In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturers of certain medical devices approved by the Food and Drug Administration (FDA)’s pre-market approval process are immune from liability, even when the devices are known to be defective.
The Court cited the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act, saying it had established a federal regulatory process for ensuring the safety of medical devices. As a result of the Riegel decision, thousands of cases of patients injured by defective medical devices are being dismissed. This leaves consumers, insurance companies,
and the government stuck paying for a manufacturer’s defect.
Restoring Access to Courts for Medical Device Patients
Federal lawmakers have introduced the Medical Device Safety Act (HR. 1346 / S. 540) to restore the rights of injured consumers to hold negligent medical device manufacturers accountable when their products prove defective, causing injury and even death.
State tort suits provide an added layer of consumer safety by encouraging manufacturers make safe products. The government doesn’t have all the necessary resources to see that all drugs and medical devices are safe, and relies on the manufacturers to provide accurate safety data.
In 2009, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can hold manufacturers accountable in state courts. This creates a disturbing double standard between prescription drugs and medical devices.
See other individuals injured by defective medical devices:
Background
Faces of Defective Medical Devics 
The Facts—The History of Complete Immunity Preemption
The Facts - Studis Offer Evidence of Flawed Device Oversight
Medical Device Safety Act—Myths v. Facts
Research
Examinging the Sprint Fidelis Effect on Medicare Costs - This new report by BYU Professor H. Dennis Tolley says taxpayers are forced to py the bill for device manufacturer negligence
Get Out Of Jail Free: How the Bush Administration Helps Corporations Escape Accountability
In Their Own Words
Quotes on Complete Immunity Preemption From the News Media
Quotes from Experts in Leading Medical Journals Highlights Dangers of Complete Immunity Preemption
Quotes from the Congressional Testimony of Dennis Quaid
Quotes from the Congressional Testimony of Leading Experts on FDA Complete Immunity Preemption
