Navigation Links
Amicus Brief Filed with U.S. Supreme Court in Riegel v. Medtronic, Inc.

Filed in Support of Federal Pre-Emption in Riegel v. Medtronic, Inc.

WASHINGTON, Oct. 22 /PRNewswire-USNewswire/ -- Leading a group of concerned organizations, the Advanced Medical Technology Association (AdvaMed) filed a joint amicus brief Friday in the U.S. Supreme Court in the matter of Riegel v. Medtronic, Inc. arguing that the FDA should continue to be the sole regulator of medical devices. The brief states that no other legislative or regulatory entity is better positioned than the Food and Drug Administration to ensure the timely access to safe and effective medical devices.

The brief also contends allowing a state-law liability approach to assessing safety and effectiveness would lead to reduced patient access to essential medical technologies.

Joining AdvaMed are DRI, Medmarc Insurance Group and the Medical Device Manufacturers Association.

"The safety and efficacy of medical technologies are best determined by FDA scientists -- not by lawsuits filed in courtrooms throughout the country. It was the specific intent of the U.S. Congress that the FDA be responsible for the timely approval of safe and effective medical technologies. Encouraging states to insert state court liability suits into the process would undermine the science-based approach to approvals currently in place and would likely result in inconsistencies in standards and delayed access to products," said Christopher White, AdvaMed Executive Vice President and General Counsel.

Two previous rulings in this case have made clear that the Medical Device Amendments (MDA) to the Federal Food Drug and Cosmetic Act (FDCA) expressly provides for FDA's ultimate regulatory authority in these matters.

"We hope the Supreme Court re-affirms the two previous lower court rulings and prevents any erosion in FDA's existing regulatory approval authority," said White.

Other key arguments made in the filing include:

-- FDA currently exercises substantial pre-marketing oversight of medical devices;

-- Enhanced state-law liability would interfere with FDA's extensive pre- and post-marketing oversight of medical devices, not fill a regulatory "gap";

-- State tort liability would stifle the innovation of important and life-saving medical devices and would undermine the affordability of medical treatments; and

-- State tort liability would encourage defensive labeling and over-warning that undermines rational prescribing by physicians.

Counsel for Amici Curiae include Daniel E. Troy, former Chief Counsel at the FDA, and Carter G. Phillips, former Assistant to the Solicitor General, both Partners at Sidley Austin LLP.

AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit

SOURCE Advanced Medical Technology Association
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. A brief Intervention Might Help To Deal With Depression
2. Brief Intervention on HIV and Alcohol Risk Encourages Safer Sex
3. Multi billion-dollar suit filed against cell phone firm for causing brain tumours
4. Finland and India to interact and cooperate in the filed of telemedicine and biotechnology
5. Public Interest Litigation Filed Favoring Mineworkers Against Silicosis
6. Suit Filed Against Horrors of Psychiatric Ward in New York Hospital
7. Suit Filed Against Horrors of Psychiatric Ward in New York Hospital
8. Supreme Court Quashed Reservation Quotas For PG Medical Courses
9. Supreme Court Verdict Gives Hope to Striking Medicos
10. Supreme Court Warns Medicos of Contempt Action
11. Supreme Court Verdict Gives Hope to Striking Medicos
Post Your Comments:
(Date:11/30/2015)... ... November 30, 2015 , ... Newly reviewed and approved “NJ ... graduated from Tufts School of Dental Medicine in 1935. His father graduated from ... family being in dentistry as well as their commitment and passion to the Practice ...
(Date:11/30/2015)... ... November 30, 2015 , ... The ... National Poison Data System (NPDS) reveals that in 2014, someone called a poison ... over two million of which were human exposure cases. , The American Association ...
(Date:11/30/2015)... ... , ... Two years ago, Debbie Gregory, the CEO of, found herself ... Meditation (TM). After encouraging a number of veterans to go through the program, ... the talk. , TM is becoming one of the best alternative treatments for Post-Traumatic ...
(Date:11/30/2015)... ... ... The American Society for Clinical Pathology (ASCP) announced today that it has launched ... ASCP shared its “Give a minute. Get tested. Find a cure.” icon and infographic ... tested for HIV. , ASCP has asked members to replace their Facebook, Twitter, or ...
(Date:11/30/2015)... Beach, FL (PRWEB) , ... November 30, 2015 ... ... of Consumer Reports magazine, quoted Michael Hansen, Ph.D., a senior scientist at Consumer ... and even more so for a child’s exposure limits. , The original Nov ...
Breaking Medicine News(10 mins):
(Date:11/30/2015)... REHOVOT, Israel , Nov. 30, 2015 ... focused on acquiring and developing innovative therapies for ear, ... of Keith A. Katkin as chairman of ... Flesher , chief executive officer for OticPharma, Ltd.  "Keith ... As chairman, he will be able to share this ...
(Date:11/29/2015)...  Strengthening its leadership in connected healthcare informatics, ... IntelliSpace Portal 8.0 , the latest edition of ... helps radiologists detect, diagnose and follow-up on treatment of ... North America Annual Meeting (RSNA) in ... the changing demands in radiology that result from an ...
(Date:11/29/2015)... GE Health Cloud 1 was unveiled today at the ... America (RSNA) meeting in Chicago ... ecosystem and its applications will connect radiologists and clinicians to ... – both inside and outside the hospital setting. ... the digital industrial leader, we are betting big on the ...
Breaking Medicine Technology: