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.
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:
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
In Their Own Words