Power Morcellator Cases – A New Area of Litigation for Certified Legal Nurse Consultants
On April 17, 2014 the FDA issued a warning to MDs against using laparoscopic morcellators in hysterectomies due to an increased risk of spreading uterine sarcoma. While the FDA did not issue an outright ban of the use of power morcellators, some hospitals have already elected to stop using these devices.
According to Reuters, Johnson & Johnson (J&J), the largest maker of these devices, suspended sales of the morcellator device. Note: J&J has not recalled these devices. The Wall Street Journal reported that J&J wrote in a letter to customers that it is waiting for the FDA and medical community to further clarify the role of morcellation.
At least one lawsuit has already been filed against medical device manufacturers for the death of a 53-year-old woman who allegedly died of metastatic myelosarcoma following a hysterectomy with uterine morcellation. I have also started seeing advertisements by law firms seeking potential plaintiffs for morcellator lawsuits.
In that lawsuit, filed on March 14, 2014 (before the FDA’s warning) there are 27 allegations of negligence against the defendant manufacturers. The following are some of the allegations:
- Failing to conduct adequate and appropriate testing of minimally invasive gynecologic products,
