When we go to the doctor or have a surgical procedure performed, we expect the physicians and nurses who perform the appointment or procedure to use the appropriate care. This includes not only the performance of the procedure but also preparing for it and preventing unnecessary infections. This same standard also applies to medical device manufacturers when it comes to designing and producing devices that mitigate against unnecessary harms like contamination and infection.
Recently, medical device manufacturer Olympus initiated a recall after reports stated that 100 patients became ill with antibiotic-resistant superbugs. The patients all were treated with one of Olympus’ medical devices, called a duodenoscope, which is a camera used in surgeries. According to several reports, Olympus makes roughly 85 percent of the duodenoscopes that are available on the market today.
The device is used to provide physicians and surgeons with an internal view of the body. It features a flexible tube and a light and is commonly used to diagnose conditions concerning the bile ducts and the pancreas. Between uses, the flexible tubing and the light must be disinfected to prevent the next patient from being exposed to the prior patient’s bacteria. Reports have indicated that the duodenoscope is virtually impossible to effectively disinfect between surgical procedures. As a result, hundreds of patients have been exposed to countless forms of bacteria, including the antibiotic-resistant strain known as carbapenem-resistant Enterobacteriaceae (CRE).
A Congressional report suggests that Olympus may have failed to comply with the FDA when it came to reviewing, approving, and investigating the potential design defects associated with its duodenoscopes. Other evidence has suggested that Olympus knew about the health risks associated with the devices as early as 2012 and that instead of initiating a recall or taking action, it may have increased its production of the devices. The U.S. Department of Justice is conducting an ongoing investigation into whether Olympus violated any laws or otherwise acted improperly in relation to the devices and their potential to cause patients harm.
The U.S. Food and Drug Administration has recently given its approval for a new version of the Olympus duodenoscope that includes new instructions and other design modifications that are intended to reduce the risk of cross-contamination. Despite these modifications, patients who become ill as a result of being exposed to earlier versions of the duodenoscope or the newest version with modifications can bring a claim against Olympus for their injuries and damages. To recover damages, a plaintiff must show that the device was unreasonably dangerous or that the manufacturer failed to provide appropriate instructions and warnings with the product.
At the Law Offices of John S. Moffa, we can assist Massachusetts residents with bringing product liability claims against a large company after becoming injured. It may seem intimidating to go up against a large medical device maker, but we have the experience and passion it takes to ensure that your rights are asserted at every step of the way. We offer a free consultation to help you learn more about product liability claims and the categories of compensation that may be available to you. Call us at 1-800-446-4485 or contact us online to set up your appointment today.