FBI & Johnson & Johnson
Back in May of 2014 I posted a blog about Uterine Morcellation. I was stunned at all that happens to women and how much experimenting is done because women have a reproductive system. How many tools are produced to various procedures and worse yet, what these procedures can do to a woman for the rest of her life and sometimes they cause more complications that can kill. I wanted women to know the dangers of this particular procedure because it could cause cancer. If you missed that blog here it is
ON May 18th 2016, this year the Wall Street journal put out an article about Johnson & Johnson’s power morcellator tools. I want women to know what has happened and pass the full article on to you so that you can review it and if you know someone who underwent this procedure, you can let them know.
Amid regulatory and industry backlash surrounding the use of laparoscopic surgical tools in gynecological procedures, Johnson & Johnson is pulling its related device from the global market.
From the moment I read what this tool does, I thought it was dangerous and barbaric. How dare they keep experimenting on women? Here’s more.
The company’s Ethicon unit will issue a worldwide letter to customers to return power morcellator tools, which slice up uterine tissue into smaller pieces so it can be removed in minimally invasive surgery, The Wall Street Journal reports. In April, Johnson & Johnson suspended sales of its morcellator devices following an FDA advisory warning that discouraged physicians from using the tools in surgical procedures. Approximately one in 350 women with fibroids also has uterine sarcoma, the agency said in its report, and power morcellators could spread tumorous cells in the abdomen and pelvis.
Before the advisory warning, the device was used in an estimated 50,000 U.S. uterine surgeries each year, according to the WSJ. European device outfits Karl Storz GmbH, Richard Wolf GmbH and LiNA Medical also make power morcellators, but declined to comment to the WSJ.
Johnson & Johnson wants to put litigation to rest over its power morcellator devices, and it wants to do it quickly. To accomplish this goal, the company is settling a number of suits claiming that its product, which J&J has since pulled from the market, harmed women by spreading cancer.
Do you really believe they would just settle these cases UNLESS they are afraid more women will find out what happened to them and then be diagnosed with cancer and this will cost them more millions? I think not. Judging by their reticence on settling mesh injury cases, which are harder to prove, they must really be scared this is going to cost them a small fortune.
About 100 cases have either been filed or prepared for lawsuits against J&J’s Ethicon unit over the company’s laparoscopic power morcellator device, which plaintiffs claim spread undetected tumors. Of those 100 claims, J&J has settled almost 70 over the past few months, Paul Pennock, a plaintiff lawyer and co-lead counsel on the steering committee for consolidated litigation in a Kansas City, KS, federal court told The Wall Street Journal.
It’s difficult to estimate exactly how much J&J will shell out to settle the cases. Some of the company’s settlements have ranged from $100,000 to about $1 million, a person familiar with the matter told the newspaper. It’s safe to say that J&J will likely spend many millions to lay the claims to rest.
We all know that this is all speculation. More than likely the lower number will be more likely, which will be shared with lawyers and the insurance companies and the women will be left to deal with the devastating consequences, without ANY proper financial compensation. History continues to repeat itself and women will get a pittance for their injuries.
The New Brunswick, NJ-based company is also in talks to resolve other morcellator claims, lawyers with knowledge of those talks told the WSJ. Meanwhile, J&J still faces separate morcellation cases pending in state courts.
J&J’s legal saga over its morcellator devices dates back a few years to when regulators began looking into alleged problems with the products. In 2014, the FDA warned against power morcellators. The agency estimated that about one in 350 women with fibroids also have uterine sarcoma, and that using morcellators on those patients can spread cancerous tissue in the abdomen and pelvis.
J&J subsequently suspended sales of its related devices. A few months later, the company pulled its power morcellator products from the global market. J&J’s move was partly influenced by an FDA panel meeting, which recommended upgrading the devices’ safety labels to reflect increased risks.
Partly influenced by the FDA panel? Bullshit! They don’t want to put out more money on fixing tools that cause problems. It is easier to trash them, or better yet sell them on to third world companies. Never believe they don’t do this crap because they do all kinds of things to get their investment back and they will pass any loss on the women who have any surgery using their products.
“Due to this continued uncertainty, Ethicon believes that a market withdrawal of Ethicon morcellation devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk,” J&J spokesman Matthew Johnson said at the time.
New technologies are developed to mitigate the risk? Once again whatever they come up with in the future, it will put women at risk because they test them on women who have no idea what is going on!
In November 2014, the FDA slapped power morcellators with a “black-box” warning–its strongest caution–and recommended against using the tools in the “majority” of women undergoing a hysterectomy. But the agency stopped short of banning morcellators altogether, saying the devices’ benefits may outweigh the risks in some cases.
Do you realize how many black box warnings are out there? Cipro is part of a family of drugs called fluoroquinolones. They all have black box warnings and yet doctors hand them out like candy for infections caused by mesh in the body. Does anyone read them or acknowledge they exist?
European device outfits Karl Storz GmbH, Richard Wolf GmbH and LiNA Medical also make power morcellators, but J&J has been the most widely scrutinized for issues tied to its devices.
