The New York Times ran an interesting article today pointing out that the decision to remove the troublesome Medtronic Sprint Fidelis device from the market does nothing to assist the tens of thousands who have already had the device installed. Such people face the difficult choice of an additional dangerous heart surgery, or to continue to live with a potentially fatal device installed in their heart. The Times reports that four people have already died during the extraction process.
Yet despite the associated deaths and the high fail rate on these devices, Medtronic has been largely shielded from lawsuits thanks to the Supreme Court decision in Reigel v. Medtronic. The Supreme Court barred common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA. The lack of testing performed on the device is seemingly irrelevant, so long as it received premarket approval from the FDA.
Democratic lawmakers are already considering a move to enact legislature reversing this decision.
Yet despite the associated deaths and the high fail rate on these devices, Medtronic has been largely shielded from lawsuits thanks to the Supreme Court decision in Reigel v. Medtronic. The Supreme Court barred common-law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA. The lack of testing performed on the device is seemingly irrelevant, so long as it received premarket approval from the FDA.
Democratic lawmakers are already considering a move to enact legislature reversing this decision.
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