As Southern Med Law Settles The First Federally Filed Power Morcellator Lawsuit, The House Passes Medical Research Legislation That Tracks Safety Of Medical Devices Such As Laparoscopic Power Morcellators That Can Potentially Spread Uterine Cancer.
Birmingham, AL -- (ReleaseWire) -- 07/21/2015 --In a move to reduce injuries and the spread of cancer after power morcellation hysterectomies and fibroid removal, the U.S. House passed a bipartisan bill that speeds up the government's process for approving drugs and medical devices, as well as improving the safety monitoring of medical devices that includes power morcellators, Southern Med Law reports. The new medical research legislation comes as Southern Med Law recently settled the first morcellator cancer lawsuits against morcellator makers, LiNA Medical APS, Kebomed AB & LiNA Medical US. According to the Wall Street Journal, the provision to improve the monitoring of medical devices was an amendment added to the "21st Century Cures Act" by Rep. Mike Fitzpatrick, R-Pa. The provision requires "unique device identifiers," such as the make and model number of medical devices, to be included in patients' medical records in the event that patients are harmed by the devices, the Wall Street Journal reported. While the U.S. Food and Drug Administration (FDA) in 2013 ordered labels of medical devices to include "unique device identifiers," Rep. Fitzpatrick's office said the amendment "adds pressure" to the FDA's ruling, according to the Wall Street Journal.
[wsj.com/articles/house-passes-bill-to-improve-safety-monitoring-of-medical-devices-1436736213, July 12, 2015]
"We are pleased that the House passed this legislation and accepted Rep. Fitzpatrick's amendment which appears to be very beneficial to patient safety," says Dr. François Blaudeau, founder of Southern Med Law. The firm is currently representing women in morcellator lawsuits and other medical device lawsuits involving Mirena, Essure, Bladder Mesh and IVC filters. To speak with one of our attorneys for a free legal evaluation please call 205-547-5525 or 205-515-6166.
You can also visit http://www.southernmedlaw.com for more information.
According to Dr. Blaudeau, who is also an attorney and obstetrician-gynecologist, power morcellators are used in about 10 percent of the 600,000 hysterectomies that are performed each year in the United States. As stated in court records, power morcellators grind uterine tissue into fragments so that they can be removed through small incisions in the abdomen. As the uterine tissue is removed, the undiagnosed cancer cells contained in the tissue spreads into the peritoneal cavity, according to court documents. Power morcellators have the potential to not only spread cancer, but upstage the disease as well.
The law firm notes that the FDA issued a safety alert in April 2014 that discouraged surgeons from using power morcellators to perform a hysterectomy (removal of the uterus) or myomectomy (removal of uterine fibroids) because of the medical device's potential to spread undiagnosed cancer which greatly reduces a woman's chances for long-term survival. The FDA issued a stronger warning in November stating that power morcellators should be avoided in the vast majority of women who require a hysterectomy or myomectomy.
[fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm, November 24, 2014].
The law firm further comments that the FBI has launched an investigation into power morcellators and the probe includes whether Johnson & Johnson, the largest morcellator manufacturer, knew about the cancer risks linked with power morcellators before pulling the devices off the market. According to a Wall Street Journal report, Johnson & Johnson suspended sales of power morcellators in wake of the FDA's warning about the devices in April 2014. The FBI has already interviewed a retired pathologist who notified Johnson & Johnson about the potential cancer risks connected to power morcellators, the Wall Street Journal stated.
[wsj.com/articles/fbi-is-investigating-surgical-device-1432746641, May 27, 2015]
As morcellation cancer lawsuit filings continue to mount, six plaintiffs have filed a petition with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate all federally filed power morcellator lawsuits alleging that power morcellators spread undiagnosed cancer cells during gynecological surgeries. In their petition, the plaintiffs asked the judicial panel to transfer 22 morcellator complaints pending in 16 different courts nationwide, to the U.S. District Court, District of Kansas for coordinated pretrial proceedings. Court records show that all of the complaints are filed against Johnson & Johnson's Ethicon unit. The JPML has scheduled oral arguments on the request for October 1. (In Re: Power Morcellator Litigation, MDL Case No. 78)
Southern Med Law reports that Dr. Blaudeau settled the first federally filed morcellator cancer lawsuit earlier this month. The lawsuit was filed on behalf of Pennsylvania resident, Scott Burkhart, whose 53-year-old wife, Donna Burkhart, died of disseminated leiomyosarcoma in February 2013, which she developed after undergoing a power morcellator hysterectomy. According to the lawsuit, Donna Burkhart had no evidence of cancer prior to having a robot-assisted hysterectomy on March 6, 2012. She was diagnosed with the aggressive uterine cancer just 9 days after having surgery. The lawsuit, which was settled for an undisclosed amount, was filed in March 2014 in the U.S. District Court, Eastern District of Pennsylvania. (No. 5:14-cv-1557)
About Southern Med Law
Southern Med Law and Dr. François Blaudeau possess a unique understanding of the medical and legal questions at issue in power morcellator cancer lawsuit claims. It is this in-depth knowledge that is tantamount to a successful legal representation that protects the rights of the injured. The staff at Southern Med Law is not only trained in successfully handling your legal needs but also understand the pain and suffering and treatment from a medical point of view, and is committed to protecting the rights of all individuals.
Southern Med Law
François M. Blaudeau, MD JD FACHE FCLM Esquire
2224 1st Avenue North
Birmingham, Alabama 35203
Medical Negligence/MedicalDevice/Pharma/Qui Tam
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