publication date: Nov. 19, 2015
The House Committee on Energy & Commerce has stepped into a key role in the controversy over power morcellation.
At a hearing earlier this week, Rep. Tim Murphy (R-Pa.), chairman of the Subcommittee on Oversight and Investigations questioned whether Johnson & Johnson and Brigham & Women’s Hospital violated federal law by not reporting adverse outcomes resulting from power morcellation.
At the Nov. 17 hearing by the Subcommittee on Health, Murphy quizzed Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, in an apparent effort to determine whether manufacturers of power morcellators as well as hospitals that used these devices had failed to notify FDA that patients were being harmed.
|FDA: Federal Law Requires Reporting of Morcellation Adverse Events, But None Were Brought to Agency’s Attention For 8 Years|
FDA officials said the agency didn’t receive any reports of adverse outcomes resulting from power morcellation prior to December 2013.
“Of note, prior to December, the FDA had received no MDRs specifically on cancer and upstaging/dissemination,” the agency said in response to questions from The Cancer Letter. “Since then, the agency has become aware of about two dozen that have discussed ‘cancer’ and ‘upstaging or dissemination’ as of November 2014. All of these reports pertained to procedures that took place prior to December 2013.”
|J&J Says There Were No Reportable Morcellation Events; Whistleblower Disagrees—and Produces Letters|
Johnson & Johnson officials said the company was unaware of any reportable adverse events resulting from the use of power morcellators prior to 2013.
“[J&J subsidiary] Ethicon was not aware of any reportable events related to morcellators and the possibility of upstaged cancer prior to December 2013,” a company spokesman said to The Cancer Letter. “Since that time, we have filed reports with the FDA for all reportable events that have come to our attention.”
Ethicon responded to The Cancer Letter’s questions after the Nov. 17 hearing by the Subcommittee on Health, where Rep. Tim Murphy (R-Pa.) noted that the company had received a report about the dangers of power morcellators.