MICHAEL G. FITZPATRICK vashwsrow cence ce ee FINANCIAL SERVICES way =“ Congress of the Unites States “Sa ‘ReGen crear House of Representatives ‘Washington, DE 20515-3808 December 18, 2015 Director George Karavetsos Office of Criminal Investigations Food and Drug Administration 7500 Standish Place Rockville, MD 20855 Dear Director Karavetsos, ‘The Food and Drug Administration (FDA) regulations contain mandatory requirements for manufacturers, importers, and device user facilities to report device-related deaths and serious injuries. These regulations were put in place to protect patient safety. Itis critically important that the FDA is made aware of dangerous and deadly medical devices so that action can be taken ina timely manner to mitigate risks or to remove the dangerous device from the market entirely. Under the Medical Device Reporting regulations, hospitals, as a user facility, must report a suspected device-related death to the FDA. Specifically, 21 CFR 803.30(a)(1) states that a hospital must report to the FDA within 10 days any information that “reasonably suggests that a device has or may have caused or contributed to the death of a patient of your facility.” Furthermore, hospitals must report to the device manufacturer within 10 days any information that “reasonably suggests that a device has or may have caused or contributed toa serious injury to a patient of your facility.” Additionally, medical device manufacturers must report a suspected device-related death or serious injury to the FDA. Specifically, 21 CFR 803.50(a)(1) states that a manufacturer must report to the FDA within 30 days any information that reasonably suggests that a device a manufacturer markets “[m]ay have caused or contributed to a death or serious injury.” ‘The regulations go on to clarify that a serious injury includes a “life threatening injury or illness.” However, it appears that these patient safety regulations may not be working as intended, leaving patients in danger. As you may be aware, hundreds, if not thousands, of women are dead because of a medical device known as a laparoscopic power morcellator. Despite the long history of this device on the market, only recently has the FDA put out guidance that the use of laparoscopicpower morcellators increases the risk of spreading unsuspected cancers in women to as high as 1 in 352 cases. In November 2014, the FDA put a black box warning on the device. For the over 2 decades since the power morcellator was first cleared for use on patients, the FDA's Medical Device Reporting regulations failed to catch the severe dangers posed to women’s health by morcellation. The FDA stated in a response letter to my office dated November 12, 2015, that “[pjrior to late 2013, FDA did not receive any adverse reports related to the spread or upstaging of unsuspected cancer through morcellation of uterine tissue.” In fact, the first time the FDA received a report of death or serious injury was neither from a user facility nor a device manufacturer. It was “from a physician 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.” It should not have taken a family devastated by this device to raise the issue to the FDA. Had the regulations works as intended, itis likely many women’s lives could have been spared from the horrific consequences of morcellation. In order to ensure the proper functioning of our nation’s patient safety laws, I respectfully request your office investigative this failure, with particular attention to the following questions: Brigham and Women’s Hospital 1. Is Brigham and Women’s Hospital a user facility subject to 21 CFR 803? What policies and procedures does Brigham and Women’s Hospital have in place to satisfy the requirements of 21 CFR 803? 2. Did Brigham and Women’s Hospital make a determination regarding whether the upstaging and spreading of leiomyosarcoma throughout a women’s body is a life threatening illness under 21 CFR 803? 3. Erica Kaitz underwent power morcellation at Brigham and Women’s Hospital in June 2012 and had an unsuspected leiomyosarcoma upstaged by the morcellator. Was this reported to the manufacturer of the power morcellator used on Ms. Kaitz? Ifno, please explain why. 4. Ms. Kaitz died on December 7, 2013 as a result of the leiomyosarcoma upstaged by the power morcellator. Was the death of Ms. Kaitz reported to the FDA by Brigham and Women’s Hospital? If no, please explain why. 5. Has Brigham and Women's Hospital ever been subjected to any enforcement actions by the FDA for a failure to follow the reporting requirements under 21 CFR 803? If yes, please provide details Rochester General HospitalIs Rochester General Hospital a user facility subject to 21 CFR 803? What policies and procedures does Rochester General Hospital have in place to satisfy the requirements of 21 CFR 803? Did Rochester General Hospital make a determination regarding whether the upstaging and spreading of leiomyosarcoma throughout a women’s body is a life threatening illness under 21 CFR 803? Barb Leary underwent power morcellation at Rochester General Hospital in 2009 and had an unsuspected leiomyosarcoma upstaged by the morcellator. Was this reported to the manufacturer of the power morcellator used on Ms. Leary? If no, please explain why. Ms. Leary died in September 2013 as a result of the leiomyosarcoma