Brayton Purcell LLP

Call For A Free Consultation
800-598-0314

Call For A Free Consultation 800-598-0314

Brayton Purcell LLP
  • Home
  • Firm Overview
    • Our Beliefs
      • Giving Back
      • Our Associations And Memberships
      • The Right To Trial By Jury
    • Regions Served
    • Careers
    • Our Employees Pets
    • Press Releases
  • Attorneys
  • Practice Areas
    • Mesothelioma/Asbestos
    • Personal Injury/Wrongful Death
    • Toxic Substances
    • Estate Planning
    • Other Areas Of Practice
  • Court Successes
    • Trial Verdicts
    • Appeals
  • Testimonials
  • Blog
  • Videos
  • Contact
  • Home
  • Firm Overview
    • Our Beliefs
      • Giving Back
      • Our Associations And Memberships
      • The Right To Trial By Jury
    • Regions Served
    • Careers
    • Our Employees Pets
    • Press Releases
  • Attorneys
  • Practice Areas
    • Mesothelioma/Asbestos
    • Personal Injury/Wrongful Death
    • Toxic Substances
    • Estate Planning
    • Other Areas Of Practice
  • Court Successes
    • Trial Verdicts
    • Appeals
  • Testimonials
  • Blog
  • Videos
  • Contact

Medical Device Lawsuits & Ensuring Product Safety

by Brayton Purcell LLP | Mar 6, 2008 | Defective Medical Devices, Legal News

Manufacturers of Unsafe Products Shielded by Supreme Court Ruling

WASHINGTON, DC — March 6, 2008 — The Supreme Court ruled in favor of limiting lawsuits on product liability. It will now be difficult for individuals to sue faulty medical products that have been approved by the U.S. Food and Drug Administration (FDA). The Supreme Court based its ruling on the fact that the FDA approval process requires manufacturers to prove the safety and effectiveness of their product. The ruling means state lawsuits on product liability are now barred because they would impose safety and effectiveness requirements that are different from federal law. With the shield of the FDA‘s approval, manufacturers will not be held responsible for personal injuries even if their products are unsafe.

The case heard last week, Riegel v. Medtronic, involved a patient whose catheter burst during a medical procedure and wanted to sue the medical device manufacturer, Medtronic. The question before the court was whether or not the patient could sue Medtronic under state law for a medical device that had been approved by the FDA. The opinion, written by Justice Antonin Scalia, will now severely limit a consumer’s ability to seek compensation for injuries that are a result of a federally approved medical device.

At least one justice, Justice Ruth Bader Ginsburg, did not agree with the Supreme Court’s overall opinion of placing business interests over the safety of individual consumers. Justice Ginsburg said that Congress never intended “a radical curtailment of state common-law lawsuits seeking compensation for injuries caused by defectively designed or labeled medical devices.” (WTOP News, February 20, 2008)

Rep. Henry Waxman (D-California) stated, “The Supreme Court’s decision strips consumers of the rights they’ve had for decades. This isn’t what Congress intended, and we’ll pass legislation as quickly as possible to fix this nonsensical situation.” (New York Times, February 21, 2008)

Medical Device Approval and the FDA

To receive approval from the FDA under current federal law, all the manufacturer of a medical device must show is the product’s safety and effectiveness to the FDA. Over the past three months, federal regulators have responded to more than 100 issues regarding unsafe medical devices. Independent groups such as The Institute of Medicine and the Government Accountability Office, as well as the FDA‘s science board, have reported poor management and scientific shortcomings within the FDA. Due to these apparent weaknesses, the FDA may be unable adequately to protect individuals against dangerous and unsafe medical devices, drugs, and food. As far back as 1997, the FDA‘s chief lawyer wrote in a brief, “even the most thorough regulations of a product such as a critical medical device may fail to identify potential problems.” (News Analysis, New York Times, February 21, 2008)

Brayton Purcell and Your Case

If you have a legal problem, we are here to help. You may contact us through this website or at any of our offices. We can arrange a convenient interview time and advise you of your legal rights. There is no charge for an initial consultation. We have offices in Portland, Oregon, in Northern California, in Southern California, and in Salt Lake City, Utah. We have been helping personal injury clients for over 24 years.

Recent Posts

  • Who is Most at Risk of Mesothelioma?
  • Boiler Room Workers and Asbestos Exposure
  • Mitigating the financial impact of mesothelioma treatments
  • The EPA’s difficulty with data disclosure
  • Judge orders EPA to close loopholes on asbestos-related reporting

Archives

Categories

RSS Feed

Subscribe To This Blog’s Feed

Free Consultation

Take The First Step In Resolving Your Issue. Send Us An Email.

Email Us For A Response

San Francisco
Bay Area Office

222 Rush Landing Road Novato, CA 94945

Novato Office
222 Rush Landing Road
Novato, CA 94945
Toll Free: 800-598-0314
Phone: 415-898-1555
Fax: 415-898-1247

Map & Directions

Southern California
Office

12 28th Street Venice, California 90291

Los Angeles Office
12 28th Street
Venice, California 90291
Toll Free: 800-598-0314
Phone: 415-898-1555
Fax: 415-898-1247

Map & Directions
  • Follow
  • Follow
  • Follow
  • Follow
  • Follow

© 2021 Brayton Purcell LLP. All Rights Reserved.

Disclaimer | Site Map | Privacy Policy | Business Development Solutions by FindLaw, part of Thomson Reuters

Review Us