Medtronic wins pain pump case on preemption | Legal News

April 19, 2012 by MassDevice staff

A federal appeals court upholds a legal win for Medtronic in a personal injury lawsuit filed after its SynchroMed EL pain pump left an Arizona man paralyzed.

Medtronic SynchroMed EL pain pump

Medtronic (NYSE:MDT) won another personal injury lawsuit based on the preemption doctrine it helped create in the U.S. Supreme Court's Riegel v Medtronic decision in 2008.

Preemption holds that patients can't sue medical device makers in state courts over products that went through the FDA's most stringent review process, called pre-market approval. But the justices left open a loophole to allow state suits that allege a "parallel claim" that the company in question broke FDA regulations.

In 2000, plaintiff Richard Stengel 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 an 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.

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The FDA approved the first SynchroMed pump in 1998 and later granted approval for the iteration used to treat Stengel. Medtronic recalled that device in 2008.

The U.S. Court of Appeals for the 9th Circuit upheld a lower court's ruling dismissing Stengel's case on preemption grounds, but the 3-judge panel's decision earned a sharp rebuke from a lone dissenter.