Federal preemption remains the holy grail of defenses in pharmaceutical products liability cases. A successful preemption defense can dispose of cases in their entirety and often quite rapidly. Not surprisingly, plaintiffs have devised an arsenal of arguments to challenge preemption defenses. Chief among these is that the Food and Drug Administration (FDA)’s Changes Being Effected (CBE) regulations allow brand manufacturers to modify a product label without prior FDA approval. However, not all labeling changes can be made via the CBE. Plaintiffs bear the burden of proving that the CBE was available to make the labeling changes at issue. Only once that burden is met does the burden shift to manufacturing defendants to show by “clear evidence” that the FDA would have rejected the proposed labeling changes.
The Food, Drug, and Cosmetic Act generally requires that FDA approve changes to prescription drug labels. Consequently, drug manufacturers commonly assert a preemption defense to defeat failure to warn claims. In response, plaintiffs raise the CBE regulations. These regulations create a pathway by which manufacturers can unilaterally make changes to a drug label in certain circumstances. See, e.g., Utts v. Bristol-Myers Squibb Co., 226 F. Supp. 3d 166, 185 (S.D.N.Y. 2016). Importantly and seemingly often forgotten, however: To qualify under the CBE, the label change must (1) reflect “newly acquired information” and (2) accomplish one of five specific objectives, including adding or strengthening a warning. 21 C.F.R. § 314.70(c)(6)(iii); Utts, 251 F. Supp. 3d at 659.
The meaning of “newly acquired information” in general parlance is not difficult to understand. However, drug companies live in a highly regulated world. To that end, the FDA narrowly defines “newly acquired information” as:
[D]ata, analyses, or other information not previously submitted to the [FDA], which may include (but is not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events, or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.
21 C.F.R. § 314.3(b) (emphasis added).
To challenge a preemption defense under the CBE, plaintiffs must show “newly acquired information” concerning the risk at issue. Yet plaintiffs often ignore this essential first prong and move straight to arguing that, under Wyeth v. Levine, 555 U.S. 555 (2009), failure to warn claims are not preempted absent “clear evidence” that FDA would have rejected the exact proposed labeling change.
For this reason, it is important to analyze a complaint at the motion to dismiss stage to determine whether plaintiffs have adequately pled facts to support the “newly acquired information” requirement. Some plaintiffs bring claims about risks that were already in the label. These claims should be preempted unless plaintiffs can demonstrate that the severity or “frequency” of events—not the number of events—increased after FDA approval. To the extent failure to warn claims are premised on the adequacy of the label at the time of FDA approval, these are also preempted. Utts, 251 F. Supp. 3d at 660 (“the Supreme Court’s decisions in Wyeth, [supra], PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013), read holistically, indicate that federal law preempts all pre-FDA approval failure to warn and design defect claims for branded prescription medication.”).
In discovery, practitioners should develop evidence that the claims are based on types of events already contained in the label and that neither the severity nor the frequency of the risk has increased. If properly developed through fact and expert discovery, any assertion that the warnings should have been contained in a different section of the label or worded differently should be preempted because these are not the kinds of changes contemplated by the CBE regulations. Similarly, if the claims relate to a boxed warning or the “Highlights” section of the label, they do not fall under the CBE and must be preempted. 21 C.F.R. § 314.70(b)(2)(v)(C).
It is important for practitioners to understand the limited circumstances when the CBE is available and to educate the courts on these issues. Claims should be preempted if the CBE was unavailable to make the labeling changes at issue. The pharmaceutical industry would benefit from additional case law reaffirming plaintiffs’ burden to demonstrate that “newly acquired information” existed such that the CBE was a viable option to update the label.