Is Federal Preemption of Medical Device Claims Backfiring?
Today, we revisit the story of a West Virginia orthopedist who has injured and killed numerous residents of his state with his unmatched incompetence. ChicagoTribune.com reports that Biomet, Inc., parent company of EBI, the manufacturer of bone stimulators used by Dr. John King during many failed surgeries, has settled 24 out of 27 claims by [...]
New England Journal of Medicine Sides with Patients Against Medical Device Makers
An editorial in today’s New England Journal of Medicine laments the result of the Riegel v. Medtronic decision, based mostly on the NEJM’s concern that “preemption will result in medical devices that are less safe for the American people.” The editors point to the most recent example of preemption in action, in which a district court judge [...]
The FDA is broken. How can it be fixed?
In a recent NY Times article, reporter Barry Meier discussed Medtronic’s acknowledgment that some 13 deaths have been attributed to malfunctions of a device it manufactured –a small cable, known as the Sprint Fidelis, that connects an implanted defibrillator to the patient’s heart. Apparently, Medtronic knew the device was failing shortly after it reached the market in 2004, according to the [...]