Delay In Reporting Power Morcellator Cancer Due To FDA’s Passive Adverse Event Reporting System

   

Power Morcellator Cancer Lawsuits Contend Undetected Uterine Cancer Was Spread During Laparoscopic Power Morcellation Used During Surgery

power-morcellator-lawsuit-uterine-cancerThe U.S. Food and Drug Administration’s (FDA) passive system of reporting adverse events delayed the agency’s ability to act on reports of laparoscopic power morcellators spreading uterine cancer in women, a government report revealed. Southern Med Law had been aware of the cancer risks associated with power morcellators before the FDA issued guidance on the medical devices in November 2014 The firm has successfully represented numerous women and their families in power morcallator cancer lawsuits who have fallen victim to the side-effects of this medical device.

“We have been seeking justice for women and their survivors through lawsuits that allege power morcellators used during a hysterectomy or fibroid removal can spread undetected cancer, including a rare and aggressive form called leiomyosarcoma,” says Dr. François Blaudeau, founder of Southern Med Law.

Southern Med Law was the first to file a federal power morcellator lawsuit in March 2014. The case was settled the following year for an undisclosed amount and the firm continues to represent numerous women in morcellator cancer lawsuits against medical device manufacturers that include Ethicon Inc., Karl Storz, and LiNA Medical.

The Government Accountability Office’s (GAO) report, issued on February 8, found the FDA has a “passive” reporting system because it relies on medical device manufacturers and facilities that use the devices to report problems with a medical device. As a result, the reporters provide limited information or the adverse event may not be reported at all, the GAO study found. The FDA was not aware of problems with morcellators because it had not received adverse events reports about the device. It wasn’t until 2013 when media reports raised concerns about morcellators spreading cancer that the FDA realized there were problems. The GAO report also found the FDA knew about the potential for a power morcellator to spread cancerous tissue when it first cleared the device in 1991 but believed the risk was low. The FDA agrees with the GAO report and is making efforts to improve its postmarket reporting system, according to the Wall Street Journal.
[wsj.com/articles/gao-says-fda-missed-cancer-risk-in-surgical-device-1486514657]
[gao.gov/assets/690/682573.pdf]

The GAO investigation was prompted by 12 bipartisan members of Congress who, in August 2015, asked the watchdog organization to look into why the FDA “took so long” to warn about the medical device’s potential to spread cancer. Laparoscopic power morcellators shred uterine tissue into fragments for removal through small incisions in the abdomen. The undetected cancer cells spread into the peritoneal cavity as the uterine tissue is being removed.
[wsj.com/articles/members-of-congress-call-on-gao-to-investgate-surgical-tool-1438978884?mod=rss_Politics_And_Policy]

In November 2014, the FDA all but banned power morcellator used in the vast majority of women who require a hysterectomy or myomectomy (fibroid removal). The agency also directed medical device manufacturers to place a black box warning on their power morcellators about the cancer risk. As of September 2016, the FDA had received 285 morcellator cancer reports. Of that number, five were related to events occurring after November 2014, the GAO report said. After the FDA issued updated safety information, some national health insurance companies stopped coverage of surgeries involving power morcellation. Johnson & Johnson also took the power morcellators of its subsidiary, Ethicon Inc., off the market. [fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm]

At the same time, women who had developed uterine cancer after having a hysterectomy or fibroid removal began filing morcellator cancer lawsuits against medical device manufacturers, including Ethicon, Inc, Karl Storz, Richard Wolf, and Gyrus ACMI. The complaints allege manufacturers failed to warn that power morcellators can spread undetected uterine sarcoma, including the rare leiomyosarcoma.

About Southern Med Law And Filing A Morcellator Cancer Lawsuit

Led by Dr. François Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at Southern Med Law possess a deep understanding of the complex medical and legal questions at issue in all aspects of laparoscopic power morcellators. Southern Med Law is a full service law firm representing men, women and their families across the country who have been victims of negligence, personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products.

Southern Med Law
François M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Phone: 205-547-5525
Fax: 205-547-5526
francois@southernmedlaw.com

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