Supreme Court Majority Appears To Support PMA Pre-emption Defense
This article was originally published in The Gray Sheet
Executive Summary
A majority of Supreme Court justices appeared to support some measure of federal PMA pre-emption over state liability claims during Dec. 4 oral arguments in the case of Riegel v. Medtronic, according to court watchers. But they say the ruling might include some caveats
You may also be interested in...
In Victory For Device Industry, Supreme Court Favors PMA Pre-emption
In a ruling that is expected to shave the volume of lawsuits against device manufacturers, the Supreme Court held that FDA premarket approval should preclude patients from suing companies for personal injury in most cases
In Victory For Device Industry, Supreme Court Favors PMA Pre-emption
In a ruling that is expected to shave the volume of lawsuits against device manufacturers, the Supreme Court held that FDA premarket approval should preclude patients from suing companies for personal injury in most cases
Firms Have Little Leeway To Change Labels Without Approval, FDA Asserts
FDA is reiterating that a drug or device manufacturer may amend product labeling without prior agency approval only if it has "newly acquired" safety information about the product. In addition, the agency says companies may strengthen contraindications and warnings "only if there is sufficient evidence of a causal association with the drug, biologic, or device.