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By Michael D. Williamson
Jan. 8 — The FDA's criminal investigators should examine why a device maker and hospitals didn't alert the agency to potentially fatal problems with a controversial gynecological medical device, according to a Republican lawmaker.
Rep. Michael Fitzpatrick (R-Pa.) asked George Karavetsos, the director of the Food and Drug Administration's Office of Criminal Investigations, to determine if Johnson & Johnson unit Ethicon, a manufacturer of power morcellators linked to deaths, failed to report problems with the device.
Power morcellators are used to remove uterine fibroids through a procedure known as a laparoscopic incision. However, if a uterine fibroid contains an undetectable cancer, the device can spread the disease throughout a woman's body.
Meanwhile, Ethicon defended its filing of reports with the FDA. The company appropriately files device incident reports in a timely manner “once information is received or noticed by the company indicating that reporting is appropriate under reporting requirements,” Matthew Johnson, the director of corporate communications for Ethicon, said in a Jan. 8 e-mail to Bloomberg BNA.
The lawmaker, in a recent letter, also urged Karavetsos to investigate why Brigham and Women's Hospital in Boston, Rochester (N.Y.) General Hospital and the University of Rochester (N.Y.) Medical Center (URMC) didn't report patient deaths associated with the morcellator devices.
A URMC spokeswoman, in a Jan. 8 e-mail to Bloomberg BNA, defended the hospital's decision not to report a 2012 death cited in the lawmaker's letter. Rochester General Hospital didn't respond to a request for a comment.
In response to an inquiry from Bloomberg BNA, Brigham and Women’s Hospital said Jan. 11 that it “first contacted the FDA about the case identified in Rep. Fitzpatrick’s letter in early 2014, and has responded cooperatively to the FDA’s subsequent inquiries on this matter. Due to pending litigation, we are not able to provide additional information at this time.”
The FDA is “aware of the letter and we plan to respond to the Congressman via our usual process,” agency spokeswoman Deborah Kotz told Bloomberg BNA in a Jan. 6 e-mail.
Fitzpatrick wrote that under the medical device reporting regulations, user facilities, including hospitals, must report a suspected device-related death to the FDA within 10 days after any information suggests that a device has or may have caused or contributed to a serious injury of a patient.
Likewise, “medical device manufacturers must report a suspected device-related death or serious injury to the FDA” within 30 days of receiving any information that suggests a company's product may have caused or contributed to a death or serious injury, Fitzpatrick wrote.
However, the current reporting regulations may not be working, according to the Pennsylvania Republican. Fitzpatrick added the first time the FDA received a report of death or serious injury “was neither from a user facility nor a device manufacturer.”
In fact, the FDA's first report about problems with morcellators was from a doctor citing the case of a family member who has a disseminated cancer that was suspected to have resulted from a procedure in which a power morcellator was used, Fitzpatrick's letter said.
According to the lawmaker, it shouldn't take a family devastated by this device to raise the issue to the FDA. “Had the regulations worked as intended, it is likely many women's lives could have been spared from the horrific consequences of morcellation.”
Fitzgerald also accuses Ethicon of becoming aware of information that laparoscopic morcellators could facilitate the seeding of cancerous tumors in a woman's body by 2006.
A Pennsylvania pathologist, Robert Lamparter, warned Ethicon in 2006 that in about one in 300 hysterectomies performed at his hospital resulted in an endometrial carcinoma (cancer) that was unexpected at the time of the surgery, Fitzpatrick wrote.
The congressman asked Karavetsos if Ethicon reported the warnings of serious injury and death to patients undergoing procedures involving laparoscopic power morcellators received from Lamparter to the FDA. “If not, please explain in detail the analysis as to why Ethicon did not believe that information to be a reported event.”
Johnson, the Ethicon corporate communications director, told Bloomberg BNA the company made a determination “when we received Dr. Lamparter’s letters in 2006 that there was not a reportable event because he did not report an actual morcellation experience with a patient.”
However, Lamparter's questions prompted Ethicon to supplement the precautions contained in the device’s instructions for use “to address the issue of the preoperative pathologic evaluation of the endometrium,” he said, adding, “Ethicon’s morcellation devices have always carried a warning about the potential spread of cancerous tissue.”
In his Dec. 18 letter, Fitzpatrick also asked Karavetsos several questions about decisions by Brigham and Women's Hospital, Rochester General Hospital and URMC to not report several deaths potentially linked to power morcellators.
Like many hospitals across the country, URMC's Strong Memorial Hospital “didn't initially report its 2012 morcellation case to the FDA because it didn't appear to meet the criteria for medical device reporting,” Barbara Ficarra, the associate director of public relations and communications at URMC, said in a Jan. 8 e-mail.
“Historically, FDA required device facility users to report information when there is a patient death or serious illness or injury of a patient, caused or contributed to by instances of device failure, malfunction, improper or inadequate device design, manufacture, labeling or user error,” the URMC spokeswoman told Bloomberg BNA. “Based on our interpretation of this language at the time, it did not fit the definition of a device ‘failure.' The device functioned as expected and was used in the way it was intended, although with unintended and tragic consequences.”
In November 2014, the FDA issued a “black box” label warning for the morcellators, which noted the devices could spread undetected cancer and decrease the long-term survival of patients.
More recently, a bipartisan group of House lawmakers last August urged the Government Accountability Office to investigate if the FDA's device clearance policies sufficiently identified risks of adverse events before the agency allowed the laparoscopic power morcellator to enter the market.
Several plaintiffs have sued Ethicon and parent company Johnson & Johnson over the effects of power morcellators.
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Full text of Fitzpatrick's letter is at http://src.bna.com/bWe.
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