Some lawyers for the plaintiffs are applauding J&J’s move to settle cases over morcellator devices. “You certainly don’t always see a company step up and take responsibility this early on. That’s something we think is appropriate,” Pennock said, as quoted by the WSJ.
So lawyers applaud their move to settle these cases? Of course they do. They stand to make a nice tidy sum of money from these terrible products and this has crap to do with companies taking responsibility. They know the FBI is digging into this and they want it to all go away.
But the plaintiffs themselves are more wary. Settlements could mean that less attention is drawn to the issue, and that history could repeat itself. “Each one of these cases is an opportunity to create a public record about what went wrong—both ethically and at a regulatory level—so nothing like it happens again,” Hooman Noorchashm, a doctor and husband to Amy Reed, an anesthesiologist who went public with health issues tied to morcellator devices, told the newspaper
The plaintiffs need to understand that when they sign on the dotted line to settle their case they are signing to say that J & J did nothing wrong and this will all go away. Look what happened to the first cases of mesh litigation. It is hard to find anything about it throughout the Internet.
Johnson & Johnson is facing more pushback over power morcellator devices used in minimally invasive gynecological procedures, as the FBI investigates how much the company knew about the products’ risks before pulling them from the market last year.
The Federal Bureau of Investigation’s Newark, NJ, office is heading up the investigation, asking patients and physicians about J&J’s knowledge of morcellators’ potential hazards, three people interviewed by the agency told The Wall Street Journal. J&J is staying mum on the probe, saying it is not aware of an investigation into its power mocellator devices, according to the WSJ story. The FBI’s Newark, NJ-based office declined to comment to the newspaper.
Mark my words. There will be so much cover-up and nothing will happen to any of these people who lie.
Over the past several months, FBI agents interviewed Dr. Robert Lamparter, a former pathologist at Lewisburg, PA-based Evangelical Community Hospital, about his 2006 correspondence with J&J’s Ethicon subsidiary about its power morcellator devices. Lamparter reportedly told Dr. David Robinson, Ethicon’s medical director at the time, that he was concerned with several issues including the risk of spreading undetected cancer with the devices. But Lamparter never cited a specific case of this happening, the WSJ reports.
If tissue holds cancer cells it doesn’t take a rocket scientist to KNOW this will mean spreading the cancer if tissue gets chopped up and thrown around inside the body.
Matthew Johnson, a, Ethicon spokesman, told Bloomberg that the company’s decision was influenced by a two-day FDA panel meeting earlier this month that examined the device’s risks and potential benefits in laparoscopic surgical procedures. The agency’s Obstetrics and Gynecology Devices panel recommended upgrading the labeling for power morcellators and advising patients about risks prior to surgery, but its suggestions are nonbinding.
This is for the FDA panel. STOP putting these decisions in the hands of the doctors. Doctors will continue to lie and never inform women of the dangers. This means nothing. It just means they will continue to do this and get away with the consequences of their actions. The women will be the ones who are left to die. This gives YOU, the FDA panel the idea you did something about this, but it is all a lie. Wake up!
“Due to this continued uncertainty, Ethicon believes that a market withdrawal of Ethicon morcellation devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk,” Johnson said (as quoted by Bloomberg).
The company’s decision also comes in the wake of troubling data, as a recent study by Columbia University physicians found that a significant number of women undergoing laparoscopic surgery with the device have increased levels of undetected cancer. Doctors surveyed a database of insurance information to identify more than 36,000 women treated with power morcellators at U.S. hospitals between 2006 and 2007, and determined that one in 370 women who underwent a hysterectomy with the device have hidden uterine cancer, according to results published in the Journal of the American Medical Association. The tools could also spread a wider range of cancers than previously expected, physicians noted in the study.
How many women? The truth is often women don’t know what these tools can do or even that they were used during their surgery and even when they find out they NEVER report it to the FDA. So there is no way to know the exact amount and some cancers may not be detected until a long way off. Women at higher risk are ones who lose their jobs and then their good insurance. They have no idea until it is too late to save them.
If this has happened to you PLEASE report it to the FDA. No one else will. Not your doctor nor your lawyer. It is YOUR VOTE! Don’t ignore it.
Johnson & Johnson is not the only company facing pushback for its power morcellator devices. In April, Intuitive Surgical cut 2014 growth projections for its da Vinci surgical system from as much as 12% to as little as 2%, citing power morcellator safety concerns as one of the factors in its lowered guidance. The company issued a recall of 1,300 of its da Vinci arms in November.
I also wrote about this. Read this blog
If you want to know what happened to other women read this
Other companies are taking a different approach, and creating minimally invasive products that provide an alternative to traditional power morcellator devices. In May, Boston Scientific shelled out $65 million for a larger stake in IoGyn, a California startup that develops products for minimally-invasive gynecological surgery. Earlier this month, California-based Gynesonics raised an additional $6 million to support development for its next-generation ultrasound treatment for uterine fibroids.
So Boston Scientific is also in the business? Stay tuned for more devastating results of the torture and deaths of unsuspecting women. I have NO DOUBT this will happen in the future.