According to a Wall Street Journal report, Ethicon Inc., a subsidiary of Johnson & Johnson, has begun the process of settling lawsuits that allege the company’s laparoscopic power morcellator spreads cancer in women. WSJ reported that the company has already settled almost 70 lawsuits to date.
The power morcellator is a medical device used to remove uterine fibroid tumors and in hysterectomies. The device cuts the fibroids into small pieces that are then removed via a small abdominal incision. Some fibroids may have undetected cancer cells, which can be spread throughout the body when the morcellator cuts them into fragments.
A 2013 WSJ story put a national spotlight on the alleged dangers of power morcellators when it reported that an operation to remove uterine fibroid tumors in a Boston doctor spread previously undetected cancer throughout her body. The patient, Dr. Amy Reed, had a rare cancer known as leiomyosarcoma in her uterine wall. Had the tumor been removed whole, her survival rate would have been 50 percent. But since it was morcellated, her survival rate fell to between zero to 20%.
The Food & Drug Administration (FDA) issued a warning about power morcellators in 2014, saying that because approximately one in 350 women with fibroids also have uterine sarcoma, the use of power morcellators could pose a dangerous risk of spreading the cancer. Ethicon removed its power morcellators from the market following that warning.
A few months after that announcement, the FDA added a “black box warning” — it most severe — on power morcellators, with the recommendation that they no longer be used for hysterectomies.
In mid-2015, the FBI office in Newark, NJ, announced that it was investigating whether Ethicon had knowledge that its power morcellators could spread cancer. In addition, Congress has called for an investigation into the FDA’s slow response to reports that the devices helped spread cancer in women.
Defective medial device claims can be quite complex. Establishing legal fault is not always simple, so it’s important to find a defective product lawyer that specializes in medical devices. The defective product lawyers at Roberts & Roberts specialize in understanding the current issues and litigation involved in these types of cases and can help you take action. Please call 800-248-6000 or contact us for a free consultation.