Medtronic had hoped to overturn a lower court’s decision that Stengel’s claims were not preempted under federal law. Preemption, established in the Supreme Court’s 2008 decision in Riegel v. Medtronic, protects medical device makers from most liability claims against devices that were cleared under the FDA’s premarket approval pathway.
The Supreme Court did not issue a statement on the decision not to hear the case, but in comments issued last month the U.S. Solicitor General argued that Stengel’s claims are not preempted because they relate to the company’s conduct, rather than to defects with the product itself. The Solicitor General urged the court to deny the case, saying that a lower court had made the right call.
Medtronic issued its own statement shortly after, saying that U.S. solicitor general Donald Verrilli misinterpreted the precedents.
Medtronic has made several efforts to have the Stengel case thrown out under federal preemption laws and even won some early decisions. The 9th Circuit Court of Appeals in January 2013 ruled against Medtronic, with a panel of judges ruling unanimously that a case against the medical device giant and its implantable pain pumps may proceed.
According to the lawsuit, plaintiff Richard Stengel in 2000 began using Medtronic’s SynchroMed EL pain pump, an implanted device that delivers medication directly to the spine via an intrathecal catheter. In 2005, Stengel began developing symptoms of paralysis from inflammation in his spine around the catheter tip.
The device and most of the inflammation were removed, "but not in time to prevent the granuloma from rendering Stengel permanently paraplegic," according to court documents.
The FDA approved the 1st SynchroMed pump in 1998 and later granted approval for the model used to treat Stengel. Medtronic later recalled that device in 2008.
Medtronic in November 2012 also initiated a recall of its SynchroMed II drug pumps after finding higher-than-expected rates of failure when the devices were used with "unapproved drugs." The company recommended that healthcare providers use the SynchroMed II only with the drugs approved on the device’s labeling.