Contact: Cecelia Prewett
Washington, DC—A new Food and Drug Administration (FDA) public health notification shows a higher death rate after five years among patients treated for abdominal aortic aneurysm with Medtronic Inc.’s Aneu-Rx stent-graft system than among those treated through conventional surgery.
The recent U.S. Supreme Court ruling in Riegel v. Medtronic, Inc. limited the rights of people to receive justice through the legal system when harmed by medical devices such as Aneu-Rx.
The following is a statement from American Association for Justice VP of Strategic Communications Cecelia Prewett:
“This latest FDA announcement once again shows the dangers of preemption.
“Preemption eliminates accountability through the civil justice system. The Riegel decision destroys any incentive for Medtronic to make Aneu-Rx safer or more effective.
“State remedies are designed to complement, not conflict with, federal health and safety regulations. Congress should take the lead in ensuring federal regulatory agencies are following Congressional intent and not preempting state tort remedies.”
For a copy of AAJ's comments, please contact Communications at firstname.lastname@example.org or 202.965.3500, x369.