Cozen O’Connor: Section 510(k) Clearance: While it Doesn't Support Preemption, is it Relevant Evidence at Trial? [Drug and Device Law]

Section 510(k) Clearance: While it Doesn't Support Preemption, is it Relevant Evidence at Trial? [Drug and Device Law]

John Sullivan, a member of Cozen O’Connor’s Commercial Litigation Department, discusses Boston Scientific Pelvic Repair System Products Liability Litigation and how the 510(k) clearance of a medical device is not only insufficient to support preemption, but it’s not probative enough to be discussed at trial. The MDL court in the Boston Scientific Pelvic Repair System Products Liability Litigation is one such court, consistently excluding from trial evidence of 510(k) clearance of the pelvic mesh device.

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John J. Sullivan

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jsullivan@cozen.com

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