Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.

Related Content

UsernamePublicRestriction

Register

MT025581

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel