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Morcellation Media Monitoring 02/04/2016
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Protect patients from medical harm with strong legislation
Feb 1, 2016 | Philly.com
By Hooman Noorchashm MD, PhD and Amy J. Reed MD, PhD Read more at http://www.philly.com/philly/blogs/healthcare/Protect-patients-from-medical-harm-with-strong-legislation.html#GJevcCY1syItKbee.99
Over the past year a number of egregious safety failures at the FDA’s medical device section have highlighted a dangerous threat to unsuspecting patients across our nation. -
Wisconsin Ethicon Gynecare Morcellator Cancer Spread Lawsuit
Feb 4, 2016 | The Legal Examiner
By Shezad Malik MD JD
Babette Davis from Wisconsin filed a morcellator product liability lawsuit in the U.S. District Court for the Eastern District of Wisconsin against Johnson & Johnson’s Ethicon unit after being diagnosed with leiomyosarcoma, a deadly aggressive form of uterine cancer. According to Davis, the Johnson & Johnson’s Ethicon Gynecare power morcellator that was used during the laparoscopic hysterectomy caused the undiagnosed uterine cancer to be spread throughout her abdomen and pelvis.
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Protect patients from medical harm with strong legislation
Feb 1, 2016 | Philly.com
By Hooman Noorchashm MD, PhD and Amy J. Reed MD, PhD Read more at http://www.philly.com/philly/blogs/healthcare/Protect-patients-from-medical-harm-with-strong-legislation.html#GJevcCY1syItKbee.99
Over the past year a number of egregious safety failures at the FDA’s medical device section have highlighted a dangerous threat to unsuspecting patients across our nation.
Feeral reports and discussions on the floor of congress are great. But a practical solution needs to be proposed and implemented quickly – because there are sure to be other devices, as yet unidentified, harming patients across our nation and costing our insurance investments untold billions.
So far the only solution that has gained traction in either house of congress is to add barcodes, known as Unique Device Identifiers (UDI) to all medical devices – this, in hopes of being able to identify trends in adverse outcomes.
But the “surveillance” method proposed by the UDI advocates is not a practical solution for many reasons. Most important among them: simply having the ability to do surveillance, assuming the system comes online anytime in the future, does not necessarily lead to adequate “active” surveillance. And to do such active surveillance would be a costly government endeavor.
There is a far simpler solution that must be recognized by all patients, patient advocates and federal lawmakers – and the medical device industry itself. Our proposed solution is the introduction of a “Medical Device Guardian Act” by congress. This act would be focused on three parameters that will ensure efficient identification of deadly risks to patients’ lives.
The first component of this proposed Guardian Act would be focused on eliminating conflicts of interest at FDA. Elimination of “experts” and FDA leaders with direct, or indirect, financial conflicts-of-interest from the FDA review process is critical. In other words, if a physician’s practice and livelihood depends on a certain medical device, that physician cannot be objective. A clear example of this type of conflict was apparent on the FDA panel on morcellation and in the minimally invasive gynecological community’s defense of morcellation.
The second component of the Guardian Act would be focused on efficient “self-reporting” of adverse events to manufacturers and to the FDA. When a device is used and causes an adverse outcome in a patient, the doctor and the hospital, almost always, have this information. It is the fear of liability and the FDA’s lax enforcement of “self-reporting” requirements that has created a “culture of complacency” in the medical device space. Most doctors, hospitals and manufacturers do not behave responsibly because FDA enforcement is poor. This is not the so much the case in the drug space – which indicates that boosting federal “self-reporting” mandates for medical devices could be a very practical and efficient means of achieving safety. Legislation that would protect individual practitioners from liability when reporting adverse outcomes associated with the use of medical devices, and prosecuting failures to “self-report”, would reveal problems very quickly.
The final component of the Guardian Act would be to ensure adequate market signals to manufacturers through the court system. The right of harmed patients to seek justice must be robustly defended in the medical device space through legislation. Currently, many medical device manufacturers are protected from any liability – the most disturbing example of this is Bayer Health’s Essure female sterilization device.
