The lawsuit was filed by Richard Stengel, a man who was paralyzed in 2005. His injury was allegedly caused by the Medtronic SynchroMed EL pain pump, a device that delivers a continuous supply of medication directly into the spine. Unfortunately, the pain pump caused inflammation and a granuloma to develop in his spine.
In most cases, federal law preempts lawsuits against manufacturers of medical devices in situations that do not involve “failure to warn,” established by Riegel v. Medtronic in 2008. However, Stengel’s lawsuit was allowed to proceed by a lower court. U.S. Solicitor General Donald Verrilli argued that Medtronic’s conduct was at issue rather than defects with the pain pump.
The SynchroMed EL pain pump was approved by the U.S. Food and Drug Administration (FDA) in 1998. A decade later, it was recalled after Medtronic discovered that it could stall and fail to deliver medicines to a patient.
Medtronic also recalled the SynchroMed II pain pump in November 2012. They found a 7% failure-rate when the device was used with unapproved medications. The recall was issued just a few months after the FDA warned Medtronic that their failure to address complaints could jeopardize patient safety. Click here to read more.