upstaged by the power morcellator. Was the death of Ms. Leary reported to the FDA by Rochester General Hospital? If no, please explain why. Linda Interlichia underwent power morcellation at Rachester General Hospital on October 21, 2013 and had an unsuspected leiomyosarcoma upstaged by the morcellator. Was this reported to the manufacturer of the power morcellator used on Ms, Interlichia? If no, please explain why. Linda Interlichia died on October 31, 2014 as a result of the leiomyosarcoma upstaged by the power morcellator. Was the death of Ms. Interlichia reported to the FDA by Rochester General Hospital? Ifno, please explain why. Has Rochester General Hospital ever been subjected to any enforcement actions by the FDA for a failure to follow the reporting requirements under 21 CFR 803? If yes, please provide details. University of Rochester Medical Center 1: Is the University of Rochester Medical Center a user facility subject to 21 CFR 803? What policies and procedures does the University of Rochester Medical Center have in place to satisfy the requirements of 21 CFR 803? Did the University of Rochester Medical Center make a determination regarding whether the upstaging and spreading of leiomyosarcoma throughout a women’s body isa life threatening illness under 21 CFR 803? Brenda Leuzzi underwent power morcellation at the University of Rochester Medical Center in September 2012 and had an unsuspected leiomyosarcoma upstaged by the morcellator. Was this reported to the manufacturer of the power morcellator used on Ms, Leuzzi? Ifo, please explain why.4 Ms. Leuzzi died on October 24, 2014 asa result of the leiomyosarcoma upstaged by the power morcellator. Was the death of Ms. Leuzzi reported to the FDA by the University of Rochester Medical Center? If no, please explain why. Has the University of Rochester Medical Center ever been subjected to any enforcement actions by the FDA for a failure to follow the reporting requirements under 21 CFR 803? If yes, please provide details. Device Manufacturer Ethicon ay Is Ethicon a medical device manufacturer subject to 21 CFR 803? What policies and procedures does Ethicon have in place to satisfy the requirements of 21 CFR 803? Did Ethicon make a determination regarding whether the upstaging and spreading of leiomyosarcoma throughout a women’s body is a life threatening illness under 21 CFR 803? By 2006, was Ethicon aware of information that laparoscopic power morcellators could facilitate the seeding of cancerous tumors throughout a women’s body? If so, what was the source of the information? 21 CFR 803.50(a) clarifies that a manufacturer must report to FDA once they become “aware of information, from any source” of a dangerous or deadly device they manufacture. Dr. Robert Lamparter, a pathologist from Lewisburg, Pennsylvania, corresponded with Ethicon in 2006 regarding the risks of spreading unsuspected cancer in procedures using a laparoscopic power morcellator. In fact, his emails to Ethicon stated: “In about 1/300 hysterectomies at our hospital, we discover an endometrial carcinoma that was unexpected at the time of surgery.” Did Ethicon report the warnings of serious injury and death to patients undergoing procedures involving laparoscopic power morcellators received from Dr. Lamparter to the FDA? Ifno, please explain in detail the analysis as to why Ethicon did not believe that information to be a reportable event. Did Ethicon conduct an investigation into the risks presented by Dr. Lamparter? If so, please provide the details of that investigation. Were the evaluations of that investigation reported to the FDA? FDA reporting regulations require manufacturers to submit information that is “reasonably known” by the manufacturer. The FDA considers information that can be obtained by contacting a user facility, such as a hospital, as information reasonably known to the manufacturer. Upon receiving the correspondence from Dr. Lamparter in 2006, did Ethicon attempt to contact hospitals or other user facilities that used Ethicon’s device regarding the risks posed by morcellating unsuspected cancer in women? Ifno, please explain why.7. In an April 5, 2006 email exchange between Ethicon Women's Health and Urology Medical Director Dr. David Robinson and Dr. Lamparter, Dr. Robinson highlighted a labeling change on Ethicon's morcellator to include a warning that “use of the GYNECARE Morcellex Tissue Morcellator may lead to dissemination of malignant tissue." [emphasis added]. Was the risk of dissemination of malignant tissue reported to the FDA? Ifno, explain why. Who within Ethicon makes the decision as to what event or information is reportable to the FDA under 21 CFR 803? Who made the decision to report or not report the information received from Dr. Lamparter in 2006 to the FDA? Has Ethicon ever been subjected to any enforcement actions by the FDA for a failure to follow the reporting requirements under 21 CER 803? If yes, please provide details. ‘The information detailed above has been obtained through public press reporting. If my office can be of assistance during your investigation, please do not hesitate to contact Justin Rusk on my staff at 202-225-4276. appreciate your attention to this request and | look forward to your prompt reply. Sincerely, “st ae Mike Fitzpatrick Member of Congress