DRI Drug and Medical Device Seminar

Fagre Baker Daniels' Amy Fiterman will present "Defending the Medical Device Claim: Strategically Approaching Your Defense" at the DRI Drug and Medical Device Seminar. She will discuss several common defense issues, including FDA 510(k) clearance evidence, causation in failure-to-report claims, and responding to manufacturing defect arguments, as well as when no FDA evidence is allowed, when FDA clearance is contained only in the judge’s instructions, and when all evidence is admissible, allowing for “fraud-on-the-FDA” arguments.