An amicus curiae brief has been filed by AdvaMed with the Supreme Court to request review of a lower-court decision in a product liability case brought over Ethicon's TVT-O pelvic mesh. The decision, which prevented the Johnson & Johnson subsidiary from providing evidence that the product met 510(k) clearance requirements as it appealed a $3.3 million verdict, prevents juries "from hearing the full story ... [and] can result in FDA's assessment of a product's safety and effectiveness being supplanted by a court ruling," said Matthew Wetzel, assistant general counsel for AdvaMed.
AdvaMed asks Supreme Court to review lower-court decision in Ethicon case
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