Power Morcellator Lawsuit Guidelines

What is a Power Morcellator and how does it work?

A power morcellator is a disposable surgical instrument whose function is to remove large portions of tissues during endoscopic procedures. After a small hole of 5-15 millimeters of diameter is opened on the patient’s body by performing an incision in the abdominal wall, a small tube called trocar cannula is inserted. Other holes can be opened to introduce various devices including cameras to closely monitor all the operations and the morcellator itself. This small “drill” consists of several cutting jaws, blades and a grasper that mince and cut organs and tissues into small fragments (morcels) that can be grabbed and pulled away into the cylinder to ease extraction. Endoscopy helps to lower the risk of blood loss, pain and complications since it minimizes the invasiveness of the whole procedure. Using this new technology also significantly reduces hospitalization and recovery time, and does not expose the patient to a risk of thermal injury since no energy is used inside the pelvic cavity.

The dangers of using a power morcellator

Uterine fibroids are a common type of benign uterine tumor that affects four out of every five women before they reach the age of 50. Also known as leiomyomas, they are dense, round masses of smooth muscle tissue that grow inside the uterus. Most patients usually never know they have one or more fibroids inside their pelvic organs, and can live their entire lives without experiencing any symptom. If the mass grows too big, however, it may hinder the blood flow of the uterine lining leading to heavy or painful menstruations and unusual bleeding.

When a patient is diagnosed with a uterine fibroid, a power morcellator can be used to remove it while keeping the uterus intact with a minimally invasive surgical procedure known as myomectomy. However, during this process, the spinning blades generate a centrifugal force that may disseminate and spread microscopic bits of potentially malignant tissue inside the abdominal and pelvic cavity. The U.S. Food and Drug Administration (FDA), in fact, estimated that some fibroids may harbor unsuspected uterine cancer (leiomyosarcoma) cells. Tumor cells possess a broad spectrum of invasion mechanisms, including the ability to adhere to other organs to start a new replication process, as well as the growth of new cancerous masses (metastases) with lethal consequences. Even benign fibroids can be spread by the morcellator blades, generating new tumor masses that may cause infections and obstructions.

Product recalls and the FBI probe

Ethicon, a subsidiary of Johnson & Johnson, was originally granted the approval to market the power morcellators in 1991. However, the FDA never required the company to perform any formal clinical trial to test the device’s safety since they were approved with the infamous the 510(k) fast-track process. In November 2014, the regulatory agency issued an official black box warning to discourage the use of these dangerous surgical instruments during myomectomy and hysterectomy procedures, and, shortly after that, the manufacturer voluntarily recalled all its products. In May 2015, however, the Federal Bureau of Investigation (FBI) started its own investigation into the matter and found a troubling truth: that J&J already knew that morcellation could be harmful at least since 2006. According to the Wall Street Journal, the agency questioned at least three people who could be persons of interest. One of them was Sarah Robinson, a physician assistant from California who was heard as a witness during an FDA hearing on the device. Robinson wrote down a list of 386 families whose cancer got worse after being operated with a morcellator, including herself.

Differences between Hysteroscopic and Laparoscopic Morcellation

The second type of morcellator called “hysteroscopic” is currently available on the market. However, only the laparoscopic one is associated with a risk of tumor cells being spread on the abdominal cavity. During the so-called “open morcellation” procedure used with laparoscopic devices, all tissue fragmentation happens inside an open cavity, and can thus lead to unpredictable spreading of cells. Hysteroscopic morcellation, instead, is a much safer alternative that minimizes the risk by trapping and collecting tissue bits inside small pouches. A specific bag has also been recently approved by the FDA to contain tissues shredded during morcellation operations for future analysis. Clinical data about these new instruments’ long-term safety is still lacking, however.

Current state of legal proceedings, verdicts and settlements

Many victims decided to file a lawsuit against J&J and Ethicon claiming that the company failed to warn the public about the dangers of their defective devices are defective. Although a recall has been issued, the ethical and moral consequences of what was perceived as a lack of proper regulation are still uncertain. Many insurance companies decided they’re not going to pay for morcellation surgery anymore, and many hospitals decided to ban these instrument. The number of litigations kept growing at a steady rate, and in October 2015, several cases have been consolidated in a Multidistrict Litigation (MDL No. 2652) in the U.S. District Court for the District of Kansas overseen by Judge Kathryn H. Vratil. Most of the attorneys that are currently managing the dispute on behalf of injured plaintiffs are women themselves.

Patients who suffered the horrifying consequences of an undetected cancer being spread throughout their bodies are seeking monetary compensation for medical expenses, as well as damages such as shortening of life expectancy and quality of life reduction. According to court documents, on March, 2016 Johnson & Johnson opted to settle at least 70 of the 100 suits filed against it. Out-of-court settlements have probably ranged from $100,000 to about $1 million, according to recent estimates. Other European companies that manufacture these devices such as LiNA Medical, Karl Storz GmbH and Richard Wolf GmbH have also been accused by many plaintiffs of marketing harmful devices that could spread cancer.