• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » Obama preempts preemption

Obama preempts preemption

May 21, 2009 By MassDevice staff

President Barack Obama issued a memorandum to the heads of federal departments and agencies preempting preemption, in a move that sets the stage for a drastic overhaul of the way product liability law is applied to medical devices.

The memo bars department heads from including statements of preemption in regulations they issue:

“[P]reemption of State law by executive departments and agencies should be undertaken only with full consideration of the legitimate prerogatives of the States and with a sufficient legal basis for preemption. Executive departments and agencies should be mindful that in our Federal system, the citizens of the several States have distinctive circumstances and values, and that in many instances it is appropriate for them to apply to themselves rules and principles that reflect these circumstances and values.”

The Supreme Court upheld the concept in Riegel v. Medtronic last year, ruling that medical device companies are shielded from product liability suits brought in state courts if the device in question was already approved by the Food & Drug Administration (thereby “preempting” the state rules).

But with Democrats in control of both houses of Congress and the White House, the memo adds another brick to the anti-preemption edifice already begun with the introduction of the Medical Device Safety Act of 2009, which would nullify the Riegel decision. And the court itself seemed to contradict its own decision in that case last March in Wyeth v. Levine, when it ruled that the pharmaceutical industry cannot claim preemption in liability suits.

The Obama memo also directs department heads to review regulations from the past 10 years “that contain statements … intended by the department or agency to preempt State law, in order to decide whether such statements or provisions are justified under applicable legal principles governing preemption.”

If preemption can’t be legally upheld in any of those cases, the agency in question must strip it from its rulebook.

For the full text of the memo, see the attachment below (PDF).

Filed Under: Business/Financial News, Legal News

More recent news

  • Imperative Care has positive stroke treatment study results
  • Medtronic enrolls first patient in study for Onyx liquid embolic system
  • Intuitive demonstrates remote telesurgery capabilities with da Vinci 5
  • BD issues voluntary recall on certain Alaris infusion pump modules
  • CVRx announces Medicare win for Barostim therapy

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy