A cardiologist testifying before a House Energy and Commerce Subcommittee has testified in favor of passage of the Medical Devices Safety Act of 2009. Dr. William Maisel, of Beth Israel Deaconess Medical Center in Boston, who chairs a Food and Drug Administration (FDA) advisory panel, noted that 10 million patients have implanted devices and that it is apparent that additional consumer safeguards are needed.
Under current U.S. law, drug companies are liable if their products cause harm, but many device makers are not. In a 2008, 8-to-1 U.S. Supreme Court decision (Reigel v. Medtronic), the justices ruled that if a device had received premarket approval from the FDA, the manufacturer was protected from liability and that individuals injured by the device could not sue the manufacturer for damages. Since that ruling, lower courts have thrown out more than a thousand cases seeking damages. The proposed bill would provide injured patients with legal recourse if they are injured by a malfunctioning implanted device.
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