In this article, Laurence Banville comments on a recent transfer order for power morcellator Ethicon, Inc. lawsuits.A recent transfer order issued instructed that all power morcellator lawsuit cancer claims filed against Ethicon, Inc. (a subsidiary of Johnson & Johnson) be moved to the United States District of Kansas. These lawsuits similarly allege that Ethicon failed to warn both physicians and consumers about risks associated with the use of their power morcellator device. This included the risk that the surgical instrument could potentially spread undetected cancer cells throughout the abdomen during gynecological surgeries.
What Is A Power Morcellator?
A power morcellator is a device used to avoid invasive, open abdominal surgeries during hysterectomies or myomectomies. It is inserted through small incisions in a woman’s abdomen, and works to tear apart the tissue once inside, ripping out uterine fibroids or tissue that is deemed a risk. The problem, however, is that studies have linked this procedure to the potential spread of cancer. When the morcellator rips apart the tissue, it can cut through previously undetected cancer cells, and spread them throughout the abdominal cavity. This can cause the patient to have new, widespread and aggressive tumors; a serious risk to their life.
What Is Being Done?
Lawsuits against manufacturer Ethicon have been consolidated into Multidistrict Litigation. Plaintiffs are happy with this recent decision, as it will help the legal process to move more quickly and efficiently. Ethicon has now discontinued production and sales of its morcellators, and has recalled those currently in use at hospitals. The FDA has published several warnings concerning the devices, and even the FBI has stepped in to investigate whether Johnson & Johnson knew about the cancer risks prior to pulling the morcellators off of the market.
What Does The FDA Say?
In April of 2014, the FDA discouraged physicians from using power morcellator devices because of their potential to spread undetected cancer. It was after this announcement that Johnson & Johnson (Ethicon) suspended their morcellator sales globally. FDA comments state:
“Today, the U.S. Food and Drug Administration is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids. In an updated safety communication, originally issued in April 2014, the FDA warns against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women.”
“In an Immediately in Effect (IIE) guidance, the FDA is also recommending that manufacturers of laparoscopic power morcellators include in their product labeling specific safety statements in the form of a boxed warning and two contraindications. The IIE guidance allows the FDA to issue its recommendations expeditiously to help address a significant public health issue.”
Lawsuits Continue To Mount
Lawsuits continue to be filed against multiple manufacturers of the tool. Documents show that these complaints have been filed either by women, or by the surviving family members for the victim who has died from cancer. In all cases, the women involved allegedly had their cancer spread and upstaged by a morcellator used during a myomectomy or hysterectomy procedure. Similar claims from the suits indicate that manufacturers neglected to properly warn consumers about the risks associated with their product.
Looking Into Legal Rights
Those who have undergone procedures where a power morcellator was used, and have subsequently suffered from a cancer diagnosis, may be entitled to file suit and attain compensation. The attorneys at Banville Law are currently working to ensure that these individuals are provided free consultations to explore their legal rights.