Lawsuit charges negligence by medical device manufacturers Olympus America, Olympus Medical Systems Corp., and Custom Ultrasonics led to Mr. Warner contracting a fatal infection from a routine endoscope procedure commonly undergone by tens of thousands of patients every year
November 20, 2015, San Francisco, CA — Lexi J. Hazam of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announced that Carla Warner, the widow of Willie Warner, Jr., as administrator of his estate, has filed a wrongful death lawsuit against Olympus America, Olympus Medical Systems Corp., and Custom Ultrasonics.
On November 24, 2013, Willie Warner lost his life after a long and painful battle with an antibiotic-resistant bacterial infection following a routine procedure known as an Endoscopic Retrograde Cholangiopancreatography (“ERCP”) at Carolinas Medical Center (“CMC”) in Charlotte, North Carolina. During an ERCP, a medical device known as a duodenoscope is inserted into the patient’s throat. It is used to visualize and treat certain problems of the biliary and pancreatic duct systems, such as gallstones. The duodenoscope used on Mr. Warner on or about January 11, 2013, was the Olympus TJF – Q180V (the “Olympus 180”), manufactured by Olympus America, Inc. and Olympus Medical Systems Corp. (“Olympus”).
As alleged in the complaint, the Olympus 180 used on Willie Warner was contaminated with deadly “superbug” bacteria known as Carbapenem-resistant Enterobacteriaceae (“CRE”) and transmitted that CRE to Mr. Warner, causing a virulent infection that eventually killed him. The complaint further alleges that this would not have happened if Olympus had designed the 180 to be safe or warned hospital personnel that the device could not be adequately cleaned.
As Ms. Warner’s complaint goes on to state, CMC cleaned its duodenoscopes, including the Olympus 180 used on Mr. Warner, with an automated endoscope reprocessor (a cleaning device also known as an “AER”) manufactured by Custom Ultrasonics, Inc. (“Custom Ultrasonics”), and that the Customs Ultrasonics device used to clean the Olympus 180 used on Mr. Warner did not adequately disinfect or sterilize the unit.
Mr. Warner suffered horribly from his CRE infection for over eight months before succumbing to its agonies. He endured excruciating pain, lost 60 pounds, was repeatedly hospitalized, required a feeding tube, required external wound drainage, and suffered delirium and oxygen deprivation. Because of the highly-contagious nature of his infection, Mr. Warner was isolated and deprived of the comfort of his friends and family during his illness. He went from a once-strong truck driver to being weak and frail, unable to perform any tasks himself.
“Bill fought the infection courageously for over many months, enduring excruciating pain and horrific injuries before ultimately losing his battle. He was only 55 years old when he died,” stated plaintiff Carla Warner.
Subsequent to Mr. Warner’s tragic and unnecessary death, both the endoscope and the AER cleaning device were the subject of safety alerts from the U.S. Food and Drug Administration. On February 19, 2015, the FDA issued a Safety Communication warning that the inherent design of ERCP endoscopes, including the Olympus 180, impedes effective cleaning, and that multi-drug-resistant bacteria may be transmitted by the endoscope even when the manufacturer’s instructions are correctly followed. On November 13, 2015, the FDA issued another safety communication finding that Custom Ultrasonics had “not demonstrated that its AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection.” The FDA has demanded that Custom Ultrasonics recall its AERs and recommended that all healthcare facilities transition from using the Custom Ultrasonics AERs to alternative cleaning methods.
The complaint charges that the Olympus duodenoscope was defectively designed, resulting in parts of the instrument being extremely difficult to access for cleaning and sterilization, and that as a result of this design defect and the ineffective cleaning by the Custom Ultrasonics AER, Mr. Warner received the super-infection that devastated his health, killing him slowly and agonizingly over the next 8 months.
Carla Warner further explained, “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. 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 levels plummeted and heard him cry out begging me not to leave his side due to the hallucinations he experienced in his delirium.”
“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 rather than sell a defective and unreasonably dangerous device, Willie Warner would not have been infected and would be alive today,” stated Hazam. “Likewise, Custom Ultrasonics shares in the legal responsibility for the devastating impact of the CRE infection Mr. Warner contracted.” Contamination with CRE of a medical instrument used upon a patient in a hospital does not ordinarily happen in the absence of negligence, the suit charges.
The lawsuit was filed on November 20, 2015, in United States District Court in the Eastern District of Pennsylvania, where Custom Ultrasonics and Olympus America are located. Mr. Warner was a resident of Statesville, North Carolina.
Legal Resources For Medical Scope Patients and Their Families
Answers to common questions on the CRE superbug outbreaks, and legal resources for affected patients and their families, can be found on Lieff Cabraser’s endoscope superbug injuries web page.
If you or a family member developed CRE or another superbug following an endoscopic procedure, please complete our superbug injury contact form to reach out to an experienced injury lawyer at Lieff Cabraser. There is no charge or obligation for our review of your case.
About Lieff Cabraser
Recognized as “one of the nation’s premier plaintiffs’ firms” by The American Lawyer, Lieff Cabraser Heimann & Bernstein, LLP is a sixty-plus attorney law firm with offices in San Francisco, New York, and Nashville. Our firm has successfully represented thousands of patients across America in individual lawsuits due to the injuries they suffered from defective medical devices. U.S. News and Best Lawyers have named Lieff Cabraser as a 2016 “Law Firm of the Year” for representing plaintiffs in class actions and mass torts.
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Lexi J. Hazam
Lieff Cabraser Heimann & Bernstein, LLP