Endoscope Infection Legal News Articles & Interviews

Washington, DC: Public Citizen is an internationally-recognized consumer advocacy group founded by perhaps the original consumer advocate, Ralph Nader. He’s the guy who railed over the safety of cars, and advocated for seat belts. And today, the organization he founded holds, amongst other things, the feet of the pharmaceutical and medical device industries to the fire over safety and efficacy. Whenever an endoscope lawsuit, for example, appears on a court docket you have to know that Public Citizen is watching in the wings. They have even launched lawsuits themselves, taking both manufacturers and the federal regulator to task.

Washington, DC: The US Food and Drug Administration (FDA) has provided the medical community with guidance on the use of ultrasonic surgical aspirators. Specifically, the agency is advising companies that make the devices to label them as contraindicated for the removal of uterine fibroids. The non-binding guidance from the agency serves to strengthen its recent warnings about the use of power morcellators to remove uterine fibroids.

Washington, DC: Many an endoscope lawsuit have alleged injury, or even death when a reusable endoscope or duodenoscope has passed potentially harmful infections between patients due to an inability to be thoroughly cleaned and sterilized. Plaintiffs have alleged everything from defective design, to a lack of training and inadequate cleaning procedures inherent with optimum disinfection protocols.

Seattle, WA: One of the world’s leading manufacturers of endoscopes, and a target of a wrongful death trial in an endoscope lawsuit, escaped liability for a patient’s fatal infection but was nonetheless compelled to pay almost $6.6 million to the hospital involved for failing to adequately instruct hospital staff.

Pittsburgh, PA: There is little doubt that endoscopes, duodenoscopes and other intricate scopes designed for ‘internal diagnostics’ are a godsend for patients and used hundreds of times a day, says Dr. Raymond Pontzer of Pittsburgh-based UPMC. “The benefit far outweighs the risks,” the director of infection prevention for the nonprofit said in comments published in the Pittsburgh Post-Gazette (07/04/17). However, the risks cannot be discounted, as many an endoscope infection lawsuit has shown.

Santa Clara, CA: An urgent recall of all Fujifilm ED-530XT duodenoscopes has been issued, due to the difficulty in what the US Food and Drug Administration (FDA) refers to as “reprocessing.” Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. The voluntary recall of the duodenoscopes also includes replacement of the ED-530XT forceps elevator mechanism including the O-ring seal, replacement of the distal end cap, and new Operation Manuals. The FDA has previously issued a warning that duodenoscopes could be linked to the spread of deadly bacteria.

Pittsburgh, PA: A recent study last month has shown that risks of infection stemming from use of endoscopes and duodenoscopes is continuing generally in the healthcare field in spite of guideline updates and other examples of tightening compliance aimed at improving, or even eliminating infection from the reusable devices. It’s the kind of infection passed along from one patient to another that has previously, and continues to fuel many an endoscope lawsuit.

:Washington, DC: Dr. Amy Reed, a physician and mother of six had surgery for uterine fibroids with a power morcelletor one year before the FDA first warned about the risk of power morcellators spreading cancer. Dr. Reed died from cancer in May—she was 44 years old.


The power morcellator had scattered malignant cancer cells inside Dr. Reed’s abdomen during surgery, which left her with advanced, Stage 4 cancer. After her surgery, a biopsy found that she had leiomyosarcoma, an aggressive type of cancer, and only then was she and her husband, surgeon Dr. Noorchashm told that a power morcellator was used to slice up her uterus, reported the New York Times (May 24, 2017).


Horrifically ironic, Dr. Reed and Dr. Noorchashm advocated against the power morcellation procedure for four years, which led to the FDA warning in 2014 against the use of laparoscopic morcellators to treat uterine fibroids. One year later, the agency was looking into whether on not Johnson & Johnson – the largest manufacturer of the device—knew about the risk of spreading cancer before pulling its power morcellator off the market. But other manufacturers did not follow suit. The power morcellator is a big seller for several medical device companies: according to the FDA, at least 50,000 women in the US undergo a hysterectomy — removal of the uterus—every year.


Incredibly, the power morcellator was approved by the FDA’s 501(k) fast -track process, meaning it didn’t undergo any human clinical trials, despite that agency estimating that 1 in 350 U.S. women who undergo fibroid procedures each year have a form of cancer called uterine sarcoma.


After going public about the power morcellator’s hazards and calling for a complete ban of the device, Dr. Reed and her husband were ostracized both by the hospital where she had the surgery and many gynecologists who favored the device. According to The Times, when Dr. Reed returned to Brigham and Women’s for a medical procedure, she and Dr. Noorchashm “were stunned to find that the hospital had assigned a guard to inspect their bags and escort them at all times, for security reasons. Dr. Noorchashm called a lawyer. A judge put a stop to the escort, issuing a restraining order against the hospital.”


This action by the hospital and the gynecology profession begs the question: are they receiving perks from power morcellation manufacturers? It wouldn’t be the first time that doctors were bribed by drug companies to increase sales, and even sit on their advisory committees…

Washington, DC: Any medical device plaintiff fighting an endoscope infection lawsuit appears to have a friend in Senator Patty Murray (D-Wash). The Democratic lawmaker noted back in April that she had become alarmed in the face of a superbug outbreak in Europe late last year, and thus had issued a request to medical device manufacturer Olympus Corp. (Olympus) for data that would demonstrate a redesigned medical device was safe.

Upper Saucon Township, PA: Olympus Corp. of the Americas has settled four lawsuits for injuries and one death allegedly related to the company's power morcellator surgical device, according to The Morning Call.