Recently, a Boston-based doctor underwent a hysterectomy during which a power morcellator was used, and during the procedure undetected cancer was spread throughout her abdomen, resulting in advanced cancer. The FDA recently reported that three major Massachusetts hospitals failed to properly report patient deaths and injuries potentially caused by medical devices. The report follows the FDA’s investigation last December of Massachusetts General, Brigham and Women’s, and UMass Memorial, as well as other hospitals around the country, concerning infections possibly linked to duodenoscopes, which examine the small intestine, and the potential spread of uterine cancer by a surgical device known as a power morcellator, which cuts up tissue. Most concerning is that the FDA discovered that the Massachusetts hospitals and others failed to timely report incidents where patients were harmed by these devices, or failed to report the incidents at all.
The FDA requires hospitals to report patient injuries and deaths suspected to be caused by medical devices. The reason is obvious. Reporting allows the FDA to analyze potential harm to patients, and determine whether new safety regulations are needed. Without hospitals fulfilling this mandate, the FDA cannot ensure that devices used in medical settings are safe for patients, potentially compromising the safety of any patient exposed to such devices. This effectively strips patients of being able to make informed decisions about their medical care, and could expose them to an increased risk of harm or death.
Todd & Weld firmly believes that transparency is a solution to rampant harm and death to patients to due to medical errors and medical devices. I am proud to participate as the only attorney representing patients on the Massachusetts Alliance for Communication and Resolution following Medical Injury (MACRMI), which promotes hospital programs focused on disclosure and resolution after a medical mistake.
I look forward to discussing these programs with attorneys of the Worcester County Bar Association on Monday, February 6th from 4 pm to 6 pm at the Worcester Registry of Deeds. Please contact me if you would like more information about this event.