Birmingham, AL -- (ReleaseWire) -- 07/22/2015 --Morcellator Lawsuit News: While robotic surgeries are being used more frequently in both men and women in minimally invasive surgeries, a new study has found that more than 100 patients have died over the past 14 years after robotic surgeries. The attorneys at Southern Med Law are highly aware of the risks of robotic surgeries after they have represented men and women in robotic surgeries lawsuits and are currently representing numerous women in morcellator lawsuits who have developed uterine cancer and even death after robot assisted hysterectomies involving uterince morcellation.

Southern Med Law has recently settled the first morcellator cancer lawsuit in the country involving a 53-year-old Pennsylvania woman who died after undergoing a robot-assisted hysterectomy with uterine morcellation. Researchers from MIT, Rush University Medical Center, and University of Illinois at Urbana-Champaign, reviewed over 10,000 adverse events reports filed with the U.S. Food and Drug Administration (FDA) regarding robotic surgery from 2000 to 2013. According to the study, there were 144 patient deaths, 1,391 patient injuries and 8,061 device malfunctions reported to the FDA. Researchers said little or no information was provided in the reports for the majority of death events. Researchers concluded that "despite widespread adoption of robotic systems for minimally invasive surgery, a non-negligible number of technical difficulties and complications are still being experienced during procedures."

[arxiv.org/ftp/arxiv/papers/1507/1507.03518.pdf, 2015]

"This study supports the power morcellation claims in power morcellator lawsuits filed on behalf of women who either developed cancer or died as a result of undergoing a robot-assisted gynecological surgery in which a power morcellator was used," said Dr. François Blaudeau, a founder of Southern Med Law.

As stated by the law firm and the FDA, laparoscopic power morcellators are used in minimally invasive and robot-assisted hysterectomies and these devices have the potential to spread cancer during the surgery. When used to remove the uterus or uterine fibroids, power morcellators grind the uterine tissue into small fragments so that they can be removed through small incisions in the abdomen. However, when uterine tissue may have undetected cancer cells, the power morcellator can disseminate the cancer cells into the abdominal or pelvic cavity where they can be spread throughout a woman's body.

The controversy surrounding laparoscopic power morcellators was instrumental in prompting U.S. House Rep. Mike Fitzpatrick, R-Pa. to offer an amendment to a bipartisan bill regarding approval of drugs and medical devices. According to a Wall Street Journal report, Rep. Fitzpatrick's amendment is designed to improve safety monitoring of medical devices by requiring patients' medical records to include the make and model number of medical devices that were used in the event that patients are harmed by the devices during treatment. The 21st Century Cures Act, which was passed earlier this month, proposes to speed up the federal government's process for approving drugs and medical devices.

[wsj.com/articles/house-passes-bill-to-improve-safety-monitoring-of-medical-devices-1436736213, July 12, 2015]

The law firm comments that the injuries alleged in complaints regarding power morcellators have lead the FBI to launch an investigation into power morcellators. According to a Wall Street Journal report, the FBI is investigating whether Johnson & Johnson, the largest power morcellator manufacturer, and its Ethicon division hid the potential cancer risks associated with their power morcellators from U.S. health regulators and the medical community, and how long they knew that their Ethicon power morcellator surgical devices purportedly carried a cancer risk. Johnson & Johnson suspended sales and distribution of power morcellators after the FDA warned in April 2014 against using the devices in hysterectomies and for removing uterine fibroids.

[wsj.com/articles/fbi-is-investigating-surgical-device-1432746641, May 27, 2015]

Dr. Blaudeau was recently involved in settling a power morcellator lawsuit that was filed on behalf of Scott Burkhart, a Pennsylvania widower whose wife died of disseminated leiomyosarcoma in February 2013, after having a power morcellator hysterectomy. According to the power morcellator lawsuit, there was no evidence of disseminated cancer in Donna Burkhart prior to her robot-assisted hysterectomy that occurred March 6, 2012. Donna Burkhart was diagnosed with the aggressive leiomyosarcoma just 9 days after having surgery. The morcellator lawsuit contends that power morcellator manufacturers, LiNA Medical APS, Kebomed AG & LiNA Medical US, failed to adequately warn about the cancer risk associated with power morcellators. The terms of the settlement were not disclosed. (Case No. 5:14-cv-1557, U.S. District Court, Eastern District of Pennsylvania)

About Southern Med Law
Southern Med Law is a patient and consumer advocacy organization providing legal representation to the victims of negligent personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. François Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They're not afraid to take on the nation's largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.

Southern Med Law
François M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Phone: 205-547-5525
Cell: 205-515-6166
Fax: 205-547-5526
francois@southernmedlaw.com
http://www.southernmedlaw.com
Medical Negligence/MedicalDevice/Pharma/Qui Tam
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