J&J Received E-Mails in 2006 about Risks Now Alleged in Power Morcellator Lawsuit Claims
A Pennsylvania doctor warned Johnson & Johnson’s Ethicon unit about problems similar to those alleged in power morcellator lawsuit claims eight years before the company opted to suspend sales of the surgical tool, the Pittsburgh Business Times reports.
A report from May 30th indicates that a pathologist from Evangelical Community Hospital in Lewisburg drafted a series of e-mails to Johnson & Johnson in 2006, asking them to “reconsider the risk to the patient” from use of a device used in fibroid removal and laparoscopic hysterectomy procedures.
PA Doctor Warns J&J about Uterine Sarcoma Risks
As pre-screening procedures for cancer are often unsuccessful, the use of a power morcellators may promote the spread of previously undiagnosed uterine sarcoma and other uterine cancers, and significantly raise a patient’s risk for danger, the doctor told Ethicon. In response, the company added a warning to the instruction label of its morcellators.
“Virtually all uteruses have some sort of pre-op screening, whether it be an endometrial biopsy or an ultrasound, so whatever screening is being done misses a certain number of malignancies,” the doctor said in an e-mail sent in February 2006. “When the operative procedure is a standard hysterectomy, no damage is done. If a morcellation is done, the patient’s survival is jeopardized.”
Despite these warnings, Johnson & Johnson did not suspend sales of its power morcellators until April 2014, after the U.S. Food and Drug Administration (FDA) warned the public about a possible association with the spread of uterine cancer. The FDA said it planned to convene an advisory panel on the matter over the summer, and discouraged doctors from using the devices in the meantime. Ethicon’s Gynecare Morcellex, Morcellex Sigma Tissue Morcellator System, and Gynecare X-Tract Tissue Morcellator were affected by the sales suspension.
In the months leading up to and following the FDA alert, a number of power morcellator lawsuit claims were filed on behalf of women whose uterine cancer allegedly spread because of a fibroid removal or laparoscopic hysterectomy aided by the device. One such case was filed this February by the husband of a 53-year old woman who died of uterine cancer shortly after undergoing a surgery involving the device. According to court documents, this power morcellator lawsuit was filed in the U.S. District Court, Eastern District of Pennsylvania.
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