> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Impact of Lawsuit Reports on Adverse Event Reporting
- URL: https://www.fdaweb.com/impact-of-lawsuit-reports-on-adverse-event-reporting/
- Published: 2019-05-21T12:00:00.000Z
- Updated: 2026-09-15T01:28:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144153

Two staffers in the CDER Office of Surveillance and Epidemiology say they are aware of instances in which prescription drug litigation has had significant impacts on signals of disproportionate reporting (SDRs) to the FDA Adverse Event Reporting System (FAERS). [Writing](http://www.fdaweb.com/download.php?file=10.1007%40s40264-019-00834-1.pdf) online in the journal *Drug Safety*, the two identified litigation-associated reports (LARs) received in FAERS through 12/31/18.

“Peaks in the LARs can be attributable to highly publicized drug safety regulatory actions,” they write. “Drugs with a high proportion of LARs, particularly when concentrated on events not frequently reported to the FAERS, can create an environment resulting in significant masking of SDRs, both within the adverse events profile of the litigated product and with the adverse events that are the subject of the litigation for other products.”

The authors say it is imperative for safety scientists using SDRs as a screening tool to be conscious of stimulated reporting sources. “We expect to continue to receive reports disproportionately focused on particular drugs and adverse events secondary to litigation,” they say. “Similarly, other influencers such as advocacy groups and industry-sponsored programs can also have significant impacts on timely signal identification and evaluation. Further research is needed to evolve the methodology and pharmacovigilance practices aimed at addressing the bias introduced by stimulated reporting on signal identification.”