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Johnson & Johnson’s Failure to Warn Prompts Backlash from the Government, Insurance Companies and Consumers
Power morcellator lawsuits are progressing against manufacturer Johnson & Johnson. As early as 2006, manufacturer Johnson & Johnson noticed that there was an increased chance of the development of leiomyosarcoma (LMS) after hysterectomy or myomectomy procedures that utilized a power morcellator device. Dr. Richard Lamparter wrote to Johnson & Johnson about the increased risk of the morcellators caused LMS to spread in the body, and called for a warning to be added by the manufacturer. While Johnson & Johnson added a warning for physicians that there may be undetected cancer present, the notice was strikingly deficient because if failed to mention the increased risk of spread of cancer with the use of the morcellator.
The power morcellator is a surgical instrument that is used to remove large masses of tissue during laparoscopic surgery, which is designed to reduce the recovery time when compared to traditional methods. The instrument is inserted into the body through small incisions and is used to mince up the targeted tissue, which is then vacuumed out through the same incision.
THE ISSUE: When the morcellator is used, it breaks down the tissue into smaller fragments. If cancer cells are present, the cells are then spread through the pelvic and abdominal area. In other words, the power morcellators can be the instrument for the spread of cancer of the patient’s body.
Power morcellators are used in over 60,000 surgeries per year. The FDA’s Obstetrics and Gynecological Devices Panel of the Medical Devices Advisory Committee met in July of 2014 to consider statistics regarding the power morcellator. Data indicates that the spread of cancerous cells and intensification of the disease occurs in 25 – 64% of individuals who had undetected cancer. The FDA reports that 1 in 350 women may be at risk for the spread of cancer after procedures using the power morcellator. These patients are believed to have a decreased chance of survival compared to those that have undergone surgeries in which a power morcellator was not used.
LMS is not the only risk associated with the use of morcellators. Other concerns include injury to organs, such as the ureters, bowel, bladder, spleen, pancreas and major vascular structures surrounding the surgery site. Another long-term result includes parasitic growth of displaced tissue that can cause adhesions, bowel dysfunction and the dissemination of other undetected cancers.
Lawsuits include claims of negligence, fraudulent misrepresentation, failure to warn, failure to test properly, consumer risk, and failure to recall. The FDA issued an April of 2014 safety communication warning against the use of power morcellators for hysterectomy and myomectomy with uterine fibroids. The communication also included the statement, “Do not use laparoscopic uterine power morcellation in women with suspected or known uterine cancer.”
In response to the FDA warning in April 2014, Johnson & Johnson’s Ethicon Division suspended the sale and marketing of the power morcellator worldwide. The manufacturer followed this with a letter in July of 2014 urging the discontinuation of the use of the morcellators and asking they be returned to the company immediately. The company recalled three types of morcellators, the Gynecare Morcellex, the Gynecare X-Tract, and the Morcellex Sigma. Johnson & Johnson is not the only manufacturer of power morcellator devices.
In November 2014, the FDA mandated an even stronger warning that “the use of laparoscopic power morcellators during fibroid surgery may spread cancer, and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.”
Recently, United Healthcare issued new limits on coverage for hysterectomies. The insurance company will not permit the use of power morcellators unless it is deemed “medically necessary”.
If you or a loved one has suffered an injury from use of a power morcellator during laparoscopic surgery, the attorneys associated with Jacoby & Meyers can help you receive compensation for your damages. Our lawyers can review the facts of your case to determine whether you have a valid claim.
Please contact the Jacoby & Meyers defective products attorneys today to schedule your free initial consultation.
Toni Zeller Kohlbeck, student intern Jacoby & Meyers
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