- Power Morcellator Lawsuit Settles
- August 12, 2015
- Law Firm: Waters Kraus LLP - Dallas Office
- Lina Medical ApS has settled a power morcellator lawsuit filed against the medical device maker in federal court in Pennsylvania. The amount of the settlement is confidential. It was expected that this would be the first power morcellator lawsuit to reach trial.
Lina Medical Settles Power Morcellator Lawsuit Involving Death of 53-Year-Old Woman
Scott Burkhart filed suit in March 2014 against Lina Medical after his wife, Donna, died in 2013 as a result of a hysterectomy performed with a power morcellator. Lina Medical was the maker of the device. Eleven months after her surgery, Mr. Burkhart’s wife died from leiomyosarcoma, a uterine cancer that had not been detected prior to the hysterectomy.
A power morcellator is shaped like a drill with a rotating blade on the end that slices up tissue inside the body. The bits of tissue are then vacuumed up through a tube inserted through small incisions. The U.S. Food and Drug Administration has warned that use of a power morcellator can spread undetected uterine cancers throughout the body, making treatment more difficult and prognosis for recovery bleak. Mr. Burkhart’s lawsuit alleged that Lina Medical failed to warn that use of its device carried a risk for spreading undetected cancers.
The FDA has now required a “black box” warning on power morcellators. In addition, the agency has warned that morcellators should not be used in gynecological procedures for most women. Use of the medical device has fallen sharply. The primary manufacturer of morcellators, Johnson & Johnson, has stopped making the devices. Many hospitals have banned their use and health insurers have limited the instances in which they will cover power morcellator surgery.