WASHINGTON, DC— Senator Edward M. Kennedy, Chairman of the Health,
Education, Labor and Pensions Committee, released the following statement today in
response to the Supreme Court’s ruling in Riegel v. Medtronic, which prevents injured
patients from suing manufacturers of FDA-approved medical devices.
“In enacting legislation on medical devices, Congress never intended that FDA approval
would give blanket immunity to manufacturers from liability for injuries caused by faulty
devices. Congress obviously needs to correct the court’s decision. Otherwise, FDA
approval will become a green light for shoddy practices by manufacturers.”