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US Pre-emption ruling could damage innovation says HIMA

This article was originally published in Clinica

Executive Summary

In a decision that could adversely affect every US medical device manufacturer, all nine judges of the US Supreme Court on June 26th agreed that the FDA's imprimatur does not protect companies from product liability suits in state courts. In their review of the legal arguments in the Medtronic vs Lohr case, in which the plaintiff is seeking damages for an allegedly faulty pacemaker lead, the judges ruled against Medtronic's pre-emption claims of 510(k) products covered under FDA regulation (see Clinica No 703, p 7).

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