The industry friendly “surveillance” paradigm involving the use of UDI’s, being proposed by congressional Democrats and several left-leaning think tanks is okay – but it does not go anywhere near solving the problem. Fear of prosecution and liability are powerful tactics to bring safety to the medical device space.
The Medical Device Guardian Act is consistent with Republican principles and politics. In a Republican-led Congress that criticizes Democrats for failing to protect citizens’ lives and to serve free-market principles, let us see if Congress finds itself capable of a Guardian Act.
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Wisconsin Ethicon Gynecare Morcellator Cancer Spread Lawsuit
Feb 4, 2016 | The Legal Examiner
By Shezad Malik MD JD
Babette Davis from Wisconsin filed a morcellator product liability lawsuit in the U.S. District Court for the Eastern District of Wisconsin against Johnson & Johnson’s Ethicon unit after being diagnosed with leiomyosarcoma, a deadly aggressive form of uterine cancer. According to Davis, the Johnson & Johnson’s Ethicon Gynecare power morcellator that was used during the laparoscopic hysterectomy caused the undiagnosed uterine cancer to be spread throughout her abdomen and pelvis.
Davis has to take expensive oral chemotherapy drugs to keep the leiomyosarcoma cancer from spreading further.
Increased Risk of Cancer Spread After Morcellator Use
Davis alleges that Johnson & Johnson failed to disclose the increased risk of cancer after laparoscopic hysterectomy morcellation use.
The morcellation also known as a power morcellator device, is used to grind up the bulky uterus filled with fibroids which may contain undiagnosed sarcomas within the uterus. This morcellation process allows for the easy removal of the ground up uterus segments via the laparoscopic technique, but can also cause rapid spread of the aggressive uterine cancer during the grinding process.
According to Davis, her doctors used a Gynecare morcellator to grind up the uterus through a laparoscopic procedure. Unfortunately, a biopsy of the removed uterine tissue was noted to contain highly malignant leiomyosarcoma cancer cells. Her doctors did not diagnose the uterine leiomyosarcoma cancer before the laparoscopic procedure. Davis received multiple cycles of chemotherapy after the hysterectomy, but three large masses were detected in her abdomen and pelvis, confirming metastatic cancer spread.
Why are Morcellators used?
Power morcellators, which is a fancy term for a tissue grinder, has been use during minimally invasive laparoscopic hysterectomy and uterine fibroid removal procedures over the past several years. These minimally invasive procedures speed up recovery time but this benefit comes at a high cost. Power morcellator use has decreased significantly since it was discovered that they cause an unreasonable risk of spreading aggressive uterine cancer cells during the procedure.
J&J Ethicon Morcellator Recall
All Ethicon power morcellators were recalled in 2014. J&J, acknowledged that the devices pose an unreasonable risk of spreading uterine cancer. Ethicon, requested that hospitals voluntarily return all laparoscopic surgery morcellators. The J&J company announced that it will no longer sell the devices since there is no way to make them safe.
FDA Morcellator Black Box Warning
The FDA announced November 24, 2014 that it is adding a black box warning to uterine morcellator devices that remain on the market. A BLACK BOX WARNING, is the strongest warning that can be placed on any medical device.
Patients, doctors and hospitals are now on notice of the potential danger of increased uterine cancer spread risk associated with the use of these devices. Furthermore, the FDA announced that power morcellators should not be used with women near menopause or post-menopausal, or in women who could have tissue removed through the vagina or via a small incision.
This contraindication prohibits the use of the devices in the vast majority of women who undergo laparoscopic or vaginal uterine morcellation procedures.
Federal Multidistrict Litigation
Since October 2015, all federal Ethicon morcellator lawsuits have been consolidated and and centralized as part of a federal MDL, or multidistrict litigation, before U.S. District Judge Kathryn H. Vratil in the District of Kansas. As of January 15, 2016 there are 34 filed Ethicon product liability lawsuits on file at the Kansas courthouse.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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