Dealing with the Pennsylvania Supreme Court’s Non-Decision on Standards Compliance Evidence
Drug & Device Law
JANUARY 15, 2024
We have discussed how exclusion of FDA compliance in pelvic mesh cases, based on a false equivalence between preemption and evidentiary admissibility, has hampered the defense in that litigation. We haven’t seen standards compliance litigated, but T.M. Janssen Pharmaceuticals, Inc. , 3d 1245 (N.J. 2d at 1013-14.
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