Wednesday, June 6, 2012

A Ray Of Sunlight Shining On A Black Box

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.