June 23, 2014 — MassDevice reports that a pain pump lawsuit will move forward after the Supreme Court denied an appeal by Medtronic.
The lawsuit was filed by Richard Stengel, a man who was paralyzed after being treated with the Medtronic SynchroMed EL pain pump. The device delivered medication directly into his spine.
In 2005, Stengel developed symptoms of paralysis caused by inflammation. The pain pump was removed, but not in time to prevent Stengel from becoming permanently paralyzed.
Federal law normally preempts most liability claims against medical device manufacturers who adequately warn about side effects. However, a lower court ruled that Stengel’s claims were not preempted.
U.S. Solicitor General Donald Verrilli argued that preemption did not apply because Stengel’s claims related to the company’s conduct, rather than defects with the pain pump.
The FDA approved the SynchroMed EL pain pump in 1998. The device was recalled in February 2008 because the motor could stall and stop delivering drugs to a patient.
Since then, the FDA has granted approval to new SynchroMed pain pumps. Unfortunately, the SynchroMed II was recalled in November 2012 because it could fail when used with unapproved drugs. The device was linked to a 7% failure-rate when used with unapproved drugs.
The FDA also issued a warning to Medtronic for failing to adequately address customer complaints. Click here to read more.