Morcellator Lawsuit News: FDA’s Approval Process For Medical Devices Under Investigation

   

Southern Med Law Represents Women In Morcellator Lawsuit Claims Who Developed Uterin Cancer or Leiomyosarcoma After Undergoing Laparoscopic Surgery To Remove Uterine Fibroids

Morcellation-lawsuit-cancerThe rising number of power morcellator lawsuit claims alleging morcellators spread cancer in women undergoing gynecological surgeries and pleas to ban morcellators have prompted an investigation into the U.S. Food and Drug Administration’s (FDA) expedited approval process for medical devices. A bipartisan Congressional group requested the investigation noting “hundreds, if not thousands of women in America are dead,” due to power morcellators.

The FDA’s 501(k) approval process allows medical device manufacturers to “fast track” their products and not conduct clinical trials if they can show that their device is substantially equivalent to one that is already on the market. Manufacturers must also demonstrate that their medical devices are safe and effective. The FDA has approved 10 power morcellators for sale over the last 24 years, according to a Wall Street Journal report.
[wsj.com/articles/members-of-congress-call-on-gao-to-investigate-surgical-tool-1438978884, August 7, 2015]

As strong advocates for women in morcellator cancer lawsuit, Southern Med Law filed the first morcellator lawsuit claim and has since settled the complaint for an undisclosed amount. “We feel very strongly about putting an end to power morcellator manufacturers Ethicon Inc., Blue Endo, and Lina Medical from continuing to market a product that we believe is very harmful to women.”

A group of 12 Congress members asked the U.S. Government Accountability Office (GAO) to scrutinize the FDA’s approval system which has come under fire for being too lax, according to a Wall Street Journal report. In a letter to the GAO, the legislators noted that studies pointed to a serious problem with morcellators decades before the FDA warned about the power morcellators’ potential cancer risk. The letter further said the FDA, the medical device industry and many gynecologists determined the cancer risk was low, “only one-in-10,000. How did they get it wrong for so long?”
[fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/, August 11, 2014]
[wsj.com/articles/members-of-congress-call-on-gao-to-investigate-surgical-tool-1438978884, August 7, 2015]

“Southern Med Law commends members of Congress for seeking an investigation into power morcellators,” says Dr. François Blaudeau, a founder of Southern Med Law which is representing many families in morcellator cancer lawsuit claims.

Laparoscopic power morcellators are surgical tools used during minimally invasive surgeries such as a hysterectomy or a myomectomy. The morcellator grinds uterine fibroids into shreds for removal through small incisions in the abdomen. The morcellated fragments may contain undiagnosed cancer, including leiomyosarcoma. The cancer cells can travel to various parts of the body if fragments are left in the abdomen and pelvic area or attach to surrounding organs.

In April 2014, the FDA advised doctors not to use the tool during uterine surgery because of the potential cancer risk. The federal agency issued a stronger warning in November 2014, that all but banned the use of laparoscopic power morcellators in the majority of women undergoing a hysterectomy or myomectomy.
[wsj.com/articles/johnson-johnson-to-call-for-voluntary-return-of-morcellators-1406754350, July 30, 2014]
[fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm, November 24, 2014]

Southern Med Law has been fighting for the rights of alleged morcellator cancer victims even before the FDA acted to warn the public about this potential danger. Dr. Blaudeau served as Lead Counsel in what was the first power morcellator cancer lawsuit filed in a U.S. court.

In September, the Firm filed two morcellator cancer lawsuit claims against Ethicon Inc., a subsidiary of Johnson & Johnson which makes power morcellators. The plaintiff in one lawsuit was diagnosed with leiomyosarcoma cancer after undergoing a hysterectomy in December 2012 in which Ethicon’s Gynecare Morcellex device was used. (U.S. District Court, Eastern District of Washington, Case 2:15-cv-00252)
The second power morcellator lawsuit was filed on behalf of a widower whose wife died of leiomyosarcoma in March 2014. His spouse had undergone a robotic laparoscopically-assisted hysterectomy and cystoscopy in June 2011, at which time the Gynecare Morcellex device was used. (Case 6:15-cv-06100, U.S. District Court, Western District of Arkansas)

Throughout his career, Dr. Blaudeau has worked hard to develop a strong reputation in healthcare litigation. His first-hand knowledge of medicine has made the Southern Med Law team an aggressive and effective advocate for those who were harmed due to negligent medical device manufacturers. If you or a woman you love was harmed by a power morcellator, please contact Southern Med Law today to learn more about your legal rights. Call today for a free, no obligation power morcellator cancer lawsuit review by filling out our online form, or by calling the office directly at 205-547-5525.

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
http://www.southernmedlaw.com
Medical Negligence/MedicalDevice/Pharma/Qui Tam

This entry was posted in Southern Med Law | Article. Bookmark the permalink.