The Federal Bureau of Investigation is reportedly trying to establish whether Johnson & Johnson—one of the largest manufacturers of power morcellators—knew as early as nine years ago that the gynecological device can disseminate uterine cancers.
According to the Wall Street Journal, the FBI’s Newark, N.J. office interviewed three people, including Robert Lamparter, a retired pathologist who alerted Ethicon, a J&J subsidiary, about potential problems with morcellators in 2006.
A full account of Lamparter’s 2006 complaint can be found at the Pittsburgh Business Times, which reported on the whistleblower case in May 2014.
FBI agents also interviewed Amy Reed, the doctor who led the campaign against power morcellation, as well as Sarah Robinson, a physician assistant in Los Altos, Calif., who told the WSJ she sent an FBI agent a list of 386 names of patients and their families who may have been harmed by the device.
It’s not publicly known whether a formal investigation has been launched. The FBI declined to comment, in response to a previous inquiry from The Cancer Letter, on the “existence or nonexistence” of an investigation (The Cancer Letter, April 10).
J&J officials told the WSJ that they were not aware of an FBI investigation. The company pulled its power morcellators from the market in July 2014, after the FDA issued a warning, and after an FDA advisory panel expressed low confidence in power morcellation as a treatment for uterine fibroids (The Cancer Letter, Aug. 1, 2014).
The FBI may be looking into whether J&J had violated federal law by neglecting to report adverse events, Hooman Noorchashm, Reed’s husband, said previously to this reporter (The Cancer Letter, April 10). Noorchashm is a cardiac surgeon at the Thomas Jefferson University Hospital.
Reed and Noorchashm’s interview with The Cancer Letter appeared on the ABC News coverage of the FBI investigation May 27.