The FDCA has a provision which expressly preempts state regulations that contradict federal regulatory decisions. Justice Scalia (and a 7-2 majority of the Supreme Court) read that broadly to bar design defect claims against FDA-cleared devices in Riegel v. Medtronic.
The Institute of Medicine's report The Future of Drug Safety made clear the FDA is neither designed to nor is it competent to determine what design choices the manufacturer could have made. Its passive role is as gatekeeper not designer. The FDA's definition of safe and effective is an unquantified "net benefit" - "better than placebo". Yet the Court found that state product liability actions are barred because FDA approval of a new device essentially satisfied the "reasonably safe product" duty imposed on sellers by state common law.
Lower courts promptly barred claims even for admittedly defective cardiac defibrillators. In re Medtronic, Inc., Sprint Fidelis Leads Product Products Liability Litigation, 592 F. Supp. 2d 1147 (D. Minn. 2009) (MDL Proceeding)
Now Henry Waxman, sponsor of H.R. 1346 - the Medical Device Safety Act of 2009 - proposes to reverse that decision. (see Open Congress status widgets below)
House Energy and Health subcommittee hearings were held May 12. The complete record including videos and prepared testimony can be found here.