Although Johnson & Johnson withdrew its laparoscopic power morcellators from the market in July 2014, it appears that the company’s problems concerning the device are far from over.
FBI Investigation of Morcellator Continues
According to a report in the Wall Street Journal, the FBI is investigating the power morcellator, a surgical tool that has been found to spread cancer in women, and J&J’s knowledge of the device’s risks. J&J was the largest manufacturer of the power morcellator until last year when it pulled the device off the market after the Food and Drug Administration warned that women undergoing fibroid surgery or hysterectomy have a one in 350 chance of having uterine sarcoma, a cancer that cannot be consistently detected before surgery.
Although the stage of the FBI’s inquiry unknown, agents have interview several people, including:
- A retired pathologist who notified J&J of potential issues concerning morcellators in 2006
- A doctor who is fighting to ban morcellators after her own cancer was exacerbated by morcellation in 2013
- A California women who has a list of nearly 400 patients and their families who may have been injured by the device
What do Power Morcellators do?
Morcellators were previously used in thousands of minimally invasive procedures each year, mostly in hysterectomies. The devices work by grinding up the uterus or uterine fibroids and removing the tissue through a small abdominal incision. But if sarcoma is present, morcellation will spread the malignancy, potentially causing it to advance rapidly to a deadly and difficult-to-treat stage. As a result, many hospitals and the nation’s largest heath care plans have either limited use of morcellators or are contemplating setting limits.
Two U.S. Congressmen, Senator Robert Casey Jr. (D-PA) and Representative Michael Fitzpatrick (R-PA) sent letters to the FDA in February 2015, asking why the agency urged healthcare providers to curtail use of morcellators but has not yet banned the device altogether. The FDA has stated that it will only respond directly to the congressmen.
If you or a loved one has suffered from cancer spread by a power morcellator during surgery, you need to make sure you know your options. You may be entitled to compensation from the company that manufactured the device that caused this horrible ordeal.
Contact the attorneys at Childers, Schlueter & Smith today. Consultations are free and without obligation.
Other Morcellator News
A recent study links the FDA’s morcellation warning to increased invasive surgeries for uterine fibroids, raising concerns about reduced access to minimally invasive treatment options for women.
Olympus America is redesigning its power morcellator with a containment system, but the FDA remains concerned about cancer risks. Legal and safety questions persist amid ongoing clinical trials and lawsuits.
The GAO report finds the FDA underestimated cancer risks from power morcellators, highlighting gaps in postmarket device monitoring and raising concerns for patients undergoing fibroid surgeries.
Johnson & Johnson has settled nearly 70 lawsuits over its laparoscopic power morcellator, with cases citing risks of spreading undetected cancer. Additional claims remain pending in multidistrict and state court litigation.
Federal courts have consolidated morcellator cancer lawsuits against Johnson & Johnson and Ethicon, streamlining pretrial proceedings for women alleging the device spread undetected cancer during surgery.
The U.S. Government Accountability Office will investigate whether FDA approval and oversight failures allowed dangerous power morcellators to remain on the market despite their potential to spread hidden cancers.
