Lawsuit Alleges Pentax was Negligent with Scope Design, Liable for Patient Death

A lawsuit has been filed in state court in Cook County, Illinois alleging that Pentax Medical, a division of Pentax of America, is liable for the death of a woman who died of a superbug infection after underoing a procedure with a duodenoscope. The August 31 lawsuit alleges that the scope was defectively designed, making it difficulty to sterilize. Duodenoscopes are snaked down the esophagus and into the small intestine to diagnose and treat gastrointestinal conditions. The devices have come under scrutiny following several outbreaks of infection from antibiotic-resistant bacteria.

The lawsuit was filed on behalf of the estate of a woman who died of infection with carbapenem-resistant Enterobacteriaceae (CRE) after undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) at Advocate Lutheran General Hospital in the Chicago suburb of Park Ridge, Illinois. The suit alleges that the hospital failed to adequately clean the scopes, leading to infections in 43 other patients.

There was a superbug outbreak at Advocate Lutheran General in 2013. Last year, the CDC confirmed 38 cases of CRE at the hospital in patients undergoing ERCP between January and September 2013.

Superbug outbreaks more recently occurred at Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center, both located in Los Angeles.

In February, the U.S. Food and Drug Administration (FDA) warned that the complex design of duodenoscopes can prevent them from being adequately sterilized, and that the devices could transmit antibiotic-resistant bacteria between patients. Last month, the FDA sent warning letters to scope makers Olympus, Pentax and Fujifilm for either failing to adequately report problems or failing to validate their cleaning methods.