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Dealing with the Pennsylvania Supreme Court’s Non-Decision on Standards Compliance Evidence

Drug & Device Law

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. In state court, Creazzo remains binding precedent. 3d 1245 (N.J. 3d 709 (Pa.