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).
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.
- “[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).