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.