Photo of Eric Hudson

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 Causation
Photo of Eric Hudson

We consistently defend the ability of physicians to engage in off-label use. Bexis helped lay the scholarly foundation for courts to utilize the term “off label use,” and two of his law review articles remain go-to reads on the subject.  Not surprisingly, we follow medical malpractice decisions that address off label use.  Back in 2009, Mark Herrmann (the Blog’s co-founder with Bexis), published a law review article articulating the reasons why package inserts should not be admitted as standard of care evidence in medical malpractice actions. More recently, we wrote a comprehensive post collecting case law rejecting the admission of package insert evidence to establish a violation of the standard of care by physicians who used drugs or devices off label. Today’s case is a detailed opinion from the Iowa Supreme Court joining what is now the majority view—that package inserts should not be admitted as substantive evidence of the standard of care.

Continue Reading Package Inserts Are Not Admissible to Establish Standard of Care