Here, what federal law permitted the Manufacturers to do could have changed, even absent a change in the law itself, depending on the actions of the FDA. . . .  This is a fair argument, but we reject it.

 

The question for “impossibility” is whether the private party could independently do under federal law what state law requires of it.  Accepting [plaintiffs’] argument would render conflict pre-emption largely meaningless because it would make most conflicts between state and federal law illusory.  We can often imagine that a third party or the Federal Government might do something that makes it lawful for a private party to accomplish under federal law what state law requires of it.  In these cases, it is certainly possible that, had the Manufacturers asked the FDA for help, they might have eventually been able to strengthen their warning label.  Of course, it is also possible that the Manufacturers could have convinced the FDA to reinterpret its regulations. . . .  Following [plaintiff’s] argument to its logical conclusion, it is also possible that, by asking, the Manufacturers could have persuaded the FDA to rewrite its generic drug regulations entirely or talked Congress into amending the Hatch–Waxman Amendments.

 

If these conjectures suffice to prevent federal and state law from conflicting for Supremacy Clause purposes, it is unclear when, outside of express pre-emption, the Supremacy Clause would have any force. We do not read the Supremacy Clause to permit an approach to pre-emption that renders conflict pre-emption all but meaningless.

Mensing, 131 S. Ct. at 2578-79 (emphasis added).

 

We note that Ray was tried shortly before Mensing was decided.  Ray, 2012 WL 1979226, at *1 (tried in April/May 2011).  At that time, the so-called “take steps” approach had been argued to the Supreme Court, but the Court had not yet issued its opinion “rejecting” that reasoning.  Undoubtedly, the plaintiff in Ray was aware of the then-currency of the “take steps” argument and adapted it to the Ray case.

 

Well, that “approach to preemption” is gone now, and since Mensing is an implied preemption case, the “take steps” rationale is invalid for all plaintiffs and all claims about lobbying any federal agency, since implied preemption is not dependent on this or that statutory language.  There’s no distinguishing Mensing, because in Ray the “take steps” approach was used in an identical fashion − to render black box preemption “meaningless.”  Indeed, Ray only confirms that the Mensing majority was correct in its overall assessment of the “take steps” approach.

 

Thus, we look forward to seeing what happens next in Ray.  Once the defendant in Ray is not facing the procedural strait-jacket of a new trial motion, it can present the Mensing preemption argument against this iteration of the “take steps” approach, unless of course the plaintiff abandons the argument (which is also questionable as a state-law theory) on retrial.  In our view it would be a winning argument.

 

Everyone in the world – at least everyone who reads our blog – knows that the Supreme Court rejected preemption in Wyeth v. Levine, in large part because the regulatory history of Phenergan (as read by the majority) did not clearly establish a conflict between the plaintiff’s warning defect claim and the FDA’s regulatory determinations concerning that drug. It was only “intermittant” activity, and in any event the FDA’s regulations allowed the defendant to change the warning whenever it wanted to. 129 S. Ct. at 1192, 1196-97. There was “no evidence in this record that either the FDA or the manufacturer gave more than passing attention to the issue of” IV-push versus IV-drip administration.” Id. at 1199.

Well guess what?

Everything you thought you knew about Phenergan labelling, might not be true anymore. Today, the FDA announced that it’s requiring a black box warning for Phenergan about precisely the same risk involved in Levine. That’s the FDA’s most serious warning – “passing attention,” indeed. As the FDA’s just issued press release begins:

The U.S. Food and Drug Administration is telling manufacturers of the drug promethazine to include a boxed warning regarding the injectable form of the drug. The warning, under FDA’s authority to require safety labeling changes, will highlight the risk of serious tissue injury when this drug is administered incorrectly. The agency is also alerting health care professionals to the new boxed warning for this product, which is used as a sedative and to treat nausea and vomiting.

We have no idea how long this has been in the works. That doesn’t mean that doing this earlier would have helped our side – it could have been quite prejudicial, depending on the timing of an earlier release. Still, the irony is so thick one can cut it with a knife.

A black box warning also has independent preemption implications. We discussed them in some detail here. The changes being effected procedure relied upon by the Supreme Court in Levine doesn’t extend to black box warnings. The FDA’s regulations so state. “If a boxed warning is required, its location shall be specified by the Food and Drug Administration.” 21 C.F.R.
§§201.80(e), 201.57(c).

So going forward, it seems that Phenergan’s labeling for the risk at issue in Levine – now a black box – will be protected by the very preemption that the FDA’s previous “no more than passing attention” did not permit.

According to the Levine opinion, this labeling process goes back to 1981. Better late than never, we suppose. But not for Ms. Levine.

