Proposed Bill would Require Doctors to Report Device Injuries to FDA

Two legislators are introducing a bill that would require doctors to report deaths and injuries associated with a medical device to the U.S. Food and Drug Administration (FDA).  Currently, the agency only mandates reports from hospitals and device makers.  Wall Street Journal reports that the bill, known as the “Medical Device Guardian’s Act” was fueled by recent safety concerns over power morcellators. 

Power morcellators are tools that cut up tissue during a hysterectomy or myomectomy to treat uterine fibroids.  According to WSJ, medical literature has shown that the tools could spread a hidden cancer since the 1990s, but the FDA was unaware until 2013.  Dr. Amy Reed, who discovered that cancerous tissue had been spread during her own procedure using a morcellator, brought these concerns to light. “ After that initial report from Amy, hundreds of other safety reports began to flow into the FDA,” said U.S. Reps.  Mike Fitzpatrick (R., Pa.) and Louise Slaughter (D.,N.Y.) in a letter to colleagues introducing the bill. “ In retrospect, it should not have fallen on patients to get the FDA’s attention,” The lawmakers assert that “everyone in the chain of care” should report these incidents to the FDA. 

The FDA placed a “black box” warning in 2014, and estimated that 1 in 350 women undergoing a hysterectomy or myomectomy for fibroids had a hidden uterine sarcoma.  This type of cancer cannot be detected before surgery, and using a morcellator on this cancerous tissue can spread malignancies. 

The issue shed light on FDA’s system of tracking medical device injuries.  In their letter, the lawmakers pointed out that Brigham and Women’s Hospital in Boston, which treated Dr. Reed, had another patient that was “harmed by a morcellator one year earlier”.  The FDA, however, did not receive a report on this incident because officials felt the “device functioned as expected and was used in the way it was intended, although with unintended and tragic consequences,” a spokesperson said. 

The proposed legislation would add doctors and their offices to the list of mandated reporters, and also prevents their reports from being used against them in a civil lawsuit. 

The Government Accountability Office is now investigating power morcellators and numerous lawsuits have been filed.  Johnson & Johnson removed its morcellator from the market in 2014, after the FDA issued its safety alert.  WSJ reports that the company has settled over 100 lawsuits.  Other device makers are also facing lawsuits, with more than 40 pending in a Los Angeles court against Karl Storz GmbH.