November 30, 2010 P0st: John Schedin took the medicine Levaquin in 2005 and soon after suffered injury to both his achilles tendons, a known risk of the drug for a relatively small number of users of the drug, an antibiotic.
Levaquin included a warning but sometime after Schedin’s incident, the warning was changed and made more prominent (made into a “black box” warning in 2008). Subsequent warning label changes would be a classic “subsequent remedial measure” inadmissible at trial if it were not for the fact that the label change was mandated by the FDA, U.S. District Court Judge John R. Tunheim has held. That changed everything.
However, the key point of Judge Tunheim’s analysis, it seems, is the sense that it would be unfair that the defendants defend the case arguing to the jury that the FDA did not mandate an enhanced warning at the time of Schedin’s injury unless plaintiff can respond by pointing to the fact that the FDA, later, did mandate the enhanced warning.
Judge Tunheim analyzed the evidence under Fed. R. Evid. 407 (regarding subsequent remedial measures), Fed. R. Evid. 403 (balancing probative value against risk of prejudicial effect), and also under federal preemption. Defendants had also challenged the evidence as irrelevant to Mr. Schedin’s claims, a position that Judge Tunheim’s order rejected only implicitly.