U.S. Lawmaker Wants Morcellator Cancer Deaths Criminally Investigated By The FDA

   

Power Morcellator Cancer Lawsuits Allege Morcellator Manufacturers Failed To Disclose The Cancer Risks Associated With Their Devices In Fibroid Tumor Surgeries.

power-morcellator-uterine-cancer-southern-med-lawU.S. Rep. Mike Fitzpatrick (R-Pa.) has called for the U.S. Food and Drug Administration (FDA) to launch a criminal investigation into certain deaths linked to laparoscopic power morcellators at hospitals in New York and Massachusetts. Power morcellators are also reasons why women and their surviving loved ones have filed morcellator cancer lawsuits claiming that the surgical tools used in removing fibroid tumors can spread and upstage cancer. (In Re: Power Morcellator Litigation, MDL Case No. 78)

“Southern Med Law commends Rep. Fitzpatrick for asking the FDA to open a criminal investigation into laparoscopic power morcellators,” says Dr. François Blaudeau, founder of Southern Med Law. who filed the first federal power morcellator cancer lawsuit in the United States. The claim against LiNA Medical APS, Kebomed AB & LiNA Medical US, on behalf of a Pennsylvania widower whose wife died of cancer in February 2013, following a morcellator hysterectomy was settled for an undisclosed amount.(Case No. 5:14-cv-1557, U.S. District Court, Eastern District of Pennsylvania) Southern Med Law is currently representing women in claims involving Ethicon.

Southern Med Law is currently representing women and their families in morcellator cancer lawsuits. Dr. François Blaudeau was recently appointed to The Plaintiffs’ Steering Committee for power morcellator litigation (MDL No. 2652), that are currently pending in the U.S. District Court, District of Kansas. Dr. Blaudeau also negotiated the first cancer lawsuit settlement for an undisclosed amount. Morcellator cancer lawsuits claim medical device manufacturer, Johnson & Johnson’s subsidiary, Ethicon Inc. failed to disclose that its laparoscopic power morcellators have the potential to spread undetected leiomyosarcoma or uterine cancer in women undergoing a laparoscopic hysterectomy or myomectomy.

In a December 18 letter to the FDA’s Office of Criminal Investigations, Fitzpatrick asked the federal regulatory agency to probe the deaths at Boston’s Brigham & Women’s Hospital, Rochester General Hospital and the University of Rochester Medical Center associated with power morcellators manufactured by Johnson & Johnson’s Ethicon unit. Under FDA rules, hospitals and makers of medical devices are required to report incidents in which devices may have caused or contributed to a patient’s death. Yet, the first time the FDA received a report of death or serious injury due to a power morcellator was from a doctor whose family member was diagnosed with cancer associated with the morcellationdevice, Fitzpatrick stated in his letter.
[massdevice.com/pa-rep-fitzpatrick-wants-fda-to-launch-criminal-probe-into-morcellator-deaths/, Mass Device, January 6, 2016]

This is not the first time Fitzpatrick has called for a probe into the controversial medical devices. In August, Fitzpatrick was among 12 bipartisan Congressional members who asked the U.S. Government Accountability Office (GAO) to investigate power morcellators, the cancer deaths linked to morcellators, and why the FDA “took so long” to warn about their potential to spread cancer. The GAO agreed to conduct the probe.
[wsj.com/articles/members-of-congress-call-on-gao-to-investigate-surgical-tool-1438978884?mod=rss_Politics_And_Policy, Wall Street Journal, August 7, 2015]

Laparoscopic power morcellators are used during a hysterectomy and myomectomy to remove uterine fibroids. The morcellator’s spinning blades grind uterine tissue into fragments so that the pieces can be removed through small incisions in the abdomen. Undetected cancer cells can hide within the uterine tissue. In November 2014, the FDA issued a strong warning that power morcellators should be avoided in the majority of women who require a hysterectomy and a myomectomy due to its potential to spread undetected cancer cells.
fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm, November 24, 2014]

Ethicon Inc., and other morcellator manufacturers including Gyrus ACMI, Richard Wolf GmbH, Karl Storz GmbH, and LiNA Medical APS are defendants in morcellator cancers lawsuits that allege power morcellators can potentially spread undetected uterine cancer, including the aggressive leiomyosarcoma. All federally filed lawsuits against Ethicon Inc. were consolidated in October in the U.S. District Court, District of Kansas for coordinated pretrial proceedings. Dr. Blaudeau was appointed to the Plaintiffs’ Steering Committee which will represent the common interests of all plaintiffs in the litigation against Ethicon. (In Re: Power Morcellator Products Liability Litigation – MDL No. 2652)

About Southern Med Law and Filing A Power Morcellator Cancer Lawsuit: Southern Med Law is a full service law firm representing victims of negligence, personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. François Blaudeau, an attorney and a practicing obstetrician/ gynecologist, and the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of power morcellators. They are not afraid to take on the manufacturers to make them accountable and enable all of their clients to have the aggressive legal representation they deserve.

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

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