Allegations that Johnson & Johnson waited eight years to remove its power morcellator from the market – despite knowledge of the inherent dangers posed by the device – have prompted the FBI to launch a criminal investigation, according to a recent report in the Wall Street Journal. Although the surgical tool has not yet been banned by the U.S. Food and Drug Administration (FDA), the agency has warned on more than one occasion against its use. Hysterectomies performed via laparoscopic power morcellation, usually for the treatment of fibroids, are risky because a small percentage of women undergoing these procedures will also have previously undetected leiomyosarcoma, a rare form of uterine cancer. According to the FDA, leiomyosarcoma can be exacerbated by the slicing of fibroid and uterine tissue performed by a power morcellator.
The FBI has already interviewed anesthesiologist, Amy Reed, whose story first shed a national spotlight on the potential adverse effects of power morcellator use. In 2013 while living in Boston, Reed underwent a hysterectomy with morcellation. Shortly thereafter she learned that she also suffered from leiomyosarcoma and that the power morcellator had caused her cancer to spread. Since that time Reed – a mom of six – has undergone chemotherapy, radiation and multiple surgeries, including a recent procedure to remove part of her spinal column.
Mandatory Medical Device Reporting Regulation
Reed’s husband also met with FBI officials. Hooman Noorchashm, a Philadelphia-based heart surgeon, says the investigation appears to center on whether Johnson & Johnson accurately reported incidents of death and injury resulting from its power morcellators to the FDA as required by Mandatory Medical Device Reporting (MDR) regulation 21 CFR 803. Under that federal law, device manufacturers like Johnson & Johnson have 30 days to disclose a death or injury caused by a medical device, and just five days to disclose when a device is potentially defective – thereby representing an ongoing public health risk. According to the FBI, Johnson & Johnson pulled its power morcellator from the market in 2014, but may have been aware of the risks the device posed for women with undetected leiomyosarcoma as early as 2006.
Philadelphia Defective Medical Device Lawyers at the Shein Law Represent Power Morcellator Victims
A hysterectomy for the treatment of fibroids should be relatively straightforward. For some women, however, the procedure will go horribly wrong. If you or a loved one had undiagnosed leiomyosarcoma worsened by a power morcellator you may be entitled to compensation. Philadelphia medical device lawyers of the Shein Law will work aggressively on your behalf. We serve clients throughout Philadelphia and New Jersey at our offices conveniently located in Philadelphia, PA and Pennsauken, NJ. Call 877-SHEINLAW (877-0743-4652) or contact us online to schedule your free consultation.