It’s hard to think of any recent litigation where plaintiffs didn’t seek overblown discovery about adverse event reports and then have their experts rely on those reports in an effort to establish causation. But as we’ve blogged about repeatedly, reports from the FDA’s Adverse Event Reporting System (“FAERS”) do not establish causation (and, for good measure, they don’t constitute newly acquired information). Today’s decision, Taylor v. Dixon, 2026 WL 865183 (M.D. Fla. Mar. 30, 2026), is a little different since it involves a federal habeas petition. But we couldn’t resist blogging about it given the court’s comprehensive take-down of the attempted use of an adverse event report to show causation.
Continue Reading Adverse Event Reports May Not Be Used to Establish CausationAdverse Events
The Narrow Gap Is Not Wide Enough For Wieder
By Lisa Baird on
The latest medical device express preemption decision, Wieder v. Advanced Bionics LLC, 2026 U.S. Dist. LEXIS 70645, 2026 WL 880370 (S.D.N.Y. Mar. 31, 2026), comes out of the Southern District of New York and involves a Class III, PMA‑approved cochlear implant.
Fluid allegedly worked its way into the device and caused a short‑circuit and device…
FDA Launching Unified Adverse Event Monitoring System
By Lisa Baird on