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Court says Arizona man paralyzed by pain pump can sue device maker

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Friday, Jan. 11, 2013
By Mary Shinn
Cronkite News

WASHINGTON – A federal appeals court has ruled that an Arizona man left permanently paralyzed by a surgically implanted pain pump can sue the pump manufacturer.

The ruling Thursday by the 9th U.S. Circuit Court of Appeals reverses an April decision by a panel of the same court, which had held that federal law prevented Richard Stengel from suing Medtronic.

The most-recent decision could finally allow Stengel to sue the company in connection with his injuries.

Stengel had a Medtronic pain pump implanted in 2000, but by 2005 he began experiencing symptoms of paralysis in his lower limbs. The paralysis was caused by a granuloma, or a type of inflammation, in his spine that formed at the tip of the catheter, according to court documents.

The court said Medtronic was not aware of any problems when it received Food and Drug Administration approval for its pump. By time Stengel was paralyzed, however, the company “had become well aware of those risks,” the court wrote.

But Medtronic did not inform the FDA of any problems with the pump. Instead, the agency discovered the risks after inspecting Medtronic plants in 2006 and 2007. Medtronic issued a recall in 2008, after the FDA issued a warning letter, court documents said.

Stengel, now a paraplegic, sued. But Medtronic’s lawyers argued the company could not be sued under state law because the FDA previously approved the devices and that federal law pre-empted state-law claims.

A divided three-judge panel of the circuit court agreed with Medtronic in April. But after reviewing the panel’s decision, the court this week said Medtronic can be sued. The failure of the company to inform the FDA of possible problems with the pump makes it liable, said the court, in an opinion written by Judge William Fletcher.

Thomas Cotter, Stengel’s attorney, refused to comment on the case.

Medtronic said in a prepared statement that it still believes there is a case on the grounds of federal pre-emption, but it would not discuss the next steps in the case.

“We believe we will ultimately prevail in this matter and are examining all of our options in light of the court’s decision,” Medtronic spokesman Justin Ihle said in a written statement.

The case has also drawn interest from state attorneys general, six of whom joined in a brief in support of Stengel’s position.

Washington Assistant Attorney General Lisa Erwin, who filed the brief, said this week’s ruling encourages legal action against companies that have not informed the FDA of medical device problems or that are misrepresenting their products.

Erwin said she asked the other states – Hawaii, Idaho, Montana, Nevada and Oregon – for their support because federal pre-emption has a “chilling effect” on such litigation against makers of faulty medical devices.

This ruling strengthens state consumer protection laws and the right of consumers to file cases, Erwin said.

“The states have a right to look at this issue because it affects the health and safety of citizens,” she said.