Johnson & Johnson is the largest manufacturer of the morcellator, a device which can spread uterine cancer in women. The FBI is looking into what knowledge Johnson & Johnson had about morcellator cancer risk prior to removing it from the market in 2014.
There is no way of knowing what stage the investigation is at, at this time. But according to three people interviewed, the FBI is overseeing the investigation and declined comment. A J&J spokesman said the medical company is not aware of any investigation into the device, called a laparoscopic power morcellator.
FBI agents, over the last several months, have interviewed a retired pathologist who began alerting J&J about potential problems with the morcellators as far back as 2006; a doctor who went public after her own cancer was worsened by the tool in 2013; and a California woman who has collected a list of about 400 patients and families of patients that may have been harmed by the tool. In November the U.S. Food and Drug Administration (FDA) warned that morcellators should be avoided in the vast majority of women. Several health plans and numerous hospitals have curtailed the use of or are considering limits of morcellator use. Previously the devices were used in tens of thousands of minimally invasive procedures a year. The morcellator instrument cuts and minces fibroid tumors and other tissue in the uterus into small pieces that can be removed through the smaller incisions used in minimally invasive surgery. The agency warned in April 2014 that women undergoing fibroid surgery have a 1 in 350 chance of having dangerous uterine sarcoma that can’t be reliably detected prior to surgery. Morcellators can spread the malignancy and worsen the outcome, according to the FDA. The agency called for a ‘black box’ warning – the most stringent warning – on the tool in November. In July amid reports of potential risk J&J removed the tools from the market. Other devices, from other manufacturers currently remain on sale. Originally posted by Sheller, P.C. on philadelphia.legalexaminer.com. Morcellator Cancer – Ball & Bonholtzer Trial Attorney – Los Angeles