Filter MDL Puts FDA Clearance Evidence Back On The Table

Law360 (February 5, 2018, 12:16 PM EST) -- As we first wrote about back in 2013, U.S. Food and Drug Administration compliance evidence generally — and the fact of a medical device’s clearance as “substantially equivalent” in safety and effectiveness to a predicate device under §510k of the Medical Device Amendments (now 21 U.S.C. §360c(f)(1)(A)) specifically — had for decades been admissible evidence in product liability litigation involving FDA-regulated drugs and devices. In 2013 we found a half dozen §510k cases directly on point.[1]

Then, in pelvic mesh litigation, rulings began to change the...
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