[May 15, 2015]

North Carolina Widow Calls on Medical Device Manufacturers and the FDA to Treat Patients as Their Highest Priority

Carla Warner of Statesville, North Carolina, yesterday provided emotionally powerful testimony to a U.S. Food and Drug Administration Advisory Panel on the devastating impact of carbapenem-resistant Enterobacteriaceae (CRE) on her husband, Willie "Bill" Warner. The Panel was convened to examine the safety of certain medical scopes, called duodenoscopes, which have been linked to the outbreak of superbug infections at hospitals nationwide. Following routine Endoscopic Retrograde Cholangiopancreatography (ERCP), a procedure undergone by over 500,000 Americans annually, Bill Warner developed antibiotic drug-resistant CRE. His procedure used the widely sold model TJF-Q180V duodenoscope, manufactured and sold by Olympus America, Inc.

Following routine Endoscopic Retrograde Cholangiopancreatography (ERCP), a procedure undergone by over 500,000 Americans annually, Willie "Bill" Warner of Statesville, North Carolina, developed a drug-resistant superbug infection and died in 2013. His procedure used the widely sold model TJF-Q180V duodenoscope, manufactured and sold by Olympus America, Inc. (Photo: Business Wire)

"Bill fought the infection courageously for over eight months, enduring excruciating pain and horrific injuries before ultimately losing his battle. He was only 55 years old when he died," Carla Warner testified.

"During Bill's long battle I watched as a man who was once strong and innovative -- a concrete mixer driver -- become unable to do even the simplest tasks himself, Carla Warner explained. "I watched him lose 60 pounds in a matter of months despite the tube feedings I ran every day. I saw his knuckles turn white from clenching the sheets in unbearable pain. I listened to him gasp for air as his O2 (News - Alert) levels plummeted and heard him cry out begging me not to leave his side due to the hallucinations he experienced in his delirium."

In 2010, Olympus redesigned and replaced its TJF-Q160V duodenoscope with the TJF-Q180V duodenoscope. One significant design change from the earlier model was that the 180V scope has a sealed feature on the device, known as the "elevator wire channel."

In litigation brought against Olympus by families whose loved ones died from infections after undergoing ERCP using a 180V scope, the complaints charge that bacteria can become lodged in the device's sealed elevator wire channel. The 180V scope's elevator wire channel is not accessible for cleaning and disinfection during reprocessing, and thereby can serve as a source for the spread of deadly superbug CRE infections between patients.

While Olympus began selling the 180V scopes in 2010, despite modifications that had clear safety implications, the company did not seek FDA approval or clearance until late 2013 or early 2014, a delay of 3 years. Nevertheless, in 2012 Olympus warned European safety regulators of contamination and infection risks posed by the 180V scopes. In her testimony, Carla Warner stated: "Olympus knew of the risk but hid that information from the FDA and from medical providers, disregarding the safety of the people they were claiming to help while continuing to make a profit at their expense."

"As a medical device manufacturer, Olympus has an obligation to develop, test, and validate the safety of its products prior to selling them. Had Olympus done this, we believe it would have learned of the heightened risk of the spread of deadly bacterial transmissions from its 180 scope," stated attorney Lexi J. Hazam, of the national plaintiffs' law firm Lieff Cabraser Heimann & Bernstein, LLP, which represents Carla Warner.

In concluding her testimony to the FDA panel, Carla Warner stated, "It is my hope that my presence will in some way help to stress the importance of change in the way the manufacturers conduct business and the FDA's regulation of same. This is truly a call to arms, and I implore each and every one of you to join me to effect change in a system that failed my husband and left me a widow way too early in life."

Answers to common questions on the CRE superbug outbreaks, and legal resources for affected patients and their families, can be found at lieffcabraser.com/superbugs.

Photos/Multimedia Gallery Available: http://www.businesswire.com/multimedia/home/20150515005492/en/

[ Back To TMCnet.com's Homepage ]