The U.S. Federal Bureau of Investigation (FBI) is reportedly investigating a Johnson & Johnson surgical device that has been linked to the spreading of cancer in women.
The American health care giant announced a recall of uterine surgery tools last year following reports that the tools could cause cancer. The Ethicon unit of the company reached out to hospitals asking them to return a line of devices used in hysterectomies and uterine surgeries. The action followed the U.S. Food and Drug Administration (FDA) advisory in April 2014 that discouraged doctors from using morcellators, as it poses a risk in spreading cancerous tissues. Morcellators are commonly used in laparoscopic operations for fibroid removal in the uterus, a procedure that calls for the extraction of the entire uterus.
During that time, speculations rose that Johnson & Johnson promptly announced the recall to avoid lawsuits and bad public relations. The company denied the allegation.
Sources told The Wall Street Journal on Thursday that the FBI is conducting an investigation to determine the extent of Johnson & Johnson's knowledge of the surgical device's hazards prior to announcing the recall. People familiar with the investigation said that the FBI has interviewed at least three people in the past few months to get information.
One of the people interviewed, Robert Lamparter, a former pathologist at Evangelical Community Hospital in Lewisburg, Pa., said that he talked to the FBI on May 12 about how he alerted the company about the potential risks of the surgical device in 2006. The Wall Street Journal was able to obtain copies of the emails and letters related to the issue.
Johnson & Johnson spokesman Matthew Johnson confirmed the alert and clarified that the company did not ignore the warning. They used the information to revise the instructions of using the device.
The FBI's Newark, N.J., office, which oversees the investigation, and Johnson & Johnson both declined to comment on the report.
