510(k) Clearance Evidence Gains New Life After $83 Million Verdicts Overturned

On March 2, 2021, a New Jersey appellate court overturned two pelvic mesh jury verdicts totaling over $83 million dollars, holding that the trial courts committed reversible error by excluding all evidence related to the FDA clearance process.  This decision represents a substantial victory for medical device manufacturers, particularly in light of the staggering jury verdicts that have been handed down over the past few years.

This ruling represents two separate cases that were consolidated for purposes of appeal.  See Hrymoc et al., v. Ethicon Inc. et al., Docket No. A-005151-17, and McGinnis et al. v. C.R. Bard Inc. et al., Docket No. A-001038-18.  In both cases, the respective juries found the medical device defendants liable for design and failure-to-warn defects that caused injuries to plaintiffs. In Hrymoc, the jury awarded the plaintiff and her husband $5 million in compensatory damages, and $10 million in punitive damages.  Conversely, in McGinnis, the jury awarded the plaintiff and her husband $33 million in compensatory damages, and $35 million in punitive damages. Continue reading “510(k) Clearance Evidence Gains New Life After $83 Million Verdicts Overturned”

New FDA Compliance Program Details FDA Expectations for Inspections of CDER- or CDRH-Led Combination Product Manufacturers

On June 4, 2020, the U.S. Food & Drug Administration implemented a compliance program, which explains how CGMP requirements are to be applied to combination products, the subject of a final guidance issued in January 2017. In particular, the new program document focuses on providing a framework for conducting inspections of manufacturers of single-entity and co-packaged finished combination products—led by either the Center for Drug Evaluation and Research or the Center for Devices and Radiological Health—that include both (i) drug and device; or (ii) biological product and device constituent parts. In addition, because the underlying 2017 Guidance was issued by OPD, CBER, CDER and CDRH collectively, the same principals would like apply to inspections  in which CBER is the lead center.

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