Johnson & Johnson and Brigham & Women's Hospital may have violated federal law by failing to report adverse effects from morcellation procedures to the FDA.
At a hearing earlier this week, the chairman of the Subcommittee on Oversight and Investigations questioned the director of the FDA's Center for Devices and Radiological Health in an effort to determine if the device manufacturer and hospital had failed to notify the FDA that the device resulted in harm to patients.
The director was asked how much he knew about the case of Erica Kaitz, a patient of Brigham & Women's Hospital who was seriously injured by a morcellator in 2012 and who soon after died in 2013. Kaitz's husband was originally told that the risk his wife would face of complications was one in 10,000 - which is nine times less than the actual risk. The director replied that he did not recall whether the incident was ever reported to the FDA.
Johnson & Johnson, who should have been aware of the potential dangers behind use of their power morcellator, claimed that they had no knowledge of any adverse effects from morcellators prior to 2013, in spite of reports as far back as 2006 made by a pathologist showing that one in every 300 morcellated tissue samples contained cancer. Johnson & Johnson's subsidiary, Ethicon, responded that the report was handled only as a complaint and not as a "reportable event" that would have warranted further action. Thus, it was only until last year that the FDA issued a warning about the device and its link to adverse effects.
It is difficult to believe that a communication breakdown such as this has occurred when it has long been known that power morcellators are dangerous medical devices linked to the spread of undetected cancer in women. Johnson & Johnson needs to be held responsible for failing to act in 2006 with the initial report, especially when the odds (one in 300), were so significant.
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Tracey & Fox is now representing women harmed by power morcellation devices in a class action lawsuit. To see if you are eligible to join, please contact a San Antonio personal injury lawyer at our firm by calling 713-955-7855.