An epidemic of failed metallic hip implant cases is growing. Thanks to the United States Supreme Court patients will have no remedy in tort. By 7-2 vote in Riegel v. Medtronic (2008) the court ruled - in an opinion by Antonin Scalia - that a tort judgment that an FDA-approved medical device was negligently designed is barred because state product liability law for design defect is preempted by a federal statute - 21 USC 360k which says that a state may not impose a "requirement" which is "different from or in addition to" one imposed by the FDA.
But as Justice Ruth Ginsburg pointed out in dissent the FDA does not know what alternative safer designs were reasonably available to the manufacturer. The design choice therefore remains the manufacturer's, not that of the U.S. Food & Drug Administration. - GWC
A Scramble for Solutions as a Hip Device Fails - NYTimes.com:"[A]t hospitals nationwide...a growing number of patients seek to have faulty metal-on-metal artificial hips removed and replaced. More than a decade ago, some researchers had warned that the hips shed tiny pieces of metallic debris that posed potential health threats to patients. But those warnings were not heeded, and now doctors and patients face a growing public health problem as one of the country’s biggest medical device failures unfolds."
'via Blog this'
