Skip to Main Content

Publications

The "Newly Acquired Information" Shift in Pharma Litigation

June 2019 - Law360
Social Logo Social Logo Social Logo

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).

Read the article here.

Related Attorneys

Related Article

Preemption vs. Public Nuisance, in Aviation and Opioids More
Driverless
A podcast that analyzes legal issues surrounding autonomous vehicles.
ERISA
Perspectives on employee benefits, executive compensation and ERISA litigation to help you attract and retain talent.
lingua negoti
The language of business.
Ohio Environmental
Insights and commentary for the business and legal community.