There has been a sea change in pharmaceutical litigation over the last four years. Before 2015, the key issue on which most pharmaceutical litigation generally turned was the adequacy of the warning given the prescribing physician; litigation was characterized by testimony about the physician’s subjective knowledge of drug-related risks, experience with the drug in question and prescribing habits.

Those issues remain central to the ultimate outcome in these lawsuits (indeed, a failure-to-warn plaintiff cannot meet his or her burden of proof without it). But a survey of pharmaceutical litigation reveals that many of these cases now turn on a more narrow preliminary question: whether there is “newly acquired information,” within the meaning of 21 CFR 314.3(b), which would permit the pharmaceutical manufacturer to change its label through the “Changes Being Effected,” or “CBE” regulatory process, defined in 21 CFR 314.70 (c)(6)iii).

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