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Morcellation Media Monitoring 06/30/2016
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Policing medical devices: It takes more than laws to protect patients
Jun 30, 2016 | Philidelphia Inquirer
By Amy J. Reed, M.D., Ph.D. & Hooman Noorchashm, M.D., Ph.D.
One of the hallmarks of an orderly and civilized society is a citizenry willing to follow the rule of law. -
New Bill Aims to Prevent Power Morcellation Cancer
Jun 28, 2016 | Top Class Actions
By Ashley Milano
Currently, doctors are not required to report adverse events or potential defects associated with medical devices used during surgical procedures, such as power morcellation to the FDA.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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Policing medical devices: It takes more than laws to protect patients
Jun 30, 2016 | Philidelphia Inquirer
By Amy J. Reed, M.D., Ph.D. & Hooman Noorchashm, M.D., Ph.D.
One of the hallmarks of an orderly and civilized society is a citizenry willing to follow the rule of law.
Even in the most lawful of nations, there are individuals and corporations that inadvertently or deliberately break the law. That's why law enforcement is critical to public health and safety.
Imagine for example if the police didn't stop drivers who ran red lights –the law would become meaningless.
But even in the U.S., there are dangerous corners of our economy where the law is absent or ignored.
Medical device regulation is under the jurisdiction of the FDA’s Office of Criminal Investigations. In this space, federal law mandates that hospitals and manufacturers “self-report” deadly hazards to the FDA’s public health experts.
But in the case of a dangerous medical device, known as a power morcellator, a vast number of women were harmed without a single physician, hospital or manufacturer bothering to “self-report” the problem to FDA. In fact, it is quite clear from publicly available information that several major hospitals had clear knowledge of the deadly complication associated with morcellation but failed to comply with the law.
U.S. Rep. Mike Fitzpatrick (R-PA) alerted the FDA’s Office of Criminal Investigations (OCI) to this noncompliance. The agency responded in a letter dated March 29, 2016 stating it inspected hospitals highlighted in the letter, but didn't indicate its results. Why won't the OCI inform the public of its findings?
The question remains: Was federal “self-reporting” law violated by hospital corporations involved with the power morcellator disaster? And if so, wouldn't that represent a serious crime given the loss of life involved here?
At the very least, it should be concerning that taxpayer dollars are being spent paying law enforcement agents who seem equivocal and slow doing their job.
Even if Congress moves to make self-reporting laws air-tight, it won't mean much without sufficient enforcement by the OCI.
Congress and the American people need to know that our public safety laws mean something – and that hospitals and manufacturers are aware that complacency in protecting patients has legal consequences.
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New Bill Aims to Prevent Power Morcellation Cancer
Jun 28, 2016 | Top Class Actions
By Ashley Milano
Currently, doctors are not required to report adverse events or potential defects associated with medical devices used during surgical procedures, such as power morcellation to the FDA.
This may soon change, though, as a new bill aims to prevent life-threatening power morcellation side effects, such as the potential to cause the spread of cancer cells during gynecologic surgeries.
Inspired by one woman’s experience with power morcellation spreading undiagnosed uterine cancer, Rep. Mike Fitzpatrick and other lawmakers have introduced a bill mandating doctors to report serious complications with medical devices like the power morcellator to the FDA.
In 2013, Dr. Amy R. and her husband embarked on a campaign to educate both the medical community and the public about a little-discussed but potentially life-threatening issue: the spread of undiagnosed uterine cancer through the use of a power morcellation during laparoscopic gynecologic surgery.
When Dr. Amy learned that leiomyosarcoma she didn’t know she had was spread throughout her abdomen after a power morcellator was used during her hysterectomy, she and her husband began to investigate the issue.
After learning that up to one in 350 women may have undiagnosed uterine cancer spread through power morcellation, she began a public crusade to save other women from morcellation cancer.
It was Dr. Amy’s story and activism that prompted Reps. Mike Fitzpatrick (R. Pa.) and Louise Slaughter (D., N.Y.) to draft the “Medical Device Guardian’s Act” and present it to Congress.
“Not one person had reported this deadly effect to the FDA” until [Amy], a mother of six, experienced it herself, said Rep. Mike Fitzpatrick, “It should not have been falling to the patients to bring this to the FDA’s attention,” Fitzpatrick said.Power
Morcellation Risks
Surgeons may use power morcellation when performing laparoscopic hysterectomies or myomectomies. Myomectomy refers to the removal of uterine fibroids and hysterectomy refers to the removal of the uterus, and possibly other reproductive organs such as the fallopian tubes, ovaries, and cervix.
When surgeons use a minimally invasive approach to perform these surgeries, the structures must be rendered into small pieces before the surgeons can remove them from the patient. Power morcellation accomplishes this.
However, in breaking up bodily structures, power morcellation also has the potential to spread undetected uterine cancer cells well beyond their point of origin, effectively turning a stage one diagnosis into a stage four diagnosis.
This is a matter of concern because some women undergoing hysterectomies and myomectomies are unaware that they have cancer before having these surgeries.
Under this proposed new law, doctors and their offices would be added to the list of mandated FDA reporters for any issues noted with medical devices. They would also be protected from civil lawsuits regarding any of their reports to the FDA.
It is hoped that this new law will help to spread awareness of potential risks or defects associated with medical devices such as morcellation cancer much more quickly, possibly preventing future adverse events.
Power Morcellation Cancer Lawsuits
Some lawsuits alleging uterine cancer after morcellation have been filed, claiming that the manufacturers should be held liable. The FDA issued a black box warning for these devices after reports of morcellator risks arose.
Johnson & Johnson pulled its power morcellators from the market. Although other brands are still available, many hospitals have restricted or eliminated their use.
If the bill is signed into law, it would facilitate precise tracking of many other high-risk medical devices, in addition to power morcellators.
While this new law could certainly reduce future damage done by faulty or defective power morcellation devices, it does not diminish the suffering of the women and families who have already suffered as a result of cancer spread by power morcellation.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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