Bacterial Infections linked to Duodenoscopes: The Role of Device Makers, Hospitals, and the FDA

The Chicago Products Liability attorneys of Zneimer & Zneimer P.C. take note of a lawsuit filed in Cook County extending from the use a medical device alleged to have caused the wrongful death of a patient. As reported by the Tribune, the lawsuit claims that 82-year-old Renate Winkler died after a contaminated duodenoscope used in a procedure performed at Park Ridge’s Advocate Lutheran General Hospital caused her to contract an antibiotic-resistant bacteria called carbapenem-resistant enterobacteriaceae (CRE). The lawsuit alleges negligence on behalf of both the device manufacturer (Pentax) as well as the hospital (Advocate). This incident was not isolated, though. In fact, the spread of deadly superbugs linked to duodenoscope contamination has been the subject of several claims, not only against this particular hospital and/or this particular manufacturer, but in hospitals nationwide and against other duodenoscope manufacturers. What’s more, the FDA is now examining the role of duodenoscope infections, including potential reporting, tracking, and regulatory enforcement issues.

In order to better understand the legal and public health issues raised by contaminated duodenoscopes, it is first helpful to know a little more about the device. A duodenoscope is a device inserted into the mouth and down the throat used to examine the duodenum, which is the first part of the small intestine beyond the stomach. The problem with these devices, according to reports, is the difficulty in accessing certain components that prevent proper and effective maintenance, cleaning, and sterilization. Contaminated duodenoscopes can lead to deadly drug-resistant infections, particularly CRE which has a 40% mortality rate.

Where the duodenoscope contamination issue becomes more controversial is in considering who, if anyone, failed the patient—the hospital, the manufacturer, the FDA, or a combination thereof? Some feel that the manufacturer should be held liable for defectively designing a product that could not be properly cleaned, and then failing to file reports with the FDA upon discovering safety risks associated with the device. Some feel that hospitals failed to properly sterilize devices and/or failed to take measures to address issues with the scope even after becoming aware of the risk of infection. Some place blame on the FDA for shortcomings in its reporting process system.

It seems a compelling argument can be made against all three.

Consider the 2008 CRE outbreak in Florida in which at least 70 patients were infected, 15 of which died, after receiving a procedure that used a duodenoscope. At the time, blame was placed on the hospitals for failing to properly clean the devices. By 2012, similar outbreaks in several other states prompted further investigation which suggested that initial conclusions regarding the Florida outbreaks may have been in error, and that the core of the problem might reside in defective design, as opposed to hospital negligence.

Upon further investigation, it was discovered that makers of this medical device, primarily Olympus, Pentax Medical, and FujiFilm, either failed to disclose outbreaks to the FDA, or did so after the 30-day reporting requirement. The FDA relies on Medical Device Reports (MDRs) in determining whether it is necessary to recall a device, issue an alert or advisory, investigate the issue further, or take other action to address the issue.

Many argue that the MDR tracking system is flawed because the FDA has almost no way of knowing whether a manufacturer failed to file a report, leaving discovery of a potential safety issue to happenstance (i.e. through agency audit/inspection of device makers; awareness created by hospital reports, medical professionals, safety groups and/or the media). The FDA itself has even acknowledged that the number of MDRs for duodenoscope-related patient infections do not account for all scope-related CRE outbreaks. Even more troubling–when a manufacturer is found to be in violation of a MDR reporting requirement, the consequence is often only a warning letter, as opposed to a harsher penalty that could deter device makers from committing violations in the future.

We must also consider the hospital’s role as well. Take Advocate, for example. There have been at least three other lawsuits filed against this hospital and Pentax (one of the makers of the device), suggesting that the hospital was possibly aware of the problem, yet continued to use the device without taking sufficient cautionary measures. The same applies to several other hospitals that experienced similar outbreaks. According to a USA TODAY investigation, duodenoscopes have been linked to the transmission of drug-resistant bacteria in at least 8 U.S. hospitals between 2012 and 2014. Some claim that financial burdens have prevented hospitals from implementing solutions, such as purchasing additional devices and hiring/training more staff to adhere to new cleaning/testing protocols.

In returning to our previous inquiry—did device makers, hospitals, or the FDA fail the patient? There appears to be an intricate relationship between each. Manufacturers designed a device that the FDA approved and that hospitals began to purchase and use. Thereafter, initial outbreaks focused on hospital cleaning techniques, but further examination revealed potential design defects, device maker reporting violations, as well as tracking and enforcement flaws within the FDA’s MDR system.

If you were injured, or a loved one was killed, after receiving a procedure that used a duodenoscope or another medical device, the Chicago Personal Injury attorneys of Zneimer & Zneimer P.C. want to review your matter and discuss your rights to compensation. Our unique combination of litigation knowledge, including matters involving product liability and hospital negligence, along with our decades of trial experience, are attributes that set us apart from other lawyers. Call us at 773-516-5100, or contact us online. We are here to help.