Posted in Defective Medical Devices on June 9, 2015
The possibility of a cover-up of a surgical tool that many accuse of spreading cancer in women has drawn the attention of the FBI. Investigators have reportedly begun interviewing witnesses to examine the possibility that several parties, including medical device makers like Johnson & Johnson, failed to report the defect to authorities.
The device in question is called a morcellator. It uses spinning blades to cut tissue into small pieces, so that the surgeon can remove it through small slits cut into the skin. Some women who underwent the procedure had undetected cancer in their uterus. The morcellator sprayed hidden malignant cells throughout their abdomen, causing the cancer to spread. The Food and Drug Administration announced in November that morcellators should not be used on “the vast majority” of women, though the agency did not issue a recall.
It appears that much of the FBI investigation is focusing on whether Johnson & Johnson took reports of this defect seriously enough. One doctor who said he spoke with an FBI agent had previously contacted the company about its morcellators, warning of the risk of spreading cancer. In response, J&J changed the language in its written instructions, which the doctor called a “legal fig leaf.” He said the training for using the device at his hospital has not substantially changed due to the new instructions.