Congressman Fitzpatrick Takes a Stance Against Power Morcellator Manufacturers
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
U.S. Representative Mike Fitzpatrick took a stance against manufacturers of harmful medical devices in December 2015 when he wrote a letter to the U.S. Food and Drug Administration to investigate the power morcellator. Johnson and Johnson are the main producers of the power morcellator. The power morcellator is a device used in women during surgeries to remove ostensibly benign uterine tumors. It is a device that has rotating mini-blades that is used to cut and remove uterine tissues. They were widely popular because of the small incisions they use and the entire process produces less post-operative pain and wound complications.
However, research has shown an increasing correlation between the use of power morcellator and cancers arising in women after surgery. Due to the speed of the blades, when the benign tumors are being cut, the device also spreads deadly dormant cancer cells. The most common cancer involved is leiomyosarcoma. There also have been many lawsuits, over 70, filed against Johnson and Johnson. The device was recalled back in 2014.
Congressman Fitzpatrick asks in his letter that the head of the Office of Criminal Investigations in the FDA investigate the deaths caused by the power morcellator. The letter also focused on the wrongdoings of hospitals, such as Brigham and Women's in Boston and University of Rochester Medical Center, and the manufacturer, Johnson and Johnson.
The correlation between this device and spreading of cancer has been ongoing for the past 20 years and Congressman Fitzpatrick has finally stepped in to take a stance against manufacturers and healthcare professionals. Recently, Congress has ordered the Government Accountability Office (GAO) to begin an investigation while the FDA investigates any non-compliance with regulations.