One of the high-profile ways in which the FDA has been strengthening product warnings lately has been to require more “black box” labeling – the FDA’s strongest form of warnings. Among other consequences, products bearing black box warnings cannot be advertised directly to consumers. Thus, the Agency’s decision to require a black box warning on a drug or medical device is a big deal. That’s the way it’s always been. Nobody but the FDA has ever – in history – ordered a black box warning. See Beach, “Black Box Warnings In Prescription Drug Labeling: Results of a Survey 0f 206 Drugs,” 53 Food & Drug L.J. 403 (1998) (reviewing 375 black box warnings concerning 206 drugs; determining that every one of them was ordered by FDA).

Predictably, the plaintiffs’ litigation response to this type of FDA activity has been to second guess it. “It’s about time,” the refrain goes. “The FDA should have done this earlier – before I got hurt.” It turns out that the FDA anticipated just such second guessing from the outset, when it first set up the current black box warning regime. Twenty-seven years ago, long before plaintiffs are willing to admit that the FDA ever favored preemption, the Agency came down hard on the side of administrative exclusivity. Only the FDA, and not Monday-morning quarterbacking plaintiffs, can authorize a black box warning.

Given how long the Agency has taken this position, it’s rather surprising the dearth of legal precedent on preemption of black box warning claims. There’s really only one case that’s ever addressed it, Ehlis v. Shire Richwood, Inc., 233 F. Supp.2d 1189 (D.N.D. 2002), aff’d, 367 F.3d 1013 (8th Cir. 2004), and even there the court really didn’t analyze the issue very thoroughly. Instead of relying upon what the FDA had specifically decided about black box warnings, that court found the claim preempted as a de facto attempt to assert a private right of action under the FDCA. Id. at 1197.

Given the lack of precedent, it’s useful to go over the regulatory basis for preemption of black box warning claims. Basically, what happened is that the FDA was afraid, unless it closely regulated the use of these warnings, that they would be overused and their impact reduced.

In 1979, the Agency created “boxed warnings” specifically for “special problems” of the most serious nature. Thus, it promulgated a regulation stating: “Special problems, particularly those that may lead to death or serious injury, may be required by the Food and Drug Administration to be placed in a prominently displayed box. The boxed warning ordinarily shall be based upon clinical data, but serious animal toxicity may also be the basis of a boxed warning in the absence of clinical data. If a boxed warning is required, its location shall be specified by the Food and Drug Administration.” 21 CFR 201.80(e), see 21 C.F.R. §201.57(c)(1) (for products approved after June 2001). Thus, it’s always been up to the FDA both to require a boxed warning and to determine where on the label it would go.

The meaning of these provisions is hardly in doubt. During their initial notice and comment period , the FDA was “asked whether a manufacturer may include a boxed warning without prior FDA approval.” 44 Fed. Reg. 37434, 37448 (FDA Jun. 26, 1979). Without equivocation or qualification, the FDA said “no.” “[T]o ensure the significance of boxed warnings in drug labeling, they are permitted in labeling only when specifically required by the FDA.” Id. “Instead, “the decision as to whether a warning is legally required for the labeling of a drug must rest with the agency.” Id. at 37447. Thus, the Agency “has emphasized that, to ensure the significance of boxed warnings in drug labeling, they are permitted in labeling only when specifically required by FDA.” Lars Noah, “The Imperative to Warn; Disentangling the ‘Right to Know’ from the ‘Need to Know’ about Consumer Product Hazards,” 11 Yale J. Reg. 293, 331 (1994).

In prohibiting any boxed warnings other than those it authorizes, the FDA has been concerned that any new boxed warning potentially dilutes the strength of others. It adopted a policy of “restraint in requiring warnings to be boxed because overuse of the box will ultimately lead to reducing its effect.” 51 Fed. Reg. 43900, 43902 (FDA Dec. 5, 1986). Unapproved emphasis “might detract from other language of equal or greater importance, and thus mislead or confuse physicians.” 44 Fed. Reg. 37434, 37440 (FDA June 28, 1979). The FDA continues to follow this policy to this day. Right now, the FDA’s website states that the Agency “reserves this format, with the warning placed in a prominently displayed box, for the most serious warnings necessary to ensure the continued safe use of the product.” < http://www.fda.gov/medwatch/report/DESK/actions.htm >.

If the FDA’s reasoning sounds familiar, that’s because it is. The same concern about dilution of black box warnings through overuse that the Agency has expressed for a quarter century has recently come to fore in global fashion. The adverse effects of overwarning that helped drive the FDA to a more pro-preemption position generally, see 71 Fed. Reg. 3922, 3935 (FDA Jan. 24, 2006), are no different than those that led the Agency to restrict the use of black box warnings in 1979.