“In this particular case, it’s my belief . . . that thousands of women since that discovery was made in Pennsylvania but never widely disseminated . . . had their fibroids morcellated, their cancer upstaged, they never knew what happened. They went home, dealt with the new diagnosis, they were treated, many of them probably went bankrupt, and most of them probably passed away.” -Rep. Mike Fitzpatrick (R-PA)
As our Texas morcellator injury lawyers have reported, power morcellators are deadly devices that spread Leiomyosarcoma (LMS) uterine cancer. The devices were used to mince or “morcellate” uterine tissue during hysterectomies and myomectomies, which enabled the operations to be performed with smaller incisions. But the devices also spread cancer, and have killed or accelerated the deaths of thousands of women.
On July 12, 2015, the United States House of Representatives passed the “21st Century Cares Bill.” This legislation increases federal funding for medical research and changes the process for drug approvals.
The Fitzpatrick Amendment
The new bill included an amendment from Pennsylvania Congressman Mike Fitzpatrick that provides:
“It is the sense of the Congress that recording unique device identifiers at the point-of-care in electronic health record systems could significantly enhance the availability of medical device data for postmarket surveillance purposes.”
The purpose of this amendment is to ensure that the model or make information from medical devices such as morcellators will be included in medical records, so that patient data trends – including whether a large number of patients are being harmed by a particular device—can be tracked.
The Food and Drug Administration (FDA), the government body charged with regulating medical devices, published a final rule establishing a unique device identification system back in 2013. But industry and the FDA have been slow to implement this “UDI Rule.” It is hoped that the Fitzpatrick Amendment will accelerate the process.
“What Happened With The Power Morcellator Should Never Be Allowed To Happen Again”
Mr. Fitzpatrick, himself a cancer survivor, stated bluntly at the H.R. 6 Rules Committee Hearing on July 8, 2015 that:
“What happened with the power morcellator should never be allowed to happen again.”
In fact, there was a great deal of congressional discussion about morcellators at the hearing, including several poignant comments from Mr. Fitzpatrick. For example, the Republican congressman voiced his belief that this is:
“[C]ertainly a medical issue. But it’s also a regulatory issue . . . it’s a transparency issue, and it’s a consent issue.”
“If a problem arises, how is the public notified so that physicians, and patients, and the public generally know that this thing is being taken off the market, and then how do women actually consent through all that?”
Odds Of Getting Cancer From Power Morcellators: 1/350
Mr. Fitzpatrick continued:
“It’s my understanding that 95 percent of all medical devices are approved in an expedited fashion.”
“This one was approved 20 years ago, and the theory was, I believe, that maybe 1 in 10,000 women have had their thyroid tumors after pathology determined to be cancerous. That number was wrong. The number being discussed today is 1 in about 350. It’s a much different number.”
When Were Dangers of Morcellators Reported To Johnson & Johnson? 10 Years Ago.
Mr. Fitzpatrick stated that:
“In this particular case a pathologist from a little known hospital in Pennsylvania discovered [that morcellators spread cancer at a very high rate] about 10 years ago and notified the manufacturer.”
FDA Medical Device Recall Process Needs To Be Changed
Mr. Fitzpatrick explained that the morcellator failures reveal FDA recall processes need to be modified:
“If the number’s not 1 in 10,000 but it’s 1 in 350 . . . Once we determine it’s doing more harm than good, how is the public notified? How is the FDA notified? What’s the process to reach back and say that one particular device needs to be recalled?
“Because as long as it takes the FDA to approve these devices, they almost never recall them. Why is that?”
Prior FDA Black Box Warning
In July 2014, the FDA issued a “black box warning” cautioning gynecologists not to use Ethicon power morcellators in most hysterectomies and myomectomies because the morcellators can cause severe personal injuries and even death by spreading or “seeding” cancerous tissue.
Or, as the FDA put it, the devices “significantly worse[n] the patient’s likelihood of long-term survival.”
Morcellators Withdrawn From Market
Johnson & Johnson, the largest manufacturer of the device, responded by pulling morcellators from the market in July 2014. Yet other manufacturers continue to make the deadly device. Morcellators have been in production for 24 years.
Texas Congressman & Former Gynecologist Opposes Morcellator Data Tracking
Incredibly, Texas Congressman and former Gynecogist Bill Burgess (R—Texas, Denton &
Tarrant Counties ) opposed the Fitzpatrick Amendment.
He said “my experience is the FDA has been good about recalling those devices when required. If you don’t think that is what happened in the case of the power morcellators, so be it.”
Morcellator Injury Lawyers Are Here To Help
The Texas Morcellator lawyers at Morrow & Sheppard help women and their families nationwide who have been affected by the deadly uterine cancer spread by power morcellators.
Please contact us now to discuss your case during a free and confidential consultation.
If you do decide to hire us, we only get paid if you win.