Medical Device Manufacturer Fails to Report Known Risks
By: Cohen, Placitella & Roth @ Apr 12, 2016
Manufacturers of medical devices are not perfect. As the adage goes, “to err is human.” Manufacturing a defective medical device may, in some cases, be an unintentional mistake that can be quickly remedied. But what is inexcusable is when the manufacturer of a dangerous device fails to report known dangers to the U.S. Food and Drug Administration (FDA), as is required per federal law. A Senate report released in January of 2016 details how one device manufacturer engaged in this precise misconduct.
Medical Device Associated with Infections
The Senate report – which was released after a year-long investigation, according to an article in The New York Times – found that closed-channel duodenoscopes (devices used in the examination of the small intestine) were linked to more than 200 cases of antibiotic-resistant infections over a three year period. Antibiotic-resistant infections are particularly worrisome because, as their name implies, they cannot be treated with antibiotics, often leaving medical providers scrambling in terms of how to control an outbreak.
Despite the fact that nearly 250 cases of infection occurred, only 75 reports regarding a connection between duodenoscopes and infection were submitted to the FDA. Eighty-five percent of the devices linked to infection were manufactured by the Japanese-based company Olympus.
Reporting Requirement for Manufacturers
The law requires that the manufactures of medical devices and other products are required to notify the FDA within 30 days’ time from the date of which a manufacturer learns that a device is associated with an injury or death. This includes reporting any instances that occur out of the country as well.
Despite the requirement, Olympus failed to notify the FDA of concerns until 2015. This is despite knowledge, garnered in early in 2013, that investigations into the duodenoscopes and their link to infection were being conducted in the Netherlands.
Steps Recommended by Congress
The report issued by Congress made recommendations to the FDA in regards to handling the issue. One of the suggestions was that the FDA evaluate the duodenoscopes and issue a recall if necessary. The report also asked that Congress fund a medical device evaluation system. The evaluation system would help to monitor safety of medical devices, and would not rely solely on manufacturers’ reporting of injury or death.
Defective Medical Device Attorneys Serving You
The experienced Pennsylvania and New Jersey defective medical device attorneys of the law firm of Cohen, Placitella & Roth, P.C. believe that patients in America deserve to be treated with devices that are safe. When a dangerous and defective device is marketed and not recalled when adverse events occur, patients’ health and lives are at risk.
If you are the victim of a defective medical device – duodenoscope or otherwise – our team of skilled lawyers wants to help you. We will work with you to determine liability for your harm, how to file a claim, and whether or not you have a worthwhile case.
You can schedule your free case consultation with our attorneys now by calling our offices directly at (215) 567-3500. Or, you can fill out our online form to tell us more about your case. We look forward to working with you!