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

In Victory For Device Industry, Supreme Court Favors PMA Pre-emption

This article was originally published in The Gray Sheet

Executive Summary

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

You may also be interested in...



US Rep. DeLauro Reintroduces Device Safety Bill To Remove PMA Product Liability Suit Protections

A US House representative and two co-sponsors have reintroduced the Medical Device Safety Act, which would remove the defense against state product liability suits for premarket-approved devices from the Federal Food, Drug, and Cosmetic Act (FDCA).

Utah Court Case Could Protect Devices From Some Liability

The Utah Supreme Court is reviewing a case that could give device companies some protection from product liability suits. Industry heavyweights including AdvaMed and the Washington Legal Foundation have weighed in by filing briefs supporting defendant Wright Medical.

Public Interest Groups Will Leverage ‘Bleeding Edge’ Lessons To Push For Device Safety Changes

Public health organizations including the Facebook group ASHES/E-Sisters, and the National Center for Health Research, are pushing for wider distribution of and a big impact from the "The Bleeding Edge" Netflix documentary. They tell Medtech Insight that they will continued to lobby Congress and US FDA to put more safety regulations and protocols into place for devices.

Related Content

UsernamePublicRestriction

Register

LL111109

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