Ethicon Power Morcellators Reportedly Targeted in FBI Probe
The FBI has launched a power morcellator investigation, and appears to be interested in the way Johnson & Johnson handled devices manufactured by its Ethicon, Inc. unit. According to The Wall Street Journal, federal agents have interviewed a number of individuals over the past several months, including a retired pathologist who voiced concerns to the company in 2006, as well as a physician who was diagnosed with uterine cancer after undergoing a morcellator hysterectomy in 2013.
Ethicon Inc. withdrew three Gynecare morcellators from the market in July 2014, several months after the U.S. Food & Drug Administration (FDA) discouraged doctors from using the devices to perform hysterectomies and uterine fibroid removals because of their potential to spread undetected uterine sarcomas and other cancers into the peritoneal cavity. Such occurrences can upstage the malignancy, and greatly reduce a woman’s odds of long-term survival, according to the agency.
In November 2014, the FDA issued a second alert, which warned doctors against using the devices in most women who require hysterectomy or fibroid removal. The agency also ordered the addition of a black box warning to the device labels in order to warn of their potential to spread uterine cancers.
FBI Morcellator Interviews
According to the Journal, not all of the interviews conducted by the FBI are focused on Johnson & Johnson. But investigators have spoken to Robert Lamparter, a former pathologist at Evangelical Community Hospital in Lewisburg, Pa. In 2006, Dr. Lamparter wrote Ethicon to discuss his concern that morcellators could disseminate undetected cancer cells beyond the uterus. Among other things, he disclosed to Ethicon that even at his small hospital, which he said had done 292 hysterectomies the previous year, gynecologists found an unexpected malignancy at least once annually. As a result of his correspondence, Ethicon did update the labeling on its morcellators to note that use of the morcellator “may lead to dissemination of malignant tissue.”
In addition to interviewing Dr. Lamparter, FBI agents have also spoken to Dr. Amy Reed, who was diagnosed with cancer following her 2013 hysterectomy. The hospital where Dr. Reed underwent her procedure has confirmed that a morcellator allowed the spread of her cancer, and she and her husband have since been at the forefront of an effort to ban the devices.
Morcellator Cancer Lawsuit Reviews
Johnson & Johnson and its Ethicon unit are just one of several medical device manufacturers named as defendants in morcellator cancer lawsuits. If you would like more information on filing your own claim, please contact Bernstein Liebhard LLP by calling 1-877-779-1414.