Surgeons reluctant to report suspected defects on medical devices like DePuy ASR hip implant


Testimony delivered so far at the trial of a former Montana prison guard who believes the DePuy Orthopaedics ASR metal-on-metal hip implant he received was defective and caused him to suffer serious and life-changing injuries has revealed a disturbing trend in modern healthcare.

According to a New York Times investigation to coincide with this ongoing trial in Los Angeles Superior Court, doctors (in this case, surgeons) are either apprehensive or couldn’t be bothered to report adverse events involving their patients to the maker of that device or to federal health officials.

Many physicians believe that their adverse event report or more serious claims that they believe a specific product is dangerous and responsible for many injuries could spur a backlash against them. The Times reports that some doctors are afraid that their claims of a medical device like the ASR hip implant being dangerous or defective could result in a loss of business, a potential lawsuit if a patient were to believe the counter that it’s not the device but the doctor.

For some surgeons/paid consultants at DePuy, their reports were largely ignored or cast aside as the company focused on improving sales and less about growing concerns among the surgeons who had implanted them. In testimony previously delivered at the ongoing trial in L.A., one surgeon who was paid royalties in exchange for clinical data on patients who had received the device had suggested that the company scale back its marketing and consider recalling the device several times before the ASR hip implant was eventually recalled in August 2010.

One noted professor at Yale School of Medicine told The Times that “questioning the status quo in medicine is not easy.”