U.S. Congressman, Michael Fitzpatrick (R-PA) has asked the Food and Drug Administration’s Office of Criminal Investigations to investigate allegations that hundreds of women have died as a result of surgical procedures done with a power morcellator. This is a controversial device that can unwittingly spread cancer in women who had uterine fibroids removed or hysterectomies performed. The FDA has warned that morcellators should not be used in most patients. The agency said the risk of spreading a hidden cancer masking as a uterine fibroid was 1 in 352. The most prominent manufacturers of morcellators is Ethicon, a subsidiary of Johnson & Johnson.
In August, 2015, Rep. Mike Fitzpatrick, Rep. Louise Slaughter (D-NY), and a bipartisan group of lawmakers sent a letter to the U.S. Government Accountability Office, asking them to scrutinize what criteria the FDA used to clear morcellators and whether the medical device reporting regulations are being followed correctly.
Congressman Fitzpatrick is asking for an investigation of Ethicon which halted sales of morcellators in 2014. He also asked the FDA to investigate hospitals that used the devices extensively. In his letter to the FDA, Congressman Fitzpatrick specifically mentions three women who likely died from cancer upstaged by the device. The letter also questions whether those deaths were properly reported to the FDA.
Fitzpatrick has been aggressive in seeking to curtail the use of medical devices he believes are unsafe. Last year, he introduced the E-Free Act that would require the FDA to withdraw approval for Bayer’s Essure contraceptive. Also last year, he worked to have an amendment added to the 21st Century Cures Act, recommending that “unique device identifiers” be included in electronic health records to help improve the tracking of device-related adverse events.
As a partner with D'Arcy Johnson Day, Andrew D'Arcy has been involved in some of the nation’s most high-profile cases and investigations, including a number of mass product/drug defect and environmental toxic tort cases. Additionally, he has been named a “Super Lawyer” by New Jersey Monthly Magazine every year since 2013.